Program for Biomedical Ethics: The Mudd Code. A Proposal to Reform IRB Review

Transcript

• 00:00Folks.
• 00:07Hey, folks. Thanks thanks so
• 00:08much for joining us for
• 00:10the the final
• 00:12biomedical,
• 00:14evening seminar of the of
• 00:15the academic year. Thank you
• 00:16all so much.
• 00:20I I really appreciate everybody's
• 00:23engagement with with the course
• 00:25over the,
• 00:27over the year.
• 00:29And I'm I'm really excited
• 00:30about this talk,
• 00:31today. We're we're we're very
• 00:33fortunate
• 00:34to to be addressing a
• 00:35a topic that is doesn't
• 00:37get a lot of,
• 00:38attention in the media, but
• 00:40I think is enormously important
• 00:43to, the field of ethics
• 00:44and to the field of
• 00:45clinical research. And and really,
• 00:47is one of the, like,
• 00:49sort of foundational issues
• 00:51in,
• 00:52modern bioethics and in particular,
• 00:55modern research ethics. And that's
• 00:56the the the question
• 00:58of independent
• 00:59IRB review in clinical research.
• 01:02And,
• 01:04as we will hear today,
• 01:05there there are a variety
• 01:07of perspectives
• 01:08on IRB research, and, we'll
• 01:11be hearing from folks
• 01:13with some very different perspectives.
• 01:15And,
• 01:17you know, this is,
• 01:20in addition to a
• 01:22discussion of,
• 01:24IRBs and the practices of
• 01:25IRBs and and,
• 01:29a review of of how
• 01:30IRBs might be,
• 01:32improved or modified.
• 01:34It's it's also an experiment
• 01:36in a public,
• 01:40recorded,
• 01:42discussion of of a somewhat
• 01:44controversial topic,
• 01:45and,
• 01:46we're gonna sort of engage
• 01:47in this together as a
• 01:48group.
• 01:49I've,
• 01:50we've been thinking a lot
• 01:51about sort of what our
• 01:53ground rules and expectations
• 01:55for these kinds of of
• 01:56conversations,
• 01:57and
• 01:59we have some thoughts about
• 02:00that.
• 02:02You know, we're we're committed
• 02:03to hosting seminars that model
• 02:05respectful,
• 02:06rigorous intellectual exchange. We invite
• 02:09speakers and discussants
• 02:10who hold genuinely different views
• 02:12on contested questions, and we
• 02:14believe that disagreements
• 02:16conducted well in full view
• 02:18of an engaged audience are
• 02:19among the most valuable contributions
• 02:21that a bioethics program can
• 02:23make within the, academic medical
• 02:25center.
• 02:27With that goal in mind,
• 02:29we're gonna ask all participants,
• 02:30That includes both the panelists
• 02:32and also,
• 02:33audience members and and folks
• 02:35who are coming in with
• 02:36questions and comments,
• 02:38from,
• 02:39the audience, which include a
• 02:40number of experts,
• 02:42in,
• 02:44IRB review, in clinical research
• 02:47to to try to embrace
• 02:49the following shared expectations.
• 02:52So these are not constraints
• 02:53on discussion. They are conditions
• 02:54that make genuine discussion,
• 02:57possible and and better.
• 03:00So some shared expectations that
• 03:02we're gonna try to to
• 03:03hold to during this,
• 03:05discussion and that we're going
• 03:06to,
• 03:07continue to use and and
• 03:09modify in in future discussions
• 03:11are the following.
• 03:12We're gonna try to assume
• 03:13good faith.
• 03:16We're going to engage with
• 03:17curiosity and not just conviction.
• 03:20We're going to, to the
• 03:21extent that time allows,
• 03:24steel man or,
• 03:26articulate
• 03:27a strong position
• 03:29of the view that you
• 03:30are critiquing.
• 03:33We're going to try to
• 03:33distinguish empirical claims from normative
• 03:36claims.
• 03:37We're going to critique the
• 03:38argument, not the person. We're
• 03:40going to be respectful,
• 03:42and we're gonna welcome intellectual
• 03:43updating.
• 03:45Our seminars are educational events,
• 03:47not debates with winners and
• 03:48losers. The measure of success
• 03:50of this event
• 03:52will be whether the not
• 03:54whether a position prevails,
• 03:56but whether the audience and
• 03:57the participants themselves leave with
• 03:59a richer and more nuanced
• 04:00understanding
• 04:02of the question and issue
• 04:03at hand. We hope that
• 04:05these shared expectations help create
• 04:06the conditions for for for
• 04:08this process.
• 04:08We're grateful to to all
• 04:10of you, especially our panelists,
• 04:12for joining us and for
• 04:13being willing to have this
• 04:14conversation in public,
• 04:17in good faith and with
• 04:18intellectual courage.
• 04:20I want to turn now
• 04:21to
• 04:22introducing you to to our
• 04:24esteemed panelists.
• 04:26So we're very fortunate today
• 04:28to have Evan Morris, PhD.
• 04:30He's a professor of radiology
• 04:31and biomedical imaging, biomedical engineering,
• 04:34and psychiatry.
• 04:35He's taught a course on
• 04:37professional ethics for, grad students
• 04:39for ten years here at
• 04:40Yale and at Indiana University
• 04:42and Purdue before that. He's
• 04:44been continuously,
• 04:46NIH funded for about twenty
• 04:47years, mostly to develop algorithms
• 04:49for the analysis of PET
• 04:50and fMRI images and to
• 04:52use the techniques to study
• 04:54addiction and other neuropsychiatric
• 04:56disease and to expedite drug
• 04:58development.
• 05:00Over the course of his
• 05:01career using human volunteers as
• 05:02research subjects, he has become
• 05:04increasingly frustrated by mission creep
• 05:05at IRBs,
• 05:07driven in part by expansion
• 05:08of the definition of harm.
• 05:09He's the originator of the
• 05:11MUD code, which we'll be
• 05:12discussing today,
• 05:13which he first proposed at
• 05:14a conference in the MUD
• 05:15Auditorium at the University of
• 05:17South Carolina.
• 05:19Peggy Mason, who will be
• 05:20joining us by
• 05:22Zoom from, I believe, Chicago,
• 05:26grew up in the Washington,
• 05:27DC area and worked in
• 05:28taxidermy at the Smithsonian Museum
• 05:30of Natural History during middle
• 05:32and high school.
• 05:34She received her BA in
• 05:35biology in nineteen eighty three
• 05:36and her PhD
• 05:38in neuroscience in nineteen eighty
• 05:39seven, both from Harvard.
• 05:41After postdoctoral work at UCSF,
• 05:44she joined the faculty at
• 05:45the University of Chicago in
• 05:47nineteen ninety two.
• 05:48She's now professor of neurobiology
• 05:50there.
• 05:51After two decades investigating the
• 05:53cellular mechanisms of pain modulation,
• 05:55doctor Mason turned her energies
• 05:57to understanding the biology of
• 05:58empathy and helping behave and
• 06:01helping behavior in rats.
• 06:03Since two thousand seventeen, she
• 06:04has studied an individual
• 06:06who uniquely lacks all cutaneous
• 06:08sensation.
• 06:10Lee Jessam is distinguished professor
• 06:12of psychology at Rutgers,
• 06:14where he has chaired the
• 06:15departments of psychology and anthropology
• 06:18and the criminal justice program.
• 06:20He's a founding member of
• 06:21the Academic Freedom Alliance and
• 06:23the Society for Open Inquiry
• 06:24in the Behavioral Sciences,
• 06:26and his scholarship addresses bias,
• 06:28accuracy,
• 06:29radicalization,
• 06:30and how dysfunctional academic norms
• 06:32threaten the validity of work
• 06:34produced by the social sciences.
• 06:37Finally,
• 06:39we have,
• 06:40Ed Monaco, MD JD,
• 06:43who brings a rare combination
• 06:45of experience
• 06:46at the intersection of emergency
• 06:47medicine, law, and research ethics.
• 06:50Doctor Monaco has spent decades
• 06:52working on questions of informed
• 06:53consent, both in the clinical
• 06:55setting and through his long
• 06:56service on Yale's institutional review
• 06:58board,
• 06:59where he's chaired multiple committees.
• 07:01He earned his MD from
• 07:03the University of Maryland,
• 07:04completed his emergency medicine training
• 07:06through the Georgetown George Washington
• 07:08shot trauma program and joined
• 07:10the Yale faculty in nineteen
• 07:11ninety three, where he helped
• 07:13establish the emergency medicine residency
• 07:14program.
• 07:16Recognizing the legal dimensions of
• 07:17the ethical challenges he encountered,
• 07:19he later earned a JD
• 07:21with a focus on health
• 07:22law.
• 07:24Doctor Monica's work explores how
• 07:26legal frameworks and clinical realities
• 07:28shape what meaningful consent looks
• 07:29like in practice.
• 07:31And so with that, I'd
• 07:32like to welcome a warm
• 07:34I'd like to give a
• 07:35warm welcome to all of
• 07:37our panelists and to our
• 07:38audience, and and thank you
• 07:39all for your participation. Thank
• 07:41you, guys.
• 07:47So we're we're going to
• 07:49start,
• 07:50with,
• 07:52doctor Morris,
• 07:53is gonna lead us off.
• 07:55And we're gonna go through,
• 07:57the the authors of the
• 07:58MUD code first over the
• 07:59course of about forty minutes,
• 08:01and then we'll turn things
• 08:02over to, doctor Monaco to,
• 08:05offer his perspective
• 08:06as a, expert in the
• 08:08IRB and an IRB chair.
• 08:10Thank you.
• 08:17Okay. So I guess you
• 08:18have the CME information
• 08:20that you need. Thank you
• 08:22very much, Ben, for the
• 08:23introduction and for everybody who's
• 08:24joining us. I'm delighted
• 08:26to be here with my
• 08:28panelists and co authors, and
• 08:29I'm delighted that Ed has
• 08:31chosen and has been willing
• 08:33to join us also.
• 08:35Okay. So
• 08:37those are the panelists.
• 08:39If you're not in the
• 08:40right place, just eat the
• 08:42free food, and we won't
• 08:43tell anybody.
• 08:45But,
• 08:46of those four people,
• 08:49this is the four who
• 08:51collaborated.
• 08:52So Sally Satel is our
• 08:53friend
• 08:54at, the American Enterprise Institute,
• 08:57who was our fourth collaborator
• 08:58on what I'm going to
• 08:59describe or we're going to
• 09:01describe collectively.
• 09:02And I have to say,
• 09:03it was a delightful
• 09:05collaboration. It's rare that we
• 09:06have so much fun
• 09:08writing a paper.
• 09:10And this is the paper.
• 09:12I'm just checking my watch.
• 09:13Good. Okay. And the paper
• 09:15we wrote,
• 09:16which was published in the
• 09:17Journal of Controversial
• 09:18Ideas
• 09:20is
• 09:20Science is the Thing, Why
• 09:23and How to Restore Balance
• 09:25Between US Institutional Review Boards
• 09:27and Investigators. And you can
• 09:29infer properly from that title
• 09:31that, yes, we believe there
• 09:32is an imbalance.
• 09:36And this is the roadmap
• 09:38as it were for what
• 09:39I want to cover with
• 09:41the help of my colleagues.
• 09:43We're gonna make a claim.
• 09:44It's in the paper. We're
• 09:46gonna,
• 09:47digress
• 09:48just a tiny bit for
• 09:49some historical perspectives,
• 09:51some historical examples,
• 09:53what we think are trends,
• 09:56one of which is particularly
• 09:57as Ben mentioned,
• 09:59what we think and others
• 10:01have written about is the
• 10:02evolution
• 10:03in the concept of harm.
• 10:05Then we come back to
• 10:06the Belmont Report
• 10:08and essentially,
• 10:10propose
• 10:11our
• 10:12principles, which we hope and
• 10:14are intended
• 10:15not to destroy the Belmont
• 10:17Report, but to
• 10:19strengthen them. To strengthen them
• 10:22and to help them be
• 10:24the focus of,
• 10:26the IRBs work.
• 10:28And then Ed will will
• 10:29add his
• 10:30thoughts.
• 10:32Okay. So here's our claim
• 10:34in short.
• 10:35IRBs have expanded their control
• 10:38and scope beyond original intent.
• 10:41Today,
• 10:42a drive to eliminate all
• 10:44risk and to preclude all
• 10:46potential criticism of the institution
• 10:49seems to animate the IRB.
• 10:52The result is frustrated
• 10:55researchers,
• 10:56alienated
• 10:57participants, meaning subjects,
• 11:00and impeded scientific
• 11:02progress.
• 11:04Now,
• 11:05it's worth also noting
• 11:07that
• 11:08part of the evolution may
• 11:10be in fact due to
• 11:12the reigning
• 11:13governing documents. And you're all
• 11:15familiar with these documents, so
• 11:16I'm gonna assume a very
• 11:17high level of knowledge on
• 11:19the part of the audience
• 11:20and I'm not gonna explain
• 11:21them per se. But I
• 11:23think it's interesting to note
• 11:24in the work of Schoopman
• 11:25and Moreno
• 11:27that they compared and contrasted
• 11:29the Nuremberg Code, which you
• 11:31know emerged
• 11:32in the
• 11:33doctor trials after World War
• 11:35II, with the Belmont Report,
• 11:37which is the American
• 11:39answer or or,
• 11:42descendant of the Nuremberg Code.
• 11:44And the Nuremberg Code was
• 11:45actually written by experimenters,
• 11:48and it can be interpreted
• 11:49as guidelines for self regulation.
• 11:53Whereas the Belmont Report
• 11:55introduced vulnerable classes
• 11:57and along with the introduction
• 11:59of the
• 12:01IRB,
• 12:02takes the perspective
• 12:04out from away from the
• 12:05investigator
• 12:07and transforms it into a
• 12:09more
• 12:10external
• 12:11regulation
• 12:13document.
• 12:14So that's why,
• 12:16it's an idea to keep
• 12:17in mind.
• 12:19And Moreno earlier
• 12:21had proposed
• 12:22or sort of dissected
• 12:25or analyzed the history of
• 12:26the IRB
• 12:27by by considering
• 12:30separate historical epics, and he
• 12:32called them the weak protection,
• 12:35moderate protection, and strong protection
• 12:37errors, and you can see
• 12:38how they're distributed in time
• 12:41from immediately after their Nuremberg
• 12:43Code to the eighties, eighties
• 12:44to two thousand, and then
• 12:45he was writing in two
• 12:47thousand and one about the
• 12:48advent of the strong protection.
• 12:51But in our paper,
• 12:53we argue that we've now
• 12:55moved into something yet different,
• 12:57which is what we call
• 12:58the era of hyper
• 13:00protection.
• 13:01And we invite you to
• 13:02read the whole
• 13:03paper at your leisure.
• 13:05So let's start just for
• 13:07perspective with what Moreno would
• 13:09have called prehistory
• 13:11before the Nuremberg Code, and
• 13:13I commend to you one
• 13:14of my favorite books, Who
• 13:16Goes First by Lawrence Altman,
• 13:18which which,
• 13:19alerted me to the story
• 13:21I'm gonna tell right now.
• 13:24And, this is from nineteen
• 13:26twenty nine in Eberswald,
• 13:27Germany, and this is extremely
• 13:29dangerous
• 13:30for an engineer to stand
• 13:31in front of what I
• 13:32suspect is a, an audience
• 13:34of many doctors and tell
• 13:36you what this is. It's
• 13:37an X-ray.
• 13:39But, of course, many of
• 13:41you, and if there are
• 13:41radiologists
• 13:42in the in the audience
• 13:44who wanna identify themselves, it's
• 13:46a particular X-ray. And what's
• 13:47most important about it is
• 13:49the catheter snaking up the
• 13:51subject's arm around the jugular
• 13:54and down into the heart.
• 13:56And this is what Forsman
• 13:58did in Germany in nineteen
• 13:59twenty nine, and you know
• 14:01who the subject was.
• 14:03It was Forsman.
• 14:06So he did it to
• 14:07himself, and what I love
• 14:08about the translated version of
• 14:10the paper is it says
• 14:12because, of course, he knew
• 14:13he had to document this.
• 14:15I had to climb staircases
• 14:17on foot and return while
• 14:19the probe was lying in
• 14:20my heart because the X-ray,
• 14:24facility was upstairs from the
• 14:26cath lab.
• 14:27But he's careful to also
• 14:29note,
• 14:30but I was not aware
• 14:31of any unpleasantness.
• 14:34So you also know if
• 14:36you're radiologists
• 14:37or just,
• 14:38devotees
• 14:39of Nobel history that Forssmann
• 14:42won the Nobel Prize for
• 14:43this work in nineteen fifty
• 14:45six, and my radiology
• 14:46colleagues have told me that
• 14:47this is really the beginning
• 14:49of interventional
• 14:50radiology.
• 14:52So there's just something
• 14:54about Forsman's daring do
• 14:57that is worth noting here
• 14:59and
• 15:00daring do that carried him
• 15:02forward even though his boss,
• 15:03according to Altman, told him
• 15:05not to do it.
• 15:07Okay. So let's move into
• 15:08an example for fun from
• 15:10the weak protection area. And
• 15:12now if there's any audience
• 15:14members who are Red Sox
• 15:15fans, they'll know that that's
• 15:17Bob Montgomery,
• 15:18former second
• 15:20string catcher for the Red
• 15:21Sox, and he's famous because
• 15:23he was the last man
• 15:24in baseball ever to bat
• 15:25with just a baseball cap
• 15:27and not
• 15:29a helmet.
• 15:30So weak protection.
• 15:32Okay.
• 15:33All the Red Sox fans
• 15:34and I will get together
• 15:35later for drinks.
• 15:37And if you're a psychiatrist
• 15:40in the audience, I know
• 15:41you're out there.
• 15:43You know these images
• 15:45from now we're in the
• 15:46weak protection era according to
• 15:47Moreno Moreno are the first
• 15:49ever dope images of dopamine
• 15:52receptors
• 15:53in the living human brain.
• 15:56And they turned out to
• 15:57be in the living human
• 15:59brain of a quite healthy
• 16:00and smart fifty six year
• 16:01old Caucasian male,
• 16:03and the paper was published
• 16:05in Science. It's quite notable
• 16:07and still cited.
• 16:09And who was that fifty
• 16:11six year old? Well, it
• 16:12just so happens here are
• 16:13the c first and senior
• 16:15authors, Henry Wagner and Mike
• 16:16Kuhar, who sent me the
• 16:18Baltimore Sun article. And, yes,
• 16:21Soree,
• 16:22it was Henry Wagner.
• 16:24He was the fifty six
• 16:25year old. And,
• 16:27at that time,
• 16:29in the early eighties, at
• 16:31least in the science paper,
• 16:33there is no mention of
• 16:35IRB approval.
• 16:36All that's mentioned in that
• 16:37paper is, well, after the
• 16:39baboon, one of us jumped
• 16:41on the table and scanned
• 16:42ourselves.
• 16:44So there's there's something about
• 16:46the
• 16:48the motivation, the passion, the
• 16:49daring do of investigators
• 16:52that all of you who
• 16:53are who are investigators,
• 16:55you have it, and I
• 16:57have it. And we we
• 17:02it will it cannot be
• 17:03lost.
• 17:04It's very valuable, and it
• 17:06has to be preserved. Keep
• 17:07that in mind. Alright. Now
• 17:09we move into the era
• 17:10of strong protection. And what
• 17:12would Bob Montgomery think of
• 17:13that
• 17:14carapace
• 17:15that,
• 17:16that, what's his name, Cunha
• 17:18wears when he gets up
• 17:19to bat?
• 17:20Strong protection. But
• 17:22you know? Okay.
• 17:24So in, Indianapolis
• 17:27in two thousand and six,
• 17:29yours truly was dreaming, and
• 17:31he was dreaming of having
• 17:33his own Henry Wagner moment.
• 17:36And so
• 17:37he hoped to
• 17:39scan himself
• 17:41as a control in a
• 17:42newly funded grant. So, of
• 17:45course,
• 17:46he followed the rules
• 17:48and appealed to the IRB
• 17:50to be able to scan
• 17:52himself.
• 17:53That's me. And the IRB
• 17:55eventually came back with this.
• 17:58How will the investigator
• 18:00consent himself?
• 18:02And I thought, oh my
• 18:03god.
• 18:04We've really confused,
• 18:06unfortunately,
• 18:07principle,
• 18:08that is to say informed
• 18:10consent, with procedure
• 18:12obtaining consent.
• 18:14And I worry that that's
• 18:16indicative
• 18:18of a
• 18:19shift towards
• 18:21too much
• 18:22concern about procedure.
• 18:25Oh, that's what I said.
• 18:27Cleaned up, suffice it to
• 18:29say.
• 18:30Okay.
• 18:31So
• 18:31this so for me and
• 18:33my interaction,
• 18:34it started shortly thereafter in
• 18:36two thousand twenty three when
• 18:38I wrote an article. And
• 18:39I said, when rules and
• 18:40regulations are illogical and overly
• 18:42burdensome,
• 18:43their primary effect is to
• 18:44dampen enthusiasm for research and
• 18:46to delay scientific progress. And
• 18:48I would say that another
• 18:50keyword to keep in your
• 18:51minds besides daring do is
• 18:53enthusiasm.
• 18:54That's what drives science. Nowadays,
• 18:56frankly, and I bet a
• 18:57lot of you,
• 18:59feel the same way, I
• 19:00don't know how many people
• 19:01are on Zoom, maybe they're
• 19:03nodding their heads,
• 19:04that sometimes I just give
• 19:05up on ideas for fear
• 19:06of the protracted review
• 19:08process.
• 19:09Okay. So quickly,
• 19:11I think there's a few
• 19:12things going on.
• 19:14There are some trends,
• 19:16and one has been
• 19:18that here's the revised common
• 19:20rule, then we'll get to
• 19:21the trend.
• 19:22It it well, it's a
• 19:23trend to look for harm.
• 19:25And in the revised common
• 19:27rule, it says that the
• 19:28IRB should not consider the
• 19:29possible long range effects
• 19:31long range effects
• 19:33of applying knowledge gained in
• 19:34the research. And yet Klitzman
• 19:36Robert Klitzman from Columbia, in
• 19:38this also very good book
• 19:39that I recommend to you,
• 19:40Ethics Police said, but after
• 19:42conducting extensive interviews with IRB
• 19:44members, Klitzman observed that IRB
• 19:46members ignore the regulations,
• 19:48that IRB should not include
• 19:50considerations of long term
• 19:52harm.
• 19:54And that's one thing to
• 19:55think about. And in this
• 19:56wonderful paper that actually the
• 19:57previous speaker at this series,
• 20:00Nicholas Christakis,
• 20:01put me on to by
• 20:02Lavari et al,
• 20:03they how many people know
• 20:05this study already?
• 20:08Okay. It's definitely go home,
• 20:10have a drink on me,
• 20:11and put your feet up
• 20:12and read it because it's
• 20:13only about three pages. And
• 20:15in short, we can get
• 20:16into it later, but,
• 20:19the study was to assemble
• 20:21faux IRB panels and to
• 20:24give them made up protocols
• 20:27of varying degrees of unethical
• 20:30behavior.
• 20:32And then in the study
• 20:34group, they had them come
• 20:35back again after they'd already
• 20:37proved that groups are very
• 20:39reproducible
• 20:40in their responses
• 20:41to these different studies,
• 20:43and they had shifted the
• 20:44degree of unethical
• 20:46behavior. They had reduced it.
• 20:48And yet
• 20:50the study,
• 20:51participants,
• 20:52the fake
• 20:53committee members still found
• 20:56the same percentage
• 20:58of unethical
• 20:59behaviors.
• 21:00And if you're a pharmacologist,
• 21:02sort of like me, then
• 21:03you know that the e
• 21:05d fifty, the the ethical
• 21:07dose, the effective dose at
• 21:10which there you
• 21:11get fifty percent
• 21:13calling out ethic unethical behavior
• 21:15shifts to the left.
• 21:18Alright? So maybe that's going
• 21:20on too. Now we're into
• 21:21hyperprotection,
• 21:22and Bob Montgomery would wonder
• 21:24if you could play baseball
• 21:26in that thing.
• 21:28And I'm going to now
• 21:29give way for a a
• 21:31good few minutes for some
• 21:33stories
• 21:34and anecdotes
• 21:35and relevant,
• 21:37words from Peggy Mason.
• 21:40Peggy?
• 21:42Can Luke Hi, everyone. So
• 21:45yeah.
• 21:47Can you hear me?
• 21:48Yep. We can see you
• 21:50too.
• 21:52Great. Great. So,
• 21:54thank you, Evan.
• 21:55So I'll give,
• 21:57a couple,
• 21:59I'll try and make a
• 22:00couple of points. And in
• 22:01this
• 22:02first
• 22:03slide,
• 22:05I was teaching
• 22:06in
• 22:07in,
• 22:08Paris in our study abroad
• 22:10program, and one of the
• 22:12really talented students
• 22:15had been in study abroad
• 22:17in Pune,
• 22:18India the quarter before.
• 22:21And it turns out I
• 22:23knew another student that had
• 22:24been there, and we talked
• 22:26about this incident that had
• 22:27happened, which was that there
• 22:29were about a dozen of
• 22:30the students off on a
• 22:32hike.
• 22:33And
• 22:35all of a sudden, a
• 22:36storm came up and
• 22:38they were standing on a
• 22:40wet rock
• 22:43and lightning hit the rock.
• 22:46And they all got hit
• 22:47by lightning,
• 22:49basically through the soles of
• 22:50their feet.
• 22:52That summer,
• 22:54this student was
• 22:56had secured a job with
• 22:58a
• 22:59company that was making a
• 23:01more affordable,
• 23:03nerve conduction,
• 23:06device.
• 23:08So she says to me,
• 23:10wouldn't it be cool if
• 23:12I
• 23:14tried to if I use
• 23:16the device on on all
• 23:18these people, it just got
• 23:19hit by lightning.
• 23:21They're all
• 23:22between the ages of nine
• 23:25twenty and twenty two,
• 23:27and they're all healthy. And
• 23:29and, you know, that would
• 23:30be fun.
• 23:32I'm sure the company would
• 23:34let me do this. And
• 23:35I thought, oh, this is
• 23:36a great idea. And at
• 23:37the time, I only worked
• 23:38on rats. So
• 23:40I said, let me see
• 23:41if I can help you
• 23:42out. And I knew that
• 23:44there had to be
• 23:45IRB approval,
• 23:47but it was my first
• 23:48interaction with IRB.
• 23:50Long story short, I I
• 23:52talked to people. They talked
• 23:53back to me. They told
• 23:55me what I had to
• 23:56do. I tried to do
• 23:57it.
• 23:58And,
• 24:01within three months,
• 24:03of
• 24:05of steadied,
• 24:07effort,
• 24:08this project and the the
• 24:10enthusiasm,
• 24:11you know, were just completely
• 24:13dead. Dead. Dead. Dead.
• 24:16Killed by, you know, this
• 24:17Byzantine
• 24:19system that certainly my student
• 24:22couldn't,
• 24:23could
• 24:24not,
• 24:26decipher, and I couldn't either
• 24:28as as it at that
• 24:29point, a tenured professor working
• 24:32on rats, but nonetheless.
• 24:34So, you can go to
• 24:35the next yeah. So two
• 24:37months later, the the project,
• 24:39our enthusiasm,
• 24:40and her ability to to
• 24:43to have fun and to
• 24:45have a first,
• 24:47project,
• 24:49of her own making,
• 24:50which was
• 24:52and, you know, I actually
• 24:53don't know what the answer
• 24:54is to it to this
• 24:55day.
• 24:56I don't think that you
• 24:57get too many situations where
• 24:59there are such a large
• 25:01collection of young, healthy
• 25:03people being struck by lightning.
• 25:06So, you know, and a
• 25:08a question that we'll never
• 25:09know the answer to. You
• 25:10know, are we gonna is
• 25:12that gonna make or break
• 25:13our our lives? Probably not.
• 25:15But,
• 25:16but
• 25:17and she did go on
• 25:18to get an MD PhD.
• 25:20She's a very talented woman,
• 25:22and so she is,
• 25:25following
• 25:25a scientific path. But,
• 25:27you know, this this didn't
• 25:29help.
• 25:31Okay. So,
• 25:34the the next thing that
• 25:35I wanna talk about is
• 25:39the way that we
• 25:43protect,
• 25:46individuals through
• 25:50a vigorous
• 25:51insistence on anonymity.
• 25:54So
• 25:54this is,
• 25:57on this slide, I talk
• 25:59about Ian Waterman. Ian Waterman
• 26:01is
• 26:03a a man now in
• 26:04his sixties,
• 26:06who lives in the UK.
• 26:07And when he was nineteen,
• 26:10he got a gastric illness.
• 26:12And then the next moment
• 26:14he know
• 26:15he he sort of he
• 26:16passes out. And when he
• 26:18wakes comes to, he says
• 26:20that he felt as though
• 26:21he was floating
• 26:23in cold.
• 26:27And,
• 26:29what had happened was that
• 26:30the gastric illness had set
• 26:32off an autoimmune response that
• 26:34had killed all of his
• 26:35large
• 26:37fiber somatosensory
• 26:38nerves.
• 26:40So he has no sense
• 26:42of touch,
• 26:44vibration,
• 26:45or proprioception
• 26:47from the neck down.
• 26:50He is
• 26:52if you wanna be a
• 26:53lumper, he's one of about
• 26:56ten who are alive, maybe
• 26:58twenty or twenty five
• 27:00of all time that are
• 27:02known with this condition.
• 27:05But you can also be
• 27:06a splitter. He's the youngest
• 27:07to ever have this, and
• 27:09he's the only one
• 27:11that we are aware of
• 27:13that had this and then
• 27:15thought himself how to to
• 27:16walk again.
