The MRCT Center, in collaboration with CDISC, is thrilled to present the newly expanded and re-designed Clinical Research Glossary. With the dedicated efforts of numerous volunteers, the original content has been updated, and more than a hundred new terms have been added. Highlights include specialized information to help support participants, and tailored, shareable images to foster engagement and understanding. Please join us on April 2nd at noon EST to learn more about what’s changed and explore all the ways in which this Clinical Research Glossary meets the needs of participants and the clinical research industry.
Introducing Research Ethics Action Collaborative for HRPPs (REACH), an initiative spearheaded by the MRCT Center, AAHRPP, PRIM&R, and Mass General Brigham. This effort aims to curate, align, and disseminate tools to advance access to and inclusion in research—for all potential participants–tailored for Institutional Review Boards (IRBs), Human Research Protection Programs (HRPPs), and the broader community.
We invite you to join an engaging webinar scheduled for Thursday, March 7 from 12 – 1:00 PM ET. This interactive session will explain the motivation behind this effort and explore actionable strategies to operationalize inclusion efforts in HRPPs.
The key discussion points include:
Making the Case for Leadership: Understand the significance of integrating inclusion and accessibility within HRPPs and explore effective ways to articulate a compelling case that resonates with stakeholders and leadership.
Establishing a Roadmap for Change: Delve into the process of creating a roadmap for change, navigating institutional processes, and garnering leadership buy-in to ensure a sustainable and impactful implementation of inclusion in HRPPs.
Presenting Resources: Explore resources available to IRBs, HRPPs, and institutions currently freely available, and provide a means for attendees to identify additional tools needed for this work.
Soliciting Examples: Hear from participants about successful practices and strategies implemented within their respective institutions, fostering a dynamic exchange of insights and best practices.
Join us in this collective endeavor to actively strategize and operationalize efforts within IRBs and HRPPs.
December 13, 2023
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8:00 am
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December 14, 2023
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12:00 pm
Ropes & Gray, Boston, MA
800 Boylston Street Boston,
Massachusetts
02199United States
Wednesday, December 13
Note: the location for meetings on Thursday, December 14 is different: Loeb House at Harvard University, 17 Quincy Street, Cambridge, MA 02138
Please join us December 13 – 14 in Boston for our 2023 Annual Meeting. The enhanced two-day program features a keynote address from Peter Arlett, Head of Data Analytics and Methods at the European Medicines Agency (EMA), several panel presentations, and Research & Regulatory Roundtable (R3) and Bioethics Collaborative (BC) sessions, all open to registrants at no cost.
While in-person attendance is encouraged, virtual participation is welcome.
Research that is executed in part or in whole through remote modalities, such as telemedicine and health care providers who visit participant homes, is increasingly commonplace yet complicated. Decentralized research raises novel questions regarding whether and which institutions are engaged in research under the Common Rule and who is a subinvestigator according to United States Food and Drug Administration (FDA) regulations. Mark Barnes, MRCT Center Faculty Director, overviewed the concept of engagement in research subject to the Common Rule and proposed a model to redefine the concept of engagement. David Peloquin, MRCT Center Senior Advisor, overviewed the investigator and subinvestigator designations in research subject to FDA regulations.
The European Union (“EU”) General Data Protection Regulation (“GDPR”) and its effect on research activities was the first topic addressed by the R3 at its initial meetings in 2018. In the four years since those meetings, there have been many developments that have continued to cause complications for trans-Atlantic research. These have included, among others, the invalidation of the EU-U.S. Privacy Shield in June 2020 by the Schrems II decision, Brexit, the release in 2021 of new Standard Contractual Clauses by the European Commission, and the introduction of data transfer impact assessments as a prerequisite for many cross-border transfers of personal data.
On March 25, 2022, the European Commission and the United States announced that they have agreed in principle on a new Trans-Atlantic Data Privacy Framework, intended to foster trans-Atlantic data flows and address the concerns raised by the Court of Justice of the European Union in the Schrems II decision. The discussion at the convened R3 considered these recent developments and identified potential solutions to ease trans-Atlantic research while complying with GDPR.
The core activities of clinical trials are typically conducted at physical locations referred to as “sites.” Traditionally, these sites are hospitals or academic medical centers. While these traditional sites remain important fixtures in the clinical trial landscape, new models including “decentralized” or even “site-less” clinical trials have emerged. David Peloquin, MRCT Center Senior Advisor and Partner at Ropes & Gray LLP, provided an overview of the clinical trial site landscape and how it has changed over time, with a particular focus on the emergence of stand-alone sites, as such sites present unique regulatory issues. He then provided several examples of these stand-alone sites and presented a handful of recent regulatory enforcement cases before moving into a discussion of the relevant legal risks and considerations.
Human challenge studies are a type of research study in which participants are intentionally exposed to a pathogen. These study designs have a long and complicated history, figuring in notorious cases of research abuse (Willowbrook, Guatemala STI experiments) but also as important components in treatment advances for conditions that tend to disproportionately impact the world’s worst-off, such as dengue and malaria. The potential for human challenge studies to be leveraged ethically in relation to Sars-CoV-2 has been a matter of recent and significant debate in the bioethics community.
Governments, companies, academic research institutions, and the public are increasingly aware of the value of data, prompting a reevaluation of who “owns,” controls, and benefits from the use of an individual’s data. Discussion at the Bioethics Collaborative focused on models of data ownership and stewardship in research. The meeting scope included data collected during clinical research and health data from the medical record that are used for research.
The roles of sex, gender, and sexual orientation in clinical research are important but underexplored. Discussion at the Bioethics Collaborative focused on two types of ethical issues related to sex, gender, and sexual orientation in clinical research. First, while sexual orientation and gender identity (SOGI) are social constructs, disease risk, manifestation, and/or response to treatment may vary by SOGI characteristics.
It is important to understand that any variation in disease risk, manifestation, or response, if it exists, is likely related to other underlying differences (e.g., hormonal status). Nevertheless, collecting and analyzing data on sex, gender, and sexual orientation may point to differences that need to be understood biologically to provide safe and effective interventions across diverse populations. Second, research should be respectful and inclusive of individuals of diverse sexes, genders, and sexual orientations. The principles of respect for persons and justice must be considered in addition to that of biologic relevance.
In November 2017, the MRCT Center published the Post-Trial Responsibilities: Continued Access to Investigational Medicines Guidance Document and Toolkit. This framework outlined a case-based, principled, stakeholder approach to evaluate and guide the ethical responsibilities related to providing continued access to an investigational medicine at the conclusion of a patient’s participation in a clinical trial.
Over the past 5 years, sponsors and investigators have utilized the MRCT Center guidance to create their own internal PTR policies. While the ethical principles and main consensus points remain valid, the application of the ethical principles and implementation of consensus points continue to challenge clinical research stakeholders and study participants. It is therefore timely to revisit and update the framework. This meeting served as a launch for revisiting the MRCT Center’s 2017 Guidance Document. Starting in January 2023, the Center will be convening a monthly task force to (1) define the current issues associated with continued access to investigational drugs and maintenance of implantable devices after trial completion and (2) identify practical and actionable resources and tools needed by stakeholders.
