Tag: randomized controlled trials

Bioethics Blogs

Not Just About Consent: The Ethical Dimensions of Research Methodology Knowledge in IRBs

Guest Post: Sarah Wieten

The recent article, “Some Social Scientists Are Tired of Asking for Permission” in the New York Times inspired a great deal of debate about the role of institutional research ethics board (IRB) oversight in social science, which some argue is in most cases unlikely to involve significant harm to participants.

While the role IRBs play in sociological research is being re-examined, the importance of IRB oversight for medical research was not similarly called into question. But what exactly does IRB oversight in medical research involve? Should these groups be content with assuring that patients and participants in medical research have provided informed consent? Or do they have wider duties? What is the relationship between methodologically rigorous science and ethical science?

The approval of research projects by IRBs is an integral part of the conduct of research in universities. IRBs ensure that all research follows key ethical guidelines and is pursued for good reason, and in doing so, they aim to keep patients and participants out of harm’s way. IRBs are important gatekeepers of institutional research, and serve as a check on the work of scientists, physicians, and others who are pursuing new knowledge.

We would assume then, that people serving on IRBs have a clear understanding of relevant research design. That way, they can check the research for ethical issues stemming from the methodology. They can also make sure that methodologically poor studies do not proceed, as this would be an unethical waste of resources (and would put participants at risk without a reasonable prospect of gaining reliable knowledge in exchange).

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Individually-randomized controlled trials of vaccines against the next outbreak

Guest Post: Nir Eyal, Marc Lipsitch

Paper: Vaccine testing for emerging infections: the case for individual randomisation 

The humbling experience of international response to Ebola taught the world a thing or two on preparing for Zika and for other emerging infections.

Some of those lessons pertain to vaccine development against emerging infections. One lesson was that vigorous vaccine development should start long in advance of outbreaks. CEPI, the Coalition for Epidemic Preparedness Innovations, was recently launched with an initial investment of half a billion US dollars from the Gates Foundation, Britain’s Wellcome Trust and the governments of Japan, Norway and Germany. There is also growing recognition that best practices on vaccine testing should be developed prior to outbreaks, from a study methodology viewpoint.

By contrast, in Zika, ethical guidelines on response in general and on an aspect of vaccine testing were created only once the pandemic erupted. Shouldn’t ethical disputes, e.g. on trial design for vaccine candidates, be ironed out in advance of emerging infections?

One persistent ethical question in vaccine testing pertains to individually-randomized control in efficacy trials. At the height of the 2014-5 Ebola outbreak, individually-randomized controlled trials were much maligned. Our paper at the Journal of Medical Ethics sets out to defend that approach for vaccine efficacy testing in emerging infections, including highly fatal and untreatable ones in developing countries.

Nearly everyone agrees that scientifically, individually-randomized controlled trials are the gold standard of clinical research. But during the Ebola outbreak, ethicists, leaders, and humanitarian workers opposed them. For testing vaccine against a highly fatal infection without approved drugs or vaccines, they deemed these designs unethical.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Special Issue! The Politics and Practices of Evidence in Global Health by Anna Zogas

For September 2016, Charlotte Brives, Frédéric Le Marcis, and Emilia Sanabria edited a special issue of Medical Anthropology titled “The Politics and Practices of Evidence in Global Health.” Evidence-based medicine (EBM), the authors write in their Introduction, is pervasive among contemporary practices of governance. The articles in this special issue provide ethnographic perspectives on the practice and production of evidence-based medicine across the world.

Here are the abstracts!

What’s in a Context? Tenses and Tensions in Evidence-Based Medicine
Charlotte Brives, Frédéric Le Marcis & Emilia Sanabria

In this special issue, we bring together articles that engage ethnographically with practices of EBM in diverse localities—a bariatric surgery ward in Vienna, a tuberculosis control unit on the periphery of Paris, the practices of child psychiatrists in Portugal, the board meetings of a global vaccine venture and its implementation in Burkina Faso, and at the intersections of human immunodeficiency virus (HIV) treatment, hunger, and nutrition in Southern Africa. Our aim is to engage with EBM not as an ideal type, everywhere the same, but rather to engage pragmatically with the translations, negotiations, adaptations, failures, and successes of its deployment on the ground.

The Precariousness of Public Health: On Tuberculosis Control in Contemporary France
Janina Kehr

Through an ethnographic exploration of tuberculosis control in one of France’s poorest regions, Seine-Saint-Denis, I interrogate the relationships between public health planning and interventions in conditions of multiple precarity. I show that the encounter between the feasible and the fantastic in the realm of public health generates feelings of absurdity and futility among medical professionals, characteristic of disease control in the precarious present.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

New Educational Module from the Bioethics Commission on Research Design in Ethics and Ebola

The Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) has released a new educational module on research design in the context of a public health emergency. The module integrates material from the Bioethics Commission’s report Ethics and Ebola: Public Health Planning and Response (Ethics and Ebola).

This module serves as a guide for instructors to help students understand key ethical challenges that might arise when conducting clinical research during public health emergencies. The module identifies ethical considerations of various approaches to clinical research during public health emergencies, including randomized controlled trials.

