|TABLE OF CONTENTS|
NIH intends to uphold high ethical, health, and safety standards in both the conduct of the research it funds and the expenditure of public funds by its recipients. The public policy requirements specified in this section set many of those standards. NIH will not accept forms or other documentation bearing generic departmental signatures or their electronic equivalent (e.g., Department of Sponsored Research). All forms and documentation submitted to the NIH must reflect the name of the individual, electronic or otherwise, with the appropriate institutional authority to submit such information. The signature of the AOR on the application certifies that the organization complies, or intends to comply, with all applicable policies, certifications and assurances referenced (and, in some cases, included) in the application instructions. The policies, certifications and assurances listed in this section may or may not be applicable to the project, program, or type of applicant organization. Requirements/objectives are listed in alphabetical order.
As noted in this section, some requirements may necessitate the submission of a separate document (e.g., human subjects assurance, certification of IRB approval or institutional exemption, civil rights assurance). Applicants and recipients should take particular note of these requirements (for example, see specific sections on Human Subjects Protections and Civil Rights Protections), the absence or inadequacy of which may delay an award or render an applicant ineligible for award.
The recipient is responsible for: 1) establishing and maintaining the necessary processes to monitor its compliance and that of its employees, consortium participants, and contractors with these requirements; 2) taking appropriate action to meet the stated objectives; and, 3) informing NIH of any problems or concerns.
If a grant is awarded on the basis of false or misrepresented information, or if a recipient does not comply with these public policy requirements, NIH may take any necessary and appropriate action, including using any of the remedies described in Administrative Requirements-Enforcement Actions or other available legal remedies.
Exhibit 4 contains information to help the recipient determine what public policy requirements, objectives and appropriations mandates apply to its activities and whether a requirement should be included in a consortium agreement or a contract for routine goods or services under the grant (see Glossary in Part I for definitions). The exhibit distinguishes between these types of transactions under a grant and indicates (by "Y" for Yes or "NA" for Not Applicable) whether a given requirement normally would apply. However, even if the exhibit indicates that a requirement is not applicable that requirement potentially could be applicable in a specific situation, e.g., if a contract under a grant involves research activity. Therefore, this exhibit should be used as general guidance only. The recipient should consult the terms and conditions of its award and should contact the GMO if it has any question concerning the applicability of a particular public policy requirement or objective.
Exhibit 4 also indicates where, in the NIHGPS, the individual public policy requirements, objectives and appropriation mandates are covered in more detail. The recipient should also consult its attorney, as appropriate, regarding particular questions about the governing statute or regulation as applied to its specific circumstances. Other cited policies or documents may provide additional information.
In addition to the requirements addressed in this section, there are applicable NIH administrative requirements outlined in the Administrative Requirements chapter.
Some programs may have special requirements and are covered in IIB.
|Requirement, Objective, or Appropriation Mandate||Recipient||Subaward/Consortium Participant||Contractor under Grant (routine goods/services)|
|Military Recruiting and ROTC Program Access to Institutions of Higher Education 4.1.19||Y||N||N|
|Seat Belt Use 4.1.28||Y||NA||NA|
|Labor Standards under Federally Assisted Construction 10.5.3||
(Construction Grants and major A&R Contracts Exceeding $100,000)
|Smoke-Free Workplace 4.1.29||Y||NA||NA|
|Drug-Free Workplace 4.1.7||Y||NA||NA|
|Flood Disaster Protection Act of 1973 â€“ Flood Insurance 10.10.1||
(Construction grants only)
|National Environmental Policy Act of 1969 (including Public Disclosure) 4.1.20 and 10.10.1||Y||NA||NA|
|Intergovernmental Review of Federal Programs under EO 12372 10.10.1||
(Construction grants only)
|Uniform Relocation Assistance and Real Property Acquisition Policies Act of 1970 10.10.1||Y||NA||NA|
|Standards of Conduct 4.1.30||Y||NA||NA|
|Federal Funding Accountability and Transparency Act (FFATA) 4.1.8 and 22.214.171.124.5||Y||
If under $25,000
If under $15,000
|President's Emergency Plan for AIDS Relief (PEPFAR Program 4.1.22||Y||Y||Y|
|Nondelinquency on Federal Debt 4.1.21||Y||Y||NA|
|National Historic Preservation Act of 1966 â€“ Archaeological and Historic Preservation Act of 1974 10.10.1||
(Construction Grants; any award involving major or minor A&R, or any work resulting in physical changes to real property)
|Lead-Based Paint Poisoning Prevention Act 10.10.1||
(Construction grants only)
|Investigational New Drug Applications/Investigational Device Exceptions 4.1.16||Y||Y||Y|
|Inclusion of Women/Minorities as Subjects in Clinical Research 126.96.36.199||Y||Y||NA|
|Metric System 4.1.18 and 10.10||Y||Y||Y|
|Lobbying (Appropriation Mandate) 4.2.6||Y||Y||Y|
|Limited English Proficiency 188.8.131.52||Y||Y||NA|
|Pro-Children Act of 1994 4.1.23||Y||Y||Y|
|Safe Drinking Water Act 10.10.1||
(Construction grants only)
|Salary Limitation/Cap (Appropriation Mandate) 4.2.10||Y||Y||NA|
|Restriction on Distribution of Sterile Needles (Appropriation Mandate) 4.2.9||Y||Y||Y|
|Select Agents (see Public Health Security & Bioterrorism Preparedness and Response Act) 184.108.40.206.1||Y||Y||Y|
|USA Patriot Act 4.1.33||Y||Y||Y|
|U.S. Flag Air Carriers 7.9.1||Y||Y||Y|
|Text Messaging While Driving 4.1.31||Y||Y||Y|
|Restriction on Abortions & Exceptions (Appropriation Mandates) 4.2.8 & 220.127.116.11||Y||Y||Y|
|Wild and Scenic Rivers Act of 1968 10.10.1||
(Construction grants only)
|Protection of Wetlands (EO 11990) 10.10.1||
(Construction grants only)
|Promotion or Legalization of Controlled Substances (Appropriation Mandate) 4.2.7||Y||Y||Y|
|Public Health Security and Bioterrorism Preparedness and Response Act (Select Agents) 18.104.22.168.1||Y||Y||Y|
|Research Misconduct 4.1.27||Y||Y||NA|
|Research Involving Recombinant or Synthetic Nucleic Acid Molecules (including Human Gene Transfer Research) 4.1.26||Y||Y||Y|
|Reporting and Assurance Requirements for Institutions Receiving Awards for Training of Graduate Students for Doctoral Degrees 4.1.25||Y||Y||NA|
|Inclusion of Children as Subjects in Clinical Research 22.214.171.124||Y||Y||NA|
|Copeland Act, when required by statute 10.10.1||
(Construction grants only)
|Controlled Substances 4.1.5||Y||Y||Y|
|Conservation of Petroleum and Natural Gas (EO 12185) 10.10.1||
(Construction grants only)
|Data and Safety Monitoring 126.96.36.199||Y||Y||Y|
|Dual Use Research of Concern 188.8.131.52||Y||Y||Y|
|Dissemination of False or Deliberately Misleading Information (Appropriation Mandate) 4.2.3||Y||Y||Y|
|Davis-Bacon Act, when required by statute 10.10.1||
(Construction grants only)
|Confidentiality of Alcohol and Drug Abuse Patient/Client Records 184.108.40.206||Y||Y||Y|
|Architectural Barriers Act of 1968 10.10||
(Construction grants and any grant involving major A&R)
|Animal Welfare 4.1.1||Y||Y||Y|
Acknowledgment of Federal Funding (Appropriation Mandate) 4.2.1
|Certificates of Confidentiality 220.127.116.11||Y||Y||Y|
|Coastal Zone Management Act of 1972 10.10||
(Construction grants only)
|Clinical Trials.gov 4.1.3||Y||Y||NA|
|Clean Air and Clean Water Act 10.10.1||
(Construction grants only); for contracts exceeding $100,000
|Earthquake Hazards Reduction Act of 1977 and Seismic Safety of Federal and Federally Assisted or Regulated New Building Construction (EO 12699) 10.10||
(Construction grants only)
|Human Subjects Protections 4.1.15||Y||Y||Y|
|Gun Control 4.2.4||Y||Y||Y|
|Fly America Act 4.1.11||Y||Y||Y|
|Hotel and Motel Fire Safety Act of 1990 14.6.1||
(Conference Grants Only)
|Human Fetal Tissue Research (Including Transplantation Research) 4.1.14||Y||Y||Y|
|Human Stem Cell Research 4.1.13||Y||Y||Y|
|Human Embryo Research and Cloning Ban (Appropriation Mandate) 4.2.5||Y||Y||Y|
|Health and Safety Regulations and Guidelines 4.1.12||Y||Y||Y|
|Endangered Species Act of 1973 10.10.1||
(Construction grants only)
|Equal Employment Opportunity 10.5||
(Construction grants and any grant involving major A&R)
If under $10,000
|Financial Conflict of Interest 4.1.10||
(NA to Phase I of the SBIR/STTR programs and to Federal institutions)
|Federal Information System Security Management Act 4.1.9||Y||Y||Y|
|Age Discrimination Act of 1975 18.104.22.168||
(NA to foreign and international organizations)
(NA to foreign and international organizations)
(NA to foreign and international organizations)
|Civil Rights Act of 1964 (Title VI) 22.214.171.124||
(NA to foreign and international organizations)
(NA to foreign and international organizations)
(NA to foreign and international organizations)
|Health Insurance Portability and Accountability Act (HIPAA) 126.96.36.199||
(if a covered entity)
(if a covered entity)
(if a covered entity)
|Debarment and Suspension 4.1.6||
(NA to certain foreign organizations)
(NA to certain foreign organizations)
If contract equals or exceeds $25,000 (NA to certain foreign organizations)
|Education Amendments of 1972 (Title IX) 188.8.131.52||
(NA to foreign and international organizations)
(NA to foreign and international organizations)
(NA to foreign and international organizations)
|Rehabilitation Act of 1973 (section 504) 184.108.40.206 and 10.10.1||
(NA to foreign and international organizations)
(NA to foreign and international organizations)
(NA to foreign and international organizations)
|Lobbying (Federalwide Certification) 4.1.17||
Certification required if total costs expected to exceed $100,000
Certification required if greater than $100,000 only
Certification required on contracts greater than $100,000 only
|Trafficking in Persons 4.1.32||
* NA: A designation of NA in this table indicates that a particular requirement does not apply to an otherwise eligible recipient, consortium participant, or contractor or may not apply because the type of activity covered is one not normally performed by such an entity.
Please note that the core set of National Policy Requirements for participating Federal research agencies is maintained by the National Science Foundation and is posted at: http://www.nsf.gov/bfa/dias/policy/rtc/index.jsp.
The PHS Policy on Humane Care and Use of Laboratory Animals (PHS Policy) requires that an approved Animal Welfare Assurance be on file with the Office of Laboratory Animal Welfare (OLAW) at the time of award for all recipient organizations receiving PHS support for research or related activities using live vertebrate animals. Recipient organizations must establish appropriate policies and procedures to ensure the humane care and use of animals, and bear ultimate responsibility for compliance with the PHS Policy in all PHS supported activities.
The PHS Policy incorporates the U.S. Government Principles for the Utilization and Care of Vertebrate Animals used in Testing, Research, and Training, and requires the recipient to maintain an animal care and use program based on the Guide for the Care and Use of Laboratory Animals. An Institutional Animal Care and Use Committee (IACUC) appointed by the Chief Executive Officer or designee, is federally mandated to oversee the institution's animal program, facilities, and procedures (Public Law 99-158, Sec. 495).
The PHS Policy defines "animal" as any live, vertebrate animal used or intended for use in research, research training, experimentation, biological testing or related purposes.
