HUMAN SUBJECTS RESEARCH ENHANCEMENTS PROGRAM (HSREP)
 
RELEASE DATE:  May 22, 2003

RFA:  OD-03-007

National Cancer Institute (NCI)
 (http://www.nci.nih.gov/) 
National Center for Complementary and Alternative Medicine (NCCAM)
 (http://www.nccam.nih.gov/) 
National Center on Minority Health and Health Disparities (NCMHD)
 (http://www.ncmhd.nih.gov/) 
National Center for Research Resources (NCRR)
 (http://www.ncrr.nih.gov/) 
National Eye Institute (NEI)
 (http://www.nei.nih.gov/) 
National Heart, Lung, and Blood Institute (NHLBI)
 (http://www.nhlbi.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 of Dental and Craniofacial Research (NIDCR)
 (http://www.nidcr.nih.gov/)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
 (http://www.niddk.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/) 

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.393, 93.394, 93.395, 
93.396, 93.399, 93.307, 93.308, 93.333, 93.371, 93.389, 93.306, 93.867, 
93.172, 93.233, 93.837, 93.838, 93.839, 93.866, 93.273, 93.855, 93.856, 
93.846, 93.864, 93.929, 93.279, 93.173, 93.121, 93.847, 93.848, 93.849, 
93.113, 93.114, 93.115, 93.242, 93.309, 93.859, 93.862, 93.821, 93.853, 
93.361
 
APPLICATION RECEIPT DATE: July 11, 2003 

THIS RFA CONTAINS THE FOLLOWING INFORMATION
 
o Purpose of this RFA
o Research Objectives
o Mechanism of Support 
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations
 
PURPOSE OF THIS RFA
 
The purpose of this initiative is to provide short-term interim support for 
institutional activities that will strengthen oversight of human subjects 
research at institutions that receive significant NIH support for clinical 
research.  While there is considerable flexibility in the types of activities 
that could be supported under this program, it is important that these 
enhance the protection of research subjects by means that will be sustained 
by the institution after the award period ends.  This is a limited  
solicitation made available to the grantees funded under the first 
RFA (OD-02-003) as a recompetition for an additional, final, one-year award.  
HOWEVER, FOR THIS SOLICITATION, THE NIH REQUIRES APPLICANTS TO COLLABORATE 
WITH OTHER INSTITUTIONS CONDUCTING HUMAN SUBJECTS RESEARCH AND ARE NOT 
CURRENTLY FUNDED UNDER THIS PROGRAM, TO SHARE EDUCATIONAL RESOURCES, COMPUTER 
TECHNOLOGIES, BEST PRACTICES, ETC. While all NIH components supporting 
clinical research are providing support for this program, it will be 
administered by the National Center for Research Resources.
 
RESEARCH OBJECTIVES
 
Background
 
The conduct of research on human subjects has come under increasing scrutiny 
in recent years, and as a consequence, has become the focus of increasing 
demands for oversight, enhanced protections, and increased education for 
those conducting the research.  Institutions are now aware of the need to 
ensure greater patient protections, to promote patients' rights and 
understanding of the research they are part of, and to train their 
investigative teams in the ethical as well as scientific aspects of human 
subjects research.  However, the added procedures and safeguards create a 
burden for institutions in providing adequate resources.
 
Scope of the Activity
 
Applicants must detail the types of activities they plan to undertake.  The 
following is a list of possible activities, but applicants are not limited to 
these, and it is not intended that an applicant would be engaged in all of 
these activities.  However, applicants may wish to use these as an indicator 
of the types of activities that could be proposed:

o  Development of educational initiatives for investigators, administrators 
and IRB members in the safe and ethical conduct of clinical research; 

o  Creation of tracking systems for monitoring and coordinating adverse event 
reporting, including expenses for site monitoring;

o  Development of infrastructure/technology for computer tracking of human 
subjects protocols, secure records retention, electronic protocol submission, 
and the like;

o  Purchase of equipment to facilitate IRB activities, such as 
teleconferencing or computer support;

o  Implementation of minor renovations to allow for confidential and secure 
data storage systems for all stages of research;

o  Development of means to coordinate the activities of IRBs that allow for 
the approval of consent forms used in multiple institutions;

o  Development of systems for coordinating activities of multiple IRBs when 
participating in multi-center clinical trials;

o  Development of Phase I/II data and safety monitoring plans, tracking 
systems, educational initiatives, etc.;

o  Development of tools for strengthening continuing reviews;

o  Development of tools to link compliance, IRB and other (e.g., DSMB) 
processes to strengthen the overall protection of human research subjects. 
 
Applications must include plans for reaching out to other institutions that 
conduct human subjects research but do not receive HSREP support.  

Note: Institutions with a General Clinical Research Center (GCRC) should 
endeavor to coordinate the activities proposed in HSREP with the activities 
of the Research Subject Advocate (RSA). However, funds from HSREP may only be 
used to support non-GCRC activities of the RSA's effort.
 
