Small Grants Program for Cancer Epidemiology

PA Number: PAR-04-159

Part I Overview Information



Department of Health and Human Services
 
Participating Organization:
National Institutes of Health (NIH), (http://www.nih.gov/)

Component of Participating Organization:  
National Cancer Institute (NCI), (http://www.nci.nih.gov/)

Announcement Type:
This Program Announcement (PAR) replaces PAR-03-010, which was published in the NIH Guide on October 16, 2002.

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

Catalog of Federal Domestic Assistance Number(s): 93.392-93.399

Release Date: September 28, 2004
Application Receipt Dates: November 21, 2005; March 20, 2006; July 20, 2006; November 20, 2006; March 20, 2007; July 20, 2007; November 20, 2007; March 20, 2008; July 21, 2008; November 21, 2008 
Peer Review Dates: February-March; June-July; October-November
Council Review Dates: May-June; September-October; January-February
Earliest Anticipated Start Dates: July, December, April
Expiration Date: March 21, 2006

Due Dates for E.O. 12372

Not Applicable

Executive Summary
The proposed PAR, using the R03 mechanism, is a reissuance of the current Small Grants Program for Cancer Epidemiology, PAR-03-010, which focuses on etiologic cancer research and provides support for pilot projects, testing of new techniques, secondary analyses of existing data, and development of innovative projects that could provide a basis for more extended research.

This PAR will use the NIH individual research project grants (R03) award mechanism.  As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.  The total budget may not exceed $100,000 in direct costs for the entire project.  The direct costs in any one year must not exceed $50,000.  The total project period for applications submitted in response to this announcement may not exceed 2 years.  The NIH has adopted a policy that limits the number of amendments to two.  The small grant is not renewable. The total amount to be awarded and the anticipated number of awards and duration will vary and depend upon the number of meritorious applications received.  

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

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.

A PI can submit one application on one topic. The application material is available at  http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format.

Telecommunications for the hearing impaired:  TTY 301-451-5936.

No set-aside funds are available for this PAR. Based on prior experience, we expect about 30-40 awards per year. The awards are $50,000 direct cost per year for a maximum of two years.

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
    3. Other - Special Eligibility Criteria

  Section IV. Application and Submission and Instructions
    1. Address to Request Application Information
    2. Content and Form of Application Submission
    3. Submission Dates
      A. Receipt and Review and Anticipated Start Dates
        1. Letter of Intent: Not applicable.
      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
    3. Merit Review Criteria
      A. Additional Review Criteria
      B. Additional Review Considerations
      C. Sharing Research Data: Not applicable.
      D. Sharing Research Resources: Not applicable.

  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. Award Criteria
    4. 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
The Division of Cancer Control and Population Sciences (DCCPs) of the National Cancer Institute (NCI) invites Small Grant (R03) applications relating to cancer epidemiology with a primary focus on etiologic cancer research.  These are short-term awards intended to provide support for pilot projects, testing of new techniques, or development of innovative projects that could provide a basis for more extended research.

1. Research Objectives

The purposes are to support pilot projects, test new techniques, and encourage innovative or high‑risk research. While definitive and costly studies are best supported by other research grants, a small grant can provide resources for essential tasks such as questionnaire development; preliminary assessment of exposure prevalence; test development, including field-testing; and secondary analyses of existing datasets.  Examples of research proposals that would apply to this PAR include, but are not limited to:

- validating measurements in body fluids and tissues of exogenous exposures  

associated with the development of cancer;

- applying epigenetic approaches in cancer epidemiology;

- analyzing existing data that otherwise may have gone unexplored, such as pooled analyses of data from multiple studies coordinated into consortia;

- explore relationship between reported tobacco use and actual delivered amounts of tobacco constituents in epidemiologic studies and other large datasets in order to develop standardized markers of exposure in cancer risk;

- planning an epidemiological study to apply validated relevant carcinogenesis markers to better understand the natural history of neoplasms and identify individuals at high risk;

- determining applicability of biomarkers of tumor initiation and progression for epidemiologic studies;

- epidemiologic studies in survivorship;

- developing and validating methods, including statistical applications, to measure dietary components and metabolites in foods and body fluids, in epidemiologic studies;

- exploring the etiology of mechanisms related to energy balance and the cancer risk and prognosis; and

- developing methodology to collect epidemiological data via the internet, maintaining integrity and confidentiality.

Investigators will be encouraged to propose epidemiologic studies using new approaches such as those involving use of circulating DNA, exfoliated cells, haplotype analysis, immunoassays, in silico assays, mass spectrometry, microsatellite assays, and proteomic arrays.  Also, investigators are encouraged to submit applications to study cancer sites not well-funded in the past by this PAR that are also needed for Epidemiology and Genetics Research Program (EGRP) portfolio balance, such as cancers of the esophagus, endometrium, liver, hematopoietic system (especially multiple myeloma), pancreas, testes, and brain. Investigators are encouraged to validate measurements in body fluids and tissues of exogenous exposures associated with development of cancer using biospecimen repositories from existing epidemiologic cohorts (http://epi.grants.cancer.gov/ResPort/cohorts.html).