Applications from organizations proposing the use of animals are incomplete if they do not thoroughly address the use of vertebrate animals required in the Research Plan of the application. If the involvement of animals is indefinite at the time of application, the applicant should provide an explanation and indicate when it is anticipated that animals will be used. If an award is made, prior to conducting any animal activities the recipient must submit to the NIH awarding IC for prior approval the detailed information about the use of animals as required in the Research Plan of the application, and meet the Assurance and IACUC approval requirements of the PHS Policy.
Noncompeting and competing awards are prohibited from using NIH funds to procure cats from USDA Class B dealers. The procurement of cats may only be from USDA Class A dealers or other approved legal sources.
NIH funds may not be used to procure or support the use of dogs from Class B dealers. Dogs used in NIH-supported research may only be from USDA Class A dealers or other approved legal sources. Any costs incurred in violation of this policy are unallowable and will be subject to a cost disallowance.
No costs for activities with live vertebrate animals may be charged to NIH if there is not a valid Animal Welfare Assurance and IACUC approval of the activity.
The PHS Policy does not supersede applicable State or local laws or regulations that impose more stringent standards for the care and use of animals in research. All recipient organizations are required to comply, as applicable, with the regulations (9 CFR, Subchapter A) issued by the U.S. Department of Agriculture under the Animal Welfare Act, as amended, 7 U.S.C. 2131 et seq., and other Federal statutes and regulations relating to animals.
An Animal Welfare Assurance is the document submitted by an institution assuring institutional compliance with the PHS Policy. OLAW is responsible for requesting, negotiating, approving or disapproving, and, as necessary, restricting or withdrawing approval of Assurances.
When an applicant institution does not have an Animal Welfare Assurance, the Authorized Organization Representative's signature on the application constitutes declaration that the institution will submit an Assurance when requested by OLAW. Upon such request, the institution shall prepare the Assurance as instructed by OLAW and in accordance with the PHS Policy, and the authorized IACUC shall review those components of the application related to the care and use of animals. Except in certain circumstances, the Assurance must be submitted to and approved by OLAW in order for the IC to award the grant. No costs for activities with live vertebrate animals may be charged to NIH grants in the absence of a valid Assurance on file with OLAW.
If the prime recipient does not have an Assurance and the animal activities will be conducted at an Assured institution named as a performance site, the recipient must obtain an Inter-institutional Assurance from OLAW. Under the Inter-institutional Assurance, the recipient and performance site agree that the research will be conducted under the auspices and program of animal care and use of the performance site's Assurance.
NIH will delay an award for research involving live vertebrate animals until the recipient organization and all performance sites are operating in accordance with approved Animal Welfare Assurances and the recipient has provided verification of IACUC approval of those sections of the application that involve use of vertebrate animals. IACUC approval must have been granted within three years of the budget period start date to be valid; however, IACUCs may determine that continuing review on a more frequent basis is appropriate.
Verification of IACUC approval may be filed at any time before award in accord with Just-in-Time procedures, unless required earlier by the IC. Therefore, following peer review and notification of impact score/percentile, applicant organizations with approved Assurances may wish to proceed with IACUC review for those applications that have not yet received IACUC approval and that appear to be in a fundable range.
It is an institutional responsibility to ensure that the research described in the application is congruent with any corresponding protocols approved by the IACUC.
No costs for activities with live vertebrate animals may be charged to NIH grants if there is not a valid IACUC approval.
Under consortium (subaward) agreements in which the recipient collaborates with one or more other organizations, the recipient, as the direct and primary recipient of NIH grant funds, is accountable for the performance of the project, the appropriate expenditure of grant funds by all parties, and all other obligations of the recipient as specified in the NIHGPS (see Consortium Agreements chapter in IIB). The animal welfare requirements that apply to recipients also apply to consortium participants and subprojects.
The primary recipient is responsible for including these requirements in its agreements with collaborating organizations, and for ensuring that all sites engaged in research involving the use of live vertebrate animals have an approved Animal Welfare Assurance and that the activity has valid IACUC approval. The approval of more than one IACUC is not required if the recipient and performance site(s) have Assurances; the institutions may exercise discretion in determining which IACUC reviews research protocols and under which institutional program the research will be conducted.
The recipient is further responsible for complying with NIH prior approval requirements related to the addition of sites not included in the approved application (see Administrative Requirements-Changes in Project and Budget-Prior Approval Requirements).
The list of organizations with approved assurances is available at the OLAW Web site (domestic institutions: http://grants.nih.gov/grants/olaw/assurance/300index.htm, and foreign organizations: http://grants.nih.gov/grants/olaw/assurance/500index.htm).
Foreign recipients must provide OLAW with an Animal Welfare Assurance for Foreign Institutions. This constitutes institutional assurance and certification of compliance with the applicable laws, regulations, and policies of the jurisdiction in which the research will be conducted, and a commitment to follow the International Guiding Principles for Biomedical Research Involving Animals. IACUC approval is not required of foreign recipients; however, OLAW encourages foreign recipients to use the standards in the Guide for the Care and Use of Laboratory Animals.
When the recipient is a domestic institution and performance sites are foreign (i.e., domestic grant with a foreign component), PHS Policy requirements are applicable. Accordingly, the recipient remains responsible for animal activities conducted at the foreign site and must provide verification of IACUC approval (i.e., certification that the activities as conducted at the foreign performance site are acceptable to the recipient). The recipient IACUC may accept, as its own, the approval of a foreign organization's IACUC; however, the recipient IACUC remains responsible for the review. Additionally, the foreign site must obtain an Animal Welfare Assurance for Foreign Institutions as described in the preceding paragraph.
Reporting requirements under the PHS Policy include an annual report to OLAW describing any change in the institution's program for animal care and use as described in the Assurance, changes in IACUC membership, and the dates the IACUC conducted its semiannual evaluations of the institution's program and facilities. The IACUC, through the institutional official signing the Assurance, must promptly report any serious or continuing noncompliance with the PHS Policy, serious deviations from the Guide for the Care and Use of Laboratory Animals, and any IACUC suspensions.
Charges to NIH grant awards for the conduct of live vertebrate animal activities during periods of time that the terms and conditions of the grant award are not upheld are not allowable. Specific situations under which charges are not allowable are:
Instances of serious noncompliance with section IV.F.3. of the PHS Policy, such as those mentioned above, are to be reported to OLAW and the IC supporting the grant award. In cases where charges have been made for unauthorized animal activities, appropriate adjustments must be made to the grant to remove those charges. NIH requires that reports contain a certification that no unallowable costs were charged to NIH grant funds during a period of noncompliance. If such a certification cannot be made, a detailed accounting of unallowable charges made to each affected grant should be included with the report. If a detailed accounting has not been completed at the time of reporting, a date when it will be provided should be included.
NIH expects recipients to continue to maintain and care for animals during periods when animal activities are conducted in the absence of a valid Animal Welfare Assurance and/or IACUC approval. ICs may allow expenditure of NIH grant funds for maintenance and care of animals on a case-by-case basis. Consultation with the IC is encouraged regarding questions concerning allowable costs.
Information about the PHS Policy, Animal Welfare Assurances, and other relevant topics is available from OLAW (see http://grants.nih.gov/grants/olaw/olaw.htm).
Before NIH may make an award to a domestic organization, the AOR must certify, by means of the signature on the application, that the organization has on file with the HHS OCR a one-time Assurance of Compliance with the statutes described in this subsection. The Assurance, Form HHS 690, is filed for the organization and is not required for each application. If the application has been recommended for funding and the applicant organization does not have an Assurance of Compliance on file, it will receive the required form and instructions for completion and submission from the awarding IC. The HHS 690 also is available from GrantsInfo@nih.gov or by telephone at 301-435-0714.
Domestic organizations that receive funding from recipients (including consortium participants and contractors under grants) rather than directly from NIH, also are required to file an HHS 690. The applicant/recipient is responsible for determining whether those organizations have the required Assurance on file and, if not, ensuring that it is filed with OCR.
Title VI of the Civil Rights Act of 1964 provides that no person in the United States shall, on the grounds of race, color, or national origin, be excluded from participation in, be denied the benefits of, or be subjected to discrimination under any program or activity receiving Federal financial assistance. The HHS implementing regulations are codified at 45 CFR 80.
Title IX of the Education Amendments of 1972 provides that no person in the United States shall, on the basis of sex, be excluded from participation in, be denied the benefits of, or be subjected to discrimination under any educational program or activity receiving Federal financial assistance. The HHS implementing regulations are codified at 45 CFR 86.
Section 504 of the Rehabilitation Act of 1973, as amended, provides that no otherwise qualified handicapped individual in the United States shall, solely by reason of the physical or mental impairment, be excluded from participation in, be denied the benefits of, or be subjected to discrimination under any program or activity receiving Federal financial assistance. These requirements pertain to the provision of benefits or services as well as to employment. The HHS implementing regulations are codified at 45 CFR Parts 84 and 85.
The Age Discrimination Act of 1975 prohibits discrimination on the basis of age in any program or activity receiving Federal financial assistance. The HHS implementing regulations are codified at 45 CFR 91.
EO 13166, August 11, 2000, requires recipients receiving Federal financial assistance to take steps to ensure that people with limited English proficiency can meaningfully access health and social services. A program of language assistance should provide for effective communication between the service provider and the person with limited English proficiency to facilitate participation in, and meaningful access to, services. The obligations of recipients are explained on the OCR Web site at http://www.hhs.gov/ocr/civilrights/resources/specialtopics/lep/.
Effective for grant applications submitted on or after January 18, 2017, that request support for the conduct of a clinical trial that is initiated on or after the policy's effective date, the NIH Policy on Dissemination of NIH-funded Clinical Trial Information establishes the expectation that all NIH-funded recipients and investigators conducting clinical trials, funded in whole or in part by the NIH, will ensure that their clinical trials are registered at, and that summary results information is submitted to, ClinicalTrials.gov for public posting. The purpose of the policy is to promote broad and responsible dissemination of information from NIH-funded clinical trials through ClinicalTrials.gov. Disseminating this information supports the NIH mission to advance the translation of research results into knowledge, products, and procedures that improve human health.
This policy is complementary to requirements in the Clinical Trial Registration and Results Information Submission regulation at 42 CFR Part 11, hereinafter referred to as the regulation.
This policy applies to all NIH-funded clinical trials regardless of study phase, type of intervention, or whether they are subject to the regulation. For example, NIH-funded phase 1 clinical trials of an FDA-regulated product are covered by this policy as are clinical trials studying interventions not regulated by the FDA, such as behavioral interventions. As such, the policy encompasses all NIH-funded clinical trials, including applicable clinical trials subject to the regulation. All NIH-funded clinical trials will be expected to register and submit results information to ClinicalTrials.gov according to the timelines described in the regulation.
This policy does not apply to a clinical trial that uses NIH-supported infrastructure but does not receive NIH funds to support its conduct.
Applicants seeking NIH funding for clinical trials will be required to submit a plan that will address how the expectations of this policy will be met. Recipients and investigators conducting clinical trials funded in whole or in part by the NIH are required to comply with all terms and conditions of award, including following their plan for the dissemination of NIH-funded clinical trial information.
The signature of the AOR on the grant or progress report form certifies that, for any clinical trials funded under the NIH award, the recipient and all investigators are in compliance with the recipient's clinical trial information dissemination plan.
Responsibilities of recipients and investigators will fall within one of the following three categories:
In addition, informed consent documents for clinical trials within all three categories are to include a specific statement relating to posting of clinical trial information at ClinicalTrials.gov.
Each NIH-funded clinical trial should have only one entry in ClinicalTrials.gov that contains its registration and results information. Recipients need not and should not create a separate record of the applicable clinical trial to comply with this policy.
Applicants and recipients should familiarize themselves with the requirements of 42 U.S.C. 282(j), also known as Sec. 801 of Public Law 110-85 (the FDA Amendments Act of 2007 or FDAAA), as implemented in regulation by 42 CFR Part 11, with respect to registration and results reporting requirements that apply to certain clinical trials. Of particular note is that, in general, results of applicable clinical trials are due not later than 12 months after the primary completion date. If this date occurs after the period of performance has ended, results reporting is still required in accordance with FDAAA and the terms and conditions of grant award.
The signature of the AOR on the grant or progress report form certifies that, for applicable clinical trials funded in whole or part by the award, the responsible party has made all registration and results submissions required by 42 CFR Part 11.
Section 301(d) of the PHS Act, as amended by Section 2012 of the 21st Century Cures Act, P.L. 114-255, states that the Secretary shall issue Certificates of Confidentiality (Certificates) to NIH funded investigators or institutions engaged in biomedical, behavioral, clinical, or other research activities in which identifiable, sensitive information is collected.
All recipients who conduct biomedical, behavioral, clinical, or other research that collects or uses identifiable, sensitive information, are covered by a new NIH Policy (NOT-OD-17-109), and are deemed to be issued a Certificate. Recipients are therefore required to protect the privacy of individuals who are subjects of such research in accordance with subsection 301(d) of the Public Health Service Act. Institutions and their investigators are responsible for determining whether research they conduct is subject to the new Policy. Certificates issued in this manner will not be issued as a separate document.
NIH considers research in which identifiable, sensitive information is collected or used, to include:
To determine if the Policy applies to research conducted or supported by NIH, investigators will need to ask, and answer the following question:
If the answer to this question is no, then the activity is not issued a Certificate. If the answer is yes, then investigators will need to answer the following questions:
If the answer to any one of these questions is yes, then the Policy will apply to the research and therefore, in accordance with subsection 301(d) of the Public Health Service Act, the recipient of the Certificate shall not:
Disclosure is permitted only when:
As set forth in 45 CFR Part 75.303(a) and NIHGPS Chapter 8.3, recipients conducting NIH supported research applicable to the Policy are required to establish and maintain effective internal controls (e.g., policies and procedures) that provide reasonable assurance that the award is managed in compliance with Federal statutes, regulations, and the terms and conditions of award.
Recipients of Certificates are required to ensure that any investigator or institution not funded by NIH who receives a copy of identifiable, sensitive information protected by a Certificate issued by the Policy, understand they are also subject to the requirements of subsection 301(d) of the Public Health Service Act. In accordance with NIHGPS Chapter 15.2.1, recipients are also responsible for ensuring that any subrecipient that receives funds to carry out part of the NIH award involving a copy of identifiable, sensitive information protected by a Certificate issued by the Policy understand they are also subject to subsection 301(d) of the Public Health Service Act.
For studies in which informed consent is sought, NIH expects investigators to inform research participants of the protections and the limits to protections provided by a Certificate issued by the Policy.
Information on CoCs is available on the NIH Web site at http://grants.nih.gov/grants/policy/coc/index.htm.
Section 543 of the PHS Act, as implemented in 42 CFR 2, requires that records of substance abuse patients be kept confidential except under specific circumstances and purposes. These protections differ from those available to patients under HIPAA and are intended to ensure that a patient in a drug or alcohol abuse program is not made more vulnerable than a similar patient who does not seek treatment. The covered records are any information, written or not, of a patient who has applied for or been given diagnosis or treatment for alcohol or drug abuse at a federally assisted program and includes any individual who, after arrest on a criminal charge, is identified as an alcohol or drug abuser in order to determine that individual's eligibility to participate in a program. This includes records of the identity, diagnosis, or treatment of any patient which are maintained in connection with the performance of any program or activity relating to substance abuse education, training, treatment, rehabilitation, or research, which is conducted under an NIH grant. Except as authorized under a court order, no patient record may be used to initiate or substantiate any criminal charges against a patient or to conduct any investigation of a patient. The regulations also describe procedures to allow for nonvoluntary disclosure of certain information by persons engaged in research on mental health, including research on the use and effect of alcohol and other psychoactive drugs.
HHS issued the final version of the "Standards for Privacy of Individually Identifiable Health Information"-the Privacy Rule-on August 14, 2002. The Privacy Rule is a Federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information. It is administered and enforced by OCR, HHS. Those entities required to comply with the Privacy Rule (classified under the rule as "covered entities") had until April 14, 2003 to do so (with the exception of small health plans which have an extra year to comply).
Decisions about applicability and implementation of the Privacy Rule reside with the researcher and the recipient organization. The OCR Web site (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including the complete text of the regulation and a set of decision tools for determining whether a particular entity is subject to the rule. An educational booklet, Protecting Heath Information in Research: Understanding the HIPAA Privacy Rule, is available through OCR's Web site and also at http://privacyruleandresearch.nih.gov/. That Web site also includes other educational materials including information specific to grants.
If controlled substances are proposed to be administered as part of a research protocol or if research is to be conducted on the drugs themselves, applicants/recipient must ensure that the DEA requirements, including registration, inspection, and certification, as applicable, are met. Regional DEA offices can supply forms and information concerning the type of registration required for a particular substance for research use. The main registration office in Washington, DC may be reached at 800-882-9539. Information also is available from the National Institute on Drug Abuse at 301-443-6300.
HHS regulations published in 2 CFR 376 implement the government-wide debarment and suspension system guidance (2 CFR 180) for HHS' non-procurement programs and activities. "Non-procurement transactions" include, among other things, grants, cooperative agreements, scholarships, fellowships, and loans. NIH implements the HHS Debarment and Suspension regulations as a term and condition of award. Accordingly, recipients of NIH grants ("primary covered transactions"), including sponsoring institutions for Kirschstein-NRSA individual fellowships, are required to determine whether it or any of its principals (as defined in 2 CFR 180.995 and 2 CFR 376.995) is excluded or disqualified from participating in a covered transaction (i.e., grant or cooperative agreement) prior to entering into the covered transaction, i.e., prior to the drawdown of funds which signals acceptance of the grant award. Recipients may decide the method and frequency by which this determination is made and may check excluded parties in SAM, although checking SAM is not required.
Prior to the drawdown of funds for each grant award, recipients must report to the funding IC if the recipient or any of its principals:
Disclosure of unfavorable information by recipients under this requirement will not necessarily cause NIH to deny participation in the grant. NIH will consider the information when determining whether to enter into the covered transaction. NIH will also consider any additional information or explanation that recipients elect to submit with the disclosed information. However, if it is later determined that a recipient failed to disclose information that it knew at the time it accepted the NIH grant award, NIH may (a) terminate the transaction for material failure to comply with the terms and conditions of the award or (b) pursue any other available remedies, including suspension and debarment.
Recipients must immediately report to the NIH funding IC if at any time during the project period, including periods of no-cost extension, they discover that they (a) failed to disclose information prior to the drawdown of funds or (b) due to changed circumstances the recipient or any of its principals for the grant now meet the reporting criteria.
"Lower tier" transactions (e.g., consortiums, subcontracts, consultants, collaborators, and contractors that require the provision of goods or services that will equal or exceed $25,000) also are subject to the HHS regulations. Prior to entering into a lower tier covered transaction with a participant (as defined in 2 CFR 180.980), recipients must verify that the person (as defined in 2 CFR 180.985) is not excluded or disqualified. Recipients may not enter into any transaction with a person who is disqualified from that transaction unless an exception under the disqualifying statue, Executive Order, or regulation has been obtained from HHS.
Recipients must require participants at the next lower tier to (a) comply with the HHS Debarment and Suspension regulations as a condition of participation in the transaction and (b) pass the requirement to comply with the HHS Debarment and Suspension regulations to each person involved in the covered transaction at the next lower tier. Likewise, before entering into such a transaction lower tier participants and contractors under grants (where the contract requires the provision of goods or services that will equal or exceed $25,000) must report to the recipient if it or any participants are presently excluded or disqualified.
Recipients also are required to assure compliance for each trainee under a Kirschstein-NRSA institutional research training grant, or other similar NIH-supported institutional training grant, before their appointment.
Organizations or individuals that are suspended, debarred, or voluntarily excluded from eligibility cannot receive NIH grants, be paid from NIH grant funds, whether under a primary or lower-tier transaction (including trainees on NIH-supported training grants), or otherwise participate during the period of suspension, debarment, or exclusion. Because individuals who have been debarred, suspended, declared ineligible, or voluntarily excluded from covered transactions may not receive Federal funds for a specified period of time, charges made to the NIH grants for such individuals (e.g., salary) are unallowable.
The Drug-Free Workplace Act of 1988 (41 U.S.C. Â§ 701 et seq.) requires that all organizations receiving grants from any Federal agency agree to maintain a drug-free workplace. By signing the application, the AOR agrees that the recipient will provide a drug-free workplace and will comply with the requirement to notify NIH if an employee is convicted of violating a criminal drug statute. Failure to comply with these requirements may be cause for debarment. Government wide requirements for Drug-Free Workplace for Financial Assistance are found in 2 CFR 182; HHS implementing regulations are set forth in 2 CFR 382.400. All recipients of NIH grant funds must comply with the requirements in Subpart B (or Subpart C if the recipient is an individual) of Part 382. Foreign applicants and recipients may be exempted from the drug-free workplace requirements of 2 CFR 182 based on a documented finding by the NIH awarding IC that application of those requirements is inconsistent with U.S. international obligations or the laws and regulations of a foreign government.
Public Law 109-282, the Federal Funding Accountability and Transparency Act of 2006 as amended (FFATA), requires full disclosure of all entities and organizations receiving Federal funds including grants, contracts, loans and other assistance and payments through a single publicly accessible Web site, USASpending.gov. The Web site includes information on each Federal financial assistance award and contract over $25,000, including such information as:
Compliance with this law is primarily the responsibility of the Federal agency. However, two elements of the law require information to be collected and reported by recipients: 1) information on executive compensation when not already reported through the Central Contractor Registry; and 2) similar information on all subawards/subcontracts/consortiums over $25,000. Information on the recipient reporting requirement for this law can be found in Monitoring-Reporting-Financial Reports-Recipient Reporting of Subrecipient Data for FFATA.
This requirement is being implemented in accordance with OMB Interim Final Guidance, Federal Register Volume 75, Number 177, September 14, 2010. Full text of the award term is available at 2 CFR 170.
All information systems, electronic or hard copy which contain Federal data need to be protected from unauthorized access. This also applies to information associated with NIH grants and contracts. Congress and the OMB have instituted laws, policies and directives that govern the creation and implementation of federal information security practices that pertain specifically to grants and contracts. The current regulations are pursuant to the Federal Information Security Management Act (FISMA), 44 U.S.C. 3541 et seq. The applicability of FISMA to NIH recipients applies only when recipients collect, store, process, transmit or use information on behalf of HHS or any of its component organizations. In all other cases, FISMA is not applicable to recipients of grants, including cooperative agreements. The recipient retains the original data and intellectual property, and is responsible for the security of this data, subject to all applicable laws protecting security, privacy, and research. If and when information collected by a recipient is provided to HHS, responsibility for the protection of the HHS copy of the information is transferred to HHS and it becomes the agency's responsibility to protect that information and any derivative copies as required by FISMA.
NIH requires recipients and investigators (except Phase I SBIR/STTR applicants and recipients) to comply with the requirements of 42 CFR 50, Subpart F, "Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought." A Final Rule amending the 1995 PHS regulation (and the companion regulation at 45 CFR 94, "Responsible Prospective Contractors," imposing similar requirements for research contracts) was published on August 25, 2011 in the Federal Register (http://www.gpo.gov/fdsys/pkg/FR-2011-08-25/pdf/2011-21633.pdf).
The requirements under the 2011 revised regulation promote objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, or reporting of research funded under PHS grants or cooperative agreements will be free from bias by any conflicting financial interest of an Investigator, defined as the PD/PI and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by PHS, or proposed for such funding, which may include, for example, collaborators or consultants. These requirements do not apply to Federal employees or Federal agencies. Federal agencies have their own set of rules governing financial conflicts of interest for employees. When submitting a grant application, the signature of the AOR certifies the applicant Institution's compliance with the requirements of 42 CFR 50, Subpart F, including that:
When the Institution determines that an FCOI exists (see #3 above), the Institution must report to the NIH awarding IC through the submission of an initial and annual FCOI report using the eRA Commons FCOI Module. The initial FCOI report will include the following information:
The annual FCOI report must be submitted to the NIH through the eRA Commons FCOI Module each year within a competitive segment or until the Institution reports that the FCOI no longer exists. The annual FCOI report will include the following information:
The Institution will incorporate, as part of a written agreement with a subrecipient, terms that establish whether the FCOI policy of the awardee Institution or that of the subrecipient will apply to subrecipient Investigators and include time periods to meet disclosure and/or FCOI reporting requirements. Subrecipient Institutions who rely on their FCOI policy must report identified Financial Conflicts of Interest to the awardee Institution in sufficient time to allow the awardee Institution to report the FCOI to the NIH to meet its reporting obligations. (See Consortium Agreements, 15.2.1 Written Agreement.)
The Institution will make certain information available concerning identified FCOI held by senior/key personnel as defined in the regulation via a publicly accessible Web site or by a written response to any requestor within five business days of a request, and update such information as specified in the regulation.
The Institution will require each Investigator (including subrecipient Investigators, if applicable) to complete training prior to engaging in NIH-supported research and at least every four years, and immediately under the designated circumstances:
As described in the regulation, examples of how FCOIs might be addressed include but are not limited to, the following:
The information above is only a sample of the regulatory requirements found in 42 CFR 50, Subpart F. Applicants and recipients must review the regulation in its entirety to ensure compliance with all of the requirements. Resources applicable to FCOI, including Frequently Asked Questions, etc. can be found on OER's Conflict of Interest Web site at http://grants.nih.gov/grants/policy/coi/index.htm.
The Fly America Act (49 U.S.C. 40118) generally provides that foreign air travel funded by Federal government money may only be conducted on U.S. flag air carriers. A "U.S. flag air carrier" is an air carrier that holds a certificate under 49 U.S.C. 41102 but does not include a foreign air carrier operating under a permit. There are limited circumstances under which use of a foreign-flag air carrier is permissible. These circumstances are outlined below:
The U.S.-EU Open Skies Agreement was amended effective June 24, 2010. GSA issued Guidance October 6, 2010. Pursuant to the amendment, federal contractors and recipients (not U.S. Government employees) need not be concerned about city-pair contract fares. However, contractors and recipients must check with the airline to ensure that the airline is covered by the U.S.-EU Open Skies agreement which may change periodically.
Additionally, pursuant to the amendment, EU airlines are no longer limited to flying passengers between points in the United States and points in the EU. Instead, EU airlines are authorized to transport passengers between points in the United States and points outside the EU if the EU airline is authorized to serve the route under the U.S.-EU Open Skies Agreement. This includes flights that originate, arrive, or stop in the European Union. For additional information, please see the text of the Amendment and GSA Bulletin FTR 11-02. For information on other "open skies" agreements in which the United States has entered, refer to GSA's Web site: http://www.gsa.gov/portal/content/103191.
Recipients are responsible for meeting applicable Federal, State, and local health and safety standards and for establishing and implementing necessary measures to minimize their employees' risk of injury or illness in activities related to NIH grants. In addition to applicable Federal, State, and local laws and regulations, the following regulations must be followed when developing and implementing health and safety operating procedures and practices for both personnel and facilities:
The following guidelines are recommended for use in developing and implementing health and safety operating procedures and practices for both personnel and facilities:
Recipient organizations are not required to submit documented assurance of their compliance with or implementation of these regulations and guidelines. However, if requested by the awarding IC, recipients should be able to provide evidence that applicable Federal, State, and local health and safety standards have been considered and have been put into practice.
Under Executive Order 13505 NIH may support and conduct responsible, scientifically worthy human stem cell research, including human embryonic stem cell (hESC) research, to the extent permitted by law. NIH Guidelines on Human Stem Cell Research, effective July 7, 2009, implement the Executive Order. The Guidelines apply to the expenditure of NIH funds for research using hESCs and certain uses of induced pluripotent stem cells.
For the purpose of the NIH Guidelines, "human embryonic stem cells (hESCs)" are cells that are derived from the inner cell mass of blastocyst stage human embryos, are capable of dividing without differentiating for a prolonged period in culture, and are known to develop into cells and tissues of the three primary germ layers. Although hESCs are derived from embryos, such stem cells are not themselves human embryos. Induced pluripotent stem cells are human cells that are capable of dividing without differentiating for a prolonged period in culture, and are known to develop into cells and tissues of the three primary germ layers.
NIH recipients may use hESCs that have been approved by NIH in accord with the NIH Guidelines and are posted on the NIH Human Embryonic Stem Cell Registry, or may establish eligibility of specific cell lines for NIH funding by submitting a Request for Human Embryonic Stem Cell Line to be Approved for Use in NIH Funded Research (NIH Form 2890). Prior to the use of NIH funds, applicants and recipients must provide assurances, when endorsing applications and progress reports submitted to NIH for projects using hESCs, that the hESCs to be used are listed on the NIH Registry and will be used in accordance with any restrictions associated with the line as cited on the Registry. If a specific line from the NIH Registry cannot be identified at the time of submission, the applicant/recipient must provide a strong justification why one cannot be identified at that time and a certification that one from the NIH Registry will be used.
DHHS regulations for Protection of Human Subjects, 45 CFR 46, Subpart A, establish safeguards for individuals who are the sources of many human tissues used in research, including non-embryonic human adult stem cells and human induced pluripotent stem cells. When research involving human adult stem cells or induced pluripotent stem cells constitutes human subject research, Institutional Review Board review may be required and informed consent may need to be obtained per the requirements detailed in 45 CFR 46, Subpart A.
In addition, 45 CFR 46, Subpart A, may apply to certain research using hESCs. This regulation applies, among other things, to research involving individually identifiable private information about a living individual, 45 CFR 46.102(f). The HHS Office for Human Research Protections (OHRP) considers biological material, such as cells derived from human embryos, to be individually identifiable when they can be linked to specific living individuals by the investigators either directly or indirectly through coding systems. Thus, in certain circumstances, IRB review may be required, in addition to compliance with these Guidelines. Applicant institutions are urged to consult OHRP guidance at https://www.hhs.gov/ohrp/regulations-and-policy/guidance/index.html.
The following uses of hESCs, even if derived from embryos donated in accordance with the NIH Guidelines and listed on the NIH Registry or human induced pluripotent stem cells, are prohibited:
In addition, the derivation of stem cells from human embryos is prohibited in NIH funded research by the annual appropriations ban on funding of human embryo research known as the Dickey Wicker Amendment. NIH funding for research using hESCs derived from other sources, including somatic cell nuclear transfer, parthenogenesis, and/or IVF embryos created for research purposes, is also prohibited.
Effective September 23, 2015, NIH will not fund any new or competing grant applications or contract proposals for research in which human pluripotent cells are introduced into non-human vertebrate animal pre-gastrulation stage embryos while the NIH considers a possible policy revision in this area. This policy will be in place until NIH issues a subsequent policy notification.
Human fetal tissue is defined as tissue or cells obtained from a dead human embryo or fetus after a spontaneous or induced abortion or stillbirth. This definition does not include established human fetal cell lines. Research involving the transplantation of human fetal tissue must be conducted in accordance with applicable Federal, State and local laws as well as the following NIH guidance.
Sections 498A and 498B of the PHS Act (42 U.S.C. 289g-1 and 289g-2) set forth specific requirements and prohibitions on research involving human fetal tissue. Research involving human fetal tissue is also subject to the HHS Regulations for the Protection of Human Subjects. 45 C.F.R. 46.204 and 46.206 may be specifically relevant.
The scientific and ethical challenges associated with research utilizing human fetal tissue make it imperative that researchers and their organizations be fully aware of and in compliance with the Federal requirements, particularly section 498B. When an application involving human fetal tissue research is submitted to NIH, the AOR's signature certifies that researchers using these tissues are in compliance with section 498B of the PHS Act. The statute specifically prohibits any person from knowingly acquiring, receiving, or transferring any human fetal tissue for valuable consideration. The term "valuable consideration" is a concept similar to profit and does not include reasonable payment for costs associated with the collection, processing, preservation, storage, quality control, or transportation of these tissues. Violation of this statute carries criminal penalties that apply to both those that supply and those that acquire human fetal tissue.
Current federal laws and regulations require informed consent for research involving the transplantation of human fetal tissue and for research with human fetal material associated with information that can identify a living individual. Most states require informed consent for the use of fetal tissue in research. Accordingly, NIH expects informed consent to have been obtained from the donor for any NIH-funded research using human fetal tissue.
When obtaining primary human fetal tissue for research purposes, NIH expects grantees and contractors to maintain appropriate documentation, such as an attestation from the health care provider or a third party supplier, that informed consent was obtained at the time of tissue collection.
Sections 498A and 498B contain additional requirements for research on the transplantation of human fetal tissue for therapeutic purposes conducted or supported by NIH. Under section 498A, the official who signs the application is certifying that the research on transplantation of human fetal tissue will adhere to the following provisions:
In submitting an application to NIH, the AOR that signs the application is certifying that, if research on the transplantation of human fetal tissue is conducted under the grant-supported project, the organization will make available for audit by the HHS Secretary or designee, the physician statements, the PD/PI's statements, and informed consents required by subsections 498A(b)(2) and (c) of the PHS Act or will ensure HHS access to those records, if maintained by an entity other than the recipient. This requirement is in addition to the requirements concerning human subjects in research.
In addition, FDA has jurisdiction over fetal cells and tissues intended for use in humans and requests that investigators contact them to determine whether any planned or ongoing clinical research would require submission of an IND application. Additional information and FDA contact information is available at http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ucm105857.htm.
The HHS regulations for the protection of human subjects, in 45 CFR 46, implement Section 491(a) of the PHS Act and provide a framework, based on established, internationally recognized ethical principles, to safeguard the rights and welfare of individuals who participate as subjects in research activities supported or conducted by the NIH or other HHS components.
The HHS regulations stipulate that the recipient organization(s), whether domestic or foreign, bears ultimate responsibility for safeguarding the rights and welfare of human subjects in HHS-supported activities (46.101(a) and 46.103(a)). Recipient institutions "engaged" in human subjects research must obtain a Federalwide Assurance (FWA) with the HHS Office for Human Research Protections (OHRP), and establish appropriate policies and procedures for the protection of human subjects. An institution is engaged in human subjects research if:
The OHRP's document entitled Guidance on Engagement of Institutions in Human Subjects Research provides additional guidance on "engagement".
The HHS regulations at Subparts B, C, and D include additional protections for specific populations as follows:
Certain research activities are exempt from regulatory requirements for an FWA and IRB oversight (45 CFR 46.101(b)). OHRP guidance states that institutions must adopt clear procedures under which the IRB (or some authority other than the investigator) determines whether proposed research is exempt from the human subjects regulations. NIH will make a final determination as to whether proposed activities are covered by the regulations or are in an exempt category, based on the information provided in the Research Plan.
Unless all research activities meet the criteria for one or more exemptions from 45 CFR 46, research involving human subjects may only be conducted under an HHS award if the organization has a current OHRP approved FWA and provides certification that an Institutional Review Board (IRB) registered under the specific Assurance has reviewed and approved the proposed activity in accordance with the HHS regulations.
