SAINT MARY'S COLLEGE INSTITUTIONAL REVIEW BOARD Protocol Review Checklist

WHEN THE IRB MEMBERS REVIEW A PROPOSAL, THEY CONSIDER IT IN LIGHT OF THE QUESTIONS LISTED BELOW:

1.    Does the project description adequately describe:
 
       Yes        No           N/A         a.  the purpose of the study
       Yes        No           N/A         b.  explanation of benefits of study
       Yes        No           N/A         c.  approximate number of subjects
       Yes        No           N/A         d.  duration of subject participation
       Yes        No           N/A         e.  subject selection (why these particular subjects are selected)
       Yes        No           N/A         f.   methodology
       Yes        No           N/A         g.  potential risks with anticipated likelihood and severity
       Yes        No           N/A         h.  measures to minimize risk
       Yes        No           N/A         i.   measures to maintain confidentiality
 

2.   Assessment of Risk:

      Physical:          High        Moderate        Low
      Psychosocial:   High       Moderate        Low
      Legal:               High       Moderate        Low

     Subjects are:        Minors        Disabled (physically/mentally)         Other

 
3.     Does the consent form include:

        Yes        No         N/A         a.  explanation of the purpose of the study
        Yes        No         N/A         b.  expected length of time
        Yes        No         N/A         c.  description of confidentiality of records including identification of individuals who will have access to records
        Yes        No         N/A         d.  reason for subject's selection
        Yes        No         N/A         e.  description of procedures
        Yes        No         N/A         f.   identification of any experimental procedure
        Yes        No         N/A         g.  description of foreseeable risk/discomforts
        Yes        No         N/A         h.  description of expected benefits to subject/others
        Yes        No         N/A         i.   anticipated circumstances under which subject's participation may be terminated
        Yes        No         N/A         j.   statement that participation is voluntary; refusal results in no penalty
        Yes        No         N/A         k.  offer to answer any questions
        Yes        No         N/A         l.   identification of contact person/phone number for questions about study
        Yes        No         N/A         m. statement that copy of consent will be given

 
ADDITIONAL INFO NEEDED:
   

4.  RECOMMENDED ACTION:

            APPROVE         APPROVE, WITH CONDITIONS        DO NOT APPROVE
 

Last updated: August, 2006

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This site was authored by Dr. Catherine Pittman and Zhou Zhu as the product of a faculty / student special project.

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