Are positive experiences of children in non-therapeutic research justifiable research benefits?

Staphorst, Mira S.; Hunfeld, J. A. M.; Vathorst, Suzanne van de

doi:10.1136/medethics-2016-103404

Cited by 6 publications

(5 citation statements)

References 22 publications

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“…This study expands the limited knowledge base on participants' perceptions about HIV cure research 3,[32][33][34][35] and adds to research 36 on HIV cure researchers' perspectives on participant benefit. Consistent with the broader literature on indirect benefits, [17][18][19][20][21]37,38 and one study of four HIV cure research participants, 31 our study revealed that participants perceive substantial benefits associated with HIV cure research, despite clear understanding that the research offered to them has no direct medical benefit. Few of our interviewees mentioned risks or negative experiences related to the research, even when strongly encouraged to do so by the interviewer.…”

Section: Discussionsupporting

confidence: 83%

“…This argument is supported by the Belmont Report 40 -an established set of ethical principles for human subjects research that encourages taking more than just medical benefits into account-as well as increasing discussion in the ethics literature about the importance of indirect or inclusion benefits. 38,[41][42][43] Our data suggest that psychological, social, behavioral, and healthcare-related benefits are commonly reported and valued by the HIV-cure research participants at the University of North Carolina at Chapel Hill. Supportive trusting relationships with study staff or access to healthcare may be just as important to participants as the altruistic motivations that they also mention.…”

Section: Discussionmentioning

confidence: 69%

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Indirect Benefits in HIV Cure Clinical Research: A Qualitative Analysis

Gilbertson

Kelly

Rennie

et al. 2019

AIDS Research and Human Retroviruses

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Currently, much of early phase HIV cure research involves unknown and potentially serious risks, with little or no chance of direct health benefits. During informed consent, researchers emphasize this lack of personal medical benefit to minimize misconceptions that undermine genuine consent. We explored participants' and researchers' perspectives on HIV cure clinical research participation and its potential benefits. We conducted semistructured interviews with 17 HIV cure research participants and nine researchers in North Carolina, USA. We analyzed interviews to identify participant experience-related themes. We were particularly interested in indirect benefits, such as psychological support or improved care. We also assessed five consent documents for benefit/risk-related language. Research participants were male, with a median age of 50 (range: 28-62); most were non-Hispanic white (15/17) and men who have sex with men (13/17). All 17 trial participants found research participation meaningful and beneficial. Reported benefits included improved healthcare (16/17), HIV knowledge (13/17), intimate relationships (10/17), and positive behaviors (6/17). In addition, all participants described psychological benefits, including increased positive outlook, improved sense of purpose, emotional support, and enriched self-image. Participants reported risks such as quality of life concerns, uncomfortable procedures (e.g., leukapheresis), latency reversal, and HIV status disclosure. While the consent documents included discussion of these and other risks, they did not mention potential indirect benefits. Individuals involved in HIV clinical research have recognized participant psychological, social, and behavioral benefits. We recommend that researchers and institutional review boards consider these benefits for inclusion during risk/benefit assessments, consent procedures, and other discussions with prospective participants.

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Section: Discussionsupporting

confidence: 83%

Section: Discussionmentioning

confidence: 69%

Indirect Benefits in HIV Cure Clinical Research: A Qualitative Analysis

Gilbertson

Kelly

Rennie

et al. 2019

AIDS Research and Human Retroviruses

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“…The parents in our study, apart from direct health benefits for their child, also considered being "checked up" regularly as benefits for their children. Staphorst, Hunfeld, and van de Vathorst (2017) found similar results concerning benefit in their interview study with children. These children also had a much broader notion of benefit than direct health benefit.…”

Section: Benefit For Their Child Was the Most Important Factor In Thesupporting

confidence: 54%

“…Staphorst and colleagues argued, based on these results, that next to direct health benefit, other specific forms of benefit (learning, altruism, and fun) could also justifiably be qualified benefits of research participation. But they also argued that “getting extra attention from health care staff” is not one of those justifiable benefits that could be used in the risk–benefit analysis (Staphorst et al, 2017; Staphorst & van de Vathorst, 2015). We agree.…”