In accepting an award that supports human subjects research, the recipient institution assumes responsibility for all research conducted under the award, including protection of human subjects at all participating and consortium sites, and for ensuring that an FWA and certification of IRB review and approval exists for each site before human subjects research may begin. When consultants are performing research involving human subjects on NIH-funded projects, the consultant's institution must establish an approved FWA.
The NIH Office of Extramural Research Human Subjects Web site contains additional information and Frequently Asked Questions that are available to help investigators understand how these Federal requirements apply to their research. See http://grants.nih.gov/grants/policy/hs/index.htm.
Applications will be considered incomplete if they do not address the involvement of human subjects in the Research Plan of the application. If human subjects research is anticipated within the period of the award but definite plans for involvement of human subjects cannot be described in the application (referred to as "delayed onset human subjects research" in the NIH grant application instructions), applicants must provide a detailed explanation of why it is not possible to develop definite plans. Prior to the involvement of human subjects the recipient must submit to the NIH awarding IC for prior approval either (1) detailed information as required in the Research Plan of the application, and meet the FWA and IRB certification requirements, or (2) if all of the research meets the criteria for one or more exemptions, identification of which exemptions(s) is/are applicable to the research, and a justification for the exemption with sufficient information about the involvement of human subjects to allow a determination that the claimed exemption is appropriate. Typically, recipients that are part of large clinical research networks or consortia that plan to add new protocols after the award must follow the awarding IC's procedures for approval of new protocols. Institutions with award mechanisms that allow them to select new projects, typically small future research projects (e.g., pilot projects), for support by their NIH award are responsible for ensuring that the selected projects follow all relevant regulations and policies including those governing the involvement of human subjects in research, including prior approval from the institutional IRB if applicable. They must follow the awarding IC's procedures for prior approval of new protocols and updating the IC on the status of funded projects in annual progress reports which are typically described in the FOA and/or NoA.
Recipients may not draw funds from the payment system, request funds from the paying office, or make obligations against Federal funds for research involving human subjects at any site engaged in nonexempt research for any period not covered by both an FWA and IRB approval consistent with 45 CFR 46. Costs associated with IRB review of human research protocols are not allowable as direct charges to NIH-funded research unless such costs are not covered by the organization's F&A rate.
The use of autopsy materials is governed by applicable State and local law and is not directly regulated by 45 CFR 46.
The Federalwide Assurance (FWA) commits the institution to compliance with the requirements set forth in 45 CFR 46, and the Terms of Assurance. Each institution that is "engaged" in HHS supported human subjects research must be covered by an FWA approved by OHRP. (See http://www.hhs.gov/ohrp/assurances/assurances/index.html.)
When an applicant organization proposes non-exempt human subjects research and does not have a FWA, the AOR signature on the application constitutes declaration that the organization will comply with 45 CFR 46 and proceed to obtain a FWA. The NIH awarding component will place a restriction in the NoA so that no human subjects research may be conducted under the award until the FWA and certification of IRB review and approval (or certification of institutional determination of exemption, if applicable) have been obtained and accepted by NIH.
Each recipient institution must file its own FWA even if the organization does not operate its own IRB and designates another IRB for that purpose. IRBs must be registered with OHRP before the IRB may be designated on an FWA as reviewing proposed research for the FWA-holding institution.
Organizations that will serve as additional performance sites that are conducting non-exempt human subjects research under the award must obtain an FWA, or, under specified circumstance, may be covered by the recipient's FWA in accordance with the OHRP's Guidance on Extension of an FWA to Cover Collaborating Individual Investigators and Introduction of the Individual Investigator Agreement.
It is the recipient organization's responsibility to ensure that all sites engaged in research involving human subjects are covered by an appropriate FWA and have IRB approval consistent with 45 CFR 46. It also is the recipient's responsibility to comply with NIH prior approval requirements related to the addition of sites not included in the approved application (see Administrative Requirements-Changes in Project and Budget-Prior Approval Requirements). A list of organizations with approved assurances is available at the OHRP Web site (http://www.hhs.gov/ohrp).
No individual may receive NIH grant funds for nonexempt research involving human subjects unless the individual is affiliated with or sponsored by an organization that assumes responsibility for the research under an FWA or the individual makes other arrangements with OHRP.
Detailed information concerning FWAs, including the OHRP Assurance Training Module, is available on the OHRP Web site (http://www.hhs.gov/ohrp/).
Recipients must provide a certification to NIH that the research application has been approved by an appropriate IRB, consistent with 45 CFR 46 and OHRP guidance. IRB approval must have been granted within 12 months before the budget period start date to be valid. Note that NIH requires the date of final IRB approval; conditional IRB approval is not sufficient. According to OHRP, in the case of IRB approval with conditions, IRB approval only becomes effective when the IRB has approved all information submitted in response to their conditions.
Certification of IRB approval may be filed at any time before award in accord with Just-in-Time procedures, unless required earlier by the IC. Therefore, following peer review and notification of impact score/percentile, applicant organizations with OHRP FWAs may wish to proceed with IRB review for those applications that have not yet received IRB approval and that appear to be in a fundable range.
The HHS regulations require that the IRB review the actual application or proposal for HHS support (45 CFR 46.103(f)). OHRP's 5/31/2000 memo IRB Review of Applications for HHS Support (http://www.hhs.gov/ohrp/policy/aplrev.html) recommends that IRBs ensure that all research described in the application or proposal is entirely consistent with any corresponding protocol(s) submitted to the IRB.
Under the HHS regulations, recipient institutions must have written procedures for ensuring prompt reporting to the IRB, appropriate institutional officials, and the NIH of any unanticipated problem involving risks to subjects or others or any serious or continuing noncompliance with 45 CFR 46 or IRB requirements (45 CFR 46.103(b)(5)). Any IRB suspension or termination of approval must include a statement of the reasons for the IRB's action and must be reported promptly to the investigator, appropriate institutional officials, and NIH (45 CFR 46.113). Recipient institutions must also file incident reports with OHRP of unanticipated problems involving risks to subjects or others, serious or continuing noncompliance with 45 CFR 46 or with the requirements or determinations of the IRB, and suspension or termination of IRB approval. See OHRP 6/20/2011 Guidance on Reporting Incidents to OHRP (http://www.hhs.gov/ohrp/compliance/reports/index.html).
OHRP has regulatory responsibility for oversight of recipient compliance with the HHS human subjects regulations. In carrying out this responsibility, OHRP evaluates all written allegations or indications of non-compliance with the HHS regulations it receives from any source. All compliance oversight evaluations are predicated on the HHS regulations and the organization's assurance of compliance. Any corrective actions imposed as a result of a compliance oversight evaluation are intended to remedy identified non-compliance and prevent reoccurrence. Because each case is different, OHRP tailors corrective actions to foster the best interest of human research subjects and, to the extent possible, of the organization, research community, and HHS. Most compliance oversight evaluations and resultant corrective actions are resolved at the OHRP level. However, OHRP may recommend actions to be taken by other HHS officials.
Information about the FWA submission process and about OHRP activities related to oversight and compliance, as well as copies of the human subjects regulations, may be obtained from OHRP at the address shown in Part III or from its home page at http://www.hhs.gov/ohrp/.
Before funds are awarded for competing applications involving human subjects, applicants must submit documentation that all senior/key personnel involved in human subjects research have received training in the protection of human subjects. Senior/key personnel include all individuals responsible for the design or conduct of the study, including senior/key personnel of consortium participants or alternate performance sites if they are participating in research that involves human subjects. This documentation should be included in the cover letter signed by the AOR that accompanies the description of other support, IRB and IACUC approval, and other information submitted prior to funding in accordance with Just-in-Time procedures. For non-competing continuation awards, the description of education for new senior/key personnel should be part of the progress report submitted as a prerequisite to award. A free, web-based tutorial that presents information about protections for human participants in research, and satisfies the NIH human subjects training requirement, is found at http://phrp.nihtraining.com/. Additional information about this education requirement is available on the NIH Web site at: http://grants.nih.gov/grants/policy/hs_educ_faq.htm.
The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. The NIH policies on data and safety monitoring specify that the level and frequency of monitoring should be commensurate with the risks, nature, and complexity of the clinical trial, and are in addition to any monitoring requirements imposed by FDA or the NIH Guidelines for Research Involving Recombinant DNA Molecules ("NIH Guidelines"). There are a number of options for monitoring clinical trials including, but not limited to, monitoring by a/an:
Applications that include clinical trials must include a general description of the data and safety monitoring plan. The description of the data and safety monitoring plan in competing applications will be reviewed by the SRG. A general description of a monitoring plan establishes the overall framework for data and safety monitoring. It must describe the entity that will be responsible for monitoring how adverse events will be reported to the IRB and the NIH and, when appropriate, how the NIH Guidelines and FDA regulations for INDs and IDEs will be satisfied.
A detailed monitoring plan must be included as part of the research protocol, be submitted to the local IRB, and be reviewed and approved by the NIH awarding IC prior to the accrual of human subjects. The awarding IC may specify the reporting requirements for adverse events, which are in addition to the annual report to the IRB. The clinical trial monitoring function is above and beyond that traditionally provided by IRBs; however, the IRB must be cognizant of the procedures used by clinical trial monitoring entities and the monitor must provide periodic reports to investigators for transmittal to the local IRB.
NIH specifically requires the establishment of DSMBs for multi-site clinical trials involving interventions that entail potential risk to the participants, and generally for Phase III clinical trials. Although Phase I and Phase II clinical trials also may use DSMBs, smaller clinical trials may not require this oversight format, and alternative monitoring plans may be appropriate.
For multi-site Phase I and II trials, investigators should organize a central reporting entity that will be responsible for preparing timely summary reports of adverse events for distribution among sites and the IRBs of participating sites. The frequency of summary reports will depend on the nature of the trial. Organizations with a large number of clinical trials may develop standard monitoring plans for Phase I and II clinical trials. However, such plans always should be evaluated for appropriateness for the particular investigation.
All multi-site trials with DSMBs are expected to forward summary reports of adverse events to individual IRBs so they can address reports related to the site for which they have responsibility. Recipients should address questions on this subject to the NIH PO.
Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).
NIH-conducted or supported clinical research must adhere to the NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects. The goal of the Policy is to increase the participation of children in research so that adequate data will be developed to support the cause, treatment and cure of diseases that affect children (http://grants.nih.gov/grants/funding/children/children.htm). NIH supported clinical research must include children in the research design unless there are scientific or ethical reasons not to include them. For the purpose of this policy requirement a child is defined as an individual under the age of 18 years for applications/proposals due on January 25, 2016 or later.
The involvement of children in clinical research must be in compliance with all applicable provisions of pertinent Federal laws and regulations, including the HHS human subjects regulations at 45 CFR 46 Subpart D, which address additional protections for children who participate as subjects in research.
Investigative teams are to have expertise in dealing with children of the ages included as subjects, facilities to must be appropriate to accommodate the children, and there must be inclusion of a sufficient number of children to contribute to a meaningful analysis relative to the purpose of the study.
NIH-conducted and â€“supported Clinical research must conform to the NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research in accord with Public Health Service Act sec. 492B, 42 U.S.C. sec 289a-2. The policy requires that women and members of minority groups and their subpopulations be included in NIH-conducted or supported clinical research, unless a clear and compelling rationale and justification establishes to the satisfaction of the NIH IC Director that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. Exclusion under other circumstances may be made by the Director, NIH, upon the recommendation of an IC Director based on a compelling rationale and justification.
