The recommendations made in this report will generate additional costs for institutions, sponsors, and the federal government (through the establishment of a new federal oversight office). The importance of identifying the needed resources to support a robust system of protection of research participants has long been a concern. In 1978, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (National Commission), concerned that Institutional Review Boards (IRBs) could not function without ade-quate resources, recommended that the oversight system be appropriately funded (National Commission 1978).
In 1998, the Department of Health and Human Service (DHHS) Office of Inspector General called attention to the critical shortage of resources, including staff, office
space, and information technology, and recommended that IRBs be given access to adequate resources (OIG 1998). The scarcity of resources for IRBs has been attributed to low levels of support from sponsors and institutions (GAO 1996).
In previous reports, the National Bioethics Advisory Commission (NBAC) recognized that research should not be thwarted because resources are not available to provide the necessary protections for human participants and that compliance would require additional resources (NBAC 1998; NBAC 1999). Sponsors of research, whether public or private, should work together with institutions conducting research to make the necessary resources available.
Limited information is available concerning the human and financial resources that federal agencies, other sponsors, and research institutions dedicate to oversight. In fact, the only information NBAC could obtain in this regard was for the federal agencies.
However, it is clear that the current system relies on other sponsors and research institutions also contributing substantial resources to oversight. Thus, the information presented below is an incomplete picture of the current resources used to support the oversight system.
Human and financial resources that directly support human research protection activities are limited at the federal level.1 As shown in Table 7.1, of the 16 federal agencies responding to an NBAC survey, 5 have no dedicated administrative unit or staff. Even within DHHS, four agencies have no dedicated administrative units or staff. Most departments spend only 1 to 2 per-cent of their human research budget on protection activ-ities. The National Institutes of Health (NIH) spent less
Table 7.1: Federal Agency Support for Research Participant Protections for FY 1999
Budget for Human
Agency Dedicated Administrative Unit Dedicated Research
Human Research Administrative Unit Budget
Central Intelligence Agency Yes, Chief of Human Subjects Research Panel and
Contracting Officer’s Technical Representatives Classified Classified Department of Commerce National Telecommunications and Information
Administration - No None reported $17,600,000
National Institute of Standards and Technology(NIST)-
personnel in Office of NIST Counsel and elsewhere $41,024,000
Census- No $158,500,000
Department of Defense 60 full-time equivalents (FTEs) $3,500,000 $37,100,000
Department of Education 1.5 FTEs $200,000 $50,000,000
Department of Energy 2 FTEs $425,000 $27,000,000
Department of Health and Human Services
Administration for Children
and Families No None reported $30,000,000
Agency for Healthcare
Research and Quality No None reported $109,411,000
Centers for Disease
Control and Prevention 6 FTEs $651,505 $172,025,000
Food and Drug Administration ~200 FTEs ~$37,000,000 $11,329,000
Health Care Financing
Administration 6 FTEs None reported $15,000,000
Health Resources and
Services Administration No None reported $75,908,000
Indian Health Service 4.7 FTEs $1,000,000 $22,400,000
National Institutes of Health 4 FTEs in Office of Human Subjects Research, $480,000 $8,580,000,000 another 10.73 in Institute’s administrative units, $334,965
19 FTEs in OPRR* $2,700,000 for OPRR
Substance Abuse and Mental
Health Services Administration No None reported $338,349,000
Department of Housing No (Office of Lead Hazard Control conducts None reported $11,000,000 and Urban Development some oversight)
Department of Justice 2 part-time employees Not available $110,705,000
Department of Transportation No None reported Not reported
Department of Veterans 3 units, 3 FTEs** None reported
Affairs (VA) for FY 1999 $175,600,000
National Aeronautics and
Space Administration 5.9 FTEs $625,000 $20,000,000
National Science Foundation Part-time employee None reported $150,360,000
Social Security Administration No None reported $40,000,000
Agency for International
Development Cognizant Human Subjects Officers None reported $60,000,000
Consumer Product Safety
Commission No None reported <$100,000
Environmental Protection Agency No None reported $ 76,000,000
*Until June 2000, OPRR was the administrative unit within DHHS that provided assurances for all DHHS agencies as well as other federal departments.
**During FY 2000, VA planned to increase to 8 FTE, and in FY 2001 there will be 12 FTE in Headquarters. There are plans for five field offices to be established in FY 2000.
