GREENVILLE HOSPITAL SYSTEM
SCIENTIFIC REVIEW OF RESEARCH PROTOCOLS INVOLVING HUMAN SUBJECTS
All protocols must undergo scientific review by a departmental research group or other designated authority prior to submission to the IRB. The review must involve individuals qualified to evaluate the scientific merit of the study being proposed. If the departmental research review group does not include individuals who are capable of evaluating the scientific merit of a particular proposal, it is the responsibility of the Medical Director of the Office of Research and Compliance Administration to have the protocol reviewed by an appropriate authority notinvolved in the study in question.
Principal Investigator: ______
Department or Medical Practice:______
Protocol Title: ______
______
______
1.Hypothesis is clearly stated. Yes No
- The scientific questions addressed in this protocol have
adequate merit to justify experimentation involving
human subjects. Yes No
- The study design is adequate to answer
the questions being asked. Yes No
- The potential risks of this study have been
accurately and fully described. Yes No
5.The study design minimizes risk to subjects. Yes No
- The investigators have adequate experience
to conduct the study. Yes No
Risk Assessment – choose one:
1. The study involves no more than minimal risk to participants.
2. The study involves more than minimal risk to participants.
The risk(s) represents a minor increase over minimal risk, or
The risk(s) represents more than a minor increase over minimal risk.
Benefits Assessment – choose one:
1. The study involves no prospect of direct benefit to individual participants, but
is likely to yield generalizable knowledge about the subject’s disorder or condition.
2. The study involves the prospect of direct benefit to individual participants.
Approved for submission to IRB
Return to Principal Investigator for changes
______
Signature of Departmental Research Group Chair Date
Version 3 November 20, 2009