Informed consent to HIV cure research

Bromwich, Danielle; Millum, Joseph

doi:10.1136/medethics-2015-103122

Cited by 22 publications

(17 citation statements)

References 28 publications

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“…Scholars have recommended that informed consent forms should clearly explain the lack of direct personal benefit, the purpose of ATIs, and the contraindications for clinical care. 16,48 Biomedical scientists should also pay attention to participant's motivations for enrolling in ATI studies, 73 use the word ''cure'' cautiously, if at all, 74 and demonstrate attention to and specificity in risk descriptions. 63 Other underexplored topics in our study were the interplay between standards of care, 17,61 and prevention standards 75 in the context of ATIs, particularly given that one of the most prevalent concerns expressed by respondents around ATIs was the risk of transmitting HIV to others.…”

Section: Limitationsmentioning

confidence: 99%

“We Need to Deploy Them Very Thoughtfully and Carefully”: Perceptions of Analytical Treatment Interruptions in HIV Cure Research in the United States—A Qualitative Inquiry

Dubé

Evans

Dee

et al. 2018

AIDS Research and Human Retroviruses

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Strategies to control HIV in the absence of antiretroviral therapy are needed to cure HIV. However, such strategies will require analytical treatment interruptions (ATIs) to determine their efficacy. We investigated how U.S. stakeholders involved in HIV cure research perceive ATIs. We conducted 36 in-depth interviews with three groups of stakeholders: 12 people living with HIV, 11 clinician-researchers, and 13 policy-makers/bioethicists. Qualitative data revealed several themes. First, there was little consensus on when ATIs would be ethically warranted. Second, the most frequent perceived hypothetical motivators for participating in research on ATIs were advancing science and contributing to society. Third, risks related to viral rebound were the most prevalent concerns related to ATIs. Stakeholders suggested ways to minimize the risks of ATIs in HIV cure research. Increased cooperation between scientists and local communities may be useful for minimizing risk. Further ethics research is necessary.

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Section: Limitationsmentioning

confidence: 99%

“We Need to Deploy Them Very Thoughtfully and Carefully”: Perceptions of Analytical Treatment Interruptions in HIV Cure Research in the United States—A Qualitative Inquiry

Dubé

Evans

Dee

et al. 2018

AIDS Research and Human Retroviruses

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show abstract

“…As some have noted, if full comprehension were a requirement for valid consent, and valid consent was necessary and sufficient for the ethics of research, all research studies involving human participants would likely be unethical. 33 It would be unreasonable—a form of ’research exceptionalism' 34 —to expect vastly higher levels of consent comprehension in research than in other comparable areas of human life. But how much less than full comprehension is ’good enough' for valid informed consent?…”

Section: Discussionmentioning

confidence: 99%

An adapted instrument to assess informed consent comprehension among youth and parents in rural western Kenya: a validation study

et al. 2018

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ObjectiveTo adapt and validate a questionnaire originally developed in a research setting for assessment of comprehension of consent information in a different cultural and linguistic research setting.DesignThe adaptation process involved development and customisation of a questionnaire for each of the three study groups, modelled closely on the previously validated questionnaire. The three adapted draft questionnaires were further reviewed by two bioethicists and the developer of the original questionnaire for face and content validity. The revised questionnaire was subsequently programmed into an audio computerised format, with translations and back translations in three widely spoken languages by the study participants: Luo, Swahili and English.SettingThe questionnaire was validated among adolescents, their parents and young adults living in Siaya County, a rural region of western Kenya.ParticipantsTwenty-five-item adapted questionnaires consisting of close-ended, multiple-choice and open-ended questions were administered to 235 participants consisting of 107 adolescents, 92 parents and 36 young adults. Test-retest was conducted 2–4 weeks after first questionnaire administration among 74 adolescents, young adults and parents.Outcome measurePrimary outcome measures included ceiling/floor analysis to identify questions with extremes in responses and item-level correlation to determine the test-retest relationships. Given the data format, tetrachoric correlations were conducted for dichotomous items and polychoric correlations for ordinal items. The qualitative validation assessment included face and content validity evaluation of the adapted instrument by technical experts.ResultsCeiling/floor analysis showed eight question items for which >80% of one or more groups responded correctly, while for nine questions, including all seven open-ended questions,<20% responded correctly. Majority of the question items had moderate to strong test-retest correlation estimates indicating temporal stability.ConclusionsOur study demonstrates that cross-cultural adaptation and validation of an informed consent comprehension questionnaire is feasible. However, further research is needed to develop a tool which can estimate a quantifiable threshold of comprehension thereby serving as an objective indicator of the need for interventions to improve comprehension.

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“…Such concerns are amplified in the context of clinical research, where the goals of the researchgenerating generalizable knowledge-may diverge dramatically from the interests of participants. The informed consent process can also help patients and participants to make better decisions-that is, decisions that are more informed and more in line with the decision-maker's values (Bromwich & Millum 2017). 31 It thereby fits with certain ideals of autonomous decision-making.…”

Section: Are the Requirements For Consent Universal?mentioning

confidence: 97%

Understanding, Communication, and Consent

Millum¹,

Bromwich²

2018

Ergo, an Open Access Journal of Philosophy

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By giving consent, competent adults can permit acts that would otherwise be rights violations. In order to give valid consent a person must be capable of autonomous decision-making and her consent must be proffered voluntarily. However, competence and voluntariness are insufficient. The person who gives consent must also understand what she is authorizing. In this paper we develop an account of the understanding requirement for valid consent. We argue, contra existing accounts, that the content of the understanding requirement is minimal. Valid consent requires that the person proffering it understand just three things: (1) that she is giving consent; (2) how to exercise her right to give or refuse consent; and (3) to what she is being asked to consent. To meet the third condition, the profferer of consent must share an understanding with the recipient of consent of how the normative boundaries between them will be redrawn. This mutual understanding is achieved through successful communication. The content of what is successfully communicated can be analyzed in terms of implicatures: the overlap in utterer-and audience-implicature contains what both parties have communicated to each other and hence mutually understand. Misconceived Consent: Miguel has stage IV lung cancer. He has nearly exhausted his treatment options when his oncologist, Dr. Llewellyn, tells him about an experimental vaccine trial that may boost his immune response to kill cancer cells. Dr. Llewellyn provides Miguel with a consent form that explains why the study is being conducted, what procedures he will undergo, what the various risks and benefits are, alternative sources of treatment, and so forth. She even sits down with him, care

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Informed consent to HIV cure research

Cited by 22 publications

References 28 publications

“We Need to Deploy Them Very Thoughtfully and Carefully”: Perceptions of Analytical Treatment Interruptions in HIV Cure Research in the United States—A Qualitative Inquiry

“We Need to Deploy Them Very Thoughtfully and Carefully”: Perceptions of Analytical Treatment Interruptions in HIV Cure Research in the United States—A Qualitative Inquiry

An adapted instrument to assess informed consent comprehension among youth and parents in rural western Kenya: a validation study

Understanding, Communication, and Consent

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