External ethical oversight provides additional protection for research subjects. Prime examples in the U.S. are the Institutional Review Boards (IRBs) that supervise human-subjects research conducted under Federal jurisdiction, which is very broad. IRBs are carefully constituted boards that conduct independent oversight of research.73
The IRB is an administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the institution with which it is affiliated. The IRB has the authority to approve, require modifications in, or disapprove all research activities that fall within its jurisdiction as specified by federal regulations and local institutional policy.
In the U.S. a research institution must have in place a properly constituted and functioning IRB to be eligible to receive Federal funding for research on humans. Some institutions pledge all of their research, regardless of the source of funding, to the standards of the Federal Common Rule. All Federal agencies conducting research on humans operate under IRBs; the Centers for Disease Control and Prevention has six IRBs, and each of the seventeen Institutes of the National Institutes of Health has at least one. At present some 3,500 IRBs are in operation in the U.S.74
No doubt different IRBs, in practice, deliver differing degrees of supervision (and thereby, protection), depending on their capabilities and how hard they apply themselves. Some Federal programs review IRB performance; others don't. The Food and Drug Administration, in its routine audits, reviews whether data submitted in the regulation of drugs, medical devices, and so on have been gathered and protected in conformance with the pertinent local IRB stipulations on the particular research protocol. Moreover, each year it inspects the work of several hundred IRBs as to adequacy of structure and performance.
"Evaluation of the risk/benefit ratio is the major ethical judgment that IRBs must make in reviewing research protocols," the OPRR Guidebookemphasizes.75 "Risks to research subjects posed by participation in research should be justified by the anticipated benefits to the subjects or society."
Importantly, the Guidebook states: "A risk is minimal where the probability and magnitude of harm or discomfort anticipated in the proposed research are not greater, in and of themselves, than those ordinarily encountered in daily life or in the performance of routine physical or psychological examinations or tests."76 Rationales of this kind are often invoked in judgments regarding design of research protocols and access to personal data in databases. They deserve elaboration now, to cope more fully with privacy risks in addition to physical and emotional risks.
For research conducted outside the U.S., the Federal Common Rule allows "Department or Agency heads to determine that the procedures prescribed by the institution afford protections that are at least equivalent" and allow substitution of the foreign procedures (§_.001(6)(h)).
Some private-sector institutions, such as managed-care organizations, have established IRBs that function similarly. This is becoming even more desirable now as more research is being performed on data from mixed sources, such as pooled or comparative data from private- sector managed-care organizations and government healthcare payors.
Similar criteria and systems of external oversight are operative in most European countries, and elsewhere.
For some kinds of research, especially perhaps for some database research for which highly dependable protections can be assured, a specially constituted national-level IRB might be workable. Some precedent might be seen in the ethics reviews that were conducted by the now disbanded Recombinant-DNA Advisory Committee. In Europe there has been some experience with multi-country IRBs for clinical trials.
There is no doubt that IRBs enhance research-subject protections and provide much public reassurance. They are an integral part of biomedical research. But it is less clear that IRBs have been attending as vigorously to privacy risks as they have to physical and emotional risks. For many IRBs the workload already is heavy. Now they may well have to be asked to become more deeply engaged with the privacy and confidentiality aspects of subject protection than they have been, in database research as well as in direct experimentation, and with genetic privacy. Whether they are able and willing to do so should be assessed.77
(73) OPRR Guidebook, as cited in endnote (67).
(74) Gary B. Ellis, remarks to the National Bioethics Advisory Commission (October 4, 1996).
(75) OPRR Guidebook, as cited in endnote (67).
(76) OPRR Guidebook, as cited in endnote (67). This is Federal Common Rule §_.002(i).
(77) A recent critique is Harold Edgar and David J. Rothman, "The Institutional Review Board and beyond: Future challenges to the ethics of human experimentation," Milbank Quarterly 73, 489–506 (1995).