Scientific Merit Review Form
Scientific Reviewer #1 Statistical Reviewer
Scientific Reviewer #2Legal Reviewer
Scientific Reviewer #3
Reviewer: Date Submitted:
BRI Study #:
Study Title:
PI:Ext:
Introduction, Specific Aims, and Background
Yes / No / N/A / Unclear/Unknown / QuestionAre the specific aims clearly specified?
Are there adequate preliminary data to justify the research?
Is there appropriate justification for this research protocol?
Comments:
Specific Issues of Concern:
Scientific Design
Yes / No / N/A / Unclear/Unknown / QuestionIs the scientific design adequate to answer the question?
Are the objectives likely to be achievable within a given time period?
Is the scientific design (i.e., randomization; placebo controls) described and adequately justified?
Comments:
Specific Issues of Concern:
Data and Statistical Analysis
Yes / No / N/A / Unclear/Unknown / QuestionIs the rationale for the proposed number of subjects reasonable?
Are the plans for data and statistical analysis defined and justified, including the use of stopping rules and endpoints?
Are there adequate provisions for monitoring data? Is a DSMB required? Or is another monitoring mechanism sufficient (i.e., investigator monitoring)?
Comments:
Specific Issues of Concern:
Research Procedures
Yes / No / N/A / Unclear/Unknown / QuestionAre the rationale and details of the research procedures accurately described and acceptable?
Is there clear differentiation between research procedures and standard of care? (May be found in the budget preparation materials.)
Are the individuals performing the procedures appropriately trained, and is the location of performing the procedure acceptable?
Are there adequate plans to inform subjects about specific results if necessary (clinically relevant results, risk of depression, suicidal, potential loss of insurance, incidental findings, etc.)?
Comments:
Specific Issues of Concern:
Protocol Layout
Yes / No / N/A / Unclear/Unknown / QuestionHave all the sections, based upon the protocol template, been addressed?
Is there a signature page. Has version control been documented and maintained?
Protocol sections are clear, concise and do not contradict other sections?
Are the consent and CRFs provided and do they match the protocol?
Comments:
Specific Issues of Concern:
Drugs, Biologics and Devices (Test Article)
Yes / No / N/A / Unclear/Unknown / QuestionIs the status of the test article described and appropriate (i.e., investigational, significant risk, new use or FDA-approved within indication)?
Has an IND or IDE been obtained where applicable?
Are the drug dosage and route of administration appropriate?
Is the test article safety and efficacy data sufficient to warrant the proposed phase of testing?
If the test article is FDA approved, is there a plan to sequester enough for the duration of the study?
Comments:
Specific Issues of Concern:
Privacy and Confidentiality
Yes / No / N/A / Unclear/Unknown / QuestionAre there adequate provisions to protect the privacy and ensure the confidentiality of the research subject?
Are there adequate plans to store and code the data?
Is the use of identifiers or links to identifiers necessary, and is the information adequately protected?
Do the CRFs and database layout (if applicable) demonstrate that no patient names or other identifiers are transmitted to the sponsor unless warranted, e.g., device registration.
Is the data stored in a secure site maintained by BRI or VMMC with password limited access.
Comments:
Specific Issues of Concern:
Eligibility Criteria for Subjects
Yes / No / N/A / Unclear/Unknown / QuestionIs the choice of subjects appropriate for the questions being asked?
Are inclusion and exclusion criteria clearly specified and appropriate?
If women, minorities, or children are excluded, is this justified?
Is the principle of distributive justice adequately incorporated into the inclusion and exclusion criteria for the research protocol? Is subject selection equitable?
Comments:
Specific Issues of Concern:
Recruitment of Subjects
Yes / No / N/A / Unclear/Unknown / QuestionAre the methods for recruiting potential subjects well defined and do they avoid potential coercion?
Are the location and timing of the recruitment process acceptable?
Is the individual performing the recruitment appropriate for the process?
Are there acceptable methods for screening subjects before recruitment and are they HIPAA compliant?
Comments:
Specific Issues of Concern:
Potential Risks, Discomforts and Benefits for Subjects
Yes / No / N/A / Unclear/Unknown / QuestionAre the risks and benefits adequately identified evaluated, and described?
Are the potential risks minimized and the likelihood of benefits maximized?
Is the risk/benefit ratio acceptable for proceeding with the research?
If children are involved, which regulatory category of risk/benefit is the protocol likely to fall within and are all the criteria within Subpart D of DHHS 45 CFR 46 and 21 CFR 50 adequately addressed?
Comments:
Specific Issues of Concern:
Compensation and Cost for Subjects
Yes / No / N/A / Unclear/Unknown / QuestionIs the amount or type of compensation or reimbursement reasonable so as to avoid potential coercion to the likely population?
Are there adequate provisions to avoid out-of-pocket expenses by the research subject, or is there sufficient justification to allow subjects to pay?
If children or adolescents are involved, who receives the compensation, and is this appropriate?
Comments:
Specific Issues of Concern:
Other Issues
Yes / No / N/A / Unclear/Unknown / QuestionAre adequate references provided?
When should the next scientific review occur? If frequent reviews are necessary, how should the interval be determined?
Comments:
Specific Issues of Concern:
Other comments:
Reviewer Name:
Reviewer Signature:Date:
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