Part I Overview Information

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)

Announcement Type
New

Update: The following update relating to this announcement has been issued:

Program Announcement (PA) Number: PAR-05-068

Catalog of Federal Domestic Assistance Number(s)
93.389

Key Dates
Release Date: March 14, 2005
Letters of Intent Receipt Date(s): April 18, 2005
Application Receipt Dates(s): May 18, 2005
Peer Review Date(s): June 2005
Council Review Date(s): September, 2005
Earliest Anticipated Start Date: September, 2005
Additional Information To Be Available Date (Url Activation Date): Not Applicable
Expiration Date: May 19, 2005

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

Table of Contents

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

Part II - Full Text of Announcement


Section I. Funding Opportunity Description

1. Research Objectives

The National Center for Research Resources (NCRR) Division for Clinical Research Resources (DCRR) supports the SEPA program that is designed 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) 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 programs that provide K-12 students and teachers and the general public a better understanding of NIH-funded basic medical science and clinical research-based research. SEPA funding provides the means for clinical and basic researchers to convey both their knowledge and an appreciation of their scientific accomplishments to science education programs. Science centers and museums are encouraged to partner with academic and clinical organizations to develop in-house and traveling exhibits and to provide public outreach programs on fundamental biological, medical and clinical research topics.

NCRR encourages the submission of grant applications from eligible organizations for science education projects whose scope of activity may include, but are not limited to, the following:

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information

1. 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 Disseminations (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 science education topic or for science centers and 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. 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

The 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 September, 2005.

Because the nature and scope of the proposed research 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 the IC 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 http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-004.html.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

You may submit (an) application(s) if your organization has any of the following characteristics:

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research 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 a principal investigator on only one SEPA grant application.

2. Cost Sharing or Matching

Not required

The most current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing.

3. Other-Special Eligibility Criteria

Section IV. Application and Submission Information

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) 435-0714, Email: GrantsInfo@nih.gov.

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:

1. 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:

2. Face Page:

a. Item 1, Title: Indicate whether this is a Phase I, a Phase II or a combination Phase I+II application.

b. Item 2, Response: Check “YES” and identify the number and title of this Program Announcement (PAR).

c. Item 4, Human Subjects Research: Check “YES”. All SEPA programs involve human subjects for which and Exemption or Human Subject Assurance must be provided. See the REQUIRED FEDERAL CITATIONS section at the end of this PAR for guidelines or contact the SEPA Program Officer or the Grants Management Specialist for assistance.

d. Item 5, Vertebrate Animals: Check “YES” or “NO” as appropriate. See the REQUIRED FEDERAL CITATIONS section at the end of this PAR for guidelines or contact the SEPA Program Officer or Grants Management Specialist for assistance.

e. Item 6. The project period start date should be the anticipated award date (i.e. September 1, 2005). The length of the project period may not exceed three years for applications requesting separate support for Phase I proposals and two years for Phase II proposals. Applications that request support for both Phase II and I should request support for five years.

3. Exemptions:

a. NIH defines human subjects research as the study of living persons with whom an investigator directly interacts, intervenes, or obtains identifiable private information.

b. If you are claiming a human subjects exemption in Item 4 on the face page you must justify it in the human subjects section (Research Plan, E. Human Subjects in the Table of Contents) of your research plan. See the REQUIRED FEDERAL CITATIONS section at the end of this PAR for guidelines or contact the SEPA Program Officer or Grants Management Specialist for assistance.

4. Inclusion:

a. You must present a plan to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the proposed SEPA project.

b. You must justify your selection of specific racial and ethnic groups for the proposed SEPA project in the human subjects section of your Research Plan. (See Inclusion Criteria included in the section on Federal Citations, below.) If you have questions regarding Inclusion Criteria please contact the SEPA Program Officer for assistance.

5. Appendix Materials:

a. Appendix materials submitted with the application must adhere to the PHS 398 requirements.

b. Letters of collaboration, support, etc., should be placed in Section J, “Letters of Support”. All other information essential for the review of the application should be contained in the main body of the application and should not be placed in the Appendix section.

