thical behavior in clinical research and therapeutic product development can help demonstrate the trust that transforms patients from research participants into research partners. In the following interview, DIA Bioethics Community Co-Chairs Karla Childers and Lindsay McNair look back at their foundational educational experiences, explain the founding of the Bioethics Community, and outline topics they anticipate this community will focus on in the future. “It’s a real privilege to think about not just what we’re doing but the people we’re doing it for and how we’re doing it,” Karla explains.
DIA: When did your interest in bioethics begin?
Lindsay McNair: My interest in bioethics started in college. I took some electives about bioethics in medicine. That interest continued through medical school and continued as I became a physician. I joined the Institutional Review Board (IRB) at Boston Medical Center when I was a research fellow during my residency, while I was also getting a Master’s in Public Health in health policy and epidemiology. When I left clinical practice to go into research full-time in biopharma, I continued to be involved in research ethics and human subject protection work and eventually formalized that with a master’s degree in bioethics.
Karla Childers: My path was a bit circuitous because I started in industry as a chemist. While I enjoyed my work as a chemist, I had the feeling that I was disconnected from the patients and healthcare providers using our products: I could make the fluffy white powder in the flask, but it didn’t necessarily matter what it was for as long as it met the purity and quality specifications. I wanted to know more about the drug development process, so I moved into project management, running drug development teams.
Along the way, I felt the need to advance my education. I’d gotten a bachelor’s degree in chemistry before I joined industry but didn’t want to be a full-time chemist after finding my love of drug development through project management. In searching for different programs, I found a health law program where I could do a master’s degree that grounded me in the laws and regulations of medicine and healthcare. I had an amazing research ethics professor in that program (Carl Coleman) who got me interested in research ethics. When I got to J&J and started supporting our policy work and bioethics education, I got interested in the discipline of bioethics and that became an important focus.
I had the great fortune of earning my bioethics degree from Columbia University. J&J had been partnering with them on an internal education program. And now I’ve found my way into a role where my day job is bioethics and that’s what I get to focus on. It’s a real privilege to think about not just what we’re doing but the people we’re doing it for and how we’re doing it. I’m still a little bit of a newcomer in the field.
LM: It has been interesting to have a formal bioethics education in this field. A lot of people have an interest in ethics and bioethics as it relates to drug development and will throw the terms “ethical” and “unethical” around in a very informal way. This is a large part of why I wanted to get the master’s degree in bioethics: That background in casuistry—how to construct arguments, how to identify ethical principles in conflict with each other, how to break down and look at positions, how to both have debates and lead debates—has been useful in this field. It makes a big difference in framing some of the challenges we have through a much more formal conceptual ethical lens rather than debating based on gut feelings of right and wrong.
KC: When I got here and was supporting the J&J bioethics committee, it was exactly like what Lindsay said: I had a sense of bioethics, ethical behavior, and thinking. But it wasn’t until I went through the degree program and learned the discipline of applying principles and resolving tensions that I gained a lot more confidence and perspective on the literature and different points of views.
DIA: Why did you create and why do you co-chair the DIA Bioethics Community?
KC: Lindsay and I had been crossing paths in a lot of different places in different industry circles, and industry itself was getting more interested in the discipline and the more academic pursuit of bioethics. We see it as a great opportunity for the perfect audience who should be interested in bioethics in the drug and medical device worlds, because DIA has people who operate across all facets of this process and see a real need to talk about these issues. When I first joined DIA, there was a community for legal interests that touched on ethics; that has since gone away, but within that the clinical community had been interested in perhaps forming a subgroup focused on ethics. We both agreed this was a wonderful opportunity to create a cross-cutting community that could bring a lot of these ideas and concepts together.
LM: Part of our reason for wanting to create the Bioethics Community in DIA was to have a defined space where people could have these conversations openly. One of the things that drives me crazy is when people say, “You can’t do that; it’s unethical.” Using the term “unethical” is almost like a lazy way to shut down discussion: “You’re wrong, I’m right. You’re unethical. That’s unethical, therefore we can’t do it. It’s off the table.”