The Research Design in Ethics and Ebola module provides background information on randomized controlled trials and considers the differences between vaccine and treatment trials, the interpretation of what constitutes “best available” supportive care, the necessity of research to be responsive to the host and affected communities, and the importance of designing trials that yield scientifically valid results. Through discussion questions, scenarios, exercises, and illustrative and timely examples, the module guides instructors to help students reflect on ethically relevant concerns that arise in designing research during a public health emergency.

The Bioethics Commission’s topic-based educational modules are grounded in contemporary ethical questions addressed by the Commission and are designed to provide instructors with foundational information, ethical analysis, discussion questions, problem-based learning scenarios, exercises, and additional resources to support ethics education and the integration of bioethical analysis into coursework across disciplines.

All Bioethics Commission educational materials are free and available at www.bioethics.gov/education. The Bioethics Commission encourages feedback on its materials at education@bioethics.gov.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

The Vaccine Project

An interview with Philip Cawkwell, MS4, NYU School of Medicine, Rudin Fellow 2014-15
By: Katie Grogan, DMH, Associate Director, Master Scholars Program in Humanistic Medicine
Assistance from Tamara Prevatt, Intern, Master Scholars Program in Humanistic Medicine

The Rudin Fellowship in Medical Ethics and Humanities supports medical trainees at NYU School of Medicine – including medical students, residents, and clinical fellows – pursuing year-long research projects in medical humanities and medical ethics under the mentorship of senior faculty. It was established in 2014 through a grant from the Louis and Rachel Rudin Foundation, Inc. and is a core component of the Master Scholars Program in Humanistic Medicine.

Philip receiving his fellowship certificate from Drs. David Oshinsky, his Rudin Mentor, and Lynn Buckvar-Keltz, Associate Dean for Student Affairs, at the Rudin Fellowship Project Showcase, July 7, 2015.

How did you become interested in vaccine refusal and why did you decide to pursue this as a project through the Rudin Fellowship?

Vaccine refusal is something I’ve been interested in for a long time. As a medical student, and someone with a lot of doctors in my family, it was just accepted that you go to the doctor and get your vaccinations. So, growing up in an age where it felt like there was this huge movement of people who weren’t vaccinating their kids, was something that I didn’t understand very well. The goal behind this project was to dig a little bit deeper and figure out why this was happening. Why weren’t kids getting vaccinated? Where were places with better or worse vaccination rates, and why?

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Unintentional discrimination in clinical research: Why the small decisions matter

by Arthur T. Ryan, M.A. and Elaine F. Walker, Ph.D.

Arthur Ryan is a graduate student in clinical psychology at Emory University. His research focuses on understanding the etiology and neuropathology underlying severe mental illness.

Elaine Walker is a Professor of Psychology and Neuroscience in the Department of Psychology at Emory University and is the Director of the Development and Mental Health Research Program, which is supported by the National Institute of Mental Health. Her research is focused on child and adolescent development and the brain changes that are associated with adolescence. She is also a member of the AJOB Neuroscience editorial board.

Arthur Ryan, M.A.
Over the past several decades, there has been a significant effort to minimize bias against individuals based on ethnicity and other demographic factors through the creation of seemingly impartial and objective criteria across a host of domains. For example, when the United States Federal Sentencing Guidelines were created in the 1980’s, one of their primary goals was to alleviate “…unwarranted disparity among offenders with similar characteristics convicted of similar criminal conduct” [1]. Unfortunately, even well-intentioned efforts such as this one can still have a disparate negative impact upon historically marginalized groups, such as the well-documented disproportionate sentencing of black individuals due to differing rules governing offenses committed with crack vs. powdered cocaine [2]. Concerns about such inadvertent bias are not limited to the legal domain. Agencies that fund clinical investigations are paying greater attention to demographic representativeness and access to participation in health-related research.

Let us consider a hypothetical example, drawn from the authors’ own field of research in a US context, of how seemingly objective research design choices can results in biases in access to research participation.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Community Health Workers and Social Change: Global and Local Perspectives — A special issue of the Annals of Anthropological Practice by Aaron Seaman

The current issue of the Annals of Anthropological Practice is a special issue, entitled “Community Health Workers and Social Change: Global and Local Perspectives.” The issue comprises an introduction by Kenneth Maes and five articles, the abstracts of which are below. Enjoy!

