Reviewer Worksheet:PROBLEMS & EVENTS
Study IDStudy Title
Principal Investigator
Pre-Reviewer / Lisa Leventhal / Date of Pre-Review
Primary Reviewer / Date of Review
REVIEWER CONFLICT OF INTEREST
Do you have any conflicts of interest related to this study that could prevent you ☐ Yes ☐ No
from providing an independent review or that may lend itself to the perception of a COI?
ANCILLARY REVIEWS
Biosafety☐ Approved ☐ Requested revisions ☐ Pending☐ N/A
Radiation Safety☐ Approved ☐ Requested revisions ☐ Pending☐ N/A
Chemical Safety☐ Approved ☐ Requested revisions ☐ Pending☐ N/A
Conflict of Interest☐ Approved ☐Requested revisions ☐ Pending☐ N/A
Office of Info. Security☐ Approved ☐ Requested revisions ☐ Pending☐ N/A
Registrar☐ Approved ☐ Requested revisions ☐ Pending☐ N/A
Human Resources☐ Approved ☐ Requested revisions ☐ Pending☐ N/A
Export Control☐ Approved ☐ Requested revisions ☐ Pending☐ N/A
Office Comments:
SECTION I: UNANTICIPATED PROBLEM / Yes / No- Unexpected: Is it 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; and (b) the characteristics of the subject population being studied?
- Related or possibly related: Is there a reasonable possibility that the incident, experience, or outcome may have been related to or caused by the procedures involved in the research?
- Risk: Does the incident, experience, or outcome suggest that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, and social harm) than was previously known or recognized?
- Was the report submitted within 3 days[i] of discovery (or 10 days if deviation only)?
Is there sufficient information to make a determination? / ☐ / ☐
Determination: Is this an unanticipated problem (Mark “yes” only if “yes” to 1, 2, AND 3)? / ☐ / ☐
SECTION II: ADVERSE EVENT / Yes / No
- Adverse event (AE): Was there an untoward or unfavorable occurrence in a human subject that was temporally associated with the subject’s participation in the research?If “no,” skip to next section.
- Attribution: Adverse event attribution will fall into one of the following categories:
a)Related or possibly related: Is therea reasonable possibility that the incident, experience, or outcome may have been caused by the procedures involved in the research? If “no,” skip to next section. / ☐ / ☐
- Severity: If there was an AE, was it mild, moderate, or severe?
a)Mild: Event results in transient discomfort; does not influence performance or functioning; does not require intervention or treatment; does not limit or interfere with daily activities; expected to resolve quickly with no physical, psychological, social, or economic consequences. If mild severity, this is not a reportable event. / ☐ / ☐
b)Moderate: Of sufficient severity to make the patient uncomfortable; may include worsening of conditions present at the onset of the study; treatment of symptom(s) may be needed; expected to resolve but short term physical, psychological, social, or economic consequences are possible. / ☐ / ☐
c)Severe: Event results in significant symptoms that prevents normal daily activities; may require hospitalization or invasive intervention. Long term physical, psychological, social, or economic consequences are possible. / ☐ / ☐
- Was the report submitted within 30 days of discovery?
Is there sufficient information to make a determination? / ☐ / ☐
Determination: Is this a reportable adverse event (“yes” to 5, 6a, and 7b or 7c)? / ☐ / ☐
SECTION III: DEVIATION / Yes / No
- Is the event or issue a deviation from the approved protocol that was unanticipated and happened without any prior approval? If “no,” skip to next section.
- Does the deviation increase risk, have potential to recur, or was it undertaken to eliminate an immediate hazard?
- Does the type or number of deviations reported by this investigator (on this study or others from this PI) warrant further action?
Is there sufficient information to make a determination? / ☐ / ☐
Determination: Is this is an Unanticipated Problem (“yes” to 10)? Refer to Section I above? / ☐ / ☐
Determination: Are there repetitive deviations for this study, or for this PI across multiple studies, which may constitute non-compliance and require further review by the convened Board (“yes” to 11)? / ☐ / ☐
SECTION IV: EXCEPTION
- Is this a circumstance in which the specific procedures called for in a protocol are not in the best interests of a specific subject and the investigator is requesting permission for a planned deviation from the approved protocol? If “no,” skip to next section.
- Does the exception increase risk or decrease benefit, affect the participant’s rights, safety, welfare, or affect the integrity of the resultant data?
Is there sufficient information to make a determination? / ☐ / ☐
Determination: Can this request for an exception be approved (answer to 13 must be “no”)? / ☐ / ☐
SECTION V: NON-COMPLIANCE / Yes / No
- Non-compliance is defined as failure to comply with any of the regulations and policies governing the OSU HRPP and/or failure to follow the determinations of the IRB. Non-compliance may be minor or sporadic, or it may be serious or continuing. Is this a report of non-compliance? If “no,” skip to next section.
- Serious non-compliance is defined as failure to follow any of the regulations and policies governing the OSU HRPP or failure to follow the determinations of the IRB and which, in the judgment of either the IRB Chair or the convened IRB, increases risks to participants, decreases potential benefits, or compromises the integrity of the human research protection program. Examples of serious non-compliance include, but are not limited to, (a) research being conducted without prior approval, and (b) participation of subjects in research activities without their prior consent (in studies where consent was not specifically waived). Is this a report of serious non-compliance?
- Continuing non-compliance is defined as a pattern of non-compliance that, in the judgment of the IRB Chair or convened IRB, suggests a likelihood that instances of non-compliance will continue without intervention. Continuing non-compliance also includes failure to respond to a request to resolve an episode of non-compliance. Is this a report of continuing non-compliance?
Is there sufficient information to make a determination? / ☐ / ☐
Determination: Is this a report of non-compliance that is NOT serious or continuing? / ☐ / ☐
Determination: Is this a report of serious and/or continuing non-compliance? / ☐ / ☐
Determination: Do theallegations or findings of non-compliance warrant suspension or termination of the research before completion of the review or investigation? / ☐ / ☐
SECTION VI: COMPLAINT / Yes / No
- Does this issue or event constitute a complaint? If “no,” skip to next section.
- Does the complaint warrant suspension of the study?
- Does the complaint involve non-compliance?
- Does the complaint involve an unanticipated problem?
- Does the complaint involve an adverse event?
Is there sufficient information to make a determination? / ☐ / ☐
SECTION VII: PROJECT REVISION / Yes / No
- Does the issue or event necessitate a project revision?
- Was a project revision submitted with this report? If “yes,” complete an additional reviewer sheet that is specific to project revisions. If “no,” skip to next section.
- Was the revision sufficient?
- Are additional revisions required?
DETERMINATIONS AND NEXT STEPS
Are materials complete and sufficient to make a determination?
☐Yes ☐No
Is the event an unanticipated problem, serious or continuing non-compliance, or does it warrant suspension or termination?
☐Yes ☐No
Is the study exempt?
☐Yes ☐No
Is the risk to subjects or others greater than minimal?
☐Yes ☐No
☐REVISIONS or COMMENTS: Request the following additional information or revisions, or include these comments in with the acknowledgement:
☐RESOLVED: No further action required as of [insert date here]
☐Send acknowledgement. If PI included a corrective action plan, the reviewer has accepted the plan as submitted.
HRPP Staff Comments:
OSU IRB FWA0000039201HRPP Form | v. date May 2016
[i] Throughout this document, “days” refer to business days, not calendar days.
ii