Use of altered informed consent in pragmatic clinical research

McKinney, Ross E.; Beskow, Laura M.; Ford, Daniel E.; Lantos, John D.; McCall, Jonathan; Patrick-Lake, Bray; Pletcher, Mark J.; Rath, Brian; Schmidt, Hollie; Weinfurt, Kevin P.

doi:10.1177/1740774515597688

Cited by 86 publications

(88 citation statements)

References 22 publications

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“…Altered methods may ensure practicability while still adhering to the requirements of ethical research [29]. Internet-based registries, for example, may represent a realistic means to establish adequately large populations of willing participants, though there may be risks associated with electronic consent such as participants rapidly scrolling or clicking through consent documents and blithely clicking “enroll,” as they might with a new smart phone application [30].…”

Section: Informed Consentmentioning

confidence: 99%

Recruiting to preclinical Alzheimer's disease clinical trials through registries

Grill

2017

A&D Transl Res & Clin Interv

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Participant registries are repositories of individuals who have expressed willingness to learn about studies for which they may be eligible. Registries are increasingly being used to improve recruitment to preclinical Alzheimer's disease (AD) clinical trials, which require large screening efforts to identify adequate numbers of participants who meet enrollment criteria. Recruiting to preclinical AD trials from registries is made more efficient through registry collection of data that permits exclusion of those who will not be eligible and identifies individuals most likely to qualify for trials. Such data could include self-reported disease family history or other risk factors but could also include cognitive, genetic, or biomarker testing outcomes. Few data are available to guide investigators overseeing registries and important ethical questions are likely to arise related to their conduct, especially in registries collecting AD risk information. This article outlines three areas of consideration for registry investigators: informed consent, disclosure, and sponsorship.

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Section: Informed Consentmentioning

confidence: 99%

Recruiting to preclinical Alzheimer's disease clinical trials through registries

Grill

2017

A&D Transl Res & Clin Interv

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“…5 A reevaluation of current regulations and institutional practices is prudent, as not all safeguards for vulnerable subjects may be appropriate, feasible, or ethical in PCTs. 6 …”

Section: Introductionmentioning

confidence: 99%

The ethics and regulatory landscape of including vulnerable populations in pragmatic clinical trials

et al. 2015

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Policies have been developed to protect vulnerable populations in clinical research, particularly the US federal research regulations (45 CFR 46 subparts B, C, and D). These policies generally recognize vulnerable populations to include pregnant women, fetuses, neonates, children, prisoners, persons with physical handicaps or mental disabilities, and disadvantaged persons. The aim has been to protect these populations from harm, often by creating regulatory and ethical checks that may limit their participation in many clinical trials. The recent increase in pragmatic clinical trials (PCTs) raises at least two questions about this approach. First, is exclusion itself a harm to vulnerable populations, as these groups may be denied access to understanding how health interventions work for them in clinical settings? Second, are groups considered vulnerable in traditional clinical trials also vulnerable in PCTs? We argue first, that excluding vulnerable subjects from participation in PCTs can be harmful by preventing acquisition of data to meaningfully inform clinical decision-making in the future. Second, we argue that protections for vulnerable subjects in traditional clinical trial settings may not be translatable, feasible, or even ethical to apply in PCTs. We conclude by offering specific recommendations for appropriately protecting vulnerable research subjects in PCTs, focusing on pregnant women, fetuses, neonates, children, prisoners, persons with physical handicaps or mental disabilities, and disadvantaged persons.

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“…In the worst scenario, the trial is terminated early 711. We should look for alternatives to the standard written informed consent for low risk pragmatic RCTs 2223…”

Section: Informed Consentmentioning

confidence: 99%