Quorum Review's July 2013 Institution Bulletin includes Letter from CEO, Cami Gearhart, JD, addressing support for effective human research protection programs, as well as Quorum's insights on two important topics: The first addresses exculpatory language in consent forms; the second provides insight on considerations when planning eConsent implementation and questions to ask the IRB.

1. July 25, 2013 | Volume 3 Issue 3
Institution Bulletin
Letter from the CEO
Sincerely,
Cami Gearhart, CEO
Quorum Review IRB
It is discouraging to read recent news reports of alleged research misconduct
by individuals in China, including the failure to disclose the results of
preclinical anaimal studies. The allegations bring to mind other cases of
misconduct. The claim that the MMR vaccine can cause autism spectrum
disorders, for example, was described in a 2011 journal article as “the most
damaging medical hoax of the last 100 years.”
“Science is at once the most questioning and . . . skeptical of activities and
also the most trusting,” said Arnold Relman, former editor of the New
England Journal of Medicine. “It is intensely skeptical about the possibility of
error, but totally trusting about the possibility of fraud.”
Scientifc misconduct is relatively infrequent, and the tools of the IRB are
limited. That being said, IRB members and staff must remember to be vigilant for the “red flags” of misconduct
and fraud. These red flags include the absence of preclinical data, data that appears “too perfect” and, of course,
complaints by research participants or staff.
We realize the resources needed to support an effective human research protection program can be daunting.
Enclosed are two articles to assist your institution in its mission to protect research participants. One article
describes conflicting FDA guidance on exculpatory language and the other discusses IRB review of new
technological “eConsent” tools.
Quorum Review is honored to have the privilege to work with you and your research teams. Please let us know if
we can be of further assistance.
1601 Fifth Avenue, Suite 1000 | Seattle, Washington 98101
T 206.448.4082 | F 206.448.4193 | QuorumReview.com

2. July 25, 2013 | Volume 3 Issue 3
One of the responsibilities of an IRB is to ensure that
the information given to subjects during the consent
process is not “exculpatory.”1
Guidance issued in 1996
provides examples of “exculpatory” and “acceptable”
language for consent forms.2
Two examples of
“exculpatory” language regarding samples are provided
below.
Examples of “Exculpatory” Language
Regarding Samples
“I voluntarily and freely donate any
and all blood, urine, and tissue
samples to the U.S. Government and
hereby relinquish all right, title, and
interest to said items.”
“By consent to participate in this
research, I give up any property rights
I may have in bodily fluids or tissue
samples obtained in the course of the
research.”
Although the guidance provides no analysis, it implies
that subjects have an ownership interest in samples
that are provided for research, and that a statement
in the consent form waiving those rights would be
considered exculpatory.
1 21 CFR 50.20; 45 CFR 46.116
2 “Exculpatory Language” in Informed Consent, Office
for Protection from Research Risks (OPRR), Cooperative Oncology
Group Chairpersons Meeting, November 15, 1996, available at:
http://www.hhs.gov/ohrp/policy/exculp.html.
In 2011, the Food and Drug Administration
(FDA) and OHRP released a draft guidance
providing a conflicting interpretation.3
The draft guidance indicates that the agencies
determined that “language…is not exculpatory if it
informs subjects that, by agreeing to allow the use of
their biospecimens for research purposes, they are
giving up any legal right to be compensated for the
use…” The draft guidance argues that such language
is not exculpatory because there is no law or policy
explicitly recognizing a legal right to compensation
for specimens.4
Given this, the agencies conclude the
statements noted above are now acceptable.
Although the 2011 draft guidance has not been
finalized, it is important for IRBs to carefully review
consent language regarding specimens. As the draft
guidance notes, in practice, researchers and sponsors
do not compensate subjects for the use of samples
or any commercial developments. Subjects should
have a clear expectation about what will happen with
3 Guidance on Exculpatory Language in Informed
Consent, DRAFT, Office for Human Research Protections, Food
and Drug Administration, August 19, 2011,available at: http://
www.fda.gov/downloads/RegulatoryInformation/Guidances/
UCM271036.pdf (Emphasis added).
4 The draft guidance indicates the agencies are unaware
of any federal or state law or policies that suggest research subjects
would have any legal right to compensation if they voluntarily sign
an informed consent form which clearly states they will not be
compensated for providing their biospecimens.
Consent Forms: Exculpatory Language and Subject Samples
1One
2Two

