A comprehensive and effective oversight system is essen-tial to uniformly protect the rights and welfare of research participants while permitting ethically and scientifically responsible research to proceed without undue delay. To achieve these goals, the oversight system should include several interrelated but distinct functions and responsi-bilities, including policy development, regulatory reform, research review and monitoring, research ethics educa-tion, and enforcement. Many parties are involved in the research enterprise and the system of oversight, including research participants, IRBs, institutions, sponsors, a federal oversight office, state regulators, professional organizations, publishers, Congress, and the public. To function as intended, the system requires that all parties act responsibly, even though the ethical obligation to protect participants lies primarily with investigators, sponsors, and IRBs.
All research participants, regardless of whether the research sponsor is a public or private entity, should be protected by this oversight system, which should apply to both domestic and international research. To accom-plish this level and extent of protection, the system must expand beyond its current scope. An independent, single federal office created to lead and coordinate the oversight system would be more effective than the current system and would solve a number of problems. Such an office should promulgate a unified and comprehensive federal policy embodied in a single set of regulations and guid-ance that can be applied to all types of research involving human participants. Federal protections should be uni-form across all sectors of government, academe, and the private sector, but should be flexible enough to be
applied in widely different research settings or to emerging areas of research.
Finally, the newly created office should include in its policy a definition of research involving human partici-pants that is subject to federal protections and develop a range of review mechanisms for the various types of covered research. To meet the goal of protecting those who participate in research, the scope and relevancy of protections must be clear to all. Investigators, IRBs, sponsors, and institutions require and must receive unambiguous guidance on the extent to which their research activities are covered by the oversight system.
Notes
1 OPRR/FDA Town Hall Meeting: June 16, 2000, Chapel Hill, North Carolina; Vanderpool, H., Testimony before NBAC. June 6, 2000. San Francisco, California.
2 NBAC Town Meetings: February 9, 2000, Houston, Texas;
April 5, 2000, Pittsburgh, Pennsylvania; May 3, 2000, Orlando, Florida; June 7, 2000, Chicago, Illinois; August 14, 2000, Portland, Oregon.
3 See Vanderpool, H., “Unfulfilled Promise: How the Belmont ReportCan Amend the Code of Federal Regulations Title 45 Part 46—
Protection of Human Subjects.” This background paper was prepared for NBAC and is available in Volume II of this report.
4 See Moreno, J., “Protectionism in Research Involving Human Subjects.” This background paper was prepared for NBAC and is available in Volume II of this report.
5 See Chalmers, D., “Research Ethics in Australia.” This background paper was prepared for NBAC and is available in Volume II of this report.
6 See Moreno, J., “Protectionism in Research Involving Human Subjects.” This background paper was prepared for NBAC and is available in Volume II of this report.
7 See Chalmers, D., “Research Ethics in Australia.” This background paper was prepared for NBAC and is available in Volume II of this report.
8 See Schwartz, J., “Oversight of Human Subject Research: The Role of the States.” This background paper was prepared for NBAC and is available in Volume II of this report.
9 See McCarthy, C., “Reflections on the Organizational Locus of the Office for Protection from Research Risks.” This background paper was prepared for NBAC and is available in Volume II of this report.
10 See Fletcher, J., “Location of the Office for Protection from Research Risks within the National Institutes of Health: Problems of Status and Independent Authority.” This background paper was prepared for NBAC and is available in Volume II of this report.
National Bioethics Advisory Commission
11 See McCarthy, C., “Reflections on the Organizational Locus of the Office for Protection from Research Risks.” This background paper was prepared for NBAC and is available in Volume II of this report.
12 Flack, D., Testimony before NBAC. March 1, 2000. Herndon, Virginia; Ley, J., Testimony before NBAC. March 1, 2000.
Herndon, Virginia. See McCarthy, C., “Reflections on the Organizational Locus of the Office for Protection from Research Risks.” This background paper was prepared for NBAC and is available in Volume II of this report.
13 See Fletcher, J., “Location of the Office for Protection from Research Risks within the National Institutes of Health: Problems of Status and Independent Authority.” This background paper was prepared for NBAC and is available in Volume II of this report.
14 All codes available at American Psychological Association, http://www.apa.org/ethics/code.html; American Sociological Association, http://www.asanet.org/members/ecostand.html.
Both sites last accessed December 12, 2000.
15 Law 88-1138 Regarding the Protection of Persons Agreeing to Biomedical Research.
16 Pub. Law 348, 93rd Congress, Title II.
17 NBAC Town Meeting: August 14, 2000, Portland, Oregon.
18 NBAC Town Meetings: February 9, 2000, Houston, Texas;
April 5, 2000, Pittsburgh, Pennsylvania; May 3, 2000, Orlando, Florida; June 7, 2000, Chicago, Illinois; August 14, 2000, Portland, Oregon.
19 Wax, M., Testimony before NBAC. April 6, 2000. Washington, D.C.; Sieber, J.E., Testimony before NBAC. April 6, 2000.
Washington, D.C.; Abowd, J.M., Testimony before NBAC.
April 6, 2000. Washington, D.C.; Shopes, L., Testimony before NBAC. April 6, 2000. Washington, D.C.
20 46 Fed. Reg.8366–8391.
21 Public Responsibility in Medicine and Research conference on human subjects protections, November 1998, “IRBs and the Shifting Sands of Public Opinion.” San Diego, California.
22 OHRP Guidance: “Engagement of Institutions in Research.”
January 26, 1999; “Issues to Consider in the Research Use of Stored Data or Tissues.” November 7, 1997; “Protections for Human Subjects in the NIGMS Human Genetic Mutant Cell Repository:
Submission of Non-Identifiable Materials to the Repository.” May 22, 1997; “Guidance on Protections for Human Subjects in the National Institute of General Medical Sciences Human Genetic Mutant Cell Repository.” May 21, 1997; “Operation of Human Cell Repositories Under HHS Regulations at 45 CFR 46.” August 19, 1996. Available at http://ohrp.osophs.dhhs.gov/humansubjects/guidance/reposit.htm.
Last accessed December 15, 2000.
23 38 Fed. Reg.3878–3883.
24 K. Ewing and L.K. George, Duke University, to E.M. Meslin, NBAC. February 16, 2001. Letter relating to draft of this report.
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Introduction
P
rotecting the rights and welfare of research participants is the major ethical obligation of all parties in the oversight system, who, to meet this obligation, must demonstrate competence in research ethics by being able to conduct, review, or oversee research involving human participants in an ethically sound manner. Such competence entails not only being knowledgeable about relevant research ethics issues and federal policies but also ensuring that conflicting interests for institutions, investigators, or Institutional Review Boards (IRBs) are disclosed and managed so that there is no question that research participants are being protected. Finally, the oversight system must include a robust monitoring process so that lapses by institutions, IRBs, and investigators can be remedied.This chapter addresses measures needed to ensure that all parties involved in the research enterprise are competent with regard to protecting research participants and are reliably carrying out their responsibilities in this area. They include measures:
■ to educate all parties involved in research with human participants about the substantive and procedural requirements of the system of protections (which includes demonstrated competence in research ethics);
■ to provide ongoing mechanisms to ensure that institutions, IRBs, and investigators are in compliance with regulations, guidance, and procedures pertaining to the protection of research participants; and
■ to manage conflicts of interest of investigators, IRBs, and institutions.