IRB PRIMARY REVIEWER WORKSHEET – INITIAL REVIEW
The following items must be addressed in your review and presentation to the IRB.
IRB Reviewer’s name: PI’s name & MIRB ID:
1. Is this an investigator initiated study?
NO. (This is Sponsor initiated study).
YES.
2. What is the overall hypothesis or prediction:
3. Is the hypothesis or prediction appropriate for the study?
YES.
NO. Comment:
4. Are study procedures or treatments appropriate for investigating the problem proposed and sound enough to yield the expected knowledge? (AAHRPP I.1.F.)
YES.
NO. Comment:
5. Does the study fit into the mission of VA research and provide knowledge that can benefit veterans?
YES.
NO. Comment:
6. Are subjects being paid for participating?
NO. Proceed to #7.
YES. Review a. and answer b.
a. Check that each payment times the enrollment total is in line with the enclosed budget. If not or if not sure, defer the budgetary review to the Research & Development Committee.
b. The amount of payment and the proposed method and timing of disbursement is neither coercive nor presents undue influence. (AAHRPP II.5.B)
- Credit for payment accrues as the study progresses and is not contingent upon the subject completing the entire study.
- Any amount paid as a bonus for completion is reasonable and not so large as to unduly induce participants to stay in the study when they would otherwise have withdrawn.
YES.
NO. Comment:
7. Is subject selection equitable? (AAHRPP II.2.B; II.3.C.)
(Consider inclusion and exclusion criteria, vulnerability of subjects, recruitment methods, purpose of research, setting in which the research will be conducted)
YES.
NO. Study cannot be approved. Comment:
If subjects with IDMC will be enrolled in the study a separate IRB Primary Reviewer Sheet must be completed.
8. Will some or all of the subjects likely to be vulnerable to coercion or undue influence?
NO. Proceed to #9.
YES. Answer a.-c.
a. Describe the reasons for including vulnerable subjects (prisoners, pregnant women, fetuses, children, mentally disabled, economically or educationally disadvantage and those likely to be vulnerable to coercion or undue influence) (AAHRPP II.4.A.):
b. Describe information concerning additional safeguards to protect the rights and welfare of vulnerable subjects. (AAHRPP II.2.A.; II.4.A.):
c. Are you knowledgeable about or experienced with the involved vulnerable population?
YES.
NO. Immediately contact the IRB Staff or IRB Chair to arrange for a review by an individual who has experienced with or is knowledgeable about the vulnerable population.
9. RISK
a. Have risks been minimized by using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk? (AAHRPP I.1.F.; II.3.A)
YES. NO.
b. Have the risks have been minimized, whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes: (AAHRPP II.3.A)
Not applicable. No clinical data will be collected for research purposes.
YES.
NO. Recommend that study be disapproved.
c. Risk /Benefit Ratio Assessment (select the appropriate response): (AAHRPP I.1.F.; II.3.A)
Risks to participants are reasonable in relationship to the potential benefits, if any to participants, and the importance of the knowledge that may be expected to result (including consideration of the validity of the research design).
Risks to participants are NOT reasonable in relationship to the potential benefits, if any to participants, and the importance of the knowledge that may be expected to result (including consideration of the validity of the research design).
*** IF RISKS ARE NOT REASONABLE, THE PROTOCOL CANNOT BE APPROVED. ***
10. CONFIDENTIALITY (AAHRPP II.3.E.)
If any of the following forms contain language about destruction of research records, recommend that the PI add following the destruction timeframe “as allowed by the VA’s policy for destruction of research records.”
- Informed consent form (Confidentiality section),
- HIPAA Authorization,
- HIPAA Waiver (Attachment B), or
- Application to Undertake Research (Confidentiality section).
a. Methods to protect data confidentiality (select all that apply):
Anonymous data collection Coding of data
Password protected access Storage of data on server
Storage of data in locked areas Other (list):
b. Are there adequate provisions to maintain the confidentiality of data? (AAHRPP I.2.B.)
YES.
