SAEM Research Learning Series Podcast: Common IRB Pitfalls

This installment of the SAEM Research Learning Series, co-hosts Dr. Mary Haas and Dr. Nate Haas interview Dr. James Paxton, Assistant Professor of Emergency Medicine and Chairman of the IRB at the Wayne State School of Medicine in Detroit, MI. The topic of this podcast focuses common IRB application pitfalls that Dr. Paxton sees from his vantage point.

Podcast: Common IRB Pitfalls

Take Home Points

1. Language: IRB committee members are comprised of a diverse group of stakeholders, some of whom are not healthcare providers but rather other scientists and community members. Write your IRB proposal using language appropriate for lay person interpretation.
2. Level of review: Is your study going to require a full, expedited, or exempted review? When in doubt, have a low threshold to consult the IRB committee before submitting your application.
3. Follow directions and use spellcheck: Pay close attention, and follow the instructions when filling out the application. Don’t leave key sections blank.
4. Consent form: The form should explain the risk clearly to the patient using appropriate terms at the level of a middle-school student.
5. Vulnerable populations: Justify why you are including or excluding such populations, such as pregnant women, prisoners, non-English speakers, or those with cognitive impairment.
6. Signatures: Do not leave this blank, and do not forget your Chair’s signature.

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