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Name:
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- Submit one signed original copy plus one electronic copyof your submission to the IRB-03 office. This must include copies of all paperwork including grants, surveys, data collection tools, articles, etc. Collate into three distinct items (as if you were sending the submission to three different places).
- You should also retain one copy of the submission for your files.
- You may need to submit copies to other committees/offices.
- All submissions must be typed.
- Submissions that do not meet our Submission Acceptability Standards will be returned to the PI. Visit for more information.
1. / Date:
2. / Principal Investigator:
3. / IRB Project #:
4. / Project Title:
5. / What are you reporting? Examples provided at end of document in hidden text.
Regulatory Noncompliance
UnplannedMajor Deviation potentially affecting (a) study subject safety, rights, welfare, or willingness to continue participating in the study, or (b) research data integrity.
NOTE 1: Plannedprotocol deviationsthat may adversely affect the rights, safety or welfare of subjects or the integrity of the research data should be submitted to IRB for review and approval prior to implementation except where necessary to eliminate apparent immediate hazards to the human subjects. Use the Project Revision Form 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 5 days on this form.
NOTE 2: Minor Deviations do NOT affect (a) study subject safety, rights, welfare, or willingness to continue study participation, or (b) research data integrity. Minor Deviations should be listed in the Deviation Tracking Log and reported at time of Continuing Review or Study Closure.
6. / Subject ID: or not applicable
7. / Date of occurrence: / Date of discovery:
8. / Please describe what occurred:
9. / Did this occur in order to eliminate an apparent immediate hazard to subjects?
Yes –- explain:
No
10. / Did any study subjects experience adverse effects or unanticipated problems as a result of the occurrence?
Yes –attach either an Adverse Event Reporting Form or Unanticipated Problem Reporting Form.
No
Other – describe:
11. / Explain why this occurrence does or does not affect the integrity of the research data:
12. / What corrective action have you taken to directly address this event?
13. / What have you done to prevent this from reoccurring?
Signature of Principal Investigator
/ DateThe IRB requires the PI to sign all paperwork. The only exceptions are: (a) if a Temporary Transfer of Study Responsibility has been signed by the PI and a sub-Investigator on the study, or (b) if the PI has left the institution, in which case their supervisor is required to sign as the individual responsible for the study.
DEVIATIONS & NONCOMPLIANCE--GENERAL INFORMATION
Examples of Major Deviations (potentially affecting (a) study subject safety, rights, welfare, or willingness to continue participating in the study, or (b) research data integrity) include but are not limited to:- Administering the incorrect dose of study medication.
- Failure to implement all protocol procedures resulting in increased risk or decreased benefit to the subject.
- Enrolling a vulnerable subject population without receiving prior IRB approval.
- Failure to obtain and/or document a subject’s Informed Consent (provided the IRB has not granted a waiver. I.e. Informed Consent is required, but study procedures are initiated prior the consent form being signed, or an informed consent form is never signed.
- Failure to retain copies of signed Informed Consent forms. (e.g. the PI lost one or more consent forms while moving offices, or cannot produce a signed consent form for all subjects enrolled in the study, etc).
- Conducting research (including data collection) without active IRB approval (including after expiration of the protocol).
- Enrolling subjects without active IRB approval for the protocol (either prior to initial approval or during a period of expired approval). Includes research approved with a waiver of consent, such as survey research or medical record research.
- Implementing a project revision without prior IRB approval (unless to protect the subjects against harm).
- Implementing planned protocol variations/exceptions without obtaining prior IRB approval – e.g. enrolling a subject who does not fit the inclusion/exclusion criteria specified in the protocol without prior IRB approval.
- Recruiting/enrolling subjects at a location or in a manner that has not been previously approved.
- Conducting your research at a site or involving outside investigators without prior IRB approval.
Examples of Unplanned Minor Deviations include but are not limited to:
- Protocol procedures completed at times outside the period specified in the protocol (e.g. protocol indicates that a blood draw should occur on day 7, but the draw is actually completed on day 8 because the subject did not show up to clinic on day 7) without adversely affecting subject safety, rights, willingness to participate in the study, or possible benefits from the study.
Deviation/Non-Compliance
IRB versiondate: 11/24/2009Page 1 of 2
PI Version date: