EVALUATION WORKSHEET
Date: / /
IRB REVIEWER:
Committee Chair / Committee Member / Other: Please Describe:
NAME OF STUDY:
SUBMITTING INSTITUTION/AGENCY/DEPARTMENT:
Your recommendation to the IRB:
APPROVAL / PENDING APPROVAL (DA) / DENY (D)
OTHER:
NOTE TO EVALUATORS:
When commenting on specific aspects of the proposal please include page / paragraph references.
Legend: A=Approved P=Pending Approval D=Deny
Proposal Evaluation Criteria / A / P / D1. Appropriate research methods
2. Research instruments
Comments about proposal:
Risks/Benefits Evaluation Criteria / A / P / D
3. Evaluation of risks to benefits
4. Favorable risk-benefit ratio
5. Provisions for adverse events
6. If deception is a component to the research protocol, has the investigator exhausted all other alternatives, and to the extent possible, disclosed the deception?
POTENTIAL RISKS / POTENTIAL BENEFITS
None / None
Minimal / None to subjects but likely for others
More than minimal / Minimal for anyone
Serious but acceptable / High
Unacceptably high / Extremely high
Unclear / Unclear
Comments about risks/benefits:
Location/Participants Evaluation Criteria / A / P / D
7. Participant population
8. Compensation
Comments about location/participants:
Safety/Security Evaluation Criteria / A / P / D
9. Protected populations issues addressed
10. Participant confidentiality
11. Access to records
12. Data storage (location, protection, length of time, etc.)
Comments about safety/security:
Evaluation Criteria / A / P / D
13. Informed consent process
Comments about the consent process:
Evaluation Criteria (informed consent) / A / P / D
14. Type of consent form(s)
15. Supporting materials
16. Language-appropriate
Comments about the consent form (see checklist on next page):
/ INVESTIGATIONAL REVIEW BOARD
INFORMED CONSENT CHECKLIST
Please indicate if an item is found in the informed consent form.
Informed consent forms include: / YES / NOProject name and dates
Name of institution(s) (i.e. Prescott College)
Researcher(s) name(s)
Contact information
Statement that information provided to participant is complete and accurate, with signature/date line
Statement of participant’s consent to participate, w. signature/date lines
Description of the study, including that it is research
Purpose of the study
Disclosure of researcher interest in study
Expected duration of participant’s participation
Procedures, including any that are experimental
Potential risks (or statement that no risks are anticipated)
Potential benefits (to participant and/or to others)
If there are minimal health risks involved, detailed information is provided regarding free resources for ongoing services/support
Compensation (or statement that none will be given)
Criteria for receiving compensation
Clear description provided regarding protection of participant privacy and confidentiality
Statement that participation is voluntary w. no penalty
Statement that participant may withdraw without penalty
And, as applicable to the study, descriptions of / YES / NO
Compensation or treatment for injury resulting from study
Circumstances for terminating a participant’s participation
Consequences of decision to withdraw from study
Procedures for withdrawing from study
Summary of findings provided to participant
Signature / Date
02/17/11 www.shieldsforfamilies.org Page 1