IRB Reviewer Checklist (Version 06.16.2017)

SUNY Downstate Medical Center University Hospital of Brooklyn INFORMED CONSENT College of Medicine REVIEWER CHECKLIST College of Health Related Professions College of Nursing School of Graduate Studies (Pilot Checklist/Under Graduate Program in Public Health 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 718-613-8480 or [email protected]

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

IRB Reviewer Checklist (Version 06.16.2017) Page 1

Comment:

Submission Materials (Related to Informed Consent Review): Material(s) Status Comments/Corrective Actions: Overall risk assessment: No greater than Comments: Concerns: minimal Requirements: Greater than Recommendations:

minimal risk If >MR with

children, check if risk is a minor increase over minimal risk What types of benefits are Are the benefits Comments: described in the IRB described in consent Concerns: protocol/IRB application or other form are consistent Requirements: materials? with all other IRB application materials? Recommendations: No direct benefit anticipated Yes to participants; future benefits to society only No Non-Therapeutic Direct Pending Benefits to research participants Direct Therapeutic Benefits to research participants Other (explain):

Financial Conflict of Interest No COI/No Issues Comments: (fCOI) Disclosures for PI and Concerns: other “investigators for the Requirements: purposes of COI” (See IRB Disclosures Office Review Worksheet) Recommendations: pending; Significant

Financial Interest (SFI) disclosed fCOI Committee

Approved Management Plan in

place SFI disclosed

appropriately in ICF

Assent Form (s). Generally Present Comments: required if you are planning to Concerns: enroll participants age 7-12. N/A Requirements: Recommendations:

Pending

Information Sheet (if applicable). Present Comments: Required when requesting a Concerns: waiver of documentation of Requirements: informed consent, when IIHI or N/A PHI is NOT involved. Recommendations: Pending

Information Sheet, including Present Comments: authorization to access, use, or Concerns: disclose IIHI or PHI (if Requirements: applicable). Required when N/A requesting a waiver of Recommendations: documentation of informed Pending consent, when IIHI or PHI is involved. Can be used for exempt research that involves IIHI/PHI. Short Form(s). May be used for Present Comments: certain studies when enrolling Concerns: non-English speaking Requirements: participants or those with Limited N/A English Proficiency (LEP). Recommendations: Indicate languages: Arabic; Pending

Simplified Chinese;

Traditional Chinese; English;

Haitian Creole; Spanish

HIPAA Waiver(s). Present Comments: Indicate Type: Full; Partial; Concerns: N/A Requirements: Alteration Recommendations: Pending

Waiver of (Process of) Informed Present Comments: Consent. Required when waiving Concerns: entire consent process (e.g., for Requirements: retrospective data reviews, for N/A situations when one research Recommendations: participant provides private Pending information about another, such as future contact when participant is not available) Are criteria met for waiver? (regardless if waiver was submitted to IRB) YES NO

Waiver of Required Element of Present Comments: Informed Consent. Required Concerns: when waiving entire consent Requirements: process (e.g., for not disclosing N/A purpose in deception research) Recommendations: Pending

Are criteria met for waiver? (regardless if waiver was submitted to IRB) YES NO

Waiver of Documentation Present Comments: (signature) of Informed Consent. Concerns: Required when waiving Requirements: documentation (e.g., signature) of N/A informed consent. NOTE: If PHI Recommendations: is involved, the IRB may accept Pending the HIPAA waiver form to document a request to waive informed consent. Are criteria met for waiver? (regardless if waiver was submitted to IRB) YES NO

Recruitment Materials (including, Present Comments: but not limited to advertisements, Concerns: flyers, brochures, ads, e-mails, Requirements: telephone script, etc.) N/A Recommendations:

Pending

Subject Recruitment Present Comments: Authorization Form (Signed by Concerns: patient). N/A Requirements: Recommendations:

Pending

Physician’s Documentation of Present Comments: Patient’s Verbal Authorization. Concerns: N/A Requirements: Recommendations:

Pending

Are ICH-GCP standards required No Comments: to be following by the sponsor for Concerns: this study? Yes Requirements: Recommendations:

Does this study involve an IND or No Comments: IDE? Concerns: Yes Requirements: Recommendations:

Is this an Applicable Clinical No Comments: Trial? Concerns: Yes Requirements: Recommendations:

Ethical Considerations:

Is the research guided by the ethical Yes No principles set forth in the Belmont Report ? Comments: Concerns: Requirements: Recommendations:

Are there any other concerns related to No Yes other applicable principles of Professional or ethical codes (e.g. Code of Ethics, Nuremburg Code, Declaration of Helsinki) Comments: NOTE: Declaration of Helsinki is Concerns: followed in Clinical Trials under GCP Requirements: Standards. 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.