The Bioethics Community could be a place where people discuss both hypothetical and real situations in an open way, without shutting anybody down. The correct answer to any question in clinical research is: “It depends.” Because there are always different circumstances and different considerations.
DIA: What is this Community’s history to date?
KC: At the beginning, we just wanted to create a community where people could have the conversations that Lindsay just described, but then also create some resources. In these first few years, we hosted a handful of webinars on timely, relevant topics. We were lucky enough to have leading ethicist Art Caplan kick off the creation of this community with our first webinar. We were able to participate in the DIA webinars which addressed the ethical considerations of clinical trials in the conflict in Ukraine. A wonderful individual who was looking for a project for his graduate work (Jordan Liebman) created a library that is available on the Bioethics Community page. He created references to public sources, the seminal and foundational information for bioethics as a discipline, but then also some other special topics, with the vision that this would eventually provide a wiki-like engagement where members would contribute to that. We’ve got the framework set up and we’re looking forward to seeing how the community can grow this resource.
LM: We’ve also been fairly active at DIA annual meetings. We’ve created sessions that reflect hot topics in bioethics because we try to focus on things that will be relevant to a lot of people. Issues around compensation of research participants has been a big one and the thinking on that in the research ethics world has evolved quite a bit over the last 10 years, which parallels the changing view of research participants as partners as opposed to subjects in the research enterprise. The approach from sponsors and others about whether it’s okay to compensate people for participating in research or not has been much slower to change, so we’ve had a lot of discussions around that. We’ve been talking about research in times of disruption, the ethical issues around research in times of disruption prompted by both the war in Ukraine and the pandemic and, of course, natural disasters, which can affect research sites and research studies. Then the other big one is artificial intelligence and how that is affecting how we design and conduct research studies.
KC: Lindsay had brought a couple of terrific colleagues into some of those discussions, which is part of the importance of the Bioethics Community. For example: Mark Fleury, the head of policy at the American Cancer Society, might not have normally been attending DIA or sharing perspectives. Sydney Lupkin, a science and pharmaceutical journalist at NPR (National Public Radio), spoke about the difficulty of avoiding misinformation during the pandemic.
Recently, we have been having conversations with colleagues in patient engagement, patient communications, and health literacy, who want to raise and discuss what they’re hearing: a concern about how AI could replace the role of people in the research process. How do we have a conversation about this real risk of leveraging a tool for good but not just for the sake of efficiency? Do we push really hard until we break it and see what goes wrong? How do we think about all the tremendous work and progress we’ve made with engaging patients, only to potentially lose that if we don’t still see them as important partners in this engagement with technology? To bring more people into conversations like this, we had a Community webinar with some great discussion in October 2023, which our DIA Community members can access online.
We see this as an important subject of discussion for DIA’s next Annual Meeting. Things like leveraging artificial intelligence and generative AI in the role of informed consent are going to be a big area of discussion as we continue to push into and see advances in this.
DIA: Where do you see opportunities for this Community within the next two to three years?
LM: We would like this to be a community that is responsive to the needs of DIA members. We can certainly come up with topics about the drug development space, questions that are coming up from teams, and questions that are coming into IRBs. But we would love to hear from members of the DIA Bioethics Community or DIA members in general: Here’s something that we’re really challenged by right now and I would love to have a discussion on the ethical issues around this to help me think about how to have this discussion with our project team, to help me think about how to frame this as we write our institutional policy or organizational policy on expanded access to investigational drugs or on whether or not we’re going to compensate the people in the clinical trial, whatever that issue is. We want to continue to add more resources in both specific and general topics to that resource library.
KC: It’s a staged approach. We started off with “what Lindsay and Karla think are interesting and top of mind” and found that’s a decent proxy for what we’re seeing in industry. But one of the reasons I was so passionate about creating this community was I don’t think any place like this exists. We have trade associations, we have professional associations, we have conferences in different places. But DIA is a unique, non-competitive, volunteer-driven space where we could come together and not have to worry about other trappings that might slow us down or affect how we’re able to collaborate. For me, that was important: Not just building webinars or a discussion forum, but what do people really want to talk about? We can create that space here without duplicating or trying to replace other important places where these discussions take place, but appreciating this unique community and how we might pull all the folks under the tent and have that conversation. Two to three years down the road, if we’re successful in creating that value and in having people see that we have thought leadership and ideas, one could even envision it being like some of the other high-functioning DIA communities, commenting on things and putting out positions. That would be a wonderful stretch goal for five to 10 years down the road.
