IRB — Revisions & Renewals

Revisions to Approved Protocols

All revisions to an existing approved protocol, including study-related procedures; personnel; or duration of the study; must FIRST be approved by the IRB, unless said changes are necessary to avoid undue harm or increased risk to the participants. Changes made in response to adverse effects or events must be reported to the IRB immediately.

Revisions eligible for expedited IRB review (Levels I and II)

• Changes in protocols for studies that have had no adverse effects or events reported, and that will not result in a change in risk to participants
• Changes in personnel or duration of the study that will not result in a change in risk to participants

Revisions requiring full IRB review (Level III)

• Changes in protocols, personnel, or duration for studies that have had adverse effects or events reported
• Changes in protocols, personnel, or duration that may result in increased risk for the participants
• Changes in protocols that involve the addition of vulnerable populations (e.g., fetuses, infants, children, prisoners, or those with diminished cognitive abilities)

Revisions to existing protocols must be submitted for approval and include the following:

• A copy of the approved protocol with requested changes highlighted, and an accompanying explanation or justification for said changes.

     — Changes that involve increased risk to participants must
         address how this risk will be managed.

     — Changes that involve the addition of vulnerable populations
         must address what measures will be taken to ensure the
         protection of these participants.


• A copy of the current and/or new consent form
• If the researcher is student, a letter or email from the supervising professor stating their approval of the revision.

Revisions to existing protocols involving only changes in personnel or duration of study:

• Addition of personnel: submit the name of the individual(s), their certificate(s) of completion of the NIH's “Protecting Human Research Participants” training, level of involvement or role in the study, and qualifications
• Removal of personnel: submit the name of the individual(s) and a brief explanation for why he/she is no longer involved in the study
• Change in duration: submit a status report, explaining how much of the experiment has been completed, how much remains, the new estimated duration, and a justification for the proposed change in the duration of the study

A research project is subject to annual review by the IRB if it extends beyond one year.

Renewals

Approval of a human subject research application is good for one year, unless the project has acceptable but significant enough risk that the committee elects to extend approval for only a six-month period. If the project continues beyond the approval period, the principal investigator must submit a status report of the project to date, including:

• The number of subjects accrued
• A summary of adverse events and any unanticipated problems involving risks to subjects or others; include the number and any reason given for the withdrawal of subjects from the research or complaints about the research since the last review
• A summary of any relevant amendments or modifications to the research since the last review
• Any other relevant information, especially information about risks associated with the research
• A copy of the current informed consent document and any newly proposed consent document