Quorum Review's Institution Bulletin includes Letter from CEO, Cami Gearhart, JD, on Tuskegee Syphilis Experiment as a leading key component of today's subject protection requirements, as well as Quorum's insights on two recent FDA draft guidances: The first addresses specific IRB responsibilities and explains how an IRB may efficiently fulfill them and the second explains that researchers must obtain informed consent before initiating clinical screening for eligibility.

1. January 29, 2013 | Volume 3, Issue 1
Institution Bulletin
Letter from the CEO
Did you have an opportunity to attend the December PRIM&R meeting in
San Diego? If so, I hope you saw the exhibit on the Tuskegee Syphilis
Experiment by photographer Tony Hooker. The exhibit featured historic
photographic images superimposed on contemporary images, as well as
personal quotes from individuals involved in the study.
The haunting images of the exhibit made me think of ghosts – the ghosts of
the individuals who died and suffered during the trial before it was exposed
by a whistleblower. It is believed that of the 400 African-American men who
started the study, 28 died directly of syphilis, 100 died of related
complications, 40 wives were infected and 19 children were born with CEO Cami Gearhart , JD
congenital syphilis.
The abuses of that trial prompted regulatory action and led to the key components of today’s subject protection
requirements, including review by an independent committee, informed consent, and regular continuing review
of the merit of the study. It’s vital that those of us involved in the research enterprise revisit Tuskegee regularly to
remember the importance of the protections of ethics review.
As the research enterprise has grown and become more complex, so have the requirements and obligations for a
human research protection program. Enclosed are two articles to assist your institution in its mission to protect
research participants. One article describes the use of screening consent and the other summarizes recent FDA
draft guidance on IRB review responsibilities.
Quorum Review is honored to have the privilege to work with you and your institution research teams. Please let
us know if we can be of further assistance.
Sincerely,
Cami Gearhart, CEO
Quorum Review IRB

2. January 29, 2013 | Volume 3, Issue 1
FDA’s Draft Guidance for IRBs, Clinical Investigators,
and Sponsors
The FDA announced the availability of a new draft guidance explains that when an IRB has previous
guidance entitled Guidance for IRBs, Clinical experience with an investigator or institution, it may
Investigators, and Sponsors: IRB Responsibilities for easily determine the investigator is appropriately
Reviewing the Qualifications of Investigators, Adequacy of qualified and the site is suitable for the research.
Research Sites, and the Determination of Whether an
IND/IDE is Needed.i The draft guidance addresses With respect to investigators, the draft guidance
specific IRB responsibilities and explains how an suggests that the IRB could rely on documentation
IRB may efficiently fulfill them. or a statement from an office at an institution
regarding the qualifications of a particular
IRB Review of Qualifications of Clinical investigator. It is suggested that review of
Investigators and Adequacy of Site information such as the curriculum vitae of the
investigator and
The draft guidance discusses review of an research staff and
investigator’s qualifications and the research site verification of
under two complementary regulatory provisions. professional
association and
• First, the IRB is obligated to “ascertain the
medical licensure
acceptability of the proposed research in
may only be
terms of institutional commitments and
necessary when
regulations, applicable law, and standards of
the IRB has no
professional conduct and practice.” 1
knowledge of the
• Second, the IRB is required to find that risks investigator or
to subjects are minimized and reasonable in the institution.
relation to anticipated benefits, if any, to
subjects. 2 The FDA did
identify three
The FDA indicates that the IRB should consider the possible scenarios
nature and risks of the proposed research as well as that warrant additional attention from the IRB when
the relationship with the investigator or institution determining whether an investigator is appropriately
where the research will be conducted when qualified:
evaluating investigator qualifications and the
adequacy of a proposed research site. The draft 1. Sponsor-investigator studies
2. A study outside the investigator’s area of
expertise
i
Available at: www.regulations.gov/#!documentDetail;D=FDA-2012-D-
0847-0001.
3. Any study design features or other
1
characteristic(s) that may significantly
21 CFR 56.107(a).
2
increase potential risk to subjects
21 CFR 56.111.