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.

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.

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 Yes consent is adequate.

If electronic informed consent is used, verify all applicable Requirement met requirements are met. See Policy IRB-01 for details.

Pending

(D) To the extent possible, technical, medical, legalese, and Recommendations met 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 N/A 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

IRB Reviewer Checklist (Version 06.16.2017) Page 8 jargon, and define any technical terms clearly whenever they are Pending used. If the definitions of technical terms are lengthy, describe in separate sentences. Comments: Concerns: Requirements: Recommendations:

(G) The IRB should review the adequacy and appropriateness of all Recommendations met 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 N/A subjects and may inhibit reading of the full document and understanding of the relevant information. Pending

(G) Pictures or diagrams may be used to improve understanding of Recommendations met medical terms or how an investigational product functions. IRBs may wish to evaluate, through subject interviews, how well the consent materials communicate critical information. N/A

Pending

(G) DO NOT Use the first-person tense (e.g., "I understand Recommendations met 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. N/A

Pending

(F) An investigator shall seek such consent only under All requirements met 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 Some requirements not met. Explain below. influence.

(F) The information that is given to the participant or the All requirements met representative shall be in language understandable to the participant or the representative. Some requirements not met. Explain below.

(F) No informed consent, whether oral or written, may include any All requirements met 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 Some requirements not met. Explain below. investigator, the sponsor, the institution or its agents from liability for negligence. Comments: Concerns: Requirements: Recommendations:

(D) The name of the sponsor (including Downstate Medical Center Page(s): or NYC H+H, Kings County) is provided. N/A

Missing

(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

(B) An explanation of the expected duration of the participant’s Page(s): participation Missing Basic Element

(B) A description of the procedures to be followed Page(s): Missing Basic Element

(D) If applicable and recommended, a description of the standard of Page(s): care options that would be offered, if the participant does not wish to participate. N/A

Missing description

(D) If applicable and recommended, a description of prohibited Page(s): materials (medications, supplements, biologics, devices) N/A

Missing description

Comments: Concerns:

Requirements: Recommendations:

(D) If applicable and recommended, a description of exclusion Page(s): criteria. N/A

Missing desrciption

(D) If applicable and recommended, information about pregnancy Page(s): testing and/or birth control requirements. N/A

Missing information

(D) If applicable and recommended, information about pregnancy Page(s): follow-up studies. N/A

Missing information

(B) Identification of any procedures which are experimental. Page(s): Missing Basic Element

(B) A description of any reasonably foreseeable risks or Page(s): discomforts to the participant. Missing Basic Element

(B) A description of any benefits to the research participants or to Page(s): others which may reasonably be expected from the research. Missing Basic Element

(B) A disclosure of appropriate alternative procedures or courses of Page(s): treatment, if any, that might be advantageous to the research participant is required if alternatives are available. N/A – no alternatives

Missing Basic Element

(B) A statement describing the extent, if any, to which Page(s): confidentiality of records identifying the participant will be maintained and that notes the possibility that the Food and Drug Missing Basic Element Administration may inspect the records (if the research is FDA regulated). Comments: Concerns: Requirements: Recommendations:

(B) For research involving more than minimal risk, an explanation Page(s): as to whether there is any compensation for potential study-related injury. N/A – no more than minimal risk

(B) For research involving more than minimal risk, an explanation Page(s): as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may N/A – no more than minimal risk be obtained.

(B) An explanation of whom to contact for answers to pertinent Page(s): questions about the research. Missing Basic Element

(B) An explanation of whom to contact for answers to research Page(s): participants’ rights. Missing Basic Element

(B) An explanation of whom to contact in the event of a research Page(s): related injury to the participant. Missing Basic Element

(H) Contact information for research team for questions, concerns, Page(s): or complaints. N/A – Additional Element is not needed

Additional information is REQUIRED BY IRB.

