Planning Project for Testosterone Trials in Aging Men

RFA Number: RFA-AG-05-005

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 Institute on Aging (NIA/NIH), (http://www.nia.nih.gov)

Announcement Type
New

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

Catalog of Federal Domestic Assistance Number(s) 93.866

Key Dates
Release Date: October 12, 2004
Letters Of Intent Receipt Date(s): December 10, 2004
Application Receipt Dates(s): January 11, 2005
Peer Review Date(s): March, 2005
Council Review Date(s): May, 2005
Earliest Anticipated Start Date: June, 2005
Additional Information To Be Available Date (Url Activation Date): Not Applicable
Expiration Date: January 12, 2005


Due Dates for E.O. 12372

Not Applicable

Executive Summary

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

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 Information
    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
      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
      D. Sharing Research Resources

  Section VI. Award Administration Information
    1. Award Notices
    2. Administrative Requirements
      A. Cooperative Agreement Terms and Conditions of Award
        1. Principal Investigator Rights and Responsibilities
        2. NIH Responsibilities
        3. Collaborative Responsibilites
        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

1. Research Objectives

The National Institute on Aging (NIA) invites applications for planning and protocol development for a coordinated set of clinical trials of the efficacy and safety of testosterone treatment in older men for specific symptomatic conditions that may be related to low testosterone levels, and of effects of testosterone treatment in middle-aged men on outcomes and risk factors possibly related to low testosterone levels. The award will support planning activities, biostatistical and other data analyses needed for trials design, and protocol development.

Background

Many older men have circulating levels of testosterone well below the usual range in healthy young men. Many older men also have conditions that might be related to low testosterone levels: e.g., muscle weakness, sexual dysfunction, and cognitive dysfunction. Though epidemiologic data and some small intervention studies indicate that testosterone treatment for older men with low testosterone levels might alleviate some of these conditions, there are no conclusive clinical trials data on this issue, nor are the adverse effects of this therapy in these populations completely understood.

Some data from epidemiologic studies and small intervention studies also indicate that testosterone treatment for older and middle-aged men with low testosterone levels may also have favorable effects on risk for cardiovascular disease, fractures, and other age-related conditions, but conclusive evidence from clinical trials is lacking regarding these possible preventive effects, and potential adverse effects on risk for these and other age-related outcomes.

Many clinical, methodological, ethical, and practical issues relate to the challenge of resolving the above uncertainties through clinical trials. Recently, in response to a request by the National Institute on Aging and the National Cancer Institute, the Institute of Medicine (IOM) of the National Academy of Sciences completed a study on these issues. The report of this study, Testosterone and Aging: Clinical Research Directions, is available from the Institute of Medicine (http://www.nap.edu/catalog/10852.html).

The report recommended that clinical trials be conducted in men 65 years of age and over with testosterone levels below the physiologic levels of young adult men, and with one or more symptoms that might be related to low testosterone. The report recommended that primary outcomes for such trials be clinical endpoints for conditions for which there have been suggestions of efficacy of testosterone, particularly where there are not clearly effective and safe alternative pharmacologic therapies. The report specifically identified four such conditions: weakness/frailty/disability, sexual dysfunction, cognitive dysfunction, and impaired vitality/well-being/quality of life.

The report also noted that the growing population of middle-aged men (age 45 to 65 years) using testosterone raises important public health concerns about the benefits and risks in this age group, and that relatively small clinical trials of the benefits of testosterone therapy in middle-aged men could readily be fielded as additional arms of the initial efficacy trials in older men.

The report made recommendations for addressing specific safety concerns regarding participants in such trials.

The report also recommended that such trials should be coordinated under a cooperative agreement or similar mechanism to produce a common core data set that would maximize the information obtained from different trials.

Objectives and Scope

This RFA seeks applications to plan and develop a protocol for a coordinated set of clinical trials of effects of testosterone treatment, consistent with the recommendations in the IOM report referred to above, in symptomatic older men to determine treatment efficacy for the four conditions identified in the report, and in middle-aged men having at least one of the four conditions. The plan to be developed should also include procedures for maximizing participants' safety, taking into consideration the issues discussed in the report.

As recommended in the IOM report, applicants are requested to plan the development of a common core data set. To implement the recommendation for coordination, applicants are requested to consider options for establishment and operation of a coordinating center and central laboratory, as well as other procedures or structures for coordination they consider to be useful.

To accomplish these tasks, applicants for the planning/protocol development award may request support for activities such as meetings of the investigators, conference calls, data analyses, acquisition of expert advice from consultants, preliminary recruitment of clinical sites, and related support and logistical activities.

