Expired PA-06-369: Research On Ethical Issues In Human Subjects Research (R01)

Department of Health
and Human Services (HHS)

NIH... Turning Discovery Into Health^®

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 Cancer Institute (NCI), (http://www.nci.nih.gov/)
National Human Genome Research Institute (NHGRI), (http://www.nhgri.nih.gov/)
National Institute on Aging (NIA), (http://www.nia.nih.gov/)
National Institute on Alcohol Abuse and Alcoholism (NIAAA), (http://www.niaaa.nih.gov)
National Institute of Allergy and Infectious Diseases (NIAID), (http://www.niaid.nih.gov/)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), (http://www.niams.nih.gov/)
National Institute of Child Health and Human Development (NICHD), (http://www.nichd.nih.gov/)
National Institute on Deafness and Other Communication Disorders (NIDCD), (http://www.nidcd.nih.gov)
National Institute on Drug Abuse (NIDA), (http://www.nida.nih.gov/)
National Institute of Environmental Health Sciences (NIEHS), (http://www.niehs.nih.gov/)
National Institute of General Medical Sciences (NIGMS), (http://www.nigms.nih.gov/)
National Institute of Mental Health (NIMH), (http://www.nimh.nih.gov/)
National Institute of Neurological Disorders and Stroke (NINDS), (http://www.ninds.nih.gov/)
National Institute of Nursing Research (NINR), (http://www.ninr.nih.gov/)
Office of Behavioral and Social Sciences Research (OBSSR), (http://obssr.od.nih.gov/)
Office of Dietary Supplements (ODS), (http://www.ods.od.nih.gov)
National Heart, Lung, and Blood Institute (http://www.nhlbi.nih.gov/)

Title: Research On Ethical Issues In Human Subjects Research (R01)

Announcement Type
This is a revision of PA-02-103, which was previously released May 1, 2002.

January 5, 2007 - The R01 portion of this funding opportunity has been replaced by PA-07-277, which now uses the electronic SF424 (R&R) application for February 5, 2007 submission dates and beyond.
October 31, 2006 - See Notice (NOT-HG-07-002) The NHGRI would like to inform the community that it is interested in receiving R03, R21 and R01 applications in response to these three Funding Opportunity Announcements and would thus like to clarify the language in the contact information.
June 9, 2006 (NOT-HL-06-130) - Notice to add NHLBI to list of participating institutes

Looking ahead: As part of the Department of Health and Human Services' implementation of e-Government, during FY 2006 the NIH will gradually transition each research grant mechanism to electronic submission through Grants.gov and the use of the SF 424 Research and Related (R&R) forms. Therefore, once the transition is made for a specific grant mechanism, investigators and institutions will be required to submit applications electronically using Grants.gov. For more information and an initial timeline, see http://era.nih.gov/ElectronicReceipt/. NIH will announce each grant mechanism change in the NIH Guide to Grants and Contracts (http://grants.nih.gov/grants/guide/index.html). Specific funding opportunity announcements will also clearly indicate if Grants.gov submission and the use of the SF424 (R&R) is required. Investigators should consult the NIH Forms and Applications Web site (http://grants.nih.gov/grants/forms.htm) for the most current information when preparing a grant application.

Program Announcement (PA) Number: PA-06-369

Catalog of Federal Domestic Assistance Number(s)
93.989, 93.213, 93.395, 93.837, 93.838, 93.866, 93.855, 93.856, 93.846, 93.865, 93.279, 93.173, 93.121, 93.847, 93.848, 93.849, 93.242, 93.361, 93.853, 93.273.