• 27:19As fate would have it,
• 27:20he
• 27:21he met Jonathan Cole,
• 27:24an amazing,
• 27:26neurologist in UK,
• 27:29and Jonathan,
• 27:31ended up
• 27:32studying,
• 27:34Ian.
• 27:35And Jonathan has studied Ian
• 27:37all over the all over
• 27:38Europe,
• 27:39all over the United States,
• 27:42and he wrote two books.
• 27:44And he also arranged for
• 27:46the BBC to create a
• 27:47a
• 27:48a movie called the man
• 27:49who lost his body.
• 27:51So what Jonathan tells me
• 27:53is that when he wrote
• 27:54the first book, which is
• 27:55called Pride in a Daily
• 27:57Marathon,
• 27:58he wrote it as IW.
• 28:01And,
• 28:02his editor said, you know,
• 28:04what do you think about
• 28:06calling him Ian Waterman?
• 28:09So,
• 28:11Jonathan
• 28:12phones up.
• 28:13Ian says,
• 28:15what would you prefer? And
• 28:16he says, yep. I'd prefer
• 28:18to be Ian Waterman.
• 28:20And,
• 28:21and so
• 28:23to this day,
• 28:25bizarrely, in,
• 28:27in scientific reports, we still
• 28:29call him IW.
• 28:30But Ian
• 28:32actually wants to be known.
• 28:33He wants
• 28:35this has changed his life,
• 28:37and he volunteers
• 28:39through the generosity
• 28:41of of you know, through
• 28:42incredible generosity to be the
• 28:44subject of,
• 28:46scientific investigations.
• 28:48He dedicates
• 28:49time to this and effort.
• 28:51He's very serious when when
• 28:53you ask him to do
• 28:54a a task.
• 28:57And we've learned a ton
• 28:58about him. Not necessarily
• 29:00not you know,
• 29:02is this clinical research? I
• 29:03don't consider it clinical research.
• 29:05I call I consider it
• 29:06basic research on a human.
• 29:08So what we've learned is
• 29:09about
• 29:10the,
• 29:12somatic we've learned basic information
• 29:14about how the somatosensory
• 29:16system works,
• 29:17with this very particular person.
• 29:19Now
• 29:20Lumper Splitter, he's rare, but
• 29:22he's not unique.
• 29:24And in the next slide,
• 29:28yeah, is a person who
• 29:30is unique. And this is
• 29:31a person who took,
• 29:33my
• 29:34course.
• 29:38I have an online course
• 29:39on neurobiology,
• 29:40and she took it.
• 29:42And
• 29:43that was back in twenty
• 29:44fourteen, and we joined forces.
• 29:46And since about twenty seventeen,
• 29:48we've had a very active,
• 29:50scientific series of scientific investigations.
• 29:56And the hurdles that we
• 29:57have gone through
• 29:59to allow her to be
• 30:01known, she does not want
• 30:02to be called by her
• 30:03initials, initials, which are k
• 30:05s.
• 30:07She wants her story told.
• 30:09She's very clear on that.
• 30:11And it it turns out
• 30:12that she's trained as a
• 30:13lawyer. So she when I
• 30:15asked her, I said, how
• 30:16do you wanna be called
• 30:17in these,
• 30:20in in
• 30:21these articles? And the journals
• 30:23were giving me a pushback
• 30:25because they didn't want,
• 30:27her name to be used.
• 30:29They wanted to protect her
• 30:31beyond
• 30:33what I told them,
• 30:35her desire was. So I
• 30:37said, Kim, they're not gonna
• 30:38listen to me, which is
• 30:39appropriate.
• 30:42Give me
• 30:43you know, you write them
• 30:44and tell them how you
• 30:45feel. And this is what
• 30:46she wrote. It is my
• 30:47desire to be identified by
• 30:48my first name
• 30:50in research papers about my
• 30:51condition. I want the world
• 30:53to know my unique story
• 30:54and all that I have
• 30:55experienced. The only way to
• 30:56accomplish this goal is to
• 30:57identify myself.
• 30:58I've made this decision on
• 30:59my own after careful consideration
• 31:01and with no undue influence
• 31:03from any research team member.
• 31:05I am fully cognizant
• 31:07of and comfortable with any
• 31:09associated
• 31:10risks. And you can see
• 31:11the the lawyerliness of this
• 31:13comes,
• 31:15shining through here.
• 31:18The the the bottom line
• 31:20is
• 31:21we we protect people
• 31:23beyond
• 31:24the
• 31:25degree to which they desire
• 31:27to be protected. And this
• 31:29is
• 31:30a
• 31:31a really
• 31:33pernicious form
• 31:35of,
• 31:37of,
• 31:41protection
• 31:42of hyperpaternalism,
• 31:45hyperprotectionism.
• 31:46And so I I just
• 31:48wanna
• 31:49encourage people to
• 31:50to allow people
• 31:52with rare conditions and with
• 31:54not rare conditions to dictate
• 31:56how they
• 31:58feel about their data
• 32:00and their privacy,
• 32:03with respect to their data.
• 32:04Okay. And I'll turn it
• 32:05back over
• 32:06to Evan and Lee.
• 32:09K. Thank you, Peggy.
• 32:11Okay. So now I'm gonna
• 32:12turn to the third member
• 32:14of our team and just,
• 32:16say that
• 32:18not all of the issues
• 32:19here
• 32:20are about
• 32:22protection of the subjects
• 32:24only. There are also issues,
• 32:26which I think Lee will
• 32:27touch on, which have which
• 32:29you could see through the
• 32:31lens of academic freedom, and
• 32:33that may come up.
• 32:36Do I,
• 32:38navigate? How do I navigate
• 32:39this? I think it's all.
• 32:40Yeah. I think it's all.
• 32:42And Yeah. Tell me, do
• 32:42you wanna stay there or
• 32:43you wanna go to the
• 32:44next one? Yeah. So I
• 32:45yeah. Okay. Well, thanks for
• 32:47having me. Thanks for hosting
• 32:48this
• 32:49sorely needed panel in my
• 32:51opinion.
• 32:54I'm gonna mostly tell you
• 32:56a story. I don't know
• 32:57if I'm gonna get to
• 32:58the
• 33:00illegal nature and how to
• 33:02rein them in
• 33:04as part of the main
• 33:05talk. But if I don't,
• 33:06I hope to in the
• 33:07q and a.
• 33:09So
• 33:10yes. Let's
• 33:11that's a much better image
• 33:13of the woman.
• 33:16Oh my god. Okay. I'm
• 33:17gonna tell you a story,
• 33:19true story.
• 33:20It's the story of how,
• 33:22Nate Honeycutt and I were
• 33:24investigated and investigated
• 33:26and investigated
• 33:27by the Rutgers IRB
• 33:29for nothing.
• 33:31Nate, joined my lab as
• 33:33a grad student in two
• 33:34thousand sixteen.
• 33:35By two thousand eighteen or
• 33:37so,
• 33:38we were collaborating on surveys.
• 33:39I'm a social psychologist. I
• 33:41don't do bio med. We
• 33:42ask people questions.
• 33:44I'll get more to that.
• 33:46Collaborating on surveys, investigating
• 33:48political bias and radicalization,
• 33:50especially among higher education faculty,
• 33:53and I'll come back to
• 33:54that in a minute.
• 33:56In two thousand twenty two,
• 33:58we were subject to three
• 33:59separate audits of our work
• 34:02initiated by the Rutgers IRB.
• 34:05This involved an outside investigator
• 34:07who was charged with performing
• 34:09a, quote, for cause, unquote,
• 34:12review of our research. So
• 34:13that's a technical term in
• 34:15the IRB world as far
• 34:16as I know. That, as
• 34:18far as I understand it,
• 34:20means that the IRB
• 34:22received
• 34:23at least one complaint about
• 34:25our study. So that's what
• 34:27makes it for cause
• 34:28somebody complained.
• 34:31The first audit caught us
• 34:32by surprise,
• 34:34and the IRB kept us
• 34:36in dark about the nature
• 34:37of the complaints
• 34:39or complaint that had lodged
• 34:41against us,
• 34:43but we
• 34:44complied with everything they told
• 34:45us to do. We had
• 34:46nothing to hide, and I'll
• 34:47get more about what that
• 34:48involved
• 34:49get to what that involved
• 34:51in a minute.
• 34:52Then we were notified that
• 34:54we were being audited a
• 34:55second time for a completely
• 34:56different study. And then when
• 34:57we learned that we were
• 34:59being audited for, yeah, the
• 35:00third study, we were like,
• 35:01what the hell is going
• 35:02on here?
• 35:05So the IRB, we later
• 35:07discovered,
• 35:08had received some, what I
• 35:09would describe as, bizarre complaints,
• 35:13about our surveys.
• 35:15They'd, been told that our
• 35:17survey questions were
• 35:19biased,
• 35:20offensive,
• 35:22and being used to
• 35:23draw conclusions or to support
• 35:25a political agenda.
• 35:27I'm gonna come back to
• 35:28that in a minute too.
• 35:29We were never told not
• 35:31only who made the complaints,
• 35:32we actually never saw the
• 35:34exact text of the complaints.
• 35:35They were just characterized to
• 35:36us by RAB folks.
• 35:38And we were never told
• 35:40which of our survey questions
• 35:41were found to be biased
• 35:42or offensive.
• 35:46I don't know whether this
• 35:47is
• 35:49like an HHS
• 35:50mandatory
• 35:51rule. But at Rutgers,
• 35:53those types of complaints
• 35:55always trigger a full investigation.
• 35:58And saying at Rutgers doesn't
• 35:59mean it's not true anywhere
• 36:00else. I have no idea
• 36:01whether it's true or not
• 36:02at other places.
• 36:04The outside investigators
• 36:05required us to produce documentation
• 36:08of every single aspect of
• 36:11each of the three projects,
• 36:13all our data,
• 36:14research protocol documents,
• 36:17informed consent forms, that is
• 36:19so if we had a
• 36:19thousand people, we had to
• 36:20provide the thousand consent forms,
• 36:23recruitment materials, survey instruments and
• 36:26questionnaires,
• 36:27data analysis materials. So we're
• 36:29doing analysis in our SPSS.
• 36:30We did give them the
• 36:32code and the progress. It's
• 36:33just crazy stuff.
• 36:35Records of all communications with
• 36:37the IRB. So when we
• 36:38get
• 36:40bureaucratic notifications
• 36:42that, we need to,
• 36:47revise a protocol, which
• 36:49we'd have to send them
• 36:50that.
• 36:52And,
• 36:53and and we had to
• 36:55provide them all communications
• 36:56with any participant across the,
• 37:00across the set of studies
• 37:01no matter what the topic.
• 37:02So if a participant had
• 37:03emailed us
• 37:05asking us to send them
• 37:06the paper after the study
• 37:08got published, we would have
• 37:09to track that email and
• 37:10all emails, write it down,
• 37:11get this to the auditor.
• 37:14They even asked us to,
• 37:15create explainer documents.
• 37:17So this is over a
• 37:18month. There's so much other
• 37:19stuff. Now yeah. Explain.
• 37:21Oh my god. I'm sorry.
• 37:24They asked us to to
• 37:25create explainer documents to accompany
• 37:27the material.
• 37:29So
• 37:30this kind of survey work
• 37:32generates a ton of paperwork.
• 37:34And over the course of
• 37:35the three audits,
• 37:37we produced over three thousand
• 37:40pages
• 37:41of supporting documentation.
• 37:44On top of that, there
• 37:45were interminable phone calls with
• 37:47either the Rutgers IRB or
• 37:48the auditors,
• 37:49and we spent more than
• 37:50five hours in meetings.
• 37:53The three investigations took six
• 37:55months
• 37:56over
• 37:57two thousand twenty two.
• 37:59None of the investigations turned
• 38:01up anything.
• 38:03Each time, the auditor reported,
• 38:05and I quote,
• 38:07there were no regulatory
• 38:08findings discovered during this review
• 38:10as the study followed the
• 38:12approved protocol.
• 38:13This should be obvious. I'll
• 38:15get to bed also in
• 38:16a minute.
• 38:17So all these hours of
• 38:19effort in this, like, mind
• 38:20numbing
• 38:21bureaucratic tedium, as far as
• 38:23I can tell, serve no
• 38:25constructive purpose whatsoever.
• 38:27The upshot was this horrendous
• 38:29waste of time, but this
• 38:31and it should have been
• 38:32a foreseeable waste of time.
• 38:35Complaints like these, like the
• 38:36questions are biased, the study
• 38:38has a political agenda, whatever
• 38:39it is, should be dismissed
• 38:41out of hand because they
• 38:43are irrelevant.
• 38:44Asking biased or offensive questions
• 38:47does not constitute an ethics
• 38:49violation.
• 38:51Social scientist asks ask,
• 38:55offensive and biased questions
• 38:57all the time. It's what
• 38:59we do. So for example,
• 39:02something that has come under
• 39:03intense investigation over the last
• 39:05ten years
• 39:06in my area of sort
• 39:08of political extremism
• 39:10is known as left wing
• 39:11authoritarianism.
• 39:13Right wing authoritarianism has been
• 39:14studied since nineteen forties and
• 39:16fifties.
• 39:17Left wing authoritarianism in the
• 39:18last ten years. So here
• 39:19are two questions from a
• 39:21common left wing authoritarianism about
• 39:23which we administer.
• 39:24So people are asked to
• 39:25agree or disagree, how much
• 39:26they agree or disagree with
• 39:27these statements.
• 39:28All political conservatives are fools.
• 39:32Second question. It's important that
• 39:34we destroy the West's nationalist,
• 39:36imperialist values.
• 39:38Are those biased questions? Of
• 39:39course, they're biased. We're trying
• 39:40to get a left wing
• 39:41authoritarian. Of course, they're biased
• 39:43questions.
• 39:44Well, shoot me now. Okay.
• 39:47Researchers
• 39:48have every right to ask
• 39:50such questions.
• 39:51And in fact, it's sometimes
• 39:52unavoidable.
• 39:53Some of the most
• 39:55widely used and trusted measures
• 39:57of political extremism
• 39:59are inherently biased because they
• 40:00measure extremist beliefs. The social
• 40:03sciences are filled with questionnaires
• 40:05assessing things like people's endorsement
• 40:07of conspiracy theories, the derogatory
• 40:10views of social groups, also
• 40:12known as prejudice,
• 40:14willingness to condone political violence.
• 40:16This is what we do.
• 40:17This is the
• 40:19it's normal social science.
• 40:21All our study participants had
• 40:23signed a consent form.
• 40:25None were coerced into doing
• 40:27anything. And if they found
• 40:29a question offensive,
• 40:30they didn't have to answer
• 40:31it or they could leave
• 40:32the study.
• 40:33There was there was
• 40:35zero risk
• 40:36of anything remotely resembling
• 40:39harm
• 40:40to the participants in our
• 40:41studies,
• 40:44and we follow the protocol.
• 40:46What that means
• 40:47is we were relentlessly
• 40:49investigated
• 40:50for the ethical equivalent
• 40:52of being accused
• 40:54of driving fifty four miles
• 40:55an hour in a fifty
• 40:57five mile an hour zone.
