[Federal Register Volume 68, Number 168 (Friday, August 29, 2003)]
[Notices]
[Pages 52036-52040]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-22299]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Announcement of Continuation of a Cooperative Agreement for the 
Responsible Conduct of Research (RCR) Program for Academic Societies

AGENCY: Department of Health and Human Services (DHHS), Office of the 
Secretary, Office of Public Health and Science, Office of Research 
Integrity.

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ACTION: Notice.

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    Project Title: Responsible Conduct of Research Program for Academic 
Societies.
    OMB Catalog of Federal Domestic Assistance: Application has been 
made for a CFDA number.

    Authority: This Cooperative Agreement is authorized under 
section 301 of the Public Health Service (PHS) Act, as amended.

SUMMARY: The Department of Health and Human Services (DHHS), Office of 
the Secretary, Office of Public Health and Science, Office of Research 
Integrity announces its plan to continue a non-competitive continuation 
award through a single source cooperative agreement with the 
Association of American Medical Colleges (AAMC) to continue to provide 
programmatic administration of the RCR Program for Academic Societies. 
The ultimate goal of the continuation of this cooperative agreement is 
to provide fiscal support through sub-award contracts to U.S. 
biomedical and behavioral academic societies for the promotion of RCR 
and research integrity (RI) education, and/or other society initiatives 
focusing on the responsible conduct of research. This program is 
designed to benefit not only the researchers who are members of 
academic societies, but the U.S. public who will benefit from 
biomedical and behavioral research conducted in a responsible manner 
worthy of the public's trust.

DATES: To receive consideration, applications must be received no later 
than September 29, 2003. Applications will be considered as meeting the 
deadline if they are: (1) Received on or before the deadline date, or 
(2) postmarked by the U.S. Postal Service on or before the deadline 
date and received in time for orderly processing. A legibly dated 
receipt from a commercial carrier such as FedEx will be accepted in 
lieu of a postmark. Private metered postmarks will not be accepted as 
proof of timely mailing. Applications hand-carried by applicants or by 
applicant couriers shall be considered as meeting an announced deadline 
if they are received on or before the deadline date between the hours 
of 8 a.m. to 5 p.m. at the address indicated below. Applications 
submitted by facsimile transmission (FAX) or any other electronic 
format will not be accepted. Applications which do not meet the 
deadline will be considered late and will be returned to the applicant 
unread.

ADDRESSES: For this cooperative agreement, Form PHS 5161-1 (Revised 
July, 2000 and approved by OMB under Control Number 0937-0189) must be 
used. An applicant is advised to pay close attention to the specific 
program guidelines and general instructions provided in the application 
kit. To obtain an application kit, write to: Office of Grants 
Management, Ms. Karen Campbell, Director of Grants Management, Suite 
550, 1101 Wootton Parkway, Rockville, MD 20852; or call Ms. Karen 
Campbell at (301) 594-0758.
    This program is subject to the Intergovernmental Review of Federal 
Programs as governed by Executive Order 12372. Executive Order 12372 
sets up a system for State and local government review of proposed 
Federal Assistance Applications. Applicants (other than federally-
recognized Indian Tribal Governments) should contact their State Single 
Point of Contact (SPOC) as early as possible to alert them to the 
prospective applications and receive any necessary instructions on the 
State process. For proposed projects serving more than one State, the 
applicant is advised to contact the SPOC of each affected State. A 
current list is included in the application kit.
    Submission Information: Applications for this announcement shall be 
submitted to: Office of Grants Management, Ms. Karen Campbell, Director 
of Grants Management, Suite 550, 1101 Wootton Parkway, Rockville, MD 
20852. Send the original application with signatures in blue ink and 2 
copies of the complete application to this address. Application receipt 
will be acknowledged by the Office of Grants Management issuing form 
(PHS-3038-1) Application Receipt Card to the applicant.