Key Dates
Release/Posted Date: April 26, 2006
Letters of Intent Receipt Date(s): Not Applicable
Application Submission Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm for details.
AIDS Application Submission Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS for details.
Peer Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward for details.
Council Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward for details.
Earliest Anticipated Start Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward for details.
Additional Information To Be Available Date (Url Activation Date): Not Applicable
Expiration Date for R01 Non-AIDS Applications: November 2, 2006
Expiration Date for R01 AIDS and AIDS-Related Applications: January 3, 2007

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

This FOA will use the Research Project R01 grant mechanism and runs in parallel with FOAs of identical scientific scope for Small Research Grants R03 (PA-06-367) and Exploratory/Developmental Grants R21 (PA-06-368) mechanisms to align proposed studies with i) investigator experience and ii) the state of knowledge in fields of interest.
Research Project applications must include hypotheses and preliminary data for proposed empirical research. Applicants are strongly encouraged to take into consideration issues that have relevance to specific missions of the NIH participating components.
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. Awards issued under this FOA are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.
Eligible organizations: For-profit or non-profit organizations; public or private institutions, such as universities, colleges, hospitals, and laboratories; units of State and local governments; eligible agencies of the Federal government; domestic or foreign institutions/organizations; faith-based or community-based organizations; and Indian/Native American Tribal Government (Federally Recognized); Indian/Native American Tribal Government (Other than Federally Recognized); and Indian/Native American Tribally Designated Organization.
Eligible Project Directors/Principal Investigators (PD/PIs) include any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution/organization to develop an application for support. PD/PI from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support
Applicants may submit more than one application, provided each application is scientifically distinct.
See Section IV.1. for application materials.
Telecommunications for the hearing impaired is available at: 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 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. Submission, 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
3. Reporting

Section VII. Agency Contacts
1. Scientific/Research Contacts
2. Peer Review Contacts
3. Financial/Grants Management Contacts

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives

This Funding Opportunity Announcement (FOA) issued by the National Institutes of Health (NIH) solicits research project grant applications (R01) addressing ethical issues that accompany the conduct of research involving human subjects

The purpose of this funding opportunity announcement is to solicit research addressing the ethical challenges of human subjects research in order to optimize the protection of human subjects and enhance the ethical conduct of human subjects research.

Recent developments in biomedical and behavioral research which include the rapid growth of new interventions and technologies, increasing involvement of foreign populations in human subjects research, and concerns about financial conflicts of interest among researchers, challenge investigators' abilities to interpret and apply the regulations. Other situations (e.g., research with vulnerable populations, research on stigmatizing diseases or conditions) may present difficulties for identifying strategies, procedures, and/or techniques that will enhance/ensure the ethical involvement of human subjects in research. Thus, research on ethical issues in human subjects research is necessary to enhance interpretation and application of ethical principles and regulatory requirements.

The research design for studies on ethical issues in human subjects research should be appropriate to the nature of the project(s) proposed and the disciplines involved. Given the conceptual and methodological complexity of many of these research questions, interdisciplinary and collaborative projects are encouraged, particularly those involving clinical researchers, ethicists, and behavioral/social scientists.

In conducting research on ethical issues in human subjects research, different conceptual frameworks for ethics (e.g., principlism, deontology, utilitarianism, rights, ethics of care, etc.) exist and may provide presuppositions and theoretical foundations from which bioethical questions can be formulated and tested. The questions and strategies for testing these issues must be consistent with existing Federal requirements. Currently, research supported by the Department of Health and Human Services (DHHS which includes NIH) follows the Code of Federal Regulations Protection of Human Subjects (45 CFR Part 46). For research conducted internationally, alternative guidelines that describe protections equivalent to those required by 45 CFR 46 may be used (http://www.hhs.gov/ohrp/humansubjects/assurance/filasur.htm), such as those developed by the World Health Organization, the Council for International Organizations of Medical Sciences, and other internationally recognized groups.

This FOA seeks applications for empirical research that address the ethical challenges of research involving human subjects with the goal of optimizing protections. The NIH is also issuing FOAs on the same topics using two other grant mechanisms: the R03 and R21, which will support conceptual as well as empirical research.

See http://grants.nih.gov/grants/guide/contacts/pa-06-367_368_369_differences.doc for an explanation of R01, R21, and R03 mechanisms.

