University of Pennsylvania, Office of Regulatory Affairs
Institutional Review Board
133 South 36th Street, Mezzanine Philadelphia, PA 19104-3246
Modifications Review Worksheet: Amendments
PI Last Name:
Reviewer Name:
Protocol Number:
Date of
Meeting/Review:
AMENDMENTS
YES NO
N/A
YES NO
N/A
Is the PI requesting an amendment to the protocol?
 If YES, does the amendment alter the risk/benefit ratio of subjects?
 Are the requested changes updated in all appropriate study materials and included for
review? - e.g. protocol, consent forms, study forms, surveys or questionnaires,
recruitment materials
Risks to participants are minimized by using procedures that were consistent with sound
research design and that did not unnecessarily expose participants to risk or by using
procedures already being performed on the participants for diagnostic or treatment purposes.
 If NO, request additional information from investigator
Risks to participants were reasonable in relationship to the potential benefits, if any, to
participants, and the importance of the knowledge that might be expected to result
 If NO, request additional information from investigator.
Does selection of participants remain equitable? Does the selection take into account the
purposes of the research and the seeing which the research will be conducted?
 If NO, request additional information from investigator.
The proposed amendment makes adequate provisions for monitoring the data to ensure the
safety of participants.
 If NO, request additional information from investigator.
Does the proposed change make adequate provisions to protect the privacy interests of
participants?
 If NO, request additional information from investigator.
When some or all of the participants were likely to be vulnerable, the request includes a
description of additional safeguards to protect their rights and welfare.
 If NO, request additional information from investigator.
CHECKLIST OF INFORMED CONSENT/ASSENT ELEMENTS & LANGUAGE
Overall, is consent/assent written in a language still easily understandable to the subject or
guardian, and void of any exculpatory language?
Are all required elements of informed consent addressed in the informed consent document or
script? Are additional elements included as appropriate?
 Ensure the following required elements are included in the informed consent. If no, require
changes.
Will the individuals communicating information to the participant or the legally authorized
representative during the consent process would presentative.
Does the informed consent process describe how information being communicated to the
participant or the representative during the consent process include exculpatory language
through which the participant or the legally authorized representative is made to waive or
appear to waive any of the participant’s legal rights, or release or appear to release the
investigator, the sponsor, the institution, or its agents from liability for negligence?
Are all required elements of informed consent addressed in the informed consent document or
script? Are additional elements included as appropriate?
 Ensure the following required elements are included in the informed consent. If no, require
changes.
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Last Updated 1/4/2007
Modifications Review Worksheet
Could this information relate to participants willingness to continue to take part in the research?
 If YES provide to participants information relating to protocol changes.
Comments/Questions – specify if required or suggested:
ASSENT FROM CHILDREN & PARENTAL PERMISSION
Is assent required?
Is assent currently being obtained?
Parental Permission (check one):
YES
NO
YES
NO
Consent of One Parent
Consent of Both Parents Required
LEVEL OF REVIEW
No further action required at this time*
Expedited
Convened IRB
* The action not does not disrupt the study progress, such that the study design and results would
be compromised, and the action does not does not compromise the safety and welfare of study
subjects, a report of the exception should be submitted to the IRB with the next continuing renewal.
REVIEWER’S ASSESSMENT
Approve
Withheld Approval
Table
Disapprove
No changes: The modification meets the regulatory criteria for approval. there is
an acceptable risk/benefit ratio and the protocol is acceptable as submitted
Minor changes needed the informed consent document, protocol or other study
materials
Minor clarification(s) regarding specific aspect of study or additional information
requested from PI
There is an unacceptable risk/benefit ratio, because (check all that apply):
Submission lacking information regarding scientific justification, study
procedures, risk reduction, etc.
It is possible that a response for the investigator could alter the risk/benefit
ratio
Ethical concerns that can be addressed by obtaining more info or requiring
changes in study design and procedures.
Risks significantly outweigh the benefit or value of the knowledge to be gained
There are significant ethical concerns or questions that deem the study
unacceptable.
Comments. Please make clear which comments are suggestions and which are required.
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version: 12/10/2006