NO. Describe the provisions that should be implemented:
11. PRIVACY
a. The Setting, Methods and Circumstances for identifying subjects for recruitment and obtaining information about subjects and conducting the research respect the individual’s Privacy and are appropriate to the nature of the information being sought.
YES. NO.
b. Methods to obtain data (select all that apply):
(Must be considered in the assessment of both privacy and confidentiality)
Clinical Evaluation Imaging tests Lab tests
Medical Record Reviews Questionnaires Interviews
Other (list):
c. There are adequate provisions to protect the privacy interests of subjects:
(Privacy interests relate to whether people feel comfortable with intrusions on what they want to keep to themselves. Those intrusions may be about information but they might not involve information. Examples of non-informational privacy interests: physical, emotional and psychological privacy)
YES.
NO. Describe the provisions that should be implemented:
12. DATA and SAFETY MONITORING: When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects: (AAHRPP II.3.B.)
Not applicable (for minimal risk 1 session study a retrospective chart review study)
YES.
NO. Comment:
13. Was a VA INFORMED CONSENT FORM submitted (AAHRPP I.2.B.)?
Note: A waiver of informed consent or waiver of documentation of consent may be required. If individually identifiable information will be used or obtained prior to or without consent, waivers are required.
NO.
YES. Confirm that no waivers are required - Skip to #16.
If a waiver of informed consent (e.g., no written or oral consent) was requested
– Skip to #19.
NOTE: A waiver of the requirement to obtain informed consent may not be granted for FDA regulated research.
If a waiver to sign the informed consent form was requested (for non-FDA regulated research) – Skip to #15.
If oral consent for FDA regulated research was requested (waive signing the informed consent form for FDA regulated research) – Skip to #14.
14. FDA REGULATED – WAIVE SIGNING CONSENT FORM:
For FDA regulated research, if consent will be obtained (e.g., oral consent) but there is a request (or need) to waive signing the informed consent,
answer a-d below. (AAHRPP II.7.G.)
a. Mark whether (1) or (2) is satisfied.
(1) The research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside the research context.
(2) The study meets the criteria for approval as planned emergency research per the Investigational Drugs, Devices and Biologics SOP.
b. CAN DOCUMENTATION OF INFORMED CONSENT BE WAIVED?
NO. Describe what has not been satisfied:
YES. Describe how protocol characteristics of the study meet each of the above applicable criteria to waive signing the consent form (waive documentation of informed consent):
c. Does the master list pose a potential risk to the subjects from a breach of confidentiality and do you recommend that the IRB grant a waiver of the requirement for the PI to maintain a Human Subject Research Consent Master List?
YES. NO.
d. Has a written description of the information that will be provided to subjects been submitted (e.g., script)? (AAHRPP I.2.B.; II.3.G.)
YES.
NO. State whether the investigator should be required to give the IRB a written description of the information that will be provided to subjects. Note that if information is being requested, the recommendation will be to disapprove the study.
e. Should the investigator be required to provide subjects a written statement regarding the research (e.g., letter, informed consent form, etc.)? (AAHRPP II.3.G.)
NO.
YES. Ask for the document that will be given to subjects regarding the research that contains the basic and additional applicable consent elements. Note that since information is being requested, the recommendation will be to disapprove the study.
CHECK HERE if recommend granting a waiver of the requirement for a signed informed consent form.
15. NON-FDA REGULATED – WAIVE SIGNING CONSENT FORM:
If consent will be obtained
but there is a request (or need) to waive signing or documentation of informed consent,
answer a.-d. below. (45CFR46.117(c)/38CFR16.117(c)) (AAHRPP II.3.G.)
a. Mark whether (1) or (2) is satisfied.
(1) The only record linking the subject and the research would be the consent document, and the principle risk would be the potential harm resulting from a breach of confidentiality. Each subject will be asked whether s/he wants documentation linking the subject with the research, and the subject’s wishes will govern.
(2) The research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside the research context.
b. Describe how the specific characteristics of this study meet each of the above applicable criteria to waive documentation of informed consent (waive signing the consent form):
c. Does the master list pose a potential risk to the subjects from a breach of confidentiality and do you recommend that the IRB grant a waiver of the requirement for the PI to maintain a Human Subject Research Consent Master List?
