Journal of Empirical Research on Human Research Ethics

Dubé, Karine; Dee, Lynda; Evans, David; Sylla, Laurie; Taylor, Jeff; Brown, Brandon; Miller, Veronica; Corneli, Amy; Skinner, Asheley; Greene, Sandra B.; Tucker, Joseph D.; Rennie, Stuart

2018 Journal of Empirical Research on Human Research Ethics

doi: 10.1177/1556264617734061pmid: 28984168

Early-phase HIV cure research is conducted against a background of highly effective antiretroviral therapy, and involves risky interventions in individuals who enjoy an almost normal life expectancy. To explore perceptions of three ethical topics in the context of HIV cure research—(a) equipoise, (b) risk–benefit ratios, and (c) “otherwise healthy volunteers”—we conducted 36 in-depth interviews (IDIs) with three groups of purposively selected key informants: clinician-researchers (n = 11), policy-makers and bioethicists (n = 13), and people living with HIV (PLWHIV; n = 12). Our analysis revealed variability in perceptions of equipoise. Second, most key informants believed there was no clear measure of risk–benefit ratios in HIV cure research, due in part to the complexity of weighing (sometimes unknown) risks to participants and (sometimes speculative) benefits to science and society. Third, most clinician-researchers and policy-makers/bioethicists viewed potential HIV cure study participants as “otherwise healthy volunteers,” but this perception was not shared among PLWHIV in our study.

Eyal, Nir; Holtzman, Lisa G.

2018 Journal of Empirical Research on Human Research Ethics

doi: 10.1177/1556264617740244pmid: 29179624

Dubé, Karine; Sylla, Laurie; Dee, Lynda

2018 Journal of Empirical Research on Human Research Ethics

doi: 10.1177/1556264617741715pmid: 29179626

We respond to Eyal et al.’s commentary focusing on how people living with HIV participating in HIV cure-related studies are defined. We argue that the types of participants enrolled in research cannot be dissociated from the study interventions, the types of anticipated risks, and the background standard of care. As the field of HIV cure research advances, more nuance and granularity will be needed to define research criteria and acceptable risk/benefit ratios for cure study participants, as well as specific tiered protocol designs that serve to protect various participant populations from untoward risks, especially in very early phase research with interventions known to have potentially serious toxicities. We highlight key lessons from the ACTIVATE study involving a latency-reversing agent, Panobinostat, for HIV cure study design involving “otherwise healthy volunteers”.

Ward, Claire Leonie; Shaw, David; Anane-Sarpong, Evelyn; Sankoh, Osman; Tanner, Marcel; Elger, Bernice

2018 Journal of Empirical Research on Human Research Ethics

doi: 10.1177/1556264617742236pmid: 29179625

This study explores ethical issues raised in providing medical care to participants and communities of low-resource settings involved in a Phase II/III pediatric malaria vaccine trial (PMVT). We conducted 52 key informant interviews with major stakeholders of an international multi-center PMVT (GSK/PATH-MVI RTS,S) (NCT00866619) in Ghana and Tanzania. Based on their stakeholder experiences, the responses fell into three main themes: (a) undue inducement, (b) community disparities, and (c) broad therapeutic misconceptions. The study identified the critical ethical aspects, from the perspectives of stakeholders, of delivering health care during a PMVT. The study showed that integrating research into health care services needs to be addressed in a manner that upholds the favorable risk–benefit ratio of research and attends to the health needs of local populations. The implementation of research should aim to improve local standards of care through building a collaborative agenda with local institutions and systems of health.

Francis, Jenny K. R.; Dapena Fraiz, Lauren; de Roche, Ariel M.; Catallozzi, Marina; Radecki Breitkopf, Carmen; Rosenthal, Susan L.

2018 Journal of Empirical Research on Human Research Ethics

doi: 10.1177/1556264617745409pmid: 29226745

The objective of this study is to understand the resolution of discordance between adolescent–parent dyads about participation in research. Adolescent (14-17 years) and parent dyads were recruited from NYC pediatric clinics to assess attitudes toward research participation. A subset of dyads participated in videotaped discussions about participation in a hypothetical study. Videos from dyads that held strongly discordant opinions about participation (n = 30) were content-coded and analyzed using a thematic framework approach. Strategies used to resolve discordance included asserting authority, granting autonomy, or recognizing inaccurate assumptions using a variety of communication behaviors. Missed opportunities to enroll initially discordant dyads may be avoided by allowing time for adolescents and parents to elicit information, clarify a situation, or convince the other.

