University Hospital of Brooklyn
College of Medicine
College of Health Related Professions
College of Nursing
School of Graduate Studies
Graduate Program in Public Health / INFORMED CONSENT REVIEWER CHECKLIST
(Pilot Checklist/Under Evaluation)
This checklist will aid the IRB Member in completing a meaningful and substantive review. For more information please refer to IRB-01 Policy, IRB Guidance, or contact the IRB at 718-613-8480or
IRBNet #:Reviewer Name:
Review Start Date:
Review Start Time:
Do you or your immediate family members have any conflicts of interests (COI)?
Note: COI may be real or perceived. COI may be financial or other (e.g., significant time spent helping the study team develop their protocol, significant efforts devoted to submission of their IRB application)
Yes No
If “Yes” is checked, please contact the IRB Office to defer to another reviewer. An IRB Member with a COI can provide feedback, upon request from the Chair/Vice-Chair, but cannot vote or approve a study.
Review Type(s) (check all applicable roles):
Note: Only the IRB Office Staff must use this form and attach in IRBNet.
This form is optional for all others; it may serve as a memory jogger for approval criteria.
IRB Member Yes No (If no, you can provide feedback, but cannot vote or approve a study)
Primary Reviewer Secondary Reviewer
Clinical Reviewer Informed Consent Reviewer Scientific Design Reviewer Prisoner Rep Member
Privacy Officer Information Security Reviewer
IRB Office Staff Consultant
Comment:
Submission Materials (Related to Informed Consent Review):
Material(s) / Status / Comments/Corrective Actions:
Overall risk assessment: / No greater than minimal
Greater than minimal risk
If >MR with children, check if risk is a minor increase over minimal risk / Comments:
Concerns:
Requirements:
Recommendations:
What types of benefits are described in the IRB protocol/IRB application or other materials?
No direct benefit anticipated to participants; future benefits to society only
Non-Therapeutic Direct Benefits to research participants
Direct Therapeutic Benefits to research participants
Other (explain): / Are the benefits described in consent form are consistent with all other IRB application materials?
Yes
No
Pending / Comments:
Concerns:
Requirements:
Recommendations:
Financial Conflict of Interest (fCOI) Disclosures for PI and other “investigators for the purposes of COI” (See IRB Office Review Worksheet) / No COI/No Issues
Disclosures pending;
Significant Financial Interest (SFI) disclosed
fCOI Committee Approved Management Plan in place
SFI disclosed appropriately in ICF / Comments:
Concerns:
Requirements:
Recommendations:
Assent Form (s). Generally required if you are planning to enroll participants age 7-12. / Present
N/A
Pending / Comments:
Concerns:
Requirements:
Recommendations:
Information Sheet (if applicable). Required when requesting a waiver of documentation of informed consent, when IIHI or PHI is NOT involved. / Present
N/A
Pending / Comments:
Concerns:
Requirements:
Recommendations:
Information Sheet, including authorization to access, use, or disclose IIHI or PHI (if applicable). Required when requesting a waiver of documentation of informed consent, when IIHI or PHI is involved. Can be used for exempt research that involves IIHI/PHI. / Present
N/A
Pending / Comments:
Concerns:
Requirements:
Recommendations:
Short Form(s). May be used for certain studies when enrolling non-English speaking participants or those with Limited English Proficiency (LEP). Indicate languages: Arabic; Simplified Chinese; Traditional Chinese; English; Haitian Creole; Spanish / Present
N/A
Pending / Comments:
Concerns:
Requirements:
Recommendations:
HIPAA Waiver(s).
