This Is the Template

IRB PRIMARY REVIEWER EVALUATION CHECKLIST

(INITIALFULL BOARD STUDY)
Note: The intent of this evaluation form is to assist the reviewer during their review ofNEW studies for initial FULL Board studies. This form is for personal reference only and does not need to be turned into BRI IRB unless used by affiliated sites for CIRB reviewed studies.
IRB Number: / Principal Investigator Name:

PRIMARY REVIEW CONSIDERATIONS:

Yes No N/A / RISK MINIMIZATION:Are risks minimized in way that is understandable to a reasonable person?
Yes No N/A / RISK/BENEFIT COMPARISON:Are the risks and benefits fully explained and consistent across all documents (e.g. Application, Consent form, Protocol, etc.)?
Yes No N/A / EQUITABLE SUBJECT SELECTION:Is clear rationale provided for the exclusion of any otherwise eligible groups?
Yes No N/A / INFORMED CONSENT:Does the consent form clearly communicate all necessary aspects of the study to the participant?
Yes No N/A / DATA MONITORING TO ENSURE SAFETY:Will the study be monitored by a Data Safety Monitoring Board? If not, is there an alternate plan in place to monitor the study? (“Monitoring” means collection and analysis of data as project progresses, to assure appropriateness of research, its design, and subject protections)
Yes No N/A / PRIVACY PROTECTION AND CONFIDENTIALITY: Have precautions been taken to ensure protection of sensitive data?
Yes No N/A / PROTECTION OF VULNERABLE SUBJECTS:Are appropriate measures in place to protect vulnerable populations?

Note: See below for additional specifics on the items listed above.

Informed consent:

Yes No N/A / Is the consent process well defined?
Yes No N/A / Is there a clear differentiation between research procedures and standard care and evaluation?
Yes No N/A / Are there adequate plans to inform subjects about specific research results that might affect the subject’s health and/or decision to continue participation?
Yes No N/A / Are the risks and benefits adequately identified, evaluated and described?
Yes No N/A / Does the process provide sufficient time, privacy, and an adequate setting for the subject to consider participation?
Yes No N/A / Does the process minimize the possibility of coercion or undue influence?
Yes No N/A / Are the individuals obtaining consent appropriate to do so?
Yes No N/A / Are incentives for participation appropriate and not overly coercive?
Yes No N/A / Does consent form(s) include all required elements per CFR 46.116? ICF_checklist
Yes No N/A / Consent form(s) written in BRI_IRB_Model_Consent_Form format (e.g. headings, standard statements, etc.)?
Yes No N/A / Does consent form(s) include all risk information from sponsor's sample ICF (if existing)?
Yes No N/A / Does consent(s) include pertinent risk info from protocol (and investigator'sbrochure, if applicable)?
Yes No N/A / Does consent(s) indicate risks/side effects which may be irreversible, long-term or life-threatening?
Yes No / Is consent free of “cut and paste” errors (e.g. study title, drug name[s], risk info, etc.)?
If you have any issues with the above, explain your concerns:

Privacy Protection and Confidentiality:

Yes No N/A / Is the use of identifiers or links to identifiers necessary and is it protected sufficiently?

Protection of Vulnerable Populations:

Yes No N/A / Are recruitment procedures designed to assure informed consent is freely given, especially to persons likely to be vulnerable to coercion or undue influence?
Yes No N/A / Does the investigator specify in the protocol and consent form whether research data and information (including informed consent) will be placed in the medical records?
Yes No N/A / Are additional protections included for "special classes” of subjects (e.g. children, pregnant women, persons with physical/mental illness, economically disadvantaged, etc.)?

Additional considerations:

Yes No N/A / Are the studies aims/objectives clearly specified?
Yes No N/A / Are there adequate preliminary data to justify the research?
Yes No N/A / Are adequate references provided?
Yes No N/A / Is there appropriate justification for this research protocol?
Yes No N/A / Is the status of the drug or device described and appropriate in the protocol/consent (investigational, new use of an FDA approved drug, or an FDA approved drug with approved indications)?
Yes No N/A / Are the drug dose and route of administration appropriate?
Yes No N/A / Are the drug or device safety and efficacy data sufficient to warrant proposed phase of testing?
Yes No N/A / Are the rationale and details of the research procedures accurately described and acceptable?
Yes No N/A / Are the inclusion and exclusion criteria clearly stated and reasonable?
Yes No N/A / Is the rationale for the proposed number of subjects reasonable? Were formal sample size calculations performed and are they available for review?
Yes No N/A / Are the location and timing of the recruitment process acceptable?
Yes No N/A / Is the individual performing the recruitment appropriate for the process?
Yes No N/A / Are all recruitment materials submitted and appropriate?
Yes No N/A / Are there acceptable methods for screening subjects before recruitment (mailings, record reviews)?
Yes No N/A / Are there adequate provisions to avoid out of pocket expenses and costs to subject if insurance denies payment? If not, is there sufficient justification to allow subjects to pay for these expenses?
Yes No N/A / Is the scientific design adequate to answer the question(s)?
Yes No N/A / Is the scientific design ( e.g. randomization; placebo controls; Phase I, II or III)described and adequately justified?
Yes No / Scientific Design: Are the study objectives likely to be achievable within a given time period?
Yes No N/A / Should the Continuing Review for this study be an annual review? If no, how often?
Yes No N/A / Are there any notable conflicts of interest?

INVESTIGATOR INITIATED STUDIES ONLY:

Risk Level (to subjects) Rating: This Rating will guide the BRI Compliance and Education Department in determining the order in which studies should be audited. Consider: [a]study phase, [b]study complexity, [c]risk of the test article, [d]investigator compliance history, [e]other (e.g. conflict of interest)explain:
The risk level will be assigned based on a scale of “1-5” (1 is minimal risk and 5 is great risk).
1 2 3 4 5

DEVICE STUDIES ONLY:

Yes No N/A / Does the study adequately address the potential for serious risk?
Yes No N/A / Does the protocol describe the nature of the harm that may result from the test article?
Yes No N/A / Do you agree with the Sponsor’s determination of significant risk (SR) or non-significant risk?
Yes No N/A / Did the submission include a copy of the Investigational Device Exemption (IDE) application approval letter (and modifications letter) from the FDA stating the “study may start”?
Yes No N/A / Does the protocol describe acceptable accountability, storage, access, and control of the devices?
If you have any issues with the above, explain your concerns:

IND STUDIES ONLY:

Yes No N/A / Has the PI considered the question of whether an IND is needed?
Yes No N/A / Has PI made determination whether an IND is needed and the basis of his/her decision?
Yes No N/A / Has the PI documented his/her decision about the need for an IND and the rationale?
Yes No N/A / Did Investigator inform the IRB of the outcome of decision?
If you have any issues with the above, explain your concerns:

CONSENT FORM CONSIDERATIONS:

ADDITIONAL COMMENTS:

Reviewer Name (print)Date

Institutional Affiliation (if outside VMMC/BRI)

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Version rev. 08/10/12