YES. NO.
d. Has a written description of the information that will be provided to subjects been submitted (e.g., script)? (AAHRPP II.2.B.; II.3.G.)
YES.
NO. State whether the investigator should be required to give the IRB a written description of the information that will be provided to subjects. Note that if information is being requested, the recommendation will be to disapprove the study.
e. Should the investigator be required to provide subjects with a written statement regarding the research (e.g., letter, informed consent form, etc.)? (AAHRPP II.3.G.)
NO.
YES. Ask for the document that will be given to subjects regarding the research that contains the basic and additional applicable consent elements. Note that since information is being requested, the recommendation will be to disapprove the study.
CHECK HERE if recommend granting a waiver of the requirement for a signed informed consent form.
CRITERIA FOR CONSENT
16. Please determine if the following criteria are met for written or oral consent: (AAHRPP II.2.B.)
a. Basic elements of informed consent are present (refer to Informed Consent (IRB) Data Collection Tool for a list of elements):
YES.
NO. Describe the missing element(s):
b. Additional elements of informed consent as required are present (refer to Informed Consent (IRB) Data Collection Tool for a list of elements):
YES.
NO. Describe the missing element(s):
c. If applicable, all information concerning Payment, including the amount and schedule of payments, is set forth in the consent document. (AAHRPP II.5.B)
Not Applicable.
YES.
NO. Describe the missing information:
d. If the study involves “usual care” confirm that the application or protocol clearly differentiate the research interventions from usual care and whether usual care will be delivered to some or to all the research subjects.
Not Applicable.
YES.
NO. Describe the missing information:
e. If the study involves “usual care” confirm that the consent process clearly defines for the subject which potential risks are related to the research and, therefore, need to be discussed with the research team, versus those associated solely with usual care provided by the subject’s health care provider?
a. The informed consent process must include language advising subjects to review the risks of usual care with their health care providers.
b. Should an IRB question a protocol’s characterization of “usual care,” its associated risks, or the person or entity responsible for specific aspects of “usual care,” the IRB is to seek clarification from the investigator and, if warranted, from qualified experts. The IRB must document its determination(s) accordingly.
NOTE: The researcher and the subject’s health care provider may be the same individual. If they are different individuals, and the subject’s health care provider is not involved in the research study, the health care provider is not considered a member of the research team.
Not Applicable.
YES.
NO. Describe the missing information:
f. Is the informed consent form consistent with the protocol and, when relevant, with the HIPAA authorization?
YES.
NO. Describe inconsistencies that need to be addressed between the protocol,
consent form and HIPAA Authorization:
17. Is the Informed Consent Process Appropriate (for studies whereby the informed consent form will be signed or whereby signing the informed consent form will be waived (e.g., oral consent)?
YES.
NO. Explain:
Checking YES indicates a determination that the consent process meets the following five regulatory requirements:
a. Investigator may not involve a human being as a participant in research unless the investigator has obtained the legally effective informed consent of the participant or the participant’s legally authorized representative.
b. Consent process provides sufficient opportunity to consider whether to participate.
c. Consent process minimizes the possibility of coercion or undue influence.
d. Consent discussion is in language understandable to the participant or the representative. (AAHRPP II.7.A)
e. Consent discussion is free of exculpatory language. (Language through which the subjects or the representative is made to waive or appear to waive any of the subject’s legal rights, or releases or appears to release the investigator, the sponsor, the institution or its agents from liability for negligence.) (AAHRPP II.3.F.)
Consider:
(1) Waiting period between informing the prospective subjects and obtaining the consent
(2) The language that will be used by those obtaining consent
(3) The language that is understood by the prospective subjects or the legally authorized representatives
(4) Who will obtain consent
(5) The timing of obtaining informed consent
(6) The setting in which consent will be obtained
18. For written consent, may the subject submit the signed and dated informed consent form to the investigator or designee by facsimile?
N/A - Not Requested
NO.
YES. If YES, are there adequate measures to assure confidentiality?