1. Purpose
This SOP describes the process to identify and report possible research-related events
(Deviations, Violations, Exceptions, Adverse Events/Serious Adverse Events (AE/SAE),
and Unanticipated Problems involving Risks to Subjects or Others (UPIRTSO) to the
WVU IRB. Researchers are required to submit the report as soon as possible after
the site investigator learns of the event, and in call cases, within 10 days. This
policy applies to all research occurring under the auspices of WVU IRB.
2. Events Requiring Reporting
2.1 Researchers and research staff are responsible for reporting to the
IRB unanticipated problems involving risks to subjects or others. Such reports
may include adverse events, subject complaints, protocol
deviations, and other untoward events involving risk. Reports may also include
events that are not categorized as adverse events and are not directly related
to an individual subject’s participation in a study but represent risk to others.
Events that do not cause detectable harm or adverse effects to subjects or others
still may represent unanticipated problems.
2.2 Events that occur in WVU research that may represent unanticipated
problems involving risks to subjects or others should be promptly reported. For the time
frame for such reporting, see section 2.3 below. The following events may represent
unanticipated problems involving risks to subjects or others:
- Adverse device effects that are serious, unanticipated, and related;
- Adverse events or injuries that are serious, unexpected, and related;
- Breaches of confidentiality involving potential risks;
- Data and Safety monitoring board (DSMB) reports, interim analyses, or other oversight
committee/monitoring
reports altering the risk/benefit profile;
- Events requiring reporting according to the protocol, sponsor, or funding agency;
- New information indicating an unexpected change in risks or potential benefits
(e.g., literature/scientific
reports or other published findings);
- Protocol deviations, violations, or other accidental or unintentional changes
to the protocol or procedures
possibly involving risks or with the potential to recur, even if no harm has
actually
occurred;
- Subject complaints indicating an unanticipated risk, or complaints that cannot
be resolved by the research staff
see SOP 032: Complaints and Concerns);
- Unapproved changes made to the research to eliminate an apparent immediate hazard
to a subject
- Audit findings, inquiry, or written report by a federal agency (e.g., FDA Form
483);
- Suspension by the sponsor, investigator, or institutional entity; or
- Other problems or findings (e.g., loss of study data or forms, a subject becomes
a prisoner while participating
in the research, etc.) that a researcher or research staff member believes
could influence the safe conduct of the research.
2.3 Timeframes for Reporting
- The events described above should be reported to the IRB using the Event Report
submission in WVU's
electronic IRB system within 10 days of the PI, researchers, or research staff
members' learning of the event.
- Events resulting in temporary or permanent interruption of study activities by
the researcher, sponsor, or DSMB
to avoid potential harm to subjects should be reported within 48 hours.
- Events resulting in the incarceration of a study subject should be reported within 72 hours (3 days) of the PI, researchers, or research staff members learning of the incarceration.
- Events that may represent unanticipated problems involving risks to subjects
or others should be reported (as
described above), regardless of whether they occur during or after the study
or involve a subject who has withdrawn from or completed study participation.
If changes to the research or consent process are proposed as a result of the
event, or if additional information will be provided to current and/or past
participants, an amendment request must also be submitted for IRB review.
- Additional sponsor reporting requirements may exist and are not outlined in this
policy.
2.4 Events that may be reasonably anticipated
(or expected) should be described in the informed consent process/form and do not
require reporting to the IRB by researchers and/or research staff.
2.5 The following
are examples of events that do not require reporting (unless outlined in 2.6 for studies with annual review):
- Adverse device effects that are non-serious, anticipated, or unrelated;
- Adverse events or injuries that are non-serious, expected, or unrelated;
- Deaths not attributed to the research (e.g., from natural causes, accidents,
or underlying disease) and the
researcher(s) have ruled out any connection between the study procedures and
the participant’s death;
- DSMB reports, interim analyses, or other reports, findings, or new information
not altering the risk/benefit ratio of the research
- Brochure updates not involving safety information;
- IND safety reports from external sites not involving WVU research;
- Protocol deviations or violations unlikely to recur or not involving the possibility
of risks to subjects (to others);
- Subject complaints that were resolved or complaints not involving risks;
- Problems or findings not involving risk (unless the investigator or research
staff member believes the information could affect participants’ willingness
to continue in the research).
