WORKSHEET: Scientific or Scholarly Review
NUMBER
DATE
PAGE
HRP-307
4/19/13
1 of 1
The purpose of this worksheet is to provide support for individuals responsible for the scientific review of research. Use this worksheet to determine
whether the research has scientific or scholarly validity. IRB members conducting scientific or scholarly review are to consult this worksheet for each
protocol. This worksheet is to be used. It does not need to be completed or retained. Consultants providing scientific or scholarly review are to complete
this worksheet and provide it to IRB staff who will retain it in the files.
Study Number:
1
Reviewer Criteria (Must be “Yes”; If there is a conflicting interest, please cease the review and inform the IRB staff immediately.)
Yes
No
I do not have a Conflicting Interest.
2
Overall Scientific and Scholarly Validity (All must be “Yes” or “N/A”)
Yes
No
Is the research protocol scientifically sound or does it have scholarly merit?
Yes
No
Does the protocol accurately describe the research in a clear, detailed protocol in terms of?
 Objectives
 Data and safety monitoring plan
 Background
 Risks
 Setting
 Potential benefits
 Procedures
 Alternatives to participation
Yes
No
The protocol has been designed to eliminate unnecessary risks while still answering the scientific question.
(consider # of subjects, procedures, selection criteria).
Yes
No
There are no additional monitoring procedures that would reduce risks to subjects and not affect the science.
Yes
No
Is the research likely to answer its proposed question?
Yes
No
Does the protocol fairly portray the importance of the knowledge expected to result?
Yes
No
Is the available background information (clinical and non-clinical) adequate to support the proposed research?
Yes
No
N/A
Will the data and safety monitoring plan promptly detect changes in the risks and benefits to participants?
(Mark N/A if the research involves no greater than minimal risk.)
3
Resources for Clinical Trials (All must be “Yes” for Clinical Trials. May be “Yes” or “N/A” if the research is not a clinical trial)
The available nonclinical and clinical information on an investigational product is adequate to support the proposed
Yes
No
N/A
clinical trial.
Yes
No
N/A
The investigator has demonstrated (e.g., based on retrospective data) a potential for recruiting the required number of
suitable subjects within the agreed recruitment period.
Yes
No
N/A
The investigator has sufficient time to properly conduct and complete the trial within the agreed trial period.
Yes
No
N/A
The investigator has available an adequate number of qualified staff and adequate facilities for the foreseen duration
of the trial to conduct the trial properly and safely.
Yes
No
N/A
The investigator will ensure that all persons assisting with the trial are adequately informed about the protocol, the
investigational product(s), and their trial-related duties and functions.
Yes
No
N/A
A qualified physician (or dentist, when appropriate), who is an investigator or a sub-investigator for the trial, will be
responsible for all trial-related medical (or dental) decisions.
Comment on the above:
Reviewer Printed Name:
Reviewer Signature:
Date: