What’s Our First Priority in Clinical Research: Generating Data or Protecting Participants?

Is the primary goal of clinical research to protect participants or to generate scientifically sound data? In this thought-provoking on-demand session, Dr. Jerry Menikoff explores this ethical dilemma and its impact on the future of clinical trials.

概览

When we conduct clinical trials, what should our primary goal be? Is it making sure that we ensure the safety and protection of research participants and optimize their outcomes? Or, as others argue, is it the collection of scientifically solid data that we can use to make evidence-based medical decisions for future patients- even if that means individual research participants may not have the best outcomes?

In this on-demand offering, Dr. Jerry Menikoff, former director of the Office of Human Research Protections at the U.S. Department of Health and Human Services (HHS), discusses the thought-provoking debate raised in his recent JAMA editorial, “Protecting Participants is Not the Top Priority in Clinical Research.” We’ll explore the ethical complexities, diverse perspectives, and the implications of this debate on the growing movement to expand clinical trial participation as a care option.

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- Overview of JAMA editorial “Protecting Participants is not the Top Priority in Clinical Research”
- Review of the fundamental principles of research ethics and regulatory definitions of research
- Discussion of how these concepts apply to the current movement for “clinical trials as a care option” and the ethical considerations
- Definition and discussion of the concept of “therapeutic misconception” as it applies to participation in research
- Review of section 8 of the Declaration of Helsinki and the physician’s responsibility to patients and research participants

What’s Our First Priority in Clinical Research: Generating Data or Protecting Participants?

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