Maintaining the overall approach for this PAR we are more guided to pilot projects for integration of technologies in special, pooled analyses of existing data from consortia, and web-based tools.

High priority areas in cancer epidemiology research have been identified by NCI-coordinated Progress Review Groups.  Applicants submitting grant applications in response to this PAR will be encouraged to review these reports and to consider research in these areas when in planning future R01 grants, developing and validating measurement methods, and linking genetic polymorphisms with other variables related to cancer risk.

R01 studies in cancer epidemiology usually require large sample sizes, complex logistics, extensive fieldwork, acquisition of biospecimens, and, sometimes, the acquisition of sensitive information such as reproductive histories.  The R03 mechanism is critical for helping ensure that these larger studies are feasible, the approaches are valid, and that pilot data are available for the grant applications.

Section II. Award Information

1. Mechanism of Support
 
This PAR (Program Announcement involving  Institute-managed review and special receipt dates) will use the NIH small research project grants (R03) award mechanism.  As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.  The total budget may not exceed $100,000 in direct costs for the entire project.  The direct costs in any one year must not exceed $50,000.  Please note that facilities and administrative (F&A) costs requested by any consortium participants are excluded from the direct cost limit per NIH Guide Notice NOT-OD-04-040.(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-040.html). The total project period for applications submitted in response to this announcement may not exceed 2 years.  NIH policy limits the number of amendments that may be submitted to one.  The small grant is not renewable.   

This funding opportunity uses just-in-time concepts. It also uses the modular as well as the non-modular budget formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular budget format described in the PHS 398 application instructions. Otherwise, follow the instructions for non-modular research grant applications.

2. Funds Available

No set-aside funds are available for this PAR. Based on prior experience, we expect about 30-40 awards per year. The awards are $50,000 direct cost per year for a maximum of two years. The start date for funded application will be July 2006.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions 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.

2. Cost Sharing
Not applicable,

3. Other-Special Eligibility Criteria  
Not applicable.

Section IV. Application Submission Instructions
1. Address to Request Application Information

The U.S. Public Health Service Form 398 (PHS 398) application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. 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 PHS 398 research grant application instructions and forms (rev. 5/2001).  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 DUNS number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/.  The DUNS number should be entered on line 11 of the face page of the PHS 398 form.  The PHS 398 document is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format.  For further assistance, contact GrantsInfo, Telephone: (301) 435-0714, Email:  GrantsInfo@nih.gov.

See also Subsection VI.2. Administrative and National Policy Requirements for additional information.

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.

3. Submission Dates

Applications must be received on or before the receipt dates listed below.

3.A. Receipt, Review and Anticipated Start Dates

Letter-of-Intent Receipt Date: Not applicable.
Application Receipt Dates: November 21, 2005; March 20, 2006; July 20, 2006; November 20, 2006; March 20, 2007; July 20, 2007; November 20, 2007; March 20, 2008; July 21, 2008; November 21, 2008
Peer Review Dates: February-March; June-July; October-November
Council Review Dates: May-June; September-October; January-February
Earliest Anticipated Start Dates: July, December, April

3.A.1. Letter of Intent

Not applicable.

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
Bethesda, MD  20817 (for express/courier service)

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

Referral Officer
Division of Extramural Activities
National Cancer Institute
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD  20892-8329
Rockville, MD  20852 (for express/courier service)

Appendix. The appendix may include original, glossy photographs, or color images of gels, micrographs, etc., provided that a photocopy (may be reduced in size) is also included within the page limits of the research plan. No publications or other printed material, with the exception of pre-printed questionnaires or surveys, may be included in the appendix.

Applications hand-delivered by individuals to the national cancer institute will no longer be accepted.  This policy does not apply to courier deliveries (i.e., FEDEX, UPS, DHL, etc.) (http://grants.nih.gov/grants/guide/notice-files/NOT-CA-02-002.html).  This policy is similar to and consistent with the policy for applications addressed to Centers for Scientific Review as published in the NIH Guide Notice at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-012.html.  Applications must be prepared using the PHS 398 research grant application instructions and forms as described above. 

3.C. Application Processing

Applications submitted in response to a PAR with specified receipt dates must be received by the dates listed on the first page of the announcement.

The NIH will not accept any application in response to this PAR 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 8 weeks.
 
4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All 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. Award Criteria).

6. Other Submission Requirements

Specific Instructions for Modular Grant applications.

