December 12, 2024 @ 9:00 am – 11:30 am
This meeting is open to sponsors of the Bioethics Collaborative. For more information about the Bioethics Collaborative and how to become a sponsor, click here.
Meeting of the Bioethics Collaborative
Tag: Bioethics Meeting
Meeting of the Bioethics Collaborative
September 10, 2024 @ 10:00 am – 12:30 pm
Topic: TBA
This meeting is open to sponsors of the Bioethics Collaborative. For more information about the Bioethics Collaborative and how to become a sponsor, click here.
Reciprocity in research: What do we owe to host communities?
June 14, 2024 @ 12:30 pm – 3:00 pm
Topic: Reciprocity in research: What do we owe to host communities?
Abstract: It is generally agreed that sponsors and other entities undertaking research in limited-resource settings incur certain duties of reciprocity. These obligations ensure that host communities are treated fairly and not exploited, given the burdens and risks of research undertaken by community members. However, the precise content of these obligations is not always clear. The next Bioethics Collaborative will be devoted to understanding and assessing different approaches to satisfying the demands of reciprocity for research undertaken in these settings.
This meeting is open to sponsors of the Bioethics Collaborative.
For more information about the Bioethics Collaborative and how to become a sponsor, click here.
Advancing Inclusion: Integrating Pregnant and Lactating People in Research
March 8, 2024 @ 11:00 am – 2:00 pm
Abstract:
There is widespread recognition, including among pregnant and lactating people, of the need for better evidence on which to base medical treatment decisions during pregnancy and the post-partum period. Despite this, pregnant and lactating people continue to be left out of clinical trials that test drugs, vaccines, devices, and other medical products for safety and efficacy. Study eligibility criteria routinely exclude both pregnant and lactating individuals, even though the biological bases for exclusion of the two populations differ; the effects of exposure of medicinal products to the fetus at the varying stages of development differ from the effects on the neonate or newborn of medicinal products possibly transferred through breast milk Eligibility often requires negative pregnancy tests prior to enrollment and effective methods of contraception for the duration of the study. Further, people who become pregnant while on an interventional trial protocol are typically withdrawn from further participation. Explanations for this are likely to involve perceived ethical, regulatory, and/or legal considerations, reflecting primarily a concern to avoid harming the developing fetus. In the United States, the regulatory framework requires special protections that must be met before pregnant people may participate in clinical research, including limits on the risks they may be asked to undertake. And there are no federal regulations on the exclusion of or additional safeguards for lactating people, despite their common exclusion. In addition, concerns about potential liability and negative public perception are likely to loom large for sponsors, funders, and investigators, motivating them toward the perceived safer strategy of excluding pregnant people from research in many situations.
At the next Bioethics Collaborative, we will examine ethical issues that bear on determining the proper scope of efforts to further the inclusion of people who are pregnant or lactating in clinical research. Discussion will seek to build on prior workshops and recommendations asking such questions as: Is the current default of excluding pregnant and lactating people from interventional clinical trials justifiable? Do pregnant people have the right to autonomously choose what level of risk is acceptable for themselves and the fetus they carry? How do clinical research entities circumscribe a reasonable range of, and limits on, risk for pregnant people in research, and does this definition align with the views of pregnant and lactating people? Are there alternatives to including pregnant people in clinical trials that can yield the data needed to improve the care of pregnant and lactating people and avoid the well-known problems that arise with seeking to protect groups by excluding them? What are the justice-based implications of placing restrictions on pregnancy? Might requirements for effective contraception, for example, inadvertently function to discourage or even preclude participation from people who are unable to afford contraception? Could these requirements, which are likely to be perceived as burdensome by some, hinder the participation of people of childbearing potential generally and further exacerbate gender inequities in clinical research? We will seek to examine these questions and others on March 8.
Bioethics Collaborative events are open to sponsors. For more information about the Bioethics Collaborative and how to become a sponsor, click here.
Expanded Access to Investigational Medicines
October 24, 2016 @ 11:30 am – 4:00 pm
The administration of an investigational product via Expanded Access is not meant to answer questions about the product’s safety and effectiveness; rather, it is intended to treat an individual patient with a serious or immediately life-threatening disease or condition for which no satisfactory alternative therapy exists. In the absence of robust guidance for assessing requests for expanded access, physicians and sponsors are left without a critical understanding of the legal, ethical, and financial considerations that ought to influence expanded access determinations.
