NIH Grants Policy Statement
Part II: Terms and Conditions of NIH Grant Awards
NIH grants are subject to requirements intended to ensure that recipient organizations handle their Federal awards responsibly. Grantees are required to adopt and enforce policies that minimize the opportunity for improper financial gain on the part of the organization, its employees, and organizations and individuals whom they may collaborate, and that limit the potential for research results to be tainted by possible financial or other gain. In addition, NIH grantees are expected to provide safe and healthful working conditions for their employees and foster work environments conducive to high-quality research.
This chapter addresses public policy requirements, objectives, and other appropriation mandates applicable to NIH awards. The term "public policy" indicates that the requirement is based on social, economic, or other objectives or considerations that may be attached to the expenditure of Federal funds by grantees, consortium participants, and contractors, in general, or may relate to the expenditure of Federal funds for research or other specified activities.
In addition to cross-cutting requirements that some or all Federal agencies must apply to their grant programs, NIH grantees are subject to requirements contained in the HHS annual appropriations act that apply to the use of NIH grant funds, applicable provisions in other Federal agencies' appropriations acts, including Treasury, and other Federal statutes. Some of those requirements are included here in a separate section titled Appropriation Mandates since they have been included in the appropriations acts for several years with little or no change. Those requirements may be changed or other requirements may be added in the future.
The public policy requirements, objectives, and appropriation mandates listed in Exhibit 4 apply to all NIH awards with exceptions as noted.
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 grantees. The public policy requirements specified in this section set many of those standards. 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, IRB certification, civil rights assurance). Applicants and grantees 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 grantee 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 grantee 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 grantee 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 grantee 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 grantee 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.
* NA: A designation of NA in this table indicates that a particular requirement does not apply to an otherwise eligible grantee, consortium participant, or contractor or may not apply because the type of activity covered is one not normally performed by such an entity.
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 grantee organizations receiving PHS support for research or related activities using live vertebrate animals. Grantee 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 grantee 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 grantee 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.
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 grantee 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 grantee does not have an Assurance and the animal work will be conducted at an institution with an Assurance, the grantee must obtain an Inter-institutional Assurance from OLAW. Under the Inter-institutional Assurance, the grantee 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 grantee organization and all performance sites are operating in accordance with approved Animal Welfare Assurances and the grantee 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 priority 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 grantee collaborates with one or more other organizations, the grantee, 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 grantee as specified in the NIHGPS (see Consortium Agreements chapter in IIB). The animal welfare requirements that apply to grantees also apply to consortium participants and subprojects.
The primary grantee 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 grantee 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 grantee 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 institutions: http://grants.nih.gov/grants/olaw/assurance/500index.htm).
Foreign grantees 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 grantees; however, OLAW encourages foreign grantees to use the standards in the Guide for the Care and Use of Laboratory Animals.
When the grantee is a domestic institution and performance sites are foreign (i.e., domestic grant with a foreign component), PHS Policy requirements are applicable. Accordingly, the grantee remains responsible for animal activity conducted at the foreign site and must provide verification of IACUC approval (i.e., certification that the activity as conducted at the foreign performance site is acceptable to the grantee). The grantee IACUC may accept, as its own, the approval of a foreign organization's IACUC; however, the grantee 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 grantees 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 301-945-7573.
Domestic organizations that receive funding from grantees (including consortium participants and contractors under grants) rather than directly from NIH, also are required to file an HHS 690. The applicant/grantee 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 part 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 part 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 part 91.
EO 13166, August 11, 2000, requires grantees 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 grantees are explained on the OCR Web site at http://www.hhs.gov/ocr/civilrights/resources/specialtopics/lep/.
Applicants and grantees should familiarize themselves with the requirements of Title VIII, Sec. 801 of Public Law 110-85 (also known as the FDA Amendments Act or FDAAA) with respect to registration and results reporting requirements that may apply to certain studies. In particular, grantees should be aware that if an applicable clinical trial is funded in whole or in part by an NIH grant or cooperative agreement, any application or progress report shall include a certification that the Responsible Party has made all required submissions to ClinicalTrials.gov. The NIH strongly encourages registration of all clinical trials, whether required by FDAAA or not. For additional information, see http://grants.nih.gov/ClinicalTrials_fdaaa/index.htm and http://www.clinicaltrials.gov.
