Submission Materials

/ SUNY Downstate Medical Center
University Hospital of Brooklyn
College of Medicine
College of Health Related Professions
College of Nursing
School of Graduate Studies
Graduate Program in Public Health / EXPEDITED/FULL BOARD 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:

Material(s) / Status / Comments/Corrective Actions:
IRBNet Registration Form / Present
Pending / Comments:
Concerns:
Requirements:
Recommendations:
Indicate Type of Application for New Study:
Expedited
Full
NOTE: Do not use this checklist to evaluate a HUD for clinical use or Emergency Use situations. / Present
Pending / Comments:
Concerns:
Requirements:
Recommendations:
If expedited, indicate research category(ies):
N/A – This is a full board study

Clinical studies of drugs and medical devices only when condition (a) or (b) is met.
Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required. (Note: Research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review.)
Research on medical devices for which (i) an investigational device exemption application (21 CFR Part 812) is not required; or (ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.
Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:
from healthy, nonpregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 ml in an 8 week period and collection may not occur more frequently than 2 times per week; or
from other adults and children [2], considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection may not occur more frequently than 2 times per week.
Prospective collection of biological specimens for research purposes by noninvasive means.
Examples: (a) hair and nail clippings in a nondisfiguring manner; (b) deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction; (c)permanent teeth if routine patient care indicates a need for extraction; (d) excreta and external secretions (including sweat); (e) uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue; (f) placenta removed at delivery; (g) amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; (h) supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques; (i) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; (j) sputum collected after saline mist nebulization.
Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing. (Studies intended to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, including studies of cleared medical devices for new indications.)
Examples: (a) physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the subject or an invasion of the subject=s privacy; (b) weighing or testing sensory acuity; (c) magnetic resonance imaging; (d) electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography; (e) moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.
Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis). (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(4). This listing refers only to research that is not exempt.)
Collection of data from voice, video, digital, or image recordings made for research purposes.
Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(2) and (b)(3). This listing refers only to research that is not exempt.)

