April 15, 2016: Considerations in the Evaluation and Determination of Minimal Risk in Research Studies

April 15, 2016: Considerations in the Evaluation and Determination of Minimal Risk in Research Studies

Speaker

John Lantos, MD, Director of the Children’s Mercy Bioethics Center at Children’s Mercy Hospital, University of Missouri, Kansas City

Topic

Considerations in the Evaluation and Determination of Minimal Risk in Research Studies

Keywords

Minimal risk; Clinical research; Quality improvement; Comparative effectiveness research; Research ethics; Federal regulations

Key Points

  • Research, quality improvement, and comparative effectiveness research may involve similar interventions and seek generalizable knowledge yet have different IRB responses.
  • Usually the knowledge that results from a quality improvement study is most applicable to the local situation—yet insights about one setting ordinarily have some applicability to other settings.
  • The phenomenon of practice variation: Wennberg et al. have shown that, for almost any medical procedure where there are options, clinical choices vary in dramatic, seemingly irrational, and unpredictable ways.
  • An IRB determination of minimal risk may lead to a waiver or modification of consent, permission to include vulnerable participants, or expedited review. But the definition of minimal risk is nonspecific, IRBs vary in risk determination, and risk aversion may restrict research or hamper multicenter research.
  • Both clinical researchers and practicing physicians should be expected to balance their moral obligations to their patients with other conflicting obligations.

Discussion Themes

What makes an activity research, and what makes an activity risky?

Which is riskier: undisclosed and unstudied idiosyncratic practice variation—or deliberate formal randomization with careful monitoring and evaluation?

Can a randomized controlled trial ever be classified as “minimal risk?” Are quality improvement studies that have an experimental design “minimal risk?” Are they even research?

How are IRBs to consider oversight of cluster-randomized trials (CRTs), in which interventions are applied to groups of patients?

What is the right ethical framework for a learning healthcare system?

For More Information

Read more about minimal risk considerations in Lantos et al. (2015) in Clinical Trials: http://1.usa.gov/1MDUKxJ.

The Hastings Center Report on Ethical Oversight of Learning Health Care Systems is available here: http://bit.ly/26bgpUd.

SACHRP has offered guidance regarding the oversight of CRTs: http://1.usa.gov/1YGUChD.

Tags
#ResearchEthics; #MinimalRisk; #pctGR
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