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These draft recommendations will be finalized at the next National Bioethics Advisory Commission meeting in May in Washington, DC.
Recommendation 4.1: All institutions and sponsors engaged in research involving human participants should provide access to educational programs on research ethics to appropriate institutional officials, investigators, IRB members and IRB staff. Colleges and universities should include research ethics in curricula related to conducting research. Professional societies should encourage, as appropriate, graduate and professional schools to include research ethics as part of the curriculum and should include research ethics in their programs of continuing education.
Recommendation 4.2: The National Office of Human Research Oversight (NOHRO), in consultation and partnership with academic and research organizations, should mount new efforts to enhance the teaching of research ethics related to protection of human research participants. NOHRO should consult with professional societies in the social sciences, humanities, public health, and clinical sciences so that educational programs are designed to meet the needs of all who conduct research. In particular, NOHRO should make educational materials and programs available to institutions and stimulate the development of innovative educational programs aimed at improving the design, review and conduct of research protocols involving human participants.
Recommendation 4.3: As appropriate, all investigators and IRB members and staff should be certified in order to conduct or review research involving human participants. The NOHRO should encourage organizations, sponsors, and institutions to develop certification programs. Various levels and types of certification for IRB members and staff and investigators should be explored. NOHRO should set standards for determining whether institutions and sponsors have an effective process of certification in place.
Recommendation 4.4: Sponsors, institutions, and IRBs should be accredited in order to conduct or review research involving human participants. The NOHRO should encourage organizations to develop accreditation programs designed to ensure that institutions conducting or reviewing human participants research have in place appropriate mechanisms to carry out ethically sound research. NOHRO should require accrediting bodies to use a uniform set of standards and develop procedures for monitoring accrediting bodies and the effectiveness of accreditation.
Recommendation 4.5: In order to reduce unnecessary burden on agencies and institutions, issuance of assurances of compliance should be centralized and handled by the NOHRO. The assurance process should be modified to serve two purposes: to reflect the broad obligation taken on by the institution and be a mechanism for registering institutions and IRBs. Assurances should not be duplicative of an accreditation program for institutions and IRBs (see recommendation 4.4).
Recommendation 4.6: Institutions should develop internal mechanisms to ensure IRB compliance and to ensure investigator compliance with regulations, guidance, and institutional procedures. Mechanisms should be put in place for reporting non-compliance to all relevant parties.
Recommendation 4.7: The NOHRO should issue guidance defining conflicts of interests and ways to ensure that these conflicts do not subject research participants to any unnecessary risk.
Recommendation 4.8: Sponsors and institutions should develop policies and mechanisms to define and manage all types of conflicts of interests but especially financial conflicts. In particular, such policies should require disclosure of financial conflicts of interests to institutions, IRBs, and participants. Policies also should describe specific types of relationships that should be prohibited. Institutions should continue to work with professional societies and sponsors to clarify other investigator and institutional conflicts of interests and to develop mechanisms for managing such conflicts through education and oversight.
Recommendation 4.9: The NOHRO should issue regulations setting minimum percentage requirements for IRB membership composition and quorum determination for members who 1) are not otherwise affiliated with the institution and 2) whose primary concerns are in non-scientific areas. At least 25% of the IRB members should be otherwise not affiliated with the institution and at least 25% of the IRB members should be non-scientists. If an individual is both a non-scientist and otherwise not affiliated with the institution, that person should be permitted to fulfill both membership requirements.
Recommendation 4.10: The NOHRO should issue guidance relating to the selection of members on IRBs. Expertise and experience of IRB members should be appropriate for the types of research reviewed by the IRB. IRBs that review behavioral and social science or historical research should have behavioral and social scientists or historians as members of the IRB.
Recommendation 4.11: The NOHRO, in consultation with sponsors, should issue guidance describing the various types of monitoring and defining the roles of institutions and sponsors in monitoring the progress of ongoing research.
Recommendation 4.12: The NOHRO should issue regulations describing requirements for continuing review of ongoing research. Continuing review should not be required for research studies involving no more than minimal risk, research involving the use of existing data, or research in the data analysis phase when there is no additional contact with participants. When continuing review is not required, other monitoring mechanisms should be in place for assessing compliance of investigators and for reporting of changes or unanticipated problems encountered in the research.
Recommendation 4.13: The NOHRO should issue guidance regarding the types of changes to approved protocols that must be reported to IRBs and the types of changes that do not need to be reported to IRBs; the types of protocol amendments eligible for administrative IRB review and the types that must be reviewed by the full IRB. NOHRO should issue guidance regarding the types of unanticipated problems that must be reported, how they should be handled by an IRB, and under what circumstances and to whom unanticipated problems should be reported to federal agencies.
Recommendation 4.14: The NOHRO and all relevant federal agencies should work together to develop a uniform system for reporting and evaluating adverse events occurring in research. As part of the system:
1. One set of regulations should be issued with supporting guidance that describes the process for reporting of adverse events in all research studies. Roles of investigators and sponsors in reporting adverse events should be clarified.
2. The roles of IRBs, data safety monitoring boards, and the relevant federal agencies in receiving and responding to adverse event reports of various types should be clarified and the activities of these bodies should be coordinated, particularly for serious adverse events that occur in clinical trials.
3. NOHRO, in conjunction with the relevant federal agencies, should address mechanisms for reporting and evaluating adverse events in multisite clinical trials especially to ensure that all serious adverse events are reported appropriately.
4. The reporting mechanisms should require reporting of adverse events in a manner that addresses concerns of sponsors about the confidentiality of proprietary information but does not compromise the protection of research participants.
Recommendation 4.15: To avoid duplicative IRB review of multisite research studies, alternative models of review are needed that ensure the protection of research participants and at the same time reduce both the work burden on IRBs and the unnecessary time delay and costs associated with multiple reviews of the same protocol. Institutions and sponsors with approval from the NOHRO should test and evaluate the various models for effective and efficient review of multisite research studies.
Recommendation 4.16: The NOHRO should issue regulations requiring all research involving human participants to be reviewed by an accredited IRB prior to initiation (see recommendation 4.4). For single site research, institutions should be able to sue the designated IRB. In order to move in the direction of avoiding duplicative IRB review for multisite research, regulations should be issued that are permissive of a central or lead IRB review. For example, rather than requiring all cooperative institutions engaged in research to review the research, regulations should state that only one accredited IRB review and approval is required and allow institutions to rely upon the review by another accredited IRB if they so choose. In such cases, the reviewing IRB should be designated as the IRB of record.
Recommendation 4.17: Congress should pass legislation establishing an administrative system that promptly and easily provides compensation for medical and rehabilitation costs caused by research participation. As part of a compensation system, information should be collected to support accurate projections of the resources needed for the compensation system.
Source: National Bioethics Advisory Commission. Ethical and Policy Issues in Research Involving Human Participants, Chapter Four: The Local Oversight System: Institutions and IRBs. Washington, DC; March 2, 2001.