• 40:59That is even if the
• 41:00accusations were completely true, they
• 41:03constituted
• 41:04no violation
• 41:05of anything.
• 41:08Oh my god. Given that
• 41:09the entire questionnaire had already
• 41:11been approved and deemed ethical
• 41:12by the IRB,
• 41:14complaints about the nature of
• 41:15the questions we asked
• 41:17should have been simply
• 41:19ignored.
• 41:20In the US,
• 41:22anyone can sue anyone else
• 41:23for anything.
• 41:25But if I sue you
• 41:26because I don't like your
• 41:27hair color because I find
• 41:28it offensive,
• 41:30civil courts will most likely,
• 41:32dismiss my suit as frivolous
• 41:35and impose all sorts of
• 41:36penalties
• 41:37on me.
• 41:40It is bizarre
• 41:41that the Rutgers IRB
• 41:43has no mechanism
• 41:45for allowing them to dismiss
• 41:47frivolous
• 41:48complaints out of hand, but
• 41:50they don't.
• 41:53And the system is clearly,
• 41:55gameable,
• 41:57by people with by malevolent
• 41:59actors with vindictive motives,
• 42:02which is what we suspect.
• 42:03I mean, in certain circles,
• 42:04I'm reasonably known as studying
• 42:06these kind of topics, kinda
• 42:07pisses some people off.
• 42:09So we suspect that this
• 42:11this was motivated.
• 42:12But we don't know that,
• 42:14because of the lack of
• 42:16transparency
• 42:17in the accusations.
• 42:19And if we hadn't kept
• 42:21meticulous records of our research,
• 42:23which we do all the
• 42:24time,
• 42:25our project our projects might
• 42:26have been shut down because
• 42:27of a technicality, because we
• 42:29didn't have something we were
• 42:31supposed to have. Even if
• 42:32we've done nothing wrong.
• 42:34Nate was approaching his dissertation.
• 42:36Nate might not have been
• 42:37able to complete his dissertation.
• 42:40And from what once I
• 42:42started going public with this
• 42:43stuff, I started hearing mouthful
• 42:45from other people.
• 42:47And as far as I
• 42:48understand, these experiences
• 42:51like, I I I don't
• 42:52know if anyone has this
• 42:53exact experience, but the general
• 42:55domain of experience is not
• 42:57unique. It is fairly common
• 42:59around the country.
• 43:01IRBs were originally designed to
• 43:03ensure the ethical treatment of
• 43:05research subjects.
• 43:06Obviously, they have an important
• 43:08role to play because researchers
• 43:09shouldn't be allowed to do
• 43:11truly harmful or risky things
• 43:12to participants without their consent.
• 43:14But with rare exceptions,
• 43:17they are irrelevant
• 43:18to the type of social
• 43:20science research that we conduct,
• 43:22which mainly involves asking people
• 43:24to answer questions.
• 43:26It would be nearly impossible
• 43:27for us to cause participants
• 43:29any real harm through our
• 43:31surveys by asking people questions.
• 43:33People ask each other questions
• 43:35all the time in daily
• 43:36life.
• 43:40When an IRB exceeds its
• 43:42mandate, it's a clear violation
• 43:44of academic freedom.
• 43:46But until there is some
• 43:47way of reining in runaway
• 43:49IRB investigations
• 43:51and mandates, we'll get to
• 43:52that too, nothing is likely
• 43:54to change. In fact, it's
• 43:55probably gonna get worse.
• 43:57It it it really
• 43:59is vital to provide an
• 44:01off ramp for IRBs, the
• 44:03system that allows them to
• 44:04summarily dismiss these sort of
• 44:05complaints without having to do
• 44:06this insane,
• 44:08intense investigation that we were
• 44:09subject subjected to. And none
• 44:11of that would be very
• 44:12hard if there was a
• 44:13will, which, of course, there
• 44:15isn't.
• 44:16Okay. How much time have
• 44:17I got? Mhmm. Sure. Sure.
• 44:19I can stop. I can
• 44:20stop here. Zero. Oh, yeah.
• 44:21Okay. Fine. Alright.
• 44:23Thank you.
• 44:26Okay.
• 44:27So I think we have
• 44:28about six or seven of
• 44:29our forty. Are you timing?
• 44:31Yes. Okay. I don't I
• 44:32wanna give Ed his
• 44:34time.
• 44:35What I'm gonna do
• 44:37at this point, because everybody
• 44:38knows what the Belmont report
• 44:40is, we've heard from Peggy
• 44:42about what we would consider
• 44:44violations of autonomy,
• 44:46and we've heard from Lee
• 44:48about what we would might
• 44:50consider
• 44:51violations
• 44:51of academic freedom of the
• 44:53person asking the questions,
• 44:55is I'm gonna go
• 44:59not gonna belabor
• 45:01those points.
• 45:02I want to just give
• 45:04a shout out and then
• 45:05to the
• 45:07this I wanna answer this
• 45:08question. Are we the first
• 45:10people to propose anything or
• 45:12to consider this or to
• 45:13be frustrated with the IRB?
• 45:13Of
• 45:21interesting editorial
• 45:22came
• 45:23from,
• 45:24CK Gonzales
• 45:26and her colleagues at University
• 45:27of Illinois
• 45:28twenty years ago
• 45:30about mission creep in the
• 45:32IRB.
• 45:33So, but I'm not gonna
• 45:34go into their very interesting
• 45:36white paper and their own
• 45:38proposals, which I would say
• 45:39were more administrative
• 45:41than ours. I wanna move
• 45:43in the remaining
• 45:44time to our concrete proposal
• 45:48because, again,
• 45:49we're not trying to propose
• 45:52to break anything
• 45:53down.
• 45:54We're proposing
• 45:56to strengthen it
• 45:58by
• 45:59offering
• 46:00principles
• 46:01which we think can help
• 46:03IRBs
• 46:05to,
• 46:06keep them
• 46:08close to their
• 46:09mission
• 46:11and and and eliminate
• 46:14the
• 46:16the damage to scientists'
• 46:18enthusiasm
• 46:19through delay
• 46:21and
• 46:22to,
• 46:23yeah, just get them back
• 46:24to the garden.
• 46:26Okay, so of those ten
• 46:28principles which I'm going
• 46:30to introduce now,
• 46:32they're categorized
• 46:34in three categories.
• 46:36One big category is transparency.
• 46:40A second big category is
• 46:41justification of risk evaluation.
• 46:43And the third is limits
• 46:45of risk reduction.
• 46:47So let's start with,
• 46:49and
• 46:49yes, as Ben said, it
• 46:51was proposed in the Mudd
• 46:52Auditorium, so it's the Mudd
• 46:54Code. And all of you
• 46:56know that the Belmont Report
• 46:57is because it was written
• 46:58in the Belmont Conference Center.
• 47:00Okay.
• 47:02And so
• 47:03in under transparency,
• 47:06we would like all our
• 47:07IRB deliberations to be transparent,
• 47:10and certainly Lee would love
• 47:12for that to be the
• 47:13case.
• 47:15We would like all reviews
• 47:16to be completed rapidly and
• 47:19as
• 47:20our our our opening gambit,
• 47:22we say three weeks just
• 47:24like the amount of time
• 47:25I'm given to review a
• 47:26paper.
• 47:28All reviewers must be identified
• 47:30by name. People have to
• 47:32own their comments.
• 47:35And finally,
• 47:37investigators
• 47:38should be able to and
• 47:39should provide feedback on the
• 47:41performance of the IRB and
• 47:43the reviewers.
• 47:44And so that would require
• 47:46that summary statistics be made
• 47:48public
• 47:50so that all of us
• 47:51can look and see how
• 47:53our IRBs are performing.
• 47:55Right now, there's an abject
• 47:57lack of data. And all
• 47:59of you who write papers
• 48:01know that journals are doing
• 48:03this. I'm forever getting emails
• 48:05asking, how am I doing?
• 48:07How am I doing? I
• 48:08filled out one about Frontiers
• 48:10or some other journal
• 48:11this morning.
• 48:13Okay.
• 48:14And we can certainly go
• 48:16back to these principles, but
• 48:18the next
• 48:19category
• 48:20is risk
• 48:21evaluation,
• 48:22which is at the core
• 48:24of the IRBs mission. And
• 48:25so our fifth principle is
• 48:28all IRB requirements for submitting
• 48:30a protocol
• 48:32must be justified
• 48:34solely based on the basis
• 48:35of autonomy,
• 48:36beneficence,
• 48:37or justice, which all of
• 48:39you in this audience know
• 48:41are the three central principles
• 48:43advanced by the Belmont Report.
• 48:45If you're making us do
• 48:47it, tell us why you're
• 48:49making us do it. It's
• 48:51gotta be one of these
• 48:52three reasons.
• 48:54Otherwise,
• 48:55it's beyond the mission of
• 48:56the IRB.
• 48:59Six,
• 49:00autonomy
• 49:01is paramount.
• 49:03A subject's
• 49:04informed
• 49:05informed is italicized.
• 49:08Preferences
• 49:09should be heeded whenever
• 49:11possible.
• 49:12And the case
• 49:13the cases that Peggy,
• 49:16gave, all of this, of
• 49:18course, is anecdotal,
• 49:19but we are confident that
• 49:21these are anecdotes that are
• 49:23representative
• 49:24of many people's experiences.
• 49:27Autonomy
• 49:29is really
• 49:30respecting the agency of the,
• 49:33excuse me, of the participants,
• 49:34and that needs to be
• 49:36foremost in an IRB's
• 49:38mind.
• 49:39And finally,
• 49:40the third category is limits
• 49:42of risk reduction.
• 49:44And the four principles
• 49:46are
• 49:47scientific and medical discovery is
• 49:49the ultimate goal. We have
• 49:51to keep that in mind
• 49:52at all times.
• 49:53The total elimination
• 49:54of all risk is not
• 49:56the goal and has never
• 49:58been the goal.
• 49:59It's a balancing
• 50:01act.
• 50:03Practices not exceeding a predefined
• 50:05minimal risk threshold
• 50:07are outside the IRB's mandate.
• 50:09And this, of course,
• 50:11is
• 50:12is topic or field specific,
• 50:15and I would argue after
• 50:16hearing Lee's impassioned
• 50:18story that there might be
• 50:21a threshold,
• 50:22an an astronomical
• 50:24threshold, and nothing in social
• 50:25psychology
• 50:26even meets the threshold
• 50:28of review.
• 50:30And and to answer eight,
• 50:32you have to have the
• 50:34participation
• 50:35of discipline
• 50:36specific
• 50:38experts who would be consulted
• 50:40whenever the IRB does not
• 50:41have sufficient domain knowledge
• 50:43of what in fact that
• 50:44minimal risk
• 50:46standard
• 50:47is.
• 50:48So again, it's discipline specific.
• 50:51And finally,
• 50:52this one galls me.
• 50:55The re evaluation
• 50:57of peer reviewed science
• 50:59is not the purview
• 51:01of the IRB.
• 51:04Mostly, when I go to
• 51:06the IRB,
• 51:07I've already written a paper
• 51:09with preliminary results.
• 51:11It passed peer review.
• 51:13I've already had my grant
• 51:15reviewed by other peers
• 51:18who accepted it and gave
• 51:19me half a million or
• 51:21five million or ten million
• 51:22dollars
• 51:23to do it.
• 51:24So, again, it's sticking to
• 51:26the mission.
• 51:27And then one little
• 51:29added
• 51:30thing, which was a wonderful
• 51:32result of a class that
• 51:34I taught for many years
• 51:35that Bette alluded to, and
• 51:36at least two of my
• 51:38wonderful
• 51:39TAs are in the audience.
• 51:41In the class last year
• 51:43or the year before,
• 51:45after we talked about the
• 51:47IRB, a student came up
• 51:48with this brilliant idea.
• 51:51That on the IRB,
• 51:52there should be an added
• 51:54position
• 51:55which we will call science
• 51:57advocate.
• 51:58So that there's somebody in
• 52:00the room
• 52:01who can stand up and
• 52:02say,
• 52:03Yeah,
• 52:04but think of the benefits
• 52:06that we would get from
• 52:07this science if it were
• 52:09successful.
• 52:10There are already this precedent.
• 52:13There are already advocates. If
• 52:14you have prisoners or if
• 52:16you have
• 52:17mentally disabled subjects or if
• 52:19you have pregnant women, why
• 52:20shouldn't there be an advocate
• 52:22for the science itself?
• 52:24Again, it's a balancing
• 52:26act.
• 52:27Okay. I think I still
• 52:28have two or three minutes,
• 52:29so I got a few
• 52:30more slides. But I'm,
• 52:32I'm gonna
• 52:34one minute?
• 52:35Okay. Wrap up. That's it.
• 52:37We're done.
• 52:38That's it.
• 52:40Okay. Now I have to
• 52:41say one more thing. Ed's
• 52:42gonna walk up here. I
• 52:43am delighted and very grateful
• 52:45that he agreed to represent
• 52:47the IRB's perspective
• 52:49because we came here only
• 52:51to have a discussion as
• 52:53Ben laid out
• 52:54and to see if we
• 52:55could get to yes or
• 52:58take at least the first
• 52:59step collectively
• 53:01to get to yes.
• 53:21Appreciate it. Thank you.
• 53:26Let's see how this works
• 53:27here, and we'll get going.
• 53:30Can you hear me?
• 53:32Alright. Good. I know we
• 53:34had brief introductions. I'm Ed
• 53:35Monaco. I've practiced emergency medicine
• 53:37here for thirty years. I've
• 53:39been on
• 53:40the IRB in one way
• 53:41or another for the same
• 53:42time period. I now chair
• 53:44several of this institution's IRB
• 53:45committees. I vice chair several
• 53:47others.
• 53:48I'm gonna speak at pace
• 53:50a bit because
• 53:51I wanna respect
• 53:52the time constraints I'm under,
• 53:54so forgive me. Wanna thank
• 53:55Ben for the kind opportunity
• 53:58to speak to you all
• 53:59today, and I wanna thank
• 54:00Karen.
• 54:01Karen and I have never
• 54:03met
• 54:04until about an hour and
• 54:05a half ago,
• 54:06but we've exchanged more than
• 54:07a few emails,
• 54:10emails about word choice and
• 54:12language, about the the brochure
• 54:13she put together representative of
• 54:15all the hard work she's
• 54:16done to put this evening
• 54:17together.
• 54:18I think Karen
• 54:20would attest to my
• 54:22pedantic nature with regard to
• 54:24choice of language
• 54:26and word choice.
• 54:27I think she would agree
• 54:29that I take word choice
• 54:30very seriously.
• 54:44We're good.
• 54:47The authors published an article
• 54:48at the end of last
• 54:49year,
• 54:51In it, they're critical of
• 54:52IRB inefficiencies,
• 54:53but they also draw conclusions
• 54:56about IRB motive and intent
• 54:58described by the authors
• 55:00with terms as sinister,
• 55:03ideologically
• 55:04motivated.
• 55:06Before sweeping accusations of motive
• 55:08and intent can be levied,
• 55:10they have to be supported
• 55:11by evidence.
