1.
May 2, 2011 | Volume 1, Issue 1
The Quorum Review: Institutional Edition
Letter from the CEO
Welcome to the first issue of Quorum Review’s Institutional Newsletter!
Quorum works with over two hundred institutions, and we know that
institutions have special needs and interests in ethics oversight. This
newsletter is intended to help you – our institutional clients – feel better
prepared to deal with the day-to-day challenges of research ethics.
In today’s research environment, more and more sponsoring
organizations are seeking to place their studies in institutional settings.
At the same time, pressure is building to centralize the ethics oversight of
multi-site studies. Here at Quorum, we realize that local review is
important in many situations. When an institution is ready to use a
central IRB, however, we are committed to supporting the institution
with a high quality review and strong staff support.
We are honored to have the privilege to work with you and other
institutions to provide ethics review of important research. Today’s
newsletter will delve more deeply into recent FDA guidance as well as the
importance of specialty expertise to an ethics board. Welcome to the
world of Quorum Review!
Sincerely,
Cami
Cami Gearhart, CEO
Quorum Review IRB

2.
May 2, 2011 | Volume 1, Issue 1
Tackling the Issue of Expertise: documents with the keen eye of an expert in the
field who is current with the standard of care
Quorum’s Use of Medical within their given area, but also with knowledge
Consultants to Assist with the of human subject protection. The job of
Quorum's consultants is two-fold. First, they
Review of Research review research to determine whether in their
opinion the research's risk to benefit ratio is
Quorum reviews a diverse range of drug, device, acceptable. This is accomplished through
and biologics research. One of the questions considering the science and procedures involved
frequently asked of our staff is "how does Quorum and considering human subject protection issues.
address the need for medical expertise across such Second, they review and present the research to
a vast and diverse expanse of therapeutic areas?" Quorum's Board members in a manner that
To ensure thorough, accurate, and efficient ethics members can understand, so that each member is
review of an ever expanding range of study able to formulate their own decision on whether
products, Quorum utilizes medical consultants. to approve the research.
These consultants are a compliment to Quorum's
knowledgeable Board members and IRB Consistent with the regulations, Quorum's
infrastructure keeping Quorum a leader in the medical consultants do not vote. Instead,
IRB field. Due to Quorum's use of consultants, a Quorum's Board members vote after considering
researcher is able to submit a study in virtually any the consultant's presentation of the research and
therapeutic area and be assured that it will be their own independent examination of the
reviewed with expertise. research. Independently, Quorum's Board
members are experts themselves in various fields
Consultants are expressly permitted, if not and experienced in human subject protection
advised, in applicable federal regulations. These review. Due to the composition of Quorum's
regulations exist because the federal government Board members, consultants are not always
understood that IRBs could not maintain a Board necessary and are used only when additional
comprised of members knowledgeable about every expertise is needed.
possible type of research. At Quorum, medical
consultants provide that additional expertise When necessary, Quorum's use of medical
necessary to permit the Board to review all types consultants combined with its Board members
of research in a manner that protects the human ensures the right combination of expertise able to
research subject. produce a thorough, accurate, and efficient review
of research. Such research that is crucial to the
Quorum's medical consultants have expertise in development of a diverse range of products critical
fields ranging from cardiology to oncology. These to improving health care.
consultants review research protocols and related

3.
May 2, 2011 | Volume 1, Issue 1
Regulatory Recap: Changes to to the databank. Quorum intends to apply this
change to new consent forms by the effective date
U.S. FDA Regulations of March 7, 2011. Although it is not required by
Regarding Consent the FDA or Quorum, clients that request an
update to existing consent forms to include the
On January 4, 2011, the Food and Drug statement may submit a request to their Study
Administration (FDA) published a rule revising Manager. It is important to note a few things
the current informed consent regulations to regarding this change.
include a new requirement for informed consent
documents and processes. This rule applies to  The exact statement must be included. While the
other elements of consent included in the FDA
specified drug and device trials and requires the
regulations allow the sponsor, site, and IRB flexibility
inclusion of a statement indicating that to craft language to address each required element,
information from the trial will be included in a this requirement does not. The FDA clearly states
databank. The databank is maintained by the that the exact statement quoted above must be
National Institutes of Health/National Library of included in consent forms and that processes must be
Medicine (NIH/NLM). Submission of in place to ensure compliance with the new
information to the databank is required by U.S. requirement.
law for specified drug and device trials. The new  This requirement only applies to some types of
required statement will be found in a new studies. The requirement only applies to an
paragraph of the FDA regulations at 21 CFR § "applicable clinical trial" as defined in FDAAA, 42
50.25(c). The effective date of this rule is March 7, U.S.C. 282(j)(I)(A), section 402(j)(I(A) of the PHS
2011, and the compliance date is one year after Act, and any relevant regulation. Quorum will rely on
the effective date, on March 7, 2012. The required the sponsor to make an assessment of whether a
statement is: clinical trial is "an applicable trial" and therefore
whether this statement is required.
A description of this clinical trial will be available on  This requirement will only be applied to new
http://www.ClinicalTrials.gov, as required by U.S. Law. studies. It only applies to clinical trials that are
This Web site will not include information that can initiated on or after the compliance date of March 7,
identify you. At most, the Web site will include a summary 2012. Quorum is proactively updating its procedures
of the results. You can search this Web site at any time. to include the statement by the effective date to
ensure compliance by the required date.
In response to this regulatory change, Quorum  This change will not require re-consent of
Review IRB (Quorum) is updating consent form participants. The FDA indicated that re-consent,
templates and procedures to ensure that this based solely on the new requirement, of clinical trial
required statement is included in consent forms participants in clinical investigations that were
for drug and device trials that must provide data initiated before the compliance date will not be
required.

4.
May 2, 2011 | Volume 1, Issue 1
A Warm Welcome
Quorum extends a warm welcome to the 19 research  Forsyth Memorial Hospital, Inc.,
organizations, academic medical centers, hospitals, Winston-Salem, NC
and universities that added Quorum to their Federal  Affiliated Clinical Research, Inc.,
Wide Assurances in the first quarter of 2011: Las Vegas, NV
 The Christ Hospital, Cincinnati, OH  NDI Medical, LLC, Cleveland, OH
 Sanford, Sioux Falls, SD  St. Francis Hospital & Health Centers,
 Diex Research Sherbrooke Inc., Beech Grove, IN
Sherbrooke, QC, Canada  Community AIDS Resource DBA
 Cardiology Associates of Mobile, Inc., Care Resource, Miami, FL
Mobile, AL  Public Hospital District No. 1 King Co,
 Bon Secours Richmond Health System, Renton, WA
Richmond, VA  Froedtert Physician Partners, Inc.,
 Main Line Hospitals, Wynnewood, PA Menomonee Falls, WI
 Medica Research Foundation (d/b/a Medical  Central Utah Clinic, Provo, UT
Research Institute), Minnetonka, MN  Sentara Leigh Hosp, Norfolk, VA
 Planned Parenthood League of  Sentara Bayside Hosp, Virginia Beach, VA
Massachusetts, Boston, MA
 West Coast Clinical Trials, Cypress, CA