With the long shadow of past atrocities hanging over human research, IRBs and their partners must act with intention to cultivate trust in subjects. By engendering all aspects of the program with this trust, they can aspire to be acknowledged as a “trustworthy” institution, a bioethicist explains.
Achieving trust in human research can be challenging in an age of precision medicine that calls for long-term relationships and potential unintended consequences far beyond a simple informed consent document.
Stephanie Kraft, JD, a bioethicist at Treuman Katz Center for Pediatric Bioethics at Seattle Children’s Research Institute, wrote two papers1,2 last year on the subject of trust in research. She discussed her findings with IRB Advisor in the following interview, which has been edited for length and clarity.
IRB Advisor: Part of your research included focus groups with racially and ethnically diverse people, who have certainly been subjected to historical abuses.
Kraft: We have a long legacy of not including or in many cases mistreating patients from minority groups. We are at a point now where we really need to be actively thinking about ways to build trust — to make sure we are not just building trust, but being trustworthy. We need to make sure we are earning the trust that researchers are asking patient participants to put in them.
We often think of research ethics in terms of informed consent. Consent is good and important, but it is not enough. It is not sufficient to really rebuild that trust and demonstrate it over the long-term. The consent form does not tell research subjects what they need to know to put trust in an institution.
IRB Advisor: What are the implications for restoring research trust for IRBs?
Kraft: This is really about oversight broadly — not just in terms of the IRB, although that is certainly part of it. What sort of structures does the IRB have in place? Do they have patient representation on their committees to oversee the research and make sure that it is being done in an appropriate way? Have they vetted the researchers who are going to be doing future projects? These are some of the messages we heard from folks. It is not just, “Did I technically give permission to have my data used in the future?” Are there protective measures in place so that even if I don’t fully understand what those future uses are, I know that [the data] will be used in an appropriate and trustworthy fashion?
IRB Advisor: You recommend addressing the role of history as part of restoring research trust. With the launch of the NIH All of Us Research Program, director Francis Collins, MD, observed in an interview that you’d better be ready to talk about Tuskegee if you ask an African-American to volunteer for research.
Kraft: Tuskegee is certainly something that comes up a lot, and not just among African-Americans. Many people have heard about Tuskegee and are aware of it. That legacy lives on beyond the African-American community in other people as well. Minority groups and nonminorities are aware that researchers have done really bad things in the past. This might give them pause when they are thinking about enrolling in research.
Tuskegee is one of many ways that we have mistreated people. [We need] to say we know that, we recognize that, and we are actively trying to overcome that — not to hide it or make false promises, but to say we are aware of that and here are the specific steps we are taking to move forward.
IRB Advisor: In that regard, in your research you also recommend addressing cultural values and communication barriers, and integrating “patient values and expectations into oversight and governance structures.” Is this essentially a call for transparency?
Kraft: Absolutely. We are finding in a new study that there can be conflicts. You might talk to patient advisors and they will give recommendations and have certain perspectives on the best way of doing something. But then when you talk to the IRB, they may have a different perspective.
I think we could do a better job collectively of making sure that what we are doing from a regulatory perspective integrates with what patients are saying that they need and want. Not that we are necessarily going to say, “A patient said this, so therefore we have to do it.” But I think we need to hear what patient preferences are.
To the extent that we don’t think that we should follow those preferences, we need to make a strong ethical justification. In some cases, that might require revisiting and rethinking about the way we have done things from a regulatory perspective.
IRB Advisor: You use the word “deontological” to describe acting in good faith regardless of the outcome, which I interpret to mean research ethics are hardwired into the institution. You write that “a research institute must not merely generate patient/participant trust, it has a duty to be trustworthy.” How can that designation be earned?
Kraft: A big part of it is the intentionality behind the activities that you do. Whatever you or the institution are doing to build trust needs to come with the intention of being a trustworthy institution.
It’s hard to measure, but it is not about a marketing campaign to make sure that people trust us. It is the institution itself actually engaging in those values.
We can tell patients that we care about decreasing health disparities and increasing diversity in research participation. We can build up trust in that regard by saying lots of nice things, but on an internal basis, we have to make sure that our policies align with the goals we are putting forth. Are we taking the steps necessary to make sure as an institution that we are allowing and encouraging the steps to be taken to reach those goals?
1. Kraft SA, Cho MK, Gillespie K, et al. Beyond Consent: Building Trusting Relationships with Diverse Populations in Precision Medicine Research. American Journal of Bioethics, 2018;18(4)3-20. DOI: 10.1080/15265161.2018.1431322.
2. Kraft SA, Cho MK, Gillespie K, et al. Trustworthiness in Untrustworthy Times: Response to Open Peer Commentaries on Beyond Consent. American Journal of Bioethics 2018;18(5)W6-W8. DOI: 10.1080/15265161.2018.1461953.