Projects

Demonstrating Respect and Acceptable Consent Strategies: What Matters to Patients in PCOR?
PIs: Nancy Kass and Ruth Faden
Building on lessons learned from our PCORI-funded pilot study (Stakeholder Views of Streamlined Informed Consent Options for CER), this studywill measure patients’ views of the acceptability of streamlined disclosure/consent procedures for a low risk randomized CER study under different conditions relating to patient respect, information about the need for more evidence about medical treatments, and the explicit use of the word “choice” when discussing disclosure/consent with patients.

PCORnet Ethics and Regulatory Task Force
Members: Jeremy Sugarman, Kevin Weinfurt, Joseph Ali
The primary goal of the Ethics and Regulatory Task Force is to assist PCORI in addressing the ethical and regulatory issues related to research that arise in its work. The Task Force will also generate solutions to problems that may involve novel approaches within the network to increase efficiency while meeting ethical and regulatory obligations.

Realizing the Goals of Continuous Learning: Insights on Ethics & Implementation from Institutional Leaders in Learning Health Care
Members: Stephanie Morain and Nancy Kass
This project interviewed leaders from health care systems committed to ongoing learning about the ethical issues they have faced in the transition towards adopting a learning health system.  The experiences of these leaders can provide guidance on relevant ethical issues encountered in this transition, and what might be done to resolve them.

Research and Treatment in Comparative Effectiveness, QI and IND Research
Team: Ruth Faden, Nancy Kass, Tom Beauchamp, Sean Tunis, Peter Pronovost, Steven Goodman
There is growing recognition that high value health care will be achievable only if the outcomes of medical interventions and practices are continuously under study. This project is intended to begin to fill the knowledge and policy gap in research ethics created by the increasing integration of research with treatment.

Stakeholder Views of Streamlined Informed Consent Options for CER
PIs: Ruth Faden and Nancy Kass
This project focused on better understanding how patients and other stakeholders feel about different ways of being informed about research projects that compare commonly-used treatments or widely-practiced medical procedures.

The NIH Collaboratory Regulatory/Ethics Core
Co-chairs: Jeremy Sugarman and Kevin Weinfurt
The Regulatory/Ethics Core identifies areas of regulatory and ethical uncertainty arising from pragmatic clinical trials and other research involving collecting data from routine care. The team works with the Demonstration Projects to navigate regulatory and ethical complexities associated with pragmatic clinical trials conducted within health care systems.

Rethinking Informed Consent Requirements for Pragmatic Comparative Effectiveness Trials
Author: Danielle Whicher
The objective of this project was to explore the question of whether there are morally permissible and socially acceptable alternatives to prospective informed consent for low-risk pragmatic comparative effectiveness trials of two or more evidence-based and widely-used medical interventions.