Institutional Review Board

Investigator Guidelines for Research that Includes Human Subjects

II. What is the Process of IRB Review?

A. Initial IRB Review (How to Apply for IRB Review)

1. Request for IRB Exemption
2. Expedited Review
3. Full Board Review

B. Continuing Review Procedures
C. Changes After IRB Approval
D. Withdrawal or Completion
E. Report of Unforeseen and Adverse Events

In many instances, the process of review is a process that may require several communications between the researcher and the HPA, or IRB reviewers, before a protocol may be approved or exempted.

A. Initial IRB Review (How to Apply for IRB Review)

Material for IRB review or Request for Exemption should be delivered to the Office of Research Compliance via mail (PO Box 9300, Portland, ME 04109-9300, or at 178 Science Bldg, Portland Campus).

Once the application is received, the Operations Specialist will review the application for completeness. If any of the required elements are missing, the investigator will be contacted. Applications that contain all required supporting documents will be forwarded to the HPA (Human Protections Administrator) for review.

The HPA will review all applications to see if the project qualifies for an Exemption under 45 CFR 46.101 or an Expedited Review according to Exemption Categories under 45 CFR 46 101(b) or Categories of Expedited Review in the federal register 63 FR 60364-60367. Those applications that do not meet the criteria for Exemption or an Expedited Review are required by Federal Regulations to be reviewed at a convened IRB meeting. If substantial content (i.e., information required for approval or exemption) is missing, the investigator will be notified for revisions. If the content is complete and requires Full Board review, the application will be submitted to the Board for review.

1. Request for IRB Exemption

Research that is deemed Exempt will be returned to the researcher within approximately 10 working days of receipt. Exempt studies do not require continuing IRB review. If a study is Exempted from IRB review, no further interaction is necessary with the Office of Research Compliance (unless changes are proposed for the project or adverse events occur).

2. Expedited Review

Protocols that may be reviewed by an expedited review process will be returned to the researcher within approximately 20 working days of receipt. Protocols that do not qualify for an Expedited Review will require a Full Board Review.

3. Full Board Review

The ORC will make every effort to disseminate protocols for Full Board Review, if the protocol is submitted to Office of Research Compliance at least 30 working days prior to a scheduled IRB meeting. The investigator will receive the results of the Full Board Review within 5 working days from the meeting date. These deadlines only apply to research projects submitted to the IRB as complete applications.

The IRB may:

1. Approve the research as submitted.
2. Approve the research contingent upon specific revisions.
3. Table the protocol for substantive changes.
4. Disapprove the research.
5. Suspend or terminate research that has not followed IRB conditions of approval or is not in compliance with USM Research Policy.
6. Monitor the research for compliance with IRB recommendations. All basic monitoring has been delegated to the ORC.

The HPA will convey the committee's decisions in writing to the investigator.

Approval:  If the protocol is approved, a letter of approval will be sent to the investigator. All forms submitted as research tools (surveys, advertising for subject recruitment, consent forms), once approved, must be altered to reflect the IRB approval date and expiration date (in most cases 1 year from the approval date). Investigators may not use expired instruments.

Approval with Revisions: If the protocol is approved, contingent upon minor revisions, the investigator will be sent a letter that describes the needed revisions. After revisions are made, the investigator must send a copy of the revised protocol to the Office of Research Compliance. If the revisions are satisfactory, the HPA will approve the changes and send a signed letter indicating approval of the minor revisions. Once approved, all forms submitted as research tools (surveys, advertising for subject recruitment, consent forms) must be altered to reflect the IRB approval date and expiration date (in most cases one year from the approval).

Tabled Protocols for Major Revisions: When a proposal is tabled, the Board decides to put the submission aside while significant, requested revisions are being made.  After the requested revisions have been made, the Board will review the protocol again.

If an investigator disagrees with the revisions or specifications or IRB decisions, the investigator may bring his or her concerns to the attention of the HPA or the Director of Research Compliance for a due process investigation.

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B. Continuing Review Procedures

Protocol approval automatically expires at the end of the IRB approval period. If a researcher would like to continue research activities past the approval period, the researcher must request continuing review. A Request for Continuing IRB Review may be found on our Applications/Forms web page . Continuing review procedures should commence thirty working days prior to the IRB approval expiration date. Investigators must submit a brief summary of the research activities, including the number of subjects enrolled in the study to date, any unexpected events, any findings of the research, and an update of the initial literature review. The researcher should deliver a copy of the continuing review summary to the Office of Research Compliance or email it to usmirb@usm.maine.edu.

Federal Regulations require review of research at least annually, consequently the date of approval always begins from the date of review and extends at the maximum one year from the review date. Because of this Federal Review Requirement, the IRB is not able to make approval dates consistent with project timelines.

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C. Changes After IRB Approval

Substantial changes in IRB protocols, including approved instruments, consent forms, or advertisements, require IRB approval before use. Investigators may initiate approval for changes by submitting a Protocol Revision and Amendment form (PRAF). Minor typographic errors may be corrected by the investigator, but the investigator must provide the altered forms to the ORC using the Protocol Revision and Amendment form. From time to time, the ORC may contact the investigator to verify use of approved IRB documents.

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D. Withdrawal or Completion

Protocol approval automatically expires at the end of the IRB approval period. When a study is withdrawn or completed prior to the IRB approval period, the ORC requests that the investigator notify the IRB in writing and indicate provisions to protect confidential information or indicate plans for destroying it. All records of IRB communications must be kept on file for three years following termination or completion of research studies. Protocols are considered to be active if data analysis or handling of data is ongoing. To withdraw or complete an IRB protocol, complete the IRB Continuing Review/Study Completion form.

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E. Report of Unforeseen and Adverse Events

All adverse events of physical or psychological harm, threats to privacy or safety of human subjects must be immediately communicated to the Office of Research Compliance. In addition, unanticipated research events in federally sponsored research will be disclosed to the Department of Health and Human Services via the Office of Research Compliance. In the event of research misconduct in projects sponsored by the Public Health Service, the Office of Research Integrity will be informed of misconduct committee proceedings.

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