The Research Ethics Consortia series is a multi-disciplinary forum for investigators, institutional review board and research ethics committee members, students, fellows and faculty of Harvard University, the Center for Bioethics, and Harvard Catalyst.
Topics range from in-depth analysis of particular research protocols to broader discussions of the new and emerging trends in the theory and practice of research ethics and oversight.
Save the third Friday of the month for Research Ethics events.
Past Events
May 2019 Research Ethics Consortium
The Ethics of Conducting Studies Within A Trial (SWATs)
Thousands of clinical trials are conducted every year with the aim of improving the evidence base for medical practice. Yet, the evidence base for how best to conduct trials--making them as efficient and ethical as possible--is surprisingly thin.
Shaun Treweek, Chair in Health Services Research at University of Aberdeen, will discuss his efforts to promote the use of Studies Within A Trial (SWAT)-that is, folding a rigorous study about clinical trial best practices into a clinical trial itself.
Presenter:
Shaun Treweek, PhD, BSc (Hons)
Chair in Health Services Research
University of Aberdeen, Scotland
Commentator:
Christopher Gill, MD
Associate Professor, Global Health
Boston University
Moderator:
Bizu Gelaye, PhD, MPH
Teaching Faculty,
Center for Bioethics
Lecturer on Global Health and Social Medicine,
Harvard Medical School
Assistant Professor of Psychiatric Epidemiology
Harvard T.H. Chan School of Public Health
April 2019 Research Ethics Consortium
Advertising Clinical Trials in Oncology
Many medical centers advertise their clinical trials. In some cases, these advertisements suggest that trial participation may offer direct benefits to patients--a suggestion that conflicts with some of the foundational principles in research ethics.
Yet, recruitment remains one of the major challenges in conducting efficient clinical research and many patients are not aware of the trials for which they may be eligible. Therefore, advertising trials may be a good way to improve participation and help patients find trials.
In this month's Research Ethics Consortium, we will explore this ethical tension surrounding advertising clinical trials in oncology.
Presenters:
Jonathan Marron, MD, MPH
Instructor in Pediatrics
Dana-Farber Cancer Institute
Boston Children's Hospital Cancer and Blood Disorders Center
Research Fellow
Center for Bioethics
Harvard Medical School
Daniel Kronish, MD
Associate Director
Medical Review Office for Human Research Studies
Dana-Farber Cancer Institute
Moderator:
Spencer Phillips Hey, PhD
Faculty and Co-director of Research Ethics
Harvard Center for Bioethics
Research Scientist
Brigham and Women's Hospital
March 2019 Research Ethics Consortium
Science, Ethics, and Deception:
A study of medications, placebos, and labeling in acute episodic migraine
This month, Professor Ted Kaptchuk will present the results of a randomized control trial for patients with acute episodic migraines. The trial, conducted at the Beth Israel Deaconess Medical Center, provided a medication and an identical-appearing placebo intervention with the goal of assessing how medication labeling might modify their effects. In addition to raising familiar ethical issues around the use and study of placebos, this trial provoked significant ethical debate because it also involved deception.
Presenter:
Ted Kaptchuk
Professor of Global Health and Social Medicine, Professor of Medicine
Harvard Medical School
Director, Program in Placebo Studies & Therapeutic Encounter
Beth Israel Deaconess Medical Center
Commentator:
Benjamin Silverman, MD
IRB Chair Partners Human Research Committee
Partners HealthCare System
Instructor in Psychiatry
McLean Hospital
Faculty,
Center for Bioethics
Harvard Medical School
Moderator:
Bizu Gelaye, PhD, MPH
Research Ethics Co-Director, Harvard Center for Bioethics
Assistant Professor,
Harvard T. H. Chan School of Public Health, Harvard Medical School and
Division of Global Psychiatry, Massachusetts General Hospital
February 2019 Research Ethics Consortium
Should patients have control over their clinical research results?
This month, Brian Edlow will present his clinical trial, "Advanced MRI and EEG for Predicting Recovery of Consciousness after Severe Traumatic Brain Injury."
Given the potential implications for their future care or insurance, some patient-participants in this trial expressed a desire to not share their study results with their clinical team. But who has the right to decide what medically relevant information from a clinical trial can or cannot be shared with clinicians? Who is ultimately the authority on research data sharing? How should IRBs consider such requests, whether from researchers or patients, to restrict the flow of information from research to the clinical setting?
