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Institution Newsletter volume 2 issue 4
1. October 18, 2012 | Volume 2, Issue 4
Institution Bulletin
Letter from the CEO
This month, two researchers were honored for basic research conducted
in academic settings. The Nobel Assembly awarded the 2012 Nobel Prize
in Physiology or Medicine to John B. Gurdon and Shinya Yamanaka,
investigators who discovered a way to develop stem cells from adult skin
cells—thus removing the need to use and destroy human embryos.
The work of these two scientists illustrates the importance of basic
research conducted every day in institutions across the country. In 1962,
Dr. Gurdon’s work was revolutionary in opening the door to cloning.
When coupled with the work of Dr. Yamanaka and other scientists, his
work now may pave the way for radical advances in medicine that allow
damaged or diseased tissues to be regenerated in the lab - or even inside
CEO Cami Gearhart , JD
patients' bodies.
Here at Quorum Review, we are privileged to review clinical research made possible by the tenacity and ingenuity
of researchers in hospitals and universities across the country. When an institution is ready to use a central IRB,
we are committed to supporting the organization with a high quality review and strong staff support. Today’s
newsletter delves more deeply into how to work with Quorum Review, from waiving jurisdiction to developing a
consent form. We look forward to an opportunity to work with you.
Sincerely,
Cami Gearhart, CEO
Quorum Review IRB
2. October 18, 2012 | Volume 2, Issue 4
Quorum Services: Custom Consent Form Service
Quorum Review offers a Custom Consent Form service to clients who would prefer to have Quorum develop the
consent document. Quorum draws on the combined expertise of legal, medical, and consent form development
staff to produce the consent forms needed for a given study.
When clients elect to use the Custom Consent Form service, they can
expect consent documents to include:
An accurate summary of relevant information about the presented in
language that is understandable to the lay reader
Elements required by Quorum Review standards, which include
regulations in the United States and Canada, and relevant U.S.
state and Canadian provincial law
HIPAA statements for U.S. consent forms and PIPEDA statements
for Canadian consents
Quorum Review’s preferred style and standards
In general, documents produced through the Custom Consent Form service will be based on Quorum Review’s
internal consent form templates. These templates can be modified to be appropriate for a wide variety of research
studies. In addition, upon request, the documents can incorporate relevant client template language between
Quorum Review and the client.
The time needed to create consent documents depends on the complexity of the study and the number of consent
forms that may be required. In general, most Custom Consent Form service requests can be fulfilled within four
to seven business days after the request submitted to Quorum. Upon receipt of a Custom Consent Form service
request, clients will be provided with a quote containing estimated costs and delivery times for the client’s review
and approval.
Clients will be asked to provide some information with a Custom Consent Form service request, including:
Descriptions of the risks of study-related products, including the study drug or device, rescue medications,
prophylactic drugs, and other products specifically indicated in the protocol
Risks of protocol procedures
Alternative treatments
The plan for compensating subjects in the event of illness or injury
If a client is not able to provide the information described above, this may extend the time needed to create the
consent documents and additional development charges may be incurred.
3. October 18, 2012 | Volume 2, Issue 4
Waiving Jurisdiction to Another IRB
For various reasons, a hospital, academic medical center, or other research organization may need to waiver
jurisdiction to an outside IRB. Institutions with a Federal Wide Assurances (FWA) from the Office of Human
Research Protections (OHRP) must ensure that the arrangements made with the outside IRB are documented in a
written agreement between the institution and the IRB if the research is covered by the FWA1. Although this
agreement is only required for research covered by an FWA, it is a best practice to ensure that arrangements for
IRB review of a study by an outside IRB are always documented in writing, regardless of whether the research
would fall under an institution’s FWA. The agreement should cover the following points:
Outline the relationship between the Institution and the organization or institution operating the IRB
Include a commitment that the IRB will adhere to the requirements of the institution’s FWA.
OHRP provides a sample authorization agreement that includes the required language but Institutions may have
good reason to expand upon this language and develop their own agreement. The agreement must be kept on file
by both organizations and must be made available to OHRP or any U.S. federal department or agency conducting
or supporting research covered by the FWA upon request. If an institution will rely on multiple external IRBs, the
institution must ensure that its FWA designates the external IRB that reviews the largest percentage of the
research covered by the FWA. The institution should also ensure that any IRB that will be reviewing research
covered by their FWA is registered with OHRP2.
Quorum Review solicits information with each new study submission to determine whether the investigator is
affiliated with an institution that has jurisdiction over the study. If so, the investigator is instructed to obtain
permission from the institution to rely on Quorum Review as the IRB for the study. It is important to note that
institutions must still authorize the jurisdiction to an outside IRB even if the institution does not maintain its
own internal IRB. An institution can waive jurisdiction to an outside IRB for a single study or multiple studies.
Quorum Review has an Institutional Jurisdiction Waiver Form and Institutional Authorization Agreement (IAA)
that can be used by institutions waiving to jurisdiction to Quorum. Quorum will also accept the template
authorization agreement developed by OHRP.
1
Assurance Process - FAQs, U.S. Department of Health & Human Services, Office of Human Research Protections, available at:
http://answers.hhs.gov/ohrp/categories/1563, accessed 09/25/2012.
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