Examples of the types of topics that would be appropriate for applications submitted under these announcements include, but are not limited to, the following:

1. Assessing Risks in Human Subjects Research

Assess how perceptions of risk may differ among investigators, IRB members, and potential subjects and their families, groups, and communities. Examine how features of the research, context of the research, or characteristics of research subjects (e.g., age, health status and stage of disease including those near the end of life, ethnic/cultural background, cognitive capacity, emotional or mental state, social status, gender, incarceration, enthusiasm/ optimistic expectation about research) may alter risk perception. Identify and evaluate strategies to respond to differing perceptions of risks by stakeholders.
Assess the severity and frequency of social, psychological, and/or economic harms (e.g., stigma, discrimination, personal and familial distress, depression, breaches of confidentiality, loss of insurance coverage, loss of employment, loss of housing, loss of benefits, domestic violence, incarceration) that may be associated with participation in or withdrawal from research. Develop and test methods to evaluate prospectively and minimize psychosocial risks in research. For example, formative research in a community may identify social or cultural issues or concerns prior to the conduct of research. Researchers may compare different methods to reduce risk, such as, for example, modifications to study design to reduce risks, or provision of additional services to research subjects.
Develop and test models of prospective risk assessment in human subjects research, including, but not limited to, risks of new technologies. Risk assessment can be particularly challenging in the case of early human trials of new technologies. How can preclinical data best be used to assess the risk of new technologies used in first human trials? How can estimates of risk be translated from animal and in vitro studies to clinical trials in human populations? How can the need to advance new technologies into clinical application be balanced with caution about exposing research subjects to unknown risks, and specifically, what scientific and ethical criteria are relevant to making these determinations? How can an assessment of the risks and benefits of research take into account the severity of disease and the urgency of need for new treatments as well as the possibility of therapeutic misconception?
Develop models for design of clinical trials of new technologies. What study designs are most appropriate to allow consideration of safety issues in the first human trials? How can information from clinical trials of related interventions be used in designing new trials and in assessing safety data?
Assess risks to privacy and confidentiality. Specific topics might include (but are not limited to): a) models for assessing confidentiality risks in research, including interventional research, social and behavioral research and research with data and specimens; b) research to assess the use and understanding of Certificates of Confidentiality and the role they play in IRB assessments of risks to subjects.

2. Issues in Informed Consent

Identify and evaluate strategies, procedures, or techniques for improving comprehension and voluntariness in the process of informed consent for research. This could include evaluation of communication processes that take place before, during or after the research, and/or measurement of comprehension, willingness to participate or continue participation, assent, and attitudes towards research. Examine how different aspects of the informed consent process affect these outcomes, including such parameters as:
Mode of presentation (e.g. oral, written, graphic, video);
Readability, complexity, and format of the language used;
Presentation of positive or negative aspects of participation in research, relative emphasis on benefits or burdens of participation;
Characteristics of the subject, such as language preference, age, gender, health status, education, emotional or mental state, cognitive capacity, cultural or ethnic background, views about medical professionals, and personal motivations;
Contextual features or circumstances in which informed consent takes place, including characteristics of the research staff; presence of an interpreter, location of the research (e.g., research hospital, private office, home); involvement of family members; involvement of subject advocates.
Evaluate different methods and identify best-practice strategies for consulting with communities in the United States and/or other countries regarding comprehension, willingness to participate, or willingness to continue with research at the individual, group, community, or population level.
Assess stakeholder attitudes regarding re-contacting subjects to obtain informed consent for additional uses of their data or to invite participation in other studies; examine the effect of re-contact on comprehension and willingness to participate.
Assess the extent to which prospective subjects decisions about joining research are voluntary. Explore models of decision-making and the effect of situational and individual characteristics on the decision-making process. Evaluate investigators attitudes regarding participants decision-making process. Assess the effects of incentives such as monetary compensation, provision of medical care or other benefits of research on decision-making and perceptions of research by potential or actual participants or study communities.
Assess the impact of communicating or not communicating individual test results, incidental findings, study progress, and/or study results on participants' willingness to continue participating in research and/or on attitudes towards research.
Assess the ethical and legal implications of various models to handle illegal behavior by participants enrolled in or being screened for a study.
Knowledge or perception of conflict of interest on the part of the investigator(s) or institution: Assess the impact of disclosing varying degrees of financial conflicts of interest involving the principal investigator, members of oversight committees, sponsor, institution, etc. on subjects willingness to participate and/or continue with research, and/or subjects understanding of the research.

