IRB Reviewer Worksheet for a Full IRB Review
Project Name______
Protocol number ______
Reviewer’s Name ______
Date ______
Level of review requested by PI______
Yes / No / NA / Comment1. Is the full review application submission checklist completed and attached?
2. Is the cover sheet completed with title and names of investigators?
- 3. Is demographic data (addresses, phone number, email, etc.) of PI and
4. Is the Level of Review Determination form filled out completely and accurately?
REVIEWER ANALYSIS: Does the IRB protocol meet the guidelines for FULL review?
FUNDING & RESOURCES
/ Yes / No / NA / Comment1. Is there an itemization of projected expenses and do they appear to be reasonable?
2. Have sources of funding been identified clearly?
- Has the location of research been
4. Are appropriate letters of agreement attached granting permission for use of space and other needed resources?
COORDINATION WITH OTHER IRBs / Yes / No / NA / Comment
1. Will subjects from other institutions be involved? Are letters of agreement from these institutions attached as appendices (if appropriate)?
2. Has this study been submitted to other IRB(s) for review? If so, are copies of these IRB forms and approval letters submitted as attached appendices?
SUBJECTS / Yes / No / NA / Comment
1. Are the numbers of subjects and controls (if applicable) identified?
2. Are subject inclusion and exclusion criteria clearly identified?
3. Are subject screening procedures clearly identified?
4. Have all screening forms been provided as appendices?
5. Has the PI clearly explained how the screening procedures will be used to identify persons who are eligible an ineligible for participation in the study?
REVIEWER ANALYSIS: Does all screening data collected appear to have a reasonable purpose?
REVIEWER ANALYSIS: Will the proposed screening procedures enable the investigators to reasonably assure that subjects are appropriate for the study? (Do the screening procedures enhance subject safety?)
6. Are recruitment procedures described?
7. Have any recruitment flyers, telephone scripts, email solicitations, or any other forms of recruitment been provided in the appendices?
8. Are subjects being recruited from outside Belmont University or during Belmont University classes or events? If so, are appropriate letters of agreement provided as an appendix?
9. If subjects are being paid does the PI clearly explain compensation amount and procedures?
STUDY DURATION / Yes / No / NA / Comment
- 1. Is the duration of the study clearly described?
2. Is the time commitment for each subject identified?
DESCRIPTION OF THE RESEARCH PLAN
Are each of the following clearly described? / Yes / No / NA / Comment
1. Brief literature review and justification for the study
2. Clear statement of purpose
3. Research design
4. Identification of variables and hypothesis (if applicable)
5. Methods
6. Instrumentation and testing tools
7. Anticipated data analysis and statistics
REVIEWER ANALYSIS: Is there a clearly stated purpose for all data collected?
REVIEWER ANALYSIS Are the details of the procedure consistent with the details of the procedure in the consent form?
REVIEWER ANALYSIS: Do the proposed methods enable the investigators to answer the research question(s) posed? (Does the study make sense?)
RISKS AND PRECAUTIONS / Yes / No / NA / Comment
1. Are potential risks and discomforts clearly described? (There are risks associated with any study so “none” is unacceptable response.)
2. Are methods intended to minimize risk clearly described?
3. Have any potential benefits to subjects been clearly described?
4. Are the risks associated with the research distinguished from the risks of not participating?
5. If appropriate, has any withholding of normal treatment and treatment alternatives been described?
6. Has the PI identified a risk: benefit analysis for the subjects?
7. Has the PI explained the conditions under which individual subjects’ participation in the study would be discontinued?
8. Has the PI described the conditions under which the entire study would be discontinued due to hazards to subjects
9. Does the study involve deception? If yes, has the method and timelines for debriefing subjects described?
10. If the study involves deception, have appropriate debriefing scripts been provided as an appendix?
REVIEWER ANALYSIS: Are the risks minimized to the extent possible?
REVIEWER ANALYSIS: Are the risks reasonable in relation to the benefits to the subjects?
REVIEWER ANALYSIS: Are the risks reasonable in relation to the importance of the knowledge to be gained?
PLAN FOR REPORTING SERIOUS OR UNEXPECTED Events / Yes / No / NA / COMMENT
1. Has the PI explained emergency procedures for the study?
2. Is there a plan for handling and reporting adverse events?
REVIEWER ANALYSIS: Are the methods proposed for handing emergencies and adverse events appropriate and adequate?
