Medical Need or Market Opportunity: Setting Research Priorities 

March 10, 2025 @ 10:00 am 1:00 pm

Location: Virtual

Topic: Medical Need or Market Opportunity: Setting Research Priorities

Abstract: Since funding and other resources for clinical research are limited, decisions must be made about which research projects to pursue, which not to pursue, and how to prioritize among the studies that are chosen. The principle of “unmet medical need” is often acknowledged as a guiding consideration in this context, and there have been calls for community input into prioritization and the choice of the study question. Further, addressing unmet medical needs, particularly in the context of the global burden of disease, is important for public health but may not, and likely will not, maximize market opportunity or financial profits – a dynamic that is particularly salient for private industry sponsors. Should prioritization then rest solely or principally with the funder? How should such entities balance economic obligations toward shareholders with the public good?

One salient principle of distributive justice is “prioritarianism,” the idea that research that stands to benefit the worse-off or those who are already underprivileged should be given priority over research that stands to benefit people in better situations: the well-being of the most disadvantaged is prioritized. Even prior to this, however, questions arise over how to understand the expected goods of research, who the beneficiaries might be, and how the well-being of different possible beneficiary groups should be measured. Further downstream, issues arise over who should engage in prioritization decisions, and in particular, whether the research community should rely solely on high-level, centralized prioritization mechanisms (e.g., industry sponsors, NIH, non-profit funders), or whether individual institutions, local communities, and/or patients and their allies might have some role to play in ensuring that studies are appropriately prioritized at a local level. How should these various voices be heard, should they be represented, and how can—or should—balance be achieved, and if so, what processes should be considered? The March Bioethics Collaborative will seek to address these and other issues in connection with the ethics of research priority-setting.  


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.

Is It Time to Retire the Concept of Deidentification?

December 12, 2024 @ 9:00 am 11:30 am

Virtual Event

In the US, research with data only qualifies as human subjects research and triggers protections, such as ethics board review and informed consent, when those data are identifiable, defined as “information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information” (45 CFR 46.102(e)(5)). The process of deidentification of data involves removing explicit identifiers such that the data cannot be readily linked to an individual; deidentified data is no longer considered protected health information subject to the protections of the Privacy Rule, implemented in response to the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”). Deidentified data, therefore, can be used without consent, without review by an IRB or ethics committee, and without oversight by a Privacy Board.

In the approximately 30 years since the passage of HIPAA and even in the 5 years since the issuance of the Common Rule, technology has advanced. The concept of deidentification may no longer be relevant. Numerous studies have demonstrated that it is relatively easy to re-identify individuals from seemingly deidentified data sets, particularly when these data are triangulated with publicly available data sources. The increasing use and sophistication of Artificial Intelligence (AI) further exacerbates this situation, raising questions about whether any types of data are beyond re-identification or fail to meet the regulatory definition of “identifiable.” Other countries (e.g., EU/EEA, China, India, and others) and even US States (e.g., California) have adopted this position and, unlike the US, have substantiated data protections and personal rights to privacy through the law.

Eliminating the concept of deidentification[1] (a concept that the HHS Office of Human Research Protections promises to review periodically) would have profound effects on clinical research, including impact on IT infrastructure, data repositories, secondary use of data, consent paradigms, and scientific discovery. But given the current ease of reidentification, might it be time to retire the concept of deidentification in the service of privacy, autonomy, and respect for persons?


[1] The HHS Office of Human Research Protections promises to review the concept of identifiability periodically, although that has not yet occurred in the five years since the effective date of the 2019 Final Common Rule. If OHRP changes its definition, FDA is likely to reconsider its interpretation of identifiability. 


 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.

Impact of Dobbs on Reproductive Health: Unintended Consequences for/on Research 

September 10, 2024 @ 10:00 am 12:30 pm

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

800 Boylston St.
Boston, MA 02199

Topic: Impact of Dobbs on Reproductive Health: Unintended Consequences for/on Research 

In 2022, the United States Supreme Court ruled, in Dobbs vs. Jackson Women’s Health Organization, against a federal right to abortion. The effects of this ruling continue to reverberate across the research ecosystem. Clinical trials often involve the administration of investigational therapies that pose reproductive risks. Because of this, participants are routinely asked to undertake measures that could pose privacy risks to them in states where elective termination of pregnancy is illegal. These measures include documentation of the results of pregnancy tests and reporting of incidental pregnancies and their outcome, among others. These risks may also extend to site staff in states where providers are prohibited from advising or facilitating elective termination of pregnancy. In addition, research on various aspects of pregnancy is itself at risk of being stifled for similar reasons. What should the research community’s response be to this situation? Is there an obligation to educate participants about these risks as part of the informed consent process? Who should bear this responsibility? What mechanisms are available to help shield participants and other stakeholders from undue risk while permitting the collection of important pregnancy data? To what extent, if any, do Certificates of Confidentiality provide sufficient legal protections? Will this ruling impact innovation in reproductive health research in the US more generally? At the next Bioethics Collaborative, we will focus on these and other questions related to the ongoing effects of the Dobbs rulingon clinical research. 

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: 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.

Click here to view the Meeting Summary.


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)

800 Boylston St.
Boston, MA 02199

Click here to view the Meeting Summary.

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