When do incentives to participate in research become coercive? The answer to this question may seem to be entirely subjective; that is, each individual faces a unique list of motivators and pressures when confronted with the informed consent process. We are all vulnerable to coercion in different ways and to differing degrees. However, a standardized scale might be useful in measuring the extent to which human subjects feel coerced. With such a scale, a researcher might know when “yes” actually means “no.”
In their recent paper, Measuring coercion to participate in research within a doubly vulnerable population … , Karen Leggett Dugosh, David S. Festinger, Jason R. Croft and Douglas B. Marlowe report the creation and testing of this tool. According to the authors, the Coercion Assessment Scale (CAS) is only the second coercion scale developed for use with human subjects. (A longer list of coercion scales have been developed for use in non-research settings.) The authors developed and tested the instrument to survey the feelings of coercion among “criminally involved substance abusers.” The 84 human subjects were facing or serving sentences in a misdemeanor drug court in Wilmington, Delaware. They were, therefore, “doubly vulnerable”–substance abusers and criminally “involved.” In other words, the subjects were in medical, financial, and legal circumstances that made them into easy targets for coercive pressures to consent to research.
Perhaps one should not be surprised, therefore, that the CAS revealed that many of the 84 subjects felt inappropriately coerced. In addition to the 12 people reporting feeling that they “could not say no to entering the study,” 33% “entered the study mainly for financial reasons,” 51% thought “the judge would like it,” and 51% believed “the study would help” their court case. Running parallel to the evaluation of the CAS, the authors were also studying the impact of research intermediaries in their efforts to improve the consent process and decrease coercive motivators. Lamentably, the effort failed to demonstrate statistically significant improvements in the subjects’ feelings of coercion.
The authors have laid the ground work for a very useful tool. They have also opened the door for ethicists to take a careful look at how prisoners (and other “criminally involved” subjects) are protected from research related harms. Although fraught with ethical complications, medical research within this very vulnerable population is essential to improving health outcomes and social rehabilitation. Although a “coercion assessment scale” will not resolve all the ethical complications of conducting research with prisoners (and others in-and-out of the criminal justice system), it could become a very useful indicator, a tool for uncovering coercion that might otherwise go unreported.
Dugosh KL, Festinger DS, Croft JR, Marlowe DB. Measuring coercion to participate in research within a doubly vulnerable population: initial development of the coercion assessment scale. J Empir Res Hum Res Ethics. 2010 Mar;5(1):93-102. PubMed PMID: 20235867.
Relalted Literature and Links
Advisory Commission on Human Radiation Experiments. Chapter 9 — Prisoners: A Captive Research Population. DOE Openness: Human Radiation Experiments.
Bioethics | Prisoners as Human Subjects. The University of Texas Health Science Center at Tyler.
Festinger DS, Marlowe DB, Dugosh KL, et al. Higher magnitude cash payments improve research follow-up rates without increasing drug use or perceived coercion. Drug Alcohol Depend. 2008 Jul 1;96(1-2):128-35. Epub 2008 Apr 18. PubMed PMID: 18395365
Gostin, Lawrence O., Cori Vanchieri, and Andrew MacPherson Pope; IOM Committee on Ethical Considerations for Revisions to DHHS Regulations for Protection of Prisoners Involved in Research. Ethical Considerations for Research Involving Prisoners. Washington, D.C.: National Academies Press, 2007.
Lerner BH. Subjects or objects? Prisoners and human experimentation. N Engl J Med. 2007 May 3;356(18):1806-7. PubMed PMID: 17476006.
Moser DJ, Arndt S, Kanz JE, et al. Coercion and informed consent in research involving prisoners. Compr Psychiatry. 2004 Jan-Feb;45(1):1-9. PubMed PMID: 14671730.
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, U.S. Reports and recommendations: research involving prisoners. 1976. Available from: https://scholarworks.iupui.edu/handle/1805/565
Office of Extramural Research, NIH. Research Involving Vulnerable Populations.
Office for Human Research Protections, HHS. OHRP Guidance on the Involvement of Prisoners in Research.
Stone, T.H. Prisoners as human subjects: clinical research reference guide. 2004. [PDF – 844 KB]
Wyman BP. Biomedical and behavioral research on juvenile inmates: uninformed choices and coerced participation. J Law Health. 2000-2001;15(1):77-104. PubMed PMID: 11930505.