CONFIDENTIALITY AND DATA MANAGEMENT / Yes / NO / NA / COMMENT
1. Have measures to protect subject confidentiality been described?
2. Are safeguards taken to protect subject confidentiality during data collection?
3. Does this study involve any recording of identifying information? If yes, is an appropriate coding system described?
4. Is the coding scheme kept in a separate locked location?
5. Is a plan for securing date in a secure location clearly described? (i.e. locked files, password protected computer files) Is the location of storage identified?
6. Are any face sheets or other documentation containing identifiers removed from the data, coded, and stored separately in a secure location?
- Is there limited access to data?
8. Is the length of time for data storage (at least three year) as well as method of data destruction clearly described?
9. Does this study involve audio or video recordings or any other type of recordings by which subjects might be identified? If yes, is a plan for the destruction of these recordings been provided?
10. If this study involves collecting health information, have all HIPAA requirements been met?
REVIEWER ANALYSIS: Are safeguards to preserve subject confidentiality appropriate and adequate?
INFORMED CONSENT / Yes / No / NA / Comment
1. Does the PI clearly and fully explain how and when informed consent will be obtained?
2. If appropriate, does the PI explain measures for obtaining informed consent on multiple occasions (i.e. longitudinal studies)?
3. Has the PI explained procedures to verify that subjects understand the consent?
4. Has a waiver of consent been requested? If yes, has the PI adequate and appropriate justification for this request?
5. If a waiver of consent been requested, does the investigator explain how consent will be obtained?
6. Are all appropriate consent forms included in the appendices?
REVIEWER ANALYSIS: If the PI has requested a waiver of consent is this a reasonable request, and is the plan to assure subjects’ understanding of the research appropriate and adequate?
REVIEWER ANALYSIS: Is the proposed plan for obtaining informed consent appropriate
VERIFICATION (SIGNATURES) / Yes / No / NA / Comment
Have all investigators signed the form?
Has the faculty advisor signed the form (for student projects only)?
STUDIES INVOLVING MORE THAN MINIMAL RISK / Yes / No / NA / Comment
1. Are subjects informed of availability of medical treatment and compensation in case of research-related injury? (check consent form)
2. Is it clear who will pay for treatment?
3. Is other compensation available?
4. Is there a contact person for research-related injury and questions after hours?
5. Is the volunteer registry data base requirements section included in the consent form?
STUDIES INVOLVING MORE THAN MINIMAL RISK AND/OR VULNERABLE POPULATIONS
REVIEWER ANALYSIS: Will the study yield useful information?1. Is the project frequently monitored?
2. Are there trained personnel to respond to emergencies?
3. Is the data coded to protect confidentiality?
4. Is there a specialized data and safety monitoring committee assigned to review the incoming data at stated intervals?
5. Is there a date for reevaluating the project?
CONSENT FORM
/ Yes / NO / NA / Comment1. Is the consent form written in second –person language?
- Is the consent form written in lay language at the fifth grade level throughout?
- Is all medical and technical jargon defined in lay terms?
- Is suggested standard wording used whenever appropriate?
- When indicated are multiple consent forms used (i.e. one for parent and one for youth in certain pediatric studies)?
REVIEWER ANALYSIS: Are the details of the consent form consistent with the IRB application form throughout?
INVITATION / Yes / NO / NA /
Comment
1. Does the invitation tell who is conducting the study, the affiliations of the investigators, and where the study is being conducted?2. Does the invitation state that participation is voluntary?
3. Does the invitation suggest the subject read the entire consent and ask questions?
PURPOSE
/ Yes / NO / NA /Comment
1. Is the purpose of the study clearly defined in lay terms?DURATION AND LOCATION
/ Yes / NO / NA /Comment
1. Is the projected time commitment for the subject clearly defined?2. Is the location of the study identified?
PROCEDURES
/ Yes / NO / NA /Comment
1. Are the procedures explained clearly and sequentially in lay language?2. Are screening procedures explained?
3. Are inclusion and exclusion criteria explained in lay language?
4. Is any distinction between experimental and standard clinical treatment procedures explained (if applicable)?
5. Is subject assignment to groups and randomization (if applicable) explained?
6. Are the number, frequency and duration of visits explained?
7. Are subjects instructed about what they should wear and/or bring to the testing sessions (if applicable)?
8. Are the procedures clearly explained step by step in lay language?
R REVIEWER ANALYSIS Are the procedures described in the informed consent consistent with procedures described in the IRB application form?
POTENTIAL RISKS & DISCOMFORTS / Yes / No / NA / Comment1. Are the risks and discomforts described for each procedure?
