Respect for Potential and Enrolled Subjects

Individuals should be treated with respect from the time they are approached for possible participation — even if they refuse enrollment in a study — throughout their participation and after their participation ends. This includes:

1. Respecting their privacy and keeping their private information confidential.
2. Respecting their right to change their mind, to decide that the research does not match their interests, and to withdraw without penalty.
3. Informing them of new information that might emerge in the course of research, which might change their assessment of the risks and benefits of participating.
4. Monitoring their welfare and, if they experience adverse reactions, untoward events, or changes in clinical status, ensuring appropriate treatment and, when necessary, removal from the study.
5. Informing them about what was learned from the research. Most researchers do a good job of monitoring the volunteers’ welfare and making sure they are okay. They are not always so good about distributing the study results. If they don’t tell you, ask.

Sources

For more information about what makes clinical research ethical, we refer you to:

Ezekiel J. Emanuel, MD, PhD; David Wendler, PhD, and Christine Grady, PhD. "What Makes Clinical Research Ethical?" Journal of the American Medical Association, Vol. 283, No. 20, May 24, 2000, pp. 2701-2711.

Copy on this website is based largely on this article, on an interview with Dr. Grady, and on Dr. Emanuel’s PowerPoint presentation, "What makes research ethical," available online: http://www.bioethics.nih.gov/slides/10-29-03-Emmanuel.pdf

Dr. Grady is acting chief of the Bioethics Department and head of the Section on Human Subjects Research. Dr. Wendler heads the Unit on Vulnerable Populations. Dr. Emanuel was chief of the CC Bioethics Department 1996-2011.

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