This Is the Template

IRB NON-LOCAL CONSULTANT REVIEWER CHECKLIST

(INITIAL FULL BOARD STUDY)
Note: The intent of this evaluation form is to assist reviewers during their review ofNEW studies for initial FULL Board studies. The use of non-voting consultant(s) is required for the initial and continuing review of CCOP studies in which non-local CCOP affiliates participate.
TITLE OF RESEARCH PROPOSAL (PROTOCOL TITLE):
IRB Number: / Principal Investigator Name:

REVIEW 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 / 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 inclusion and exclusion criteria clearly stated and reasonable?
Yes No N/A / Is the principle of distributive justice adequately incorporated into the inclusion and exclusion criteria for the research protocol? Is subject selection equitable?
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 risks and benefits adequately identified, evaluated and described?
Yes No N/A / Is the consent process well defined?
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 risks to participants (e.g. physical, psychological, social and economic)justified by anticipated benefits to participants or society?
Yes No N/A / Are the risks to participants minimized insofar as possible?
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 / 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 privacy and confidentiality procedures adequate?
Yes No N/A / Is the use of identifiers or links to identifiers necessary and is it protected sufficiently?
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 / Is the researcher’s monitoring plan adequate? (“Monitoring” means collection and analysis of data as project progresses, to assure appropriateness of research, its design, and subject protections).
Yes No N/A / Are incentives for participation appropriate and not overly coercive?
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 / Are additional protections included for "special classes” of subjects (e.g. children, pregnant women, persons with physical/mental illness, economically disadvantaged, etc.)?
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?
If you have any issues with the above, explain your concerns:

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:

Yes No N/A / Does consent form(s) include all required elements per CFR 46.116? Consent Form Instructions and Checklist
Yes No N/A / Consent form(s) written in BRI Model Consent and HIPPA Template 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:

This Is the Template

IRB NON-LOCAL CONSULTANT REVIEWER CHECKLIST

Reviewer Name (print)Date

Institutional Affiliation (outside VMMC/BRI)