Additional information is recommended.

(H) Contact information for someone independent of the research Page(s): team (e.g., IRB) for problems, concerns, information or input.

N/A – Additional Element is not needed

(B) A statement that participation is voluntary. Page(s): Missing Basic Element

(B) A statement that refusal to participate will involve no penalty or Page(s): loss of benefits to which the participant is otherwise entitled. Missing Basic Element

(B) A statement that the participant may discontinue participation at Page(s): any time without penalty or loss of benefits to which the participant is otherwise entitled. Missing Basic Element

(B) When seeking informed consent for an “Applicable Clinical Page(s): Trial”, as defined FDA Amendments Act of 2007 (FDAAA); the following statement must be included in the informed consent N/A – This is not an “Applicable Clinical Trial” documents and should be included in the information sheet, when documentation of informed consent is waived by the IRB: "A Missing Basic Element description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web Comments: 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 Concerns: Web site at any time." Requirements: Recommendations:

(F/D) When IHII (or PHI) is involved in the study, the required Page(s): HIPAA authorization language must be included with the informed consent to cover the uses and disclosures of IHII (or PHI). This N/A – Study does not involve IHII (or PHI) language is included in the templates in the IRB Application and Reporting System. For additional information see: Missing HIPAA Authorization Language (provide details  DMC HIPAA-28 Policy: Uses and Disclosures for Research Purposes or mark up the consent in tracked changes)  DMC HIPPA-32 policy: Uses and Disclosures Requiring Comments: Patient Authorization Concerns: NOTE: See Informed Consent template for recommended Downstate Requirements: language. Be sure required language from template is included when Recommendations: a sponsor’s model form is used. (N/D) Include applicable Downstate template language regarding HIV- Page(s): related information. N/A – HIV information is not included in study

(F) When a Certificate of Confidentiality (CoC) is granted by the Page(s): NIH for the study, include the required language from the NIH. N/A – CoC not included in study

(A) When applicable, include a statement that the particular Page(s): treatment or procedure may involve risks which are currently unforeseeable to the participant (or to the embryo or fetus, if the N/A – Additional Element is not needed participant is or may become pregnant). Additional risks need to be described (details below).

(A)When applicable, include anticipated circumstances under which Page(s): participation in the research may be terminated by the investigator. 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 Page(s): the study. 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 Page(s): may result from participation in the research. N/A – Additional Element is not needed

Information on costs of research participation were not

provide and needs to be added to the ICF. Other (describe below)

(A) When applicable, include the consequences of a participant’s Page(s): decision to withdraw from the research and procedures for orderly termination of participation. N/A – Additional Element is not needed

Consequences of participant’s decision to withdraw are

not provided and need to be added to the ICF. Comments: Concerns: Requirements: Recommendations:

(A) When applicable, include a statement that significant new Page(s): findings developed during the course of the research which may relate to the participant’s willingness to continue participation will be N/A – Additional Element is not needed provided to the participant. Missing / Additional Element is Needed

Comments:

Concerns: Requirements: Recommendations:

(A) When applicable, include the approximate number of Page(s): participants that will be in the study. N/A – Additional Element is not needed

Missing / Additional Element is Needed

(A) When applicable, include the number of participants (approved Page(s): by the IRB) to be involved in the study. For multi-site studies, it is best to indicate both the number that will be enrolled at the local site N/A – Additional Element is not needed and all sites. Missing / Additional Element is Needed

(D) When applicable, describe any financial relationships or interests Page(s): or conflict of interest management plans. N/A – Additional Element is not needed

(N) When the study involves genetic testing for CLINICAL Page(s): PURPOSES, include all of the required statements described for NYS 79-L. N/A – No Clinical Genetics tests

Note: If all genetics testing are done for research purposes, NYS Additional statements about genetic testing are not needed 79-L does not apply; however, some statements in the ICF template Some additional statements may be helpful (see below) might be helpful to tell participants. Comments: Concerns: Requirements: Recommendations:

(D) When applicable, describe when specimens or information may Page(s): be stored for future studies N/A – Additional Element is not needed

(D) When applicable, include tiered consent options for additional Page(s): optional research N/A – Additional Element is not needed

