U.S. and Canadian Approaches to Biospecimens

by Rev. Frederic Koning

The Final Rule: Deception, Waiver of Consent, and Laud Humphreys

The fit between the ethics of human subject research and the regulations is not always immediately clear.

Recent changes to the Common Rule (Final Rule) include a new category of exemption for benign behavioral research interventions under Category 3.1 Because it allows intervention, not just observation, Category 3 also opens up the possibility of exempt research that uses deception.

To qualify for Category 3, the investigator must have no reason to think the subjects will find the intervention “offensive or embarrassing.”2 In the study plan, the investigator must inform participants who are to be misled about the purpose of the study. Thus, subjects are, by way of prospective agreement, to be afforded the opportunity to authorize the deception.3 Category 3 also adds a protective provision for data whose disclosure would be harmful—requiring limited IRB review to ensure adequate privacy and confidentiality safeguards are in place.4

The Final Rule, when applied to observational research such as the highly controversial Tearoom Trade Study, can serve to illustrate the challenges associated with interpreting and applying the regulations in the ethical spirit of the Belmont Report.

The Tearoom Trade Study

In 1966-67 Laud Humphreys, a PhD student in sociology, studied men engaged in sexual activities in public restrooms of city parks (“tearooms”). Humphreys got his data by acting as a “watch queen,” or lookout. Importantly, the men involved did not know he was a researcher. As the study was conducted years before the National Research Act of 1974, the Belmont Report, or the enactment of the Common Rule, it was conducted without ethics review or IRB oversight.

Humphreys’ research objective was to understand the relationship between these men’s anonymous acts and their public lives. To that end, he recorded their license plates as they returned to their cars, and then obtained their addresses with the help of “friendly police.” A year later, he changed his hair, dress, and car and went to the homes of 50 men. He introduced himself as a social science researcher, interviewing them under false pretenses to gain information on their marital status, sexuality, sexual orientations, and occupations.

The study outraged many in the ethics and social science communities. “The subjects,” wrote one social science scholar, “never consented; deception was used; and the names could have been used to blackmail subjects, to end marriages, or to initiate criminal prosecutions.”5

Yet many view the study as seminal in helping modernize society’s understanding of sexuality. The world is said to have gained a more comprehensive understanding of the behavioral motivations of the male mind.6 Following the release of his study, police arrests and raids on tearooms decreased in frequency, which, to some exemplifies how the understanding of human nature benefits everyone.7

Humphreys’ supporters point to his commitment to and skill in protecting the identity of his subjects. He is said to have “kept the list of his subjects’ identities in a locked box, at a secret location 1,000 miles from where his research was conducted.”8 Others with intimate knowledge of Humphreys and his study report, “He destroyed the list when a possibility arose that there could be outside interests in the list.”9

But do these steps translate to ethical research? Would the research qualify for exemption under the Final Rule?

It seems unlikely that the Tearoom Trade Study would be considered eligible for Category 3 exemption.

Laud Humphreys’ disguising his identity to help the men in their private pursuits while collecting potentially harmful information could be seen to have used deception to negotiate a privileged observational position for himself in circumstances where there was the presumption of privacy (tearoom). Such interaction therefore may exceed what is envisioned as ”benign behavioral intervention” in the Final Rule.

The Tearoom Trade Study lacked any provision to disclose to subjects that they would be deceived for a research purpose. In the absence of prospective agreement, the men had been denied the opportunity to authorize the deception.

In the absence of a benign intervention and prospective agreement, Humphreys’ study would not be eligible for limited IRB review. Limited IRB review—which does not include consideration or application of approval criteria required for full review—is only intended to review the adequacy of privacy and confidentiality protections for studies, including scenarios where disclosure of information gathered places a subject at risk of criminal or civil liability, or is damaging to the subject’s financial standing, employability, educational advancement, or reputation.

Full IRB Review for the Tearoom Trade Study

The necessary conditions of ”benign intervention” and ”prospective agreement” are key ingredients in the consideration in determining whether studies like the Tearoom Trade Study meet exemption criteria under Category 3. Whenever these features are absent in a behavioral study involving deception, IRB review would be required and the approval criteria applied.

Striking a Balance for Oversight of Observational Activities

The American Anthropological Association lobbied hard to remove observational activities from the Final Rule’s new definition of human subject research, and therefore from normal IRB review altogether. The risks posed by the Humphreys study illustrate the importance of maintaining some level of oversight to ensure that researchers employ appropriate study activities that are both ethical and protective.

 

Correction: This article was updated on December 14, 2017 at 10:47 AM PST

 


 

References

1 [ to be codified at &____. 104 (d)(3)(iii)

2 Id.

3 Id.

4 Id.

5 (Neuman, 1997:447). Newman, W. Lawrence. 1997. Social Research Methods: Qualitative and Quantitative Approaches. 3rd ed. Boston: Allyn and Bacon.

6 Smith, Candace. “Laud Humphreys ‘Tearoom Trade: The Best and Worst of Sociology.” The Society Pages. Sociology Lens, 5 Feb. 2013. Web.28 Feb. 2017.

7 DuBois, James M. “The Tearoom Trade Study-Ethics in Mental Health Research.” Ethics in Mental Health Research. N.p., n.d. Web 28 Feb. 2017.

8 (Michael Lenza, International Journal of Sociology and Social Policy Vol 24 Number 3/4/5 2004 p.25).

9 Reiss 1978:175; Reiss, A.J. 1978. “Conditions and Consequences of Consent in Human Subject Research,” In K. Wulff(Ed.) Regulation of Scientific Inquiry. pp. 161-184. Boulder: Westview Press Mitchell 1993:53) Mitchell, Richard G. 1993 Secrecy and Fieldwork. Newbury Park: Sage Publications.

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