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Public Health Practice Vs Public Health Research: the Role of the Institutional Review Board

Posted on: Tuesday, 9 November 2004, 12:00 CST

The Journal is to be commended for presenting another Health Policy and Ethics Forum (June 2004) just 2 years after grappling with similar controversies in July 2002. It is, however, disappointing to see that the public health community continues its special pleading to circumvent the protection of human research subjects required by federal regulation.1 The assertion that "primary intent" exempts public health research from institutional review board (IRB) oversight is arbitrary and unjustified.2 Intent to publish the results of innovative public health efforts is sufficient (if not necessary) to meet the regulatory definition of human subjects research. Attempts to evade the protection of federal regulations in the belief that the ends justify the means are worrisome indeed. While the loss of publishable data because of delays in the review process is unfortunate, it is not too high a price to pay for meaningful oversight and consistency.

The increased scrutiny given to therapeutic maneuvers in the research context is not yet applied to therapeutic innovation not destined to be used for generalizable knowledge. IRB oversight might, in fact, provide needed protection in some instances of creative but risky unpublished clinical innovation. In any case, the dilemma of distinguishing public health practice from public health research would be eliminated if all such undertakings were reviewed by an IRB to determine whether IRB jurisdiction is appropriate. Any policies promulgated to simplify the review process, particularly for minimally risky research, would be equally welcome for clinical investigations not performed as public health endeavors.

The Nazi doctors, too, were motivated by public health concerns when they exposed unconsenting prisoners to trauma, infections, fatal low air pressure, and freezing temperatures, simulating disasters in war. If we reject the "end justifies the means" rationale for medical research, it is to be hoped that the slippery slope will be left to history.

Richard P. Wedeen, MD

About the Author

The author is with the Department of Veterans Affairs, New Jersey Health Care System, East Orange, and the University of Medicine and Dentistry of New Jersey, Newark.

Requests for reprints should he sent to Richard P. Wedeen, MD, Department of Veterans Affairs, New Jersey Health Care System, 385 Tremont Ave, East Orange, NJ 07018-1095 (e-mail: wedeen@umdnj.edu).

References

1. MacQueen KM, Buehler JW. Ethics, practice, and research in public health. Am J Public Health. 2004;94: 928-931.

2. Wedeen RP. Ethics in public health institutions. Am J Public Health. 2002;92:1884-1885.

MACQUEEN AND BUEHLER RESPOND

In our article we addressed a number of questions regarding the boundary between human subjects research, as defined by federal regulations, and public health practice, as defined by state and federal public health policy and law. The vast majority of work done by public health agencies is not research, and this boundary is usually clear. For example, a randomized controlled trial to evaluate an experimental tuberculosis therapy is human subjects research, despite the public health mission driving the work, and should be reviewed by an institutional review board (IRB). Conversely, a state mandate that physicians report cases of tuberculosis to public health authorities represents public health practice, despite the potential richness of the resulting data for research, and allows health departments to monitor tuberculosis trends and direct prevention and care services. Mechanisms exist to protect the confidentiality of those reported to public health surveillance systems or receiving public health services.

There are, however, areas of practice where oversight may be inadequate or lacking. In contemplating new approaches to ensuring ethical public health practice, oversight by a group familiar with public health law and human rights would be more meaningful than review by an IRB familiar mainly with research ethics and procedures.

We share Wedeen's interest in ethical public health. We made no arguments justifying ends over means, and Wedeen's assertion that we have taken such a position represents a serious misreading of our article. We explicitly argued for the creation of oversight or guidance mechanisms that are meaningful and appropriate for public health. Our intent was to promote thoughtful discussion and informed action in resolving the challenges faced by public health practitioners and researchers who strive to meet their obligations ethically.

The National Bioethics Advisory Commission called for innovative solutions to correct the limitations of current procedures for distinguishing research from practice and for ensuring the ethical conduct of investigations in which the risks primarily involve stigmatization or potential threats to privacy and confidentiality.1 The engagement of community advisory boards by public health agencies is one approach to addressing these concerns,2,3 reflecting parallel interest in such boards for research projects.4 Another approach would he to more clearly inform and engage the public concerning the objectives, methods, and procedures of public health practice, in turn improving the oversight of public health agencies already provided by the political process of governance.5

Kathleen M. MacQueen, PhD, MPH

James W. Buehler, MD

About the Authors

Kathleen M. MacQueen is with Family Health International, Durham, NC. James W. Buehler is with the Center for Public Health Preparedness and Research, Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, Ga.

Requests for reprints should be sent to Kathleen M. MacQueen, PhD, MPH, Family Health International, PO Box 13950, Research Triangle Park, NC 27709 (e-mail: kmacqueen@fhi.org).

References

1. Ethical and Policy Issues in Research Involving Human Participants, vol 1 : Report and Recommendations of the National Bioethics Advisory Commission. Bethesda, Md: National Bioctbics Advisory Commission; 2001.

2. Holtgrave DR, Thomas CVV, Chen H, Edlavitch S, Pinkerton SD, Fleming P. HIV prevention community planning and communities of color: do resources track the epidemic? AIDS Public Policy J. 2000;15(2):75-81.

3. Cargo M, Levesque L, Macaulay AC, et al. Community governance of the Kahnawake Schools Diabetes Prevention Project, Kahnawake Territory, Mohawk Nation, Canada. Health Promot Int. 2003;18(3):177- 187.

4. Quinn SC. Protecting human subjects: the role of community advisory boards. Am J Public Health. 2004; 94:918-922.

5. Burris S. Surveillance, social risk, and symbolism: framing the analysis for research and policy. J Acquir Immune Defic Syndr. 2000;25(suppl 2):S120-S127.

Letters to the editor referring to a recent Journal article are encouraged up to 3 months after the article's appearance. By submitting a letter to the editor, the author gives permission for its publication in the Journal. Letters should not duplicate material being published or submitted elsewhere. The editors reserve the right to edit and abridge letters and to publish responses.

Text is limited to 400 words and 10 references. Submit on-line at www.ajph.org for immediate Web posting, or at submit.ajph.org for later print publication. On-line responses are automatically considered for print publication. Queries should be addressed to the department editor, Jennifer A. Ellis, PhD, at jae33@columbia.edu.

Copyright American Public Health Association Nov 2004

Source: American Journal of Public Health

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