Applicants are encouraged to include in their planning group individuals with expertise in the wide range of scientific areas pertinent to this research, including biostatistics, clinical trials design and implementation, data management, central laboratory procedures, endocrinology (particularly with regard to androgen therapy), medicine (including geriatrics), evaluation of muscle and physical performance, sexual dysfunction, cognitive dysfunction, psychology, psychiatry, functional assessment methodology, and evaluation of prostate conditions and symptoms.

NIA expects that at the end of this one year planning/protocol development project, the awardee will submit a proposal to the Institute to support the coordinated set of trials. This proposal will be peer-reviewed by a NIA scientific review group, with secondary review by the National Advisory Council on Aging. Any resulting award will be a Cooperative Agreement with appropriate terms and conditions of award.

NIA has planned for the option of allocating up to $24 million (direct plus indirect costs) over up to five years of support for the set of coordinated trials that will be planned by the awardee. The set of coordinated trials should be planned assuming that the contribution from NIA is not more than $24 million. NIA funding of the planning/protocol development project will not obligate NIA to accept an application for the set of trials, nor will NIA acceptance of such a proposal imply that NIA will necessarily fund the set of trials. In the event that NIA agrees to accept such an application to support the coordinated set of trials , the final scope and budget range of the proposed set of clinical trials that NIA will accept will be determined by the NIA.

Section II. Award Information

1. Mechanism of Support

This funding opportunity will use the National Institutes of Health (NIH) U01 award mechanism.

The NIH (U01) is a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the section VI. 2. Administrative and National Policy Requirements, "Cooperative Agreement Terms and Conditions of Award".

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. http://grants.nih.gov/grants/funding/phs398/phs398.html

This RFA is a one-time solicitation. The total project period for applications submitted in response to this RFA may not exceed one year.

2. Funds Available

NIA intends to commit approximately 700,000 dollars in total costs in FY 2005 to fund one new grant in response to this RFA. An applicant may request a project period of up to one year. Applications requesting a larger amount will be returned to the applicant.

Although the financial plans of the NIA provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

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.

2. Cost Sharing

This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing

3. Other-Special Eligibility Criteria
An applicant may submit one application under this announcement.

Section IV. Application Submission Instructions

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. 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 D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

See Section VI.2 Administrative 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 application receipt date listed below.

3.A. Receipt, Review and Anticipated Start Dates

Letter of Intent Receipt Date: December 10, 2004
Application Receipt Date: January 11, 2005
Peer Review Date: March, 2005
Council Review Date: May, 2005
Earliest Anticipated Start Date: June, 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:


Sergei V. Romashkan, M.D., Ph.D.
Clinical Trials Branch
Geriatrics and Clinical Gerontology Program
National Institute on Aging
7201 Wisconsin Avenue
Suite 525A
Bethesda, MD 20892-9205
(Fed Ex Packages use ZIP 20814)
Telephone: 301-435-3047
Fax: 301-480-1066
Email: romashks@nia.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:


Mary Nekola, Ph.D., Chief
Scientific Review Office
National Institute on Aging
7201 Wisconsin Avenue,
Suite 2C212
Bethesda, MD 20892-9205
Telephone: (301) 496-9666
FAX: (301) 402-0066
Email: NekolaM@nia.nih.gov


Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.

3.C. Application Processing

Applications must be received on or before the application receipt date listed in the heading of this funding opportunity. If an application is received after that date, it will be returned to the applicant without review. Applications will be evaluated for completeness by CSR and for responsiveness by the NIA. Incomplete and nonresponsive 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 review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

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 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

All of the following instructions apply to the proposal for the planning/protocol development project.

1. The proposed applicant team may include staff of one institution or a consortium of institutions.

2. Applicants should present a table of organization for the planning/protocol development grant and time line indicating the sequence and date by which steps in planning and protocol development will be accomplished.

3. Prior experience in clinical research, including, IRB submissions, DSMB participation, FDA submissions, subject recruitment, and human subject protection should be described. Applicants must give evidence of their ability to recruit and retain subjects in clinical trials. Documentation of institutional support for participating in multi-center clinical trials should be provided in the form of letters of support from the appropriate institution officials.

4. The application must reflect adequate time commitment of personnel. Time commitment for the PI should be no less than 20%.

5. In order to ensure that data analysis is done independently of data acquisition, the Coordinating Center cannot have the same Principal Investigator as any of the clinical centers. In addition, there should be no overlap in personnel between the Coordinating Center and Clinical Centers.