Section 301(d) of the PHS Act provides that the Secretary may authorize people engaged in biomedical, behavioral, clinical, or other research activities to protect the privacy of research subjects by withholding the names and other identifying characteristics of those subjects from individuals not engaged in the research. Individuals that have such authorization may not be compelled to disclose subjects' names or other identifying characteristics in any Federal, State, or local civil, criminal, administrative, legislative or other proceeding. CoCs may be granted for studies collecting information that, if disclosed, could have adverse consequences for subjects or damage their financial standing, employability, insurability, or reputation. By protecting researchers from being compelled to disclose information that would identify research subjects, CoCs contribute to achieving research objectives and promote participation in studies by helping to ensure confidentiality and privacy to participants. Information on CoCs is available on the NIH Web site at the CoC Kiosk at http://grants.nih.gov/grants/policy/coc/index.htm. Requests for CoCs should be submitted to the GMO, and, subject to awarding IC review and approval, a certificate may be issued pursuant to section 301(d).
Research subject protections under CoCs differ from those provided under the HIPAA Privacy Rule 42 CFR parts 160 and 164 (HIPAA) and under Section 543 of the PHS Act (see Confidentiality of Alcohol and Drug Abuse Patient Records below) by protecting identifiable health information from forced disclosure (e.g., by court order). Therefore, researchers may obtain CoCs to withhold (protect) information that otherwise may be subject to the Privacy Rule or Section 543 of the PHS Act.
Section 543 of the PHS Act, as implemented in 42 CFR part 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 grantee 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/grantees 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 part 376 implement the government-wide debarment and suspension system guidance (2 CFR part 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 part 180.995 and 2 CFR part 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. Grantees may decide the method and frequency by which this determination is made and may check the Excluded Parties List System (EPLS) located at https://www.epls.gov/, although checking the EPLS is not required.
Prior to the drawdown of funds for each grant award, grantees must report to the funding IC if the grantee or any of its principals:
Disclosure of unfavorable information by grantees 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 grantees elect to submit with the disclosed information. However, if it is later determined that a grantee 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.
Grantees 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 grantee 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 part 180.980), grantees must verify that the person (as defined in 2 CFR part 180.985) is not excluded or disqualified. Grantees 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 DHHS.
Grantees 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 grantee if it or any participants are presently excluded or disqualified.
Grantees 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. § 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 grantee 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 part 182; HHS implementing regulations are set forth in 2 CFR part 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.
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 part 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 grantees applies only when grantees 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 grantee 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 grantee 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 grantees and investigators (except Phase I SBIR/STTR applicants and grantees) to comply with the requirements of 42 CFR part 50, Subpart F, "Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought." A Final Rule amending this PHS regulation (and the companion regulation at 45 CFR part 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). An Institution applying for or receiving PHS funding from a grant or cooperative agreement that is covered by the rule must be in full compliance with all of the revised regulatory requirements no later than August 24, 2012, and immediately upon making its institutional Financial Conflict of Interest (FCOI) policy publicly accessible as described in the regulation. In the interim, Institutions should continue to comply with the prior version of the regulation published in 1995 and report Investigator FCOIs to NIH as required by that framework.
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 Project Director or Principal Investigator 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 part 50, Subpart F, including that:
When the Institution determines that a Financial Conflict of Interest 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 will include the following information:
The Institution will incorporate as part of a written agreement with a subrecipient terms that establish whether the Financial Conflict of Interest policy of the awardee Institution or that of the subrecipient will apply to subrecipient Investigators and include time periods to meet disclosure and/or Financial Conflict of Interest reporting requirements. Subrecipient Institutions who rely on their Financial Conflict of Interest policy must report identified Financial Conflicts of Interest to the awardee Institution in sufficient time to allow the awardee Institution to report the Financial Conflict of Interest 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 Financial Conflict of Interest 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 Financial Conflicts of Interest 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 part 50, Subpart F. Applicants and grantees must review the regulation in its entirety to ensure compliance with all of the requirements. Resources applicable to Financial Conflict of Interest, 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:
Grantees 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:
Grantee 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, grantees 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 grantees 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 grantees 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/grantee must provide assurance that one from the NIH Registry will be used.
DHHS regulations for Protection of Human Subjects, 45 CFR part 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 part 46, Subpart A.
In addition, 45 CFR part 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 part 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 http://www.hhs.gov/ohrp/policy/index.html#topics.
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.
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.
Guidance for grantees conducting research on human fetal tissue and other information on the governing Federal statute is found in sections 498A and 498B of the PHS Act, 42 U.S.C. 298g-2.
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.
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 grantee. 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 part 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 grantee 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)). Grantee 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 part 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 part 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 grantee 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 plans for involvement of human subjects cannot be described in the application, applicants must provide a detailed explanation why it is not possible to develop definite plans. Prior to the involvement of human subjects the grantee 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.