Reference:
Although the study could be expedited under the Federal Regulations, the study will be sent to the full board, based on IRB-01 Policy for the follow reason(s):
Research involves an IND, IDE, or is a NSR study.
Biomedical interventions with children, pregnant women, neonates, prisoners, or cognitively impaired adults
Certificate of Confidentiality
Comments:
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:
Risk assessment for investigational studies designed to evaluate safety and effectiveness of a medical device. / N/A
Significant Risk (SR)
Non- SR (NSR) / Comments:
Concerns:
Requirements:
Recommendations:
Scientific Review Worksheet. Comments present? Yes No / Present
Pending / Comments:
Concerns:
Requirements:
Recommendations:
Conflict of Interest Disclosures for PI and other “investigators for the purposes of COI” (See IRB Office Review Worksheet) / Present
Pending/missing
SFI disclosed
Management Plan in place / Comments:
Concerns:
Requirements:
Recommendations:
Required Training (See IRB Office Review Worksheet) / Present
Pending/missing / Comments:
Concerns:
Requirements:
Recommendations:
Protocol Type: Sponsor Investigator / Present
Pending/missing / Comments:
Concerns:
Requirements:
Recommendations:
Grant Application or Grant Cover sheet: NIH application section “Key Personnel” and “Human Subjects section and Research Methodology” (Required for Federally funded/supported studies, through 1/18/18) / Present
N/A
Pending/missing / Comments:
Concerns:
Requirements:
Recommendations:
Consent Form(s); Check if includes:
HIPAA Authorization Language
Parental Permission Form(s)
Assent (Children ages 13-17) / Present
N/A
Pending/missing / Comments:
Concerns:
Requirements:
Recommendations:
Assent Form (s). Generally required if you are planning to enroll participants age 7-12. / Present
N/A
Pending/missing / 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/missing / 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/missing / 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/missing / Comments:
Concerns:
Requirements:
Recommendations:
HIPAA Waiver(s). Indicate Type: Full; Partial; Alteration / Present
N/A
Pending/missing / Comments:
Concerns:
Requirements:
Recommendations:
Waiver 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/missing
Are criteria met for waiver? (regardless if present)
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/missing
Are criteria met for waiver? (regardless if present)
YES NO / Comments:
Concerns:
Requirements:
Recommendations:
Waiver of Documentation 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/missing
Are criteria met for waiver? (regardless if present)
YES NO / Comments:
Concerns:
Requirements:
Recommendations:
HIPAA Preparatory to Research Certification Form / Present
N/A
Pending/missing / Comments:
Concerns:
Requirements:
Recommendations:
Recruitment Materials (including, but not limited to flyers, brochures, ads, e-mails, telephone script, etc). / Present
N/A
Pending/missing / Comments:
Concerns:
Requirements:
Recommendations:
Subject Recruitment Authorization Form (Signed by patient). / Present
N/A
Pending/missing / Comments:
Concerns:
Requirements:
Recommendations:
Physician’s Documentation of Patient’s Verbal Authorization. / Present
N/A
Pending/missing / Comments:
Concerns:
Requirements:
Recommendations:
Questionnaires/Surveys. / Present
N/A
Pending/missing / Comments:
Concerns:
Requirements:
Recommendations:
Data Collection Tools (or list of data to be collected). / Present
N/A
Pending/missing / Comments:
Concerns:
Requirements:
Recommendations:
*Investigator Brochure for study involving an IND (investigational drug or biological agent). / Present
N/A
Pending/missing / Comments:
Concerns:
Requirements:
Recommendations:
*FDA Form 1572 for study involving an IND (investigational drug or biological agent). / Present
N/A
Pending/missing / Comments:
Concerns:
Requirements:
Recommendations:
*IND letter for study involving an IND for an investigational drug or biological agent. / Present
N/A
Pending/missing / Comments:
Concerns:
Requirements:
Recommendations:
*Device Package Insert for IDE study. / Present
N/A
Pending/missing / Comments:
Concerns:
Requirements:
Recommendations:
CV or Biosketch of PI (optional). This is generally not needed unless the PI is new; however, the IRB may request this to evaluate the PI’s qualifications, as required by the FDA and OHRP regulations. In general, this should be provided for any PI that is External to Downstate or H+H, Kings County.
*CV must be submitted to IRB if this is a clinical trial which follows GCP standards. / Present
N/A
Missing. Please request CV/Biosketch to evaluate PI qualifications.
Missing. Required for GCP. / Comments:
Concerns:
Requirements:
Recommendations:
Credentials of PI or other study staff (optional). / Present
N/A
Pending/missing / Comments:
Concerns:
Requirements:
Recommendations:
Sponsor contract (optional). Generally not needed, unless the IRB needs to review language in the informed consent regarding injuries or additional costs. / Present
N/A
Pending/missing
Request Pre-Award review of ICF to check adequacy of language regarding injuries or additional cost / Comments:
Concerns:
Requirements:
Recommendations:
Letter of support from the external site (except KCHC) when not covered by an IRB Reliance Agreement or External IRB approval. / Present
N/A
Pending/missing / 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. / No
Yes
Comments:
Concerns:
Requirements:
Recommendations:

Investigator Qualifications:

Is the PI qualified to conduct and oversee the research?
Review CV if not familiar with the investigator / Yes
No
Comments:
Concerns:
Requirements:
Recommendations:
Are there any other concerns related to investigator qualifications?
Check when applicable or concerned:

Lists posted on FDA’s website
Clinical Investigator Status (Biologics)
Inspection Classification Database Search
Clinical Investigators - Disqualification Proceedings
Inspections, Compliance, Enforcement, and Criminal Investigations

/ No
Yes
Comments:
Concerns:
Requirements:
Recommendations:

PI Status:

Does the PI have the required status? / Yes
No
Comments:
Concerns:
Requirements:
Recommendations:
If multiple PIs are used in this project, are there any concerns with the roles, responsibilities or relationship to the primary PI? / No
N/A
Yes
Comments:
Concerns:
Requirements:
Recommendations:

Adequacy of Research Site:

Does the site adequate to conduct the research?

