New in Ethics & Human Research, September-October 2019

October 01, 2019

Participant Engagement in Translational Genomics Research: Respect for Persons--and Then Some

Janet E. Childerhouse, Candice R. Finnila, Joon-Ho Yu, Barbara A. Koenig, Jean McEwen, Stacey L. Berg, Benjamin S. Wilfond, Paul S. Appelbaum, and Kyle B. Brothers

The expansion of both formal and informal frameworks of "engaged" research in translational research settings raises emerging and substantial normative concerns. The article draws on findings from a focus group study with members of a national consortium of translational genomic research sites. Responses from genetic counselors and other members of research teams revealed that engaged research is a deliberate strategy to achieve instrumental research goals and to "do research differently" in response to past research injustices. Among the findings, both researchers and participants see the blurring of clinical care and research as a desirable "feature" of participant engagement in translational research and not a "bug." But these types of relationships appear similar to those that have been criticized for perpetuating the therapeutic misconception. Indeed, for the study informants, the principle of respect for persons--a principle of research ethics--implies an obligation to adopt practices that look a great deal like clinical care. The findings invite normative questions about the governance of these practices

Improving Translation and Cultural Appropriateness of Spanish-Language Consent Materials for Biobanks

Kathleen M. Brelsford, Ernesto Ruiz, Catherine M. Hammack, and Laura M. Beskow

A growing proportion of prospective research participants in the United States speak limited or no English. The researchers conducted cognitive interviews with native Spanish speakers to test Spanish-language translations of simplified and traditional biobank consent forms. Comprehension was generally high and did not differ by form. However, certain characteristics of written Spanish are seemingly at odds with recommended actions to simplify consent forms; thus, even when significant empirical effort has been expended to develop simplified consent materials in English, additional work is needed to ensure the accuracy, comprehensibility, and cultural-congruence of Spanish-language translations.

Reported Participation Benefits in International HIV Prevention Research with People Who Inject Drugs

Jeremy Sugarman, Ilana Trumble, Erica Hamilton, Riza Sarasvita, Kostyantyn Dumchev, Ha Viet, Irving Hoffman, William Miller, and Brett Hanscom

Given ethical concerns about research involving people who inject drugs and those affected by HIV, identifying potential participation benefits is important. The authors evaluated participant-reported benefits in a trial conducted in Indonesia, Ukraine, and Vietnam that assessed an intervention combining psychosocial counseling and referral for antiretroviral therapy and substance use treatment for HIV-infected people who use drugs. Most of the participants reported at least one benefit. Clinical trial participation can provide broad direct and indirect benefits for stigmatized populations, which has implications for assessing the ethical appropriateness of studies with such populations.

Randomization Among: The Other Randomization

Deborah R. Barnbaum

A valid informed consent process for a randomized controlled trial requires the disclosure to potential participants that they will be randomized to receive the study intervention or a control intervention. This is a case of randomization within a trial, a type of randomization that has received significant attention in research ethics. When institutions recruit large numbers of research participants for multisite clinical trials, a different, hidden form of randomization may occur: randomization among clinical trials. If it is essential to disclose to potential participants randomization within a clinical trial, then it may also be the case that randomization among clinical trials recruiting individuals from the same cohort of eligible participants should also be disclosed. This article examines how randomization among clinical trials might take place and the ethical issues such randomization raises about informed consent to research participation.
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