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Ethical responsibilities toward indirect and collateral participants in pragmatic clinical trials.

Publication ,  Journal Article
Smalley, JB; Merritt, MW; Al-Khatib, SM; McCall, D; Staman, KL; Stepnowsky, C
Published in: Clin Trials
October 2015

Pragmatic clinical trials are designed to inform decision makers about the benefits, burdens, and risks of health interventions in real-world settings. Pragmatic clinical trials often use for research purposes data collected in the course of clinical practice. The distinctive features of pragmatic clinical trials demand fresh thinking about what is required to act properly toward people affected by their conduct, in ways that go beyond ensuring the protection of rights and welfare for "human research subjects" under conventional research ethics regulations. To stimulate such work, we propose to distinguish among categories of research participants in pragmatic clinical trials as follows: Direct participants: (1) individuals being directly intervened upon and/or (2) individuals from whom personal identifiable data are being collected for the purposes of the pragmatic clinical trial. Indirect participants: individuals who are (1) not identified as direct participants and (2) whose rights and welfare may be affected by the intervention through their routine exposure to the environment in which the intervention is being deployed. Collateral participants: patient groups and other stakeholder communities who may be otherwise affected by the occurrence and findings of the pragmatic clinical trial. We illustrate these distinctions with case examples and discuss the distinctive responsibilities of researchers and pragmatic clinical trial leadership toward each type of participant. We suggest that pragmatic clinical trial investigators, institutional review boards, health systems leaders, and others engaged in the research enterprise work together to identify these participants. For indirect participants, risks and benefits to which they are exposed should be weighed to ensure that their rights and welfare are protected accordingly, and communication strategies should be considered to help them make well-informed decisions. Collateral participants could provide input on the design, planning, and conduct of a pragmatic clinical trial and offer insights regarding the best way to communicate the trial's results to their constituencies.

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Published In

Clin Trials

DOI

EISSN

1740-7753

Publication Date

October 2015

Volume

12

Issue

5

Start / End Page

476 / 484

Location

England

Related Subject Headings

  • Statistics & Probability
  • Research Design
  • Patient Selection
  • Patient Safety
  • Humans
  • Ethics Committees, Research
  • Decision Making
  • Clinical Trials as Topic
  • Canada
  • 5203 Clinical and health psychology
 

Citation

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Smalley, J. B., Merritt, M. W., Al-Khatib, S. M., McCall, D., Staman, K. L., & Stepnowsky, C. (2015). Ethical responsibilities toward indirect and collateral participants in pragmatic clinical trials. Clin Trials, 12(5), 476–484. https://doi.org/10.1177/1740774515597698
Smalley, Jaye Bea, Maria W. Merritt, Sana M. Al-Khatib, Debbe McCall, Karen L. Staman, and Carl Stepnowsky. “Ethical responsibilities toward indirect and collateral participants in pragmatic clinical trials.Clin Trials 12, no. 5 (October 2015): 476–84. https://doi.org/10.1177/1740774515597698.
Smalley JB, Merritt MW, Al-Khatib SM, McCall D, Staman KL, Stepnowsky C. Ethical responsibilities toward indirect and collateral participants in pragmatic clinical trials. Clin Trials. 2015 Oct;12(5):476–84.
Smalley, Jaye Bea, et al. “Ethical responsibilities toward indirect and collateral participants in pragmatic clinical trials.Clin Trials, vol. 12, no. 5, Oct. 2015, pp. 476–84. Pubmed, doi:10.1177/1740774515597698.
Smalley JB, Merritt MW, Al-Khatib SM, McCall D, Staman KL, Stepnowsky C. Ethical responsibilities toward indirect and collateral participants in pragmatic clinical trials. Clin Trials. 2015 Oct;12(5):476–484.
Journal cover image

Published In

Clin Trials

DOI

EISSN

1740-7753

Publication Date

October 2015

Volume

12

Issue

5

Start / End Page

476 / 484

Location

England

Related Subject Headings

  • Statistics & Probability
  • Research Design
  • Patient Selection
  • Patient Safety
  • Humans
  • Ethics Committees, Research
  • Decision Making
  • Clinical Trials as Topic
  • Canada
  • 5203 Clinical and health psychology