Unanticipated Events/Deviation/ Non-compliance Reporting Form

Directions: A form must be completed and submitted to the IRB via email () for each incident of an unanticipated event or deviation within 5 days of the P.I. becoming aware of the occurrence(see comment below regarding reporting participant non-compliance.)

Filing of this form with the IRB does not release the Principal Investigator from any other reporting requirements to the government, sponsor, or other regulatory agency. Please fill in all narratives on the form electronically. Additional supporting documents may be sent as an attachment along with this form to .

Examples of Reportable Events (not inclusive):

(a) An unplanned protocol deviation that harmed participants or others; that indicates participants or others may be at increased risk of harm; that could adversely affect the safety or welfare of subjects; or that compromises the integrity of the research data. (Note: A planned protocol deviation requires IRB approval of a report of change prior to implementation.)

(b) Any change made to the research without prior IRB approval in order to eliminate apparent immediate harm.

(c) Any unforeseen harmful or unfavorable occurrence to participants or others that is related or possibly related to the research protocol (such as injuries, psychological events, or drug errors).

(d) Any unforeseen development related or possibly related to the research, that potentially increases the likelihood of harm to participants or others in the future.

(e) Adverse events which, in the opinion of the PI, are both unexpected and related or possibly related to the subject’s participation in the research.

(f) Information that indicates a change to the risks or potential benefits of the research.

(g) Breach of privacy or confidentiality.

(h) Incarceration of a participant in a protocol not approved to enroll prisoners.

(i) Complaint of a participant when the complaint indicates unexpected risks or cannot be resolved by the research team.

(j) Sponsor-imposed suspension for risk.

(k) Allegation of non-compliance with protocol requirements or IRB policies.

(l) Any safety reporting requirements specified by the IRB as a condition of approval.

(o) Any other problem or event that the investigator considers to be unanticipated and indicates that subjects or others are at increased risk of harm.

Definitions:

Unanticipated Eventis any incident, experience, or outcome that meets all of the following criteria:

  1. 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;
  2. related or possibly related to participation in the research (in this guidance document, possibly related means there is a reasonable possibility that the incident, experience, or outcome may have been caused by the procedures involved in the research); and
  3. 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 (

Deviations are variances from the IRB approved protocol and protocol related materials that have not been pre-approved.

IRB #: example (12-000) / IS THIS A/AN: Unanticipated Event Deviation
PROTOCOL TITLE:
IF THIS IS A SPONSORED PROJECT, PROVIDE NAME OF SPONSOR:
TOTAL APPROVED NUMBER OF HUMAN SUBJECTS:
TOTAL NUMBER OF HUMAN SUBJECTS AFFECTED:
TODAY'S DATE: / DATE OF OCCURRENCE:
1. / Describe the adverse event/deviation/violation/ participant non-compliance:
2. / Explain why this occurred.
3. / What steps were taken to resolve this particular occurrence?
4. / What is being done to prevent similar occurrences in the future?
5. / Did the occurrence result in an adverse event or a violation of the rights of a human subject (e.g. violation of privacy, consent process not followed)?
Yes – Explain in Detail Below No
6. / Will the participant continue with the research?
Yes No – List Date Stopped:
7. / Will the research project itself continue?
Yes No – List Date Stopped:

By submitting this form to , I (type your name) acknowledge that the information contained in the study is accurate to the best of my knowledge. I verify that I am the Faculty Advisor or the Principal Investigator for this study and that I shall be responsible for the oversight of the conduct of the research and adherence to all applicable University policies and procedures.

1

IRB Unanticipated Event /Deviation Reporting Form09/05/12