• 55:12Instead, the authors offer
• 55:14anecdote,
• 55:15anecdote
• 55:16masquerading as evidence.
• 55:18But But if we're going
• 55:18to take evidentiary
• 55:19standards seriously, we need to
• 55:21start by looking at the
• 55:22editorial standards of the publishing
• 55:24venue for context
• 55:26and for a fair assessment
• 55:27of the validity of the
• 55:28author's conclusions. The authors decided
• 55:30to publish their article in
• 55:32the Journal of Controversial
• 55:34Ideas.
• 55:35For the uninitiated,
• 55:37the Journal of Controversial
• 55:39Ideas is apparently an online
• 55:40journal that makes explicit
• 55:42on their website
• 55:44that they cater to morally,
• 55:46socially, and ideologically
• 55:47offensive material,
• 55:49so much so
• 55:51that they offer their authors
• 55:53anonymity,
• 55:54a pseudonym to write under
• 55:56so they can distance themselves
• 55:57from their work. These authors
• 55:59didn't avail themselves of that
• 56:00opportunity.
• 56:01A journal that obviously published
• 56:03other articles
• 56:04in and around the time
• 56:05the authors published theirs,
• 56:07one on the philosophical
• 56:09permissibility of cannibalism,
• 56:12another on the moral permissibility
• 56:14of zephilia, a term I'll
• 56:16let you look up on
• 56:16your own time,
• 56:18and then there's the author's
• 56:19article.
• 56:21In it,
• 56:22the authors are critical of
• 56:23IRB inefficiencies,
• 56:26mission creep,
• 56:29variable determinations
• 56:30in and between IRBs,
• 56:33prolonged and arduous decision making.
• 56:36I get all of that.
• 56:38It's all true.
• 56:39I've been reading about
• 56:41those criticisms
• 56:43for years.
• 56:45They've been written about by
• 56:46noted authors, some of whom
• 56:48I suspect you recognize,
• 56:50and they've published their opinions
• 56:52in journals I know you
• 56:53recognize.
• 56:54This is one such article.
• 56:55It's written by Abbott and
• 56:56Grady
• 56:58published in twenty ten.
• 56:59In it, they performed a
• 57:01systematic analysis of twenty three
• 57:04journal articles dedicated to looking
• 57:06at the functionality of IRBs
• 57:08across the United States.
• 57:09They looked at functionality,
• 57:13structure,
• 57:14composition,
• 57:15processes.
• 57:16When when it came to
• 57:18performance and outcome,
• 57:19they concluded there just wasn't
• 57:21enough evidence in the academic
• 57:23literature to make any substantive
• 57:25conclusions.
• 57:27I keep an eye on
• 57:28this literature, and I contribute
• 57:30to it in my own
• 57:30small way. I
• 57:33reread the systematic analysis in
• 57:35preparation for tonight's talk as
• 57:37well as the other journals
• 57:40and articles I alluded to
• 57:41in the prior two slides.
• 57:43And nowhere in that body
• 57:45of work
• 57:46can I find imputations of
• 57:47motive or intent, let alone
• 57:49the language used by these
• 57:50three individuals,
• 57:52ideological
• 57:53abuse,
• 57:55disrespect for persons,
• 57:58manipulated for sinister
• 58:00and ideological
• 58:01purposes?
• 58:02For the benefit of the
• 58:03authors that aren't part of
• 58:04the Yale system, Yale has
• 58:06a cancer center.
• 58:07We actively engage in phase
• 58:09one clinical trials.
• 58:11Phase one clinical trials deal
• 58:12with
• 58:14safety
• 58:16safety,
• 58:17high risk research,
• 58:20side effects,
• 58:22and significant adverse events are
• 58:24not only foreseeable,
• 58:26they're expected. This is an
• 58:28article published just a few
• 58:29years ago in the Journal
• 58:30of the National Cancer Institute.
• 58:33It found that physicians
• 58:35significantly
• 58:36underestimate
• 58:38the frequency and severity of
• 58:40adverse events
• 58:41in these trials. They occur
• 58:43greater than ten percent of
• 58:44the time. They describe
• 58:46toxicity
• 58:46as intrinsic in this research,
• 58:49and it increases with dose
• 58:50escalation,
• 58:51I would say,
• 58:53mirroring our experience
• 58:55here at Yale,
• 58:58not only with cancer drugs,
• 58:59but other first in human
• 59:00experimentation,
• 59:01other safety
• 59:03and efficacy studies.
• 59:05These are just some of
• 59:06the adverse events
• 59:08that Yale IRB committees struggle
• 59:10with
• 59:11on a weekly basis, literally.
• 59:13We struggle with
• 59:15word choice
• 59:16and how to tell
• 59:18participants who engage in these
• 59:20trials what they're likely to
• 59:21experience, and we change what
• 59:22we tell them
• 59:24along in conjunction with the
• 59:25investigators and the sponsors
• 59:28as we learn more about
• 59:29the drugs.
• 59:31This is information taken from
• 59:32the YCCI website. It shows
• 59:34that this
• 59:36institution,
• 59:37and no doubt the other
• 59:38institutions mentioned in the author's
• 59:40article, has a storied legacy
• 59:42in engaging in high risk
• 59:44research,
• 59:45sometimes with great success.
• 59:48There seems to be a
• 59:49tension
• 59:50in the author's argument that,
• 59:52well, on the one hand,
• 59:54institutions like ours
• 59:57can engage in this high
• 59:58risk research. But on the
• 59:59other hand, IRBs that approve
• 01:00:01that research
• 01:00:02strive for zero risk.
• 01:00:04When I'm speaking, you ask
• 01:00:05them to resolve that tension.
• 01:00:10The authors,
• 01:00:11how should I say,
• 01:00:13romanticize
• 01:00:14about self experimentation.
• 01:00:16They choose Werner Fosman as
• 01:00:18one of their examples.
• 01:00:19As you heard, Werner Fosman,
• 01:00:21German physician, nineteen twenty nine,
• 01:00:23successfully passed
• 01:00:25a urinary catheter from his
• 01:00:27left arm
• 01:00:28in and around the vicinity
• 01:00:29of his right atrium,
• 01:00:30memorializing the distal tip position
• 01:00:32through the use of an
• 01:00:33X-ray.
• 01:00:34The authors contend that because
• 01:00:37of Forsman's autonomy,
• 01:00:40their understanding
• 01:00:41of the Belmont Report would
• 01:00:43dictate important word, word choice,
• 01:00:46dictate
• 01:00:48that Forsman's self experiment go
• 01:00:49forward.
• 01:00:51The Belmont Report doesn't say
• 01:00:52that.
• 01:00:53Nowhere in the Belmont Report
• 01:00:55does it say that if
• 01:00:56you have autonomy,
• 01:00:58all other ethical principles are
• 01:01:00rendered moot.
• 01:01:02The Belmont Report
• 01:01:03pro offers three coexisting, coequal
• 01:01:06pillars of autonomy, beneficence, and
• 01:01:08justice.
• 01:01:09All three have to be
• 01:01:10satisfied
• 01:01:12for human experimentation to be
• 01:01:13ethically permissible, self experiment or
• 01:01:15not.
• 01:01:18Government agencies
• 01:01:20that operationalize
• 01:01:21the report interpret it to
• 01:01:23mean
• 01:01:23other things
• 01:01:25as well, that if any
• 01:01:26part of an activity is
• 01:01:27research,
• 01:01:28it should be reviewed,
• 01:01:31and that autonomy is important
• 01:01:33unless, of course, it's detrimental
• 01:01:35to someone else.
• 01:01:38And that institutions have an
• 01:01:39obligation to maximize benefits and
• 01:01:41minimize risks.
• 01:01:43For all intents and purposes,
• 01:01:45Fosman sought review,
• 01:01:47review as it existed in
• 01:01:48the day. The day, remember,
• 01:01:50was nineteen twenty nine.
• 01:01:52Review is essentially permission, permission
• 01:01:54from his superior,
• 01:01:55permission that was denied twice.
• 01:01:57He offered to perform this
• 01:01:59experiment on a dying patient.
• 01:02:01The answer was no.
• 01:02:02He then offered to perform
• 01:02:03this experiment on himself.
• 01:02:05The answer was no.
• 01:02:07So what did he do?
• 01:02:09He performed it anyway
• 01:02:11behind a closed door,
• 01:02:13deceived a nurse in the
• 01:02:14process to gain access to
• 01:02:16the equipment he needed. Some
• 01:02:17reports indicate that he restrained
• 01:02:20her to a table,
• 01:02:23advanced his catheter, walked to
• 01:02:24another part of the hospital
• 01:02:26to convince somebody to shoot
• 01:02:27a chest X-ray of his
• 01:02:28chest.
• 01:02:30Where in the Belmont Report
• 01:02:32is that activity condoned?
• 01:02:36The authors offer an explanation,
• 01:02:38a rationale. They say that,
• 01:02:39well, Fosman's autonomy
• 01:02:42was informed.
• 01:02:45It was informed
• 01:02:46because he had performed cadaveric
• 01:02:48experiments
• 01:02:49in preparation for his self
• 01:02:50experiment.
• 01:02:52They cite Altman
• 01:02:54as one of their sources.
• 01:02:55Altman's book on self experimentation.
• 01:02:57I also read Altman.
• 01:03:00Altman says no such thing.
• 01:03:02In fact, Altman says the
• 01:03:03exact opposite.
• 01:03:04Altman makes very clear that
• 01:03:06Fosman admitted he lied about
• 01:03:08cadaveric experiments. He was told
• 01:03:09to lie by his superior
• 01:03:11because he wouldn't get his
• 01:03:11paper published.
• 01:03:13Recall our conversations
• 01:03:16about editorial standards,
• 01:03:20validity.
• 01:03:24The authors also contend that
• 01:03:27this Forsman activity
• 01:03:29was consistent with their understanding
• 01:03:31of the Nuremberg Code. The
• 01:03:33Nuremberg Code
• 01:03:35or a proper understanding of
• 01:03:37the code forecloses any appeal
• 01:03:39of success as ethical justification.
• 01:03:43In fact, the mindset
• 01:03:46that the prospect of a
• 01:03:47positive outcome in research,
• 01:03:49no matter how you define
• 01:03:51positive outcome,
• 01:03:52could somehow retroactively
• 01:03:55justify unethical back activity
• 01:03:58or make good bad science
• 01:04:00is the kind of mindset
• 01:04:01that in part made the
• 01:04:02Nuremberg trials necessary.
• 01:04:06The MUD code,
• 01:04:08ten
• 01:04:09principles,
• 01:04:10suggestions
• 01:04:12to decrease IRB inefficiency and,
• 01:04:14presumably,
• 01:04:16mitigate
• 01:04:16sinister behavior,
• 01:04:19ideologic agenda.
• 01:04:21Let's go through a couple
• 01:04:22of them. The
• 01:04:23authors contend
• 01:04:25and the mud coat offers
• 01:04:26that
• 01:04:31excuse me.
• 01:04:36Oh,
• 01:04:38we'll start with the first
• 01:04:39one.
• 01:04:40Deliberations
• 01:04:41between IRB members
• 01:04:44at committee level reviewing a
• 01:04:46protocol for human subject research
• 01:04:48should be made public
• 01:04:50in real time
• 01:04:52even.
• 01:04:54This institution's
• 01:04:56IRB committees, as well as
• 01:04:57many other IRB committees, review
• 01:04:59a large amount of proprietary
• 01:05:01information,
• 01:05:03large pharma,
• 01:05:05small boutique pharmaceutical firms,
• 01:05:08Silicon Valley startups with patented
• 01:05:10algorithms for
• 01:05:11large language models and other
• 01:05:13AI applications.
• 01:05:15Then, of course, there's institutions
• 01:05:17with
• 01:05:18special proprietary
• 01:05:21and security needs like the
• 01:05:22DOD, just to name a
• 01:05:23few. I can't think of
• 01:05:25a better way to hinder
• 01:05:26research
• 01:05:27than to announce to Eli
• 01:05:28Lilly that we're gonna make
• 01:05:29public
• 01:05:31deliberations about their proprietary protocols.
• 01:05:36Presumably,
• 01:05:39the authors got their paper
• 01:05:40published
• 01:05:41in the Journal of Controversial
• 01:05:43Ideas
• 01:05:44within three weeks.
• 01:05:46So therefore, they're of the
• 01:05:47opinion that IRB should operate
• 01:05:48under the same time constraints.
• 01:05:50Review of a manuscript for
• 01:05:52publication
• 01:05:54and review
• 01:05:56by an IRB
• 01:05:57of human subject research operates
• 01:05:59under two vastly different mandates.
• 01:06:01The former
• 01:06:03deals with work that's already
• 01:06:04completed.
• 01:06:06IRB review deals with work
• 01:06:07that hasn't even started yet,
• 01:06:09and that work crosses many
• 01:06:10domains,
• 01:06:12conflict of interest, code of
• 01:06:14federal regulations,
• 01:06:15state and federal law,
• 01:06:18vulnerable populations,
• 01:06:20and many others. I've never
• 01:06:22heard anyone conflate the two.
• 01:06:28The authors also offer through
• 01:06:29the mud code that
• 01:06:32in some de facto way,
• 01:06:35institutions
• 01:06:36should have their own definition
• 01:06:37of minimal risk.
• 01:06:39I don't know if they
• 01:06:40know, but federal regulations do
• 01:06:42not allow anyone to redefine
• 01:06:44their definitions.
• 01:06:45But just to play off
• 01:06:46the mindset,
• 01:06:47can you imagine the chaos
• 01:06:49that would ensue,
• 01:06:50multisite study, thirty sites scattered
• 01:06:53throughout the United States,
• 01:06:54each site with its own
• 01:06:56definition of minimal risk, triggering
• 01:06:58different levels of protection?
• 01:07:00That wouldn't harmonize research. It
• 01:07:01would fragment it.
• 01:07:05Also,
• 01:07:06the authors believe that if
• 01:07:07a risk
• 01:07:10exists in daily life
• 01:07:12and that risk has a
• 01:07:14chance of materializing
• 01:07:16because of participation in a
• 01:07:17research protocol
• 01:07:19that that risk somehow
• 01:07:21disappears.
• 01:07:24Parity with daily life does
• 01:07:25not make risk disappear. It
• 01:07:27normalizes risk, and it's part
• 01:07:29of the function of an
• 01:07:30IRB to justify the imposition
• 01:07:31of a normalized risk
• 01:07:33onto a human subject participant.
• 01:07:35We don't pretend to ourselves
• 01:07:37or to the participant
• 01:07:39that the risk vanished.
• 01:07:45And perhaps
• 01:07:47most chilling of all
• 01:07:50is that
• 01:07:51the authors believe that by
• 01:07:52virtue of membership on an
• 01:07:54IRB,
• 01:07:55that member does not have
• 01:07:56the right
• 01:07:58to review peer review research.
• 01:08:01IRB committee members at Yale
• 01:08:02consist of many specialists, emergency
• 01:08:04medicine, neurology, oncology, cardiology, infectious
• 01:08:07disease, psychiatry,
• 01:08:09many others, and those are
• 01:08:10just the scientists.