Applications requesting up to $250,000 per year in direct costs must be submitted in a modular budget format. The modular budget format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular budgets. Additional information on modular budgets is available at http://grants.nih.gov/grants/funding/modular/modular.htm.


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. See the NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps and http://www.ott.nih.gov/policy/rt_guide_final.html. Investigators responding to this funding opportunity should include a plan for sharing research resources that address how unique research resources will be shared or explains why sharing is not possible.

The adequacy of the resources sharing plan and any related data sharing plan 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). See Section VI.3. Award Criteria.

Section V. Application Review Information


1. Criteria

This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm.

2. Review and Selection Process

Applications that are complete and responsive to the PAR will be evaluated for scientific and technical merit by an appropriate peer review group convened by the Division of Extramural Activities of the NCI in accordance with the review criteria stated below.  Incomplete and/or non-responsive applications will not be reviewed.

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

3. Merit Review Criteria

The NIH R03 small grant is a mechanism for supporting discrete, well-defined projects that realistically can be expected to be completed in 2 years and that require limited levels of funding.  Because the research plan is restricted to 10 pages, a small grant application will not have the same level of detail or extensive discussion found in an R01 application.  Accordingly, reviewers should evaluate the conceptual framework and general approach to the problem, placing less emphasis on methodological details and certain indicators traditionally used in evaluating the scientific merit of R01 applications including supportive preliminary data. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or from investigator-generated data.  Preliminary data are not required, particularly in applications proposing pilot or feasibility studies. 

The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health.  In the written comments, reviewers will be asked to evaluate the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals.  The scientific review group will address and consider each of these criteria in assigning the application’s overall score, weighting them as appropriate for each application. 

The 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, how will scientific knowledge be advanced?  What will be the effect of these studies on the concepts or methods that drive this field?

Approach:  Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project?  Does the applicant acknowledge potential problem areas and consider alternative tactics?

Innovation:  Does the project employ novel concepts, approaches or methods? Are the aims original and innovative?  Does the project challenge existing paradigms or develop new methodologies or technologies?

Investigator:  Is the investigator 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 (if any)?

Environment:  Does the scientific environment in which the work will be done contribute to the probability of success?  Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements?  Is there evidence of institutional support? 

3.A. Additional Review Criteria:

In addition to the above criteria, the following items will 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 also Section VIII - Other Information.

• 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 also Section VIII-Other Information.

• 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 398 research grant application instructions (rev. 5/2001) will be assessed.

3.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. 

3.C. Sharing Research Data

Not required.

3.D. 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. See the NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps and http://www.ott.nih.gov/policy/rt_guide_final.html. Investigators responding to this funding opportunity should include a sharing research resources plan that addresses how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the Principal Investigator before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590). See Section VI.3. Award Criteria.

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/archive/grants/policy/nihgps_2003/index.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.

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.

The NGA will be sent via e-mail to the administrative official whose name is listed in Block 12 on the Face Page of the Form PHS 398.

2. Administrative and National Policy Requirements  

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/archive/grants/policy/nihgps_2003/index.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/archive/grants/policy/nihgps_2003/index.htm).

2.A. Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Award Criteria  

The following will be considered in making funding decisions:

4. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually: (see http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement.

Section VII. Agency Contacts


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:

Mukesh Verma, Ph.D.
Division of Cancer Control and Population Sciences
National Cancer Institute
6130 Executive Blvd., EPN Room 5104
Bethesda, MD  20892-7324
Rockville, MD 20852 (for express/courier service)
Telephone:  (301) 594-7344
FAX:  (301) 402-4279
Email: vermam@mail.nih.gov


2. Peer Review Contacts:

Referral Officer
National Cancer Institute
Division of Extramural Activities
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 496-3428
FAX: (301) 402-0275
Email:  ncirefof@dea.nci.nih.gov

3. Financial or Grants Management Contacts:

Crystal Wolfrey
Team Leader, DCCPS Team
Grant Adminstration Branch
National Cancer Institute
6120 Executive Blvd., EPS Suite 243
Bethesda, MD 20892
Telephone:  (301) 496-8634
FAX:  (301) 496-8601
Email:  wolfreyc@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 (see http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing http://grants.nih.gov/grants/policy/data_sharing or state why this is not possible.

Investigators should seek guidance from their institutions on issues related to institutional policies, local Institutional Review Board (IRB) rules, as well as local, State, and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

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://grants1.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html). 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 at http://grants.nih.gov/archive/archive/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 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 U.S. Office of Management and Budget (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 that is available at 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.

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov/).  It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research. Applications that do not include this information will be returned without review.

Public Access to Research Data through the Freedom of Information Act:
The OMB Circular A-110 has been revised to provide public 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 PA 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.

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 PAR 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:
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.


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NIH Funding Opportunities and Notices


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