# IRB.018
Standard Operating Procedure:
Continuing Review of Previously
Approved Research
Last Review Date: New
Origination Date: 8/2013
Submitted By: Director, Office of
Research Compliance
Institutional Review Board
Policy Council
Medical Executive Committee
Board of Trustees
08/2013
09/2013
09/2013
09/2013
Page 1 of 3
SCOPE:
Institutional Review Board, Principal Investigators and Research Teams
PURPOSE:
To provide guidance on a systematic review of non-exempt human subject
research activities that supports the protection of human subjects and is
compliant with state and federal regulations.
POLICY:
Institutional Review Boards must conduct substantive and meaningful continuing
review of non-exempt research with human subjects at intervals appropriate to
the degree of risk, but not less than once per year. Thus, each approval period
for research may extend no more than one calendar year after the conditions of
IRB review have been met.
PROCEDURE:
A.
Ensuring Continuing Review Prior to Expiration of Approval
Prior to expiration of IRB approval, the Principal Investigator/designee may be
notified in writing that continuing review of the research study is coming due and
is referred to the Sunrise Health Institutional Review Board website for the
instructions and documents required for a substantive review. To ensure that IRB
approval is maintained, without which the study cannot continue, the Investigator
is responsible for providing the information the IRB needs to perform its
continuing review function in a timely and complete manner, whether or not the
IRB provides any reminders. Once the completed form and required documents
are received, the protocol is reviewed either at a convened meeting of the IRB or
through the expedited review procedure as described previously. The Principal
Investigator will be notified in writing of the IRB’s determination.
B.
Criteria for Research that Needs Verification from Sources Other than the
Principal Investigator that no Material Changes Have Occurred Since
Previous IRB Review
Generally, unless given reason otherwise, the IRB can accept information from
the investigator as accurate. The IRB may decide to seek or ask for additional
verification from sources other than the investigator that no material changes
have occurred since the previous IRB review. Common reasons the IRB may
desire to seek such verification may include (a) projects conducted by
investigators who previously have failed to comply with regulations or
requirements/determinations of the IRB; (b) projects where information provided
in continuing review reports or from other sources indicate possible material
changes occurring without IRB approval have occurred; (c) a novice or seemingly
Board of Trustees
Continuing Review of Previously Approved
Research
Page 2 of 3
disengaged investigator or clinical research coordinator; or (d) excessive
turnover or long gap in replacement of the PI or clinical research coordinator.
Independent verification of information may be requested by the IRB at convened
meetings or by the IRB Chairperson in the course of carrying out reviews through
the expedited review procedure. Such verification may include a directed audit
by the Sunrise Health Office of Research Compliance.
As part of this independent verification, the IRB may also request and evaluate
communications between the FDA (Food and Drug Administration) or OHRP
(Office for Human Research Protections), the sponsor/IND holder, NIH
communication and reviews, back translations of consent forms or other
materials for subjects, and letters of review or approval from other collaborating
IRBs. Also, the IRB may rely on Data Safety Monitoring Board reports as a
source of external verification.
C.
Expiration of IRB Approval
When IRB approval expires, the Principal Investigator will be notified in writing
that all research activities must stop. Research activities include, but are not
limited to, recruitment and enrollment of subjects, collection of specimens,
research on previously collected specimens, review of medical records or other
health information, data analysis, performance of research tests/procedures, and
treatment or follow-up on previously enrolled subjects.
Conducting a study subject to IRB oversight during a period of lapsed approval is
a violation of an Investigator’s duties under FDA and OHRP regulations.
If treatment and/or follow-up of subjects is necessary for subject safety and
welfare and/or for the orderly withdrawal of subjects, the Principal Investigator
must inform the IRB in writing immediately to request permission to continue
previously enrolled subjects on study. The IRB Chair is responsible for
considering these requests on a case-by-case basis and providing written
documentation of the determination, and whether the determination applies to
one or more individuals or all enrolled subjects, and the timeframe approved if
granted.
The IRB may decide, at its discretion, to require the Principal Investigator to
continue treatment and/or follow up of subjects if deemed necessary for subject
safety and welfare. The IRB is responsible for considering such circumstances
on a case-by-case basis and providing to the Principal Investigator written
documentation of the determination, and whether the determination applies to
one or more individuals or all enrolled subjects, and the timeframe approved if
required.
REFERENCES:
HCA Policy CSG.IRB.007 IRB Initial and Continuing Review of NonExempt Research with Human Subjects
21 CFR 312.60
21 CFR 312.66
21 CFR 812.100
Board of Trustees
Continuing Review of Previously Approved
Research
21 CFR 812.110(a)
21 CFR 56.103(a)
Page 3 of 3