• 01:08:12I can't think of a
• 01:08:13more chilling effect on safety
• 01:08:15than to announce to an
• 01:08:16oncologist sitting on our IRB,
• 01:08:19our oncology IRB committee,
• 01:08:21that in his review of
• 01:08:22a new kinase inhibitor for
• 01:08:24breast cancer, he doesn't have
• 01:08:25the right to look at
• 01:08:27peer review research. To borrow
• 01:08:29a term from the authors,
• 01:08:30I can't think of a
• 01:08:31bigger disrespect for persons that
• 01:08:32we'll talk about tonight.
• 01:08:34Last slide.
• 01:08:37How are IRBs
• 01:08:39evaluated?
• 01:08:40And how should they be
• 01:08:40evaluated?
• 01:08:41IRBs are evaluated
• 01:08:43in different ways.
• 01:08:44One way is through internal
• 01:08:46metrics, constant feedback from the
• 01:08:48administration to the chairs and
• 01:08:49the members,
• 01:08:51also by comparing our IRB
• 01:08:53to other IRBs with similar
• 01:08:54metrics,
• 01:08:55looking at performance. Then, of
• 01:08:57course, there's audits,
• 01:09:00audits by accrediting agencies like
• 01:09:02AHARP, and, of course, audits
• 01:09:04by institutions like the FDA.
• 01:09:06Audits are necessary. They're important,
• 01:09:08but they're not sufficient. Audents
• 01:09:10look at compliance with regulations,
• 01:09:14housekeeping,
• 01:09:14or minutes are in order.
• 01:09:16Do we have a sufficient
• 01:09:17expertise?
• 01:09:18But what's missing from audits,
• 01:09:21what's missing from the academic
• 01:09:22literature
• 01:09:24that Abbott and Grady frustratingly
• 01:09:26found out,
• 01:09:27what's missing from the author's
• 01:09:29article is evidence. When a
• 01:09:31pedantic chair
• 01:09:32fixated on language weighs in
• 01:09:34on a consent form,
• 01:09:36working with the investigator or
• 01:09:38a protocol, did the chair
• 01:09:39actually make the consent form
• 01:09:41more readable? Do we have
• 01:09:42a metric for that? Is
• 01:09:43the protocol safer? We don't
• 01:09:45have good metrics for that.
• 01:09:46If you wanna learn
• 01:09:47about what we do
• 01:09:49as an IRB, watch us
• 01:09:50deliberate, become a guest. We
• 01:09:52have many guests,
• 01:09:53students,
• 01:09:55faculty, and at times investigators
• 01:09:57who wanna learn about our
• 01:09:58processes,
• 01:09:59watch us deliberate ethical issues
• 01:10:01like on our evolving technology
• 01:10:02committee where we see a
• 01:10:04case of first impression almost
• 01:10:05every week with AI and
• 01:10:06its applications.
• 01:10:08All I ask in return
• 01:10:10is two things. Grant me
• 01:10:12one request and permit me
• 01:10:14to issue one warning.
• 01:10:16First, the request.
• 01:10:18When you read the academic
• 01:10:19literature
• 01:10:21about IRB
• 01:10:23inefficiencies,
• 01:10:25separate signal from noise,
• 01:10:27scholarship from rhetoric,
• 01:10:29and now the warning,
• 01:10:31providing a platform and an
• 01:10:32audience
• 01:10:34to unsubstantiated
• 01:10:36speculation
• 01:10:37doesn't clarify issues. It amplifies
• 01:10:39them. Not every complaint deserves
• 01:10:41a microphone.
• 01:10:43Parting comment.
• 01:10:45Last thought.
• 01:10:47The achievement of the COVID
• 01:10:48nineteen vaccine
• 01:10:50is thought by many to
• 01:10:51be a testament to biomedical
• 01:10:53agility.
• 01:10:54We didn't get there by
• 01:10:55circumventing ethical review.
• 01:10:57We got there by marshaling
• 01:10:58resources and working together.
• 01:11:00So be scientists.
• 01:11:01Look for evidence. Forget the
• 01:11:03rest.
• 01:11:04There's a lot of work
• 01:11:04to be done, and there's
• 01:11:06little time. Thank you.
• 01:11:17Right.
• 01:11:21I wanna
• 01:11:22thank all of our panelists,
• 01:11:26for a
• 01:11:27spirited discussion.
• 01:11:29I I would like we
• 01:11:30have
• 01:11:33eighteen minutes. I we're gonna
• 01:11:34go a few minutes over,
• 01:11:37but we're we're gonna stop
• 01:11:38by,
• 01:11:39six forty.
• 01:11:42I do wanna give folks
• 01:11:43the opportunity to
• 01:11:46to, share questions and comments.
• 01:11:48I'm gonna actually take the,
• 01:11:51opportunity to to the prerogative
• 01:11:53to to ask one question
• 01:11:54myself to to the panel.
• 01:11:56I I do wanna invite
• 01:11:57the the, folks that we
• 01:11:58have here in the room
• 01:11:59from the panel to to
• 01:12:00come on up. And, if
• 01:12:02if you would,
• 01:12:04you can you can join
• 01:12:04us here. And can we
• 01:12:05get is it possible to
• 01:12:06get,
• 01:12:07Peggy
• 01:12:08back?
• 01:12:13I'm here. Thanks, Peggy. Thank
• 01:12:15you so much. Yep.
• 01:12:17So,
• 01:12:18as we're shifting over into
• 01:12:22What's your name?
• 01:12:23So as we're shifting over
• 01:12:25into
• 01:12:28questions and comments from the
• 01:12:29audience, you know, I want
• 01:12:30to again,
• 01:12:31you know, emphasize the the
• 01:12:33request that to the panelists
• 01:12:35sent it to the audience
• 01:12:36to,
• 01:12:37you know,
• 01:12:39assume good intent to,
• 01:12:45treat each other with respect,
• 01:12:47to try to to
• 01:12:49formulate the strongest
• 01:12:53version of the
• 01:12:56perspective of which you may
• 01:12:57be criticizing or critiquing,
• 01:13:00and,
• 01:13:01to to criticize the,
• 01:13:04argument, not the the speaker.
• 01:13:07I wanted to take the
• 01:13:08prerogative to ask one question
• 01:13:10to begin with, and this
• 01:13:11is open to to any
• 01:13:12of the panelists.
• 01:13:13You know, I I heard
• 01:13:14a lot of
• 01:13:17critique and disagreement.
• 01:13:18I also heard
• 01:13:20snippets of agreement.
• 01:13:23I think I think I
• 01:13:24heard consensus
• 01:13:26that
• 01:13:27there has been an expansion
• 01:13:30of,
• 01:13:31the IRB
• 01:13:32mission and scope and and
• 01:13:34that there there has been,
• 01:13:36mission creep. I think that
• 01:13:37was mentioned by,
• 01:13:38multiple speakers.
• 01:13:41I think there there has
• 01:13:42been a lot of
• 01:13:44comments about the
• 01:13:48speed of review.
• 01:13:50I don't think I heard
• 01:13:51agreement about what to do
• 01:13:52about these issues, but I'm
• 01:13:54I'm
• 01:13:55I wanna
• 01:13:57ask the speakers from their
• 01:13:58perspective if if having heard
• 01:14:00each other's
• 01:14:04views and perspectives, if if
• 01:14:05they're able to identify
• 01:14:07points of consensus or agreement
• 01:14:09with within that discussion.
• 01:14:11I'd open that to any
• 01:14:12and or all of the
• 01:14:13speakers, and then we'll move
• 01:14:14on to the audience.
• 01:14:17I'll start. We we I
• 01:14:18mean,
• 01:14:19I think we need, as
• 01:14:20I said, more
• 01:14:22empiric evidence with regard to
• 01:14:23performance, which we don't have.
• 01:14:24It's lacking in the literature.
• 01:14:26And, I think that's where
• 01:14:28things would start with evidence.
• 01:14:30And we try, particularly internally,
• 01:14:32by looking at feedback
• 01:14:34and metrics that we accumulate
• 01:14:36constantly and getting constant feedback
• 01:14:37from the administration with regard
• 01:14:39to inefficiencies and presenting cases
• 01:14:41to find out where we
• 01:14:42could do a better job.
• 01:14:44That's all important stuff, but
• 01:14:45we don't have
• 01:14:47the evidence or the or
• 01:14:48the, empiric evidence, at least
• 01:14:50in the literature,
• 01:14:53to really make an impact
• 01:14:54yet.
• 01:14:56Can I can I ask
• 01:14:57you a question? I I
• 01:14:58found that that's very interesting.
• 01:15:00I'm just curious
• 01:15:03whether you think
• 01:15:05that
• 01:15:06any data should be released.
• 01:15:08I mean, it's wonderful that
• 01:15:09there's this in house
• 01:15:11evaluation
• 01:15:12of your own metrics,
• 01:15:14but
• 01:15:16it's
• 01:15:18arguably not the most
• 01:15:20rigorous,
• 01:15:22investigation
• 01:15:24of of how you're doing.
• 01:15:26And
• 01:15:30so do you see any
• 01:15:31place for transparency for the
• 01:15:33release of data so that
• 01:15:35people
• 01:15:36can actually use data
• 01:15:38from IRBs
• 01:15:41to test their ideas.
• 01:15:43Fair point. Right now we
• 01:15:45just don't we don't have
• 01:15:46the data because
• 01:15:48IRBs aren't giving us the
• 01:15:49data.
• 01:15:51Yeah. If you're referring to
• 01:15:54performance data with regard to
• 01:15:55the IAB turnaround, things like
• 01:15:57that,
• 01:15:58then I would tend to
• 01:15:59agree
• 01:16:00that that that could be
• 01:16:01transparent and and and made
• 01:16:03available.
• 01:16:05Monica, please. Which we do.
• 01:16:07Which we do. Right? I'm
• 01:16:09not the director of human
• 01:16:10research protection program, which supports
• 01:16:12the LIRBs,
• 01:16:13and I agree with transparency.
• 01:16:15So we actually do make
• 01:16:16our data available. We meet
• 01:16:18on Do I need to
• 01:16:20No. No. Just Mhmm. Oh,
• 01:16:21okay.
• 01:16:22I wasn't sure if that
• 01:16:23was for me. So I
• 01:16:24agree with the transparency, and
• 01:16:25we do make our data
• 01:16:27available. It's online.
• 01:16:29We actually have HRPP news
• 01:16:31forums where
• 01:16:32quarterly when we discuss our
• 01:16:34turnaround times, and we actually
• 01:16:36pay attention to why things
• 01:16:38are taking a little bit
• 01:16:38longer and include all of
• 01:16:40the outliers.
• 01:16:41So we do have that,
• 01:16:42and I agree that other
• 01:16:43IRBs could do the same,
• 01:16:45as well. Just wanted to
• 01:16:46add that. Good. Yeah.
• 01:16:48Thank you.
• 01:16:51So thank you to the
• 01:16:52panel. And my my question
• 01:16:53is directed towards doctor Monica,
• 01:16:55but
• 01:16:56everybody's welcome to weigh in.
• 01:16:57So it's been a few
• 01:16:58years since I
• 01:17:00have been doing research, but
• 01:17:02when I was a junior
• 01:17:03faculty member, I I did
• 01:17:05do a a fair number
• 01:17:06of investigator initiated trials and
• 01:17:08then some pharmaceutical
• 01:17:10trials.
• 01:17:11And what I didn't hear
• 01:17:12discussed tonight was the educational
• 01:17:15role of the IRB, which
• 01:17:16I just wanna comment was
• 01:17:18I thought one of the
• 01:17:18most valuable aspects of my
• 01:17:20interactions with the IRB,
• 01:17:22that the feedback I got
• 01:17:24helped me understand what I
• 01:17:26might not have known as
• 01:17:27an investigator
• 01:17:28in terms of risks that
• 01:17:30I thought were minimal, but
• 01:17:31then to really understand why
• 01:17:32they were not,
• 01:17:34or
• 01:17:36Sorry.
• 01:17:38Addressing issues related to what
• 01:17:40really constitutes informed consent, and
• 01:17:42I think the comment that
• 01:17:43you made about the outcome
• 01:17:44not justifying,
• 01:17:46the the research in and
• 01:17:47of itself. So, you know,
• 01:17:49Ed, I'm just curious about
• 01:17:50what you see the educational
• 01:17:51role of the IRB for
• 01:17:53the investigators
• 01:17:54when they submit
• 01:17:56a proposal. Yeah. I'm quite
• 01:17:57confident we we we educate
• 01:17:59both. We educate both ourselves.
• 01:18:01We have a very,
• 01:18:02good subcommittee
• 01:18:03that's involved with education of
• 01:18:05not only ourselves in a
• 01:18:06continuous basis, but we do
• 01:18:07offer education to the investigators
• 01:18:09with regard to different parts
• 01:18:11of the,
• 01:18:12code of federal regulations, particularly
• 01:18:14if there's a change or
• 01:18:15there's a nuance that we
• 01:18:16need that we see a
• 01:18:16trend in where we see,
• 01:18:19you know, a series of
• 01:18:20of protocols where there's a
• 01:18:21commonality
• 01:18:22where we obviously didn't get
• 01:18:23the point across, and and
• 01:18:24we do offer education to
• 01:18:25the investigators. Absolutely.
• 01:18:28Yeah. And it's great seeing
• 01:18:29you again.
• 01:18:32Hey.
• 01:18:33Oh, there we go. Hey.
• 01:18:35So,
• 01:18:36I think you did an
• 01:18:37excellent job of making a
• 01:18:38great legal defense,
• 01:18:40for why the what the
• 01:18:42purpose of the IRB in
• 01:18:44what the reasons why we're
• 01:18:45kind of doing what we're
• 01:18:46doing. And I've have I've
• 01:18:48feel feel like I'm in
• 01:18:49a very interesting perspective for
• 01:18:51someone whose career is still
• 01:18:52on the beginning side and
• 01:18:53that I've, interacted extensively with
• 01:18:55both social science research, basic
• 01:18:57science research, and also animal
• 01:18:59science research. So I've interacted
• 01:19:01with a lot of different
• 01:19:02perspectives, and I couldn't help
• 01:19:03but notice that a lot
• 01:19:04of the critiques
• 01:19:06from this this lecture came
• 01:19:07on the social sciences side
• 01:19:09where a lot of your
• 01:19:10rebuttals focused on the very
• 01:19:12basic science, especially the cutting
• 01:19:14edge science side.
• 01:19:16And I I'm wondering, do
• 01:19:17you do you think that
• 01:19:19perhaps part of this this
• 01:19:20conflict is coming from the
• 01:19:22the inherent mismatch between the
• 01:19:24needs of cutting edge, like,
• 01:19:27research trials in phase one
• 01:19:28or phase two compared to
• 01:19:31the very different needs of
• 01:19:32a social science survey background
• 01:19:34that's seeking to elicit beliefs
• 01:19:37as opposed to, like, side
• 01:19:38effects?
