Advances in medicine just wouldn’t be possible without the people who volunteer to participate in research studies. But how can we be sure that people who enroll in research are treated ethically? In this episode of Ethically Sound, host Hillary Wicai Viers talks with Bioethics Commission member Dr. Nita Farahany and Dr. Jerry Menikoff, and discusses the Bioethics Commission's report Moral Science: Protecting Participants in Human Subjects Research.
Advances in medicine just wouldn’t be possible without the people who volunteer to participate in research studies. But how can we be sure that people who enroll in research are treated ethically? Welcome to Ethically Sound, a podcast of the Presidential Commission for the Study of Bioethical Issues. I’m Hillary Wicai Viers.
We’ll be talking today with Commission Member Dr. Nita Farahany, Director of Science & Society at Duke University. But first, a word from Dr. Jerry Menikoff who heads up the Office for Human Research Protections at the U.S. Department of Health and Human Services.
Quite a few years ago, I took a new job that required me to serve on an institutional review board—a committee that reviews and approves research, ensuring that any people who participate in the research are appropriately protected.
I knew almost nothing about research ethics at the time, having come from the world of corporate law.
As part of my job on the IRB, I started reading consent forms—this is the document that researchers provide to the people who are asked to participate in their research. Among other things, it explains what the study will involve and describes the risks to which participants might be exposed. What I learned was eye-opening: The researchers frequently left out many of the important details that would have allowed a prospective subject to make a truly informed decision about whether to enroll in a clinical trial. And many of the consent forms appeared to have been intentionally “dumbed down,” to avoid giving any specific information that might have caused someone to say “no” to participating.
I remember one study that involved women with metastatic breast cancer. These women would be assigned at random to either receive radiation, or to not receive it, in addition to the surgery and chemotherapy all participants would get. The consent form contained just one sentence about the effectiveness of radiation – saying that physicians didn’t yet know whether adding radiation helped. Just by chance, the New York Times ran a story on the topic at about the same time. In just a few paragraphs, that story provided much more information than the consent form did – including the undisputed fact that receiving radiation would reduce by two thirds the chance of the cancer ever returning. Since then, making sure that people who are thinking about participating in clinical trials are given the information they need to make fully informed decisions has been an important part of my life’s work. My office is entrusted with ensuring that research subjects are adequately protected. It is a trust that I – and every member of my staff – take very seriously.
That was Dr. Jerry Menikoff, Director of the Office for Human Research Protections at the U.S. Department of Health and Human Services. Dr. Menikoff talked about two very important mechanisms for ensuring research involving people is conducted in ethical ways. Treating participants ethically means ensuring that they voluntarily agree to participate; that they understand what the research study is testing and what potential harms they face by participating; that their personal information is kept confidential and their well-being is protected. Institutional Review Boards and informed consent are part of a larger system of rules and regulations that have been put in place to protect people who participate in research. These regulations are known collectively as the Common Rule.
After it came to light in 2010 that U.S. scientists intentionally infected vulnerable people with sexually transmitted infections in Guatemala back in the 1940s, President Obama formally apologized to the people and President of Guatemala. He also asked the Bioethics Commission to conduct an ethical analysis of what happened and to assess the current U.S. regulations to determine whether they would prevent such events from happening today. The Commission’s first task was to enumerate the number and types of studies supported by the U.S. Government around the world. They identified more than 50,000 research projects involving human participants worldwide that were conducted or supported by U.S. funds in 2010.
Its conclusion: Current practices adequately protect those who participate in research. It is clear that nothing like what happened in Guatemala would be permitted under today’s system for human subjects protection. But, the Commission found that not all government agencies were able to readily identify basic information about the human research they fund. For example, it took several departments many months to provide the Bioethics Commission with data such as the titles, locations, funding levels, and number of subjects associated with human experiments they funded in the past year.
In its report, Moral Science, the Bioethics Commission urged greater transparency about the scope and volume of human subjects research, recommending that the government make publicly available a core set of data describing basic characteristics of the research projects it supports. The Bioethics Commission also recommended a number of steps the federal government could take to even more fully protect people who volunteer for medical research, including studying the need for a system of compensating subjects who are injured in the course of research. Since the Bioethics Commission released its report, the Obama administration has proposed new rules to modernize and strengthen The Common Rule.
You can download the report Moral Science: Protecting Participants in Human Subjects Research, and all the Commission’s reports at www.bioethics.gov.
Here today to talk about the report Moral Science is Bioethics Commission member and director of the Science and Society initiative at Duke University, Dr. Nita Farahany.
Dr. Farahany, welcome to Ethically Sound.
How did the Bioethics Commission’s interdisciplinary approach inform its recommendations on the topic of protections for research participants?
One of the really great things about the Bioethics Commission has just been how interdisciplinary, both the commissioners but also the approach, has been for each of the issues that we’ve addressed. And so we were able to bring a few different perspectives to bear on the questions that we were facing in Moral Science. So one was we were to look at the legal perspective, and it was really essential to start with that, to be able to understand how do the governmental agencies really currently operate? What do they do in terms of funding, how do they monitor human subjects research, what are the rules and regulations that they have in place in order to govern it today.
