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ACHRE Report

Part III

Chapter 14


The Federal Policy for Human Subject Protections (The Common Rule)

Research Involving Ionizing Radiation

Scope of Programs of Research Involving Human Subjects

Administravtive Structures and Procedures for Research Oversight

Federal Responses to Violations of Human Subjects Protections

Protections for Human Subjects in Classified Research


Chapter 14: Footnotes

1 . Agency data reported to the Advisory Committee. See table 1 at end of this chapter and supplemental volume for the individual agency spending estimates that make up this total figure.

2 . The sixteen departments and agencies that adopted a common policy for human subjects protection are the Department of Agriculture, Department of Energy, National Aeronautics and Space Administration, Department of Commerce, Consumer Product Safety Commission, Agency for International Development, Department of Housing and Urban Development, Department of Justice, Department of Defense, Department of Education, Veterans Administration (now Department of Veterans Affairs), Environmental Protection Agency, Department of Health and Human Services, National Science Foundation, Department of Transportation, and pursuant to an executive order, the Central Intelligence Agency. The Food and Drug Administration, a subagency of Health and Human Services, has somewhat different regulations governing human subjects research, based on its distinct statutory authority to regulate research for the licensing of new drugs, devices, and biologics (e.g., vaccines).

3 . Federal Policy for the Protection of Human Subjects; Notices and Rules, 56 Fed. Reg. 28002 - 28032 (June 18, 1991). Each department and agency subject to the Common Rule incorporated its provisions within the agency's own regulations (e.g., DHHS regulations are reflected in 45 Code of Federal Regulations [C.F.R.] pt. 46, while DOD regulations are reflected in 32 C.F.R. pt. 219). The June 1991 Federal Register announcement is the only publication of the Common Rule as such. The Common Rule is not applicable to nonfederally funded research unless the research is performed at an institution whose research is subject to a multiple project assurance (MPA), described later in this chapter.

4 . President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, Protecting Human Subjects: The Adequacy and Uniformity of Federal Rules and Their Implementation (Washington, D.C.: GPO, 1981).

5 . Ibid., 140.

6 . DHHS regulations specify additional protections for research on certain subject populations: pregnant women, fetuses, and subjects of in vitro fertilization research; prisoners; and children. The DHHS regulation is codified at 45 C.F.R. pt. 46 (1991). Subpart A of this regulation is the Common Rule. Subpart B provides additional protections for research involving pregnant women, fetuses, and in vitro fertilization, subpart C for research involving prisoners, and subpart D for research involving children. At their discretion, some of the other federal agencies whose research programs involve subjects in one of these categories have adopted these regulations as agency guidelines. See table 1 at the end of this chapter for information on the applicability of special protections by agency. Some agencies, such as DOD impose other safeguards in addition to those of the Common Rule. Information on individual agency policies and oversight practices at the other ten agencies, and greater detail on the policies of the six agencies above, are reported in a supplemental volume to this report.

7 . The Common Rule directs that IRBs must include at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas. They must also include at least one member who is not otherwise affiliated with the institution (§___.107). (The provisions of the Common Rule are designated as "§ ___.000." The "____" indicates that these sections are reproduced within the regulations of various departments. Thus §___.107 of the Common Rule is codified for DHHS at 45 C.F.R. § 46.107.)

8 . Federal Policy for the Protection of Human Subjects, [[section]]___.116(a).

9 . Ibid., [[section]]___.116(b).

10 . Common Rule, ___.116(d). Under the Common Rule, four requirements must be met in order for an IRB to waive the rule's informed consent requirements: "(1) the research involves no more than minimal risk; (2) the waiver or alteration will not adversely affect the rights and welfare of the subjects; (3) the research could not practicably be carried out without the waiver or alteration; and (4) whenever appropriate, the subjects will be provided with additional pertinent information after participation."

11 . Ibid., [[section]] ___.109.

12 . Radioactive Drugs for Certain Uses, 21 C.F.R. [[section]] 361.1

13 . National Institutes of Health, Office for Protection from Research Risks, Protecting Human Research Subjects (Washington, D.C.: GPO, 1993), 5-23 - 5-28.

