Quorum Review's February 2014 Institution Bulletin includes a letter from CEO, Cami Gearhart, JD, discussing factors to consider when assessing the strength of your IRB, SACHRP guidelines on internet research, international ethics review, and how the 2014 Congressional Appropriations Bill impacts clinical research.

1. February 11, 2014Volume 3 4 Issue3
July 25, 2013 | | Volume Issue 1
Institution Bulletin
Letter from the CEO
This spring will mark the fifth anniversary of the downfall
of Coast IRB. In March 2009, it was announced that Coast
IRB had fallen for a sting operation. Congress and the
Government Accountability Office had sent several IRB’s a
sham medical device study for review. The study proposal had
several flaws, including no device description, no preclinical
data, questionable procedures and outdated investigator
licensure documentation. Coast IRB’s board approved the
study unanimously. Within weeks of disclosure of the sham,
the FDA issued a warning letter and Coast chose to close its
doors.
Many in the ethics community were not surprised. Coast IRB had never been accredited and had received a
disturbing FDA Warning Letter the prior year. Disillusioned employees had been seeking work elsewhere.
Nevertheless, it’s worthwhile to take steps to ensure that your IRB – or the IRB to which you outsource – does
not make this type of mistake. Factors to consider in assessing the strength of an IRB include accreditation status;
quality of the IRB members; availability of regulatory support during Board meetings; documented separation
of business interests and ethics review; and the organization’s commitment to quality assurance and compliance
measures.
Quorum Review is committed to the highest standards in all these areas. When an institution is ready to use a
central IRB, we are committed to supporting the institution with a high quality review, a strong regulatory team
and multiple quality control and compliance processes. And to help support you and your ethics board, today’s
newsletter describes new guidelines from SACHRP as well as Quorum’s ability to support international research.
We look forward to an opportunity to work with you.
Sincerely,
Cami Gearhart, CEO
Quorum Review IRB
1501 Fourth Avenue, Suite 800 | Seattle, Washington 98101
T 206.448.4082 | F 206.448.4193 | QuorumReview.com

2. February 11, 2014Volume 3 4 Issue3
July 25, 2013 | | Volume Issue 1
International Ethics Review: Now Available From Quorum Review IRB
O
ver the last decade, clinical
researchers have
expanded their use
of study sites located outside of
North America. While this shift
has increased participant availability
ty
in the clinical trials pipeline, it has
also exposed research protocols to
redundancy and delays arising from
multiple ethics review requirements and
d
multiple service providers.
Quorum’s Commitment to International
tional
In response, Quorum Review IRB has delivered on
vered
our strategic commitment to develop the expertise
pertise
and processes needed to meet the research industry’s
dustry’s
demand for international and domestic ethics reviews.
As a result, sponsors, CROs, and institutions can now
access Quorum’s industry leading ethics review or
consulting services even when protocols employ study
sites across the globe.
Quorum’s strategic investment in international
capabilities builds on more than 20 years of
experience conducting ethics reviews in North
America. Already boasting one of the industry’s
largest team of regulatory attorneys, Quorum has
bolstered this expertise with extensive research on
international laws and policies governing participant
ethics reviews. In addition, Quorum has crafted
submission requirements that ensure qualifying
international protocol submissions can benefit from
the same standard turnaround times available to
North American studies.
What kinds of international ethics reviews
are available to Quorum’s clients?
Quorum’s expertise gives us the flexibility to provide
ethics reviews in one of three ways, depending on the
client’s individual needs and requirements under local
law:
 Ethics reviews based solely on United States
standards.
 Hybrid ethics reviews in which both United
States and country-specific standards are
considered.
 Ethics reviews based solely on country-specific
requirements. Typically, this form of review
is only available when the country-specific
standards are the same or more protective than
U.S. Common Rule.
Learn more at:
QuorumReview.com/International

3. February 11, 2014Volume 3 4 Issue3
July 25, 2013 | | Volume Issue 1
SACHRP Guidelines on Internet Research:
Practical Considerations for Online Consent
In March of this year, the Secretary’s Advisory
Committee on Human Research Protections (SACHRP)
developed recommendations related to Internet
research1. The Committee acknowledged that the
human subject protection regulations, written over thirty
years ago, are inadequate in the context of Internet
research. In eighteen pages, the Committee attempts to
address some of the dilemmas faced in online research
and provides practical guidance for IRBs and researchers
in this space.
may not be a critical issue. The recommendations point
out that the federal Children’s Online Privacy and
Protection Act (COPPA) mandates parental permission
if subjects under the age of 13 are being recruited and
they provide identifiable information2. Ultimately, the
Committee recommends that researchers and IRBs
need to be aware that identity verification is a major
issue online. IRBs are provided with some points of
consideration when determining whether a given
identity verification approach is adequate:
While the entire
document is a
worthwhile read, the
SACHRP Committee’s
recommendations
addressed three
particular concerns
related to consent and
Internet research that
are worth noting, including: (1) verifying identification;
(2) ensuring comprehension; and (3) obtaining
appropriate documentation when needed.
 The importance to the research. That is, are there
eligibility criteria? Is there likelihood of repeat or
fraudulent participation, whether for mischief or
to collect multiple payments?
Identity Verification and Parental Permission
The Committee begins by explaining that adequate
identity verification may be handled through vendors or
software, or in some cases, such as minimal risk research,
1 Id., Considerations and Recommendations Concerning Internet
Research and Human Subjects Research Regulations.
 The level of risk to subjects. Low-risk surveys where
parental consent could be waived may require only
minimal identity verification, perhaps a checkbox.
High-risk studies involving the transmission of
sensitive information may warrant multiple-factor
authentication, such as passwords delivered by
mail or telephone, or via an identity verification
software or vendor.
There may be a third-party policy or terms of agreement
in place that the researcher should acknowledge when
considering identity confirmation. For example,
Facebook® has a “real-name” only policy, so anonymity
2
See http://answers.hhs.gov/ohrp/questions/7249.