(D) When applicable, include permission to collect contact Page(s): information for a personal representative. NOTE: A wavier of informed consent is needed to collect this N/A – Additional Element is not needed information. Missing / Additional Element is Needed

(D) When applicable, include option to provide contract information Page(s): of the research participant or legally authorized representative. N/A – Additional Element is not needed

(H) The amount and schedule of all payments to the participant. Page(s): N/A – Additional Element is not needed

(GCP) When GCP is followed, or when deemed applicable, Page(s): information regarding payment to subjects, including the methods, amounts, and schedule of payment to trial subjects, is set forth in the N/A- GCP not required for this study and/or it is deemed written informed consent form and any other written information to be provided to subjects. The way payment will be prorated should be that this element is not otherwise required nor recommended specified. GCP requirements met.

Missing / Additional GCP Element is Needed

(GCP) When GCP is followed, or when deemed applicable, none of Page(s): the oral and written information concerning the trial, including the written informed consent form, should contain any language that N/A- GCP not required for this study and/or it is deemed causes the subject or the subject's legally acceptable representative to waive or to appear to waive any legal rights, or that releases or appears that this element is not otherwise required nor recommended to release the investigator, the institution, the sponsor, or their agents GCP requirements met. from liability for negligence. Missing / Additional GCP Element is Needed

(GCP) When GCP is followed, or when deemed applicable, the Page(s): investigator, or a person designated by the investigator, should fully inform the subject or, if the subject is unable to provide informed N/A- GCP not required for this study and/or it is deemed consent, the subject's legally acceptable representative, of all pertinent aspects of the trial including the written information and the approval/ that this element is not otherwise required nor recommended favorable opinion by the IRB/IEC. GCP requirements met.

(GCP) When GCP is followed, or when deemed applicable, the Page(s): language used in the oral and written information about the trial, including the written informed consent form, should be as non- N/A- GCP not required for this study and/or it is deemed technical as practical and should be understandable to the subject or the subject's legally acceptable representative and the impartial that this element is not otherwise required nor recommended witness, where applicable. GCP requirements met.

(GCP) When GCP is followed, or when deemed applicable, before Page(s): informed consent may be obtained, the investigator, or a person designated by the investigator, should provide the subject or the N/A- GCP not required for this study and/or it is deemed subject's legally acceptable representative ample time and opportunity to inquire about details of the trial and to decide whether or not to that this element is not otherwise required nor recommended participate in the trial. All questions about the trial should be answered GCP requirements met. to the satisfaction of the subject or the subject's legally acceptable representative. Missing / Additional GCP Element is Needed

(GCP) When GCP is followed, or when deemed applicable, Prior to a Page(s): subject’s participation in the trial, the written informed consent form should be signed and personally dated by the subject or by the subject's N/A- GCP not required for this study and/or it is deemed legally acceptable representative, and by the person who conducted the informed consent discussion. that this element is not otherwise required nor recommended GCP requirements met.

(GCP) When GCP is followed, or when deemed applicable, Page(s): If a subject is unable to read or if a legally acceptable representative is unable to read, an impartial witness should be present during the entire N/A- GCP not required for this study and/or it is deemed informed consent discussion. After the written informed consent form and any other written information to be provided to subjects, is read that this element is not otherwise required nor recommended and explained to the subject or the subject’s legally acceptable

IRB Reviewer Checklist (Version 06.16.2017) Page 21 representative, and after the subject or the subject’s legally acceptable GCP requirements met. representative has orally consented to the subject’s participation in the trial and, if capable of doing so, has signed and personally dated the informed consent form, the witness should sign and personally date the Missing / Additional GCP Element is Needed consent form. By signing the consent form, the witness attests that the information in the consent form and any other written information was Comments: accurately explained to, and apparently understood by, the subject or Concerns: the subject's legally acceptable representative, and that informed consent was freely given by the subject or the subject’s legally Requirements: acceptable representative. Recommendations:

(GCP) When GCP is followed, or when deemed applicable, both the N/A- GCP not required for this study and/or it is deemed informed consent discussion and the written informed consent form and any other written information to be provided to subjects should that these elements are not otherwise required nor include explanations of the recommended following: All GCP requirements of this subsection are met. (a) Page(s): That the trial involves research. Missing / Additional GCP element(s) is(are) needed (b) Page(s): The purpose of the trial.