Deliverables
Projects
Early Termination of Clinical Trials
January 31, 2017 @ 11:00 am – 4:00 pm
Clinical trials are closed prematurely for a variety of reasons, including for scientifically-driven reasons of efficacy, safety, and futility wherein there is no justification for continuing to enroll participants. The majority of clinical trials, however, terminate early as a result of operational issues—such as inadequate recruitment, commercial product viability, insufficient funding or resources, or de-prioritization by an investigator, institution, or sponsor. The decision to terminate a trial raises complex ethical questions regarding the appropriate communication with and responsibilities owed to participants.
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Meeting Summary
Released on: February 27, 2020
Developed by: MRCT Center Bioethics Collaborative
See Meeting Summary
Publications
Diversity in Clinical Research
May 15, 2017 @ 11:00 am – 4:00 pm
Efficacy and safety of medicines can vary depending on a number of intrinsic and extrinsic factors, such as an individual’s genetic background, ethnicity, lifestyle, and age. In appreciation of these differences and in the interest of generating generalizable knowledge—the participant population enrolled in a clinical trial ought to be representative of the general population. Despite this normative ideal, underrepresentation of gender, sex, ethnic, and racial minorities in clinical trials persists.
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Publications
Recruitment of and Fair Payment to International Research Participants
October 2, 2017 @ 10:00 am – 3:00 pm
Presently, there is no operational framework to guides investigators in designing, and IRBs in evaluating, recruitment methodologies and payment proposals to international research participants. This lack of guidance has been a cause for concern amongst regulators, trialists, advocacy groups, and research participants –especially when conducting clinical trials in low-and middle-income countries (LMICs).
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Projects
Publications
July 2021: Fair payment and just benefits to enhance diversity in clinical research
November 2020: On Measuring Attitudes About Payment for Research
February 2020: Economic Vulnerability and Payment for Research Participation
October 2019: Ethics of Payment in Clinical Research
August 2019: Relocation of Study Participants for Rare and Ultra-Rare Disease Trials: Ethics and Operations
April 2018: Truth in Advertising: Disclosure of Participant Payment in Research Recruitment Materials
February 2018: A Framework for Ethical Payment to Research Participants
Enabling Informed Selection of Clinical Trials: Institution, Provider and Participant Responsibilities
January 23, 2018 @ 10:00 am – 3:00 pm
This meeting of the MRCT Center Bioethics Collaborative will explore the ethical considerations underscoring the challenge of informed selection of clinical trials. We will examine the responsibilities of various stakeholders within the clinical trial ecosystem, and we will discuss potential solutions.
The current landscape of clinical trial identification, referral, selection, and enrollment depends largely upon access to clinical trial information by a multiplicity of stakeholders. Unfortunately, access to this information is fragmented. Treating physicians do not routinely discuss clinical trials with their patients; investigators recommend enrollment in the clinical trials in which they or their institution are involved, but often not others; institutional IRBs evaluate the potential benefit/risk calculus for a given trial without consideration of the entire landscape of competitive trials; institutions do not consistently provide patients with instructions or guidance on navigating patient advocacy and trial registry websites, nor do they refer patients to external resources (e.g., patient advocacy groups and disease advocacy organizations) to help navigate the choice among alternative trials; existing clinical trial databases are often incomplete and complex, and they do not convey information in ways that help patients and providers choose among available trials. As a result, patients’ knowledge of their clinical trial options is often incomplete, and enrollment decisions are based on limited information.
Patients can, and often want to, be empowered with clinical trial information that is understandable and accessible. But institutional walls appear to have created artificial boundaries around the choice of clinical trials. We have not equipped patients to compare the suitability of the clinical trial(s) offered by their physicians with those offered down the block or across the river, concordant with their own preferences. As availability of electronic information increases (and with the appreciation that more information is not necessarily better information), our current systems may be improved to better uphold the foundational ethical principles of clinical research. These principles—respect for persons, beneficence, and justice—and their application to how we offer, and how patients select, clinical trials deserve review.
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Meeting Summary
Return of Individual Results to Research Participants and Axes of Communication
April 24, 2018 @ 10:00 am – 3:00 pm
The MRCT Center Return of Individual Results Work Group has formulated key principles and recommendations on the return of individual results to research participants from clinical trials in which the participants were enrolled (see above). A number of unanswered questions, however, related to return of individual results to research participants persist. For example, who should communicate urgent results and urgent incidental findings to individual research participants? The lead or site investigators? The referring health care provider? The study sponsors? This meeting explored the pragmatic considerations underlying the return of individual results to research participants and axes of communication.
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Projects
Meeting Summary