4. February 11, 2014Volume 3 4 Issue3
July 25, 2013 | | Volume Issue 1
is not possible. The norms and expectations of users and
venues must be considered.
Subject Comprehension
The SACHRP recommendations include a number of
options for confirming subject understanding in the
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.
• 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
context of Internet research. In choosing a particular
option, the Committee advises that comprehension
checks should be designed in the context of the research.
Consent typically
consists of a consent
form or other
document that provides
information for the
subject’s reference and
documents the initial
consent interaction,
yet the intent remains
that informed consent
is an ongoing exchange
of information between the investigator and subject.
For lower risk research, the Committee suggests that a
checkbox indicating the user “understands and agrees”
may be appropriate. However, for higher risk or more
complex research, a greater level of documentation, such
as quizzes to check comprehension, may be appropriate.
The Committee specifies that however the consent
process is conducted, individuals should be provided
with an opportunity to have their questions and
concerns addressed on an individual basis.3
Appropriate
Determination of Consent
Documentation of consent
is the third major issue
addressed in relation
to consent for Internet
research. Depending on the
nature of the research, it
may be appropriate to waive
or alter some elements of
consent in an online setting
and include a statement
that the subject is agreeing
3 SACHRP, Considerations and Recommendations Concerning
Internet Research and Human Subjects Research Regulations, Final
Document, approved at SACHRP meeting March 12-13, 2013,
available at: http://www.hhs.gov/ohrp/sachrp/mtgings/2013%20
March%20Mtg/internet_research.pdf

5. February 11, 2014Volume 3 4 Issue3
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Title of Article
to participate in the research when completing the
survey. Consent for a higher risk study may involve
aThe Article Here..... and in-person interactions,
combination of online
including a Skype® or LifeChat® discussion with the PI,
comprehension quizzes, and emailing or mailing the
consent form for
a signature (either
traditional or
e-signature) from
the subject.
With regard
to the validity
of electronic
signatures, in the
United States,
the ESIGN
law authorizes
signatures in
certain contexts.
OHRP has provided guidance that an IRB can allow
such technology “as long as the IRB has considered
applicable issues such as how the electronic signature
is being created, if the signature can be shown to be
legitimate, and if the consent or permission document
can be produced in hard copy for review by the
potential subject.”4
SACHRP does not advocate for a more stringent review
of Internet research; however, the Committee does
recognize a need for heightened awareness of subjects’
privacy, confidentiality, and identities and places
the responsibility on the investigator for good data
stewardship. All parties have an interest in ensuring
Internet research meets regulatory requirements.
Researchers and IRBs will need to approach online
consent with flexibility and creativity and consider
consent approaches that will be effective in the context
of a given project.
4 Citing, http://www.coppa.org/comply.htm; also see FTC’s
August 1, 2012 proposed changes to COPPA, including changes
to the COPPA definition of “personal information” to include
persistent identifiers (Ropes & Gray, 2012).
2014 Congressional Appropriations
Bill: The Effects on Research
Under the auspices of bipartisanship, the U.S.
Congress and President Barack
Obama passed the 2014
Omnibus Appropriations Bill
in mid-January to fund the U.S.
government through September
30. Here are some of the increases
in funding that were included in
the bill:
 The Food and Drug Administration (FDA) - $217
million above 2013’s fiscal year amount – as well as
expansions for other government agencies responsible
for researcher research
 The Department of Defense saw surges in its medical
research programs including $200 million for the
Peer-Reviewed Medical Research Program, $125
million for Traumatic Brain Injury and Psychological
Health studies, and $120 million for breast cancer
research
 The National Institutes of Health (NIH) obtained
a $1 billion increase over its 2013’s fiscal year
allotment (albeit this is below the pre-Sequester 2012
budget level).
Another highlight of the bill is the expansion of
public access to a larger portion of Federally-funded
research – a mandate to which only the NIH was
previously bound. Under the new provision, any
research budgeted at $100 million or more would
have to be made available to the public online within
1 year of being published in a peer-reviewed journal.
Iowa’s Senator Tom Harkin (D) was a key player in
getting the original NIH access put into law. The

6. February 11, 2014Volume 3 4 Issue3
July 25, 2013 | | Volume Issue 1
Title of Article
Senator told the Washington
Post, “Expanding this policy to
The Article Here.....
public health and education
research is a step toward a more
transparent government and
better science.”
Despite the bill’s escalation
of funding - which will allow
current programs to continue
and permit approximately 385 new research studies many in the investigative field criticized the amount
as being insufficient, especially since the 2013
sequester gutted many competitive research grants
and forced deep staffing cuts. Many believe that
government-funded research remains a crucial part
of the drug and device development industry. For
example, NIH endowments routinely provide funding
for those types of research considered too risky or
unconventional for private investors.
You can read the Detailed Omnibus Summary by
click here.
Upcoming Events
iiBIG’s Clinical Study Teamwork
Conference
Raleigh-Durham, NC
April 10-11, 2014
Join Quorum Review’s
Mitchell Parrish, JD, RIC, CIP
as he moderates an intriguing
breakout session covering
Proxy Consent—Children and the
Cognitively Impaired.
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 - East
nearnhardt@quorumreview.com
T| 919-930-5198
Lyndsey Broerman
Institutional Specialist - West
lbroerman@quorumreview.com
T| 513-417-4234
The Institution Bulletin is a special publication of the
Quorum Forum, and brought to you by the Institution
Team at Quorum Review IRB.