Grantees 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 part 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 part 46.
The Federalwide Assurance (FWA) commits the institution to compliance with the requirements set forth in 45 CFR part 46, and the Terms of Assurance. Each institution that is "engaged" in HHS supported human subjects research must obtain an FWA from 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 part 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 have been obtained and accepted by NIH.
Each legally separate entity must file its own FWA even if the organization does not operate its own IRB and designates another IRB (registered with OHRP and agreeing to the designation) for that purpose. Affiliated organizations or organizations that will serve as additional performance sites for the grant-supported research also must file an FWA. It is the grantee organization's responsibility to ensure that all sites engaged in research involving human subjects have an appropriate FWA and IRB approval consistent with 45 CFR part 46. It also is the grantee'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/).
Grantees must provide a certification to NIH that the research application has been approved by an appropriate IRB, consistent with 45 CFR part 46. IRB approval must have been granted within 12 months before the budget period start date to be valid.
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 priority 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 part 46.203(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, grantee institutions must have written procedures for ensuring prompt reporting to the IRB, appropriate institutional officials, and the NIH any unanticipated problem involving risks to subjects to others (45 CFR part 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 any supporting department or agency head (45 CFR part 46.113). Grantee institutions must also file incident reports with OHRP of unanticipated problems involving risks to subjects or others, serious or continuing noncompliance with 45 CFR part 46 or with the requirements or determinations of the IRB, and suspension or termination of IRB approval. See OHRP 5/27/2005 Guidance on Reporting Incidents to OHRP (http://www.hhs.gov/ohrp/policy/incidreport_ohrp.html).
OHRP has regulatory responsibility for oversight of grantee 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 compliance oversight evaluations 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. 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 and how adverse events will be reported to the IRB, the NIH and, when appropriate, follow OBA guidelines, and FDA regulations for INDs and IDEs.
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. Grantees 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 21 years.
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 part 46 Subpart D, which addresses 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.
188.8.131.52 Inclusion of Women and Minorities as Subjects in Clinical Research and Reporting Sex/Gender and Racial Ethnic Participation
NIH-conducted and –supported Clinical research must conform to the NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm), in accord with section 492B of the PHS Act, added by the NIH Revitalization Act of 1993. 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 women and members of minority groups and their subpopulations must be addressed in developing a research design appropriate to the scientific objectives of the study. A proposed outreach program for recruiting women and minorities as participants should also be included. When an NIH-defined Phase III clinical trial is proposed, investigators must consider whether clinically important sex/gender and race/ethnicity 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 project is 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."
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 subject protection. Among other provisions, FDA regulations for human subjects protection 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 grantee, 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 grantee or to a pharmaceutical company, the legal responsibility for monitoring the clinical trial and reporting to FDA rests with the sponsor rather than the grantee. This generally will be the case for larger, multi-site clinical trials. If the grantee is the IND/IDE holder, commonly referred to as an "investigator-initiated IND/IDE," the grantee or the investigator serves as the sponsor and assumes the legal responsibility. In any case, the grantee 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 grantee 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 grantee), 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 grantee even if the grantee 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 part 93, which also describes types of activities, such as legislative liaison activities and professional and technical services, which are not subject to this prohibition.
Applicants for NIH awards with total costs expected to exceed $100,000 are required to certify that they
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 an additional restriction concerning Lobbying.
Consistent with EO 12770 (July 25, 1991), Metric Usage in Federal Government Programs, measurement values in applications and grantee-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.
4.1.19 Military Recruiting and Reserve Officer Training Corps Program Access to Institutions of Higher Education
Section 588 of the National Defense Authorization Act of 1995, amended (10 U.S.C. §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, grantees 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.
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 note, 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 part 73, 9 CFR part 121 and 7 CFR part 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 DNA molecules also is subject to the NIH Guidelines for Research Involving DNA Molecules (NIH Guidelines) (see Recombinant DNA Molecules, Research Involving (including Human Gene Transfer Research) in this section for applicability of these guidelines). The NIH Guidelines apply to (1) research projects involving recombinant DNA that are conducted at or sponsored by an organization that receives NIH support for recombinant DNA research (for research performed abroad, the NIH Guidelines apply if the research is supported by NIH funds) and (2) research projects involving testing in humans of materials containing recombinant DNA developed with NIH funds, if the organization that developed the materials sponsors or participates in those projects. The NIH Guidelines are available at http://oba.od.nih.gov/oba/index.html.