Indicate Type: Full; Partial; Alteration / Present
N/A
Pending / Comments:
Concerns:
Requirements:
Recommendations:
Waiver of (Process of) Informed Consent. Required when waiving entire consent process (e.g., for retrospective data reviews, for situations when one research participant provides private information about another, such as future contact when participant is not available) / Present
N/A
Pending
Are criteria met for waiver? (regardless if waiver was submitted to IRB)
YES NO / Comments:
Concerns:
Requirements:
Recommendations:
Waiver of Required Element of Informed Consent. Required when waiving entire consent process (e.g., for not disclosing purpose in deception research) / Present
N/A
Pending
Are criteria met for waiver? (regardless if waiver was submitted to IRB)
YES NO / Comments:
Concerns:
Requirements:
Recommendations:
Waiver of Documentation(signature) of Informed Consent. Required when waiving documentation (e.g., signature) of informed consent. NOTE: If PHI is involved, the IRB may accept the HIPAA waiver form to document a request to waive informed consent. / Present
N/A
Pending
Are criteria met for waiver? (regardless if waiver was submitted to IRB)
YES NO / Comments:
Concerns:
Requirements:
Recommendations:
Recruitment Materials (including, but not limited to advertisements, flyers, brochures, ads, e-mails, telephone script, etc.) / Present
N/A
Pending / Comments:
Concerns:
Requirements:
Recommendations:
Subject Recruitment Authorization Form (Signed by patient). / Present
N/A
Pending / Comments:
Concerns:
Requirements:
Recommendations:
Physician’s Documentation of Patient’s Verbal Authorization. / Present
N/A
Pending / Comments:
Concerns:
Requirements:
Recommendations:
Are ICH-GCP standards required to be following by the sponsor for this study? / No
Yes / Comments:
Concerns:
Requirements:
Recommendations:
Does this study involve an IND or IDE? / No
Yes / Comments:
Concerns:
Requirements:
Recommendations:
Is this an Applicable Clinical Trial? / No
Yes / Comments:
Concerns:
Requirements:
Recommendations:
Ethical Considerations:
Is the research guided by the ethical principlessetforthinthe Belmont Report? / Yes No
Comments:
Concerns:
Requirements:
Recommendations:
Are there any other concerns related to other applicable principles of Professional or ethical codes (e.g. Code of Ethics, Nuremburg Code, Declaration of Helsinki)
NOTE: Declaration of Helsinki is followed in Clinical Trials under GCP Standards. / NoYes
Comments:
Concerns:
Requirements:
Recommendations:
Obtaining Informed Consent from Individuals with Limited English Proficiency (LEP):
The information that is given to the research participant or the representative shall be in language understandable to the research participant or the representative.
The process which can be approved for this study:
No proposal to recruit those with LEP
No proposed plans, however, the IRB recommends recruitment of those with LEP for the following reasons:
A translated written consent document. An amendment must be submitted to the IRB after the English version is approved.
The use of the short form written consent can be used.
Comments:
Concerns:
Requirements:
Recommendations:
For more information, please see IRB Guidance – Legally Effective Informed Consent and HIPAA Research Authorization.
Children Who are Wards:
Are additional applicable protections for research involving a child who is a ward (i.e. in custody or oversight by any state or city agency) adequate for this research project?
N/A – Wards are not are part of this study. Yes: Additional protections are adequate.
No.
Comments:
Concerns:
Requirements:
Recommendations:
Newborn Screening Spots:
Are informed consent requirements met for research involving newborn screening spots?
N/A – Check reason: Research does not involve new born screening spots; or this is not HHS-funded research
Yes. No.
Comments:
Concerns:
Requirements:
Recommendations:
Planned Emergency Human Research or Clinical Trials:
Are the specific conditions met to waive prospective consent of the participant for planned emergency research as provided by 21 CFR 50.24 and OHRP guidance?
N/A – This is not planned emergency research. Yes. No.
Comments:
Concerns:
Requirements:
Recommendations:
Informed Consent Requirements:
Codes:
(A) Additional Federal Element, if applicable
(B) Basic Required Federal Element
(D) Downstate recommendation
(F) Federal Regulation
(G) Federal Guidance (Recommendation)
(N) New York regulation (Required)
(GCP) Required under GCP standards (GCP trials must also follow all other requirements). IRB can require the study to follow a GCP for any research, when deemed applicable.
