03-22299. 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.

ACTION:

Notice.

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 [phone].

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 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 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 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 [phone].

Dated: August 26, 2003.

Chris B. Pascal,

Director, Office of Research Integrity.