3. July 25, 2013 | Volume 3 Issue 3
their samples and the risks associated with the sample
collection and use. Several points to address in the
consent form are provided below.
Points to Address in the Consent Form
„„ The samples that will be taken (consider
including type, amount, and collection
procedure)
„„ The coding or de-identification procedures for
the samples
„„ A realistic discussion of privacy protections and
risks5
„„ The use of the samples for this research and
future research or, if it is unknown, whether
future research may be conducted with the
samples
„„ The length of time samples will be stored
„„ Whether samples can be withdrawn or
destroyed at the request of the subject and if so,
the process for making such a request
„„ The plans for or possibility of commercial
development and the ownership of such
developments
5 Given that identification of individuals is possible with
limited data and publicly available information it is important to
avoid guarantees of absolute privacy. See, Melyissa Gymrek, et. al.,
“Identifying Personal Genomes by Surname Inference.” Science,
2013; 339 (6117) 321-324. See also Kolata, Gina, “Poking Holes in
Genetic Privacy.” New York Times [New York] 13 Jun. 2013. Web.
26 Jun. 2013. Available at: http://www.nytimes.com/2013/06/18/
science/poking-holes-in-the-privacy-of-dna.html?src=rechp&_r=0.
When Performance Matters
Choose Quorum Review
Working with Institutions to
Achieve Great Things
Quorum Review personalizes the IRB approach
for your specific research studies with customized
coversheets and model consent forms that
utilize language preferences. We understand and
recognize your needs and we are here to facilitate
your research process.
• Streamlined process
• Unbiased results
• Regulatory leadership
• Experienced Board
• Personalized Account
Manager
• OnQ online
document portal
• Diverse training options
• Fast turnaround times
• Phase I-IV review
• Customized approach
Learn more about Quorum’s
customized processes for the ethics
review of institutional research at:
www.quorumreview.com/institutions

4. July 25, 2013 | Volume 3 Issue 3
eConsent in Clinical Research: Planning and Questions for the IRB
With the adoption of EHRs and electronic data
collection, researchers, trial sponsors and IRBs
are looking toward possible adoption of electronic
consent processes and systems. The use of an
eConsent process has many advantages. However,
early consideration, planning and close coordination
at the IRB review stage is important before
implementation.
In June, Quorum Review released a new information
sheet on eConsent in Clinical Research. The following
is taken from the document. You can download the
full information sheet at www.quorumreview.com.
Considerations When Planning eConsent
Implementation
When considering
the use of eConsent
processes and systems
in clinical research,
early planning and
close coordination is
important. A carefully
planned implementation process involves choosing the
eConsent approach that works best for the study, the
sites and the patients involved, and working closely
with the IRB to understand the review processes for
using eConsent, including how the eConsent system
may impact IRB review and steps involved in meeting
documentation requirements.
To have a smooth IRB review, talk to the IRB about
review and documentation requirements for eConsent
and the IRB’s background in reviewing eConsent
materials and documentation.
Questions to Consider When Talking to the IRB
„„ Has the IRB reviewed eConsent previously?
„„ What additional documents or forms does the
IRB require to review eConsent?
„„ What additional information does the IRB
require to review eConsent?
„„ How will the IRB review the eConsent?
„„ What file requirements (format and size) does
the IRB have?
„„ What are the expected timelines for review
of the eConsent? Will it take longer than the
review of a paper consent?
„„ Does the IRB have any specific restrictions
or requirements related to eConsent that we
should be aware of?
Contact Quorum Review
Interested in learning more about Quorum
Review?
Our Institutional Team is ready to answer your
inquiries regarding your organization’s specific
institutional IRB needs.
Nancy Jane Earnhardt
Institutional Specialist
nearnhardt@quorumreview.com
T| 919-930-5198
The Institution Bulletin is a special publication
of the Quorum Forum, and brought to you by
the Institution Team at Quorum Review IRB.