Cost is not an acceptable reason for exclusion except when the research would duplicate existing data. Women of childbearing potential should not be routinely excluded from participation in clinical research. The policy applies to research subjects of all ages in NIH-supported clinical research studies (see definition of clinical research). The inclusion of individuals on the basis of sex/gender, race, and ethnicity must be addressed in developing a research design appropriate to the scientific objectives of the study. A proposed outreach program for recruiting should also be included. When an NIH-defined Phase III clinical trial is proposed, investigators must consider whether clinically important sex/gender, racial, and/or ethnic differences in the intervention effect are to be expected and plan the research accordingly.
Investigators must also collect and annually report information on sex/gender, race, and ethnicity in clinical research studies. The OMB minimum standards for maintaining, collecting, and presenting data on race and ethnicity for all grant projects are described in OMB Directive No. 15. The categories in this classification are social-political constructs and should not be interpreted as being scientific or anthropological in nature. The standards include five racial categories: American Indian or Alaska Native, Asian, Black or African American, Native Hawaiian or Other Pacific Islander, and White. There are two categories for ethnicity: "Hispanic or Latino," and "Not Hispanic or Latino."
For more information on policies and procedures related to inclusion: Inclusion Procedures
NIH funded research using newborn dried blood spots collected on or after March 18, 2015, will be considered to be non-exempt human subjects research, and therefore, must follow the HHS protection of human subjects regulations at 45 CFR part 46.
Grant applications and R&D contract proposals submitted to NIH that will use such materials in research should be designated as non-exempt human subjects research and include a complete human subjects section per relevant NIH instructions including plans for inclusion on the basis of sex/gender, race, ethnicity, and age per the NIH Policies on the Inclusion of Women, Minorities, and Children.
Such applications and proposals that are funded by NIH must comply with all the relevant federal regulatory and NIH policy requirements for human subjects research including the requirement that the awardee institution (and all engaged institutions) have a Federalwide Assurance (FWA) from OHRP and certification of IRB approval of the proposed research.
Parental permission must have been obtained in order to use newborn dried blood spots collected on or after March 18, 2015, in NIH-funded research. Waiver of parental permission for such research is not permitted under this legislation.
Continuing NIH awards that are conducting research with newborn dried blood spots collected on or after March 18, 2015, will also have to comply with these new requirements. Awardee institutions will need to meet all NIH requirements for human subjects research, including IRB approval, prior to starting such research.
Non-identifiable newborn dried blood spots collected prior to March 18, 2015, may continue to be used in NIH-funded research without parental permission, and this activity would continue to be considered research that does not involve human subjects under the current human subjects regulations.
NIH recognizes that there is no universal agreement on the optimal timing for collection of parental permission for research purposes. Obtaining permission at the time the dried blood spots are collected may be one option. Ideally, an educational process could take place prior to the process of obtaining permission, and may be provided prenatally or after the birth of the child.
Section 12 of the Newborn Screening Saves Lives Reauthorization Act of 2014 applies to use of newborn dried blood spots in HHS funded research, as "research" is defined in 45 CFR 46.102 (d). Research funded solely by state or private entities does not constitute "Federally funded research" and is not subject to Section 12 of the new law.
NIH expects that all NIH-funded investigators and staff who are involved in the conduct, oversight, or management of clinical trials to be trained in Good Clinical Practice (GCP), consistent with principles of the International Conference on Harmonisation (ICH) E6 (R2). (See https://www.fda.gov/downloads/drugs/guidances/ucm073122.pdf).
The principles of GCP help assure the safety, integrity, and quality of clinical trials. GCP provides a standard for ensuring clinical trial compliance, implementation, data collection, monitoring, and reporting (e.g., safety data, accrual reports, study status, protocol deviations, unanticipated problems, or final data), and outline the responsibilities of Institutional Review Boards (IRBs), investigators, sponsors and monitors. GCP addresses elements related to the design, conduct and reporting (e.g., safety data, accrual reports, study status, protocol deviations, unanticipated problems, or final data) of clinical trials.
GCP principles constitute an international ethical and scientific quality standard for designing, conducting, recording, and reporting clinical trials. The principles were developed in 1996 by the ICH in collaboration with representatives from the European Union, Japan, and the United States. The U.S. Food and Drug Administration (FDA) requires GCP compliance for studies conducted under an investigational new drug application or investigational device exemption.
GCP describes the responsibilities of investigators, sponsors, monitors and IRBs in the conduct of clinical trials. Compliance with GCP provides assurance that the rights, safety and well-being of human subjects are protected, that clinical trials are conducted in accordance with approved plans with rigor and integrity, and that data derived from clinical trials are reliable.
GCP training complements other required training on protections for human research participants. Since June 2000, the NIH Extramural Research Program has required training on protections for human research participants for all NIH-funded investigators and individuals responsible for the design or conduct of a research involving human subjects.
This policy applies to NIH-funded investigators and clinical trial site staff who are responsible for the conduct, management and oversight of NIH-funded clinical trials. GCP training includes the Principles of ICH GCP found in Section 2 of ICH E6. GCP training may be achieved through a class or course, academic training program, or certification from a recognized clinical research professional organization. Acceptable GCP courses include the NIAID GCP Learning Center website (http://gcplearningcenter.niaid.nih.gov) and National Drug Abuse Treatment Clinical Trials Network (https://gcp.nidatraining.org/). Completion of GCP training will demonstrate that individuals have attained the fundamental knowledge of clinical trial quality standards for designing, conducting, recording and reporting trials that involve human research participants. GCP training should be refreshed at least every three years in order remain current with regulations, standards and guidelines. Recipients of GCP training are expected to retain documentation of their training, and make it available to NIH upon request.
For purposes of Good Clinical Practice training the following definitions apply:
Investigator: The individual responsible for the conduct of the clinical trial at a trial site. If a clinical trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator.
Clinical trial staff: Individuals, identified by the investigator, who are responsible for study coordination, data collection and data management. The central focus of clinical trial staff is to manage participant recruitment and enrollment, to maintain consistent study implementation, data management, and to ensure integrity and compliance with regulatory and reporting requirements. These individuals may also seek informed consent from prospective participants, enroll and meet with research participants, and collect and record information from research participants. Clinical trial staff may also be called the research coordinator, study coordinator, research nurse, study nurse or sub-investigator.
To be eligible for NIH funding, all clinical research involving investigational drugs and devices, or other products regulated by the FDA, must comply with all applicable FDA requirements, including those for INDs, IDEs, and human subjects protections. Among other provisions, FDA regulations for human subjects protections are published in 21 CFR Parts 50 and 56 with additional standards found in Parts 312 and 812.
When applicable, the sponsor of the IND/IDE, whether NIH, a recipient, or a third party, is legally responsible for meeting the FDA requirements for sponsors. If the sponsor is also the PI, then the sponsor will need to satisfy FDA's requirements for sponsor-investigators. If the IND/IDE sponsor is a third party, such as a pharmaceutical company or research organization under contract to a recipient or to a pharmaceutical company, the legal responsibility for monitoring the clinical trial and reporting to FDA rests with the sponsor rather than the recipient. This generally will be the case for larger, multi-site clinical trials. If the recipient is the IND/IDE holder, commonly referred to as an "investigator-initiated IND/IDE," the recipient or the investigator serves as the sponsor and assumes the legal responsibility. In any case, the recipient is ultimately responsible to NIH for ensuring compliance with the applicable requirements for protection of human subjects, including compliance with FDA's requirements.
Following the filing of an IND, FDA has a 30-day period in which to review it. FDA may allow the IND to proceed or may defer approval of the IND until changes it deems acceptable are made. FDA also may order a clinical trial to be suspended or terminated, at any time, based on information it receives about that clinical trial.
When NIH funds any part of a clinical study involving an IND or an IDE, NIH must be knowledgeable about any significant communications with FDA concerning the study. The recipient organization must report certain types of FDA communications to the NIH awarding IC within 72 hours of receiving a copy of, or upon being informed of, the FDA communication (through the PD/PI or another person acting on behalf of the recipient), whichever occurs first. This notification requirement applies to any of the following communications from FDA with the sponsor of the IND or IDE:
The notification should be made in writing, but also may be done by telephone if a written notice would delay the notification. It should include a statement of the action taken or contemplated and the assistance needed to resolve the situation. These requirements apply to the recipient even if the recipient or the NIH-funded PD/PI is the sponsor. Failure to comply with this requirement may result in NIH imposing a corrective and/or enforcement action (see Administrative Requirements-Enforcement Actions). FDA communications are considered grant-related records for purposes of retention and access (see Administrative Requirements-Monitoring-Record Retention and Access).
Recipients of Federal grants, cooperative agreements, contracts, and loans are prohibited by 31 U.S.C. 1352, "Limitation on use of appropriated funds to influence certain Federal contracting and financial transactions," from using appropriated Federal funds to pay any person for influencing or attempting to influence any officer or employee of an agency, a Member of Congress, an officer or employee of Congress, or an employee of a Member of Congress with respect to the award, continuation, renewal, amendment, or modification of any of these instruments. These requirements are implemented for HHS in 45 CFR 93, which also describes types of activities, such as legislative liaison activities and professional and technical services, which are not subject to this prohibition under certain circumstances.
Applicants for NIH awards are required to certify and disclose that they:
Certifications and disclosures must be filed at the times prescribed in the regulations based on the expected total costs.
The signature of the AOR on the application serves as the required certification of compliance for the applicant organization. Disclosure reporting is addressed in Administrative Requirements-Monitoring-Reporting.
See also Appropriation Public Policy Requirements Mandates Lobbying-Appropriation Prohibition for additional restrictions.
Consistent with EO 12770 (July 25, 1991), Metric Usage in Federal Government Programs, measurement values in applications and recipient-prepared reports, publications, and other grant-related documents should be in metric. See Construction Grants chapter in IIB for requirements for metric usage in construction activities.
Section 588 of the National Defense Authorization Act of 1995, amended (10 U.S.C. Â§983), precludes NIH grant awards to institutions of higher education that DoD determines have an anti-Reserve Officer Training Corps (ROTC) policy or practice (regardless of when implemented) that either prohibits or, in effect, prevents the Secretary of Defense from gaining entry to campuses or access to students or information for military recruiting. DoD publishes each determination of ineligibility in the Federal Register as well as publishing, once every 6 months, a list of all currently ineligible schools. If DoD determines that an institution is ineligible during an ongoing project period, NIH will suspend support of current and future grant awards as provided in Administrative Requirements-Enforcement Actions-Suspension, Termination, and Withholding of Support. Funding eligibility may be restored on the basis of new information provided by DoD.
All NIH grants, whether or not they include construction or major A&R activities, are subject to the requirements of the National Environmental Policy Act (NEPA) of 1969, as amended. This Act requires Federal agencies to consider the reasonably foreseeable environmental consequences of all grant-supported activities. As part of NIH's implementation of this Act, recipients are required to promptly notify NIH of any reasonably foreseeable impacts on the environment from grant-supported activities, or certify that no such impacts will arise upon receipt of a grant award. In addition, NIH has determined that most NIH research grants are not expected to individually or cumulatively have a significant effect on the environment unless any part of the proposed research and/or project includes one or more of the following categorical exclusions listed below:
This requirement is in addition to other public policy requirements for grants for construction and alteration and renovation activities discussed more fully in the Construction chapter - Construction, Modernization, or Major Alteration and Renovation of Research Facilities-Public Policy Requirements.
The Federal Debt Collection Procedures Act of 1990 (Act), 28 U.S.C. 3201(e), provides that an organization or individual that is indebted to the United States, and has a judgment lien filed against it, is ineligible to receive a Federal grant. NIH cannot award a grant unless the AOR of the applicant organization (or individual in the case of a Kirschstein-NRSA individual fellowship) certifies, by means of his/her signature on the application, that the organization (or individual) is not delinquent in repaying any Federal debt. If the applicant discloses delinquency on a debt owed to the Federal government, NIH may not award the grant until the debt is satisfied or satisfactory arrangements are made with the agency to which the debt is owed. In addition, once the debt is repaid or satisfactory arrangements made, NIH will take that delinquency into account when determining whether the applicant would be a responsible NIH grant recipient.