6. Budget Information: Applicants should request support for the PI and other personnel, as outlined above. In addition, the budget for costs such as travel to the meetings of investigators, scheduling and conducting conference calls, acquisition of expert advice from consultants, preliminary data analyses, and related support and logistical activities associated with the project should be included. Applicants should budget for face-to-face meetings of the major investigators and for costs associated with organizing these meetings.

Plan for Sharing Research Data
Not applicable.

Plan for Sharing Research Resources
Not applicable.

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

Applications that are complete and responsive to this RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIA in accordance with the review criteria stated below.

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

3. Merit Review Criteria

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 discuss the following aspects of 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?

Reviewers will evaluate the processes, organization, staffing, and types of information or analyses that applicants propose to use in developing their plans for the trials. Examples include approaches to evaluate and select options for protocol design, organization, and conduct of the Study, and approaches to selecting essential study components (e.g., clinical centers, a Coordinating Center, etc.).

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?

Investigators: 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, reviewers will also consider plans for the Study to address the items below:

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 Minorities in Research: The adequacy of plans to include subjects from all racial and ethnic groups (and subgroups) as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. See also Section VIII-Other Information.


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
Data Sharing Plan: No data will be generated during the initial planning phase of the study.

3.D. Sharing Research Resources
In the planning phase no research resources will be generated.

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 award will be provided to the applicant organization by email. The notice of award 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 (Notice of Grant Award) are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

2. Administrative 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/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.

2.A. Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement (U 01 ), an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.


2.A.1. Principal Investigator Rights and Responsibilities

The Principal Investigator will have the primary responsibility for planning and protocol development for the Study within the guidelines of the RFA and for performing the scientific activity.

Awardees will retain custody of, and have primary rights to, the protocol(s) and other Study materials developed under this award, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

2.A.2. NIH Responsibilities

NIA staff assistance as NIA Collaborating Scientist will be provided by the representative of the Geriatrics and Clinical Gerontology Program, NIA. This NIA Collaborating Scientist will have substantial scientific/programmatic involvement during the conduct of this activity through technical assistance, advice and coordination above and beyond normal program stewardship for grants.

During performance of the award, the NIA Collaborating Scientist may provide appropriate assistance, advice, and guidance by: participating in the design of the activities; advising in the selection of sources or resources; and advising in management and technical performance.

Additionally, the NIA Program Official will be assigned to perform normal program stewardship responsibilities for this award and will be named in the award notice. The Government, via the NIA Program Official, will have access to data generated under this Cooperative Agreement and may periodically review the data and progress reports. The NIA Program Official may use information obtained from the data for the preparation of internal reports on the activities of the project. However, awardee will retain custody of, and have primary rights to, all data developed under this award. The NIA Program Official also may serve as an NIA Collaborating Scientist.

2.A.3. Collaborative Responsibilities

The planning/protocol development phase will be a collaborative effort that will require frequent interactions of awardees among themselves and with the NIA. Applicants must explicitly indicate their willingness to: participate in the study planning group meetings (expected to occur approximately four times during the planning/protocol development phase), and regular (bi-weekly) telephone conference calls . The NIA Collaborating Scientist will be a voting member of this planning group.

2.A.4. Arbitration Process

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to arbitration. An Arbitration Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

3. Award Criteria

The following will be considered in making funding decisions:

4. Reporting

Awardees will be required to submit a final PHS Non-Competing Grant Progress Report, Form 2590: 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:


Sergei V. Romashkan, M.D., Ph.D.
Clinical Trials Branch
Geriatrics and Clinical Gerontology Program
National Institute on Aging
7201 Wisconsin Avenue
Suite 525A
Bethesda, MD 20892-9205
(Fed Ex Packages use ZIP 20814)
Telephone: 301-435-3047
Fax: 301-480-1066
Email: romashks@nia.nih.gov


2. Peer Review Contacts:

Mary Nekola, Ph.D., Chief
Scientific Review Office
National Institute on Aging
7201 Wisconsin Avenue
Suite 2C212
Bethesda, MD 20892-9205
Telephone: (301) 496-9666
FAX: (301)402-0066
Email: nekolam@nia.nih.gov


3. Financial or Grants Management Contacts:

Deborah Stauffer
Grants and Contracts Management Office
National Institute on Aging
7201 Wisconsin Avenue
Suite 2N212
Bethesda, MD 20892-9205
Telephone: (301) 496-1472
FAX: (301) 402-3672
Email: stauffed@nia.nih.gov

Section VIII. Other Information

Required Federal Citations

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.

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity, and dose-finding studies (phase I); efficacy studies (Phase II) efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants. (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

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.

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.

Public 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 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.

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.


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