• 01:19:41Sure. If you're if you're
• 01:19:42directing the comment to me,
• 01:19:43I I think you made
• 01:19:44a very astute observation. We
• 01:19:46do have a separate chair
• 01:19:47for social science research. You're
• 01:19:48absolutely right. So you picked
• 01:19:49up on that. And I
• 01:19:51think you're you're probably correct
• 01:19:52too. I had not noticed,
• 01:19:53but there could be a
• 01:19:53mismatch
• 01:19:55between earlier presentation and and
• 01:19:57and and my comments.
• 01:19:59I I think though, at
• 01:20:00least with regard to
• 01:20:03the original article, the paper
• 01:20:04didn't differentiate
• 01:20:05between social and and biomedical.
• 01:20:07So I was just talking
• 01:20:08about the paper to the
• 01:20:09article itself. But I think
• 01:20:10you're absolutely correct, and you
• 01:20:11you picked up on that,
• 01:20:12and I didn't, that
• 01:20:15there could be a significant,
• 01:20:18mismatch in in in, you
• 01:20:20know, what you're hearing.
• 01:20:22Thanks for that.
• 01:20:29Yeah. So it's it's a
• 01:20:30comment. I'm, Cyril D'Souza. I'm
• 01:20:33professor of psychiatry, and I've
• 01:20:35been doing clinical research for
• 01:20:36the past thirty five years.
• 01:20:38One of my concerns is
• 01:20:40that
• 01:20:41I've seen a trend that,
• 01:20:43a lot of junior investigators
• 01:20:46are kind of giving up
• 01:20:47because of the regulatory process.
• 01:20:50And,
• 01:20:51they find it crushing,
• 01:20:53and the timelines don't align
• 01:20:55with their career milestones.
• 01:20:58And, it's getting harder and
• 01:21:00harder for for us to
• 01:21:02convince junior investigators
• 01:21:04to to pursue clinical research.
• 01:21:06So that's one.
• 01:21:08A second
• 01:21:09related comment is, do we
• 01:21:11think that this mission creep
• 01:21:13that many have spoken about
• 01:21:15has actually made research safer?
• 01:21:18I've been doing this for
• 01:21:19thirty five years,
• 01:21:21and a lot of the
• 01:21:22studies that I do
• 01:21:24involve the same kinds of
• 01:21:25approaches.
• 01:21:27But
• 01:21:28I would say the scrutiny,
• 01:21:30oversight, and regulations have changed
• 01:21:34exponentially over the last twenty
• 01:21:36five years, making it harder
• 01:21:37to do studies the same
• 01:21:39studies that I was doing
• 01:21:40twenty five years ago now.
• 01:21:42And so I suppose a
• 01:21:44general question for everyone is,
• 01:21:46do we think the mission
• 01:21:47creep has really
• 01:21:49improved
• 01:21:50or reduced,
• 01:21:52risk,
• 01:21:53overall? Perhaps you'll never know,
• 01:21:55but I'm just raising that
• 01:21:56as a comment.
• 01:21:57I wanna hit something slow.
• 01:21:59It's a different
• 01:22:00how do I get the
• 01:22:01slide back? Oh, can you
• 01:22:03can you pull out the
• 01:22:04slide?
• 01:22:06Blah blah.
• 01:22:08Actually, you can use that
• 01:22:10microphone on the stage. Oh,
• 01:22:11yeah. That sounds good.
• 01:22:14Hold on. Let me help
• 01:22:15you. One second. Just forget
• 01:22:17to remove the verification
• 01:22:19one. Sorry. I want to
• 01:22:21do one.
• 01:22:23I have a slide on
• 01:22:26you know, we're talking about
• 01:22:27mission creep, and yet it's
• 01:22:30sort of vague. So I
• 01:22:31have some concrete examples of
• 01:22:33mission creep at Rutgers,
• 01:22:35which I suspect are not
• 01:22:36unique to Rutgers. And when
• 01:22:37I saw the mission creep,
• 01:22:39our definition of mission creep
• 01:22:41are these
• 01:22:42are,
• 01:22:43a continuing,
• 01:22:48addition
• 01:22:49of requirements,
• 01:22:51that as far as I
• 01:22:52can tell, don't implement any
• 01:22:54of the principles of Belmont
• 01:22:55report.
• 01:22:56So, actually, I would be
• 01:22:57very interested in what Telstra
• 01:22:58Monocco has to say about
• 01:23:00whether they do or not.
• 01:23:02Do you want these guys?
• 01:23:04Yeah. Wait. Yeah. Yeah. Let's,
• 01:23:06oh, oh, wait. Okay. Let's
• 01:23:07hold hold on. Yeah. But
• 01:23:08I I I I can
• 01:23:09do it. I can do
• 01:23:10it from here. I can
• 01:23:10do it. Do you want
• 01:23:11me to run it, though,
• 01:23:12for you? I know.
• 01:23:13Just just make it go
• 01:23:15like that.
• 01:23:18Oh, dear. Yeah. Sorry. Alright.
• 01:23:19So you know what? Walt
• 01:23:20Walt has understood this. Let's
• 01:23:21go through this. I have
• 01:23:23a question for you.
• 01:23:25Sit sit with the the
• 01:23:26because there's official a lot
• 01:23:27of people online. Or he
• 01:23:28can
• 01:23:29Right. My cousin. If you
• 01:23:30want
• 01:23:31Yeah. Let me have the
• 01:23:34Let me have a look.
• 01:23:35Okay. I I have a
• 01:23:36question for you.
• 01:23:39In June,
• 01:23:42New Haven,
• 01:23:44raise your hand
• 01:23:45if you like.
• 01:23:47If you prefer
• 01:23:48sunny days to cloudy days.
• 01:23:51Raise your hand so I
• 01:23:52can see it. Go right
• 01:23:53to high. Okay. Put them
• 01:23:55down.
• 01:23:56Now if you like, raise
• 01:23:57your hand if you prefer
• 01:23:58cloudy days to sunny days.
• 01:24:03K. So there's overwhelmingly
• 01:24:05a preference
• 01:24:07for sunny days in New
• 01:24:08Haven and Joan.
• 01:24:11K. I didn't ask for
• 01:24:13IRB approval.
• 01:24:15I asked you questions.
• 01:24:17I presented them publicly.
• 01:24:19It contributes to knowledge.
• 01:24:23I am now in violation
• 01:24:24of the rules governing IRBs.
• 01:24:26Technically,
• 01:24:27Rutgers could sanction me for
• 01:24:29doing exactly that, and that
• 01:24:31is exactly how
• 01:24:33that's one example
• 01:24:34of how they are clearly
• 01:24:36a violation of academic freedom
• 01:24:38and probably
• 01:24:39I mean, I'm not a
• 01:24:41lawyer.
• 01:24:42I would love for somebody
• 01:24:44to bring a first amendment
• 01:24:46case against this because we
• 01:24:47just had a conversation.
• 01:24:49And the government, that is
• 01:24:51HHS, Yelp can do whatever
• 01:24:52the hell it wants, but
• 01:24:53HHS can't be in the
• 01:24:55business of preventing you and
• 01:24:56I from having the conversation.
• 01:24:59Oh, hold on. Hold on.
• 01:25:01Alright. Are are we up
• 01:25:02to the so that's so
• 01:25:03I'm I'm technically right. I
• 01:25:05could probably be banned from
• 01:25:06doing research
• 01:25:07because I conducted it.
• 01:25:09I didn't get I didn't
• 01:25:10consent you.
• 01:25:12And,
• 01:25:14I I I don't have
• 01:25:16I don't have any approval
• 01:25:17to do this,
• 01:25:18and I reported it publicly.
• 01:25:20Okay. Now can we get
• 01:25:21to my slides?
• 01:25:24Yeah. Kind
• 01:25:25of.
• 01:25:26We can go through that.
• 01:25:29No.
• 01:25:32No. Where was this?
• 01:25:36No. It's earlier. Oh, it's
• 01:25:37not here.
• 01:25:39Okay. I I can do
• 01:25:40this. I I can wing
• 01:25:41it here. Rutgers has a
• 01:25:43slew of Rutgers IRB has
• 01:25:45a slew of requirements that,
• 01:25:46as far as I can
• 01:25:47tell, have no relationship whatsoever
• 01:25:50to protecting anybody.
• 01:25:51So, for example, let's say
• 01:25:53I get a protocol approved,
• 01:25:55to conduct a survey with
• 01:25:56a hundred questions.
• 01:26:00And I decide, you know
• 01:26:01what? That's too many questions.
• 01:26:03We're only gonna ask seventy.
• 01:26:05It is completely impossible
• 01:26:07for us, a hundred question
• 01:26:09questionnaire
• 01:26:10that was approved
• 01:26:11to violate
• 01:26:13any ethical principle or create
• 01:26:15harm if you ask fewer
• 01:26:16questions.
• 01:26:17In order to do that,
• 01:26:19I need to file an
• 01:26:19amendment.
• 01:26:21I I can't just
• 01:26:24if I adjust the study
• 01:26:25and just do it, I'm
• 01:26:26in violation of IRB rules
• 01:26:28and could be sanctioned in
• 01:26:29all sorts of ways. That's
• 01:26:30example number one. Example number
• 01:26:32two.
• 01:26:34I have no idea why
• 01:26:35they did this, but but
• 01:26:36this is yet another thing
• 01:26:37they did. Within the last
• 01:26:39couple of year well, within
• 01:26:40the last three or four
• 01:26:41years, they started requiring
• 01:26:44participant limits.
• 01:26:47So in the olden days,
• 01:26:48you could say, well, we're
• 01:26:50gonna,
• 01:26:51you know,
• 01:26:51we we estimate,
• 01:26:53the,
• 01:26:54sample size at about a
• 01:26:55thousand, and that was fine.
• 01:26:57No. No. Now you have
• 01:26:57to have the limit.
• 01:26:59So
• 01:27:00if the protocol is approved
• 01:27:02and, again, we're doing questionnaire
• 01:27:03studies.
• 01:27:04I I you know, I
• 01:27:05would agree. If you're doing
• 01:27:06clinical research with some very
• 01:27:09rare conditions
• 01:27:10that that you might deplete
• 01:27:12the this is an entirely
• 01:27:13different we're talking questionnaire studies
• 01:27:15where we pay ten dollars
• 01:27:16ahead to get answers.
• 01:27:18Places like,
• 01:27:21Prime Panels and Prolific and
• 01:27:23the like. Okay.
• 01:27:24So
• 01:27:25if we exceed then this
• 01:27:27actually happened to me.
• 01:27:29In one case, we exceeded
• 01:27:31the limit,
• 01:27:33and they re the IRB
• 01:27:35required us to delete
• 01:27:37participants
• 01:27:37over the limit.
• 01:27:39That was more unethical
• 01:27:41than anything we did
• 01:27:43because lower sample sizes
• 01:27:46undermine the credibility of the
• 01:27:48of the research.
• 01:27:50And it is completely
• 01:27:51impossible
• 01:27:52for something that was ethical
• 01:27:54to do to two hundred
• 01:27:55people would be unethical to
• 01:27:56do for two hundred and
• 01:27:57twenty five people. Obviously, a
• 01:27:59questionnaire. Administering a questionnaire to
• 01:28:01two hundred people to two
• 01:28:02hundred and twenty five people
• 01:28:04cannot possibly
• 01:28:05be more unethical than administering
• 01:28:07it to two hundred people.
• 01:28:09It is not possible.
• 01:28:12And most recently,
• 01:28:14we have to complete
• 01:28:16conflict of interest forms.
• 01:28:19And now we were talking
• 01:28:20about this over lunch. There
• 01:28:21are rare,
• 01:28:22very specific cases where even
• 01:28:24I might agree that certain
• 01:28:26kinds of conflict of interest
• 01:28:28are actually relevant.
• 01:28:30But what but Rutgers asked
• 01:28:32us to complete is anything
• 01:28:34we've gotten paid for outside
• 01:28:35of Rutgers,
• 01:28:37you know, over the last
• 01:28:37year. So Evan bought me
• 01:28:39lunch.
• 01:28:41I have to put that
• 01:28:42on my I mean, I
• 01:28:43cannot put it on, but
• 01:28:45if I get caught, I
• 01:28:46can be sanctioned.
• 01:28:48If I go and give
• 01:28:49a talk,
• 01:28:50at Lehigh, which I did
• 01:28:51a couple years ago, they
• 01:28:52give me an honorarium, which
• 01:28:53they did. I have to
• 01:28:54report that.
• 01:28:56That has nothing has nothing
• 01:28:58to do with any of
• 01:28:59the project. It's completely unrelated.
• 01:29:02This is normal academic.
• 01:29:04I'm going I'm going to
• 01:29:05France in a a few
• 01:29:07weeks to give a talk,
• 01:29:08and they're putting me up.
• 01:29:09They're paying for my lodge.
• 01:29:10I'm gonna have to reward
• 01:29:11that.
• 01:29:13This is crazy stuff.
• 01:29:15This is completely
• 01:29:16crazy
• 01:29:17stuff that as as far
• 01:29:19as I can tell, has
• 01:29:20nothing to do with the
• 01:29:21principles of the Belmont Report.
• 01:29:22And by virtue
• 01:29:24of being this sort of
• 01:29:25time suck, it absolutely
• 01:29:28is dampening the kind of
• 01:29:30enthusiasm. It's It's making it
• 01:29:31difficult for junior researchers to
• 01:29:33making it more difficult for
• 01:29:35junior researchers to continue in
• 01:29:36the field and, like and
• 01:29:37I I I mean, the
• 01:29:38answer is to one way
• 01:29:40or another is to go
• 01:29:41back to the principles of
• 01:29:42the Belmont Report. I mean,
• 01:29:44I'm open to the idea
• 01:29:45that maybe we got something
• 01:29:46something's wrong. I'm like
• 01:29:50but but but the issue
• 01:29:51but the issue is going
• 01:29:52to the principles of the
• 01:29:52of the Belmont report.
• 01:29:54Yes.
• 01:29:56I think we had a
• 01:29:57question here. All around.
• 01:30:04Yes. Okay.
• 01:30:06I happen to have the
• 01:30:07microphone, so I'm next. But
• 01:30:09I just have to I
• 01:30:10had another question, but I
• 01:30:11just wanna make a point
• 01:30:11that I don't think us
• 01:30:13raising our hands about the
• 01:30:14weather is the same thing
• 01:30:16as doing a survey because
• 01:30:17there's a balance of power,
• 01:30:19I think, that has something
• 01:30:20to do with why the
• 01:30:21IRB gets involved in surveys.
• 01:30:23But the, other point that
• 01:30:25I that I asked for
• 01:30:26the microphone about was having
• 01:30:27to do with
• 01:30:28asking for reviews of reviewers.
• 01:30:31I,
• 01:30:32experience here at Yale that
• 01:30:33it's difficult to get people
• 01:30:35to be reviewers. It's an
• 01:30:37extraordinary
• 01:30:38time suck.