Comments: (c) Page(s): The trial treatment(s) and the probability for random Concerns: Requirements: assignment to each treatment. Recommendations: (d) Page(s): The trial procedures to be followed, including all invasive procedures. (e) Page(s): The subject's responsibilities.

(f) Page(s): Those aspects of the trial that are experimental.

(g) Page(s): The reasonably foreseeable risks or inconveniences to the subject and, when applicable, to an embryo, fetus, or nursing infant. (h) Page(s): The reasonably expected benefits. When there is no intended clinical benefit to the subject, the subject should be made aware of this. (i) Page(s): The alternative procedure(s) or course(s) of treatment that may be available to the subject, and their important potential benefits and risks. (j) Page(s): The compensation and/or treatment available to the subject in the event of trial related injury. (k) Page(s): The anticipated prorated payment, if any, to the subject for participating in the trial.

(l) Page(s): The anticipated expenses, if any, to the subject for participating in the trial. (m) Page(s): That the subject's participation in the trial is voluntary and that the subject may refuse to participate or withdraw from the trial, at any time, without penalty or loss of benefits to which the subject is otherwise entitled. (n) Page(s): That the monitor(s), the auditor(s), the IRB/IEC, and the regulatory authority(ies) will be granted direct access to the subject's original medical records for verification of clinical trial procedures and/or data, without violating the confidentiality of the subject, to the extent permitted by the applicable laws and regulations and that, by signing a written informed consent form, the subject or the subject's legally acceptable representative is authorizing such access. (o) Page(s): That records identifying the subject will be kept confidential and, to the extent permitted by the applicable laws and/or regulations, will not be made publicly available. If the results of the trial are published, the subject’s identity will remain confidential. (p) Page(s): That the subject or the subject's legally acceptable representative will be informed in a timely manner if information becomes available that may be relevant to the subject's willingness to continue participation in the trial. (q) Page(s): The person(s) to contact for further information regarding the trial and the rights of trial subjects, and whom to contact in the event of trial-related injury. (r) Page(s): The foreseeable circumstances and/or reasons under which the subject's participation in the trial may be terminated. (s) Page(s): The expected duration of the subject's participation in the trial. (t) Page(s): The approximate number of subjects involved in the trial.

(GCP) When GCP is followed, or when deemed applicable, Page(s): Prior to participation in the trial, the subject or the subject's legally acceptable representative should receive a copy of the signed and dated N/A- GCP not required for this study and/or it is deemed written informed consent form and any other written information provided to the subjects. During a subject’s participation in the trial, that this element is not otherwise required nor recommended the subject or the subject’s legally acceptable representative should

IRB Reviewer Checklist (Version 06.16.2017) Page 23 receive a copy of the signed and dated consent form updates and a GCP requirements met. copy of any amendments to the written information provided to subjects. Missing / Additional GCP Element is Needed

(GCP) When GCP is followed, or when deemed applicable, Page(s): When a clinical trial (therapeutic or non-therapeutic) includes subjects who can only be enrolled in the trial with the consent of the subject’s N/A- GCP not required for this study and/or it is deemed legally acceptable representative (e.g., minors, or patients with severe dementia), the subject should be informed about the trial to the extent that this element is not otherwise required nor compatible with the subject’s understanding and, if capable, the subject recommended should sign and personally date the written informed consent. GCP requirements met.

(GCP) When GCP is followed, or when deemed applicable, except as Page(s): described in above, a non-therapeutic trial (i.e., a trial in which there is no anticipated direct clinical benefit to the subject), should be N/A- GCP not required for this study and/or it is deemed conducted in subjects who personally give consent and who sign and date the written informed consent form. that this element is not otherwise required nor recommended GCP requirements met.

(GCP) When GCP is followed, or when deemed applicable, non- Page(s): therapeutic trials may be conducted in subjects with consent of a legally acceptable representative provided the following conditions are N/A- GCP not required for this study and/or it is deemed fulfilled: (a) The objectives of the trial cannot be met by means of a trial in that this element is not otherwise required nor subjects who can give informed consent personally. recommended (b) The foreseeable risks to the subjects are low. GCP requirements met. (c) The negative impact on the subject’s well-being is minimized and low. (d) The trial is not prohibited by law.

