Topic

Ethical Responsibilities Toward Indirect and Collateral Participants in Pragmatic Clinical Trials (PCTs)

Presenter

Jaye Bea Smalley, MPA, Engagement Officer at the Patient-Centered Outcomes Research Institute (PCORI)

Keywords

Research ethics; Human research subject; Cluster randomized trials; Collateral participant; Indirect participant; Patient engagement; Pragmatic clinical trials; Stakeholder engagement

Key Points

• As more patients and stakeholders begin to take active roles in the research continuum, it is important to distinguish between those who are considered participants strictly speaking (as human research subjects) and other collaborators.
• Because PCTs are typically embedded in the delivery of healthcare, a systematic approach to identifying types of participants is needed in the early phases of the trial:
  - Direct participants are individuals intentionally targeted by a study intervention or those on whom protected health information (PHI) is collected for the purposes of the PCT.
  - Indirect participants are individuals 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 are patient communities and other stakeholders who may be affected by the implementation and findings of the PCT.
• Trial information should be adequately communicated and disseminated to indirect participants as well as to the institutionally defined leadership and officials who bear responsibility. These include investigators, IRBs, healthcare system leadership, and others charged with delineating risk.
• PCTs may introduce further distinct responsibilities for trial leadership to proactively engage with collateral participants such as patient advocacy groups, caregivers, community members, and healthcare provider professional associations. Further research is required to evaluate when and how to engage collateral participants.

Discussion Themes

What resources, funding, or training materials are available to educate trialists about ethical considerations for indirect and collateral participants?

Bringing research into the healthcare setting requires a culture change—how do we help lay the groundwork?

How does this type of work fit with the business model of most healthcare systems?

How do we engage health plans—governmental and commercial—in the research early and often?

For More Information

Read more about the ethical responsibilities toward indirect and collateral participants in PCTs in Smalley et al. (2015): http://1.usa.gov/1U8tZUx.

Tags
#ResearchEthics; #pctGR
@PCTGrandRounds, @Collaboratory1, @PCORnetwork