Radford University Institutional Review Board

RadfordUniversity Institutional Review Board

Project Title:
Principal Investigator:
Name of Reviewer: / Date:

Signature of Reviewer:

Investigator/ SiteYesNoN/A

Does the investigator’s expertise appear to be sufficient to conduct this research?
Has the investigator delegated their duties appropriately to trained individuals?

ProtocolYesNoN/A

Introduction and background information clear?
Objectives clearly stated?
Purpose of the study clear and acceptable?
Study design consistent with research procedures?
Name/address/qualifications for each investigator and/or student?
Summary of data analysis and statistical methods to be used?
Observations and measurements to be made during the study?

Subject Privacy and Confidentiality of the DataYesNoN/A

Does the investigator adequately explain how they will access information from or about the subjects?
Does the investigator adequately explain their agreement with the subject about how the participant’s identifiable private information will be handled, managed and disseminated?
Are there adequate provisions to protect the privacy interests of participants?
Are there adequate provisions to protect the confidentiality of identifiable data?
Is the researcher applying for a Certificate of Confidentiality?
If NO, should they?

Informed ConsentYesNoN/A

Is the PI obtaining an informed consent?
Are any other study personnel obtaining informed consent?

Has the PI satisfactorily trained persons who will be obtaining consent?

Will informed consent be sought from each prospective participant or the participant’s LAR?
Has the PI adequately explained when and where the informed consent will be obtained and is it appropriate?
Will the circumstances of the consent process provide sufficient opportunity to consider whether to participate?
Will the circumstance of the consent process minimize the possibility of coercion or undue influence?
Does the informed consent have all the required elements (see IC Checklist)
Will the research team communicate in the language understandable to the participant or LAR?

Risks and BenefitsYesNoN/A

Does the study pose greater than minimal risk?
Do the benefits of the research outweigh the risks?
Are the risks clear in terms of physical, social, economic, legal or psychological terms?
Are the risks minimized by using procedures consistent with sound research, which do not unnecessarily expose participants to risk?
Are risks minimized by using procedures already being performed on the participants for diagnostic treatment purposes, when appropriate?
Is the research design likely to generate the knowledge expected?
Is the importance of this potential knowledge clear?
Are risks reasonable in relationship to the anticipated benefits, if any, and the importance of the knowledge that might be reasonably expected?

Role of Subject and Research ProceduresYesNoN/A

Are the number of subjects and duration stated and appropriate?
Selection of subjects reflects purposes of the research?
Study population listed?
If a subject population is excluded, is it justified?
Is the selection of subjects equitable?
Are children subjects?

If yes, is there an assent

Is the study population considered to be a vulnerable population?

Is the use of a vulnerable population justified?

Are any additional safeguards added to protect the subjects?

Recruitment and CompensationYesNoN/A

Is there compensation paid to subjects?
Compensation appropriate and non-coercive?
Is a prorated plan proposed?

If no, is there justification?

AdvertisementYesNoN/A

Does the advertisement clearly state that the project is research/
Is the name and address/phone number of the investigator and institution listed?
Is the time or other commitment required listed (# visits, total duration, etc)?
Compensation appropriate and non-coercive?
Is a brief list of procedures involved included?
Inclusion/ exclusion criteria, in summary form, included?
Is the condition under study and/or purpose of the research included?
Location of the research and contact person for information included?

Additional Comments/ Notes:

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Revision Date: 1/19/2019