EXPIRED
Department of Health and Human Services
Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov)
Components of Participating Organizations
National Center for Research Resources (NCRR), (http://www.ncrr.nih.gov)
Title: NCRR Science Education Partnership Award (SEPA) [R25]
Announcement Type
This is a reissue of PAR-05-068 issued March 14, 2005
Program Announcement (PA) Number: PAR-06-080
Catalog of Federal Domestic Assistance Number(s)
93.389
Key Dates
Release Date: November 30, 2005
Letters of Intent Receipt Date(s): December 27, 2005
Application Receipt Dates(s): January 27, 2006
Peer Review Date(s): March 2006
Council Review Date(s): May 2006
Earliest Anticipated Start Date: July 2006
Additional Information To Be Available Date (Url Activation Date): Not applicable
Expiration Date: January 28, 2006
Due Dates for E.O. 12372
Not Applicable
Additional Overview Content
Executive Summary
Part I Overview Information
Part II Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
Section II. Award Information
1. Mechanism(s) of Support
2. Funds Available
Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2.Cost Sharing or Matching
3. Other - Special Eligibility Criteria
Section IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Receipt and Review and Anticipated Start Dates
1. Letter of Intent
B. Sending an Application to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements
Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award Dates
Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
A. Cooperative Agreement Terms and Conditions of Award
1. Principal Investigator Rights and Responsibilities
2. NIH Responsibilities
3. Collaborative Responsibilities
4. Arbitration Process
3. Reporting
Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)
Section VIII. Other Information - Required Federal Citations
1. Research Objectives
The National Center for Research Resources (NCRR), Division for Clinical Research Resources supports the SEPA program that is designed to stimulate the interest in K-12 students in health related careers and to improve public awareness and knowledge of NIH supported research. SEPA projects may be three-years Phase I (Development and Implementation), two-year Phase II (Dissemination of an existing project) or five-year combination Phase I+II.
SEPA programs bring together biomedical and clinical researchers, educators, community groups, and other interested organizations in partnerships to create and disseminate science education programs on basic and clinical research accomplishments to K-12 students and teachers and the general public. Science centers and museums are encouraged to partner with academic and clinical organizations to develop in-house exhibits, public outreach programs and traveling exhibits on medical and clinical research topics.
SEPA projects are encouraged to employ novel concepts, approaches or methods that will challenge existing paradigms or develop new methodologies or technologies. Particular importance will be given to SEPA applications that target K-12 educational topics that may not be addressed by existing science curricula or other community and media activities whose scope of activity may include, but are not limited to, the following:
Proposed SEPA projects must represent new activities in health-related science education. However, coordination, via an independent but complementary project, with existing science education programs, such as those funded by the National Science Foundation, Howard Hughes Medical Institute, Department of Energy, Department of Education and others is encouraged.
See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.
Section II. Award Information1. Mechanism(s) of Support
This funding opportunity will use the NIH R25 award mechanism. Applicants may choose to submit: (1) a three-year Development (Phase I) application, (2) a two-year Dissemination (Phase II) application or (3) a five-year combined Development and Dissemination (Phase I + Phase II) application. Combined Phase I + Phase II applications are recommended for ongoing science education programs where the existing infrastructure and instructional model will be utilized to develop a new and unique science education topic and for science center or museum projects. Grant funds may be requested for direct costs that are clearly related and necessary to conduct the proposed research plan. Under the R25 mechanism, allowable Facilities and Administrative (F&A) costs are reimbursed at eight percent of the total allowable direct cost base. Subcontractors will be reimbursed at their standard F&A rate.
As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.
This funding opportunity uses the just-in-time budget concepts. It also uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application.
2. Funds Available
NCRR intends to commit approximately $3 million dollars in FY 2005 to fund approximately 10 new and/or competing continuation SEPA projects in response to this PAR. An applicant may request a direct costs budget of up to $250,000 per year. It is anticipated that the start date for awards will be June/July 2006.
Because the nature and scope of the proposed SEPA activity will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of NCRR provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.
Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.
Section III. Eligibility Information1. Eligible Applicants
1.A. Eligible Institutions
You may submit an application if your organization has any of the following characteristics:
An organization may be the applicant organization, or the sub-contractor organization, on only one active SEPA project or SEPA application.
1.B. Eligible Individuals
Any individual with the skills, knowledge, and resources necessary to carry out the proposed SEPA activity is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs.
An individual may be the principal investigator or co-investigator on only one SEPA project or SEPA application.
