Quorum Review's April 2014 Institution Bulletin includes a letter from CEO, Cami Gearhart, JD, discussing the need to reform the regulations around biobanking and repositories, HIPAA templates and procedures, and the lessons IRBs can learn from 2013 FDA Warning Letters.

1. July 25, 2013 | Volume 3 Issue 3
Institution Bulletin
Letter from the CEO
Every day seems to bring additional evidence of the need to reform the rules governing
IRB review of data repositories. Earlier this month, for example, I attended a panel
discussion about PCORNet, a collaboration founded to pursue certain objectives of the
Affordable Care Act. The ACA authorized creation of the “Patient-Centered Outcomes
Research Institute” (PCORI) to conduct comparative effectiveness research, and PCORI
has formed PCORNet to develop national networks of clinical treatment data. Some
of the speakers discussed a vision of national-level repositories of electronic clinical
treatment data that can be mined for research purposes, but opined this simply “cannot
be done” under current IRB and privacy rules.
I think we all can agree that an overhaul of the rules surrounding the collection, storage
and use of data is overdue. A PRIM&R workgroup called for reform in 2007, saying
“certain provisions of the existing regulations pose significant barriers to research using
human specimens and data while offering little additional protection for the individuals
from whom the specimens were obtained.”1
SACHRP echoed the call in 2011.2
Many of us are anxiously awaiting the agencies’
next steps after the 2011 ANPRM3
solicited feedback about regulatory revisions affecting repository research.
Without agency action, IRBs are left to struggle through the existing crazy quilt of regulatory provisions and guidance. To help
support you and your ethics board, Quorum recently presented a webinar on IRB review of biorepositories that you can find on
our website at www.QuorumReview.com/Resources. One of the enclosed articles in this Bulletin looks at the recent HIPAA/
HITECH Omnibus Final Rule regarding the “future use” of data; the other article focuses on trends in FDA Warning Letters.
Please contact us if we can be of further assistance. We look forward to an opportunity to work with you!
Sincerely,
Cami Gearhart, CEO
Quorum Review IRB
1 Report of the Public Responsibility in Medicine and Research (PRIM&R)
Human Tissue/Specimen Banking Working Group (March, 2007) at p.1
2 Attachment A to January 24, 2011 SACHRP Letter to the Secretary
3 76 Fed Reg 44512 (July 26, 2011)
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April 24, 2014 | Volume 4 Issue 2

2. July 25, 2013 | Volume 3 Issue 3
Although the HIPAA/HITECH Omnibus Final Rule was
effective in March of 2013, the changes relating to research
are worth reviewing- particularly if you or your organization
is involved with research that proposes to store information
for future research. The new HIPAA rule offers flexibility
that it is intended to alleviate administrative burdens on
researchers and subjects and harmonize with the Common
Rule documentation requirements.
Compound Authorizations
Under the previous HIPAA rule - when individuals
were asked to take part in a study that had an optional
component (for example banking of tissue, or additional
pharmacogenomics analysis) - it was not allowable to
combine the authorization for the main study and that
optional component. Instead individuals should have
been presented with two separate authorizations: one
for the required part of the study (the “conditioned
authorization” and one for the optional parts of the study
(the “unconditioned authorization”). This was logistically
problematic in that it was confusing and created additional
paperwork. It also conflicted with the Common Rule
informed consent requirements which allow individuals to
consent to all aspects of a study in a single document.
Under the new HIPAA rule, a single authorization can
address both required and optional parts of a study as long
as there is clear delineation between the “conditioned”
and “unconditioned” components of the research, and
the subject is given the option to participate in the
unconditional activities.
It is important to note that the rule allows covered entities,
researchers, and IRBs discretion with respect to the
documentation of the decisions related to optional aspects
of the research. The consent could have an additional
signature line, check-boxes, or initial lines, for example.
One option that was explicitly not allowed under the rule
is an “opt out” provision, for example: “check this box if
you do not want to participate in the sub-study”. HHS
explains that this approach does not allow individuals
to clearly affirmatively authorize the optional part of the
research and could be considered coercive.
Specificity Requirements
Another important change relates to the scope of
an authorization. Under the previous HIPAA rule,
authorizations were required to be specific and individuals
could not authorize unspecified future research using their
information. Again, this interpretation conflicted with the
Common Rule standards related to consent.
The 2013 Final Rule does not require an authorization
to be specific, rather an authorization must include
a description of each purpose of the requested use or
disclosure in such a way that it would be reasonable to
expect the individual should understand that their PHI
could be used and disclosed for such future research. As
with the change related to compound authorizations, HHS
gives discretion to covered entities, researchers, and IRBs
as to how to adequately describe future research. Another
important note is that HHS indicated covered entities and
researchers could rely on IRB-approved consent forms that
were obtained prior to the effective date of the final rule
— if the consent form reasonably informed an individual
about the future research and was combined with a
HIPAA-compliant authorization.
These changes offer enhanced efficiencies and facilitation
of research initiatives. It is important to ensure that your
policies, procedures, and forms reflect these changes to
take full advantage of these updates.
Evaluating Your HIPAA Authorization Template and Procedures
April 24, 2014 | Volume 4 Issue 2

