search involving pregnant women, the human fetus, and human in vitro fertilization. (See Appendix A.)

Sanctions. If an institution or principal investigator is found to have "failed materially" to protect human subjects, the Secretary may terminate or suspend current funds or withhold further HHS research funding (whether or not HHS funds were involved in the research in which the failure to protect subjects occurred).

Summary and Analysis of the Regulations of
Other Federal Agencies

The HHS regulations summarized above provide the gauge against which to measure the regulations and policies of the other Federal agencies.

The Degree of Uniformity: Minor Variations. Seventeen of the twenty-two Federal entities other than HHS that conduct or support biomedical or behavioral research involving human subjects have regulations or policies that substantially conform with HHS regulations (see Table 4). That is, they require review and approval of proposed research by an IRB or similar committee, using standards for review and consent provisions that mirror, or are similar to, those in the HHS regulations.

The regulations of two of these seventeen Federal entities, however, apply to some but not all of the research conducted or supported by those agencies. The Department of Education's regulations for the protection of human subjects apply to contracts, but not to grants. NASA requires IRB review for intramural research but not for extramural research.

Among the agencies that generally conform to 45 CFR 46, however, there are minor differences that complicate the work of IRBs. For example, the Army, Navy and Air Force require that IRBS determine that prior animal studies have been conducted, where possible, prior to approving human studies. They also require IRBs to determine that facilities where the research will be conducted are adequate to handle foreseeable injuries. The Consumer Product Safety Commission has the same requirement. The National Highway Traffic Safety Administration requires IRBs to review research involving cadavers; HHS and all agencies that follow 45 CFR 46 limit review requirements to research involving living human subjects.

Agencies also have a variety of rules regarding special classes of subjects. The Army has adopted special protections (similar to recommendations of the National Commission) for the participation of children, prisoners, and the mentally disabled in Army research activities. The Navy and the Air Force simply exclude prisoners and the mental

Agency Conformity with HHS Regulations (45 CFR 46)

ly disabled; the Air Force also excludes children. The Army (but not the Navy or the Air Force) specifically prohibits the participation of prisoners of war. The Department of Agriculture excludes pregnant or lactating women from certain kinds of studies; the Air Force excludes females "unless there is reasonable assurance of no concomitant pregnancy that would place the fetus at risk and if methods adopted for contraception do not place the female subject at increased risk without complete disclosure to the female subject."

There are also minor variations regarding what must be disclosed to subjects in the consent process. A number of agencies require information regarding the Privacy Act and the extent to which research data will (or can) be kept confidential; others have no such requirement. The Office of Justice Assistance, Research, and Statistics (OJARS) of the Department of Justice supports research involving surveys, questionnaires and observational data which may deal with sensitive topics such as drug or alcohol use and illegal conduct. With research of this kind, the significant risk to subjects is the possibility of a breach of confidentiality. Therefore, OJARS has extensive regulations that protect the confidentiality of data even from subpoena. In place of IRBs, advisory boards meet several times a year with project staff to review the progress of the research.

The Bureau of Standards provides a completely different description of informed consent. The Bureau's definition (which, among other features, equates “informed consent" with the document that records the agreement reached by investigator and subject) includes:

(a) information on all features of the research that are likely to influence the subject's willingness to participate, such as risk of injury or possibility of embarrassment, discomfort, or emotional stress;

(b) explanation of other aspects of the research about which the subject inquires which is consistent with maintaining the validity of the research; and

(c) an agreement, to be signed by the subject and the principal investigator, which states the responsibilities of each and the relevant features of the research and which makes explicit the right of the subject or the principal investigator to terminate the subject's participation at any time without incurring any legal liability.

The Bureau of Standards also adds that subjects must be free from undue coercion and undue pressure as well as from the inducement of excessively high rewards (monetary or otherwise). The Bureau of Prisons limits incentives for participation to soft drinks and snacks given at testing time. The Navy requires that the sponsor of the research be

identified and NASA requires that subjects be informed if, for any reason, withdrawal during the conduct of the research is not an option (e.g., because it would be unwise, dangerous, or impossible).

