Reciprocity in Research: Does Justice Support Community Investment?

June 18, 2024 @ 9:30 am 12:00 pm

Virtual Event

Topic: Reciprocity in Research: Does Justice Support Community Investment?

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 expectations, content, and limitations of these obligations are not defined. The next Bioethics Collaborative will be devoted to understanding and assessing different approaches to satisfying the ethical contorts 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

Hybrid: In-person (Boston) and Virtual (Zoom)

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 Further, people who become pregnant while on an interventional trial protocol are typically withdrawn from further participation.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.

Deliverables

Expanded Access to Investigational Medicines

October 24, 2016 @ 11:30 am 4:00 pm

Ropes & Gray, Boston, MA

800 Boylston Street
Boston, Massachusetts 02199 United States

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

Ropes & Gray, Boston, MA

800 Boylston Street
Boston, Massachusetts 02199 United States

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.

Deliverables

Projects

Meeting Summary

Released on: February 27, 2020

Developed by: MRCT Center Bioethics Collaborative

See Meeting Summary

Diversity in Clinical Research

May 15, 2017 @ 11:00 am 4:00 pm

Harvard Faculty Club, Cambridge, MA

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.

Deliverables

Recruitment of and Fair Payment to International Research Participants

October 2, 2017 @ 10:00 am 3:00 pm

Ropes & Gray, Boston, MA

800 Boylston Street
Boston, Massachusetts 02199 United States

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).

Deliverables

Projects

Enabling Informed Selection of Clinical Trials: Institution, Provider and Participant Responsibilities

January 23, 2018 @ 10:00 am 3:00 pm

Ropes & Gray, Boston, MA

800 Boylston Street
Boston, Massachusetts 02199 United States

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.

Deliverables

Projects

Meeting Summary

Released on: January 23, 2018

Developed by: MRCT Center Bioethics Collaborative

See Meeting Summary

Return of Individual Results to Research Participants and Axes of Communication

April 24, 2018 @ 10:00 am 3:00 pm

Ropes & Gray, Boston, MA

800 Boylston Street
Boston, Massachusetts 02199 United States

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.

Deliverables

Projects

Meeting Summary

Released on: April 24, 2018

Developed by: MRCT Center Bioethics Collaborative

See Meeting Summary