3. July 25, 2013 | Volume 3 Issue 3
In the recent edition of
our sister publication, The
Quorum Forum, we discussed
reflecting on the past year
as a means to formulate
possible improvements to IRB
procedures. A review of FDA
warning letters to IRBs from
2013 provides an opportunity
to evaluate your IRB procedures and policies and evaluate
them against the regulatory requirements for IRBs. If you
are interested in the specifics, FDA warning letters are
posted publicly on the FDA website, here.
The handful of warning letters issued to IRBs list several
failings that may seem straightforward; however, it is
worthwhile to review the issues FDA raised and evaluate
your own IRB procedures and policies. This exercise can
help to ensure that each of these regulatory requirements
is met.
For ease of reference covering the points noted in warning
letters, Quorum Review has developed a checklist for your
use:
Another important point to consider is whether the study
file provides adequate documentation that the above-
referenced procedural requirements are followed. Once
procedures have been identified that meet the regulatory
requirements, it would be prudent to self-audit study
files to ensure the documentation in the files clearly
records that the IRB is following procedures and fulfilling
regulatory obligations.
In addition, to procedural failings, the FDA warning letters
addressed a lack of appropriate documentation in IRB
minutes. Again, it may be worthwhile to review examples
of recent minutes to ensure the following information is
documented in minutes appropriately.
For your convenience, Quorum Review has developed a
checklist for Board minutes:
To download the Word document formats of these special
checklists, please visit our website:
www.QuorumReview.com/institution-bulletin-apr2014-
warning-letters
Learning from 2013 Warning Letters to IRBs
April 24, 2014 | Volume 4 Issue 2

4. July 25, 2013 | Volume 3 Issue 3
New Offerings in 2014 from Quorum Review IRB
We are constantly improving our services to better serve you and your Institutional needs
15 Board Meetings per Week
In April 2014, Quorum expanded its Board meeting
schedule to include a Monday meeting for new
protocols and consent forms, thus giving us a total
of 15 meetings per week. This change allowed us to
offer an additional North American Board on Fridays
- giving us 2 meetings a week for U.S.-Canadian
research review. We continue to offer our Cambridge,
Massachusetts oncology Board on Tuesday, our two
daily meetings (Monday through Friday), as well as our
weekly meetings on Wednesday and Thursday.
FREE WEBINAR: May 13 & 15, 2014
On May 13th and May 15th, join Quorum Review for
a free webinar on Understanding Reporting Obligations
to the IRB. Our own regulatory attorney, Mitchell
Parrish, JD, RAC, CIP will be hosting this one-
hour live web broadcast which will provide guidance
on how and when to report safety findings and
unexpected events to your IRB. Sign up below!
Go to www.QuorumReview.com/free-webinar-
understanding-reporting-obligations-irb
International Research Review
Quorum Review now offers ethics review for research
performed outside of the U.S. and Canada. We can
perform according to any of the following criteria:
• Compliance under ICH GCP, local standards, and
U.S. standards (if applicable)
• Coordinate with local review committees if they
exist
• Serve as the sole IRB of record where no local
review committees exist (and is permitted to do so
by local standards)
Learn more by visiting us as:
www.QuorumReview.com/International
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.
April 24, 2014 | Volume 4 Issue 2