Perrault, Evan K.; Keating, David M.

2018 Journal of Empirical Research on Human Research Ethics

doi: 10.1177/1556264617738846pmid: 29117849

Participants often do not read consent forms in social science research. This is not surprising, especially for online studies, given they do not typically offer greater risk than what is encountered in daily life. However, if no one is reading, are participants really informed? This study used previous research to craft experimentally manipulated consent forms utilizing different visual presentations (e.g., greater use of line spacing, bullets, bolding, diagrams). Participants (n = 547) were randomly exposed to one of seven form variations. Results found no significant differences between forms in reading or comprehension. Open-ended questions asked participants why they do not read consent forms and what would influence them to read the forms. Participants most frequently stated forms need to be shorter, and important information needs to be highlighted. We suggest improvements to informed consent forms, including removing much of the information that is constant across forms, and only including unique aspects of studies.

Antes, Alison L.; Walsh, Heidi A.; Strait, Michelle; Hudson-Vitale, Cynthia R.; DuBois, James M.

2018 Journal of Empirical Research on Human Research Ethics

doi: 10.1177/1556264617744121pmid: 29226747

Qualitative data provide rich information on research questions in diverse fields. Recent calls for increased transparency and openness in research emphasize data sharing. However, qualitative data sharing has yet to become the norm internationally and is particularly uncommon in the United States. Guidance for archiving and secondary use of qualitative data is required for progress in this regard. In this study, we review the benefits and concerns associated with qualitative data sharing and then describe the results of a content analysis of guidelines from international repositories that archive qualitative data. A minority of repositories provide qualitative data sharing guidelines. Of the guidelines available, there is substantial variation in whether specific topics are addressed. Some topics, such as removing direct identifiers, are consistently addressed, while others, such as providing an anonymization log, are not. We discuss the implications of our study for education, best practices, and future research.

Pratt, Bridget; Hyder, Adnan A.

2018 Journal of Empirical Research on Human Research Ethics

doi: 10.1177/1556264617741022pmid: 29160115

An ethical framework called “research for health justice” provides initial guidance on how to link health systems research in low- and middle-income countries to health equity. To further develop the largely conceptual framework, we tested its guidance against the experience of the Maternal and Neonatal Implementation for Equitable Health Systems (Manifest) project, which was performed in rural Uganda by researchers from Makerere University. We conducted 21 in-depth interviews with investigators and research implementers, directly observed study sites, and reviewed study-related documents. Our analysis identifies where alignment exists between the framework’s guidance and the Manifest project, providing initial lessons on how that was achieved. It also identifies where nonalignment occurred and gaps in the framework’s guidance. Suggestions are then made for revising and expanding “research for health justice.”

Solomon Cargill, Stephanie

2018 Journal of Empirical Research on Human Research Ethics

doi: 10.1177/1556264617742237pmid: 29226746

Governments, funders, and institutional policies increasingly encourage and even mandate the involvement of nonscientists in the ethical review of research, most famously in institutional review boards (IRBs), but also on community advisory boards (CABs) and other committees that contribute to research governance. In spite of these requirements, few have examined how different factors such as recruitment strategies, training, and different qualifications shape the contributions of nonscientists to the research enterprise. This pilot study begins to fill in this lacuna by interviewing nonscientist members of IRBs and community members of CABs. Results suggest patterned differences in demographics, recruitment strategies, training, and perceived qualifications between community members on these two types of boards with potential implications for how we perceive the scope of contributions that nonscientists can provide to the ethical review of research and the strategic ways these contributions can be elicited.

Hadden, Kristie B.; Prince, Latrina; James, Laura; Holland, Jennifer; Trudeau, Christopher R.

2018 Journal of Empirical Research on Human Research Ethics

doi: 10.1177/1556264617742238pmid: 29243548

Institutions are required to ensure that persons involved in human subjects research receive appropriate human subjects protections training and education. Several organizations use the Collaborative Institutional Training Initiative (CITI) program to fulfill training requirements. Most researchers find the CITI program too complex for community members who collaborate with researchers. This study aimed to determine the readability of CITI modules most frequently used in community-based participatory research (CBPR). The mean readability level of the CITI modules is 14.8 grade; CBPR readability levels ranged from 11.6 to 12.0 grade (sixth- to eighth-grade reading level is recommended). With a baseline objective measure, modifications can be made to improve the plain language quality and understandability of human subjects training modules for community members.