Speakers
Stephanie Morain, PhD, MPH
Assistant Professor
Berman Institute of Bioethics & Johns Hopkins Bloomberg School of Public Health
Kayte Spector-Bagdady, JD, MBioethics
Associate Director, Center for Bioethics & Social Sciences in Medicine
Assistant Professor of Obstetrics & Gynecology
University of Michigan Medical School
Keywords
Ethics, Data Sharing, Pragmatic Clinical Trials
Key Points
- As one of the federal departments and agencies with the largest research and development budget, the NIH came out with one of the first federal data sharing policies in 2003 called the NIH Data Sharing Policy and Implementation Guidance.
- The guidance has been updated over the years, and in 2020 NIH came out with the final iteration that goes into effect in January 2023 that applies to any research funded in whole or in part by NIH to maximize data sharing through the informed consent process. Additionally, in August 2022, the latest federal data-sharing memorandum, Ensuring Free, Immediate, and Equitable Access to Federally Funded Research Memorandum (2022 OSTP Memo), was released requiring articles resulting from federal funding be made “freely available and publicly accessible” without embargo or delay.
- When you apply these rules to pragmatic clinical trials (PCTs), there are ethical challenges because PCTs often use waivers or alterations of informed consent and are embedded into ongoing clinical care using extant data.
- Traditionally data sharing is presented as honoring the preferences of trial participants with a heavy emphasis on the role of informed consent to fulfill the ethical obligation to respect those whose data are shared. But if PCTs use a waiver/alteration of consent, the trial cannot assume sharing data is consistent with preferences of patient-subjects and cannot rely on informed consent to fulfill the ethical obligation of respect.
- For PCTs, data volume is potentially larger, data may be “about” those beyond patient-subjects (i.e. clinicians, health systems), data may have been collective for administrative/clinical purposes, data may be more representative of “real world” conditions, and data may be controlled by a third party (e.g. CMS).
- For investigators and health systems, there are substantial risks and burdens of data sharing with unclear benefits. There are substantial logistical burdens in preparing data for sharing, meaningful risks of reidentification, and concern for biased or misleading analyses, with little demonstrated demand for PCT data and relatively low social value from PCT data reuse.
- Two takeaways: 1. Look beyond informed consent processes to fulfill obligations of respect when sharing individual level data from PCTs. 2. If public demand for greater data sharing is to be driven by awareness of its benefits, then PCTs need to do a better job measuring and communicating about the benefits.
Discussion Themes
-Can you better define data sharing, is it the publication? Data sharing has been in the context of the patient-level deidentified data from these studies. The government has made an interesting transition to focusing on sharing data that are generated in research for secondary analyses but then shifted to wanting access to data from the primary analysis.
–How can we include diverse communities in this discussion especially in terms of trust? The context of PCT data sharing support arguments made elsewhere for engaging individuals who are going to be enrolled in these studies. We need to look beyond informed consent when we look at ways we respect individuals and make sure we have an understanding of their values and preferences for the study itself and how data is shared downstream. There could be broader engagement of stakeholders in these communities, better transparency, and creative ways to demonstrate respect outside of informed consent.
Tags
#pctGR, @Collaboratory1