Source: NBAC, “Federal Agency Survey on Policies and Procedures for the Protection of Human Subjects in Research.” This staff analysis is available in Volume II of this report.
National Bioethics Advisory Commission
than .05 percent of its human research budget directly on protection activities, even when the Office for Protection from Research Risks (OPRR) was administratively part of the agency.
The lack of adequate resources also has been noted in site visits by the Office for Human Research Protections (OHRP), formerly OPRR, and in testimony presented to NBAC. For example, in a site visit by OPRR to Duke University, OPRR found that the university had assigned only 2.5 to 3 full-time staff members to the IRB, even though the university reviewed over 1,700 protocols annually.2IRB administrators, in particular, who testified to NBAC described the need for resources and strongly encouraged NBAC to consider the issue of resources in its recommendations.3 A report commissioned by NIH, Reducing Regulatory Burden, noted that resources available to IRBs are decreasing despite increases in workload and recommended providing additional federal resources when adding to IRB duties (Mahoney 1999).
Data estimating the costs of institutional protection programs are nearly 20 years old (Brown et al. 1979;
Cohen 1982). In 1982, it was estimated that the total cost (administrative plus meeting costs) of IRB review at uni-versities without medical schools was $137 per protocol,
$154 at universities with medical schools, and $207 at hospitals. Adjusting these cost estimates for inflation using the Consumer Price Index, the total cost of IRB review at universities without medical schools would currently be estimated at $245 per protocol, $275 per protocol at universities with medical schools, and $369 per protocol at hospitals. Based on these inflation-adjusted figures, the current cost of protecting human research participants at research institutions nationwide is estimated to be $32.12 million. It is difficult, however, to estimate IRBs’ costs at academic institutions, because costs are not itemized separately in grant applications;
rather they are part of the costs recovered, at least partly though the indirect cost mechanism (Goldman and Williams 2000).
Some information, however, is available about the prices (which may be higher or lower than costs) being charged for IRB review. One commentator reported that her independent IRB charged $1,000 for an initial review of a protocol and $275 for initial review of a research
site.4Another commentator estimated that the average fee for a protocol review was $1,000.5 The number of aca-demic institutions charging for IRB review of research that is not federally funded has been increasing in the past few years, with fees ranging from $500 to $2,000 for initial review and an average fee of $1,130.6
In addition to the call for additional resources, aca-demic institutions have expressed concerns about the costs of the IRB being billed through the indirect cost mechanism, because an administrative capitation pre-vents them from requesting additional resources (AAU 2000). Alternatives, such as a direct budget line for protection of research participants, have been suggested (AAU 2000).
Recommendation 7.1: The proposed oversight system should have adequate resources to ensure its effectiveness and ultimate success in protect-ing research participants and promotprotect-ing research:
a) Funds should be appropriated to carry out the functions of the proposed federal oversight office as outlined in this report.
b) Federal appropriations for research programs should include a separate allocation for over-sight activities related to the protection of human participants.
c) Institutions should be permitted to request funding for Institutional Review Boards and other oversight activities.
d) Federal agencies, other sponsors, and institu-tions should make additional funds available for oversight activities.
Future Research
This report has raised many questions about ethical issues that could not be answered because of insufficient or nonexistent empirical evidence. Little research has been conducted on the actual conduct of research, although some studies are under way.7Current thinking about ethical issues in research—including the impor-tance of conducting analyses of risks and potential bene-fits, obtaining informed consent, protecting privacy and confidentiality, and protecting those who are vulnerable—
would greatly benefit from research designed to address
these specific issues. For example, approaches for assess-ing cognitive competency, evaluatassess-ing what participants want to know about research, and ascertaining best practices for seeking informed consent are deserving of more study. Clearer guidance could be developed from a stronger knowledge base.
In addition, although a good deal of ethical analysis has been conducted on many research issues, some (e.g., ethical standards for informed consent) have received more attention from ethicists than others (e.g., under-standing what constitutes undue inducement or exploita-tion in research). In general, increased interdisciplinary discussion that includes biomedical and social scientists, lawyers, and historians would advance understanding of the ethical conduct of research.
Recommendation 7.2:The federal government, in partnership with academic institutions and professional societies, should facilitate discus-sion about emerging human research protection issues and develop a research agenda that addresses issues related to research ethics.