3. International Research

Evaluate different methods and identify best-practice strategies for consulting with communities and stakeholders in host countries as well as in the United States during all phases of human subjects research (planning, execution, and dissemination of results). Identify and test models from participatory research that are appropriate in different settings. Community consultation might address issues such as the significance or priority of the research project in light of local public health priorities; choice of timing of consultation during the development of the research plan; assessment of community members likely comprehension of the research; community perspectives on the design of the research; the willingness of community members to join or continue participation in research; and plans for feedback of information to communities during and after the research.
Identify and evaluate strategies for investigators and sponsors of research to build trust and collaborative partnerships with host country communities, investigators and health care delivery systems.
Evaluate how foreign human subjects protection systems are applied to US-funded international research. Evaluate the extent to which such protections could satisfy U.S. regulatory requirements for equivalent protections. Evaluate experiences of investigators dealing with foreign regulatory systems and develop models for dealing with multiple human subjects protections systems and standards.
Identify and evaluate strategies to protect research subjects in countries with different political and cultural environments and different attitudes towards personal autonomy.
Develop methods to assess vulnerability, including economic and social vulnerability, in resource-limited settings and evaluate remedies to enhance human subjects protections of vulnerable populations or groups.
Address the ethical and practical aspects of providing medical care in the context of human subjects research in low-resource settings, particularly in the international setting. Assess stakeholders perceptions of requirements or requests to provide ancillary care during the conduct of human subjects research.
Identify and evaluate strategies to build health care and/or human subjects research capacity; assess durability of capacity building strategies; recommend best practices.

4. Study Design in Clinical Trials and Its Relationship to Medical Care

Identify the ethics implications of specific scientific parameters in clinical trial design, such as the choice of appropriate control arm(s) in clinical trials of biomedical and/or behavioral interventions. Develop and/or evaluate strategies to address study design issues that pose particular ethical and scientific challenges.
Evaluate how different study designs might entail different risks or benefits to subjects or to society at large in terms of social value of the research, including issues such as social acceptability, protection of the welfare of subjects in the trial, scientific rigor, relevance, feasibility, and timeliness.
Evaluate the scientific and ethical implications of different types of controlled trials, including consideration of choice of flexible versus controlled conditions, physician or patient preferences in medical care, and strategies for handling scientific and medical disputes about usual or standard care. These issues can arise in studies that include biomedical interventions, behavioral interventions, or both.
Evaluate the scientific and ethical acceptability of placebo-controlled trials in different scenarios, the societal and individual benefit from different trial designs and criteria to guide the conduct of trials using placebo or active controls.

5. Research Oversight: IRBs, DSMBs, and COI Committees

Identify and evaluate strategies to improve the oversight of protections for human subjects by IRBs. Examples might include:
Assessment of different models of IRB review, such as cooperative review arrangements for multi-site or complex research protocols; collaborative IRB arrangements for multi-site studies or complex research projects; collaborative IRB arrangements in international studies; or division of labor among multiple IRBs reviewing the same research plan;
Development and testing of models for effective communication, delegation of responsibilities, and joint decision-making of multiple Institutional Review Boards in international research;
Assessment of stakeholder attitudes toward different IRB models including views of researchers, IRB members, institutional officials, community members, and research sponsors;
Development of appropriate outcomes measures and quality indicators for the IRB review process for measurement of adequate protection of human subjects. Development and testing of a framework for assessing IRB review quality; determination of when variability in IRB outcomes would be acceptable and when such variation would indicate inconsistent quality.
Develop and test models or outcome measures for assessing the functioning of Data and Safety Monitoring Boards (DSMB). For example, develop and test models for effective communication, delegation of responsibilities, and joint decision making among multiple IRBs and DSMBs; compare and evaluate different methods and strategies for facilitating the submission and enhancing the interpretation of adverse event reports submitted to review bodies. Compare and evaluate different methods and strategies for identifying, reporting, and handling adverse events, severe adverse events, or unanticipated problems based on the perspectives of individual participants, institutions, DSMBs, and/or IRBs.
Evaluate effectiveness of Conflict of Interest (COI) committees. For example, identify and evaluate strategies to address non-financial COI among research teams, sponsors, advisory boards or other stakeholders. Assess the impact of perceived or real conflicts of interest among members of oversight committees on decision-making about the acceptability of research protocols, interpretations of adverse events, and/or perceptions of "independence of review" by the research community.

