Good Clinical Practice: A Question & Answer Reference Guide - May 2014 - 326

GCP: A Question & Answer Reference Guide
sponsor on a case-by-case basis. If the investigator or sponsor believes that there are other conflicting requirements,
the sponsor may request a waiver from FDA from the specific requirement under 21 CFR 312.10."
While the FDA has long emphasized that the ICH GCP guideline is entirely consistent with its own GCP
standards, there are several IRB-related provisions that do differ in emphasis or specificity. Since the ICH GCP
guideline was released in 1997, several IRB-related differences have been noted, including the following:
* The ICH guideline specifically calls for an IRB review of subject recruitment procedures, the investigator's
brochure, payments and compensation to study subjects, and the curriculum vitae of the investigators. FDA
regulations require IRBs to review "all research activities," which is generally understood to include all these
elements. The FDA also has guidance documents calling for IRB review of certain recruitment materials and
practices.
* FDA regulations allow an expedited initial review of certain types of studies that involve no more than
minimal risk. The ICH GCP guideline has no such provision.
* The ICH GCP guideline calls on IRBs, when asked, to provide copies of their written procedures and
membership lists to investigators, sponsors, or regulatory authorities. FDA regulations require only that IRBs
provide such information to regulatory authorities upon request.
* The ICH GCP guideline calls for IRBs to review investigator qualifications. Although the FDA regulations do
not specifically require IRB review of the qualifications of the investigator and the study staff, IRBs consider
such a review a necessary part of fulfilling the requirements of 21 CFR 56.111-Criteria for IRB approval of
research.
* For subjects who can be enrolled only with the consent of their legally acceptable representative, the ICH
GCP guideline calls for the assent of the subjects as well (i.e., if the subject is capable). This includes adults
as well as children (4.8.12).
* The ICH GCP guideline recommends that participation in nontherapeutic trials be restricted to those who
personally give consent and sign and date the consent form (4.8.13).
* The ICH GCP guideline permits those who cannot personally provide their consent to participate in
nontherapeutic trials when all of the following conditions are fulfilled: (a) the objectives of the trial cannot be
met by enrolling only subjects who can personally give consent; (b) the foreseeable risks to the subjects are
low; (c) the negative impact on the subject's well-being is minimized and low; (d) the trial is not prohibited
by law; and (e) the approval/favorable opinion of the IRB/IEC is expressly sought on the inclusion of such
subjects, and the written approval/favorable opinion covers this aspect (4.8.14).
* The ICH GCP guideline recommends that the informed consent form be signed and dated by the person
conducting the consent interview as well as the subject or legally acceptable representative (4.8.8).
* The ICH GCP guideline specifically recommends that the responsibilities of the study subject be explained in
the informed consent form (4.8.10(e)).
8.75 Q. Can an IRB function as a HIPAA Privacy Board?
A. According to Mark Barnes, then with Ropes & Gray, an IRB can also serve as a privacy board under the
Privacy Rule (HIPAA), provided that its members meet the qualifications under the Privacy Rule. It is important to
remember that HIPAA is not a FDA regulation, but a HHS regulation. As a result, other duties or functions assigned
to an IRB are the jurisdiction of the institution and are not covered by the FDA regulations for IRBs. A privacy
board is an entity that may be created under the Privacy Rule to review researchers' requests for alteration or waiver
of the Privacy Rule's requirements for individual authorization. In brief, privacy boards must comprise members
with varying backgrounds and professional competency, and must include at least one member not affiliated with
the research institution or sponsor. Today, most institutions use their IRBs to fulfill privacy board functions.
8.76

Q. Can an IRB function as a data monitoring committee (DMC), also called a data safety and monitoring board?

A. In its guidance documents, the FDA is clear in pointing out the different roles of the IRB and the DMC,
assuming one is involved in a particular study. The FDA defines a clinical trial DMC as "a group of individuals
with pertinent expertise that reviews on a regular basis accumulating data from one or more ongoing clinical trials.
The DMC advises the sponsor regarding the continuing safety of trial subjects and those yet to be recruited to the
trial, as well as the continuing validity and scientific merit of the trial."
326

Good Clinical Practice: A Question & Answer Reference Guide - May 2014

Table of Contents for the Digital Edition of Good Clinical Practice: A Question & Answer Reference Guide - May 2014