Human Research Protection Program: Policy
Expedited Review of Protocols
Adopted
By: All Campus IRB
Adoption Date: November 10, 2005
Revised: January 22, 2009
Purpose: This document describes
UW-Madison IRBs’ policies and procedures for conducting expedited reviews of
research protocols.
Policy
I. UW-Madison follows the federal regulations [45 CFR
46.110 and 21
CFR 56.110] and federal guidance governing expedited review of
research. The federal regulations allow an IRB to use the expedited review
procedure to review either or both of the following:
“Minimal risk” means a risk of harm to the subject
from participation in the research that is no greater than the risk encountered
in normal day to day activities or during routine physical or psychological
examinations. “Risk” involves more than physical risk and can encompass
breaches of confidentiality and/or social/economic or psychological repercussions.
B. Minor changes in previously approved research during the period (of one
year or less) for which approval is authorized.
C. UW-Madison IRBs do not review
classified research.
II. Expedited Initial Review of Minimal Risk Research.
A. Use of expedited initial review procedures are limited to specific
research categories published in the Federal Register at 63 FR 60364-60367
(see, http://www.hhs.gov/ohrp/humansubjects/guidance/expedited98.htm).
Additions to, and extrapolation from, the List of Categories of
Research That May Be Eligible for Expedited Review by the institution or the
IRB are not appropriate. For example, it is inappropriate to use an expedited
review procedure for the initial review of either research that involves
minimal risk but does not appear in the list of categories or research that
involves greater than minimal risk.
B. UW-Madison IRBs do not use expedited review procedures for the initial
review of research involving prisoners.
III. Expedited Review of Minor Changes to Previously Approved Research.
A. Federal regulations do not define
“minor change” eligible for expedited review. UW-Madison defines “minor
change” as a change that does not adversely affect the risk/benefit ratio of
the study or make it less favorable for research subjects. A change in
a protocol that would add procedures involving increased risk or discomfort is
not a “minor change” that can be reviewed by the expedited review procedure.
Examples
of “minor changes” include:
1. Administrative (non-medical) changes
2. Minor changes to consent form, HIPAA form, surveys, questionnaires,
brochures or recruitment materials
3. Submission of new consent form, HIPAA form, surveys, questionnaires,
brochures or recruitment materials that are easily compared to previously
approved forms or materials
4. Editorial changes for purposes of clarification
5. Minor study design changes that do not negatively affect the risk/benefit
ratio
6. Addition of study personnel or study sites
IV. Expedited Continuing Review.
A. Continuing review of research may be
done using an expedited procedure if the research meets the requirements stated
in the List of Categories of Research
That May Be Eligible for Expedited Review (see, Sec. II.A, above).
Categories one through seven of the list of categories pertain to both initial
and continuing IRB review. Categories eight and nine apply only to continuing
review.
B. Generally, if research did not qualify
for expedited review at the time of initial review, it does not qualify for
expedited review at the time of continuing review, except in limited circumstances
described by expedited review categories (8) and (9) at 63 FR 60364-60367:
1. where (i) the research is permanently closed to the enrollment of new
subjects; (ii) all subjects have completed all research-related interventions;
and (iii) the research remains active only for long-term follow-up of subjects,
or
2. where no subjects have been enrolled and no additional risks have been
identified, or
3. where the remaining research activities are limited to data analysis.
4. where research is not conducted under an investigational new drug
application or investigational device exemption, categories (2) through (8) do
not apply, but the IRB has determined and documented at a convened meeting that
the research involves no greater than minimal risk and no additional risks have
been identified.
C. It is also possible that research
activities that previously qualified for expedited review in accordance with 45
CFR 46.110 or 21 CFR 56.110, have changed or will change, such that expedited
IRB review would no longer be permitted for continuing review.
D. Continuing review of research
involving prisoners may be expedited only if there are no changes in the
protocol, no problems have been reported with the protocol and the prisoner
representative on the IRB is one of the designated reviewers for that protocol.
