1. Midwife crisis: A cultural and
financial mandate for talking
to research participants
Misha Angrist, PhD
Future of Genomic Medicine VI
La Jolla, California
7 March 2013
2. Disclosure
• I serve on the Duke University Health System
Institutional Review Board but I do not speak
for it nor do I speak for Duke University.
• They mostly think I’m crazy
3. “Ah but it’s hard
to live by the rules.
I never could…and
still never do”
– Chrissie Hynde
“Talk of the Town”
Photo: Carlos Alvarez/Getty Images
5. Juror #10: I want to ask you something:
do you believe his story?
Juror #8: I don’t know whether I believe
it or not – maybe I don’t.
Juror #7: So how come you vote not guilty?
Juror #8: Well, there were eleven votes
for guilty. It’s not easy to raise my hand
and send a boy off to die without talking
about it first.
6. Case #1, 2012:
A massive biobank and
the impossibility of sending
participants a Christmas card
7. • YOU will get NO compensation.
• But WE will try to make money from your samples
• We can come back to you to get MORE
• You aren’t allowed to see your own data
• If you get injured in OUR STUDY, we will treat
you…but the bill goes TO YOU.
• At least you’re not giving up any of your rights!
8. My proposal
"If you wish to receive an annual
notification of which research groups are
studying your samples and a brief
description of what they are studying,
please provide an email address at the end
of this consent form.”
9. Response #1
• Yearly newsletter and list of publications?
• No personal contact because of this
scenario: “Patient gets very excited and
wants her results (‘just tell me if I am
one of the ones who needs chemo’).
Results cannot be released. Patient
ends up very unhappy.”
• Bottom line: we can’t have patients
badgering researchers
10. My second proposal
“What if you left off the PI's name and
institution and just briefly described the
specific research projects in which the
patient's sample was being used? That way
the repository remains the gatekeeper.”
11. PI Response #2
• “Let me think about it.”
• “The repository may not have a clear
understanding of the research that is
being done on a patient’s tissue”
• “We are a disinterested third party”
• “I am not sure how to make a patient-
specific communication work.”
12. My third communiqué
• “I’m not asking for a detailed understanding of what
specific investigators are doing”
• “…provide a couple of sentences from the external
investigator's IRB-approved protocol in plain English”
• “In my opinion it is exactly that piece--the
personal acknowledgement--that would add
value to the participants and ultimately redound
to you and the repository.”
15. “Dear Dr. X…
Your consent form says: ‘The tests done for this
study are for research purposes only. Therefore, you
will receive no results from these genetic studies…’
But both the genotyping and the INR measurements
will be done in CLIA-certified labs. If that's true, then
I am wondering why participants should not have
access to their CYP2C9/VKORC1 genotypes and their
INR values?”
16. “Dear Misha…
The INR results are considered standard of care.
Everyone has access to the INR results. The genotype
testing is being performed by research personnel.
While it is being performed in a CLIA laboratory it is
for research only…The additional costs associated
with providing genetic counseling for this purpose
[were] not in the NIH budget for this study.”
20. “A Phase III Trial of DRUG X or Placebo in
Combination with DRUG Y as First-line Therapy for
Metastatic Adenocarcinoma of the Pancreas”
• August 2012: sponsor ends study on
account of futility
• PI: “We have communicated the
findings to the two subjects on study”
• Me: “Have you told the other five?”
• IRB: “Well, we usually don’t.”
21. Pyrrhic Victory is Mine!
“The study team must inform the
IRB on how it plans on informing
the five people who completed the
study about the reason why the
study was closed.”
22. What do these cases reveal?
• A reluctance to share even basic
information with participants
• Fealty to the rules rather than people
• Unilateral and maybe arbitrary decisions
about what constitutes research
• Genetic exceptionalism
• Institutional detachment
• Lack of resources
23. How might we address the lack
of a culture of transparency and
dedicated resources for
communication with
participants?
24. Scientific publishing: the good old days
“…more specific services may eventually supplant
conventional journal publication…Any process of
supplanting can therefore be evolutionary, with no
direct and immediate threat to the status quo; (the
status quo being defined as the mess we are in). I
especially wish to emphasize that I by no means
advocate the deliberate proliferation of
uncontrolled and informal communication.
American Psychologist,
Vol 21(11), Nov 1966, 1005-1010
25.
26. “Unimpeded access to these archives and
open distribution of their contents will enable
researchers to take on the challenge of
integrating and interconnecting the
fantastically rich, but extremely fragmented
and chaotic, scientific literature.”
27. Midwifery
4 May 2001
“Midwives have found it possible to earn a
living by delivering babies for a fee and
turning them over immediately to their
parents. We see no reason to doubt that
scientific publishing can readily operate on
a midwife model…”
38. Closing thoughts
• We can argue about CLIA and HIPAA, but those types of
rules have long since ossified into fig leaves and excuses
• If it hadn’t already, the clear research-clinical divide ended
when Nic Volker had his DNA sequenced in 2009
• The same doubts, lack of incentives and lack of
infrastructure that kept open-access publishing down are
inhibiting us from talking to the people we study
• The same types of incentives and infrastructure that
fostered open-access publishing can be applied to
participant communication
• If we are to monetize human tissue and information,
should not some of that filthy lucre be funneled back into
ways to inform and engage the people from whom the
material and data came?
39. Acknowledgements
Duke Elsewhere
Sara Katsanis George Church (Harvard; PGP)
Nico Katsanis Michelle Meyer (Harvard)
Erica Davis Dan Vorhaus (PGP)
Mike Cotten Jason Bobe (Harvard; PGP)
Heidi Cope Leila Jamal (Johns Hopkins)
Azita Sadeghpour Sharon Terry (Genetic Alliance)
Leigh Ann Simmons Jen Wagner (Penn)
John Wiener Gholson Lyon (CSHL)
David Goldstein
Bob Cook-Deegan
40. “I am a man of substance,
of flesh and bone, fiber
and liquids—and I might
even be said to possess a
mind. I am invisible,
understand, simply
because people refuse to
see me.”
- Ralph Ellison (1914-1994),
Invisible Man
