As a newly appointed member of the U.S. Department of Health and Human Services Secretary’s Advisory Committee for Human Research Protections (SACHRP), Dr. Douglas Diekema has always had a passion for interpreting and applying the regulatory laws for research involving human subjects to support the children and families that participate in research at Seattle Children’s.
Although he just assumed his role on the national committee that guides medical research activity across the U.S. this July, Diekema is no stranger to research oversight: he has served as the chair of Seattle Children’s Institutional Review Board (IRB) for the last two decades. In his time as chair, he’s witnessed Seattle Children’s Research Institute grow from a fledgling initiative into the burgeoning enterprise it is today, overseeing hundreds of research studies across nearly every pediatric specialty.
Here, Diekema reflects on what he’s most looking forward to as a member of SACHRP and why it’s very likely you’ve never heard of an IRB before.
Q: How would you explain what an IRB does and why the SACHRP committee exists to the average person?
A: While many people have never heard of an IRB or SACHRP, I think what’s important for people to know is that before research takes place at an institution like Seattle Children’s what can and cannot be done and how it can and cannot be done, including everything from informed consent to research procedures, is ultimately reviewed and approved by an IRB. That IRB is bound by a set of federal laws that specify what consent needs to look like and what can and cannot be done in a research context.
The Office of Human Research Protections (OHRP) regulates that space at a federal level. One way they do this is by applying the federal regulations, which like all legal language, is open to interpretation. That’s to some degree where SACHRP comes in. The committee provides guidance about interpreting the regulations, not only to OHRP, but to IRBs so they know how OHRP will be interpreting this language.
Most people don’t spend much time thinking about IRBs or federal regulatory bodies, because they operate behind the scenes. But their role is really important because when people sign up for a research project, at least at a major university or hospital, they should feel comfortable with the fact that there are multiple layers of review taking place before that study can ever be offered to them.
Q: Why are you excited about the opportunity to join SACHRP?
A: I’ve always been interested in the questions that SACHRP wrestles with. When I started my career as an IRB chair, I became really interested in the regulatory interpretations and how the rules apply to research in a pediatric setting. Those are exactly the kind of questions SACHRP weighs in on.
They’re also doing work that has practical applicability. It’s not a committee that just wrings its hands or writes documents that nobody cares about or ever looks at. What SACHRP does often gets implemented in important ways by most IRBs in the country.
It’s energizing to be part of a process that does have influence and can lead to positive change in the research arena.
Q: What are some of the issues you foresee coming before the committee?
A: I’m very excited about a couple of the initiatives that they’re just getting started on. One of these is very timely given the current pandemic, and that is the definition and interpretation of public health surveillance.
Current regulations consider public health surveillance activities like tracking viral transmission in the community to not be human subjects research, and therefore not in need of review, approval, and oversight by an IRB.
In the early weeks of the pandemic, especially here in Seattle with the Greater Seattle Coronavirus Assessment Network (SCAN) study, questions were raised about whether IRB review was required to conduct that kind of research, since at least some of the results were being used by public health to track viral transmission. Sorting out what constituted research versus public health surveillance was not a straightforward assessment. SACHRP will be looking to provide further guidance about what can be done – and when oversight is needed by an IRB – from a public health surveillance perspective.
The other issue that we’re going to be considering is the role of justice as an ethical principle in human subjects research. Research is no exception to a commitment to an equitable and just society.
In the U.S., we have a document called the Belmont Report, which is the closest thing our nation has to a code of human subjects research ethics. The Belmont Report spells out that research ethics should be grounded in three principles: respect for autonomy, beneficence and justice.
The first two principles have been explored in great detail, but there has not been a lot of attention paid to what exactly it means to do research in a way that’s fair and how the principle of justice should be applied to the research context.
I’m excited to be a part of this committee, participate in it’s important work, and inspired to think we can have a positive impact in the arena of human subjects protection.