Evaluate the adequacy of the facility’s staff and medical equipment
Evaluate the adequacy of emergency or specialized care, if the need arises
May require a statement from the research site indicating the site is adequate or require a description from the PI that includes a description of the facility where the research will take place, including staffing and resources relevant to the research under review.

/ Yes
No
Comments:
Concerns:
Requirements:
Recommendations:

General Criteria For IRB Approval of Non-Exempt Human Research/Clinical Investigations:

Criteria / Is Criteria Met?
Risks to research participants are minimized:

by using procedures which are consistent with sound research design and which do not unnecessarily expose research participants to risk, and
whenever appropriate, by using procedures already being performed for diagnostic or treatment purposes.

/ Yes
No
Comments:
Concerns:
Requirements:
Recommendations:
Risks to research participants are reasonable in relation to anticipated benefits, if any, to research participants, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB considers only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies research participants would receive even if not participating in the research). The IRB does not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility. / Yes
No
Comments:
Concerns:
Requirements:
Recommendations:
Selection of research participants is equitable. In making this assessment the IRB takes into account the purposes of the research, the adequacy of inclusion and exclusion criteria, and the setting in which the research will be conducted. The IRB is particularly cognizant of the special problems of research involving interactions or interventions with vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons. / Yes
No
Comments:
Concerns:
Requirements:
Recommendations:
Informed consent and HIPAA research authorization will be sought from each prospective research participants or their LAR, in accordance with, and to the extent required by the federal regulations and will be appropriately documented, unless waived.

The IRB members review the informed consent document to ensure all required elements and appropriate additional elements are provided to the research participant at the time of initial review.
At the time of continuing review, the IRB must also review the informed consent document to determine if any additional changes are required.

/ Yes
No
Informed Consent adequate
Informed Consent is NOT adequate
HIPAA Authorization adequate
HIPAA Authorization is NOT adequate
Informed Consent (process) Waived (all requirements met)
Request to waive the process for informed consent is NOT adequate
Documentation of IC (signature) waived; Information sheet OK
Request to waive documentation (signature) of informed consent is NOT adequate
HIPAA Authorization Waived
Criteria to waive HIPAA Authorization are not met
Comments:
Concerns:
Requirements:
Recommendations:
When appropriate, the research plan must make adequate provision for monitoring the data collected to ensure the safety of research participants. / Yes
N/A
No; provide more details below:
Comments:
Concerns:
Requirements:
Recommendations:
When appropriate, there are adequate provisions to protect the privacy of research participants and to maintain the confidentiality of data. / Yes
N/A
No; provide more details below:
Comments:
Concerns:
Requirements:
Recommendations:
When some or all of the research participants are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, the IRB must evaluate whether additional safeguards have been included in the study to protect the rights and welfare of these research participants based on the IRB application materials. The IRB may require additional safeguards, if needed. / Yes
N/A
No; provide more details below:
Comments:
Concerns:
Requirements:
Recommendations:
In order to approve research involving some or all research participants that include vulnerable populations, the IRB must also ensure the research is in compliance with regulations to the extent required by 45 CFR 46, subpart B, C, and D and 21 CFR 50, subpart D and DMC Policies. See next sections for more details. / Yes
N/A
No; provide more details below:
Comments:
Concerns:
Requirements:
Recommendations:
FDA requires the sponsor or the sponsor-investigator to determine whether an IND or IDE is required for a particular study. The IRB may request the basis for the determination or request supporting documentation from the FDA. If the IRB is unable to resolve the issue, it will be considered a controverted issue and cannot approve the study until the matter is resolved. / Yes
N/A
No; provide more details below:
Comments:
Concerns:
Requirements:
Recommendations:
For investigational device studies, the IRB’s determination that a device study is significant risk (SR) or non-significant risk (NSR) can be made at a convened meeting. A SR device study must have an IDE from the FDA before the IRB can approve the investigation. / Yes
N/A
No; provide more details below:
Comments:
Concerns:
Requirements:
Recommendations:

Category of permissible research for Children: