ethics

January 20, 2021: New Article Explores Ethical Obligation to Monitor Signals of Behavioral and Mental Health Risk in Pragmatic Trials

Posted on by Karen Staman

In a new Contemporary Clinical Trialslsarticle, members of the Ethics and Regulatory Core of the NIH Pragmatic Trials Collaboratory explore the ethical obligation of investigators to address signals of behavioral and mental health risk in pragmatic clinical trials.

The article was published online ahead of print in Contemporary Clinical Trials and will appear in a forthcoming special issue on pragmatic and virtual trials.

Some pragmatic trials collect sensitive data that could signal distress, such as suicidal ideation, opioid use disorder, or depression. Investigators have an ethical obligation to monitor these signals and identify in advance if, when, and how such signals will trigger a response. Using examples from the NIH Collaboratory Trials, the authors offered preliminary recommendations and identified opportunities for future work.

The NIH Collaboratory Trials discussed in the article are supported by the PRISM program—Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing. The projects are studying the real-world effectiveness of nonpharmacologic interventions to improve pain management and reduce reliance on opioids.

Read the full article.

The PRISM program is a part of the Helping to End Addiction Long-Term Initiative℠, or NIH HEAL Initiative℠. The NIH Pragmatic Trials Collaboratory Coordinating Center serves as the PRISM Resource Coordinating Center.

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.

November 29, 2021: New Article From the NIH Collaboratory Examines Use of Incentives and Payments in Pragmatic Clinical Trials

Posted on by Damon Seils
Head shot of Dr. Andrew Garland
Dr. Andrew Garland

Members of the NIH Collaboratory’s Ethics and Regulatory Core examined the use of incentives and payments to patients included in pragmatic clinical trials. Their findings and preliminary recommendations are published in the December issue of Clinical Trials.

Incentives and payments to patients are used in both pragmatic trials and conventional explanatory trials. However, because pragmatic trials typically evaluate interventions in the context of “real-world” clinical settings, the use of incentives and payments can raise logistical, ethical, and regulatory challenges.

Dr. Andrew Garland, a postdoctoral fellow at the Johns Hopkins Berman Institute of Bioethics who works in the Ethics and Regulatory Core, and who is the lead author of the article, reviewed 9 NIH Collaboratory Trials that used incentives and other payments to patients. Garland and coauthors Dr. Kevin Weinfurt and Dr. Jeremy Sugarman used these examples to describe how the standard conceptual framework for ethical payments and incentives may not always be appropriate for pragmatic trials.

Read the full report.

This work was supported within the NIH Collaboratory by the NIH Common Fund through a cooperative agreement from the Office of Strategic Coordination within the Office of the NIH Director. This work was also supported by the NIH through the NIH HEAL Initiative.

October 26,2021: New Article Examines Justice and Equity in Pragmatic Clinical Trials

Posted on by Karen Staman

Learning Health Systems

In a new article published recently in Learning Health Systems, colleagues from the Pain Management Collaboratory examined challenges related to justice and equity in pragmatic clinical trials (PCTs) on pain management.

Based on our experience with PCTs in health systems that serve military and veteran populations,  we suggest it is particularly important to recognize that: (a) some individuals with chronic pain are vulnerable to injustice, (b) structural and sociocultural challenges that exist within health systems can complicate chronic pain research, and (c) PCTs involving NPTs [nonpharmalogical treatments] provide one lens through which injustices may be identified and addressed with the proactive input of a broad range of stakeholders.

Broadly engaging diverse stakeholders throughout the lifecycle of a PCT will take creativity, and the authors suggest specific strategies to enhance justice and equity for different phases of a PCT, including conduct and design, recruitment, selection and implementation of interventions, and stakeholder engagement .

Within learning health systems, principles of continuous learning and feedback to improve care can potentially be put to use not only to secure value in healthcare, but also to support evidence development to guide equitable practice.

Read the full article.

October 18, 2021: Application Period Opens for Postdoctoral Fellowship in Ethics and Regulatory Aspects of PCTs

Posted on by Damon Seils

Johns Hopkins Berman Institute of Bioethics logoThe Johns Hopkins Berman Institute of Bioethics this week opened the application period for its 2022-2023 postdoctoral fellowships, including a Postdoctoral Fellowship in the Ethics and Regulatory Aspects of Pragmatic Clinical Trials.

From the announcement:

The Johns Hopkins Berman Institute of Bioethics invites applications for a Postdoctoral Fellowship in the Ethics and Regulatory Aspects of Pragmatic Clinical Trials. This position includes pursuing independent research, working alongside faculty members involved with the ethics and regulatory aspects of large-scale pragmatic clinical trials and participating in the Hecht-Levi Postdoctoral Fellowship in Bioethics.

The postdoctoral fellow is expected to pursue one or more projects addressing the ethics and regulatory aspects of pragmatic clinical trials in collaboration with Berman Institute faculty members. The Fellow will actively engage with the Ethics and Regulatory Cores of the NIH Health Care Systems Research Collaboratory and the Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing (PRISM) Resource Coordinating Center.

