Good Clinical Practice: A Question and Answer Guide2024/2025 Edition - 206

GCP: A Question & Answer Reference Guide
the IRB may review under an expedited review procedure (21 CFR 56.110(b)(2)). Such a move between research
sites may or may not entail changing the IRB. If the reviewing IRB changes as a result, then the considerations
except initial or continuing IRB review must be conducted. The regulations require that an IRB may not approve a
change in research without first conducting an initial or continuing review (21 CFR 56.103(a), 21 CFR 56.108(a)
(4), and 21 CFR 56.110(b)(2)). The guidance further notes that even if the IRB remains the same when a study is
transferred to a new research site, IRB review/approval for the new research site is required, because such a move
is considered a change in previously approved research. Additionally, the sponsor must notify FDA of any change
in research site, clinical investigator, and/or IRB. For drug or biologics studies, this notification can generally be
accomplished through an IND protocol or information amendment, whereas for device studies it can generally be
accomplished in an Investigational Device Exemption (IDE) annual report.
7.84 Q. In the past, we have seen devastating storms in different regions of the US and in the world. How
should a site handle IRB oversight activities when the institution is not functioning due to the storm
aftermath?
A. Following a severe winter storm in the Northeast US in December 2012, the FDA and OHRP issued a statement
on how to handle the lack of continuity of services during such crises. According to OHRP, " one option is to refer
review to another IRB that is not affected by the storm. However, where IRB records are not available to send to
another IRB, it may not be possible or practical to prevent the expiration of IRB approval. Nor may it be feasible
to notify investigators that research for which IRB approval has expired must be suspended. Of course, any such
research that is determined to be in the best interest of the subjects may continue after IRB approval has expired. "
OHRP does encourage that institutions make a reasonable attempt to suspend or refer research to another IRB.
However, if circumstances prohibit such efforts, OHRP will use available flexibility in any decision making about
affected institutions that fail either to conduct continuing review in time or to suspend expired research. This
flexibility will continue for as long as storm devastation prevents the IRB from either conducting continuing review
or temporarily referring that responsibility to another IRB.
7.85 Q. How should a site handle subject interventions when the institution is not available or functional due
to storm damage?
A. Again, in response to the severe winter storm in the Northeast US in December 2012, OHRP has stated that subjects
may receive those interventions temporarily at other facilities that are able to provide them. OHRP anticipates
that the majority of institutions to which research subjects are temporarily referred will not be " engaged " in the
research according to OHRP's 2008 " Guidance on Engagement of Institutions in Human Subjects Research " (see
http://www.hhs.gov/ohrp/policy/engage08.pdf). " For example, non-engaged scenario B(3) describes institutions
not initially selected as research sites whose employees or agents administer study interventions on a one-time
or short-term basis. These institutions are not required to obtain an FWA or to secure IRB review and approval
in order to provide the research interventions. Even when such facilities are considered engaged in the research,
subjects should continue to receive investigational treatments if that is in the best interests of subjects. "
7.86 Q. When an IRB or site is unavailable or unable to provide oversight or subject interventions due to storm
damage, does this need to be reported to FDA and/or OHRP as an " unanticipated problem involving risk
to subjects " ?
A. According to OHRP, the disruptions of human subject protections programs by a storm such as experienced
in late 2012 do not constitute unanticipated problems involving risks to subjects or others, serious or continuing
noncompliance, or suspension or termination of IRB approval. Therefore, these events need not be reported to
OHRP as such.
7.87 Q. What is the FDA's stance regarding a site that has enrolled staff from the site, spouses, and possibly
staff who have worked on the study? Assuming the protocol does not specify anything regarding enrolling
subjects who may work at the site or are relatives of site staff, is there something specific from FDA that
references this issue? What should be done if it has already occurred? What follow up would be expected?
A. According to FDA, there is nothing in FDA's regulations regarding the conduct of clinical trials that forbids a
Principal Investigator from enrolling site and/or study staff and relatives, and there is no guidance document that
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http://www.hhs.gov/ohrp/policy/engage08.pdf

Good Clinical Practice: A Question and Answer Guide2024/2025 Edition

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