Background

    The Department of Health and Human Services, Office of Public 
Health and Science, Office of Research Integrity carries out its 
mission of promoting research integrity in order to reduce the 
incidence of research misconduct in DHHS supported biomedical and 
behavioral research by, among other activities, working to educate the 
biomedical and behavioral sciences research community in the 
responsible conduct of research. Toward this end, the ORI works in 
collaboration with universities, medical schools, research centers, and 
academic and professional societies to educate researchers.
    For more than a decade, the ORI has been initiating efforts to work 
with organizations representing the biomedical and behavioral research 
community to foster a joint commitment to RCR education understanding 
the crucial role these organizations have in the promotion of research 
integrity. In 1989, the Institute of Medicine (IOM) stated that 
``Professional and scientific organizations representing the research 
community should develop educational and training activities and 
materials to improve the integrity of research.'' IOM noted that 
``Professional organizations, including the various disciplinary 
societies, play an important role in developing consensus about the 
goals and values that should shape research practice'' and ``* * *that 
more can be done by these and other organizations to promote the 
responsible conduct of research'' (IOM, 1989:36).
    Academic societies are well-positioned to play a crucial and 
pivotal role in defining and promoting standards for the responsible 
conduct of research as has been widely recognized by the IOM and 
others. While some academic and professional societies have 
demonstrated leadership in educating their members to further integrity 
in the conduct of research they perform, others are just recently 
turning their attention toward such initiatives.
    Over the past several years, ORI efforts to educate researchers in 
the responsible conduct of research have been growing. Nonetheless, 
they are still limited given the thousands of researchers yet to be 
reached. In order to continue to effectively extend its reach in 
educating researchers in the RCR, to encourage increased and sustained 
leadership by academic societies in this regard, and to build stronger 
ties with the biomedical and behavioral sciences research community in 
promoting the responsible conduct of research, ORI intends to continue 
the RCR Program for Academic Societies with the AAMC as the single 
source administrator.

Purpose

    The ORI announces its plan to continue a non-competitive 
continuation award through a single source cooperative agreement with 
the AAMC as the programmatic administrator for the RCR Program for 
Academic Societies for four (4) more years subject to available 
funding. (The current project period is from 09/30/02 through 09/29/
03). The purposes of this cooperative agreement are: (1) To provide 
sub-awards contracts to U.S. biomedical and behavioral academic 
societies to promote responsible conduct of research education and 
other RCR initiatives with their members in order to foster research 
integrity in DHHS sponsored research specifically; and generally, 
within the research conducted by the U.S. biomedical and behavioral 
research scientists; and (2) to continue utilizing the AAMC as a

[[Page 52038]]

programmatic administrator for the program.
    For the purposes of this program, ``academic societies'' are non-
profit organizations active in the United States in the fields of 
medicine, biomedical, or the behavioral sciences, whose primary 
missions include advancing medical education and/or biomedical or 
behavioral research. Eligibility for sub-award funding is not limited 
to societies within the AAMC Council of Academic Societies. Of 
particular interest are academic societies whose membership base 
consists largely of university and medical school faculty members, a 
significant portion of whom conduct DHHS (i.e., National Institutes of 
Health, Centers for Disease Control, Food and Drug Administration, 
Health Resources and Services Administration, Agency for Healthcare 
Research and Quality, and Indian Health Service) funded research.

Award Information

    The ORI intends to make available approximately $275,000 for the 
purposes of this program in fiscal year 2003. This award will begin 
prior to or on September 30, 2003, for a 12 month budget period with a 
project period of four years. Funding estimates may vary and are 
subject to change. Continuation awards within the project period will 
be made on the basis of satisfactory progress and availability of 
funds.
    Of the $275,000, ORI intends to direct $25,000 (i.e., less than 
10%) to the AAMC for programmatic administration. (The cooperative 
agreement does not require fund matching or sharing in project costs.) 
The remaining $250,000 will support approximately 12 sub-awards in the 
form of contracts to academic societies following a competitive, peer 
reviewed process administered by the AAMC.