(H) AAHRPP standard or tip (recommendation for DMC/not required)
(F) The process for recruitment, enrollment, and obtaining informed consent is adequate. / Yes
N/A
No;
Comments:
Concerns:
Requirements:
Recommendations:
If electronic informed consent is used, verify all applicable requirements are met. See Policy IRB-01 for details. / Requirement met
N/A
Pending
Comments:
Concerns:
Requirements:
Recommendations:
(D) To the extent possible, technical, medical, legalese, and scientific concepts should be explained in lay terms (i.e. understandable to the people being asked to participate), especially explanation of the study's purpose, duration, experimental procedures, alternatives, risks, and benefits. Typically, the consent should be understandable to someone who is educated to the 6th to 8th grade level. Avoid long sentences and medical/technical jargon, and define any technical terms clearly whenever they are used. If the definitions of technical terms are lengthy, describe in separate sentences. / Recommendations met
N/A
Pending
Comments:
Concerns:
Requirements:
Recommendations:
(G) The IRB should review the adequacy and appropriateness of all wording in the consent materials, as well as the overall length and presentation of information. Consent forms that are long, complex, legalistic, and have a high reading level may overwhelm potential subjects and may inhibit reading of the full document and understanding of the relevant information. / Recommendations met
N/A
Pending
Comments:
Concerns:
Requirements:
Recommendations:
(G) Pictures or diagrams may be used to improve understanding of medical terms or how an investigational product functions. IRBs may wish to evaluate, through subject interviews, how well the consent materials communicate critical information. / Recommendations met
N/A
Pending
Comments:
Concerns:
Requirements:
Recommendations:
(G) DO NOT Use the first-person tense (e.g., "I understand that ..."), as it can be interpreted as suggestive, may be relied upon as a substitute for sufficient factual information, and can constitute coercive influence over a subject. / Recommendations met
N/A
Pending
Comments:
Concerns:
Requirements:
Recommendations:
(F) An investigator shall seek such consent only under circumstances that provide the prospective participant or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. / All requirements met
Some requirements not met. Explain below.
Comments:
Concerns:
Requirements:
Recommendations:
(F) The information that is given to the participant or the representative shall be in language understandable to the participant or the representative. / All requirements met
Some requirements not met. Explain below.
Comments:
Concerns:
Requirements:
Recommendations:
(F) No informed consent, whether oral or written, may include any exculpatory language through which the participant or the representative is made to waive or appear to waive any of the participant’s legal rights, or releases or appears to release the investigator, the sponsor, the institution or its agents from liability for negligence. / All requirements met
Some requirements not met. Explain below.
Comments:
Concerns:
Requirements:
Recommendations:
(D) The name of the sponsor (including Downstate Medical Center or NYC H+H, Kings County) is provided. / Page(s):
N/A
Missing
Comments:
Concerns:
Requirements:
Recommendations:
(B) A statement that the study involves research / Page(s):
Missing Basic Element
Comments:
Concerns:
Requirements:
Recommendations:
(B) An explanation of the purposes of the research / Page(s):
Missing Basic Element
Comments:
Concerns:
Requirements:
Recommendations:
(B) An explanation of the expected duration of the participant’s participation / Page(s):
Missing Basic Element
Comments:
Concerns:
Requirements:
Recommendations:
(B) A description of the procedures to be followed / Page(s):
Missing Basic Element
Comments:
Concerns:
Requirements:
Recommendations:
(D) If applicable and recommended, a description of the standard of care options that would be offered, if the participant does not wish to participate. / Page(s):
N/A
Missing description
Comments:
Concerns:
Requirements:
Recommendations:
(D) If applicable and recommended, a description of prohibited materials (medications, supplements, biologics, devices) / Page(s):
N/A
Missing description
Comments:
Concerns:
Requirements:
Recommendations:
(D) If applicable and recommended, a description of exclusion criteria. / Page(s):
N/A
Missing desrciption
Comments:
Concerns:
Requirements:
Recommendations:
(D) If applicable and recommended, information about pregnancy testing and/or birth control requirements. / Page(s):
N/A
Missing information
Comments:
Concerns:
Requirements:
Recommendations:
(D) If applicable and recommended, information about pregnancy follow-up studies. / Page(s):
N/A
Missing information
Comments:
Concerns:
Requirements:
Recommendations:
(B) Identification of any procedures which are experimental. / Page(s):
Missing Basic Element
Comments:
Concerns:
Requirements:
Recommendations:
(B) A description of any reasonably foreseeable risks or discomforts to the participant. / Page(s):
Missing Basic Element
Comments:
Concerns:
Requirements:
Recommendations:
(B) A description of any benefits to the research participants or to others which may reasonably be expected from the research. / Page(s):
Missing Basic Element
Comments:
Concerns:
Requirements:
Recommendations:
(B) A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the research participant is required if alternatives are available. / Page(s):
N/A – no alternatives
Missing Basic Element
Comments:
Concerns:
Requirements:
Recommendations:
(B) A statement describing the extent, if any, to which confidentiality of records identifying the participant will be maintained and that notes the possibility that the Food and Drug Administration may inspect the records (if the research is FDA regulated). / Page(s):
Missing Basic Element
Comments:
Concerns:
Requirements:
Recommendations:
(B) For research involving more than minimal risk, an explanation as to whether there is any compensation for potential study-related injury. / Page(s):
N/A – no more than minimal risk
Missing Basic Element
Comments:
Concerns:
Requirements:
Recommendations:
(B) For research involving more than minimal risk, an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained. / Page(s):
N/A – no more than minimal risk
Missing Basic Element
Comments:
Concerns:
Requirements:
Recommendations:
(B) An explanation of whom to contact for answers to pertinent questions about the research. / Page(s):
Missing Basic Element
Comments:
Concerns:
Requirements:
Recommendations:
(B) An explanation of whom to contact for answers to research participants’ rights. / Page(s):
Missing Basic Element
Comments:
Concerns:
Requirements:
Recommendations:
(B) An explanation of whom to contact in the event of a research related injury to the participant. / Page(s):
Missing Basic Element
Comments:
Concerns:
Requirements:
Recommendations:
(H) Contact information for research team for questions, concerns, or complaints. / Page(s):
N/A – Additional Element is not needed
Additional information is REQUIRED BY IRB.
