Reframing Consent for Clinical Research: A Function-Based Approach

Dickert, Neal W.; Eyal, Nir; Goldkind, Sara F.; Grady, Christine; Joffe, Steven; Lo, Bernard; Miller, Franklin G.; Pentz, Rebecca D.; Silbergleit, Robert; Weinfurt, Kevin P.; Wendler, David; Kim, Scott Y. H.

doi:10.1080/15265161.2017.1388448

Cited by 100 publications

(62 citation statements)

References 44 publications

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“…In other research settings such as trials of therapies to treat acute stroke, investigators have attempted to balance the goals of informed consent with unavoidable constraints created by the clinical situation by implementing more brief and focused informed consent processes. 27 Our study participants expressed support for transparency, feeling respected and the ability to refuse the organ based on the fact that research was performed on it. Not meeting patients' expectations may risk jeopardizing public trust in the transplant system, thereby reducing organ donation.…”

Section: Study Conclusionmentioning

confidence: 90%

Transplant candidates’ perceptions of informed consent for accepting deceased donor organs subjected to intervention research and for participating in posttransplant research

Gordon

Knopf

Phillips

et al. 2020

American Journal of Transplantation

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Deceased donor organ intervention research holds promise for increasing the quantity and quality of organs for transplantation by minimizing organ injury and optimizing function. Such research will not progress until ethical, regulatory, and legal issues are resolved regarding whether and how to obtain informed consent from transplant candidates offered intervention organs given time constraints intrinsic to distribution. This multi‐center, mixed‐methods study involved semi‐structured interviews using open‐ and closed‐ended questions to assess waitlisted candidates’ preferences for informed consent processes if offered an organ after undergoing intervention. Data were analyzed thematically. Sixty‐one candidates participated (47% participation rate). Most were male (57%), white (61%), with a mean age of 56 years. Most candidates (79%) desired being informed that the organ offered was an intervention organ before accepting it, and were likely to accept an intervention organ if organ quality was good (defined as donor age 30) (81%), but fewer candidates would accept an intervention organ if quality was moderate (ie, donor age 50) (26%). Most perceived informed consent important for decision‐making, while others considered it unnecessary given medical necessity to accept an organ and trust in their physician. Our findings suggest that most candidates desire an informed consent process before accepting an intervention organ and posttransplant data collection.

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Section: Study Conclusionmentioning

confidence: 90%

Transplant candidates’ perceptions of informed consent for accepting deceased donor organs subjected to intervention research and for participating in posttransplant research

Gordon

Knopf

Phillips

et al. 2020

American Journal of Transplantation

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“…Lengthy ICFs with full disclosure of everything may obscure the important and relevant information for decision making whether to participate in a study [ 14 ]. Exhaustive disclosure of detailed information of every single aspect related to the study may overwhelm potential research participants with too excessive information [ 15 ]. Based on a systematic review on the desired information by potential participants of biomedical research, there is limited empirical evidence on this subject [ 16 ].…”

Section: Introductionmentioning

confidence: 99%

What information and the extent of information research participants need in informed consent forms: a multi-country survey

Karbwang¹,

Koonrungsesomboon²,

Torres³

et al. 2018

BMC Med Ethics

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BackgroundThe use of lengthy, detailed, and complex informed consent forms (ICFs) is of paramount concern in biomedical research as it may not truly promote the rights and interests of research participants. The extent of information in ICFs has been the subject of debates for decades; however, no clear guidance is given. Thus, the objective of this study was to determine the perspectives of research participants about the type and extent of information they need when they are invited to participate in biomedical research.MethodsThis multi-center, cross-sectional, descriptive survey was conducted at 54 study sites in seven Asia-Pacific countries. A modified Likert-scale questionnaire was used to determine the importance of each element in the ICF among research participants of a biomedical study, with an anchored rating scale from 1 (not important) to 5 (very important).ResultsOf the 2484 questionnaires distributed, 2113 (85.1%) were returned. The majority of respondents considered most elements required in the ICF to be ‘moderately important’ to ‘very important’ for their decision making (mean score, ranging from 3.58 to 4.47). Major foreseeable risk, direct benefit, and common adverse effects of the intervention were considered to be of most concerned elements in the ICF (mean score = 4.47, 4.47, and 4.45, respectively).ConclusionsResearch participants would like to be informed of the ICF elements required by ethical guidelines and regulations; however, the importance of each element varied, e.g., risk and benefit associated with research participants were considered to be more important than the general nature or technical details of research. Using a participant-oriented approach by providing more details of the participant-interested elements while avoiding unnecessarily lengthy details of other less important elements would enhance the quality of the ICF.Electronic supplementary materialThe online version of this article (10.1186/s12910-018-0318-x) contains supplementary material, which is available to authorized users.

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“…This function of informed consent is just one that has been identified by Dickert and colleagues (Dickert et al 2017). Others they discuss include providing transparency, allowing control and authorization, promoting concordance with participants' values, protecting and promoting welfare interests, satisfying regulatory requirements, and promoting integrity in research (Dickert et al 2017).…”

Section: Editorialmentioning

confidence: 99%