SUPPLEMENTARY INFORMATION:

Sub-Awards

    The purpose of the sub-awards is to provide funds to academic 
societies to specifically address some, or all, of the nine core 
components of responsible conduct of research education described on 
the ORI Web site (http://ori.hhs.gov). These are: (1) Data acquisition, 
management, sharing, and ownership (2) mentor/trainee responsibilities 
(3) publication practices and responsible authorship (4) peer review 
(5) collaborative science (6) human subjects (7) research involving 
animals (8) research misconduct, and (9) conflicts of interest and 
commitment.
    It is envisioned that the sub-awards would be directed toward 
establishing a long-term commitment to RCR education involving multiple 
generations of researchers. Such a commitment would move beyond more 
traditional, episodic educational events, and emphasize a well-
conceived long-term plan, and attendant process of creating and 
coordinating RCR/RI initiatives that are then adopted, integrated, and 
sustained as enduring elements into an academic society's 
infrastructure, and into the culture of the discipline.
    During FY 2003, as a result of the first two rounds of competitive 
review for the RCR Program for Academic Societies administered by the 
AAMC, sub-award contracts were made to 13 academic societies for 15 
projects or programs. Examples of past sub-awards include a one day 
workshop, A Course in Responsible Research, for emergency medical 
personnel; a mini-conference in RCR education for chairpersons in 
departments of physiology; an association session at annual meeting on 
Promoting Research Integrity in Obesity Research; the development of a 
multi-step process focused on defining and communicating RCR and 
ethical guidelines for the genetic disease intervention clinical 
research community; the development and distribution of Guidelines for 
the Ethical and Legal Conduct of Clinical Research Involving Critically 
Ill Patients; a workshop and development of a Code of Research Ethics 
for General Pediatrics; and the development, dissemination, and 
evaluation of an Ethics Curriculum for Psychiatric Research.
    Sub-awards made to academic societies following a competitive 
review process administered by the AAMC will be subdivided into three 
categories. The first category will fund approximately five (5) sub-
awards of up to $5,000 to support single events or activities such as a 
special meeting, a national conference, or a publication. The second 
category of sub-awards will fund approximately five (5) sub-awards of 
up to $25,000, and the third category will fund approximately two (2) 
sub-awards up to $50,000. These two latter categories will be used for 
major program initiatives aimed at promoting the responsible conduct of 
research.
    Successful proposals for the sub-awards categories will demonstrate 
an understanding and focus on RCR education as distinct from bioethics. 
(Sub-award applicants unfamiliar with the distinction are referred to 
the ORI web site information on RCR Education). Areas of emphasis for 
the $25,000 sub-awards would include, but not be limited to: (1) The 
use of leadership summit meetings, national symposia, focus groups, 
and/or needs assessments to identify RCR/RI educational gaps, and/or 
(2) the development of a society RCR task force, subcommittee, or 
committee to begin to identify a society's RCR needs, goals, 
objectives, strategies, and effective actions central to sustaining RCR 
education as a core component of its members' professional research 
development, and their life-long learning, or (3) a RCR national 
symposium or conference (teleconferences and/or satellite broadcasts 
would be acceptable) to include some discussion on methods for 
integrating RCR education into existing coursework for graduate 
students, and/or (4) the development of a publication addressing a RCR 
topic(s) of particular interest to a society (e.g., ``Instructions to 
Authors,'' or responsible resource sharing), (5) the development of a 
society inter-generational dialogue (through one, or a series of 
sessions) on RCR to include new and experienced researchers on a 
particular component, or aspect, of RCR education, (6) an RCR plenary 
at an annual conference to launch an RCR educational and/or evaluative 
initiative, (7) a national colloquium addressing a comprehensive RCR 
program for its members with proceedings published in a society journal 
on the nine core areas of RCR, and/or (8) the development, and 
publication, of a 1-year series on some of the core RCR instructional 
areas in a society's journal.
    Areas of emphasis for the larger category of sub-awards of up to 
$50,000 will include proposals featuring the development of a multi-
year RCR educationally-directed plan with a focus on goals, measurable 
objectives, and intermediate outcomes to address RCR education across a 
full-spectrum of generations of researchers, as well as providing 
specific actions to be taken. Examples of specific actions that a 
society may choose to focus on as part of its plan are: (1) The 
development of a curriculum, and an outcomes focused evaluation, for a 
practically-oriented (i.e., with both knowledge and skills development 
emphasis) RCR training program for society members (with special focus 
on new society members, or with a goal of providing a basic RCR 
education to members who are graduate students, and postdoctoral 
fellows on an ongoing basis), with the findings to be shared with the 
membership at an annual meeting, and/or through an article(s) in the 
society's journal, (2) the development of an outcomes-directed RCR 
educational program evaluative tool(s) to assess the impact, and 
quality of a society's activities to increase its