14 . These figures represent the total amount of funds obligated for projects in which any human subjects were involved regardless of how minimal such involvement may be. Since it is virtually impossible to determine, within any given grant, the exact dollar amount that goes to human subject research, only the funding for the entire project could be calculated.

15 . Lily O. Engstrom, Office of Extramural Research, NIH, to Wilhelmine Miller, ACHRE, 21 February 1995 ("Response to ACHRE Request No. 013095-E") and 4 April 1995 ("Additional Information in Response to ACHRE Request No. 013095-E").

16 . The PHS comprises a number of agencies, including the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA). The NIH is the world's largest medical research center and conducts biomedical research (both basic science and clinical) dedicated to the improvement of the public's health. The CDC focus is primarily on health promotion and disease-prevention, in addition to basic research in epidemiology, disease surveillance, laboratory science, and training of disease-prevention officials. The FDA is responsible for regulating and overseeing the safety and effectiveness of food, cosmetic, medical device, and human and veterinary drug industries, in addition to studying and monitoring consumer products and the industries that produce them. Department of Health and Human Services, Public Health Service, Office of the Assistant Secretary for Health, January 1993 ("The U.S. Public Health Service Today") (ACHRE No. HHS-091395-A).

17 . Joseph V. Osterman, Environmental and Life Sciences, Office of the Director of Defense Research and Engineering, DOD, to Principal Deputy Assistant to the Secretary of Defense (Atomic Energy), 27 February 1995 ("White House Advisory Committee on Human Radiation Experiments").

18 . Richard Pell, Jr., Deputy Chief of Staff, VA, to Jeffrey Kahn, ACHRE, 10 February 1995 ("We have prepared the enclosed fact sheet"), and Richard Pell, Jr., to Wilhelmine Miller, ACHRE, 19 January 1995 ("In response to your request"), enclosure pages 9-10.

19 . DOE Database, Fiscal Year 1994, reported by David Saumweber, ACHRE, to Advisory Staff, ACHRE, 17 October 1994 ("DOE Current Research"), and oral communication by Susan Rose, Office of Health and Environmental Research, Office of Energy Research, DOE, to Wilhelmine Miller, ACHRE, 13 January 1995. There is ongoing discussion as to how large the commitment to RERF will be and how it will be administered.

20 . J. Stoklosa, NASA Office of Aerospace Medicine, to Wilhelmine Miller, ACHRE, 14 February 1995 ("Enclosed is the response to"), 2. Figures for in-flight biomedical research were not provided.

21 . Notes of Gary Stern, ACHRE, regarding 7 March 1994 meeting with CIA inspector general's staff, 8 March 1994. John F. Pereira, CIA, to Gary Stern, Anna Mastroianni, and Sara Chandros, ACHRE, 7 August 1995 ("Information for Committee's Final Report"). No additional information on this issue was made available by the CIA in response to Advisory Committee queries.

22 . In addition, several federal agencies have adopted as policy guidelines the additional provisions of the DHHS regulation, 45 C.F.R. pt. 46, for pregnant women, fetuses, and in vitro fertilization; prisoners; and children (subparts B, C, and D, respectively). See table 1 at the end of this chapter for references to such agency policies.

23 . Federal Policy for the Protection of Human Subjects, [[section]]___.103(a).

24 . Occasionally, a federal agency may rely on an IRB at an adjacent academic institution to review research projects conducted at the federal facility. This sometimes occurs at VA hospitals that are affiliated with teaching hospitals and is the case for the Environmental Protection Agency, whose own research facility is located at the University of North Carolina.

25 . Federal Policy for the Protection of Human Subjects, [[section]]___.103 and [[section]]___.113.

26 . James M. Lamiel, Chief, Clinical Investigation Regulatory Office, Consultant to the Army Surgeon General for Clinical Investigation, to Director, Radiation Experiments Command Center, 28 July 1995 ("Revised Chapter Drafts of the Advisory Committee").

27 . Ibid., [[section]] ___.109 and [[section]]___.113.

28 . Federal Policy for the Protection of Human Subjects, [[section]]___.103(a).

29 . Gary Ellis, Director, OPRR, to OPRR Staff, 7 December 1993 ("Compliance Oversight Procedures"), 1-4.

