Informed consent in clinical research: Consensus recommendations for reform identified by an expert interview panel

Lorell, Beverly H.; Mikita, J Stephen; Anderson, Annick; Hallinan, Zachary P.; Forrest, Annemarie

doi:10.1177/1740774515594362

Cited by 36 publications

(45 citation statements)

References 6 publications

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“…As in our study, other research has found (Cortes et al 2010)—and indeed there seems to be consensus (Lorell et al 2015)—that the leading problem regarding informed consent is the length and amount of information included in informed consent documents. However, much of this information is critical.…”

Section: Discussionsupporting

confidence: 84%

Improving informed consent: Stakeholder views

Anderson

Newman

Matthews

2017

AJOB Empirical Bioethics

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Purpose Innovation will be required to improve the informed consent process in research. We aimed to obtain input from key stakeholders—research participants and those responsible for obtaining informed consent—to inform potential development of a multimedia informed consent “app.” Methods This descriptive study used a mixed-methods approach. Five 90-minute focus groups were conducted with volunteer samples of former research participants and researchers/research staff responsible for obtaining informed consent. Participants also completed a brief survey that measured background information and knowledge and attitudes regarding research and the use of technology. Established qualitative methods were used to conduct the focus groups and data analysis. Results We conducted five focus groups with 41 total participants: three groups with former research participants (total n = 22), and two groups with researchers and research coordinators (total n = 19). Overall, individuals who had previously participated in research had positive views regarding their experiences. However, further discussion elicited that the informed consent process often did not meet its intended objectives. Findings from both groups are presented according to three primary themes: content of consent forms, experience of the informed consent process, and the potential of technology to improve the informed consent process. A fourth theme, need for lay input on informed consent, emerged from the researcher groups. Conclusions Our findings add to previous research that suggests that the use of interactive technology has the potential to improve the process of informed consent. However, our focus-group findings provide additional insight that technology cannot replace the human connection that is central to the informed consent process. More research that incorporates the views of key stakeholders is needed to ensure that multimedia consent processes do not repeat the mistakes of paper-based consent forms.

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Section: Discussionsupporting

confidence: 84%

Improving informed consent: Stakeholder views

Anderson

Newman

Matthews

2017

AJOB Empirical Bioethics

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“…It is anticipated that the role for multimedia in the consent process will become more common as nearly 90% of the United States population regularly uses the internet and media-based technology costs continue to decrease and become more portable [18, 57]. Therefore, it is critical that the development of new electronic consent tools be integrated with a cognitive approach to improve learning and rigorously tested in clinical trials to evaluate effects on comprehension [58]. …”

Section: Discussionmentioning

confidence: 99%

A cognitive approach for design of a multimedia informed consent video and website in pediatric research

Antal¹,

Bunnell

McCahan

et al. 2017

Journal of Biomedical Informatics

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Objective Poor participant comprehension of research procedures following the conventional face-to-face consent process for biomedical research is common. We describe the development of a multimedia informed consent video and website that incorporates cognitive strategies to enhance comprehension of study related material directed to parents and adolescents. Materials and methods A multidisciplinary team was assembled for development of the video and website that included human subjects professionals; psychologist researchers; institutional video and web developers; bioinformaticians and programmers; and parent and adolescent stakeholders. Five learning strategies that included Sensory-Modality view, Coherence, Signaling, Redundancy, and Personalization were integrated into a 15-minute video and website material that describes a clinical research trial. Results A diverse team collaborated extensively over 15 months to design and build a multimedia platform for obtaining parental permission and adolescent assent for participant in as asthma clinical trial. Examples of the learning principles included, having a narrator describe what was being viewed on the video (sensory-modality); eliminating unnecessary text and graphics (coherence); having the initial portion of the video explain the sections of the video to be viewed (signaling); avoiding simultaneous presentation of text and graphics (redundancy); and having a consistent narrator throughout the video (personalization). Discussion Existing conventional and multimedia processes for obtaining research informed consent have not actively incorporated basic principles of human cognition and learning in the design and implementation of these processes. The present paper illustrates how this can be achieved, setting the stage for rigorous evaluation of potential benefits such as improved comprehension, satisfaction with the consent process, and completion of research objectives. Conclusion New consent strategies that have an integrated cognitive approach need to be developed and tested in controlled trials.

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“…suggest changing the guideline to permit trial inclusion of children without a legally acceptable representative . The length and technical language of the consent form is a highly debated topic in both the north and south, as is the view that its content serves mainly to protect sponsors .…”

Section: Discussionmentioning

confidence: 99%

“…For example, Kalabuanga et al suggest changing the guideline to permit trial inclusion of children without a legally acceptable representative [33]. The length and technical language of the consent form is a highly debated topic in both the north and south, as is the view that its content serves mainly to protect sponsors [32,34]. Based on the results and the discussion in the previous paragraph, some interviewees seemed unaware that GCP as a guideline allows for an adapted application.…”

Section: Discussionmentioning

confidence: 99%

The Good Clinical Practice guideline and its interpretation – perceptions of clinical trial teams in sub‐Saharan Africa

Vischer

Pfeiffer

Joller

et al. 2016

Tropical Med Int Health

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Abstractobjectives To explore the advantages and challenges of working with the Good Clinical Practice (GCP)-International Conference of Harmonization (ICH) E6 guideline and its interpretation from the perspective of clinical trial teams based in sub-Saharan Africa.methods We conducted 60 key informant interviews with clinical trial staff at different levels in clinical research centres in Kenya, Ghana, Burkina Faso and Senegal and thematically analysed the responses.results Clinical trial teams perceived working with ICH-GCP as highly advantageous and regarded ICH-GCP as applicable to their setting and efficiently applied. Only for informed consent did some clinical trial staff (one-third) perceive the guideline as insufficiently applicable. Specific challenges included meeting the requirements for written and individual consent, conditions for impartial witnesses for illiterates or legally acceptable representatives for children, guaranteeing voluntary participation and ensuring full understanding of the consent given. It was deemed important to have ICH-GCP compliance monitored by relevant ethics committees and regulatory authorities, without having guidelines applied overcautiously.conclusion Clinical trial teams in sub-Saharan Africa perceived GCP as a helpful guideline, despite having been developed by northern organisations and despite the high administrative burden of implementing it. To mitigate consent challenges, we suggest adapting GCP and making use of the flexibility it offers.keywords clinical trials, Africa South of the Sahara, good clinical practice, qualitative research, guideline

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Informed consent in clinical research: Consensus recommendations for reform identified by an expert interview panel

Cited by 36 publications

References 6 publications

Improving informed consent: Stakeholder views

Improving informed consent: Stakeholder views

A cognitive approach for design of a multimedia informed consent video and website in pediatric research

The Good Clinical Practice guideline and its interpretation – perceptions of clinical trial teams in sub‐Saharan Africa

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