Domestic grantees who conduct research involving select agents or toxins (see Section 3 and 4 of 42 CFR part 73 and 9 CFR part 121 and Section 3 of 7 CFR part 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 Institutions and International Organizations who conduct research involving select agents (see 42 CFR part 73 for the select agent list; and 7 CFR part 331 and 9 CFR part 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 part 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. Grantees 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 part 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.
Grantees who conduct research involving select agents (see 42 CFR part 73 for the select agent list; and 7 CFR part 331 and 9 CFR part 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. grantee must provide information from the foreign institution satisfactory to the NIH that a process equivalent to that described in 42 CFR part 73 for U.S. institutions is in place and will be administered on behalf of all select agent work sponsored by these funds. Grantees must be willing to address the following key elements appropriate for the foreign institution: 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 part 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.
The NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines) (January 2011 or latest revision) apply to all research projects that involve recombinant DNA and are conducted at or sponsored by an organization that receives NIH support for recombinant DNA research. A copy of the NIH Guidelines is available at http://oba.od.nih.gov/rdna/nih_guidelines_oba.html.
As defined by the NIH Guidelines, recombinant DNA molecules are either (1) molecules that are constructed outside of living cells by joining natural or synthetic DNA segments to DNA molecules that can replicate in a living cell or (2) molecules that result from the replication of those described in (1). 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 DNA research at the organization, or a requirement for NIH prior approval of any or all recombinant DNA projects at the organization. Two specific requirements of the NIH Guidelines are discussed below, but the grantee should carefully review the NIH Guidelines in their entirety to ensure compliance with all of the requirements for projects involving recombinant DNA techniques.
Recombinant DNA research involving select agents also is subject to pertinent CDC and USDA regulations, 42 CFR part 73, Select Agents and Toxins; and 7 CFR part 331 and 9 CFR part 121, Possession, Use, and Transfer of Biological Agents and Toxins.
Each organization that conducts research involving recombinant DNA, 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 DNA 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's Office of Biotechnology Activities (OBA). 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.
Section IV of the NIH Guidelines also specifies the roles and responsibilities of PD/PIs, biological safety officers (BSOs) and grantee institutions with respect to the safe conduct and oversight of recombinant DNA 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 PD/PIs to report serious adverse events that are unexpected and are possibly associated with human gene transfer intervention to OBA and the IBC within 15 calendar days of investigator notification of the sponsor, or within 7 days if life-threatening or fatal. In addition, annually, investigators must submit to OBA certain information about protocols. Further information about the content of these reports can be found in Appendix M-I-C-3 of the NIH Guidelines. Investigators may use GeMCRIS database (http://www.gemcris.od.nih.gov/) as an electronic tool to report adverse events on human gene transfer trials to NIH OBA.
4.1.25 Reporting and Assurance Requirements for Institutions Receiving Awards for Training of Graduate Students for Doctoral Degrees
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:
D43, TU2, T15, T32, T37, T90, U2R, U90, and U54/TL1
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.
Grantees 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 non-competing continuation progress report (PHS 2590).
Title 42 CFR part 93, PHS Policies on Research Misconduct, Subpart C, "Responsibilities of Institutions" specifies grantee 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 part 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 grantee 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 grantee 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 part 93, Subpart C. The grantee 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 grantee 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 grantees with investigating and reporting on research misconduct, and IC staff members are available to provide technical assistance and to work with grantees to protect funded projects from the adverse effects of research misconduct.
The grantee is responsible for the actions of its employees and other research collaborators, including third parties, involved in the project. When the grantee finds research misconduct by anyone working on an NIH grant-supported project, whether at the grantee organization or at a third-party organization, the grantee 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. Examples of possible sanctions by NIH are withdrawal of approval of the PD/PI or other senior/key personnel, debarment, disallowance of costs associated with the invalid or unreliable research, withholding of a continuation award, or suspension or termination, in whole or in part, of the current award. These actions are described in Administrative Requirements—Enforcement Actions.
Where research misconduct has affected data validity or reliability, ORI or NIH may require the grantee 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 grantee does not comply with this requirement, NIH may invoke its rights, under 45 CFR part 74 or 92, 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 grantees 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 grantees 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 grantees 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 grantee 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 grantee 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 grantee 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 grantee against a PD/PI or other senior/key personnel under an NIH grant, the grantee must request prior approval of the proposed replacement as specified in Administrative Requirements—Changes in Project and Budget—Prior Approval Requirements.
The grantee 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 grantees 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 grantee 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 part 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 part 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).