Presenters:
Brian L. Edlow, MD
Neurocritical Care Faculty, Massachusetts General Hospital
Associate Director,
Center for Neurotechnology and Neurorecovery
Director,
Laboratory for NeuroImaging of Coma and Consciousness
Affiliated Faculty,
Athinoula A. Martinos Center for Biomedical Imaging
Assistant Professor of Neurology, Harvard Medical School
Discussant:
Elizabeth Hohmann, MD
Associate Professor of Medicine/Infectious Diseases,
Physician Director and Chair, Partners Human Research Committee
Massachusetts General Hospital
Moderator:
Spencer Phillips Hey, PhD
Faculty and Co-director of Research Ethics,
Harvard Center for Bioethics
Research scientist,
Brigham and Women's Hospital
December 2018 Research Ethics Consortium
Exception from Informed Consent and the IMMEDIATE Trial
The IMMEDIATE Trial was a double-blind randomized controlled clinical effectiveness trial that evaluated the impact of intravenous glucose, insulin, and potassium for acute coronary syndromes patients. Since this intervention was administered by paramedics in the prehospital setting with a narrow therapeutic time window, it was granted an exception from informed consent (EFIC).
This month, we will discuss the ethical challenges involved in planning and conducting the IMMEDIATE Trial, and explore some of the broader patterns and ethical issues seen across EFIC trials more generally.
Presenter:
Joni Beshansky, LPD, MPH
Co-PI of the IMMEDIATE Trial
Associate Professor of Medicine
Tufts University School of Medicine Associate Professor
Regis College School of Health Sciences
Director, Regulatory Affairs and Clinical Research Graduate Program
Reviewer:
William Feldman, MD, DPhil
Fellow, Pulmonary and Critical Care Medicine
Brigham and Women's Hospital and Harvard Medical School
Moderator:
Bizu Gelaye, PhD, MPH
Research Ethics Co-Director, Harvard Center for Bioethics
Assistant Professor,
Harvard T. H. Chan School of Public Health, Harvard Medical School and
Division of Global Psychiatry, Massachusetts General Hospital
November 2018 Research Ethics Consortium
Ethical Issues in an Audit Method Study of Telemedicine
Studies that use audit method or "mystery-shopper technique" are widely used to understand the experiences of patients although they raise several ethical challenges. This month, we will discuss a study that uses an audit method where patients act as real patients buying birth control online from well known tele-birth control vendors. What are some of the ethical challenges surrounding the design and conduct of such a study?
Presenter:
Ateev Mehrotra, MD, MPH
Associate Professor Health Care Policy and Medicine, Harvard Medical School
Hospitalist, Beth Israel Deaconess Medical Center.
Reviewer:
Leslie Howes, MPH, CIP
Director, Office of Human Research Administration, Harvard Faculty of Medicine and Harvard T. H. Chan School of Public Health
Moderator:
Bizu Gelaye, PhD, MPH
Co-Director, Research Ethics, Harvard Center for Bioethics
Assistant Professor, Harvard T. H. Chan School of Public Health, Harvard Medical School and Division of Global Psychiatry, Massachusetts General Hospital
October 2018 Research Ethics Consortium
Is the Future of Clinical Cancer Research a Global Adaptive Trial?
Adaptive clinical trials are now mainstream science. This month, we will discuss the ethical implications of a new approach to cancer research, called "Global Cumulative Treatment Analysis" (GCTA), that takes adaptive trials to their logical conclusion-striving to optimize patient outcomes, trial efficiency, and cost by continuously integrating data collection, analysis, and decision making in a rapid learning loop. In the GCTA model, every patient is automatically a participant in a "global trial" that encompasses every plausible treatment regimen and test, and all available data is used to inform decisions at the point of care.
