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IV.14
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Review of Serious Adverse Events
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Objective
As part of its continuing review of research involving human subjects,
the Committee for the Protection of Human Subjects (CPHS) reviews reports of
serious adverse events and unanticipated problems involving risks to
participants or others, and this Policy/Procedure describes the process for
reviewing them.
Policy/Procedure
I.
All serious adverse events and unanticipated problems to participants or
others are submitted to the CPHS using the Internet Research Information System
(iRIS) according to the following.
A. The following require reporting
to the CPHS within 10 working days of the Investigator’s knowledge of the
problem which includes serious adverse events, injuries, side effects, or other
problems occurring in the conduct of research governed by CPHS;
B. Any event that in the
Investigator’s opinion was unanticipated, involved risk to participants or
others and was possibly related to the research procedures;
C. Any event that requires
prompt reporting to the sponsor in accordance with the protocol (e.g., serious
adverse events);
D. Any accidental or
unintentional change to the CPHS-approved protocol that increases risk or
decreases benefit, affects the participant’s rights, safety, welfare, or
affects the integrity of the resultant data;
E.
Any deviation from the protocol taken without prior CPHS review except to
avert or minimize an apparent immediate hazard to a research participant;
F.
Any publication in the literature, safety monitoring report including a
Data and Safety Monitoring Report, interim result, or other finding that increases
risk or decreases benefit, affects the participant’s rights, safety, welfare,
or affects the integrity of the resultant data;
G. Any adverse event that is
both a serious adverse event and an unexpected adverse event, which in the
Investigator’s opinion is more likely than not to be related to the research
procedures, including but not limited to:
1. Inpatient hospitalization or prolongation of
hospitalization in which there is a reasonable possibility that the experience
may have been caused by the research;
2.
Unanticipated or life-threatening
events;
3. Persistent or significant disability/incapacity or
permanent harm or disability (either physical or psychological);
4.
A breech in confidentiality that
may involve risk to that individual or others;
5. Events that jeopardize the subject and require
medical or surgical intervention to prevent one of the outcomes listed above;
6.
Congenital anomaly/birth defect
in the offspring of research participant
H. Any complaint of a
participant that indicates an unanticipated risk or which cannot be resolved by
the research staff; and/or
I.
Unanticipated events that exceed the nature, severity, or frequency
described in the protocol or the Investigator’s Brochure
J.
SAEs or deaths occurring within 30 days of a
participant’s active participation or treatment must be reported to the
CPHS. SAEs or
deaths that occur beyond 30 days after active participation or treatment may
need to be reported if there is a guideline or more stringent reporting
requirement set forth in the protocol or mandated by the sponsor, or if the PI
chooses to report them for other reasons.
II. All deaths must be
reported to CPHS within 24 hours of knowledge of the event, followed by a full
report in iRIS within 10 days.
III. Only those events reported
by the sponsor occurring at other sites that are serious, related and
unanticipated must be reported to the CPHS.
IV. The Clinical Research
Monitor shall review the Serious Adverse or Unanticipated Event Report and shall
determine if the report meets the criteria above and thus requires review by a
CPHS member (Reviewer).
A. Those needing to be
reviewed will be forwarded to the designated Reviewer who will evaluate the
report via iRIS. The Reviewer may impose additional
requirements including but not limited to the following:
1.
No action necessary;
2.
Complete review and approval of
the study by the Full CPHS;
3.
Modification of the study;
4.
Modification of the consent
process;
5.
Modification of the consent
document;
6.
Providing additional information
to current participants (e.g., whenever the information may relate to the
participant’s willingness to continue participation or to their welfare);
7.
Providing additional information
to past participants;
8.
Alteration of the frequency of
continuing review;
9.
Requiring additional training of
the PI or his/her research staff;
10. Refer the study to the clinical research monitor to
monitor the study and provide a follow-up report;
11. Referral of the issue to the Panel Chairperson and/
or Executive Chairperson to consider suspension of the research pending a more
thorough review (following Policy and Procedure 29 on suspensions and
termination); or
12. Referral of the issue to the full
committee to consider termination of the study.
B. Those not meeting the
requirements to be reviewed by a CPHS member will be processed as “no action
required” by the Clinical Research Monitor.
C. The PI will be notified of
the outcome via iRIS.
1. If the reviewer recommended or directed further
action the PI is required to act upon that recommendation/directive in a timely
fashion.