Anyone who has been judged to be in default on a Federal debt and who has had a judgment lien filed against him or her should not be listed as a participant in an application for an NIH grant until the judgment is paid in full or is otherwise satisfied. No funds may be used for or rebudgeted following an award to pay such an individual. NIH will disallow costs charged to awards that provide funds to individuals in violation of this Act.
These requirements apply to all types of organizations and awards, including foreign grants.
Special terms and conditions concerning prostitution and sex trafficking apply to all grants awarded under the U.S. President's Emergency Plan for AIDs Relief (PEPFAR) program. These are:
Additional requirements regarding the opposition to prostitution and sex trafficking may be applied to grants awarded under PEPFAR and issued to foreign Non-Governmental Organizations (NGOs). Subject to the United States Supreme Court's decision in Agency for International Development, et al., v. Alliance for Open Society International, Inc., et al., 133 S. Ct. 2321 (2013) and subsequent proceedings, the terms and conditions for such agreements with foreign NGOs may include the following:
|a.||The U.S. Government is opposed to prostitution and related activities, which are inherently harmful and dehumanizing, and contribute to the phenomenon of trafficking in persons. None of the funds made available under this agreement may be used to promote or advocate the legalization or practice of prostitution or sex trafficking. Nothing in the preceding sentence shall be construed to preclude the provision to individuals of palliative care, treatment, or post-exposure pharmaceutical prophylaxis, and necessary pharmaceuticals and commodities, including test kits, condoms, and, when proven effective, microbicides.|
|(1)||Except as provided in (b)(2) and (b)(3), by accepting this award or any subaward, a non-governmental organization or public international organization awardee/subawardee agrees that it is opposed to the practices of prostitution and sex trafficking because of the psychological and physical risks they pose for women, men, and children. Any enforcement of this clause is subject to Agency for International Development, et al., v. Alliance for Open Society International, Inc., et al., 133 S. Ct. 2321 (2013) and subsequent proceedings|
|(2)||The following organizations are exempt from (b)(1): the Global Fund to Fight AIDS, Tuberculosis and Malaria; the World Health Organization; the International AIDS Vaccine Initiative; and any United Nations agency.|
|(3)||Contractors and subcontractors are exempt from (b)(1) if the contract or subcontract is for commercial items and services as defined in FAR 2.101, such as pharmaceuticals, medical supplies, logistics support, data management, and freight forwarding.|
|(4)||Notwithstanding section (b)(3), not exempt from (b)(1) are recipients, subrecipients, contractors, and subcontractors that implement HIV/AIDS programs under this assistance award, any subaward, or procurement contract or subcontract by:|
|(i)||Providing supplies or services directly to the final populations receiving such supplies or services in host countries;|
|(ii)||Providing technical assistance and training directly to host country individuals or entities on the provision of supplies or services to the final populations receiving such supplies and services; or|
|(iii)||Providing the types of services listed in FAR 37.203(b)(1)-(6) that involve giving advice about substantive policies of a recipient, giving advice regarding the activities referenced in (i) and (ii), or making decisions or functioning in a recipient's chain of command (e.g., providing managerial or supervisory services approving financial transactions, personnel actions).|
|c.||The following definitions apply for purposes of this provision:
|d.||The recipient shall insert this provision, which is a standard provision, in all subawards, procurement contracts or subcontracts.|
|e.||This provision includes express terms and conditions of the award and any violation of it shall be grounds for unilateral termination of the award by NIH prior to the end of its term.|
Public Law 103-227, Title X, Part C, Environmental Tobacco Smoke, also known as the Pro-Children Act of 1994, imposes restrictions on smoking in facilities where federally funded children's services are provided. NIH grants are subject to these requirements only if they meet the Act's specified coverage. The Act specifies that smoking is prohibited in any indoor facility (owned, leased, or contracted for) used for the routine or regular provision of kindergarten, elementary, or secondary education or library services to children under the age of 18. In addition, smoking is prohibited in any indoor facility or portion of a facility (owned, leased, or contracted for) used for the routine or regular provision of federally funded health care, day care, or early childhood development (Head Start) services to children under the age of 18. The statutory prohibition also applies if such facilities are constructed, operated, or maintained with Federal funds. The statute does not apply to children's services provided in private residences, facilities funded solely by Medicare or Medicaid funds, portions of facilities used for inpatient drug or alcohol treatment, or facilities where Women, Infants and Children (WIC) coupons are redeemed. Failure to comply with the provisions of the law may result in the imposition of a civil monetary penalty of up to $1,000 per violation and/or the imposition of an administrative compliance order on the responsible entity.
Because of the nature of NIH programs and funding, individual transactions, rather than entire programs, may be subject to these requirements. The signature of the AOR will indicate the intent to comply. Any questions concerning the applicability of these provisions to an NIH grant should be directed to the GMO.
The Public Health Security and Bioterrorism Preparedness and Response Act of 2002, 42 U.S.C. 201, is designed to provide protection against misuse of select agents and toxins whether inadvertent or the result of terrorist acts against the U.S. homeland or other criminal acts. The Act was implemented, in part, through regulations published by HHS and USDA at 42 CFR 73, 9 CFR 121 and 7 CFR 331 or commonly referred to as "Select Agent Regulations." Copies of these regulations are available at http://www.selectagents.gov/Regulations.html, or can be obtained from CDC, 1600 Clifton Road, MS A-46, Atlanta, GA 30333; telephone: 404-718-2000.
Research involving select agents and recombinant or synthetic nucleic acid molecules also is subject to the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines). The NIH Guidelines apply to all research projects (NIH-funded and non-NIH-funded) that involve recombinant or synthetic nucleic acid molecules and are conducted at or sponsored by an organization that receives NIH support for recombinant or synthetic nucleic acid molecule research. A copy of the NIH Guidelines are available at http://osp.od.nih.gov/office-biotechnology-activities/biosafety/nih-guidelines.
Domestic recipients who conduct research involving select agents or toxins (see Section 3 and 4 of 42 CFR 73 and 9 CFR 121 and Section 3 of 7 CFR 331) must maintain a registration with CDC (or USDA, depending on the agent) before using NIH funds. No funds can be used for research involving select agents or toxins if the registration certificate maintained by CDC or USDA is suspended or revoked.
Foreign Organizations and International Organizations who conduct research involving select agents (see 42 CFR 73 for the select agent list; and 7 CFR 331 and 9 CFR 121 for the relevant animal and plant pathogens) must provide information satisfactory to the NIH that a process equivalent to that described in 42 CFR 73 for U.S. institutions is in place and will be administered on behalf of all select agent work sponsored by NIH funds before using these funds for any work directly involving select agents. Recipients must be willing to address the following key elements appropriate for their institutions: safety, security, training, procedures for ensuring that only approved/appropriate individuals have access to the select agents, and any applicable laws, regulations and policies equivalent to 42 CFR 73. If this work will not, in fact, involve select agents (e.g. excluded strains), and you provide documentation satisfactory to the NIH that your work does not now nor will it in the future (i.e. throughout the life of the award) involve select agents, no further action will be necessary.
Recipients who conduct research involving select agents (see 42 CFR 73 for the select agent list; and 7 CFR 331 and 9 CFR 121 for the relevant animal and plant pathogens) must complete registration with CDC (or USDA, depending on the agent) before using NIH funds for any work directly involving the select agent at the U.S. institution. No funds can be used for research involving select agents if the final registration certificate is denied. Before using NIH funds for any work directly involving the select agents at a foreign subrecipient, the U.S. recipient must provide information from the foreign organization satisfactory to the NIH that a process equivalent to that described in 42 CFR 73 for U.S. institutions is in place and will be administered on behalf of all select agent work sponsored by these funds. Recipients must be willing to address the following key elements appropriate for the foreign organization: safety, security, training, procedures for ensuring that only approved/appropriate individuals have access to the select agents, and any applicable laws, regulations and policies equivalent to 42 CFR 73 are followed. If this work will not, in fact, involve select agents (e.g. excluded strains), and you provide documentation satisfactory to the NIH that your work does not now nor will it in the future (i.e. throughout the life of the award) involve select agents, no further action will be necessary.
On September 24, 2014, the Federal government issued a policy for the oversight of life sciences "Dual Use Research of Concern" (DURC). This policy applies to all New and Renewal awards issued on applications submitted on or after January 25, 2015, and to all non-competing continuation awards issued on or after January 25, 2015. Institutions must then implement the Policy by September 24, 2015. DURC is defined as life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies that could be directly misapplied to pose a significant threat with broad potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, materiel, or national security. Despite its value and benefits, some research may be misused for harmful purposes. The fundamental aim of this oversight policy is to preserve the benefits of life sciences research while minimizing the risk of misuse of the knowledge, information, products, or technologies provided by such research.
The DURC policy applies to recipients in the United States that receive Federal funding for life sciences research and that conduct or sponsor research involving one or more of the 15 agents or toxins listed in the policy and to foreign recipients that receive Federal funding to conduct or sponsor research involving one of these 15 agents or toxins. Institutions must establish an Institutional Review Entity (IRE) which must review research involving these agents or toxins to determine if it involves one or more of the listed experimental effects and if so, whether it meets the definition of DURC. Recipients also must establish an Institutional Contact for Dual Use Research (ICDUR), as required by the U.S. Government's DURC Policy, and explain the ICDUR's role. The award recipient must maintain records of institutional DURC reviews and completed risk mitigation plans for the term of the research grant or contract plus three years after its completion, but no less than eight years, unless a shorter period is required by law or regulation.
For research that may be considered DURC, NIH will work collaboratively with the institution and investigators to develop a risk mitigation plan, which may be implemented through a term of award and that the NIH must approve. For example, NIH may request that institutions periodically review a project for its DURC potential, propose any modifications to the risk mitigation plan, and share any resulting manuscripts with their Program Official prior to submitting the manuscript to a journal.
The United States is one of 175 States Parties to the Chemical Weapons Convention (CWC), which prohibits the development, production, stockpiling, and use of chemical weapons (CW). The CWC does not prohibit production, processing, consumption, or trade of related chemicals for peaceful purposes, but it does establish a verification regime to ensure such activities are consistent with the object and purpose of the treaty.
NIH researchers engaged in activities involving these chemicals, especially Schedule 1 chemicals, may be required to submit declarations and/or reports to the Bureau of Industry and Security (BIS) and may be subject to inspection by the Organization for the Prohibition of Chemical Weapons, which administers the CWC. In addition, trade in certain chemicals with States not Party to the CWC may be prohibited or subject to an export license and or end-use certificate.
Schedule 1 chemicals include, but are not limited to, the toxic chemicals sarin, soman, tabun, VX, sulfur mustards, Lewisites, saxitoxin, ricin, and nitrogen mustards. More information about the U.S. CWC, including complete lists of Schedule 1, 2, and 3 chemicals under the CWC may be found at http://www.cwc.gov/index.html. Federal regulations that apply to the CWC are 15 CFR CHAPTER VII, SUBCHAPTER B, PARTS 710-722, SUBCHAPTER C, PARTS 730-774; 22 CFR CHAPTER I, PART 103, PARTS 120-130. These CRFs and other applicable safety standards issued by the Department of Commerce and Department of State are available at http://www.cwc.gov/regulations_cwc_regulations.html.
