bioethics

December 3, 2024: Sharing Results With Research Participants Raises Special Considerations in Pragmatic Trials

Posted on by Damon Seils

Cover image of the journal Clinical TrialsIn a new report from the NIH Pragmatic Trials Collaboratory, a team of bioethicists explores the ethical obligation to share aggregate results from pragmatic clinical trials with research participants. They conclude with recommendations for how to meet this obligation.

The article was published online ahead of print in Clinical Trials.

There is growing appreciation of the importance of sharing aggregate results of clinical trials with research participants. However, this practice has not been examined in the context of pragmatic clinical trials, which have special features that may complicate the ethics and logistics of sharing aggregate results.

The report’s authors summarize the ethical arguments for sharing aggregate results and describe the features of pragmatic trials that may raise logistical and other barriers to disclosure. They also discuss the important role healthcare system partners play in sharing results from pragmatic trials.

The authors offer the following recommendations:

  • Sharing aggregate results with research participants should be the default, and decisions not to share should be justified
  • Planning for sharing aggregate results should begin early in the planning of the trial
  • The healthcare care systems in which the trial is embedded should be key partners in decisions about what and how to share
  • Proactive sharing of results from a pragmatic trial that was conducted under a waiver or alteration of consent, including an explanation for why consent was not obtained in the study, can promote trust in the investigators and their healthcare system partners

Read the full report.

The article was coauthored by members of the NIH Pragmatic Trials Collaboratory’s Ethics and Regulatory Core, including Stephanie Morain, Abigail Brickler, Joseph Ali, Caleigh Propes, and Kayla Mehl of Johns Hopkins University; Pearl O’Rourke, formerly of Partners HealthCare; Kayte Spector-Bagdady of the University of Michigan; Benjamin Wilfond of the Seattle Children’s Hospital; Vasiliki Rahimzadeh of the Baylor College of Medicine; and David Wendler of the NIH Clinical Center.

Advancing Justice and Equity in Pragmatic Clinical Trials

Headshot of Joe AliVA HSR&D Cyberseminars: Spotlight on Pain Management
“Advancing Justice and Equity in Pragmatic Clinical Trials”
Joe Ali, PhD
Johns Hopkins University

Advance registration required.

“Pragmatic clinical trials (PCTs) can help bring evidence‐based therapies to people living with pain and co‐occurring conditions, with an emphasis on developing insights that are relevant to patients, practitioners and others. However, in order to reach their potential within a diverse society, pain PCTs must thoughtfully consider how patient vulnerabilities and experiences of injustice and inequity might affect trial design and implementation. Drawing from the experiences and insights of the NIH‐DOD‐VA Pain Management Collaboratory, this seminar will situate the concepts of justice and equity within a pain PCT context, identifying challenges and offering strategies to potentially enhance the value of such trials for various key populations.”

Joe Ali is an associate professor in the Johns Hopkins Bloomberg School of Public Health and the associate director for global programs at the Johns Hopkins Berman Institute of Bioethics. He is a member of the NIH Pragmatic Trials Collaboratory’s Ethics and Regulatory Core.

December 20, 2021: NIH Supplemental Funding Available for Bioethics Capacity Building

Posted on by Damon Seils

NIH logoThe NIH announced the availability of an administrative supplement to fund research on ethical considerations related to biomedical research and projects that support capacity building in bioethics.

Over the past 3 years, the NIH Office of the Director has partnered with NIH Institutes and Centers to support projects spanning the wide range of intersections between bioethics and biomedical research. The new funding opportunity applies to both basic and clinical research and supports a variety of research projects, from ethical considerations in emerging technologies to developing capacity to further engage research participants as partners in research. Applications will be accepted until March 17, 2022.

View the official notice.

July 3, 2019: New Article Describes the Public’s Beliefs Regarding Responsibility to Participate in Research

Posted on by Karen Staman

Findings from a new article suggest that the majority of patients do not feel a personal responsibility to participate in clinical research. In the article, Kevin Weinfurt, Li Lin, and Jeremy Sugarman report the results of a national survey of nearly 3000 people regarding their attitudes towards research responsibilities as well as their trust in doctors, healthcare systems, and medical research. Ethical frameworks for learning health systems have suggested that patients have a responsibility to contribute to learning activities, including research. The findings from this survey suggest that most patients in the U.S. do not currently endorse such a responsibility.

“These data provide a useful snapshot of the public’s views toward the obligation to participate in research. It is unclear how, if at all, these views will shift with increased efforts to create mature learning health systems. And if such views do not shift, it is uncertain what that would mean for the success of learning health systems.” —Kevin Weinfurt, PhD

Read the full article: Public Views Regarding the Responsibility of Patients, Clinicians, and Institutions to Participate in Research in the U.S.

For more on alternate approaches to consent, see the Living Textbook Chapter on Consent, Disclosure, and Non-Disclosure

March 15, 2018: New Resource for Understanding Ethical and Regulatory Architecture of Patient-Centered Outcomes Research Data

Posted on by Karen Staman

Using patient-centered outcomes research (PCOR) data requires balancing the need for sufficient private health information to support meaningful research with the need to protect patient privacy and autonomy. In support of this dual goal, The Office of the National Coordinator for Health Information Technology (ONC) has just released a document that provides a collection of tools and resources aimed at helping a broad audience of stakeholders understand the ethical and regulatory requirements related to collecting, using, sharing, and disclosing PCOR data.

“An architecture is necessary to ensure patient privacy is protected and health information is appropriately secured during collection, access, use, and disclosure as required by law, regulation, and/or policy.” —Legal and Ethical Architecture for PCOR Data

PCOR data will help expand the evidence base for therapies and improve health outcomes for individual patients.

Read the full document: Legal and Ethical Architecture for Patient-Centered Outcomes Research (PCOR) Data (“Architecture”)

The document is divided into 5 chapters:

Chapter 1: Overview of Legal and Ethical Architecture for PCOR Data provides background for the project and an overview of key ethical and regulatory requirements.

Chapter 2: Legal and Ethical Significance of Data for PCOR describes fundamental concepts for organizing data into categories such that legal and ethical frameworks can be applied. The chapter includes key considerations and types of data relevant to PCOR, such as clinical, administrative, patient-generated, etc.

Chapter 3: Linking Legal and Ethical Requirements to PCOR Data organizes the relevant legal provisions according to the key data considerations outlined in Chapter 2: identifiability, subject, source, access and use/purpose, consent/authorization, security, and legal status.

Chapter 4: Framework for Navigating Legal and Ethical Requirements for PCOR is designed as a decision tool that builds on the key data considerations described in Chapters 2 and 3. The goal of this chapter is to help researchers determine whether laws apply to particular data and if so, what requirements to attach to their collection and use.

Chapter 5: Mapping Research Flows to Legal Requirements identifies 6 hypothetical use cases, identifies decision trigger points, and maps representative data flows to the relevant legal requirements.