This checklist assists OPRS and the IRB in their reviews of compensation in human subject research. The checklist is a guide and need not be completed or retained.

RPI Name:
Protocol #:
Project Title:
Reason for Review:
Review Type & Category:
Funding Source:
Vulnerable Population and applicable Subpart:

Determine the risk to subjects in this research. Minimal riskmeans that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.(For continuing reviews, consider any reports of new findings, new knowledge, unanticipated problems, or complaints reported by the investigator on the attached renewal form. Is additional information/verification from sources other than investigator required?)

No more than minimal risk

More than minimal risk

Determination of Review Type [if applicable]

Check Expedited Review Category to concur with IRB Staff Reviewer Checklist or change category with comment.

Expedited Review Categories: 1 2 3 4 5 6 7 8 9

Investigator Qualifications:
Is the investigator qualified to conduct the research [they have completed human subject training, coursework on research or have actual experience with this type of research]?
Yes No
Is there a conflict of interest? Yes No
Coercion:
Does the recruitment/consent process include any possible influence or coercion that unduly entices participation? Yes No
Examples: excessive compensation, unequal relationships [provider – patient, employer – employee, faculty – student]. Defer protocol for full board review if potential for coercion is substantial
Risks:
Risks to subjects are minimized; research design does not necessarily expose subjects to risk? Yes No
Risks to subjects are reasonable I relation to anticipated benefits, if any, to subjects; and the importance of the knowledge that may reasonable be expected to result? Yes No
Sensitive information:
Does the protocol breach sensitive subjects? Yes No
Examples: child abuse; violence; some infectious diseases; report of conditions that could affect insurability, compensation, economic standing, employability or litigation [civil or criminal]
Stigmatization/Loss of Service:
Does participation in the protocol put a participant at risk of loss of insurance or entitled services, social or self-stigma, screening or diagnosis of diseases with significant potential for loss of insurance or other services [e.g., carrier of an incurable genetic disease, HIV]
Yes No
Deception
Does the protocol include any elements of deception? Yes No
  • Major: mislead subjects about their health status, the researchers, or research purposes
  • Minor: incompletely disclose some purpose of the study to avoid biasing the results

Subject Selection
Is the selection of subjects equitable? Yes No Not applicable
If any group is excluded, is there adequate justification? Yes No
Consent Process:
Are the procedures adequate to obtain informed consent? Yes No
Does the protocol adequately describe the following consent processes:
  • How the person obtaining the consent will be trained? Yes No
  • The setting in which consent will be obtained [does the subject have adequate time to consider and is the environment appropriate? Yes No
  • How the subjects’ autonomy and comprehension is assessed? Yes No
  • A copy of the consent form is provided to the subject? Yes No
  • Revised confidentiality language incorporated? Yes No
If requested, is waiver of documentation, or alteration of consent process provided and justified?
Monitoring Data – for more than minimal risk studies:
When appropriate, the research plan makes for adequate provision for monitoring the data collected to ensure the safety of participants? Yes No
Confidentiality
Are the procedures adequate to maintain confidentiality, anonymity, security and privacy of the subjects? Yes No
Will the non-computer data be held in a secure manner? Yes No
Will computer data be held in a secure manner? Yes No
Is a certificate of confidentiality used? Yes No
Protocol Documents
Are all other documents to be used in the study [e.g., recruitment material, questionnaires, etc.] described? Are they all submitted? Yes No

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