Request to Modify a Study
HRP-213 Modification of Approved Human Research Form – Instruction Guide
This form is used to request any modification to an approved study, including the submission of an ad, a personnel change, or a translated consent document.
Section A serves as a reminder that certain modifications require the review and approval from other institutional committees/ offices prior to the implementation of any changes.
If any of the components in Section A are affected by the proposed modification, check “Yes” and follow the instructions in the next column.
Please note that the GCO requires notification of personnel changes occurring at the investigator level only.
Section B is used to summarize the modification. A summary may also be attached. The summary of the modification must include the proposed changes, where the changes can be found (specify the form, template, protocol as well as the specific location of the change) and the justification for the change.
Section C serves as the checklist for what other materials might be necessary to include in the submission. Any document affected by the modification must be submitted with the changes underlined, highlighted or otherwise clearly marked.
Section D must be signed by the Principal Investigator, as any change to the project must be acknowledged and authorized by the PI.
Program for the Protection of Human Subjects
For submissions and general inquiries send e-mail to: IRB@mssm.edu
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