The second was to look at it from a scientific perspective and to both draw on the expertise within the Commission, but also to have expertise domestically and internationally that could really help us understand in an increasingly global system, where clinical trials happen abroad, where medicine and health is really a global issue: how do different systems, different countries, govern the ways in which human subjects research proceeds.
And then finally, we were able to bring a strong community perspective as well. And so one of the things that I think is really terrific about the deliberative approach that we take through both our meetings and our processes, is to ensure that we have the perspective of research participants, their families, the people who are actually subjecting themselves to the risks that help science and help society improve the current state of knowledge.
In Moral Science, the Bioethics Commission stressed the importance of professional ethics education for researchers. Since you issued the report, what progress has been made to better prepare scientists for the ethical challenges that might await them?
So one thing that our Bioethics Commission has really emphasized has been the importance and centrality of bioethics education, including research, ethics education across all of the different projects we’ve done.
And you know, recognizing those issues and making those recommendations doesn’t mean that that’s just something we’ve put out there as a call to others. We’ve also recognized that the Commission sets an incredibly unique position to be able to provide those types of educational tools and resources to researchers to all sorts of individuals across the different professional disciplines. And so, we have produced over 60 educational materials that are companions to all of our reports, and these are available for free at our website bioethics.gov under the education tab, and for Moral Science in particular, we have educational materials on community engagement, on compensation for research injuries and a database of all of the 2006 to 2010 data that the Commission and the Commission’s staff gathered from the various federal agencies that are available for individuals to be able to use as well.
One of the Bioethics Commission’s most surprising findings was that many federal offices could not provide basic data about the research they support. How has this changed since the Bioethics Commission issued its report?
One of the things that we found about the ways in which clinical research was really proceeding was that the systems and the transparency that are really necessary to put accountability into practice, weren’t necessarily keeping up to speed with technological advances, and weren’t really accessible to the general public. And so, we made the recommendation that in order to improve that transparency and accountability, it really would make sense for agencies that fund human subjects research to make some basic data about studies like the title, the investigator, the location, the funding, publicly available, but in a way that really would be accessible to individuals. And ideally, this could happen through something that’s like a unified federal system so that it’s really easy for somebody to navigate the system, but short of that, each agency can do this through their own systems and integrate it into their own systems that they’re using.
And one of the things that was really gratifying to see was less than a year after we issued that report, the Department of Defense announced that it’s developing a unified web-based system that would do exactly that, and it cited the Commission’s report and noted that its new database will help alleviate the agency’s initial difficulty in putting together a really complete picture for individuals to access of their human research portfolio.
So, you know, why this is so important is this kind of publicly available information really helps give individuals, themselves, the ability to be able to ascertain what we, in the Commission, feel like we did, which was to find that back to kind of the question of laws and regulations that those laws and regulations are really doing a very good job protecting people who volunteer for research studies funded by the federal government. But it’s important for people to see this themselves, to be able to access and hold accountable other individuals through the kind of transparency that such a process would afford.
Mobile phones, social media and other new technologies have opened up new avenues for research. Is the Bioethics Commission’s report still relevant in today’s environment?
So, absolutely. I think technology will continue to evolve and advance, and I believe that our reports, nevertheless have a timeless quality to them for a few reasons.
The first is we’re drawing upon principles that, no matter what the technological development is, remain relevant in every context. And so just to draw from a couple of those, one that we’ve talked about is the importance of accountability. One of the challenges of moving a lot of research to new platforms like mobile phones or more direct citizen science, is potentially a decrease of accountability because of less oversight and more direct contact with individuals that might not have been able before through a more formalized process. And it’s essential for that kind of research to continue to afford the same kind of protection to human subjects, but those systems and those researchers also ensure that they’re accountable, also ensure that they are transparent about the processes that they’re using, the kinds of consents that they’re obtaining from individuals, the kind of information that they’re providing to human subjects. And it shows all the more importance about ethics discourse and ethics education because as research and the face of research continues to evolve and change, and who counts as a researcher becomes expanded through sort of the democratization of research, it’s all the more important that ethics education and ethics discourse be part of our everyday language, happen for everybody across every different segment of society to ensure that we really are promoting the protection of human research subjects.
And I think it also is consistent with the idea of promoting community engagement, which is a greater involvement in engagement of the community and research, but also a broader engagement in the practices that are involved in this more devolved form of research. So I think understanding the bioethics principles really transcend time and technology is something that remains true, but a lot of the more specific recommendations that we make in Moral Science are ones that I think are equally, if not even more, applicable to the changing face of research.
Thank you for being with us today, Dr. Farahany it was a pleasure.
You’ve been listening to Ethically Sound: A podcast of the Presidential Commission for the Study of Bioethical Issues. Thanks for joining us. You can check out our full series online at bioethics.gov.