As a member of the Hecht-Levi cohort of Bioethics Postdoctoral Fellows at the Berman Institute, the Fellow will have access to Berman Institute faculty and resources, including weekly seminars, presentations, discussions with leading academics and policy makers, professional development training, outreach efforts, and teaching opportunities commensurate with experience and background.

Read the full information about the fellowship. Applications are due by Friday, December 19, 2021.

September 21, 2020: IMPACT Collaboratory Opens Application for 2022 Training Workshop

Posted on by Damon Seils

Logo for the NIA IMPACT CollaboratoryThe IMPACT Collaboratory is inviting applications from early- and mid-career researchers for its second annual training workshop, “Building Skills to Conduct Embedded Pragmatic Clinical Trials (ePCTs) Among People Living With Dementia (PLWD) and Their Care Partners.” A limited number of participants will be accepted to attend the event on January 26 and 27, 2022.

This virtual 1.5-day workshop will provide a foundation in practical aspects of designing and conducting ePCTs in Alzheimer disease and related dementias through a combination of panel discussions, small group sessions, and networking opportunities with experts in the field. Workshop modules will focus on integrating health equity into ePCTs, ethical considerations for ePCTs for PLWD and their care partners, and the challenges and opportunities related to conducting ePCTs with care partners of people living with dementia.

Read more about the event and how to apply.

The IMPACT Collaboratory is supported by a grant from the National Institute on Aging. Its mission is to advance care for persons with dementia and their caregivers in real-world settings by building national capacity to conduct pragmatic clinical trials that test interventions embedded in healthcare systems.

August 18, 2021: MOTIFS Explores Patients’ Reactions to Notifications of Collateral Findings

Posted on by Damon Seils

Cover the the Journal of General Internal MedicinePatients’ reactions to a letter notifying them about collateral findings from a pragmatic clinical trial were unrelated to who signed the letter, the type of collateral finding, or the letter’s level of detail about the trial, according to a new study from the NIH Collaboratory.

The article was published online ahead of print in the Journal of General Internal Medicine.

Collateral findings of pragmatic clinical trials are findings, whether discovered intentionally or unintentionally, that do not address the trial’s research question but may have implications for the health of patients in the trial. For example, when collecting data from electronic health records for a pragmatic trial, the researchers might detect the use of contraindicated medications in some patients. It is uncertain how best to notify patients of these findings.

Researchers from the NIH Collaboratory’s Ethics and Regulatory Core Working Group and colleagues from the Johns Hopkins Berman Institute of Bioethics conducted a survey experiment in which participants were randomly assigned to respond to 1 of 16 hypothetical scenarios. In each scenario, the participant read a letter notifying them of a collateral finding from a pragmatic clinical trial and asking them to contact their doctor immediately. The scenarios differed by who signed the letter, the type of collateral finding, and whether the letter included a detailed description of the pragmatic trial.

Participants’ reactions to the letter and their intention to contact their doctor immediately were not affected significantly by who signed the letter or whether the pragmatic trial was described in the letter. Participants’ reported level of understanding was generally lower for versions of the letter that included a description of the trial.

Read the full report.

This work was supported within the National Institutes of Health (NIH) Health Care Systems Research Collaboratory by the NIH Common Fund through a cooperative agreement from the Office of Strategic Coordination within the Office of the NIH Director. Supplemental funding for this work was provided by the National Center for Complementary and Integrative Health. The aim of the supplement, Management of Trial Incidental Findings Study (MOTIFS), is to develop an empirically informed, ethically sound approach to managing incidental findings in pragmatic clinical trials.

July 14, 2021: New Resource from the Ethics and Regulatory Core

Posted on by Gina Uhlenbrauck

The Collaboratory’s Ethics and Regulatory Core has recently explored issues around data monitoring in pragmatic clinical trials (PCTs). Important considerations for data monitoring in this context are related to the design, intent, and operational features specific to PCTs. Data Monitoring in Pragmatic Clinical Trials: Points to Consider suggests a set of key areas to evaluate:

  • Composition of Data Monitoring Committees
  • Use of health systems records data
  • Study design and statistical analysis
  • Monitoring adherence
  • Futility
  • Safety
  • Efficacy

“Finding ways to describe and disseminate experiences with PCT DMCs should be encouraged in an effort to improve practices and policies.” (Ethics and Regulatory Core)

April 22, 2021: Materials From the NIH Collaboratory Steering Committee’s Virtual Meeting Now Available

Posted on by Gina Uhlenbrauck

On April 14 and 15, 2021, more than 100 participants joined the online Steering Committee meeting to discuss important considerations for Collaboratory trials and the embedded pragmatic clinical trial ecosystem at large, including adaptations made due to COVID-19, data sharing models and experiences, barriers encountered, and lessons learned. All presentations are available for download.

April 1, 2021: Grand Rounds Podcast with Dr. Susan Ellenberg on DSMBs for COVID-19 Trials is Available

Posted on by Gina Uhlenbrauck

Prof. Susan EllenbergIn the latest episode of the NIH Collaboratory Grand Rounds podcast, Dr. Adrian Hernandez and Dr. Susan Ellenberg continue their discussion about the challenges of DSMBs and COVID-19 trials. The full March 5 Grand Rounds webinar with Dr. Ellenberg is also available.