Presenters:
Jeff Shrager
Director of Research,
Cancer Commons
Adjunct Professor in Symbolic Systems,
Stanford University
Commentator:
Brian Alexander
Director,
Harvard-MIT Center for Regulatory Science
Associate Professor,
Radiation Oncology
Harvard Medical School
Moderator:
Spencer Hey
Faculty and Co-director of Research Ethics,
Harvard Center for Bioethics Research Scientist,
Brigham and Women's Hospital
September 2018 Research Ethics Consortium
Ethical Challenges of Phase 1 Clinical Trials
Research that involves phase I clinical trials raise particular ethical challenges, especially trials that involve novel therapies being tested in humans for the first time. This month, we will discuss ethical challenges around a phase 1 clinical trial in Rennes, France that resulted in the death of one person and the hospitalization of five others.
Presenters:
Spencer Hey, PhD
Co-Director, Research Ethics, Harvard Center for Bioethics
Research Fellow, Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital
Joseph Cravero, MD
Senior Associate, Perioperative Anesthesia and Pain Medicine
Associate Professor of Anesthesia, Harvard Medical School
Commentator:
Barbara Bierer, MD
Faculty Director, Multi-Regional Clinical Trials Center, Harvard University
Professor of Medicine, Harvard Medical School
Moderator:
Bizu Gelaye, PhD
Co-Director, Research Ethics, Harvard Center for Bioethics
Assistant Professor, Division of Global Psychiatry, Massachusetts General Hospital
April 2018 Research Ethics Consortium
Open-label Placebo: Rationale, methods, data, and ethics
Open label placebo (OLP) - honestly prescribed placebos - is an emerging research agenda. The talk examines the ethical conundrum that led to this research, describes some OLP research, and analyzes accompanying ethical issues. The talk will focus on the first RCT published on OLP performed at the BIDMC. This study will be contrasted with more recent OLP studies in an effort to see the evolution of informed consent in OLP.
Study Documents:
1. Placebos without Deception: A Randomized Controlled Trial in Irritable Bowel Syndrome
2. Open-Label Placebo Treatment for Cancer-Related Fatigue: A Randomized-Controlled Clinical Trial
3. Are Open-Label Placebos Ethical? Informed Consent and Ethical Equivocations
Presenter:
Ted Kaptchuk
Professor of Global Health and Social Medicine, Professor of Medicine
Harvard Medical School
Director, Program in Placebo Studies & Therapeutic Encounter
Beth Israel Deaconess Medical Center
Commentator:
Laura Specker Sullivan
Post-doctoral Research Fellow
Center for Bioethics
Harvard Medical School
February 2018 Research Ethics Consortium
The 'Real World' of IRB Review:
Ethical and practical challenges in studying research ethics oversight
Through the process of ethical review, institutional review boards (IRBs) help to protect human subjects and uphold the integrity of the research enterprise. But how much do we actually know about the people, relationships, and practices that constitute the real world of IRB review? And how much do we need to know in order to judge whether IRBs are serving as good stewards of the research enterprise?
Eric Campbell, professor of medicine at Harvard Medical School and core faculty at the Mongan Institute for Health Policy, has conducted several studies examining conflicts of interest in the world of IRBs. In this consortium, he will present insights from this work and discuss some of the ethical and practical challenges in researching the people in charge of research ethics oversight.
Shannon Sewards, the director of IRB Administration for the Committee on the Use of Human Subjects at Harvard University, will provide commentary.
Presenter:
Eric G. Campbell, PhD
Teaching Faculty, Harvard Medical School Center for Bioethics
Faculty, Morgan Institute for Health Policy, Massachusetts General Hospital
Commentator:
Shannon Sewards, MA, CIP
Director of IRB Administration, Committee on the Use of Human Subjects, Harvard University
January 2018 Research Ethics Consortium
Can Researchers Predict the Outcome of Clinical Trials in Their Medical Specialty?
The quality and safety of clinical trials depend upon the ability of experts to make accurate predictions about the risks and likely benefits. However, we know very little about whether or not experts are actually good at making these risk/benefit predictions.
In this talk, Jonathan Kimmelman will describe a series of studies that he and his team at McGill University have conducted, which measured whether experts could accurately forecast the events, outcomes, and risks in trials. His findings suggest that although a subset of clinical experts show a high level of skill in predicting trial outcomes, most clinical experts under-perform simple prediction algorithms.
