Federally Required Reporting

Adverse Events & Unanticipated Serious Problems

An adverse event or serious problem may include but are not limited to:

• Breakdowns in the consent process.
• Violations of confidentiality of the data
• Complaints by participants
• Adverse physical events
• Adverse psychological events

An adverse event may result from any of the following:

• The interventions and interactions used in the research;
• The collection of identifiable private information under the research;
• An underlying disease, disorder, or condition of the human subject; and/or
• Other circumstances unrelated to the research or any an underlying disease, disorder, or condition of the subject.

How to Report an Adverse Event/Serious Problem

Please follow these steps to report an Adverse Event:

• Go to “Forms and Applications” on the IRB home page at http://www.ccny.cuny.edu/irb.
• Select “Forms and Applications”.
• Complete and submit the Unanticipated Adverse Event/Problem Form.

Additional Information about the nature of Adverse Events as well as examples may be found on OHRP’s website at http://www.hhs.gov/ohrp/requests/aerg.html

Protocol Deviations (Breaches in Protocol)

A requirement by Federal Regulations: all protocol deviations or instances of noncompliance with IRB regulations must be reported to the IRB by the principal investigator as soon as the deviations are discovered.

What is a protocol deviation?

A protocol deviation occurs whenever a Principal Investigator, or any key personnel change a procedure—breach in protocol, or omit a procedure in the research so that the protocol no longer reflects what is described in the original protocol (reviewed and approved by the IRB).

Following are examples of common protocol deviations:

• Unreported modifications in the IRB approved protocol or consent documents
• Amendments to procedures for the purposes of protecting research participants from immediate hazards
• Enrolment of participants outside approved protocol’s inclusion/exclusion criteria
• Enrollment of participants under an amended/revised protocol prior to obtaining official IRB approval of the submitted amendment request
• Breach of confidentiality or privacy
• Omissions such as failure to perform research-related tasks or follow-ups as specified by the approved protocol
• Errors in medication or intervention, e.g., incorrect drug/intervention or incorrect dosage of a drug
• Exceeding participant enrollment numbers described in the approved IRB protocol
• Performing research activities without an approved continuing review

How to Report a Protocol Deviation to the IRB:

Please follow the same steps as in reporting an Adverse Event.

• Go to “Forms and Applications” on the IRB home page at http://www.ccny.cuny.edu/irb .
• Select "Forms and Applications"
• Complete and submit the Protocol Deviation Form.

Terminating a Project:

A study should be terminated ONLY when all subjects have completed the study and research-related activity has ceased, including subject follow-up, data collection, and/or data analysis.

Steps for terminating a protocol:

• Go to “Forms and Applications” on the IRB home page at http://www.ccny.cuny.edu/irb .
• Select “Forms and Applications”.
• Select the "Continuing Review/Final Report Form"
• Complete and submit your Final Report.

The final report should include:

• Responses to all questions on the form
• Include a copy of the old consent form that was used in the study

Please contact the IRB office at 212.650.5397 if you have questions about IRB review or procedures.