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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
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
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
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.

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Institution bulletin volume 3 issue 3

  • 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.