Ethics and Regulation Core
Core Activities
The Ethics and Regulation Core aims to assure that embedded pragmatic clinical trials (ePCTs) in dementia care meet the ethical challenges and regulatory requirements for human subjects research with attention to the unique considerations of persons living with dementia (PLWD) and their care partners.
Core members support the design and conduct of ePCTs among PLWD and their care partners by providing guidance and consultation to IMPACT investigators on relevant ethical and regulatory issues. Members also enhance investigator capacity by conducting training activities and mentoring faculty scholars and post-doctoral trainees on ethical and regulatory issues in conducting ePCTs among PLWD and their care partners. Additionally, the Core develops and disseminates knowledge to advance best practices and methodologies on topics related to ethical and regulatory issues pertinent to ePCT design and conduct.
Key Resources
News & Publications
- Karlawish calls for the breaking of tyranny of treatment and prioritization of patient-centered care
- IMPACT authors examine ethical value of consulting community members in non-emergency trials with waivers of informed consent
- IMPACT authors explore ethical challenges of using algorithms for dementia diagnosis
- New article highlights how IMPACT Lived Experience Panel contributes to improving ePCTs in dementia care
- Clapp to present at Society for Clinical Trials 44th Annual Meeting
- Watch – Words Matter: Shortcomings and challenges of nomenclature in Alzheimer’s disease
- IMPACT members to discuss nomenclature in dementia
Leadership
 Jason Karlawish, MDCore Leader |
 Emily Largent, PhD, JDAssociate Core Leader |