2. Are emotional, psychological and risks associated with loss of confidentiality considered?
3. Are procedures to minimize each risk clearly described?
ANTICIPATED BENEFITS TO SUBJECTS / Yes / No / NA / Comment
1. Are benefits to subjects described? (If there is no direct benefit to subjects then PI must say so.)
2. Are anticipated benefits to the field of study described?
ALTERNATIVES TO PARTICIPATION / Yes / No / NA / Comment
1. Are other alternatives (therapeutic, diagnostic, or preventative) to participation described? Often an alternative is to not participate in the study
PAYMENT FOR PARTICIPATION
(Omit this section if it does not apply to the study) / Yes / No / NA / Comment1. Is the amount of payment described?
2. Describe when and how payment is to be received.
3. Explain how pay will be prorated if the subject does not complete the study
4. Explain how subjects will be reimbursed for expenses
FINANCIAL COSTS TO SUBJECT
(Omit this section if it does not apply to the study)
1. Explain if the subject is responsible to pay for tests, procedures etc.
2. Explain the circumstances under which the insurance company may be billed
POSSIBLE COMMERCIAL PRODUCTS
(Omit this section if it does not apply to the study) / Yes / No / NA / Comment
1. If human materials will be stored and may have future commercial value, the subject must be informed and asked to sign a separate sample donation form
2. Is a Specimens Release Form provided in the appendices?
MEDICAL CARE FOR RESEARCH RELATED INJURY / Yes / No / NA /
COMMENT
1. Are procedures for medical emergencies described? (If appropriate for the study)2. Are procedures for payment (or lack there of) for medical care related to research-related injuries described clearly? (The use of the standard wording provided in the consent form directions is strongly encouraged.)
CONFIDENTIALITY / Yes / No / NA / COMMENT
1. Are procedures to maintain confidentiality during data collection (if applicable) described?
2. Is there a system described to maintain confidentiality of data? Are codes substituted for identifiers? Are any face sheets or other documentation containing identifiers removed from the data, coded, and stored separately?
3. Is the coding system kept in a separate locked location?
4. Is there a description of where the data will be stored and how it will be protected from unauthorized access
5. Is there a description of how and when data will eventually be destroyed?
6. Are videotapes and audiotapes destroyed after data analysis? (if applicable)
7. Are safeguards taken to protect subject confidentiality during subsequent presentations and publications?
8. Note: When research records are subject to FDA, a funding agency, or an industrial sponsor standard wording must be used (see example)
9. Note: If student records are used, there should also be a statement about following FERPA guidelines
PARTICIPATION AND WITHDRAWAL
/ Yes / No / NA / COMMENT1. Is the standard text used that outlines the right to not participate and to withdraw from the study?
CONSEQUENCES OF WITHDRAWAL
(Omit this section if it does not apply to the study) / Yes / No / NA / COMMENT- Explain the consequences (usually these are potential medical consequences that may occur as a result of a subject choosing to stop a given medical intervention) of subjects decision to withdraw.
2. Explain follow up the subject may be asked to complete for safety reasons
WITHDRAWAL OF PARTICIPATION BY THE INVESTIGATOR / Yes / No / NA / COMMENT
1. Is the standard wording used?
2. Are the circumstances listed under which an investigator may remove a subject from the study?
NEW FINDINGS
(This may be omitted if it does not apply) / Yes / No / NA / COMMENT1. Is the standard wording used?
IDENTIFICATION OF INVESTIGATORS / Yes / No / NA / COMMENT
1. Is the standard language used?
2. Is there a person clearly identified to contact in case of research-related injury or adverse reaction? Note: In certain studies it may be necessary to also provide contacts for other resources that subjects may seek for assistance (physicians, counseling services, etc.)
REVIEWER ANALYSIS: Are contacts for research related injury or adverse reaction provided sufficient and appropriate?
VOLUNTEER REIGISTRY DATA BASE
(This must be included if the study involves greater than minimal risk)
1. Is standard wording used
RIGHTS OF RESEARCH SUBJECTS
1. Is standard wording used?
2. Is an individual’s name provided who is not associated with the study and who can provide subjects with information about their rights? This person should be knowledgeable about federal regulations involved in human research.
3. If this study involves patients from the VA, then the VA patient representative number must be included.
OFFER TO ANSWER QUESTIONS
1. Has someone been designated to answer questions who would be able to answer subjects’ questions about the study design and procedures (usually the PI)?2. Has someone been designated as the contact person should a research-related injury occur? (Research-related injury POC is also usually the PI although in the case of student projects this person should be the faculty advisor)
SIGNATURES
- Is standard formatting and wording used? (Each subject must sign his or her own consent form.)
2. Subject signature and date
3. Witness signature and date
4. Investigator signature and date
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IRB/forms/Worksheet for full IRB review_8-14-05