Reporting Unanticipated Problems that are Not Adverse Events
Click here
to view an audio video presentation outlining WIRB's current expectations for the
reporting of unanticipated problems.
Federal Regulation 21CFR §56.108(b)(1) and 45 CFR 46.103(b)(5) require the
IRB to "follow written procedures for ensuring prompt reporting to the IRB…any
unanticipated problems involving risk to human subjects or others."
An unanticipated problem is defined as any incident, experience, or outcome that
meets all of the following criteria:
- Unexpected (in terms of nature, severity, or frequency) given (a) the research procedures
that are described in the protocol-related documents, such as the IRB-approved research
protocol and informed consent document, or the Investigator Brochure; and (b) the
characteristics of the subject population being studied;
- Related or possibly related to participation in the research (possibly related means
there is a reasonable possibility that the incident, experience, or outcome may
have been caused by the drugs, devices or procedures involved in the research);
and
- Suggests that the research places subjects or others at a greater risk of harm (including
physical, psychological, economic, or social harm) than was previously known or
recognized.
All reports to the IRB of unanticipated problems should explain clearly why the
event is "unanticipated" and clearly explain why the event represents a “problem
involving risks to human subjects or others.”
WIRB expects reports to the IRB of unanticipated problems to include a corrective
action plan to address the issue, or written justification for why none is provided.
Please note that unnecessarily reporting problems that do not meet the criteria
outlined above may impair the Board’s ability to review and respond in a timely
manner to actual situations where subject rights, welfare or safety are threatened.
Instructions for reporting unanticipated problems that are not adverse events:
Use the Report Form for Unanticipated Problems that are Not Adverse Events
(smart form or
paper version) to report the following unanticipated problems:
- Unanticipated problems that do not fit the definition of an adverse event, but which may, in the opinion
of the investigator, involve risk to the subject, affect others in the research
study, or significantly impact the integrity of research data. For example, report
occurrences of breaches of confidentiality, accidental destruction of study records,
or unaccounted-for study drug.
- Unplanned protocol deviations/violations that have already occurred, that
may adversely affect the rights, safety or welfare of subjects or the integrity
of the research data, AND that meet the definition of an unanticipated problem (i.e., it involves risk to subjects or other people)
.
Report occurrences within 10 days of becoming aware of them.
Note: Planned protocol deviations
Due to differing regulatory requirements, WIRB reporting requirements for planned protocol deviations differ depending on whether your research federally funded or is covered by a federal-wide assurance (FWA):
- If the research is not federally funded and the research is not conducted under an FWA, planned protocol deviations that may adversely affect the rights, safety or welfare of subjects or the integrity of the research data should be submitted to WIRB for review and approval prior to implementation
except where necessary to eliminate apparent immediate hazards to the human
subjects [(DHHS 45 CFR § 46.103(b)(4); (FDA 21 CFR § 56.108(a)(4); ICH
3.3.7].
- If the research is federally funded or is conducted under an FWA, all planned protocol deviations must be submitted to WIRB for review and approval prior to implementation except where necessary to eliminate apparent immediate hazards to the human subjects [ (DHHS 45 CFR § 46.103(b)(4); (FDA 21 CFR § 56.108(a)(4); ICH 3.3.7].
The reason for these different requirements regarding planned protocol deviations is that the Office for Human Research Protections (OHRP) has adopted the regulatory interpretation that every planned protocol deviation is a change in research that needs prior IRB review and approval before implementation. However, the Food and Drug Administration (FDA) has not adopted this interpretation.
Use the WIRB CIR/Subject Recruitment Submission Form (smart form or
paper version) to request approval of a planned protocol deviation prior
to implementation. (Deviations necessary to eliminate apparent immediate hazards
to the human subjects should be reported within 10 days on the Report Form for Unanticipated
Problems that are Not Adverse Events.)
Links to the agency guidance:
http://www.wirb.com/download/FDA_AE_guidance_01-2009_(final).pdf
http://www.wirb.com/download/OHRP_guidance.pdf
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