Administrative details also vary among agencies. The Consumer Product Safety Commission and the Navy both require that all consent forms be submitted to the agency along with the research proposal; most agencies apparently do not. The Navy requires that documentation of IRB approval be signed by every member of the IRB; most agencies (including HHS) accept the signature of the chairman. Most agencies require that IRB records pertaining to research activities be retained for a period of 3-5 years following completion of the research. The Navy requires that such records be retained permanently, and the Air Force requires that copies of all such records be forwarded to the Air Force upon completion of the research.

Clearly, IRBs that review hundreds of research proposals per year, many of which may be submitted to (and even funded by) more than one agency, need to have copies of the regulations of each agency at hand in order to assure compliance with these varied provisions. Furthermore, the regulations are constantly changing. Several Federal departments or entities are now in the process of developing new regulations for the protection of human subjects, including the Departments of Defense and of Transportation, which are formulating department-wide standards, the Department of Agriculture, which is bringing its policies into conformity with the most recent HHS revisions, and the Bureau of Prisons, within the Department of Justice, which is currently drafting new regulations for the protection of inmates as research subjects that generally conform to the HHS regulations.

Agencies Without Formal Regulations. Four Federal entities have no formal regulations specifically for the protection of human subjects involved in research. Three of these four are components of the Department of Transportation (DOT). The Department reports that it is in the process of developing department-wide regulations for the protection of human subjects; however, in 1977 DOT reported to the National Commission that it was then engaged in such an effort. Until the new regulations, which are to conform with HHS regulations, are implemented, three of the four components of the Department lack rules specifying their means of protecting human subjects, while the remaining DOT agency (the National Highway Traffic Safety Administration) has rules that parallel the HHS regulations.

The Department of Housing and Urban Development (HUD) is the only other Federal agency conducting research with human subjects that does not have formal regulations

for the protection of human subjects. In HUD's initial response to the Commission's inquiry, Donna Shalala (Assistant Secretary for Policy Development and Research) stated that except for a study co-sponsored with HEW, involving the testing of an aversive additive in paint to deter children from eating paint chips, HUD "has never sponsored any human subject or biomedical studies."16 Moreover, Dr. Shalala challenged the statement in the National Commission's report that HUD's "housing allowance experiment" constituted research with human subjects.17

The definition of "research with human subjects" and the possible inclusion of HUD's activities within such a definition was explored more fully with Dr. Shalala and her staff at hearings before the Commission in July 1980 and in subsequent correspondence. The result was HUD's acknowledgement that some of its research may present risk to human subjects. The Department has now developed a departmental memorandum that requires internally generated projects as well as "unsolicited research proposals" involving risk to human subjects to be approved by an independent review board. 18 Certification of the board's approval of the research design, as well as a description of the review board's procedures and membership, must be forwarded with the proposal (see Appendix B). The memorandum does not set forth the standards of review nor require IRB approval at the home institutions of those carrying out human research with HUD funds. Moreover, the memorandum does not supply the fundamental analysis needed to establish the differences and similarities between the concerns that motivate regulation of biomedical and behavioral research and those that are appropriate in the case of "social policy experiments" of the type supported by HUD.19

16 Letter (March 28, 1980) from Donna E. Shalala, Assistant Secretary for Policy Development and Research, Department of Housing and Urban Development.

17 IRB Report, supra note 2, at 96, 100–101.

18 HUD Policy Memorandum (February 21, 1981) from Arthur S. Newburg, Director, Office of Management and Program Control, to "All PD&R Staff" attached to letter (February 24, 1981) from Mr. Newburg to Alexander M. Capron.

19 See, e.g., Alice M. Rivlin and P. Michael Timpane, eds., Ethi