30 . FDA Protection of Human Subjects, 21 C.F.R. pt. 50 and Institutional Review Board Requirements, 21 C.F.R. pt. 56 (1995), [[section]] 56.115 and [[section]] 56.120. See supplemental volume for further discussion of the FDA's distinctive policies and oversight practices.

31 . Medical monitors are not permitted to be investigators involved in the protocol. Medical monitors have the authority to terminate an individual volunteer's participation in the study or suspend the study for review by the IRB. Lamiel, "Revised Chapter Drafts of the Advisory Committee."

32 . DOE, Office of Health and Environmental Research, Progress Report: Protecting Human Research Subjects (Washington, D.C.: DOE, November 1994), A2.

33 . See for example, Department of Defense Instruction 5000.2: "Defense Acquisition Management Policies and Procedures," 23 February 1991 (Administration); Army Regulation 40-10, "Medical Service Health Hazard Assessment Program In Support of the Army Matériel Acquisition Decision Process," 15 September 1983 (Administration and Safety Issues); Army Regulation 70-8: "Research, Development, and Acquisition, Personnel Performance and Training Program (PPTP), (Research Guidelines and Procedures; Training and Indoctrination)"; Army Regulation 70-8: "Research, Development, and Acquisition, Soldier-Oriented Research and Development in Personnel and Training," 31 July 1990 (Research Guidelines and Procedures Training and Indoctrination); Donald J. Atwood, Deputy Secretary of Defense, Department of Defense Directive Number 5000.1: "Defense Acquisition," 23 February 1991.

34 . Oral communication by Colonel John Boslego, Deputy Director, WRAIR, to Shobita Parthasarathy (ACHRE Staff), 13 September 1995.

35 . Lamiel, "Revised Chapter Drafts of the Advisory Committee."

36 . Major Dale Vander Hamm, Chief, Human Use Review and Regulatory Affairs Division, Headquarters, U.S. Army Medical Research and Matériel Command, to Shobita Parthasarathy, ACHRE, 27 July 1995 ("Human Volunteers in U.S. Army Research in 1995").

37 . Ibid., [[section]] ___.113.

38 . Ibid., [[section]] ___.103(b) and (f), [[section]] ___.122 - ___.123.

39 . Each agency has its own regulations regarding the oversight of compliance. For example, debarment procedures are specified for DHHS at 45 C.F.R. [[section]] 76. These procedures are summarized in a memorandum from Gary Ellis to OPRR staff, 5 February 1993 ("Compliance Oversight Procedures"), 3.

40 . California Health and Safety Code, vol. 40B, [[section]] 24176 (1995).

41 . Joseph V. Osterman, Environmental and Life Sciences, Office of the Director of Defense Research and Engineering, to Principal Deputy, Assistant to the Secretary of Defense (Atomic Energy), 27 February 1995 ("White House Advisory Committee on Human Radiation Experiments"). Larry Magnuson, M.D., CIA, in oral communication to Gary Stern, ACHRE.

42 . Osterman to Assistant to the Secretary of Defense (Atomic Energy), 27 February 1995.

43 . Notes of Gary Stern (ACHRE staff), regarding meeting with inspector general's staff, CIA, 7 March 1994 (8 March 1994).

44 . Ibid.

45 . Ellyn R. Weiss, Office of Human Radiation Experiments, DOE, to Daniel Guttman, ACHRE, 13 February 1995 ("This letter is in response to . . .").

46 . Described in the DOE guidance, Protecting Human Subjects at the Department of Energy, Human Subjects Handbook, Office of Health and Environmental Research, 1992, "Review of Classified Research," unpaginated (ACHRE No. DOE-050694-A).

47 . The FDA and DOD, memorandum of understanding of May 1987 ("Concerning Investigational Use of Drugs, Antibiotics, Biologics, and Medical Devices by the Department of Defense"), 4.

48 . Veterans Administration, "Policy Manual MP-1" (21 November 1979), part 5, chapter 1, 5-8.

49 . Janis Stoklosa, Office of Aerospace Medicine, NASA, in oral communication to Wilhelmine Miller, ACHRE, February 1995.

50 . Federal Policy for the Protection of Human Subjects, [[section]] ___.116 (d).

51 . Ibid., [[section]]___.101(i). This provision also allows for a statute or executive order to override the notification and publication requirements.

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