Spectrum Health Research and Human Rights Committee Standard Operating Policies
403-D
Reviewer Checklist – Criteria For Approval
Spectrum Health IRB #
Criteria for Approval Review Due Date:
Full Study Title
Principal Investigator:
Coordinator:
Instructions: Check the applicable boxes below and complete the text boxes, as necessary.
Do you have a potential conflict of interest with this research? (Refer to www.spectrumhealth.org/research/COI for further information)
Yes
No
If yes, please notify the IRB Chair at irb@spectrum-health.org in writing immediately.
1. Risk to Participants are Minimized
Criteria Met
Criteria Not Met
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Risks to participants are minimized by using procedures that are consistent
with sound research design and that do not unnecessarily expose
participants to risk.
Research uses procedures consistent with sound research design
The research design is sound enough to yield the expected knowledge
Avoids unnecessary exposure to risks
In making this determination, the IRB has considered physical, psychological, social, economic and legal risks
Notes/Comments:
Criteria Met
Criteria Not Met

Risks to participants are minimized, when appropriate, by using procedures
already being performed on the participants for diagnostic or treatment
purposes.
Use of standard of care procedures when possible
Notes/Comments:
2. Risks are Reasonable in Relation to the Anticipated Benefits [Ref 6.]
Criteria Met
Criteria Not Met
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Risks to participants are reasonable in relationship to the potential benefits,
if any, to participants, and the importance of the knowledge that may be
expected to result.
Risks are reasonable compared to benefits and are justified by importance of information to be gained from the study
All known risks are identified
Any direct benefits are identified
Notes/Comments:
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Reviewer Checklist – Criteria For Approval
3. Participant Population – Equitable Selection [Ref 7. (a) – (f)]
Criteria Met
Criteria Not Met
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Participant selection is equitable.
Inclusion of any vulnerable population is justified
Appropriate additional protections are in place for any vulnerable populations
No group inappropriately targeted or excluded
Target number of participants sufficient
Inclusion/Exclusion criteria appropriate
Setting where study will be conducted is appropriate
Regulatory criteria have been met when vulnerable populations are involved
All known risks are identified
Notes/Comments:
4. Informed Consent Process [Ref 12.]
Select Box 1 or 2 below and confirm whether criteria have been met:
Criteria Met
Criteria Not Met
N/A
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Box 1: Informed consent will be obtained from the participant or the
participant’s legally authorized representative.
The circumstances of consent provide the prospective participant or the representative sufficient opportunity to consider whether or not
to participate and minimize the possibility of coercion or undue influence.
The information that will be given to the participant or the representative will be in language understandable to the participant or
representative.
No information will be provided to the participant or the representative that waives or appears to waive any of the participant’s legal
rights, or releases or appears to release the investigator, the institution or its agents from liability for negligence.
All required and appropriate additional disclosures will be provided to the participant or the participant’s representative.
Notes/Comments:
Criteria Met
Criteria Not Met
N/A
Box 2: The consent procedure will be waived or altered.
Check to confirm the research is not FDA-regulated.
 Protocol specific findings justifying the determination that the research involves no more than
minimal risk:
 Protocol specific findings justifying the determination that the research could not be practicably
carried out without the waiver because:
 Protocol specific findings justifying the determination that the waiver will not adversely affect the
rights and welfare of participants:
 Protocol specific findings regarding whether it is appropriate to provide participants with additional
pertinent information after participation:
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Reviewer Checklist – Criteria For Approval
5. Informed Consent Documentation [Ref 12.]
Criteria Met
Criteria Not Met
N/A
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Informed consent will be documented using the consent document.
The consent form includes the required elements and appropriate additional disclosures (see Informed Consent Reviewer Checklist)
The participant or the representative will sign and date the consent form.
A copy of the consent form will be given to the person signing the consent.
The investigator will give either the participant or the representative adequate opportunity to read the consent document before it is
signed.
