Rationale for the Budget Request General Departmental Management The FY 2003 request for OEP is $15,649,000, an increase of $1,101,000 above the FY 2002 appropriation. At this level, OEP is requesting $1,001,000 to partially cover increased pay and inflation costs, as well as $100,000 for the Commissioned Corps Readiness Force and Corps revitalization efforts. An additional $107,240,000 is requested in the Public Health and Social Services Emergency Fund request. Activities funded by this GDM request include office/regional operations, some training and exercises coordinated with other agencies, planning and evaluation, communications, accrual costs for the Civil Service Retirement Fund, and Commissioned Corps Readiness Force/Inactive Reserve and Reserve Affairs activities. Commissioned Corps Readiness Force (CCRF)/Ready Reserve. An increase of $100,000 (total of $1,300,000) is requested for the CCRF and other Corps revitalization efforts to continue to develop and refine training programs that deal with field effectiveness issues, including course development training materials and equipment to train commissioned Officers who have joined. who join with their medical/specialty certification have never been deployed in an emergency CCRF deployments are now becoming a routine element of emergency responses. Many officers situation, and require training to ensure that CCRF is a viable and rapidly deployable force. OEP will focus efforts on developing and expanding the CCRF. n of Estimates for Appropriations Committees Page 118 Current Law Budget Authority Accrual Costs Proposed Law Bud Set Authority FTE Purpos General Departmental Management OFFICE FOR HUMAN RESEARCH PROTECTIONS FY 2001 $5,800,000 217,000 28 43 +$6,017,000 and Method of Operations program to O was created in June 2000, as part of a broad o enhance protections for human research subjects. Based upon recommendations of a The Oce for Human Research Protections (OHRP) review Panel convened by the Director of the National Institutes of Health, OHRP was created Office of the Secretary from the former Office for Protection from Research Risks at effective platform from which the new office NIH. This move was intended to provide a more could lead reform, both within HHS and across all Federal agencies that subscribe to the Federal I protections of human subjects in research, known as the Common Rule (45 CFR Part 46, Subpart A). within the OHRP is responsible for overseeing human research protections functions and related functions where research involves the use of human subjects. To accomplish this mission, OHRP has the following specific responsibilities: Develop, protection of human subjects involved in research conducted or supported by any HHS monitor, and exercise compliance oversight relative to HHS regulations for the component Coordinate in coordination with other Departments and Agencies in the Federal government; appropriate HHS regulations, policies, and procedures both within HHS and or supported research involving human subjects; sectors with respect to the involvement of human subjects in research; and generating educational resource materials; and implementation of educational and instructional programs General Departmental Management Evaluate the effectiveness of HHS policies and programs for the protection of human subjects; Serve as liaison to the Executive Branch, Legislative Branch, and non-governmental entities established to examine ethical issues in medicine and research; and Exercise leadership in identifying and addressing ethical issues related to the use of Since the reorganization, OHRP has made significant strides in coordinating the national effort to improve the protection of human research subjects. Specifically, OHRP has accomplished the following tasks furthering the mission of the office. Compliance Oversight Activities. In FY 2001 the Division of Compliance Oversight (DCO) conducted four compliance oversight visits. Additionally, DCO opened 37 new compliance oversight cases and closed 96 cases during FY 2001. The number of open cases has been reduced from its peak of 182 in July 2000 to 108 as of December 31, 2001. A new program of not-for-cause compliance oversight surveillance evaluations is a highlight of efforts to increase accountability of the human subjects protection system, working in concert with education, support and quality improvement efforts. OHRP has established a target of up to ten such surveillance evaluations per month, subject to resource availability. Accreditation of Human Research Protection Programs. Under the leadership of OHRP, efforts will continue in the Department to promote private, voluntary accreditation of human research protection programs as a complement to the government's oversight processes. Continuous review of accreditation standards will be included in the accreditation process. Institutional Review Board (IRB) Registration. In collaboration with FDA, OHRP has developed a unified IRB Registration System. The new system was launched at the beginning of December 2000 and provides for the voluntary registration of IRBs through a web-based system. Regulations are being developed to require registration of all IRBs as part of HHS efforts to increase accountability in the system and facilitate education and communication with IRBs. Education and Training. OHRP is enhancing it's education efforts in order to ensure that investigators and IRB members are well informed about the regulatory requirements. As part of this effort OHRP will be increasing the number of workshops, town meetings, and presentations conducted by the staff of the Education Division. Already, OHRP hosted seven workshops and town meetings in FY 2000, and eight in FY 2001, and plans to host multiple conferences to showcase the new education programs of OHRP in FY 2002. OHRP will also expand its use of information technology to conduct video conferences to reach a wider audience. Finally, OHRP will be developing an interactive guidance resource/repository to provide easier access to OHRP guidance. OHRP is also planning a public education campaign to better inform lay persons about the research process, informed consent, IRBs and the like. This will ultimately strengthen the consent process and afford greater recognition of OHRP's public service role and the General Departmental Management importance of the private accreditation process. Federal-wide Assurance Process Revision/Simplification. OHRP has developed a simplified Institutional Assurance system in conjunction with the IRB Registration System. This system will greatly reduce the administrative burden on the individual institutions and OHRP, resulting in faster assurance approvals and allow for reallocation of human resources to more effective, service oriented support and quality improvement processes (vide infra). This system is set to be implemented once approval is granted by OMB according to the Paperwork Reduction Act. Continuous Quality Improvement (QI) Initiative. The development and implementation of an interactive, collaborative quality improvement program is the cornerstone of OHRP's efforts to shift from a post-hoc compliance-focused system of oversight and sanctions to a performancebased system for prevention of harm or injury to research participants. The program was officially initiated in December 2001 and its capacity will be expanded toward a target of 60 QI consultations every month, subject to resource availability. National Human Research Protections Advisory Committee. The National Human Research Protections Advisory Committee (NHRPAC) held its first meeting on December 20-21, 2000 and has held three subsequent meetings and provided important advice to OHRP on important issues including financial relationships and conflicts of interest in human research, children as research subjects, and review of social and behavioral research. This newly established Committee will provide expert advice and recommendations to senior Departmental officials on a broad range of issues and topics pertaining to or associated with the protection of human research subjects. Strengthening Protections for Human Subjects in International Research. In FY 2002, OHRP expanded its international activities. For example, through OHRP, HHS hosted and improtant meeting of Strategic Initiative for Developing Capacity in Ethical Review (SIDCER). SIDCER is an independent international cooperative project designed to facilitate the development of global capacity for ethical review of biomedical research. This initiative is already having a global impact. Participants came to Washington from around the world, looking to HHS as a partner and leader in efforts to build an effective global system for ethical review of biomedical research and protection of human subjects. OHRP is working in collaboration, with FDA and NIH's Fogarty International Center to improve protections for human subjects in international research by developing effective harmonized review capacity and recommending policy guidance Its current oversight functions are carried out by the OHRP Divisions for projects which are wholly or in part carried out in another country with particular emphasis on developing countries. As noted in a recent Inspector General's report, international research poses special and ever increasing challenges, and much remains to be done. The report ask that OHRP take the lead for HHS in this effort Rationale for the Budget Request The FY 2003 request for OHRP is $7,804,000, an increase of $549,000 above the FY 2002 appropriation. The request includes program increases to expand international activities |