Section: Discussionmentioning

confidence: 99%

Parents’ Perspectives on Decisions to Participate in Pediatric Clinical Research: Results From a Focus Group Study With Laypeople

Tromp

Vathorst

2019

Journal of Empirical Research on Human Research Ethics

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Knowing why parents decide to consent or dissent to participation of their child in pediatric clinical research is essential to further the ethical debate concerning pediatric research. We performed this qualitative focus group study with 16 parents from the Dutch general public to explore their perspectives on decisions to participate in pediatric clinical research. Group discussion revealed the following: Parents conflate clinical research and clinical care, they do not grasp the trajectory of pediatric drug development, their protectiveness matches current research guidelines, and benefit for their child is the most important factor in their decision. Research professionals should be aware of the knowledge gap of parents, the pitfalls of jargon, and unintended false expectations.

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“…Finally, anxiety during MRI scanning can be lessened by age-appropriate information for children, as well as by distraction [25], but these interventions were not part of the study protocol. Moreover, it should be kept in mind that, for at least some children, MRI scanning is not a source of stress, but actually a positive experience [14, 26, 27].…”

Section: Discussionmentioning

confidence: 99%

A comparison study of anxiety in children undergoing brain MRI vs adults undergoing brain MRI vs children undergoing an electroencephalogram

et al. 2019

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Background Magnetic resonance imaging (MRI) of the brain in children and adolescents is a well-established method in both clinical practice and in neuroscientific research. This practice is sometimes viewed critically, as MRI scans might expose minors (e.g. through scan-associated fears) to more than the legally permissible “minimal burden”. While there is evidence that a significant portion of adults undergoing brain MRI scans experience anxiety, data on anxiety in children and adolescents undergoing brain MRI scans is rare. This study therefore aimed to examine the prevalence and level of anxiety in children and adolescents who had MRI scans of the brain, and to compare the results to adults undergoing brain MRI scans, and to children and adolescents undergoing electroencephalography (EEG; which is usually regarded a “minimal burden”). Method Participants were 57 children and adolescents who had a brain MRI scan (MRI-C; mean age 12.9 years), 28 adults who had a brain MRI scan (MRI-A; mean age 43.7 years), and 66 children and adolescents undergoing EEG (EEG-C; mean age 12.9 years). Anxiety was assessed on the subjective (situational anxiety) and on the physiological level (arousal), before and after the respective examination. Results More than 98% of children and adolescents reported no or only minimal fear during the MRI scan. Both pre- and post-examination, the MRI-C and the MRI-A groups did not differ significantly with respect to situational anxiety ( p = 0.262 and p = 0.374, respectively), and to physiological arousal ( p = 0.050, p = 0.472). Between the MRI-C and the EEG-C group, there were also no significant differences in terms of situational anxiety ( p = 0.525, p = 0.875), or physiological arousal ( p = 0.535, p = 0.189). Prior MRI experience did not significantly influence subjective or physiological anxiety parameters. Conclusions In this study, children and adolescents undergoing a brain MRI scan did not experience significantly more anxiety than those undergoing an EEG, or adults undergoing MRI scanning. Therefore, a general exclusion of minors from MRI research studies does not appear reasonable.

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Are positive experiences of children in non-therapeutic research justifiable research benefits?

Cited by 6 publications

References 22 publications

Indirect Benefits in HIV Cure Clinical Research: A Qualitative Analysis

Indirect Benefits in HIV Cure Clinical Research: A Qualitative Analysis

Parents’ Perspectives on Decisions to Participate in Pediatric Clinical Research: Results From a Focus Group Study With Laypeople

A comparison study of anxiety in children undergoing brain MRI vs adults undergoing brain MRI vs children undergoing an electroencephalogram

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