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All researchers who wish to make changes to the research protocol as described in the IRBPHP Initial Application must complete the IRBPHP Modification Application. Changes include participants, timelines, procedures, wording of consent documents, instruments, correspondence, etc.
The IRBPHP Modification Application is found in Appendix E and in a separate link,https://www.dominican.edu/directory/academic-affairs/institutional-review-board-irb.
The Modification Application must provide the following information:
Description of Proposed Changes to Protocol: Describe any and all changes proposed to the original research study as approved in the IRBPHP Initial Application. Include a detailed summary of changes and attach copies of revised materials, including revised correspondence, consent forms, instruments or other research tools proposed.
Rationale for Proposed Changes: Provide detailed justification and rationale for the changes proposed above.
Impact on Potential Risks to Human Participants: Describe any impact on the level of potential risk to human participants resulting from the proposed change. The impact can be an increase or decrease; if no change, state clearly.
Minimization of Increased Potential Risk: If an increase in potential risk is described indicate how the researcher intends to minimize it.
Impact on Potential Benefits to Human Participants: Describe anticipated benefit to human participants resulting from the proposed change. Focus should be on individual participants not on benefits to society in general. If no change, state clearly.
Signatures: Provide signature and date of signature of the applicant and, when the applicant is a student, the faculty advisor.
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