- Identify how consideration of ethical and regulatory issues in the design phase of an ePCT with PLWD can help make the study more pragmatic.
- Review the regulatory requirements for a waiver or alteration of informed consent and discuss related ethical considerations.
- Apply what we’ve covered to two case studies.
Watch the Webinar
Download the slides: IMPACT Grand Rounds February 20 2020.
- 45 CFR 46 – Protection of Human Subjects
- Scott Kim and Frank Miller. “Waivers and alterations to consent in pragmatic clinical trials: Respecting the principle of respect for persons.” IRB: Ethics and Human Research. January-February 2016, Vol 38, issue 1.
- January 31, 2008 SACHRP letter to HHS Secretary: Recommendations related to waiver of informed consent and interpretation of “minimal risk,” available at https://hhs.gov/ohrp/sachrp-committee/recommendations/2008-january-31-letter/index.html