3. January 29, 2013 | Volume 3, Issue 1
Finally, FDA recommends that IRBs routinely review Research Studies Can be Conducted Without an IND 1,
lists on FDA-hosted websites for investigators that which when finalized will represent FDA’s current
have been the subject of investigations and warning thinking on this topic. Similarly, with device studies,
letters, investigators that have been notified of the IRB must review studies that do not have an IDE
initiation of a disqualification proceeding, and also to determine whether they are appropriately
disqualified investigators. categorized as non-significant risk or exempt by a
sponsor. The draft guidance indicates that the FDA
With respect to evaluation of the site, FDA suggests is available to assist sponsors, investigators and IRBs
that the IRB could simply note that a particular in making NSR or SR determinations, and suggests
institution has adequate resources such as emergency
review of the guidance Procedures for Handling
or specialized care, rather than requiring the
Inquiries Regarding the Need for an Investigational Device
investigator to provide an explanation of such
Exemptions Application for Research Involving Medical
resources if the facility were part of a major medical
Devices 2 for information on how to request
institution. The draft guidance indicates that a
assistance.
statement from an appropriate person at a research
site stating the facilities are adequate could be used The draft guidance proposes some flexibility for IRBs
in lieu of a statement from an investigator describing in evaluating investigators and proposed research
the facility, staffing and resources where the research sites in circumstances where the IRB is familiar with
will take place. the institution and/or investigator and the nature of
the study does not warrant additional scrutiny. As to
IRB Determination of Necessity of an the IRB determination of necessity of an IND or
IND or IDE IDE, the FDA re-iterates the IRB’s responsibility of
The draft guidance indicates that IRBs should evaluating a sponsor’s determination as to whether
evaluate the sponsor’s explanation if they have the IND or IDE regulations apply to a particular
determined that an IND or IDE is not necessary for study. The draft guidance indicates that FDA expects
a particular study. If the IRB questions whether an the IRB to obtain and evaluate an explanation as to
IND is necessary and the explanation is not why the sponsor would not seek an IND or IDE for
satisfactory, the research involving FDA-regulated products.
IRB should delay Comments on the draft guidance were due January 22, 2013.
approval of the To see the proposed draft Guidance, please visit
study until the www.regulations.gov.
matter is resolved.
The draft guidance
suggests reviewing
another guidance: 1
Available at:
Draft Guidance for http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryI
nformation/Guidances/UCM229175.pdf .
Industry: 2
Available at:
Investigational New http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Gui
Drug Applications danceDocuments/ucm126598.htm.
(INDs) –Determining
Whether Human

4. January 29, 2013 | Volume 3, Issue 1
Screening Subjects: To Consent or Not?
Quorum frequently receives questions from A common scenario, as part of screening for a
investigators and study staff about whether a consent clinical trial, is an individual patient being asked to
form is necessary for the screening process for a fast prior to coming in for a visit. If that individual
given study. The FDA has issued guidance on this would not otherwise be asked to fast for their clinic
question, indicating that informed consent must be visit, they should be consented before they are asked
obtained prior to initiation of any clinical to fast. This request may occur over the phone, and
procedures that are performed solely for the purpose therefore the researcher is not able to obtain a signed
of determining eligibility for research.1 consent form prior to requesting that the patient be
fasting when they come in for their next visit.
The FDA provides some examples of “procedures”
that could be performed solely for the purpose of In this scenario,
determining research eligibility, such as: withdrawal the researcher
from medication (or wash-out) and diagnosis or can request that
treatment of a disease or medical condition. the IRB waive
the requirement
Because clinical screening procedures for research for a signed
eligibility are considered part of the subject selection consent form.
and recruitment process, the FDA indicates they This is also
require IRB oversight, and recommends that the IRB known as a
receive the following information regarding the “waiver of documentation of consent.” The criteria
screening process that will be conducted by an that must be met in order to waive documentation of
investigator: consent are defined in the FDA and HHS
regulations as follows:
 An outline of the screening procedure to be
followed “The IRB may, for some or all subjects, waive the
requirement [of a] sign[ed] written consent form if it
 A description of how consent for screening
finds that the research presents no more than
will be obtained
minimal risk of harm to subjects and involves no
 A screening consent form including a brief procedures for which written consent is normally
summary description of the study in which required outside of the research context.”3
they may be asked to participate OR request
for a waiver of consent for the screening Although a screening procedure or processes may
procedures (if appropriate)21 qualify for a waiver of documentation of consent, the
IRB can still require that the investigator provide
individuals with a written statement regarding the
research. In the case of a phone-based consent
1
FDA Information Sheet, Screening Tests Prior to Study Enrollment, available
at:
process for screening procedures this may be a
http://www.fda.gov/RegulatoryInformation/Guidances/ucm126430.htm ,
accessed 12/26/2012.
2 3
Id. 45 CFR 46.117(c)(2); 21 CFR 56.109(c)(1).

5. January 29, 2013 | Volume 3, Issue 1
statement that is read to subjects over the phone, • How paper copies/records related to the
often described as a “screening” or “receptionist” screening are handled (shredded, readable copies
script. Typically, the IRB would require the elements put out as trash)1
of consent to be covered in this statement.
Generally, Quorum would recommend sites develop
The FDA has also provided guidance covering a standard operating procedure (SOP) or other policy
oversight of the use of such scripts. Specifically, the document describing the use of screening scripts and
FDA has identified several issues that are appropriate addressing the points of concern outlined by FDA
for an IRB to consider when evaluating the use of a when a screening script is used.
script for screening purposes:
• A description of what happens to personal
1
information if the caller ends the interview or FDA Information Sheet, Recruiting Study Subjects, available at:
http://www.fda.gov/RegulatoryInformation/Guidances/ucm126428.ht
simply hangs up m, accessed 12/26/2012.
• Whether the data is gathered by a marketing
company
• How the data will be used, if it is sold, etc.
• Whether names of non-eligible individuals are
maintained in case they would qualify for
Contact Quorum Review
another study
Interested in learning more about Quorum Review?
Our Institutional Team is ready to answer your
inquiries regarding your organization’s specific
“
Although a screening institutional IRB needs.
Nancy Jane Earnhardt
procedure or processes Institutional Specialist
may qualify for a waiver nearnhardt@quorumreview.com
T | 919-930-5198
of documentation of
The Institution Bulletin is a special publication of
consent, the IRB can the Quorum Forum, and brought to you by the
still require that the Institution Team at Quorum Review IRB.
investigator provide
individuals with a written
statement regarding
the research.”