Grand Rounds Ethics and Regulatory Series February 10, 2023: Informing and Consenting: What Are the Goals? (P. Pearl O’Rourke, MD; David S. Wendler, PhD, MA; Miguel Vazquez, MD; P. Michael Ho, MD, PhD)

Posted on by Elizabeth Mccamic

Speakers

Pearl O’Rourke, MD (retired)
Harvard Medical School

David S. Wendler, PhD, MA
Senior Researcher
Head, Section on Research Ethics
Department of Bioethics
NIH Clinical Center

Miguel Vazquez, MD
Professor of Internal Medicine
UT Southwestern Medical Center

Michael Ho, MD, PhD
Professor of Medicine
University of Colorado School of Medicine

 

 

Keywords

Ethics and Regulatory, Consent, Waiver of Consent, Notification

 

Key Points

  • Using informed consent addresses two of the Belmont Principles, respect for persons by informing and autonomy by allowing choice. The regulations recognize that consent is not always possible and allow for alteration, where some of the required elements of informed consent can be altered or not included, and waiver of consent, where no consent is required.
  • It is not uncommon to see waivers of consent in pragmatic clinical trials because many trials meet minimal risk criteria and involve numerous institutions and thousands of subjects. There are also concerns that obtaining consent could alter the “real-world” medical care being studied, may introduce an alteration of routine care, may introduce bias or make research impossible to conduct.
  • Informed consent is not the only way to inform. Think about methods of notification, from detailed study-specific information to a general statement that research is being conducted. There are consequences of notification, such as logistics and cost. If you are notifying, when do you offer an opt-out option and what do you do when potential subjects have questions or do not want to be in the research?
  • ICD-Pieces studied patients with chronic kidney disease (CKD), diabetes and hypertension. The intervention was to facilitate delivery of guideline-based care. The study had a waiver of informed consent. The study used a patient-information sheet to inform patients about the research, how patient data would be handled, and an option to opt-out of including their data in the study.
  • The Nudge Study is a pragmatic clinical trial seeking to improve medication adherence to patients’ already-prescribed cardiovascular medications through a series of theory-based text or voice messages that served as “nudges.” The study mailed patients an opt-out packet that included an introductory letter from the site PI, a FAQ sheet and opt-out form. If they did not opt-out within a month, we would monitor their prescription refills and send a nudge if one went unfilled for more than 7 days.
  • Participants always know some things and agree to some extent. When not getting full regulatory consent, the relevant questions are: What should they know? What should they agree (not object) to?

 

Discussion Themes

– How did the various types of notifications in the ICD-Pieces study impact opt-outs? The patient population and geography across sites was very different. The opt-outs were also very different. It was up to individuals how to deliver or make information about the study available than other sites in the study. It would be difficult for us to say a poster or letter is better.

– Whichever type of notification was used, did you tell people they could opt-out and explain how they could opt-out and give them assurance that opting-out would not impact care? For ICD-Pieces, there was a bullet that stated clearly that patients could opt-out and a phone number to opt-out. There was also a statement that said they would receive the best care from their provider. For NUDGE, there was the initial letter where patients could opt-out by sending a postcard and they could also opt-out in response to the text messages. Opt-outs were different across health systems.

 

Tags

#pctGR, @Collaboratory1