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Lecture Series Reviews Regulations for Human Participants Research

A lecture hall seen from the podium, filled with people sitting at tables

The Center for Bioethics is hosting a series of lectures on the policies, regulations and practices researchers need to know before beginning a study that involves human participants.

Standards for Research with Human Participants, led by Dr. Steven Miles, professor of medicine and Maas Family Endowed Chair in Bioethics, explores the most critical and timely topics in the field and boils down policy jargon to clarify what researchers need to know.

The lectures inform researchers on topics such as the purpose of an institutional review board, the regulations that govern informed consent and the difference between confidentiality and privacy. Knowing this information will help anyone involved in research with human participants, including faculty, graduate students, staff and other health care professionals, conduct ethical studies as well as comply with national regulations, state policies and the publication standards of academic journals.

“Human participants play a crucial role in cutting-edge research to improve our health and well-being,” said Brian Herman, Ph.D., the U’s vice president for research. “This lecture series enhances the existing educational and ethics training offered at the University to ensure researchers are equipped to approach studies with human participants with the highest standards of ethical conduct.”

Researchers can choose which lectures to attend based on what is most relevant to their work, Miles said. For example, researchers who work in other countries should consider the lecture on international research, while the lecture on impaired consent may draw in mostly neurologists and psychologists.

The lectures can be used to fulfill the University’s Responsible Conduct of Research requirements or be taken for CME/CNE credit or be taken as a complete series for academic credit. They will be offered as a webcast beginning in summer 2016.  Existing RCR-approved lectures are not affected.

Bioethics in the U.S. has evolved since Harvard medical ethicist Henry Beecher’s influential 1966 report on ethics and clinical research that highlighted cases of unethical clinical research that risked patients’ lives. In the years following the report, institutional review boards were formed across the nation and many new regulations were created. In 1997, for example, the U.S. Food and Drug Administration began requiring pharmaceutical researchers to register all results from their clinical trials, preventing companies from obscuring negative results to make new drugs seem more beneficial.

“The bar of medical ethics is steadily rising compared to where it was,” Miles said. “Bioethics infractions have diminished over time, but they are still present today.”

Miles’ expertise stems from an extensive career related to bioethics, which has led to significant improvements in health care insurance, end-of-life care, the use of restraints in nursing homes, refugee camp medicine and prison medical ethics. He has published three books and more than 200 scholarly articles on medical ethics, human rights, tropical medicine and end-of-life care, and is currently seeking out physicians across the globe who assist in torture to see that they are held accountable. Miles was also one of two U of M doctors to recommend the nation’s schools eliminate football to reduce the pressure on children to participate in a sport with a high rate of concussions.

Standards for Research with Human Participants

Lectures are held from 4:30 to 5:30 p.m. in 2-530 Moos Tower every Thursday through May 5, with the exception of March 17. Walk-ins are welcome. Attendees only need to register in advance if they would like to receive continuing CME/CNE credit.

Upcoming lecture subjects include:

  • Feb. 25: Vulnerable Persons
  • March 3: Conflicts of Interest
  • March 10: Standards for Publication
  • March 24: Data Safety Monitoring
  • March 31: International Research
  • April 7: Research Misconduct
  • April 14: Trial Registries
  • April 21: Human Biospecimens
  • April 28: Sentinel Events
  • May 5: Community Consent

Lectures will be posted online at a later date. For more details, visit the Center for Bioethics’ lecture series page.

Kevin Coss

Kevin Coss

Kevin is a writer with the Office of the Vice President for Research.

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