E-Newsletter - February 2022
Spotlight on Alliance Ethics Committee

Navigating Ethical Dilemmas, Guiding Investigators During the Conduct of Oncology Clinical Trials


Fay J. Hlubocky, PhD, MA
University of Chicago Medicine
Co-Chair, Alliance Ethics Committee


Jeffery M. Peppercorn, MD, MPH
Massachusetts General Hospital
Co-Chair, Alliance Ethics Committee

It is common for ethical dilemmas related to clinical research to arise during, and even well after, clinical trials in oncology have closed for accrual and are under data analysis. These ethical challenges may surface when scientific questions and techniques evolve in the course of a study, when the appropriate course of action for the research team is vague or when disagreement or concern among members of the research team arises.  Frequently, questions involve investigators’ uncertainty surrounding the interests of research participants, or potential conflicts between scientific research goals of a study and the protection of research participants. For example, inquiries may be related to the utilization of stored biospecimens when the initial consent form is inadequate by modern standards or contains elements that may conflict with aspects of the newly proposed research, questions involving interpretation of older consent forms and obligations to trial participants, or questions related to the inclusion of research biopsies or other aspects of trials that involve risk or burden without direct benefit to trial participants.

The Alliance Ethics Committee (EC) was established for the purpose of aiding Alliance leadership, investigators, and study team members to address these critical issues via education, ethics consultation and conflict resolution, policy and procedural development, research, and provision of recommendations for ethical action in the conduct of oncology clinical trials. The EC’s goals involve the provision of support and guidance to all Alliance investigators, clinicians, staff, and patient advocates who serve as decision-makers for research. The EC provides assistance by reviewing research conflicts via timely ethics consultation and seeks to clarify research conduct that is ethical and legal via recommendations for action. This committee aids Alliance members in the clarification of discussing alternatives and compromises in order to promote the rights of patients who serve as trial participants. The EC aims to promote fair policies and procedures to maximize the likelihood of achieving optimal patient-centered outcomes.  Importantly, the EC also serves as an ethical “backstop” so that anyone working within the Alliance can bring forward concerns related to the ethical conduct of research and have a place where their issue can be confidentially addressed, in the interest of protecting our patients and the foundation of all we do in the Alliance. 

In addition to addressing consultations submitted by Alliance members regarding the conduct of Alliance clinical trials and data analysis, recent EC initiatives have included policy development of Decisional Capacity guidelines to inform policy on the enrollment of participants with impaired decision-making capacity on clinical trials and a recently published empirical research survey involving  Alliance member oncologists experiences with patient-initiated recordings of clinical visits (Jimenez et al. Cancer 2021) with additional research endeavors underway.

Work by the EC stemming directly from consultations on the ethics of mandatory research biopsies led to a research biopsies publication (Peppercorn, et al. JCO 2010) and numerous subsequent publications on this topic culminating in the recent ASCO Ethical Framework for Including Research Biopsies in Oncology Clinical Trials (Levit et al, JCO 2019).

The Alliance Ethics Committee is a multidisciplinary group consisting of clinicians, researchers, and patient advocates.  Any member of the Alliance may submit a question or request for consult.  Our committee meetings during the Alliance Spring and Fall Group meetings are open to all who wish to attend.


For other articles in this issue of the Alliance E-News newsletter, see below.