IRB Guidelines - Amendments/Modifications to a Protocol

All modification/changes in a project previously approved by the UMass Amherst Human Subjects Institutional Review Board (IRB) must be received and approved by the IRB before they are initiated except where necessary to eliminate apparent immediate hazard to the subject. Requests for approval of modifications/changes may be submitted at any time by an investigator.

"Major" modification requests for protocols that were approved by full IRB review must be reviewed through the full committee review process. Major modifications to protocols initially review by the expedited review process may receive expedited review. However, depending on the nature of the modifications the reviewer may recommend review by the full committee. Examples of modifications considered to be major include, but are not limited to, escalation in the drug(s)/dosages; the introduction of additional drug(s); the addition of a new invasive procedure. Major modifications may impact on the risk/benefit ratio in the study. It is the investigator's responsibility to assess the degree of change in the risk/benefit ratio.

"Minor" modification requests are reviewed administratively. If during this review it is determined that the modification is not minor the investigator will be contacted with instructions on how to proceed. A modification is approved only to the expiration date that was received at the protocol's most recent review.

SUBMISSION REQUIREMENTS

A cover letter with the name of principal investigator, project title, and protocol approval date. The letter should state that a modification is being requested. The request should clearly explain what the modification is, why it is being requested, and any potential changes to the risks or benefits to the subject.
The revised informed consent document, or, if no revision to the IC form is needed, a copy of the original informed consent document. Revisions should be highlighted.
Where changes are major, submit a revised Form 441 and Abstract with revisions highlighted.
If the changes include the addition of minors the modifications may require the addition of parental consent, child's assent, and a discussion of the risk management procedures.

NOTE: Modifications to graduate student projects must be submitted by the faculty sponsor.

C. FURTHER INFORMATION

For further information and/or clarification regarding modifications of a protocol please call the Human Protection Administrator at 545-3428. All completed application materials should be sent to the:

Human Research Protection Office (HRPO)
108 Research Administration Building
70 Butterfield Terrace
University Of Massachusetts
Amherst, MA 01003-9242

Phone: (413) 545-3428
FAX: (413) 577-1728
Email: humansubjects@ora.umass.edu




Research Home Compliance Home Animal Use Biological Safety Feedback Forms Human Subjects Research Policies Responsible Conduct Staff		IRB Guidelines - Amendments/Modifications to a Protocol All modification/changes in a project previously approved by the UMass Amherst Human Subjects Institutional Review Board (IRB) must be received and approved by the IRB before they are initiated except where necessary to eliminate apparent immediate hazard to the subject. Requests for approval of modifications/changes may be submitted at any time by an investigator. "Major" modification requests for protocols that were approved by full IRB review must be reviewed through the full committee review process. Major modifications to protocols initially review by the expedited review process may receive expedited review. However, depending on the nature of the modifications the reviewer may recommend review by the full committee. Examples of modifications considered to be major include, but are not limited to, escalation in the drug(s)/dosages; the introduction of additional drug(s); the addition of a new invasive procedure. Major modifications may impact on the risk/benefit ratio in the study. It is the investigator's responsibility to assess the degree of change in the risk/benefit ratio. "Minor" modification requests are reviewed administratively. If during this review it is determined that the modification is not minor the investigator will be contacted with instructions on how to proceed. A modification is approved only to the expiration date that was received at the protocol's most recent review. SUBMISSION REQUIREMENTS A cover letter with the name of principal investigator, project title, and protocol approval date. The letter should state that a modification is being requested. The request should clearly explain what the modification is, why it is being requested, and any potential changes to the risks or benefits to the subject. The revised informed consent document, or, if no revision to the IC form is needed, a copy of the original informed consent document. Revisions should be highlighted. Where changes are major, submit a revised Form 441 and Abstract with revisions highlighted. If the changes include the addition of minors the modifications may require the addition of parental consent, child's assent, and a discussion of the risk management procedures. NOTE: Modifications to graduate student projects must be submitted by the faculty sponsor. C. FURTHER INFORMATION For further information and/or clarification regarding modifications of a protocol please call the Human Protection Administrator at 545-3428. All completed application materials should be sent to the: Human Research Protection Office (HRPO) 108 Research Administration Building 70 Butterfield Terrace University Of Massachusetts Amherst, MA 01003-9242 Phone: (413) 545-3428 FAX: (413) 577-1728 Email: humansubjects@ora.umass.edu


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