Presenters:
Jonathan Kimmelman, PhD
Associate Professor
Biomedical Ethics Unit/Social Studies of Medicine, McGill University
Commentator:
Mark Barnes, JD
Faculty Co-director & Co-chair
Multi-Regional Clinical Trial (MRCT) Center, Brigham and Women's Hospital and Harvard Medical School
Partner, Ropes & Gray LLP
December 2017 Research Ethics Consortium
Keeping Good Patients Out of Bad Trials
The risks and costs of clinical trials are ethically justified by the promise of advances in scientific knowledge and the potential for benefits to future patients. However, many conducted trials are destined to provide no useful information because of issues in trial design, conduct, or reporting. These trials compete with potential useful studies for the same pool of research participants.
In this consortium, Deborah Zarin, the director of ClinicalTrials.gov, will examine these issues and discuss how the world's premier clinical trial registry can help stakeholders address this issue.
Paul McLean, a member of the Harvard Catalyst Research Subject Advocacy Board, and Luke Gelinas, senior researcher at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics will provide commentary.
Presenters:
Deborah Zarin, MD
Director,
Senior Scientist, National Institutes of Health
Commentators:
Paul McLean
Member, Harvard Catalyst Research Subject Advocacy Board
PCORI Co-Investigator, Governance of Learning Activities in Learning Healthcare Systems
Luke Gelinas, PhD, MA
Senior Researcher, Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, Harvard Law School
November 2017 Research Ethics Consortium
Visualizing Data on Clinical Trials: Can It Help IRBs Fulfill Their Social Mission?
The focus of research ethics oversight tends to be on the properties of an individual protocol. However, some of the core judgments in ethics review --- such as a study's social and scientific value --- require that a protocol be evaluated in the context of the accumulating body of evidence and other ongoing research activities.
This month, presenters will demonstrate some new approaches for systematically visualizing data on clinical trials, and discuss ways in which these approaches may help research ethics committees to assess the value of a proposed study.
Presenters:
Spencer Hey, PhD
Faculty, Harvard Center for Bioethics
Research Scientist, Program on Regulation, Therapeutics, and Law (PORTAL)
Stephen Rosenfeld, MD
Executive IRB Chair, Quorum Review IRB, Chair, the Secretary's Advisory Committee for Human Research Protections (SACHRP)
Commentator:
Barbara E. Bierer, MD
Professor of Medicine, HMS
Faculty Co-Director, Multi-Regional Clinical Trials (MRCT) Center
Director, Regulatory Foundations, Ethics and the Law Program at Harvard Catalyst
October 2017 Research Ethics Consortium
The Role of the IRB in Quality Improvement and Human Subjects Research
When should a study be considered "quality improvement" (not requiring institutional review) and when should an institutional review board or research compliance officer be involved?
While many have tried to draw a sharp line between these two types of data gathering, there is little clear consistency and some projects fall in a gray area.
- month we will discuss an improvement survey on hospital culture of safety which generated subsequent interest around the secondary use of QI data for further research.
Principle Investigator:
Al Ozonoff, PhD, CPPS
Associate Professor of Pediatrics, Harvard Medical School
Director, Center for Applied Pediatric Quality Analytics, Boston Children's Hospital
Research Reviewer:
Susan Kornetsky, MPH
Director, Clinical Research Compliance, Boston Children's Hospital
Moderator:
Bizu Gelaye, PhD, MPH
Faculty Member, HMS Center for Bioethics
Research Scientist, Department of Epidemiology,
Harvard T.H. Chan School of Public Health
September 2017 Research Ethics Consortium
Ethical Issues in a Qualitative Study of Schizophrenia in Ethiopia
The prevalence of schizophrenia in Ethiopia appears to affect men at a rate of 5:1 over women - much higher than in other places. Where are the women with schizophrenia? A research study aimed to understand community members' cultural explanations of schizophrenia and improve cultural and gender sensitivity in identifying new patients with schizophrenia.
- How should such understandings be explored in a small rural area?
- What ethical concerns might arise in using community health workers to identify patients with schizophrenia?
- What are the ethical issues in using qualitative methodologies such as focus groups and individual interviews?
Principle Investigator:
Christina Borba, MPH, PhD
Director of Research, Department of Psychiatry, Boston Medical Center, Assistant Professor, BU School of Medicine
Commentator:
Bizu Gelaye, PhD
Faculty Member, HMS Center for Bioethics
Research Scientist, Harvard T.H. Chan School of Public Health