The following statutory provisions limit the use of funds on NIH grants, cooperative agreements, and contract awards. These are provided separately in this section since they are subject to change annually based on specific appropriation language that restricts the use of grant funds. References to "Act" in these sections refer to the governing HHS annual appropriation Act. A list of Appropriation Mandates applicable to each fiscal year can be found on the OER Web site.
All HHS grantees must acknowledge Federal funding when issuing statements, press releases, requests for proposals, bid invitations, and other documents describing projects or programs funded in whole or in part with Federal money. Grantees are required to state (1) the percentage and dollar amounts of the total program or project costs financed with Federal money and (2) the percentage and dollar amount of the total costs financed by nongovernmental sources.
See also Availability of Research Results—Rights In Data (Publication and Copyrighting) for additional information on acknowledging NIH grant support for each publication that results from NIH grant-supported research.
None of the funds appropriated or otherwise made available by the governing appropriation Act may be used to enter into a contract in an amount greater than $5,000,000 or to award a grant in excess of such amount unless the prospective contractor or grantee certifies in writing to NIH that, to the best of its knowledge and belief, the contractor or grantee has filed all Federal tax returns required during the 3 years preceding the certification, has not been convicted of a criminal offense under the Internal Revenue Code of 1986, and has not more than 90 days prior to certification, been notified of any unpaid Federal tax assessment for which the liability remains unsatisfied, unless the assessment is the subject of an installment agreement or offer in compromise that has been approved by the Internal Revenue Service and is not in default, or the assessment is the subject of a non-frivolous administrative or judicial proceeding.
None of the funds made available in the governing appropriations Act may be used to disseminate scientific information that is deliberately false or misleading
NIH funds may not be used to support human embryo research. NIH funds may not be used for (1) the creation of a human embryo or embryos for research purposes; or (2) for research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero under 45 CFR part 46.204(b) and subsection 498(b) of the PHS Act (42 U.S.C. 289g(b)). The term "human embryo or embryos" includes any organism not protected as a human subject under 45 CFR part 46, as of the date of enactment of the governing appropriations act, that is derived by fertilization, parthenogenesis, cloning, or any other means from one or more human gametes or human diploid cells.
In addition to the statutory restrictions on human fetal research under subsection 498((b) of the PHS Act, by Presidential memorandum of March 4, 1997, NIH is prohibited from using Federal funds for cloning of human beings.
NIH appropriated funds may not be used, other than for normal and recognized executive-legislative relationships for publicity or propaganda purposes, for the preparation, distortion, or use of an kit, pamphlet, booklet, publication, radio, television, or video presentation designed to support or defeat legislation pending before the Congress or any State legislature, except in presentation to the Congress or any State legislature itself. No part of any governing appropriation Act shall be used to pay the salary or expenses of any grant or contract recipient, or agent acting for such recipient, related to any activity designed to influence legislation or appropriations pending before the Congress or any State legislature. Also see Public Policy Requirements and Objectives—Lobbying Prohibition and Cost Considerations—Allowability of Costs and Activities—Selected Items of Cost.
Grantees are prohibited from knowingly using appropriated funds to support activities that promote the legalization of any drug or other substance included in Schedule I of the schedule of controlled substances established by section 202 of the Controlled Substances Act, 21 U.S.C. 812 except for normal and recognized executive-congressional communications. This limitation does not apply if the grantee notifies the GMO that there is significant medical evidence of a therapeutic advantage to the use of such drug or other substance or that federally sponsored clinical trials are being conducted to determine therapeutic advantage (see also Public Policy Requirements/Controlled Substances).
NIH appropriated funds and funds in any trust fund to which funds are appropriated in the governing appropriation Act may not be spent for any abortion. None of the funds appropriated in the governing appropriation Act, and none of the funds in any trust fund to which funds are appropriated in this Act, shall be expended for health benefits coverage that includes coverage of abortion. The term "health benefits coverage" means the package of services covered by a managed care provider or organization pursuant to a contract or other arrangement.
NIH appropriated funds may not be used to distribute any needle or syringe for the purpose of preventing the spread of blood borne pathogens in any location that has been determined by the local public health or local law enforcement authorities to be inappropriate for such distribution.
None of the funds appropriated in the governing appropriation Act for the NIH, shall be used to pay the salary of an individual through a grant or other extramural mechanism at a rate in excess of Executive Level 1. Applications and proposals with categorical direct cost budgets reflecting direct salaries of individuals in excess of Executive Level 1 per year will be adjusted in accordance with the legislative salary limitation. Current and historical information on the applicable salary cap for each fiscal year is found on the OER Salary Cap Summary webpage.