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Session 3: Planning the Study: ELSI Issues in Study Design and Governance – Pearl O’Rourke

Pearl O’Rourke:
Great. Thank you. I am so much — I don’t have slides. It’s a fake. I’ve already
trashed four drafts of PowerPoints, and I’m violating my basic rule of presentation — which
is if you don’t have data, use slides as a distraction — but here it is. [laughter] My comments are going to be focused primarily
on — through the lens of the IRB, and by first raising a very basic question. In the
U.S., we have a very weird system of oversight of research. Not all human subjects researched
have to be reviewed by an IRB. They aren’t under the regulations, so, question — I think
maybe towards ELSI folks, “Will Citizen Science research actually increase the amount
of research that is outside the regs?” And the question there — getting it published,
will that be the rule and force them to get an IRB? Or is this an opportunity for looking
at another way of oversight? Okay. That’s a throwaway. In terms of IRB issues, I would first like
to remind people of some of the basics. It is fun to trash IRBs. I know; I am the recipient
of that oftentimes. IRBs are part of a system. You can’t just fix the IRB. We live within
a web of federal-wide assurance issues: federal laws, state laws, local regs, conditions of
grant awards that masquerade as regulations — such as the new NIH genome data sharing
policy — and institutional policies and procedures as well as local cultural issues. The IRB
has to listen to all of these. Okay, that is point number one. Point number two: the IRB focuses on their
review on a protocol-specific basis. We don’t go out and think, “Hey, I think you’re
a good researcher.” No, what we do is we look at both the science and the study team.
If it’s bad science, it’s harmful. If it’s bad science, is any risk at all justifiable
for the participant? I would say no. In terms of the research team, the team aggregate has
to have all of the appropriate expertise. The team could be a single person; this team
could be many people. The team could involve true investigators, consultants, ad hoc advisory
groups. It doesn’t all have to be investigators. The study staff is considered by the IRB in
the context of what each member is going to do in that specific protocol. If I’m the
PI, I can’t do statistics; I can’t even spell “TTests,” so I’m not doing statistics;
whereas the statistician should not be reading the X-rays. My feeling is that the citizen
scientists have to go through the same filter. They bring very valuable pieces of information
to the table. They shouldn’t be doing statistics unless they are statistically trained; they
should — again, what is the expertise they’re bringing? So, I think as we talk about this,
we really do need to talk about, “How do we keep — maintain the integrity of the science
and the integrity of the team?” My third area — my first was just that throwaway;
the second was how the IRB use things — are there new issues? I think we’ve heard talk
— many people refer to defining the role of the citizen scientist, and I think I’m
going to expand that a little bit saying, “understanding, maximizing, and protecting
the citizen scientist role.” I think this starts with definition. If you are doing research
out of an institution — this research institution — and if you are an investigator, we have
ways of dealing with external investigators. It’s not always pretty. It’s credentialing;
its CORI checks; it’s conflict of interest; it’s education. If you’re going anywhere
toward a patient, you’re going to have a TB test and Lord knows what other infections
disease screening. That is the price for being an investigator at an institution. If you’re
a consultant or ad hoc advisor, you kind of skip many of those issues. So, number one, I think, is truly defining.
We are getting investigators coming in who realize they — the importance of having citizens
involved in the research, and they don’t tell us what they’re going to do. So, our
first question is, “Well, can you,” you know, “so what are they going to do?”
“Oh, you know, we want to maximize their potential.” “Well, okay. Have a CORI check.”
Well, I mean, so I think it’s very important that from the get go — what is the role the
citizen scientist is doing enhance what is — how does that complement the rest of the
team? I think potential issues that need to be looked
at — avoiding undue influence of the citizen scientist. We have heard investigators say,
“Well, you know, I’m so happy to have my citizen scientist on board; I’m a little
reticent to question their input.” That is not a healthy, respectful system. We have
to avoid meaningless inclusion. “Okay. Check. Got a patient on my study team. All done!”
I think that’s the bigger risk, and we really need to look at that. I think we need to define
who is the citizen scientist. Is it an individual who is speaking for his or herself — and
some of these were already noted — or is it the leader of an advocacy group who actually
owns a for-profit company that’s coming in with their own agenda? Very, very different.
They all bring things, but very different. And I think there’s some possibly new, gnarly
issues that IRBs are going to have to consider. I’ll just point out a few and hopefully
others can come up with others. Will having a citizen scientist as part of the study team
raise the potential of coercive recruitment, forceful recruitment of kindred folk: “You
owe it to me. We have the same disease. What do you mean you’re not going to be in this
research?” Saying “no” may be more difficult. Will citizens who are not the citizen scientist
— how will they feel about their colleague having access to their potentially identifiable
information? Is this a new risk that will have to be considered? I think — I forget
who commented on this, but somebody mentioned the issue of blurring of clinical and research
boundaries, particularly with all of the apps that we’re talking about. You know, I have
my little wrist watch that has my blood pressure, my 02 stat, and it’s going to go right into
my electronic medical record and be there for research information. Well, let’s say
my blood pressure is, you know, 400 over 300. I’m hoping everybody realizes that’s not
normal. [laughter] In fact, it’s really bad not normal, and
it ends up in my medical record. Who is going to check it out to see A, if it’s wrong,
or B, that I’m about to have a stroke? I think we need to include clinicians as we
start talking about all this massive data coming in. Is it my primary care doctor’s
responsibility to go and say, “Whoa, Pearl is looking bad today?” So, there’s liability
issues there. And then the final one is, I think someone — I already commented on it
in a question, and that’s sustainability of both citizen scientists and citizen fatigue.
Some of these studies that we’re seeing, they want to outgo to our entire patient group
and look at issues — one minute, and I’ll speak very slowly and use every second I have
left — you know, how often can we go to our entire patient community? We have more and
more requests for blast emails for this important study, that important study. “Oh, we want
to pull all these cohorts together.” I do worry about overloading our citizens, and
I think also the citizen scientists who are being called to the table currently are being
called to many tables. We really need to improve the education and the expertise of the — I
think a very valuable population out there. And with that, I will stop. Thank you. [applause] [end of transcript]

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