(e) The approval/favorable opinion of the IRB/IEC is expressly sought Missing / Additional GCP Element is Needed on the inclusion of such subjects, and the written approval/ favorable opinion covers this aspect. Such trials, unless an exception is justified, should be conducted in patients having a disease or condition for Comments: which the investigational product is intended. Subjects in these trials Concerns: should be particularly closely monitored and should be withdrawn if Requirements: they appear to be unduly distressed. Recommendations:

(GCP) When GCP is followed, or when deemed applicable, in Page(s): emergency situations, when prior consent of the subject is not possible, the consent of the subject's legally acceptable representative, if present, N/A- GCP not required for this study and/or it is deemed should be requested. When prior consent of the subject is not possible, and the subject’s legally acceptable representative is not available, that this element is not otherwise required nor enrolment of the subject should require measures described in the recommended protocol and/or elsewhere, with documented approval/favourable GCP requirements met. opinion by the IRB/IEC, to protect the rights, safety and well-being of the subject and to ensure compliance with applicable regulatory requirements. The subject or the subject's legally acceptable Missing / Additional GCP Element is Needed representative should be informed about the trial as soon as possible and consent to continue and other consent as appropriate should be Comments: requested. Concerns: Requirements: Recommendations:

(G/D) When applicable, include language regarding any Page(s): anticipatable incidental finding. N/A- Not required nor recommended For more information see Downstate Guidance on Legally Effective Informed Consent or the Presidential Commission for the Study of N/A Bioethical Issues (Bioethics Commission) report: Anticipate and Communicate: Ethical Management of Incidental and Secondary Comments: Findings in the Clinical, Research, and Direct-to Consumer Contexts, the primer for IRB Members: Incidental and Secondary Findings, or Concerns: the primer for Researchers: Incidental and Secondary Findings. Requirements: Recommendations:

(G/D) A version # or version date is recommended. N/A- Not required nor recommended

Recommendations met

Pending

(G/D) For FDA regulated research, the “date” of the signature must be Page(s):

IRB Reviewer Checklist (Version 06.16.2017) Page 25 included. Downstate recommends a date always be included, regardless N/A- Not required nor recommended of whether the study is FDA regulated.

Date included for each signature

List any signature line which is missing a date: Comments: Concerns: Requirements: Recommendations:

(F/N) The following signatures lines are required on the informed consentPage(s): (or information sheet w/HIPAA Authorization) for this study: All required signature lines are provided. Adult (with capacity to consent) List any signature line which is missing: Legally Authorized (Personal) Representative Comments: Child Assent (ages 13-17) Concerns: Requirements: Parent/Legal Guardian (Required when enrolling a child, under the Recommendations:

age of 18) 2nd Parent/Legal Guardian (Required for 406 and 407 research

categories) Married or Emancipated Minor (if applicable)

Interpreter (Required when enrolling individuals with Limited

English Proficiency [LEP]) Witness (Required when enrolling individuals with LEP)

(D/GCP) The following signatures lines are required or recommended for Page(s): this study: All required signature lines are provided. Investigator (Generally always recommended) List any signature line which is missing: Impartial Witness (Recommended for the following: 1) Comments: Clinical Trial involving an IND 2) Device study involving an IDE Concerns: 3) When the Short Form is used for any reason 4) When a Requirements: potential research participant is: Cognitively impaired; Limited with their English proficiency; Blind, visually impaired, or Recommendations: enrolled using a brail consent; Deaf or hearing impaired; Unable to read; Cannot write or physically sign the consent form or must signal consent or make his/her “mark” on the consent form)

Independent Consent Monitor (Generally required when

enrolling Married Minor or Emancipated Minor, or Ward, when parental permission is waived, and for clinical trials that follow GCP)

For DOD, VA, or other government funded study, are all additional informed consent requirements met? N/A

Yes. All other requirements are met.

No. Describe below.

Additional Information:

Quality Improvement:

Please provide any feedback to help improve the review process:

Review End Date: Review End Time: Estimated time it took to complete this review:

NOTICE OF GCP COPYRIGHT: Information regarding GCP requirements was taken from the: International Council for Harmonisation (ICH) Harmonized Guideline: Integrated Addendum to ICH E6 (R1): Guideline for Good Clinical Practice E6 (R2).