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members' RCR knowledge, skills development, and formal research 
practice, (3) the creation of a multi-year plan with strategies and 
actions to provide professional development sessions, or workshops on 
educating its members on RCR and reinforcing standards for the 
responsible conduct of research (e.g., in the areas of data 
acquisition, management, sharing, and ownership; publications 
practices; and mentoring).

Expected Program Outcomes for Sub-Awards

    Expected outcomes of the sub-awards made through this cooperative 
agreement include: (1) Increased numbers of researchers receiving RCR 
education; or (2) increased numbers of other academic society endeavors 
(e.g., developing new RCR ``infrastructure'' such as an RCR committee, 
subcommittee, or task force) in order to begin to establish, or to 
strengthen, the institutionalization of RCR in academic societies 
representing the research community largely responsible for conducting 
DHHS-supported research; or (3) increased numbers of society 
publications on one, or more, of the 9 core areas of RCR education 
described previously in this announcement, or (4) an increase in the 
number of programmatic development plans for RCR education and 
evaluation.

ORI Activities and the Cooperative Agreement

    The ORI uses cooperative agreements to support its mission to 
promote research integrity with the biomedical and behavioral research 
community. Through current cooperative agreements, ORI has increased 
its capacity to create public-non-profit partnerships to extend the 
reach and effectiveness of its work.
    With the continuation of this non-competitive continuation award 
through a single source cooperative agreement with the AAMC, the ORI 
will continue its substantial programmatic involvement along with the 
AAMC in the RCR Program for Academic Societies. ORI will continue 
working cooperatively with the AAMC in establishing specific goals and 
areas of emphasis for this program, and will participate in the 
development of the RCR Program for Academic Societies Request for 
Applications (RFA). It will assist the AAMC in locating reviewers for 
the peer review process, and participate in the review process. ORI 
will also assist in announcing the RFA, and the competitive review sub-
award results. Along with the AAMC, the ORI will promote the academic 
societies' RCR projects and programs, and ORI staff will attend some of 
the professional societies' programs, and review the final report on 
these initiatives from the AAMC.