• 01:30:39And most of us here,
• 01:30:41at the School of Medicine
• 01:30:42spend our lives attempting to
• 01:30:43get grants so that we
• 01:30:44can survive and
• 01:30:46publish so that we can
• 01:30:47survive. So to add
• 01:30:49the,
• 01:30:51task of
• 01:30:53an IRB review as well,
• 01:30:55which is a generous thing
• 01:30:57to do, is would be
• 01:30:58difficult and then to be
• 01:31:00reviewed
• 01:31:01and criticized in public if
• 01:31:02you reviewed us in past
• 01:31:04muster.
• 01:31:05It it would be hard
• 01:31:06to institute that. I'm I'm
• 01:31:07just being, you know, sort
• 01:31:09of practical about that.
• 01:31:11And I wonder if there
• 01:31:13if you are going to
• 01:31:14propose,
• 01:31:15you know, positive steps, because
• 01:31:17I think we all know
• 01:31:18that the IRB does have
• 01:31:19its limitations. I I experienced
• 01:31:21some of this. I also
• 01:31:23know that if I need
• 01:31:24to include more subjects, I
• 01:31:26send an amendment to the
• 01:31:27IRB. I think my IRB
• 01:31:29the Yale IRB must be
• 01:31:30better than Rutgers because of
• 01:31:31the kinds of things you're
• 01:31:32experiencing.
• 01:31:33I don't. My COI,
• 01:31:35doesn't require me to report
• 01:31:37a meal.
• 01:31:38But the,
• 01:31:39you know, so,
• 01:31:41you know, if these,
• 01:31:43steps are gonna be proposed,
• 01:31:45it might be good to
• 01:31:47think about some of the
• 01:31:48practicalities involved as well because,
• 01:31:52you know, some of the
• 01:31:53things I saw up there
• 01:31:54would be good. I think
• 01:31:55sometimes the IRB
• 01:31:57does overstep.
• 01:31:59And I also think with
• 01:32:00with, students,
• 01:32:02saying, oh, I can't do
• 01:32:03this. It's, you know, it's
• 01:32:04gonna take too much time.
• 01:32:05I also am aware that
• 01:32:06the animal care committee is
• 01:32:08also a time suck. So
• 01:32:09then, you know, like, there
• 01:32:11it's very hard to do
• 01:32:12research. So a person has
• 01:32:14decided something that they really
• 01:32:16wanna do and take the
• 01:32:17time to do it. I
• 01:32:18I,
• 01:32:19I can kind of see
• 01:32:20both sides both sides of
• 01:32:22it here.
• 01:32:23So I just I just
• 01:32:25wanna share that if we're
• 01:32:26going to actually move forward
• 01:32:27and make some changes and
• 01:32:29work, you know, it might
• 01:32:31be a good idea to
• 01:32:32to think about,
• 01:32:34a a couple more practical
• 01:32:35solutions.
• 01:32:38I just wanted to add
• 01:32:39that I think it's
• 01:32:42impractical and unlikely
• 01:32:44that the review process
• 01:32:47can will be transferred. I
• 01:32:49could imagine.
• 01:32:50I don't think many of
• 01:32:51my colleagues would want
• 01:32:53the internal discussions
• 01:32:55about protocols
• 01:32:57to be in the public
• 01:32:58domain just as,
• 01:33:01just as peer review in
• 01:33:02the grant review process,
• 01:33:05which is which is anonymized.
• 01:33:08I think it's hard for
• 01:33:09that or something like that
• 01:33:10to be submitted.
• 01:33:12But I had a, a
• 01:33:13related question here is my
• 01:33:15experience with the commercial
• 01:33:17IRBs has been that they
• 01:33:18are brisket in responding.
• 01:33:21And can we learn something?
• 01:33:23Can we understand what the
• 01:33:24differences
• 01:33:26between
• 01:33:27commercial IRBs
• 01:33:29and academic IRBs that allow
• 01:33:33commercial IRBs to to be
• 01:33:35as
• 01:33:36responsive
• 01:33:37and quick as they have
• 01:33:38been.
• 01:33:39Just general question.
• 01:33:41Yeah.
• 01:33:42I think can I
• 01:33:45I was gonna bring up
• 01:33:47the issue of commercial IRBs,
• 01:33:49and I would go so
• 01:33:50far as to say that,
• 01:33:54again, without
• 01:33:56data,
• 01:33:57that the average
• 01:33:59individual,
• 01:34:00the average investigator at Yale
• 01:34:02would prefer to send his
• 01:34:04or her material
• 01:34:06to a professional
• 01:34:07IRB
• 01:34:08if they could afford it?
• 01:34:10But since one is free
• 01:34:11and the other is costly,
• 01:34:14probably it's a deterrent.
• 01:34:16I would argue that things
• 01:34:17fit.
• 01:34:18Yes. I and I agree
• 01:34:20a hundred percent. We finally
• 01:34:21have come to an element
• 01:34:22of agreement.
• 01:34:27But there's a question here
• 01:34:28I wanna hear. Hi. Yeah.
• 01:34:30I
• 01:34:31really appreciate both of the
• 01:34:32perspectives that we're presented today.
• 01:34:34I,
• 01:34:36empathize a lot with your
• 01:34:37experience at Rutgers. I'm sorry
• 01:34:39about that. It seems traumatic
• 01:34:40for you.
• 01:34:43And I also conduct,
• 01:34:44biomedical research in neonatology,
• 01:34:47which, is a protected population.
• 01:34:49So I really value your
• 01:34:51perspective of your biomedical
• 01:34:54clinical research background and the
• 01:34:56protect protections that are necessary
• 01:34:58for those subjects.
• 01:35:01I
• 01:35:02while
• 01:35:03the principles of the MUD
• 01:35:04report were being presented, I
• 01:35:05think the tenth point,
• 01:35:09stuck out to me that,
• 01:35:12about
• 01:35:14IRBs
• 01:35:15not being permitted.
• 01:35:17The word the verbiage is
• 01:35:18here. Well, it might be
• 01:35:20a little bit wrong here.
• 01:35:21Okay. Reevaluation of peer reviewed
• 01:35:22science is not the purview
• 01:35:24of the IRB.
• 01:35:27I understand that your
• 01:35:30hope in these principles, and
• 01:35:32I agree that a lot
• 01:35:33of them are are really
• 01:35:34wonderful,
• 01:35:35is to kind of get
• 01:35:36back to the original purposes
• 01:35:37of the Belmont Report.
• 01:35:40And I would just like
• 01:35:41to kind of highlight
• 01:35:42the circumstances in which the
• 01:35:44Belmont Report was,
• 01:35:47created after the Tuskegee trials,
• 01:35:51which were, as we may
• 01:35:53all
• 01:35:55know,
• 01:35:57IRB or not IRB reviewed,
• 01:35:59but peer reviewed research, published
• 01:36:01research, medical research that
• 01:36:03medical professionals were
• 01:36:05aware of
• 01:36:07for decades before the,
• 01:36:10public became aware. But it
• 01:36:12was never a secret, and
• 01:36:13it was never a
• 01:36:17series of
• 01:36:18trials that were
• 01:36:20being
• 01:36:21kept under wraps in medical
• 01:36:23community. So I would just
• 01:36:24like to hear,
• 01:36:27the author's
• 01:36:28response
• 01:36:29to
• 01:36:30how that tenth principle
• 01:36:32of
• 01:36:33reevaluation
• 01:36:34of peer review would hold
• 01:36:36up under that circumstance.
• 01:36:38Yeah. I I think that
• 01:36:39maybe
• 01:36:41well,
• 01:36:42I'll clarify
• 01:36:46if I can.
• 01:36:48As I said before,
• 01:36:50when I submit a protocol
• 01:36:52to the Yale IRB, it's
• 01:36:54already undergone
• 01:36:56one, if not two or
• 01:36:57more
• 01:36:58series of scientific
• 01:37:00reviews.
• 01:37:02I did the right
• 01:37:04analysis.
• 01:37:05I had the right matching
• 01:37:07of groups. I used the
• 01:37:08right mathematical
• 01:37:10model.
• 01:37:11That's the science
• 01:37:13as I understand it. No.
• 01:37:15No. No. As I read
• 01:37:16it,
• 01:37:17the IRB is to evaluate
• 01:37:20the risk
• 01:37:22that will be undertaken
• 01:37:24by
• 01:37:26volunteers
• 01:37:27into my study.
• 01:37:29So I stand by my
• 01:37:31words.
• 01:37:32The IRBs business is not
• 01:37:34to question
• 01:37:36the science. Am I using
• 01:37:38the right model?
• 01:37:39Am I using the right
• 01:37:41statistics? Am I making the
• 01:37:42right statistical correction? Am I
• 01:37:45using the right chemicals or
• 01:37:46enzymes or treatments?
• 01:37:49That's what I'm talking about.
• 01:37:51This is a
• 01:37:52an abbreviated
• 01:37:53version. I invite you all
• 01:37:55to read the paper and
• 01:37:57send me your criticisms,
• 01:37:59but I stand by that.
• 01:38:02And perhaps offline we can
• 01:38:04discuss. I frankly don't see
• 01:38:06what Tuskegee
• 01:38:07has to do
• 01:38:09with are you suggesting that
• 01:38:11the IRB would have somehow
• 01:38:13a well functioning IRB,
• 01:38:16would have caught
• 01:38:18what was
• 01:38:19really just a,
• 01:38:21an unethical
• 01:38:23mess
• 01:38:24and which I think never
• 01:38:26actually resulted in any published
• 01:38:27papers. So,
• 01:38:30I am suggesting that if
• 01:38:32the I if a well
• 01:38:33functioning IRB were to review
• 01:38:35the research that your research
• 01:38:36is founded on and found
• 01:38:37that that research,
• 01:38:39despite being published Yeah. And
• 01:38:41peer reviewed was deeply unethical
• 01:38:44and harmful if that would
• 01:38:46be within the scope of
• 01:38:48the IRB to then deny
• 01:38:50your building off of Well,
• 01:38:51I don't think I agree.
• 01:38:53I'm sorry. This is an
• 01:38:54excellent and a wonderful Oh,
• 01:38:55and this is a question.
• 01:38:57The PENFORS,
• 01:38:59Atlas debate. Right? Is that
• 01:39:01what it's called? PENFORS?
• 01:39:02Where's Peggy? Perkop.
• 01:39:04Perkop.
• 01:39:05Perkop. But, you know, can
• 01:39:06I just say one thing
• 01:39:07about the the Tuskegee thing?
• 01:39:09That was not what failed
• 01:39:11was not a scientific
• 01:39:13review. What failed was a
• 01:39:15was an ethical review.
• 01:39:18So
• 01:39:20so that would I agree.
• 01:39:21You know, and that is
• 01:39:22the purview of the IRB.
• 01:39:24But I think the The
• 01:39:26ethics, not the not the
• 01:39:27science. And so the we're
• 01:39:29talking apples and oranges here.
• 01:39:31Yeah. I I think so.
• 01:39:32I I think the there's
• 01:39:33an implicit assumption in Evan's
• 01:39:35perspective,
• 01:39:36and that is or not
• 01:39:38it's probably not assumptions, probably
• 01:39:39based on experience, that IRB
• 01:39:41panels sometimes
• 01:39:42review the protocols
• 01:39:44or the proposals on their
• 01:39:45scientific merits.
• 01:39:47That they do that. That's
• 01:39:48a violation. That's that is
• 01:39:50them exceeding their mission. They
• 01:39:52should be evaluating
• 01:39:54them on their ethical,
• 01:39:55merits and on whether they're
• 01:39:57mis and, again, whether they're
• 01:39:58mistreating anybody, but they should
• 01:40:00not be reevaluating
• 01:40:01them on scientific grounds. That's
• 01:40:04that's I I think that's
• 01:40:05your So so so guys,
• 01:40:06I we're we're we're at
• 01:40:07six forty. We're gonna I'm
• 01:40:08going I I appreciate that
• 01:40:10there's a lot of interest,
• 01:40:11and certainly the panelists can
• 01:40:13stay around and audience members
• 01:40:14can stay around. We're gonna
• 01:40:16have one last comment, and
• 01:40:18then we're gonna formally wrap.
• 01:40:19I do wanna say,
• 01:40:21in wrapping, I want to
• 01:40:22remind
• 01:40:23students in particular to sign
• 01:40:24in. If you want to
• 01:40:25get credit for this
• 01:40:27seminar, the sign in sheet
• 01:40:28is there.
• 01:40:29Students in particular, there is
• 01:40:31food left over. And please
• 01:40:32help yourselves.
• 01:40:33And a final comment.
• 01:40:35This is just to address
• 01:40:36the issue of whether the
• 01:40:37IRB should be conducting scientific
• 01:40:39reviews. So having served on
• 01:40:41the IRB at the VA
• 01:40:42for many years, I would
• 01:40:44say that there are many
• 01:40:45of my studies that have
• 01:40:47gone through a grant review
• 01:40:48process
• 01:40:50and are likely in very
• 01:40:51good shape.
• 01:40:52But then there are other
• 01:40:53studies that I've just conceived
• 01:40:55that haven't gone through the
• 01:40:56peer review process.
• 01:40:58And arguably, there are times
• 01:41:00that there may be things
• 01:41:01that I may have missed
• 01:41:02in the review process that
• 01:41:05an IRB might pick up.
• 01:41:07But not all my studies
• 01:41:09have been grant reviewed or
• 01:41:11gone through the peer review
• 01:41:12process. So I think there's
• 01:41:14probably some room. I guess
• 01:41:16the question is how much
• 01:41:17of and how extensive of
• 01:41:19a scientific
• 01:41:20review
• 01:41:21does the IRB need to
• 01:41:22conduct?
• 01:41:23Well, I think the principle
• 01:41:25says
• 01:41:26peer review.
• 01:41:28There should there should be
• 01:41:29no
• 01:41:31rereview
• 01:41:32of the science of peer
• 01:41:34review
• 01:41:36science. So we were careful.
• 01:41:37I don't want to start
• 01:41:38on that. So are you
• 01:41:39saying that, are you saying
• 01:41:40that if I have a
• 01:41:42proposal that's been that's undergone
• 01:41:45NIH peer review? Yes. Then
• 01:41:46I should tell the IRB
• 01:41:48it's not through NIH. They're
• 01:41:49doing that. And from what
• 01:41:50they're saying, the IRB should
• 01:41:52not do the second side
• 01:41:54of it.
• 01:41:55Yes. I think that's a
• 01:41:56that's a very nice,
• 01:41:58refinement
• 01:42:00of what we
• 01:42:01what we proposed.
• 01:42:03But, yes, but but we
• 01:42:05were careful to use the
• 01:42:06term peer reviewed
• 01:42:08in the principle.
• 01:42:10Okay. Now I wanna pause
• 01:42:12here and give folks an
• 01:42:14opportunity to leave if you'd
• 01:42:15like. I wanna thank our
• 01:42:16panelists and our audience.
• 01:42:18Thank you very much.
• 01:42:22And if the panelists would
• 01:42:24like to stay around and
• 01:42:25audience members would like to
• 01:42:25stay around, you're certainly welcome
• 01:42:26to, but we're gonna we're
• 01:42:27gonna end the event now.
• 01:42:29Thank you. Oh, it's good
• 01:42:30to see you. Good to
• 01:42:30see you again.