Additional information is recommended.
Comments:
Concerns:
Requirements:
Recommendations:
(H) Contact information for someone independent of the research team (e.g., IRB) for problems, concerns, information or input. / Page(s):
N/A – Additional Element is not needed
Additional information is REQUIRED BY IRB.
Additional information is recommended.
Comments:
Concerns:
Requirements:
Recommendations:
(B) A statement that participation is voluntary. / Page(s):
Missing Basic Element
Comments:
Concerns:
Requirements:
Recommendations:
(B) A statement that refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled. / Page(s):
Missing Basic Element
Comments:
Concerns:
Requirements:
Recommendations:
(B) A statement that the participant may discontinue participation at any time without penalty or loss of benefits to which the participant is otherwise entitled. / Page(s):
Missing Basic Element
Comments:
Concerns:
Requirements:
Recommendations:
(B) When seeking informed consent for an “Applicable Clinical Trial”, as defined FDA Amendments Act of 2007 (FDAAA); the following statement must be included in the informed consent documents and should be included in the information sheet, when documentation of informed consent is waived by the IRB: "A description of this clinical trial will be available on , as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time." / Page(s):
N/A – This is not an “Applicable Clinical Trial”
Missing Basic Element
Comments:
Concerns:
Requirements:
Recommendations:
(F/D) When IHII (or PHI) is involved in the study, the required HIPAA authorization language must be included with the informed consent to cover the uses and disclosures of IHII (or PHI). This language is included in the templates in the IRB Application and Reporting System. For additional information see:
- DMC HIPAA-28 Policy: Uses and Disclosures for Research Purposes
- DMC HIPPA-32 policy: Uses and Disclosures Requiring Patient Authorization
N/A – Study does not involve IHII (or PHI)
Missing HIPAA Authorization Language (provide details or mark up the consent in tracked changes)
Comments:
Concerns:
Requirements:
Recommendations:
(N/D) Include applicable Downstate template language regarding HIV-related information. / Page(s):
N/A – HIV information is not included in study
Comments:
Concerns:
Requirements:
Recommendations:
(F) When a Certificate of Confidentiality (CoC) is granted by the NIH for the study, include the required language from the NIH. / Page(s):
N/A – CoC not included in study
Comments:
Concerns:
Requirements:
Recommendations:
(A) When applicable, include a statement that the particular treatment or procedure may involve risks which are currently unforeseeable to the participant (or to the embryo or fetus, if the participant is or may become pregnant). / Page(s):
N/A – Additional Element is not needed
Additional risks need to be described (details below).
Comments:
Concerns:
Requirements:
Recommendations:
(A)When applicable, include anticipated circumstances under which participation in the research may be terminated by the investigator. / Page(s):
N/A – Additional Element is not needed
Anticipated circumstances under which participation in the research may be terminated by the investigator are missing and need to be added to the ICF.
Comments:
Concerns:
Requirements:
Recommendations:
(D) When applicable, describe the consequences of withdrawing from the study. / Page(s):
N/A
Missing. Need to add a description of the consequences of withdrawing from the study.
Comments:
Concerns:
Requirements:
Recommendations:
(A)When applicable, include any additional costs to the participant that may result from participation in the research. / Page(s):
N/A – Additional Element is not needed
Information on costs of research participation were not provide and needs to be added to the ICF.