6. Research with Specimens and Data

Assess the perspectives and attitudes of subjects about the use of specimens and/or data in research, including special cultural or religious beliefs and attitudes concerning the use of discarded clinical specimens.
Assess how much subjects expect to know about how their specimens and/or data will be used in research.
Develop novel approaches for obtaining informed consent for research use of specimens and data collected during the course of routine clinical care.
Explore and develop ways of addressing ethical issues related to the return of individual research results to subjects, including studies of associated risks and harms.
Explore and develop ways of addressing ethical issues related to intellectual property and ownership of specimens.
Explore issues related to benefit sharing in the context of tissue research. Identify models and mechanisms that can be used to engage communities, sponsors, and researchers in benefit-sharing arrangements and assess the social and ethical acceptability and practicability of these arrangements.
Identify and evaluate strategies for balancing the responsibility for protecting and/or minimizing disclosure of private information with the obligation for maximizing the social value of research when identifiable data are:
Collected via the internet or other electronic method;
Preserved for secondary analysis, e.g., a tissue or gene bank, data archive or warehouse.

7. Dissemination of Research Findings

Explore when and how research results and incidental findings should be reported and disseminated to lay communities, including research subjects and the general public.
Develop and evaluate methods for communicating research results and incidental findings with medical implications to research subjects and families.
Develop and evaluate scientific and ethical parameters that should be considered when reporting generalized, aggregate research findings; develop and evaluate methods for communicating the evolving and sometimes conflicting nature of scientific evidence to lay audiences.

To assist you in identifying which NIH Institute/Center most closely matches your research topic, the following website provides additional information about Institute/Center-specific research interests that will be supported by this FOA: http://grants.nih.gov/grants/guide/contacts/pa-06-367_368_369_contacts.doc

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 Announcement (FOA) invites applications for Research Project Grant (R01) Projects. The NIH plans to issue FOAs of identical scientific scope for Small Research Grants (R03) and Exploratory/Developmental Grants (R21) mechanisms to align proposed studies with i) investigator experience and ii) the state of knowledge in fields of interest.

See http://grants.nih.gov/grants/guide/contacts/pa-06-367_368_369_differences.doc for an explanation of R01, R21, and R03 mechanisms.

This funding opportunity uses just-in-time concepts. It also uses the modular as well as the non-modular budget formats. Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular budget format; otherwise, follow the instructions for non-modular research grant applications. (See Budget Instructions described in the PHS 398 Grant Application (Revised 9/2004) for step-by-step guidance in preparing modular and non-modular budgets.) However, subaward budget/contractual Facilities and Administrative (F&A) costs requested by consortium participants are no longer factored into this direct cost limit. They may be requested in addition to the $250,000 level. See NOT-OD-05-004, November 2, 2004.

2. Funds Available

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 NIH participating components provide support for this program, awards issued under this funding opportunity 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:

For-profit organizations
Non-profit organizations
Public or private institutions, such as universities, colleges, hospitals, and laboratories
Units of State government
Units of local government
Eligible agencies of the Federal government
Foreign Institutions
Domestic Institutions
Faith-based or community-based organizations
Indian/Native American Tribal Government (Federally Recognized)
Indian/Native American Tribal Government (Other than Federally Recognized)
Indian/Native American Tribally Designated Organization

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/organization 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 support.

2. Cost Sharing or Matching

This program does not require cost sharing as defined in the current NIH Grants Policy Statement.

3. Other-Special Eligibility Criteria

Not Applicable

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) 710-0267, Email: [email protected].

Telecommunications for the hearing impaired: TTY (301) 451-00 88.

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 Internet 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 PHS 398 application form and the YES box must be checked.

Foreign Organizations
Several special provisions apply to applications submitted by foreign organizations:

Charge back of customs and import fees is not allowed.
Format: every effort should be made to comply with the format specifications, which are based upon a standard United States paper size of 8.5" x 11."
Funds for up to 8% administrative costs (excluding equipment) can now be requested (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-028.html).
Organizations must comply with Federal/NIH policies on human subjects, animals, and biohazards.
Organizations must comply with Federal/NIH biosafety and biosecurity regulations. See Section VI. 2., Administrative and National Policy Requirements."
Additional information regarding foreign grants is available in the NIH Grants Policy Statement (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part12.htm#_Toc54600260).

Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources.

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Submission, Review, and Anticipated Start Dates

Letters of Intent Receipt Date(s): Not Applicable
Application Submission Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm for details.
AIDS Application Submission Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS for details.
Peer Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward for details.
Council Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward for details.
Earliest Anticipated Start Date: Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward for details.

3.A.1. Letter of Intent

A letter of intent is not required for the funding opportunity.

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant application forms found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the Checklist, and five 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)

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

3.C. Application Processing

Applications must be submitted on or before the application submission date(s) identified in Section IV.3.A.

Upon receipt applications, will be evaluated for completeness by the Center for Scientific Review, NIH. Incomplete applications will not be reviewed.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique.

Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.

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.

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 renewal (formerly 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 renewal 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 the NIH Grants Policy Statement.

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. (See Budget Instructions described in the PHS 398 Grant Application (Revised 9/2004) for step-by-step guidance in preparing modular budgets.) However consortium/contractual Facilities and Administrative (F&A) costs requested by consortium participants are no longer factored into this direct cost limit. They may be requested in addition to the $250,000 level. See NOT-OD-05-004, November 2, 2004.

Specific Instructions for Applications Requesting $500,000 (direct costs) or More per Year.

Applicants requesting $500,000 or more in direct costs for any year must carry out the following steps:

1) Contact the NIH program staff identified in Section VII.1., Scientific/Research Contacts, at least 6 weeks before submitting the application, i.e., as you are developing plans for the study;

2) Obtain agreement from the NIH program staff that the NIH component will accept your application for consideration for award; and

3) Include a cover letter with the application that identifies the staff member (and NIH component) who agreed to accept assignment of the application.

This policy applies to all investigator-initiated New (type 1), Renewal (type 2), competing supplement (type 3), or any amended or revised version of these grant application types. See NOT-OD-02-004, October 16, 2001, for additional information.

Plan for Sharing Research Data

The precise content of the data sharing plan will vary, depending on the data being collected and how the PD/PI is planning to share the data. Applicants planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal Web site, through a data archive or enclave). PD/PIs choosing to share under their own auspices may wish to enter into a data sharing agreement. References to data sharing may also be appropriate in other sections of the application.

All applicants must include a plan for sharing research data in their application. PD/PIs responding to this funding opportunity should include a description of how final research data will be shared, or explain why data sharing is not possible (e.g., proprietary considerations).

The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. For more information on data sharing, see http://grants.nih.gov/grants/policy/data_sharing and http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.

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 submitted for this funding opportunity will be assigned to the NIH participating components on the basis of established PHS referral guidelines.

Appropriate scientific review groups convened 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:

Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score.
Receive a written critique.
Receive a second level of review by an appropriate national advisory council or board.

The following will be considered in making funding decisions:

Scientific merit of the proposed project as determined by peer review.
Availability of funds.
Relevance of program priorities.

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. 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 by the scientific review group 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, a PD/PI 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 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?

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

Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the PD/PI and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?

Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? 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 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 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 in the PHS 398 research grant application instructions will be assessed.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

2.C. Sharing Research Data

The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The presence of a data sharing plan will be part of the terms and conditions of the award. The NIH funding component will be responsible for monitoring the data sharing policy.

2.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 (NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by program staff of the NIH funding component 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., Reporting.

3. Anticipated Announcement and Award Dates

Not Applicable

Section VI. Award Administration Information

1. Award Notices

After peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

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.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 12 on the PHS 398 Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the business official.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Section IV.5., Funding Restrictions.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities.