Eligible Applicants

    Assistance will be provided only to the Association of American 
Medical Colleges. No other applications are solicited for this 
activity. The AAMC is uniquely suited to conduct the activities under 
this cooperative agreement because:
    1. The AAMC has the unique distinction of having established 
access, and ongoing, daily communication with 96 biomedical and 
behavioral academic societies through its Council of Academic Societies 
(CAS). As the AAMC states, ``The mission of the CAS is to help the 
faculty of academic medical centers in their primary responsibilities 
of research education, and patient care, with an ultimate goal of 
improving the health of all Americans.'' The CAS is comprised of 
``faculty who represent medical school departments and their chairs, 
academic societies, and individual faculty members.'' It is because of 
this organizational relationship that the AAMC has a unique capacity to 
work directly with key academic societies that intersect with the DHHS 
supported research community. Ready access to the CAS network makes the 
AAMC unique in terms of suitability over other biomedical and 
behavioral institutional associations in terms of having ready, daily 
access to a substantially larger network of academic societies for the 
promotion of the RCR Program for Academic Societies RFA, and the 
announcements following the competitive review process of sub-award 
projects and programs. (Although sub-award eligibility for the RCR 
Program for Academic Societies is not limited to the CAS members, the 
extensive AAMC's CAS network is a distinct competitive advantage for 
performing the services related to the program).
    2. The AAMC, founded in 1876, is a leading biomedical non-profit 
association with education and research emphases comprised of 126 
accredited U.S. medical schools, 400 major teaching hospitals including 
56 health systems, 75 Department of Veterans Affairs medical centers, 
and 96 academic and professional societies representing more than 
100,000 members, including the nation's 67,000 medical students and 
103,000 residents. The AAMC has been nationally prominent and 
instrumental in providing continuing forums for the discussion and 
exchange of RCR/RI information for over a decade; not only within its 
membership but also among academic researchers more broadly, from the 
clinical sciences to basic research. No other academic organization has 
such a diverse membership and at the same time is so directly 
associated with the research programs sponsored by DHHS. Significantly, 
no public comments were received by ORI following the first Federal 
Register announcement (June 12, 2002) of ORI's intention to enter into 
the current single source cooperative agreement with the AAMC to 
support the RCR and the promotion of research integrity with academic 
societies.
    During the current project period (09/30/02 through 09/29/03), the 
AAMC has assisted ORI in forming vital partnerships with the extramural 
community to foster the responsible conduct of research and promote 
research integrity. It has demonstrated that it can work successfully 
with both the ORI and the scientific community in launching and 
providing programmatic administration for the RCR Program for Academic 
Societies. Accordingly, the ORI intends to continue to substantially 
enhance and increase its performance in reaching larger numbers of 
researchers in the future by promoting RCR education and research 
integrity through the continuation of a non-competitive continuation 
cooperative agreement with the AAMC.

Application Review Criteria

    Criteria to be utilized with this non-competitive continuation 
award sole source cooperative agreement include the following, listed 
in order of priority: (1) Linkage to a large network of biomedical and 
behavioral academic societies (i.e., greater than 75) comprised of 
scientific researchers (2) demonstrated experience in the programmatic 
administration of a DHHS program to increase RCR education and other 
RCR related initiatives with biomedical and behavioral academic 
societies to promote research integrity, and (3) a demonstrated 
commitment to RCR education as indicated by a history of RCR programs, 
policies, and other publications.

Recipient Activities

    The AAMC will provide programmatic administration of the RCR 
Program for Academic Societies as it is performing currently. It will 
develop a (revised) RFA for the program as well as criteria for 
competitive review of sub-award applications; promote the RFA to 
academic societies to encourage application submissions through two

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cycles; select external AAMC reviewers for the competitive sub-awards 
review process; select an internal AAMC staff member (who is 
experienced in working with RCR activities and academic societies) to 
participate in the review of proposals; make sub-award selections; 
announce the results of the sub-awards competitive review; disperse 
sub-award funds; and review reports from the sub-awardees. The AAMC 
will also prepare and submit a final report to ORI evaluating the 
short-term implementation of the program. As it has done this during 
the current project period, the AAMC will assist the ORI in efforts to 
nurture the process of institutionalization of RCR into the 
infrastructure of biomedical and behavioral academic societies as part 
of its commitment to educating researchers which is central to the 
educational mission of the AAMC.

FOR FURTHER INFORMATION CONTACT: Carolyn R. Fassi, MPH, DPA, Director, 
ORI RCR Program for Academic Societies, Division of Education and 
Integrity, Office of Research Integrity, Suite 750, 1101 Wootton 
Parkway, Rockville, MD 20852; or call Dr. Carolyn Fassi at (301) 443-
5300.

    Dated: August 26, 2003.
Chris B. Pascal,
Director, Office of Research Integrity.
[FR Doc. 03-22299 Filed 8-28-03; 8:45 am]
BILLING CODE 4150-31-P