Dept. of Research - Worksheet for Initial Review

IRB Worksheet for Initial Review
Protocol ID*
Protocol Title*
Reviewer Name*

First NameLast Name
E-mail*
To approve research the following minimum criteria must be present:
Does the protocol have scientific merit?*

YesNo
If no, why not?
Is the protocol written in order to minimize risk to participants?*

YesNo
If no, why not?
Is the selection of participants equitable (fair and reasonable)?*

YesNo
If no, why not?
Are the participants’ risks balanced by the potential benefits of the research?*

YesNo
If no, why not?
Are the rights and welfare of research participants adequately protected?*

YesNo
If no, why not?
Are there adequate plans to protect the privacy and confidentiality of participants and their data?*

YesNo
If no, why not?
Is the informed consent process adequate?*

YesNoN/A
If no, why not?
If there is risk to the participants, does the protocol make adequate provision for monitoring the study and the data collected so that risks to participants are minimized?*

YesNoN/A
If no, why not?
If vulnerable groups are enrolled, are there adequate safeguards in the study design and consent process to protect these persons from undue influence and/or coercion?*

YesNoN/A
If no, why not?
Are the protocol and IRB application congruent and are they both reflected accurately in the informed consent form?*

YesNoN/A
If no, why not?
Does the Principal Investigator have qualifications and experience to adequately perform the research proposed?*

YesNo
If no, why not?
Comments
Recommendations*

ApproveApprove pending revisionsTableDisapprove
Continuing Review Recommendation

AnnualLess than one year
Reviewer Signature

Clear
Today's Date*

MonthDayYear
Date
Should be Empty:

IRB Worksheet for Initial Review