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Grant Progress Report (PHS 2590) annually 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:

Central NIH Program Contact (for general inquiries):
Office of Extramural Programs, OER, OD, NIH
1 Rockledge Centre, Suite 350 , Room 3531
6705 Rockledge Drive MSC 7963
Bethesda , MD 20892-7963
Email: [email protected]

NIH Institute/Center/Office Program Contacts:
National Cancer Institute
Kim Witherspoon
Division of Cancer Treatment and Diagnosis|
6130 Executive Blvd (EPN), Rm 7009, MSC 7432
Bethesda, MD 20892-7432
Telephone: 301-496-8866
Fax: 301-480-4663
Email: [email protected]

National Human Genome Research Institute
Elizabeth J. Thomson, MS, RN, CGC, FAAN
Building 31, Room B2B07
31 Center Drive, MSC 2033
Bethesda, MD 20892-2033
Telephone: (301) 402-4997
Fax: (301) 402-1950
Email: [email protected]

National Institute on Aging
Neil Buckholtz, Ph.D.
Neuroscience and Neuropsychology of Aging Program
National Institute on Aging
Gateway Building, Suite 350
7201 Wisconsin Avenue Bethesda, MD 20892-9205
Telephone: (301) 496-9350
FAX: (301) 496-1494
Email: [email protected]

National Institute on Alcohol Abuse and Alcoholism
Page Chiapella, Ph.D.
Division of Treatment and Recovery Research
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Suite 2044, MSC 9304
Bethesda, MD 20892-9304
Telephone: (301) 443-4715
FAX: (301) 443-8774
Email: [email protected]

National Institute of Allergy and Infectious Diseases
Lawrence J. Prograis, Jr., M.D.
DAIT
6700 B Rockledge, Room 5134
Bethesda, MD 20892-6601
Telephone: (301) 496-1886
Fax: (301) 402-2571
Email: [email protected]

National Institute of Arthritis and Musculoskeletal and Skin Diseases:

Madeline Turkeltaub, RN, PhD, CRNP, FAAN
Clinical Research Project Manager
Extramural Program
One Democracy Plaza
6701 Democracy Blvd., Suite 800, MSC 4872
Bethesda, MD 20892-4872
Telephone: (301) 451-5888
Fax: (301) 480-4543
Email:[email protected]

National Institute of Child Health and Human Development
Lisa Freund, Ph.D.
Building 6100, Room 6B05D, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 435-6879
Fax: (301) 408-0230
Email: [email protected]

National Institute on Deafness and Other Communication Disorders
Ling Chin, M.D., M.P.H.
Chief, Clinical Trials and Epidemiology, Biostatistics
6120 Executive Blvd EPS Room 400C MSC-7180
Bethesda, MD 20892-7180
Telephone: (301) 435-0598
FAX: (301) 402-6251
Email: [email protected]

National Institute on Drug Abuse
Ruben Baler, Ph.D.
Science Policy Branch
Office of Science Policy and Communications
6001 Executive Boulevard, Room 5248
Bethesda, MD 20892-9541
Telephone: (301) 443-6070
FAX: (301) 480-2485
Email: [email protected]

National Institute of Environmental Health Sciences
Kimberly A. McAllister, Ph.D.
Susceptibility and Population Health Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233 (MD EC-21)
Research Triangle Park, NC 27709
Phone: (919) 541-4528
FAX: (919) 316-4606
Email: [email protected]

National Institute of General Medical Sciences
Rochelle M. Long, Ph.D.
Pharmacology, Physiology, and Biological Chemistry Division
Building 45, Room 2AS.49G, MSC 6200
(45 Center Drive for express/courier service)
Bethesda, MD 20892-6200
Telephone: (301) 594-3827
Fax: (301) 480-2802
Email: [email protected]

National Institute of Mental Health
William T. Riley, Ph.D.
Division of AIDS and Health Behavior Research
6001 Executive Boulevard, Room 6226, MSC 9615
Bethesda, MD 20892-9615
Telephone: (301) 435-0301
Fax: (301) 480-2920
Email: [email protected]

National Institute of Neurological Disorders and Stroke
Barbara Radziszewska, Ph.D., M.P.H.
Clinical Research Project Manager
Clinical Trials Cluster
6001 Executive Blvd., Room 2216
Bethesda, MD 20892-9520
Telephone: (301) 496-2076
Fax: (301) 480-1080
Email: [email protected]