Procedure
V. Submission Process.
A. An investigator seeking an expedited review of a new protocol must
submit an initial application for review to the appropriate IRB.
For HS-IRB and MR-IRB protocols: Initial Review
Form
For SB-IRB and ED-IRB protocols: Initial Protocol Form
B. An investigator seeking expedited review of a minor change in a
protocol must submit a change of protocol form to the appropriate IRB.
For HS-IRB and MR-IRB protocols: Expedited Change
Form
For SB-IRB and ED-IRB protocols: Change of Protocol
Form
C. An investigator seeking a continuing review through an expedited
procedure must submit a continuing review application to the appropriate IRB.
The UW-Madison electronic protocol management
system notifies investigators automatically, based on the continuing review
schedule specified for their research, when they need to submit an application
for continuing review. The electronic protocol management system also notifies
investigators and automatically terminates a research study if an application
for continuing review is not approved prior to expiration of the specified
continuing review schedule.
For HS-IRB and MR-IRB protocols: Continuing Review Form
For SB-IRB and ED-IRB protocols: Continuation
of Protocol Form
D. In each case, the investigator’s submission should include all
information requested in application form. The IRB Office will request
additional information from the investigator if necessary to determine whether
the protocol is eligible for expedited review.
VI. Review Process.
A. Expedited reviews are carried out by the IRB chair or by one or more
experienced reviewers designated by the chair from among members of the IRB in
accordance with the requirements set forth in the 45 CFR 46.108 (b) and 21 CFR
56.110 (b). Designees of the chair must be experienced IRB members and may
include the IRB director or manager, if they are experienced IRB members.
An experienced IRB member means a voting member or alternate voting
member who has served on an IRB for at least one year, has received training
relative to the expedited review categories, and possesses the expertise needed
to review the proposed research.
B. In reviewing the research, the reviewers may exercise all of the
authorities of the IRB except that the reviewers may not disapprove the
research. A research activity may be disapproved only after review in
accordance with the non-expedited procedure set forth in 45 CFR 46.108 (b) and
21 CFR 56.108 (c).
C. The expedited reviewer will be provided all materials provided to the
primary reviewer for the review of research by the convened IRB, or if no
primary reviewer system is used, all materials provided to all IRB members for
the review of research by the convened IRB.
D. Expedited review must fulfill all the requirements of review found at
21 CFR 56.111 and subpart D, if applicable, and 45 CFR 46.111 and subparts B , C
, and D, if applicable, as well as the requirements for informed consent (or
for altering or waiving the requirement for informed consent). See, 21 CFR
50.20, 50.25, 50.27 and 45 CFR 46.116, 46.117.
D. If necessary, the reviewer may request revisions to the protocol. The
investigator may either revise the protocol as requested or provide a
justification, which will be reviewed by the expedited reviewer. If the
reviewer cannot resolve the issue with the investigator, the protocol may be
referred to the full IRB.
E. If the expedited reviewer, after applying Expedited Review Policy
Sections I-IV, above, determines that the protocol is not eligible for
expedited review, the protocol will be referred to the full IRB for review.
F. The expedited reviewer may refer an eligible protocol to the full IRB
for review if additional expertise is needed or if it involves a potentially
sensitive topic.
VII. Documentation Process.
A. The investigator is notified in writing of the expedited reviewer’s
determination and the applicable regulatory category. Approval of minor
administrative changes in protocols may be sent to investigators by email.
B. A record of each expedited determination is entered into an electronic
database along with a citation to one of the specific permissible categories
justifying expedited review [See, list of categories (see, Sec. II.A, above)]
and documentation of the review and action taken by the designated reviewer and
any findings required under the federal regulations.
C. The full IRB is informed of decisions on expedited review of protocols
by including the determinations on the agenda or in the minutes of the next IRB
meeting.