6. Summer Interns:

a. Both Phase I and Phase II applications may include a summer research or intern component for the students and/or teachers.

b. In these instances, the applicant must provide the names and competencies of the selection committee, a description of the participant selection process and a summary of the training and/or research experiences that the project will provide.

7. Preliminary Studies: (Phase I applications only):

a. For Phase I (model development), include the results of preliminary studies relevant to your application conducted by the principal investigator and/or other key personnel.

b. Provide other relevant information that will establish the experience and competence of both the program leadership staff and partnership organizations to effectively carry out the proposed project.

8. Progress Report: (Phase II dissemination applications only)

a. Phase II applications must provide a detailed progress report of achievements with the existing Phase I or pilot model, including:

  i. A description of the educational approach, the scientific content, and the nature and extent of existing educational ands scientific partnerships and collaborative interactions.
 ii. A detailed description of the educational material produced. Identify the actual materials as “Exhibits” and include in the application. Do not label these materials as Appendices. Some examples of Exhibit items are: 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.
iii. 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.
iv. A summary of the impact of the current Phase I SEPA project, or your pilot project, to date. Include an enrollment table with the numbers of students, teachers, an/or the public impacted by this approach and other relevant outreach accomplishments.
v. A description of any dissemination activities to date, or a description of the stage of development of the current model with respect to future dissemination plans.

9. Research Plan: (Phase I and Phase II applications):

a. Describe in detail the activities proposed and how they will contribute to achieving the stated goals of the program.

b. Give quantitative data on the numbers of teachers, students, and/or members of the general public projected to be involved and the quantity and types of educational materials to be produced and/or disseminated.

c. Explain the relevance and potential of this project for dissemination to a broad population, including efforts aimed at underrepresented groups in science, both women and minorities.

d. Explain clearly:

  i. The nature and extent of educational and scientific partnerships and collaborations to be developed
 ii. For those already established, any plans for expansion or modification
iii. The roles of key participants in the planning and conduct of the project.

e. Provide documentation of the interest and commitment of partnership members to this project in the form of letter of support.

f. Discuss how the proposed educational programs are appropriate and adequate to achieve the educational goals outlined.

g. Discuss how the project design plan will develop both the science education module as well as the methodology to present the module.

h. Both Phase I and II applications may include a summer internship or research component for the students and/or teachers. If relevant to your application:

  i. Provide the names and competencies of the selection committee
 ii. Describe the selection process and selection criteria
iii. Provide examples of the research experience that students and/or teachers will be provided

i. Describe the administrative plan to organize and manage the project content, staff and budget

j. Project a realistic timetable for the various tasks and activities for the entire project period requested.

10. Evaluation:

a. All applications must include a detailed Evaluation Plan for assessing the success of the proposed SEPA program. The Evaluation Plan should be an integral component of the early planning stages and must continue through the life of the SEPA project.

b. A minimum of ten percent (10%) of the direct costs budget should be devoted to project evaluation.

c. The use of external evaluators is required unless a valid justification can be made for an internal evaluation team.

d. Provide a detailed plan for evaluating the effectiveness of the program in achieving its objectives.

e. Document that the devaluation team is appropriate and qualified for your type of SEPA project.

f. Describe the development and implementation of the plan for formative and summative evaluation of the project activities. Include strategies for revisions to evaluative instruments and educational processes and/or materials.

11. Outreach:

a. Science centers and museums should be include in their proposals comprehensive plans to develop:

 i. Field trip programs for minority and underserved K-12 students, their teachers and families.
ii. Public outreach activities such as scientific presentations, plays, public forums and other outreach activities that will engage and educate the museum community as well as the general public on clinical trial results and other health related topics as reported in the popular press.

12. Innovations: SEPA projects are encouraged to:

a. Employ novel concepts, approaches or methods.

b. Challenge existing paradigms or develop new methodologies or technologies.

c. Include related learning tools, such as teamwork, writing and mathematics skills, inquiry-based thinking and problem solving under the umbrella of your main science education project.

13. Sustainability: Phase I + II and Phase II proposals must provide a plan for sustaining your SEPA program by means of institutional or other funding sources after the formal funding period ends.

