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

Ethical responsibilities toward indirect and collateral participants in pragmatic clinical trials. Clin Trials. 2015 Sep 15; Authors: Smalley JB, Merritt MW, Al-Khatib SM, McCall D, Staman KL, Stepnowsky C Abstract 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 aff...
Source: Clinical Trials - Category: Research Authors: Tags: Clin Trials Source Type: research