National Institute of Nursing Research
Alexis Bakos, Ph.D.
6701 Democracy Boulevard, Suite 710
Bethesda, MD 20892-4870
Telephone: (301) 594-2542
Fax: (301) 480-8260
Email: [email protected]

2. Peer Review Contacts:

Not Applicable

3. Financial or Grants Management Contacts:

National Cancer Institute
Eileen Natoli
6120 Executive Boulevard, EPS 243
Bethesda, MD 20892-7180
Telephone: (301) 496-8791
Fax: (301) 496-8601
Email:[email protected]

National Human Genome Research Institute
Cheryl Chick
5635 Fishers Lane, Rm 4076
Bethesda, MD 20892-9306
Telephone: (301) 435-7858
Fax: (301) 402 -1951
Email: [email protected]

National Institute on Aging
Jeff Ball
7201 Wisconsin Avenue
Gateway Building, Suite 2N212
Bethesda, MD 20892-9205
Telephone: (301) 402-7732
Fax: (301) 402-3672
E-Mail: [email protected]

National Institute on Alcohol Abuse and Alcoholism
Judy Fox
Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 3023, MSC 9304
Bethesda, MD 20892-9304
Telephone: (301) 443-4704
Email: [email protected]

National Institute of Allergy and Infectious Diseases
Cindy McDermott
Division of Extramural Activities
6700-B Rockledge Drive, Rm 2132, MSC 7614
Bethesda, MD 20892-7614
Telephone: (301) 594-7456
Fax: (301) 480-3780
Email:[email protected]

National Institute of Arthritis and Musculoskeletal and Skin Diseases
Melinda Nelson
Building 45, Rm 5AS49F
Bethesda, MD 20892-6500
Telephone: (301) 594-3535
Fax: (301) 480-5450
Email: [email protected]

National Institute of Child Health and Human Development:
John Chris Robey
6100 Executive Boulevard, Rm 8A01, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 435-6996
Fax: (301) 402-0915
Email:[email protected]

National Institute on Deafness and Other Communication Disorders
Christopher Myers
6120 Executive Boulevard, EPS 400B, MSC 7180
Bethesda, MD 20892-7180
Telephone: (301) 402-0909
Fax: (301) 402-1758
Email: [email protected]

National Institute on Drug Abuse
Gary Fleming, J.D., M.A.
6001 Executive Boulevard, Room 3131, MSC 9541
Bethesda, MD 20892-9541
Telephone: (301) 443-6710
Fax: (301) 443-6847
E-mail: [email protected]

National Institute of Environmental Health Sciences:
Donald Ellis
EC 3175
PO Box 12233
(MD EC-20)
Research Triangle Park, NC 27709-2233
Telephone: (919) 541-1874
Fax: (919) 541-2860
Email: [email protected]

National Institute of General Medical Sciences
Antoinette Holland
Building 45, Room 2AN.50B, MSC 6200
(45 Center Drive for express/courier service)
Bethesda, MD 20892-6200
Telephone: (301) 594-5132
Fax: (301) 480-3423
Email: [email protected]

National Institute of Mental Health
Rebecca D. Claycamp, CRA
6001 Executive Boulevard, Room 6122, MSC 9605
Bethesda, MD 20892-9605
Telephone: (301) 443-2811
Fax: (301) 443-6885
Email:[email protected]

National Institute of Neurological Disorders and Stroke
Maxine Davis-Vanlue
Neuro Science Center, Rm 3248
6001 Executive Boulevard
Bethesda, MD 20892-9537
Telephone: (301) 496-9231
Fax: (301) 402-0219
Email:[email protected]

National Institute of Nursing Research
Brian Albertini
6701 Democracy Boulevard, Rm 710
One Democracy Plaza
Bethesda, MD 20892-4870 (Courier use 20817)
Telephone: (301) 594-6869
Fax: (301) 402-4502
Email: [email protected]

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 Protections:
Federal regulations (45 CFR 46) 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, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

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 or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions, on issues related to institutional policies and local 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.

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Sharing of Model Organisms:
Not applicable

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.

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 (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 provide this information will be returned without review.

NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov/) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process, please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov/ and view the Policy or other Resources and Tools, including the Authors' Manual.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002 . The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:

This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

The 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.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov/.