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A sample of IRB’s comprehensive training manual

The human research protection office at Washington University in St. Louis has a 43-page training tool that covers general and specific research protection information and tasks for new IRB staff.

IRBs Train Staff to be Experts

Here's how one human research protection program developed a formal training program that empowered its staff.

FIRST study proves a point, but which one?

A controversial study that was branded as unethical by some critics because it altered surgical residents’ training hours without informed consent from patients has found that “flexible, less restrictive” duty hours did not increase patient mortality or serious complications.

French study’s death recalls 2006 UK clinical trial disaster

It was an unsettling sense of deja vu for researchers and bioethicists when French authorities reported in January that one man died and five others were seriously injured after being administered an investigational drug in a Phase I clinical trial.

Should infection control research be IRB exempt?

The Association for Professionals in Infection Control and Epidemiology warns that proposed revisions to the Common Rule may have unintended consequences if infection prevention research is not excluded from approval by IRBs.

This IRB “party” gets the job done

There might be a simple solution to IRB workflow issues that stem from graduate student research cycles: A party.

Strategies for improving study recruitment of minorities

Investigators and IRBs are finding a variety of ways to increase minority representation in studies and clinical trials, including policies mandating such recruitment.

Research communities work creatively to improve minority recruitment in clinical trials

In the three years since Congress passed the Food and Drug Administration Safety and Innovation Act of 2012 with its provision encouraging the inclusion of minorities in clinical trials, IRBs and research sites have continued to struggle with the need to diversify study participant pools.

Top medical journals propose mandating data sharing

The International Committee of Medical Journal Editors — which counts several prestigious periodicals among its members — is giving authors an offer they can’t refuse: Agree to share your clinical trial data with subsequent researchers or your manuscript will not be published.

IRB members in their own words

Robert L. Klitzman, MD, interviewed some 45 IRB members for his new book, The Ethics Police? The following are some of the published comments by both IRB chairs and members on how they came to be on an IRB and their challenges in weighing the risks and benefits of human research.