2.6 The following are examples of events that should be reported at the next continuing annual review/renewal if the protocol type requires annual review:
- DSMB reports, interim analyses, or other reports, findings, or new information not altering the risk/benefit ratio of the research;
- Brochure updates not involving safety information;
- Protocol deviations or violations unlikely to recur or not involving the possibility of risks to subjects (or others);
- Problems or findings not involving risk (unless the investigator or research staff member believes the information could affect participants' willingness to continue in the research).
3. Procedures for Reporting Research Related Events
3.1 The PI reports the problem under this policy by completing and electronically
submitting the information via
the Notify IRB function within the WVU electronic IRB system. The PI attaches
the Research Event Report Form (can be found on WVU OHRP’s website within the Forms
page) to the submission in the electronic system.
3.2 The submission is assigned by WVU OHRP staff through the WVU electronic
IRB system to an IRB reviewer for review and evaluation. The IRB reviewer may request
clarifications, corrections, or revisions to the report from the PI if further
information is needed to evaluate the event.
3.3 If the IRB reviewer determines that the event is not an unanticipated
problem involving risks to participants or others as defined in this policy, the
reviewer indicates such in the electronic IRB system. The PI is notified via the
electronic IRB system, and no further action is taken.
3.4 If the IRB reviewer determines the problem might be, or likely is,
an unanticipated problem involving risks to participants or others as defined by
this policy, the event is referred to the convened IRB for review. All applicable
materials are forwarded to the convened IRB at 5 business days prior to the convened
meeting.
3.5 Based on the nature of the event and the expertise required to assess
it, the IRB Chair or designee acts as the primary reviewer and presents his or
her findings to the convened IRB. The convened IRB evaluates the event by considering
whether the problem is an unanticipated problem involving risks to participants
or others as defined by this policy. The convened IRB votes on whether the report
is an unanticipated problem involving risks to participants or others. IRB staff
records the discussion and rationale for any action and vote in the minutes.
3.6 If the convened IRB determines that the problem is not an unanticipated
problem involving risks to participants or others as defined by this policy, the convened IRB acknowledges
the event as submitted, indicating the event is not considered to be an unanticipated
event involving risks to participants or others. The PI is notified via the electronic
IRB system, and no further action is taken.
3.7 If the convened IRB determines that the problem is an unanticipated
problem involving risks to participants or others as defined by this policy, the
convened IRB may consider any of the following actions, but is not limited to:
- Modification of the protocol;
- Modification of the information disclosed during the consent process provided
by the investigator;
- Providing additional information to current participants (this must be done whenever
the information may relate to the participant’s willingness to continue participation);
providing additional information to past participants;
- Requiring current participants to re-consent to participation;
- Alteration of the frequency of continuing review;
- Observation of the research or the consent process;
- Requiring additional training of the investigator;
- Notification of investigator(s) at other site(s);
- Obtaining additional information; or
- Administrative hold, termination, or suspension of the research (see SOP 029:
Suspension, Termination, and Investigator Hold, Early Termination).
3.8 If the IRB determines that the event was an unanticipated problem involving risks
to participants or others, the matter is referred to the OHRP staff to handle according
to SOP 034: Reporting to External Agencies.
4. References
Federal Regulations:
21 CFR 50.25(b)(5)
21 CFR 56.108(b)(1)
21 CFR 812.150(a)(1)
45 CFR 46.103(b)(5)(i)
45 CFR 46.116(b)(5)
AAHRPP:
Element II.2.G
Versions:
1.0 New SOP (12/20/2021), 2.0 Clarification for section 2.5 (11/17/2023)