2. Cost Sharing or Matching
Not required.
3. Other-Special Eligibility Criteria
1. Address to Request Application Information
The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: [email protected].
Telecommunications for the hearing impaired: TTY 301-451-5936.
2. Content and Form of Application Submission
Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.
The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.
Supplementary Instructions:
Applications in response to this PAR should detail the Research Design and Methods (Phase I) and, if appropriate the Dissemination (Phase II) for development of a SEPA project incorporating the elements described below:
Face Page:
Page 4: Detailed Budget Page for Initial Budget Period:
Page 5: Budget for Entire Proposed Period of Support.
Project Description:
Progress Report:
Describe the educational approach, the scientific content, and the nature and extent of existing educational ands scientific partnerships and collaborative interactions.
Describe I detail any educational material produced. Identify the actual materials as Exhibits and include in the application. Examples of Exhibit items include: print materials (newsletters, booklets), videos, diskettes, and other computer software. Limit exhibits to items that are readily portable and to materials considered to be essential to the review and evaluation of your Phase II proposal.
A description of the Evaluation process for the project of pilot study. Summarize the result of this process. Include the evaluation instruments in the Appendix.
A summary of the impact of any current pilot project, or any current Phase I SEPA project, support received to date. Include an enrollment table with the numbers of students, teachers, and/or the public impacted by this approach, together with any other relevant outreach accomplishments.
Describe any dissemination activities to date, or describe the development of the current model relative to future dissemination plans.
Research Plan: (Phase I and Phase II applications):
Partnerships:
Teaching Curriculum and Materials:
Summer Teacher Training and Internships:
Dissemination:
Administrative management:
Evaluation:
Evaluation of K-12 Formal Science Education:
Evaluation of Science Centers, Museums and Informal Science Education:
Outreach: Science centers and museums should be include comprehensive plans to develop:
Appendix Materials:
3. Submission Dates and Times
See Section IV.3.A for details.
3.A. Receipt, Review and Anticipated Start Dates
Letter of Intent Receipt Date: December 27, 2005
Application Receipt Date(s): January 27, 2006
Peer Review Date: March 2006
Council Review Date: May 2006
Earliest Anticipated Start Date: June/July 2006
3.A.1. Letter of Intent
Prospective applicants are asked to submit a letter of intent that includes the following information:
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
The letter of intent should be e-mailed by the date shown above to:
L. Tony Beck, Ph.D.
Division for Clinical Research Resources
National Center for Research Resources
6701 Democracy Blvd, Room 916
Bethesda, MD 20892
Telephone: (301) 435-0805
FAX: (301) 480-3661
Email: [email protected]
3.B. Sending an Application to the NIH
Applications must be prepared using the research grant application forms found in the PHS 398 instructions for preparing a research grant application.
Submit one signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)
Also submit two additional copies of the application and all five copies of the Appendix to:
Office of Review
National Center for Research Resources
6701 Democracy Blvd, Room 1011
Bethesda, MD 20892
20817 Zip Code for courier deliveries
Telephone: (301) 435-0809
Fax: 301-480-3660
Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).
3.C. Application Processing
Applications must be received on or before the application receipt/submission date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review.
Upon receipt applications will be evaluated for completeness by CSR. Incomplete applications will not be reviewed.
The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique.
Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.
4. Intergovernmental Review
This initiative is not subject to intergovernmental review.
5. Funding Restrictions
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.
Pre-Award Costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or competing continuation award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new award.
The incurrence of pre-award costs in anticipation of a competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.
6. Other Submission Requirements
Not applicable
Plan for Sharing Research Data
Not applicable
Sharing Research Resources
NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.
The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting.
Applications must include a plan for sharing the educational materials and resources developed during and after the proposed SEPA project. Combined Phase I + II and Phase II applications must provide a detailed plan for wide scale dissemination of physical and web-based materials and for inclusion of these materials on the SEPA web site
1. Criteria
Only the review criteria described below will be considered in the review process.
2. Review and Selection Process
Applications that are complete will be evaluated for scientific and technical merit by an appropriate review group convened by the NCRR in accordance with the review criteria stated below.
As part of the initial merit review, all applications will:
The following will be considered in making funding decisions:
In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed project will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.
Significance: Does this study address an important problem? If the aims of the application are achieved, will this project foster student interest and participation, increase the awareness of the scientific process and ultimately generate a high level of confidence in the students for health science related careers. Will public awareness of NIH-support research be enhanced? What will be the effect of these activities on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?
Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?
Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?
Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Does the organizational structure of the applicant institution provides a stable environment where the principal investigator can fulfill the managerial and leadership duties required to successfully implement the proposed plan? Is there institutional commitment to the project in terms of support for the SEPA project, adequate space, and classroom time? If the proposal includes teacher training workshops, is there a mechanism to support teacher release time?
2.A. Additional Review Criteria:
In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:
Dissemination:
Sustainability:
Partnerships:
Evaluation:
Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section E on Human Subjects in the PHS Form 398).
Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan, Section E on Human Subjects in the PHS Form 398).
Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions will be assessed.
Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.
2.B. Additional Review Considerations
Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.
2.C. Sharing Research Data
Not applicable
2.D. Sharing Research Resources
The adequacy of a plan for sharing the educational materials and resources developed during and after the proposed SEPA project will be considered by SEPA Program staff when making recommendations about funding applications. Phase I + II and Phase II applications must provide a detailed plan for wide scale dissemination of physical and web-based materials and for inclusion of these materials on the SEPA web site.
3. Anticipated Announcement and Award Dates
Not applicable
1. Award Notices
If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA, signed by the grants management officer, is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 14 on the Application Face Page). If a grantee is not email enabled, a hard copy of the Notice of Award will be mailed to the business official.
Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Also Section IV.5. Funding Restrictions.
2. Administrative and National Policy Requirements
Human Subjects Research:
The definition of Human Subject means a living individual about whom an investigator conducting research obtains either data through intervention or interaction with the individual, or identifiable private information. Research is a systematic investigation designed to develop or contribute to generalizable knowledge. SEPA projects are therefore defined by the NIH to be Human Subjects Research. You must include a discussion of: (1) whether you will request a Human Subjects Exemption status or obtain Institutional Review Board (IRB) approval knowledge and (2) your plans for Inclusion of women, minorities and children.
SEPA Credit:
All publications, web sites, audiovisual materials and other products resulting from SEPA activities supported entirely or in substantial part by SEPA funding should include the following or comparable statement of support: "This project was supported by a Science Education Partnership Award (SEPA) from the National Center For Research Resources, National Institutes of Health. Its content is solely the responsibility of the authors and does not necessarily represent the official views of NCRR or NIH .
SEPA projects at science centers and museums may not be a component of a larger exhibit. Proposed projects must be identifiable as SEPA-supported exhibits and should have the following or comparable credit signage posted in a clearly visible location, Funding provided by a Science Education Partnership Award (SEPA) from the National Center For Research Resources, National Institutes of Health . Additional or follow-on support for the SEPA project should be credited as Additional Support Provided by".
Annual Meeting:
A SEPA Program Directors meeting is held annually to provide for the exchange of ideas, a forum for problem solving and networking among within the SEPA community. SEPA program directors and key staff are expected to attend in the annual meeting. The cost for attending the annual meeting should be included in the budget.
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the Notice of Award. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).
3. Reporting
Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement.
We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:
1. Scientific/Research Contacts:
L. Tony Beck, Ph.D.
Division for Clinical Research Resources
National Center for Research Resources
6701 Democracy Blvd
Room 916-MSC 4874
Bethesda, MD 20892
Telephone: (301) 435-0805
FAX: (301) 480-3661
Email: [email protected]
2. Peer Review Contacts:
Sheryl K. Brining, Ph.D.
Director, Office of Review
National Center for Research Resources
6701 Democracy Blvd
Room 1074 MSC 4874
Bethesda, MD 20892
Telephone: (301) 435-0809
FAX: (301) 480-3660
Email: [email protected]
3. Financial or Grants Management Contacts:
Ms. Leslie Le
Office of Grants Management
National Center for Research Resources
6701 Democracy Blvd
Room 1051 MSC 4874
Bethesda, MD 20892
Telephone: (301) 435-0856
FAX: (301) 480-3777
Email: [email protected]
Required Federal Citations
Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.
Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.
Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.
Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.
Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.
All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).
Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.
NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.
For more information about the Policy or the submission process please visit the NIH Public Access Policy Web site at http://www.nih.gov/about/publicaccess/ and view the Policy or other Resources and Tools including the Authors' Manual (http://www.nih.gov/about/publicaccess/publicaccess_Manual.htm).
Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to 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, and is administered and enforced by the DHHS Office for Civil Rights (OCR).
Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.
Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.
Authority and Regulations
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.
The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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Department of Health and Human Services (HHS) |
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