Notes/Comments:
Assent (indicate here if no children
involved in the conduct of the research)
Assent will be obtained from all children aged 7-17
Assent not applicable (children under 7)
Assent document written in age appropriate language
Requesting for Waiver of Assent [Ref Supplemental Application Appendix G. Request for Waiver]
Notes/Comments:
6. Data Monitoring Plan [Ref 11. (a) – (c)] (not required for low risk studies)
Criteria Met
Criteria Not Met
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Not Required
When appropriate, the research plan makes adequate provision for
monitoring the data collected to ensure the safety of participants.
Plan provides adequate capturing and reporting adverse events
Plan provides adequate data and safety monitoring (including what is reviewed, who will be responsible, stopping rules, etc)
Plan provides adequate procedure to facilitate accuracy, validity, and integrity of data collection and entry
Plan provides adequate monitoring to ensure safety of participants.
Notes/Comments:
Refer to questions 1, 4 and 6 on the scientific review and question 7 on the stats review to determine if the study should include an
independent data and safety monitoring board.
7. Privacy and Confidentiality [Ref 13.(a) – (d)]
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Criteria Met
Criteria Not Met
If appropriate, there are adequate provisions to protect the privacy of
participants.
Criteria Met
Criteria Not Met
If appropriate, there are adequate provisions to maintain the confidentiality
of the data.
Privacy protections adequate
Plan to protect confidentiality of data adequate
Plan addresses security of data transmission and storage
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Reviewer Checklist – Criteria For Approval
Notes/Comments:
8. Participant Population – Vulnerable Participants [Ref 7.(f)]
Criteria Met
Criteria Not Met
N/A
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Additional Safeguards are included for vulnerable populations.
Additional safeguards if participants likely to be vulnerable to coercion or undue influence
In making this determination, the IRB has considered the research purpose, the research setting, whether participants may be
vulnerable to coercion or undue influence, the selection criteria, recruitment and enrollment procedures and payment.
9. Children’s Findings [Ref Supplemental Application Appendix D.]
No Children
Minimal risk research
Greater than minimal risk research with benefit
Greater than minimal risk research with no prospect of direct benefit but likely to yield
generalizable knowledge about the subject’s disorder or condition
Research not otherwise approvable which presents a reasonable opportunity to further the
understanding, prevention, or alleviation of a serious problem affecting the health or welfare of
children
Justify:
10. Multi-Site Study 5 (b) – (e)
Is this a multi-site study in which the investigator is the lead site?
Yes
No, proceed to question 11.
 PI oversight plans should describe how the investigator will ensure adherence to the study protocol, obtain informed
consent, secure and maintain the protocol, monitor adverse events or other unanticipated problems, interim results,
protocol modifications, and ensure general coordination of study conduct at the other sites.
If yes, is the investigator’s management plan adequate?
Yes
No, explain:
11. Payment Review ref 7 (e) and informed consent
Will payment to subjects be provided?
Yes, answer the following questions
No, proceed to question 12.
Is the amount of payment (and the proposed method and timing of disbursement) reasonable?
 Consider whether payment may be coercive or present undue influence to the potential participant.
 Ensure that payment credit will accrue as the study progresses and will not be contingent upon the participants
completing the entire study.
Yes, reasonable
No, explain:
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Spectrum Health Research and Human Rights Committee Standard Operating Policies
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Reviewer Checklist – Criteria For Approval
Will there be any amount paid as a bonus for completion?
Yes, answer the following question
No, proceed to question 12.
If yes, is the bonus reasonable and not so large as to unduly induce participants to stay in the study
when they would otherwise have withdrawn?
Yes, reasonable
No, explain:
12. Approval Recommendation
Motion or recommendation to approve:
Yes
No
The IRB shall consider the following factors in determining the criteria for studies requiring more frequent review:
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Nature, probability and magnitude of anticipated risks to subjects;
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Likely medical or psychological condition of the proposed subjects;
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Overall qualifications of the PI and other members of the research team;
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Specific experience of the PI and other members of the research team in conducting similar research;
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Nature and frequency of adverse events observed in similar research at this and other facilities;
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Vulnerability of the population being studied (this should be understood to include unfamiliarity with the language used
on consent forms and other printed matter intended for subjects in the study);
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Other factors the IRB deems relevant.
Recommended approval/renewal period:
Annual
For a period of
or for
subjects or other
Additional Comments/Notes/Points for Discussion:
/
Signature
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/
Date
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