14. Sharing of SEPA-developed teaching materials and evaluation data: Provide a plan for sharing the methods, teaching materials and evaluation data generated as a result of your SEPA proposal.

3. Submission Dates and Times
Applications must be mailed on or before the receipt date described below (Section IV.3.A). Submission times N/A.

3.A. Receipt, Review and Anticipated Start Dates

Letter of Intent Receipt Date: April 18, 2005
Application Receipt Date(s): May 18, 2005
Peer Review Date: June 2005
Council Review Date: September 2005
Earliest Anticipated Start Date: September 2005

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 is to be sent by the date listed at the beginning of this document.

The letter of intent should be sent 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: beckl@mail.nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the PHS 398 research grant application instructions and forms as described above. Submit a 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)

At the time of submission, two additional copies of the application and all copies of the Appendix material must be sent to:

Sheryl Brining, Ph.D.
Director, Office of Review
National Center for Research Resources
6701 Democracy Blvd, Room 1074
Bethesda, MD 20892
Telephone: (301) 435-0809
Fax: 301-480-3660
E-mail: brinings@mail.nih.gov

3.C. Application Processing

Applications must be received on or before the application receipt 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 and responsiveness by the NCRR.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial 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 (see also Section VI.3. Reporting).

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 or competing continuation award.

The incurrence of pre-award costs in anticipation of a competing or non-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
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.

Section V. Application Review Information

1. Criteria
Only the review criteria described below will be considered in the review process.

2. Review and Selection Process

Upon receipt, applications will be reviewed for completeness by the CSR and for responsiveness by the NCRR. Incomplete applications will not be reviewed.

Appropriate scientific review groups convened by NCRR in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit.

As part of the initial merit review, all applications will:

The following will be considered in making funding decisions:

SEPA's mission is to foster the development of new programs to improve K-12 and the general public's understanding of health science advances created by National Institutes of Health (NIH) funded clinical and basic research. 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. SEPA encourages applicants to submit proposals that will educate the general public on the clinical trials process and of the safeguards provided for patients participating in these trials. SEPA also encourages proposals that target topics that may not be addressed in existing K-12 science education curricula or by other community and media activities.

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 research 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.

1. Significance. Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Is the rationale for selecting the scientific area, the educational approach, and the target population clear?

2. 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?

3. 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? Does the proposed project address an unmet need, a broad population and minority and underrepresented groups?

4. 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? Has the PI committed sufficient time to the project to ensure that it will be implemented as proposed?

5. 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? Is there evidence of institutional support?

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:

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.

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.

Evaluation:

Sustainability:

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.

Section VI. Award Administration Information

1. Award Notices

After the peer review of the application is completed, the Principal Investigator will also receive a written critique called a Summary Statement.

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 Grant Award (NGA) will be provided to the applicant organization. The NGA signed by the grants management officer is the authorizing document.

The Notice of Grant Award will be sent electronically or by mail to the Business/Signing Official of the applicant organization as listed on the face page of the application.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NGA 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

Principal Investigator: The Principal Investigator has the primary responsibility to NCRR for implementation of the proposed project. This responsibility includes managerial authority over the SEPA-funded project, SEPA-supported staff and the allocation of the SEPA budget.

Annual Meeting: An annual SEPA Principal Investigator Meeting will be convened to foster collaboration, discuss newly emerging national strategies, coordinate dissemination, share evaluation methodologies and outcomes, and minimize duplication of efforts. Travel funds for these activities should be included in the budget request for each year, and a statement regarding willingness of the Principal Investigator to participate in these activities should be included in the application.

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the notice of grant 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. An Enrollment Inclusion Table, http://grants.nih.gov/grants/funding/2590/enrollmentreport.doc, should be included with the 2590 progress report.

Section VII. Agency Contacts

NCRR SEPA Program and Grants Management staff encourages potential applicants to contact them to discuss potential SEPA projects, scientific content, grant application issues or other questions related to the SEPA program. 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: beckl@mail.nih.gov

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: brinings@mail.nih.gov

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: leleslie@mail.nih.gov

Section VIII. Other Information

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).

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.

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.

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.


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NIH Funding Opportunities and Notices


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