MECHANISM OF SUPPORT
 
This RFA will use the NIH S07 award mechanism.  As an applicant you will be 
solely responsible for planning, directing, and executing the proposed 
project.  This RFA is a one-year limited competition for the current 
grantees.  The anticipated award date is September 30, 2003.  Awards are for 
direct costs only; i.e., F&A costs will not be provided.  The duration of 
support will be one year.  It is expected that institutions will propose only 
those new activities that can be encompassed in this one-year award, and/or 
activities that are continuations or expansions of their first-year S07 
programs.  Institutions are expected to have explicit plans for how they will 
continue any innovations after the end of the award.  This RFA uses just-in-
time concepts, but not modular budgets.
 
FUNDS AVAILABLE
 
The participating ICs intend to commit approximately $25M in FY 2003 to fund 
current HSREP grantee institutions that re-compete successfully for an 
additional, final year. The specific number of applications to be funded as 
well as the amount awarded for each will depend on the merit of the 
applications received. 
 
ELIGIBLE INSTITUTIONS
 
Current grantees under the Human Subjects Research Enhancements Program who 
are eligible to receive support under this program are listed in the 
following URL: http://grants.nih.gov/grants/policy/hsrea/hsrea_list.htm.             
The dollar limits set for the previous competition ($250K, $150K, or $100K, 
depending on the tier) are the dollar limits set for this recompetition.  
Applicants may refer to the previous NIH Guide announcement 
(http://grants.nih.gov/grants/guide/rfa-files/RFA-OD-02-003.html) to remind 
them of those dollar limits. 
 
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS   
 
The Principal Investigator (PI) should be a high-level institutional 
official, such as a Vice Provost for Research or Dean of the Medical School.
 
SPECIAL REQUIREMENTS 
 
Applicants must include in the application their plan for reaching out to 
other institutions, not already receiving support from the HSREP, that 
conduct human subjects research.  This plan should detail, for example, how 
initiatives will be shared with these other institutions.

APPLICATIONS NOT INCLUDING SUCH PLANS WILL BE RETURNED TO THE APPLICANT AS 
BEING NON-RESPONSIVE TO THIS RFA.
 
The final reports submitted by the grantees at the end of the award period 
will be used to provide insights for the NIH to share with other institutions 
regarding promising approaches to strengthening the systems of protections 
for research subjects.  The final report should include not only a 
description of what was accomplished, but also the methodology for 
development of those programs, and an evaluation of their potential 
usefulness, impact and feasibility for other institutions.
 
WHERE TO SEND INQUIRIES
 
We encourage inquiries concerning this RFA and welcome the opportunity to 
answer questions from potential applicants.  

o Direct inquiries to:
 
L. Tony Beck, Ph.D.
Division of Clinical Research
National Center for Research Resources
National Institutes of Health
One Democracy Plaza
6701 Democracy Blvd., Room 916
Bethesda, MD 20892-4874
(20817 Zip Code for courier deliveries)
(301) 435-0805; FAX: (301) 480-3661
e-mail: beckl@mail.nih.gov
 
SUBMITTING AN APPLICATION
 
Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  The PHS 398 is available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive 
format.  For further assistance contact GrantsInfo, Telephone (301) 435-0714, 
e-mail: GrantsInfo@nih.gov.

An application from a single institution is limited to 5 pages instead of the 
usual 25. (Those current awardees who are funded as consortia are limited to 
10 pages.) 

USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) 
application form 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.
 
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of 
the application, including the Checklist, and TWO signed, photocopies, in one 
package to:
 
Center For Scientific Review
National Institutes Of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD  20892-7710
Bethesda, MD  20817 (for express/courier service)
 
AT THE TIME OF SUBMISSION, THREE ADDITIONAL COPIES OF THE APPLICATION MUST BE 
SENT TO THE INDIVIDUAL LISTED UNDER "WHERE TO SEND INQUIRIES." 

APPLICATION PROCESSING: Applications must be received by the application 
receipt date listed in the heading of this RFA.  If an application is 
received after that date, it will be returned to the applicant without 
review.
 
PEER REVIEW PROCESS  
 
Upon receipt, applications will be reviewed for completeness by the CSR and 
responsiveness by NIH staff.  Incomplete and/or non-responsive applications 
will be returned to the applicant without further consideration.
 
Applications that are complete and responsive to the RFA will be reviewed by 
NIH staff for adherence to program guidelines and cost allowability.  To 
allow for this review, the application should include specific details as to 
how the institution will make use of the funds received under this program by 
drawing from the examples listed under "Scope of the Activity" above, and/or 
by proposing other similar initiatives, and by relating these activities to 
those already ongoing at the institution. A second level review will be done 
by the NCRR National Advisory Council.
 
RECEIPT AND REVIEW SCHEDULE
 
Application Receipt Date: July 11, 2003
Review Date: August/September 2003
Council Review: September 2003
Earliest Anticipated Start Date: September 30, 2003
 
AWARD CRITERIA

Award criteria that will be used to make award decisions include:
 
o Responsiveness to this RFA
o Availability of funds

Requests that propose lasting enhancements to the quality assurance 
capacities of the institution and its investigators to support and monitor 
the use and safety of human subjects in clinical research are encouraged.

REQUIRED FEDERAL CITATIONS 
 
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 
RFA 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 No. 93.337, and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.  Awards are made under authorization of Sections 301 
and 405 of the Public Health Service Act as amended (42 USC 241 and 284)and 
administered under NIH grants policies described at 
http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 
42 CFR 52 and 45 CFR Parts 74 and 92.
 
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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