Incident Report Form Instructions

Instructions for Completing the Incident Report Form

Version Date: January 2024

Please answer all required questions. Individuals completing this form may also review the “Guidance in Reporting Incidents to OHRP” for additional information. Do not include any individual private health information in the report. Please note the regulatory sections listed below refer to the U.S. Department of Health and Human Services’ (HHS) Federal Policy for the Protection of Human Subjects (the Common Rule), which is codified for HHS at 45 CFR part 46, subpart A,

1. Report Status

• FULL REPORT: Select this if this is an initial report that is complete and will not require a follow-up report.

• INITIAL REPORT: Select this if this is an initial report that will require a follow-up report to be completed. This may be required for instances where the institution has not implemented a corrective action plan or has not completed gathering all information but is required to report incidents as required by the pre-2018 Requirements at 45 CFR 46.103(b)(5), and the 2018 Requirements at 45 CFR 46.108(a)(4). An initial report number will be provided by OHRP for follow-up reports.

• FOLLOW-UP: Select this if this is a follow-up report to a previously submitted initial report. Provide the initial report number provided by OHRP.

2. Report Type (check all that apply)

• UNANTICIPATED PROBLEM: Select this option if the incident is unexpected and related or possibly related to the research and poses additional risks to subjects or others. If this item is selected, question #3 must be completed.

• SERIOUS NON-COMPLIANCE: Select this option if the incident involves serious noncompliance with 45 CFR part 46 or the requirements or determinations of the IRB. If this item is selected, question #4 must be completed.

• CONTINUING NON-COMPLIANCE: Select this option if the incident involves continuing noncompliance with 45 CFR part 46 or the requirements or determinations of the IRB. If this item is selected, question #4 must be completed.

• SUSPENSION: Select this option if the IRB suspended the study or suspended enrollment of subjects. If this item is selected, question #4 must be completed.

• TERMINATION: Select this option if the IRB terminated the study. If this item is selected, question #4 must be completed.
  
  
  

3. If Unanticipated Problem, (check all that apply)
   This item should be completed only if UNANTICIPATED PROBLEM is selected in #2.

• RISK/BREACH OF CONFIDENTIALITY: Select this option if the incident led to a risk of breach or breach of confidentiality.

• Any OTHER INCIDENT: Incidents that are unexpected and related or possibly related to the research and that pose additional risks to subjects or others.

For more guidance on unanticipated problems, review “Unanticipated Problems Involving Risks & Adverse Events Guidance (2007)”

4. Category of Incident

This item should be completed only if SERIOUS NON-COMPLIANCE, CONTINUING NON-COMPLIANCE, SUSPENSION, or TERMINATION is selected in #2.

Select all options that accurately describe the incident that is being reported:
A. Research conducted without IRB approval

B. Issues related to informed consent or assent

C. Failure to follow IRB-approved protocol

D. Issues related to the IRB

E. Other

5. Federalwide Assurance (FWA) Number or Institutional Organization (IORG) number of the reporting institution
   Enter the FWA number or IORG number of the organization submitting this form. In some cases, the organization reporting an incident may not be the same as the organization conducting the research. Organizations with both an IORG number and an FWA number should enter the FWA number.
   
   
   

6. IORG # for Reviewing IRB
   Enter the IORG number of the institution serving as the reviewing IRB.

7. FWA(s) of the Institution(s) Conducting the Research
   Enter the FWA number(s) of institution(s) conducting the research. Include all institutions affected by the incident, separated by commas.

8. Study Title(s)
   If applicable, enter the study title(s) that was affected by the incident.

9. Protocol Number(s)
   If applicable, enter the protocol number(s) assigned by the institution that was affected by the incident.
   
   
   

10. Principal Investigator(s)
    If applicable, enter the name(s) of the site principal investigator(s) (PI) leading the research that was affected by the incident. However, if this event affected all research sites in a multisite study, it may be appropriate to enter the overall PI in this field instead of the site PI.

11. Research Sponsor(s)
    If applicable, enter the name(s) of the funding source(s) of the research.
    
    
    

12. Award Number(s)
    If applicable, enter the grant number(s) or contract number(s) associated with the research that was affected by the incident.
    
    
    

13. Brief Description of the Research

If applicable, provide a brief description of the research or research protocol. The description should be enough to provide sufficient context for understanding the incident. Please provide an attachment if additional space is needed.

14. Detailed Description of the Incident
    Provide a detailed description of the unanticipated problem, serious or continuing non-compliance, or rationale for the suspension or termination. Include the date(s) and location(s) of the incident. Please provide an attachment if additional space is needed.
    
    
    

15. Corrective Action Plan Description
    Provide the corrective actions the institution is taking or plans to take to address the unanticipated problems or non-compliance. Please provide an attachment if additional space is needed.
    
    
    

16. Corrective Action Plan Category

Select all options that describe the corrective action plan that will be or have already been implemented:

1. Re-seeking consent or notifying subjects

2. Revising IRB policies and procedures

3. Revising research policies and procedures

4. Revising protocol and/or consent form

5. Educating or training for IRB members/staff, investigators, research staff, or institutional officials

6. Suspending or revoking principal investigator’s privileges to conduct human subject research

7. Audit(s) plan for research

8. Suspended or terminated study

9. Other
   
   
   

1. Name of the FWA Signatory Official or IORG Senior/Head Officer
   If Box 5 uses an FWA number, provide the name of the signatory official of the organization submitting this form. If Box 5 uses an IORG number, provide the name of the Senior/Head Officer.
   
   
   

2. Human Protections Administrator (HPA) Name
   If Box 5 uses an FWA number provide the name of the Human Protections Administrator of the organization submitting this form. If Box 5 uses an IORG number, provide the name of the Information Provider.
   
   
   

3. Name and address of the organization submitting this form
   Enter the name and address of the organization submitting this form.
   
   
   

4. Name of Person Submitting this form
   Enter the name of the person submitting this form.

21. Submitter’s Email
    Enter the email address of the person submitting this form.

22. Submitter’s Phone Number
    Enter the phone number of the person submitting this form. Use the following format: xxx-xxx-xxxx.
    
    
    

23. Date
    Enter the date the form is being submitted.