This ties into the next point: What are some of the other complementary, different types of organizations in this space? If people are interested in bioethics in drug development, there are other organizations such as the American Society for Bioethics and Humanities (ASBH), Public Responsibility in Medicine and Research (PRIM&R), The Clinical Research Ethics Consultation Collaborative, and other educational opportunities. There are lots of different formal academic programs.
LM: ASBH is a very strong group with a large annual meeting, although their remit is bioethics in a broad sense and if you’re specifically interested in research ethics, that’s just a fraction of their content. But it’s an academically focused organization that helps to educate on that fundamental ethical framework and provides good networking. PRIM&R is the largest organization for research ethics and has good education and resources and a great annual meeting; they address theoretical issues but most of their members are IRB- or IACUC (Institutional Animal Care and Use Committee)-oriented, so they sometimes approach issues from a regulatory perspective as much as from an ethical perspective. But people from biopharma who attend their meetings often love it because they get such a different view of so many topics. PRIM&R and DIA have started early conversations about areas of synergy for what we can offer members.
DIA: What would you tell people who are thinking about joining this Community?
LM: The risk-benefit of joining this Community is entirely on the benefit side. If someone thinks this is something they might be interested in, even if they don’t think they have anything to contribute or don’t want to actively participate, or they don’t have a big topic weighing on them, there are so many different perspectives that come from the field we work in and having those different perspectives represented in these discussions is so important. Even if you don’t work on the clinical research side, even if you’re on the marketing side, or you’re in legal, or in pre-clinical—there are still places for you in these discussions and interesting perspectives you can bring.
If you do join the Community, then please also make sure to enable the notifications on the Community website so that we can reach out to you and let you know about events and announcements. Otherwise, you must remember to go look at the page … and who has time for that?
KC: It reminds me of the bioethics committee we have internally at J&J, which has so many different functions and subject matter experts that bring important diverse perspectives to different topics and we all bring our own personal perspectives, too. Truly, this is a community effort to understand these important questions we are tackling in industry and in patient care. You don’t have to have any expertise, knowledge, or anything as a point of entry. Just come and participate in the conversation in whatever way you feel comfortable and help us drive what the Community will be interested in.
DIA: What is your definition of bioethics? Is there a standard, agreed-upon definition? When we say this word, what do we mean and does everybody mean the same thing?
LM: The formal, short definition is “the study of the ethical issues that arise in medicine and biomedical research.”
KC: When I colloquially describe it, or when I tell people when they ask me what I do, I tell them (depending on the audience) it is ethics: it is applying moral judgment and making determinations around values and principles to situations that largely cover medicine, science, and healthcare. When I talk about bioethics internally or from an industry perspective, I generally indicate that we focus a lot on research ethics. This also brings in clinical ethics, but largely around the value judgments and the morals and principles we apply to biomedical sciences, healthcare, and so on.
LM: We also specify bioethics as opposed to general ethics, which gets us into a much broader range of topics. We tend to not spend a lot of time on issues around drug pricing, clinical healthcare equity, distribution of scarce resources and things like that, all of which are relevant to drug development but don’t really fall under the umbrella of bioethics and are considered more business ethics or societal/public health ethics.
KC: With everybody on the bandwagon to talk about ethical AI and AI ethics, there was originally a push to just drop this into the bioethics bucket. I am not an expert on supply chain. I’m not an expert on human resources. I’m not an expert on finance. I can talk about the implications from a bioethics perspective as it pertains to product development, clinical care, medicine, and things like that. AI is connected to that, but I don’t want to weigh in on the ethics of how we use AI in recruiting employees or doing finances. Distinguishing between that broader discipline of ethics in general and thinking of ethics in an applied way to different areas is an important part of bioethics, especially in drug development and product development.
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