Community health workers and social change: An introduction
Kenneth Maes

Major global health institutions, public and private, currently see community health workers (CHWs) as crucial resources. But the daily experiences and complex motives of CHWs, as well as their concerns and criticisms, remain poorly understood by the institutions that promote their value and draw on their labor. Donors, states, NGOs, and other public health institutions often approach the motivations and performance of CHWs as problems that can be solved with a mix of psychological, economic, and management theories; novel incentive packages and supervisory structures; and surveys, interviews, and randomized controlled trials. This special issue shifts the goal toward documenting power inequalities, labor relations, and interactions among CHWs, donors, health officials, supervisors, and care recipients. The articles in this issue offer valuable ethnographic accounts of CHWs in 21st-century Africa, Latin America, and Asia, and deliver a clear message: CHWs participate in important relationships and politics, seeking change in their own job conditions and roles, and other social, political, and economic changes. These forms of “participation” are variable, evolving, and shaped by unique local histories as well as transnational policies and norms. The articles here aim to demonstrate that ethnography and mixed methods can help bring about improvements in policy and practice by explaining and interpreting CHW practices and governance and by encouraging global health actors to treat CHWs not as magic bullets or human resources, but as people with multiple skills, desires, and perspectives.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Research Ethics Roundup: Addressing Poverty Through Randomized Controlled Trials, Lessons from Science Fraud, and More

Traditional research methodologies are being used to address a number of longstanding challenges, including how to make health care more efficient and effective, and how to fight poverty. This week’s Research Ethics Roundup sheds light on the role of research in answering those questions, as well as other stories related to research ethics and oversight.

Don’t Weaken the FDA’s Drug Approval Process: The 21st Century Cures Act proposes significant changes to the approval process for many medical products. In this opinion piece for The New York Times, Gregg Gonsalves, Mark Harington, and David A. Kessler warn that “Congress should be wary of changing standards that paved the way for the development and approval of breakthrough drugs for AIDS and other diseases and that, importantly, have been proven to be effective and safe.”

EU Rejects Effort to Ban Animal Research: In this article for the Washington Post, Tania Rabesandratana reports on the European Commission’s decision to reject a proposal supported by 1.17 million signatories to “abolish animal research across the European Union.” To address some of the concerns that prompted the petition, the Commission plans to “speed up the development and adoption of alternative methods and to better monitor compliance with the directive in member states.”

How Institutional Review Boards Can Support Learning Health Systems While Providing Meaningful Oversight: Learning health systems can play an important role in improving healthcare quality, while cutting costs, however, IRBs need clearer guidance on how to evaluate whether data collection in this context constitutes research. In this post for the Health Affairs Blog, Mildred Solomon argues that IRBs need to strike a “delicate balance” between being too lax and too stringent when evaluating risks and the need for informed consent in learning health systems.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Ask the Right Questions

By Vinisha Bhatia, research associate, Staff Development and Knowledge Management at Innovations for Poverty Action

As an IRB Coordinator for an international research and policy nonprofit, Innovations for Poverty Action (IPA), I had the opportunity to attend PRIM&R’s IRB Administrator 201 course during the 2015 Spring Regional Meeting in April. My goal was to learn more about IRB administration and review processes in order to apply this knowledge to my organization’s work in social and behavioral research in the international development sector. My biggest takeaway from this meeting? That we need to ask the right questions from the very beginning in order to gather all the necessary information to set up the framework to assess risks and benefits for those participating in the study.

During a group submission review exercise, many of us quickly jumped to critiquing the informed consent document of the protocol under discussion. The seasoned instructors politely pointed out that the class had gotten ahead of themselves – before we get to the informed consent stage, we need to take a step back and first ask two important questions:

  1. Is IRB review required?
    It is important for IRB coordinators to answer this question initially when reviewing IRB submissions in order to properly allocate the IRB’s time for protocols that actually need the review. This question can be answered by a two-part test: 
  1. Is it research, program evaluation, or quality improvement?
  2. Does the research involve human subjects?

  • Is informed consent required?
    The answer to this question is partially dependent on the answer to the first question.
  • The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

    Bioethics Blogs

    Research Ethics Roundup: Addressing Questions Raised by Compassionate Use, Ebola Drug Trials, and More

    In this week’s Research Ethics Roundup, we explore how new approaches are being used to address longstanding questions, such as those raised by expanded access or compassionate use, and chart a course for the future of biomedical innovation.

    Company Creates Bioethics Panel on Trial Drugs: In an effort to address concerns related to compassionate use requests, Johnson and Johnson announced last week that they have appointed bioethicist Arthur L. Caplan, PhD, to “to create a panel that will make decisions about patients’ requests for potentially lifesaving medicine.”

    House Seeks Momentum on Medical Cures: On May 14, the most recent draft of the 21st Century Cures bill, which seeks to “accelerate the pace of cures in America,” was unanimously approved by the US House of Representatives’ Energy and Commerce Committee’s Health Subcommittee. This article from The Hill outlines the next steps for the legislation, as well as the Senate’s progress on a similar bill.

    Disputes Emerge on African Ebola Drug Trials: The 2014 West African Ebola outbreak is waning. However, questions about how best to develop Ebola vaccines and therapeutics remain. This article from the Wall Street Journal considers the debate surrounding the use of randomized controlled trials to study experimental Ebola vaccines and therapeutics.

    Drugmaker and University Ally to Seek Cure for AIDS: Last week, the University of North Carolina at Chapel Hill and GlaxoSmithKline announced they are partnering in an effort to find a cure for HIV and AIDS. The partnership is part of a growing trend “in which pharmaceutical companies are working directly with university researchers.”

    The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.