Correspondence

Consent for Clinical Research

N Engl J Med 1997; 337:282-283July 24, 1997

Article

To the Editor:

In 1966, Henry Beecher shocked the medical community when he documented the unethical research methods and practices used in many scientific studies published in U.S. medical journals after World War II.1 Recently (March 20 issue), Giardiello et al.2 reported the results of a study in which they interviewed physicians and genetic counselors about their use of a commercial genetic test. The researchers sought to determine whether the patients gave informed consent for the study and whether the clinicians understood the test results. In an accompanying editorial,3 Veatch questioned the methods used by Giardiello et al.

Veatch is correct to focus first on the process rather than the results. Beecher denied that a utilitarian argument could justify the methods used in an experiment: “An experiment is ethical or not at its inception. It does not become ethical post hoc — ends do not justify means.” 1 However, Veatch's concern is misdirected.

A study that seeks to determine physicians' compliance with consent procedures and their understanding of laboratory data and that is published without identifying the physician-subjects should not require their consent. Physicians are routinely monitored by quality-improvement measures to assess their performance, their use of new forms of technology, and their use or misuse of laboratory tests. Generally, employers perform such studies and use them to make changes within the organization. Nevertheless, one would hope that if internal monitoring revealed that almost one third of physicians misunderstood a new technique, the information would be made public on the assumption that others were making similar errors.

Lainie Friedman Ross, M.D., Ph.D.
University of Chicago, Chicago, IL 60637

3 References

1. 1

   Beecher HK. Ethics and clinical research. N Engl J Med 1966;274:1354-1360
   Full Text | Web of Science | Medline

2. 2

   Giardiello FM, Brensinger JD, Petersen GM, et al. The use and interpretation of commercial APC gene testing for familial adenomatous polyposis. N Engl J Med 1997;336:823-827
   Full Text | Web of Science | Medline

3. 3

   Veatch RM. Consent, confidentiality, and research. N Engl J Med 1997;336:869-870
   Full Text | Web of Science | Medline

Author/Editor Response

Dr. Veatch replies:

To the Editor: My editorial acknowledged that the findings of Giardiello et al. are important and disturbing and emphasized that the questions I raised about their research were not an attempt to single them out for criticism, but rather an effort to ask whether the existing regulations are adequate. Current regulations exempt interviews and research on existing data from consent requirements, provided the information is recorded by the investigators in such a manner that the subjects cannot be identified. Although it is not clear whether Giardiello et al. were able to record their data in ways that did not identify the subjects, their use of the records and their interviews seem in other respects to conform to existing regulations.

Dr. Ross does not address the fact that sensitive information in patients' confidential records was accessed, apparently without their permission, and that the data may have been recorded in a way that identified patients or their physicians — a violation of existing regulations in either case. Moreover, Dr. Ross believes that if the findings are published without identifying the physician-subjects, the study “should not require their consent.” Pointing out that physicians are routinely monitored for purposes of quality improvement without their explicit consent, Dr. Ross seems to believe that the same standard should apply to publishable research on their behavior. I think that assumption is unwarranted.

The purpose of quality assurance is quite different from that of research designed to produce publishable, generalizable knowledge. Quality-assurance procedures are well known to physicians. They have given implied consent to them. They at least are aware that such assessments are being conducted. On the other hand, if they are the subjects of research, they will not know it and may object to the purposes of the study, consenting to which is a legitimate part of the consent process. Dr. Ross seems to believe that consent is not needed if the subjects are physicians. Presumably, that is either because they will not be identified in the published article or because they are physicians. Neither reason is sufficient to exempt them from the normal rules of consent. I think they should be treated like other subjects and asked to consent, especially if they might disapprove of the purpose of the study or if the data are collected with identifiers. In any case, the patients for whom sensitive data were used by the researchers were never given the opportunity to consent. These circumstances seem to me to raise legitimate questions that need further attention.

Robert M. Veatch, Ph.D.
Georgetown University, Washington, DC 20057