As required by Section 403C of the Public Health Service Act, each institution receiving an NIH award for the training of graduate students for doctoral degrees must provide information on completion rates and time to degree to all applicants to doctoral programs supported by NIH training awards. Specifically, institutions must provide applicants with the following information for the programs to which they apply:
Institutions affected by this Assurance and information disclosure requirement are doctoral degree granting institutions that receive any of the following institutional training grant awards or cooperative agreements from the NIH for the doctoral training of graduate students:
Institutions are not affected by this requirement if they:
In complying with this Assurance and information disclosure requirement, institutions may decide how best to present the required information to applicants and may wish to consider consolidating data by department or broad program to which candidates apply, or providing additional information in order to provide context.
Recipients with awards for any of the activity codes listed above are also required to provide corresponding information on trainees supported by each of their awards when submitting a renewal application or RPPR.
The NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) (April 2016 or latest revision) apply to all research projects (NIH-funded and non-NIH-funded) that involve recombinant or synthetic nucleic acid molecules and are conducted at or sponsored by an organization that receives NIH support for recombinant or synthetic nucleic acid molecule research. A copy of the NIH Guidelines is available at http://osp.od.nih.gov/office-biotechnology-activities/biosafety/nih-guidelines
According to the NIH Guidelines, recombinant and synthetic nucleic acid molecules are defined as (1) molecules that a) are constructed by joining nucleic acid molecules and b) can replicate in a living cell, i.e. recombinant nucleic acids, or (2) nucleic acid molecules that are chemically or by other means synthesized or amplified, including those that are chemically or otherwise modified but can base pair with naturally occurring nucleic acid molecules, i.e. synthetic nucleic acids, or (3)molecules that result from the replication of those described in (1) or (2). The NIH Guidelines apply to both basic and clinical research studies. Specific guidance for the conduct of human gene transfer studies appears in Appendix M of the NIH Guidelines.
Failure to comply with these requirements may result in suspension or termination of an award for recombinant or synthetic nucleic acid molecule research at the organization, or a requirement for NIH prior approval of any or all recombinant or synthetic nucleic acid molecule projects at the organization. Two specific requirements of the NIH Guidelines are discussed below, but the recipient should carefully review the NIH Guidelines in their entirety to ensure compliance with all of the requirements for projects involving recombinant or synthetic nucleic acid molecules.
Recombinant or synthetic nucleic acid research involving select agents also is subject to pertinent CDC and USDA regulations, 42 CFR 73, Select Agents and Toxins; and 7 CFR 331 and 9 CFR 121, Possession, Use, and Transfer of Biological Agents and Toxins.
Each organization that conducts research involving recombinant or synthetic nucleic acid molecules, including contractors under grants, must have policies and procedures to ensure compliance with the NIH Guidelines and must establish a standing IBC. The IBC is required to review each proposed project for recombinant or synthetic nucleic acid molecule experiments to ensure that the procedures, project, personnel, and facilities are adequate and in compliance with the NIH Guidelines. Section IV of the NIH Guidelines specifies the composition of IBCs. A roster of the IBC members and biosketches for each member must be submitted to the NIH. At a minimum, the roster should indicate the name of each IBC member, as well as which IBC members are serving as the chairperson, contact person, and, as applicable, experts in biosafety or plant, animal, or human experimentation. Biosketches should include a description of the occupation and professional qualifications of each member. Organizations can register their IBC with NIH on-line by utilizing the IBC Registration Management System (RMS). IBC-RMS can be accessed at: http://ibc-rms.od.nih.gov
Section IV of the NIH Guidelines also specifies the roles and responsibilities of PIs, biological safety officers (BSOs) and recipient institutions with respect to the safe conduct and oversight of recombinant or synthetic nucleic acid research. Investigators, laboratory staff, BSOs, and institutional officials should read and be aware of their duties and expected biosafety practices, as described by the NIH Guidelines.
Appendix M-I-C-4 of the NIH Guidelines requires PIs to report serious adverse events (SAEs) that are both unexpected and possibly associated with the human gene transfer product to the NIH Office of Biotechnology Activities and the IBC as soon as possible but no later than 15 calendar days after the sponsor's initial receipt of the information (i.e., at the same time the event must be reported to the FDA). SAEs that are also fatal or life-threatening must be reported no later than seven calendar days. In addition, investigators must submit to OBA annual reports covering certain information about the protocol. Further information about the content of these reports can be found in Appendix M-I-C-3 of the NIH Guidelines. Investigators may use the GeMCRIS database (http://www.gemcris.od.nih.gov/) as an electronic tool to report adverse events or annual reports on human gene transfer trials to NIH OBA.
Title 42 CFR 93, PHS Policies on Research Misconduct, Subpart C, "Responsibilities of Institutions" specifies recipient responsibilities to have written policies and procedures for addressing allegations of research misconduct, to file an Assurance of Compliance with the HHS Office of Research Integrity, and take all reasonable and practical steps to foster research integrity. Research misconduct is defined as the fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results. The HHS Office of Research Integrity (ORI) has responsibility for addressing research integrity and misconduct, monitors institutional investigations of research misconduct and facilitates the responsible conduct of research through education, preventive, and regulatory activities (http://www.ori.dhhs.gov).
To be eligible for PHS funding an institution must have an assurance on file with ORI stating that it has developed and will comply with an administrative process for responding to allegations of research misconduct in PHS-supported research that complies with 42 CFR 93. An institution establishes an assurance when an official signs the face-page (SF 424 (R&R) or PHS 398) of the grant application form or when the institution files a separate assurance form. Once established, institutions maintain their assurance by filing the Annual Report on Possible Research Misconduct (between January 1 and March 1 each year), submitting their policy for responding to allegations of research misconduct for review when requested by ORI, revising their policy when requested by ORI to bring the policy into compliance with the PHS regulation, and complying with the PHS regulation.
As stated throughout the NIHGPS, the recipient has primary responsibility for ensuring that it is conducting its NIH-funded project in accordance with the approved application and budget and the terms and conditions of the award. The recipient must carry out its responsibilities with extra care where research misconduct has been found or where a research misconduct investigation has been initiated, as specified in 42 CFR 93, Subpart C. The recipient must report promptly to ORI any decision to initiate an investigation of research misconduct.
The regulations specify the timing of an institutional investigation, related reporting to ORI, notice to the respondent, custody of records, documentation, opportunity for respondent to comment on the report, and the components on a final institutional investigative report.
If a misconduct investigation is initiated, the recipient must take any necessary steps, in addition to its normal and ongoing responsibilities under the grant, to protect the scientific integrity of the project, protect human subjects and live vertebrate animals, provide reports to ORI, and ensure the proper expenditure of funds and continuation of the project during the investigation, if appropriate. ORI staff members are available to help recipients with investigating and reporting on research misconduct, and IC staff members are available to provide technical assistance and to work with recipients to protect funded projects from the adverse effects of research misconduct.
The recipient is responsible for the actions of its employees and other research collaborators, including third parties, involved in the project. When the recipient finds research misconduct by anyone working on an NIH grant-supported project, whether at the recipient organization or at a third-party organization, the recipient must assess the effect of that finding on the ability to continue that project, as originally approved by NIH, and must promptly obtain NIH approval of any intended change of PD/PI or other senior/key personnel or change of scope. A recipient's failure to comply with the terms and conditions of award, including confirmed instances of research misconduct, may cause NIH to take one or more enforcement actions including disallowance of costs, withholding of further awards, suspension, or termination. These actions are described in Administrative Requirements-Enforcement Actions.
Where research misconduct has affected data validity or reliability, ORI or NIH may require the recipient and its employee/collaborator authors to submit a correction or retraction of the data to a journal, publish the corrected data, or both. If the recipient does not comply with this requirement, NIH may invoke its rights, under 45 CFR 75, to access the data (including copyrightable material developed under the award), have the data reviewed, and submit the correction.
Pursuant to EO 13043 (April 16, 1997), Increasing the Use of Seat Belts in the United States, NIH encourages recipients to adopt and enforce on-the-job seat belt policies and programs for their employees when operating vehicles, whether organizationally owned or rented or personally owned.
NIH strongly encourages recipients to provide smoke-free workplaces and to promote the nonuse of tobacco products. NIH defines the term "workplace" to mean office space (including private offices and other workspace), conference or meeting rooms, corridors, stairways, lobbies, rest rooms, cafeterias, and other public spaces.
NIH requires recipients to establish safeguards to prevent employees, consultants, members of governing bodies, and others who may be involved in grant-supported activities from using their positions for purposes that are, or give the appearance of being, motivated by a desire for private financial gain for themselves or others, such as those with whom they have family, business, or other ties. These safeguards must be reflected in written standards of conduct. Except as provided below, NIH does not require a recipient to establish separate standards of conduct if it maintains such standards for its non-grant-supported activities, as long as those standards are consistent with State and local laws and cover, at a minimum, expected conduct in regard to financial interests, gifts, gratuities and favors, nepotism, and such other areas as political participation and bribery. The standards also must do the following:
The recipient is not required to submit its general standards of conduct to NIH for review or approval. However, a copy must be made available to each of its officers, each employee and consultant working on the grant-supported project or activity, each member of the governing board, if applicable, and, upon request, to NIH. The recipient is responsible for enforcing its standards of conduct, taking appropriate action on individual infractions, and, in the case of financial conflict of interest, informing the IC CGMO if the infraction is related to an NIH award. (A listing of the NIH GMOs is available at http://grants.nih.gov/grants/stafflist_gmos.htm.) If a suspension or separation action is taken by a recipient against a PD/PI or other senior/key personnel under an NIH grant, the recipient must request prior approval of the proposed replacement as specified in Administrative Requirements-Changes in Project and Budget-Prior Approval Requirements.
The recipient must promptly report issues involving potential criminal violations, such as misappropriation of Federal funds, to the HHS OIG .
Executive Order 13513 (E.O. 13513) requires each Federal agency to encourage contractors, subcontractors, and grant and cooperative agreement recipients and subrecipients to adopt and enforce policies that ban text messaging while driving company-owned or -rented vehicles or Government Owned Vehicles, or while driving Personally Owned Vehicles when on official Government business or when performing any work for or on behalf of the Government.
To further the requirement of encouraging such policies, the NIH encourages recipients to consider new rules and programs, reevaluate existing programs to prohibit text messaging while driving, and conduct education, awareness, and other outreach for employees about the risks associated with texting while driving. These initiatives should encourage voluntary compliance with the recipient agency's text messaging policy while off duty.
For the purposes of this policy and pursuant to E.O. 13513, the following definitions apply:
This government-wide award term implements Section 106 (g) of the Trafficking Victims Protection Act (TVPA) of 2000, as amended (22 U.S.C. 7104), located at 2 CFR 175. This is implemented in accordance with OMB Interim Final Guidance, Federal Register Volume 72, No. 218, November 13, 2007. A Final Notice is expected to be issued in the future; however, HHS agencies have implemented this award term based on the Interim Final Guidance.
In accordance with the statutory requirement, in each agency award under which funding is provided to a private entity, section 106(g) of the TVPA, as amended, requires the agency to include a condition that authorizes the agency to terminate the award, without penalty, if the recipient or a subrecipient -
Full text of the award term is provided at 2 CFR 175.15.
The Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism Act (USA PATRIOT Act) (P.L. 107-56) amends 18 U.S.C. 10 and provides criminal penalties for possession of any biological agent, toxin, or delivery system of a type or in a quantity that is not reasonably justified by a prophylactic, protective, bona fide research, or other peaceful purpose. The Act also establishes restrictions on access to specified materials. "Restricted persons," as defined by the Act, may not possess, ship, transport, or receive any biological agent or toxin that is listed as a select agent (see Public Health Security and Bioterrorism Preparedness and Response Act in this section).
Federal financial assistance recipients will be subject to the reporting requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75. Recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 must report and maintain information in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75.
The FAPIIS Public Access â€“ Search Page is provided at https://www.fapiis.gov/fapiis/index.action.