Ethics & Regulation

NIH Pragmatic Trials Collaboratory Chapter: ETHICAL CONSIDERATIONS OF DATA SHARING IN PRAGMATIC CLINICAL TRIALS

Posted on by Sonya Sutton

Published on the NIH Pragmatic Trials Collaboratory website April 3 2023, this new chapter of the living textbook presents the human subjects research regulations that may impact data sharing and examines the intersection of enabling critical ePCT research, and respecting the interest of patients who become ePCT participants.

The scientific motivations for data sharing are clear: health information can enable scientific discovery, as well as enhance transparency and reproducibility in trial results. However, the ethical considerations of sharing data from embedded pragmatic clinical trials (ePCTs) are less well defined, especially when data are collected with a waiver or alteration of informed consent, as is often the case in ePCTs. Therefore, in this chapter, we describe the human subjects research regulations that may impact such data sharing and examine the intersection of enabling critical ePCT research, and respecting the interests of patients who become ePCT participants.

Access the chapter: https://rethinkingclinicaltrials.org/chapters/ethics-and-regulatory/ethical-considerations-of-data-sharing-in-pragmatic-clinical-trials/introduction-to-ethical-considerations-of-data/ 

 

Watch – Words Matter: Shortcomings and challenges of nomenclature in Alzheimer’s disease

Posted on by Jeannine Sato

IMPACT Ethics and Regulation Core Leader, Jason Karlawish, MD, hosted a virtual conversation on the shortcomings and challenges of nomenclature in Alzheimer’s disease and related dementias and learn about the opportunities to address these challenges. He was joined by IMPACT Stakeholder Advisory Committee member, Angela Taylor, BA of the Lewy Body Dementia Association.

Karlawish and Taylor discussed questions and consideration in the field’s nomenclature including:: What’s the difference between Alzheimer’s disease and dementia? Should we still use the word dementia? Does it make sense to say that a person with MCI can progress to Alzheimer’s disease? In the term ADRD, does the second “D” stand for “disease,” “disorder,” or “dementia”?

The entire discussion can be viewed on You Tube.

IMPACT members to discuss nomenclature in dementia

Posted on by Manda

Penn Memory Center at University of Pennsylvania Health System, is hosting a virtual event with IMPACT’s Jason Karlawish, MD and Angela Taylor, who will discuss the shortcomings and challenges of nomenclature in Alzheimer’s disease and related dementias. Karlawish and Taylor are working to find the answers to questions like:

  • What’s the difference between Alzheimer’s disease and dementia?
  • Should we still use the word dementia?
  • Does it make sense to say that a person with mild cognitive impairment (MCI) can progress to Alzheimer’s disease?
  • In the term “ADRD,” which stands for Alzheimer’s Disease and Related, does the second “D” stand for “disease,” “disorder,” or “dementia”?

The “Words Matter: Nomenclature in Dementia” event will take place January 18, 2023 at 12 pm ET.

Registration closed.

Supported Decision Making With People at the Margins of Autonomy

Posted on by Beth C

Supported Decision Making With People at the Margins of Autonomy

December 29, 2020

A paper that argues supported decision making is ideal for people with dynamic cognitive and functional impairments when compared to guardianship and similar surrogate decision-making frameworks. The authors propose a three-step model that specifies the necessary conditions of supported decision making and identify a series of challenges for this framework, providing preliminary responses, and highlighting avenues for future bioethics research. Read the full article here.