Northwell Health - Human Research Protection Program
                                            Informed Consent Review Checklist
        The Human Research Protection Program at Northwell Health conducts routine and for-cause reviews of research studies
        to ensure adherence to federal and state regulations (e.g. FDA, OHRP, HIPAA, NYS, etc.), institutional policies (e.g. 
        Northwell Health, HRPP), and best practices such as current Good Clinical Practice (GCP) E6 Guidance related to informed
        consent process and documentation to ensure protection of rights, safety and welfare of research subjects
        GENERAL INFORMATION
        Name of person completing checklist:                                           Date:
        Study Title
        IRB Protocol Number
        Principal Investigator
        PI contact info./E-mail Address
        Study Coordinator(s)
        Coord. contact info./E-mail Address
        Department/ Service Line*
        *For oncology studies, auditors must 
        complete ORC NCI oncology checklist that is
        applicable for this review.
                                             ☐ Hospital Facility (specify):
        Location(s) of Research Reviewed     ☐ Ambulatory site (specify location):
                                             ☐ Other (specify):
        Investigator Initiated Study?        ☐  YES           ☐ NO
        If yes, does the investigator hold   ☐ YES           ☐ NO         ☐ N/A
        IND?
        Sponsor(s)
        Funding (check all that apply)       ☐ Industry   ☐ Government   ☐ Internal/Department
                                             ☐ Foundation   ☐ Other: ______________
        Regulatory requirements that apply   ☐ FDA   ☐ DOD   ☐ GCP   ☐ NIH   ☐ Other: ____________
        IRB of Record                        ☐ Northwell Health IRB        ☐ BRANY  
                                             ☐ External IRB (specify):____________________
        IRB Determined Risk Category         ☐ Minimal Risk     ☐ Greater than Minimal Risk
        IRB Review Type                      ☐  Expedited      ☐ Full Board    
        Renewal                              ☐ Annual Check in       ☐ Full Renewal Review
        Northwell Health Office of Research Compliance v. August 2021                                                             Page 1 of 10
                                                                  IRB Initial Approval Date: ________
            Study Information                                     Institutional Approval Date: __________
                                                                  First Subject Consent Date: ___________
                                                                  Current IRB Expiration Date: __________
                                                                  ☐ Not Applicable
                                                                  ☐ (1) Research not involving greater than minimal risk (§45CFR46.404, §21CFR50.51).
                                                                  ☐ (2) Research involving greater than minimal risk, but presenting the prospect of direct benefit to the 
                                                                  individual subjects (§45CFR46.405, §21CFR50.52).
            Pediatric Risk Category                               ☐ (3) Research involving greater than minimal risk and no prospect of direct benefit to individual subjects, 
                                                                  but likely to yield generalizable knowledge about the subject’s disorder or condition (§45CFR46.406, 
                                                                  §21CFR50.53).
                                                                  ☐ (4) 46.407 Research not otherwise approvable which present an opportunity to understand, prevent, or 
                                                                  alleviate a serious problem affecting the health or welfare of children (§45CFR46.407, §21CFR50.54).
            Enrollment # (Enrolled is anyone who                  # IRB Approved: ________  # Enrolled to date: ________
            signed an ICF)
                  1. STUDY PERSONNEL QUALIFICATIONS
              NIH Policy NOT-OD-16-148: Policy on Good Clinical Practice Training for NIH Awardees Involved in NIH-funded Clinical Trials
              GCP  2.8; 4.1.1;  HRPP Policy 5.1 & 5.2: Principal Investigator & Research Team Members
              Northwell Health Research Policy GR085: Training Requirements for the HRPP
              Northwell Health Research Policy GR065: Review and Management of External Interests(COIs) in Research (Individual)
              Northwell Health Research Policy GR097: IND/IDE Sponsor-Investigator Responsibilities
                                                                         Completed HRPP Education
                                                                               & Registration
                                                                               Requirements?2                                                                     On File?
                                                                                                                                        Annual COI
                                                          Can obtain      CITI (HST & GCP (3yrs)),         Date IRB       Date IRB      Disclosure                         License
               #              Name                Role    consent?1           COI (4yrs), etc.)            approved       removed       Certified?3         CV:            (If app)
             1.
             2.
             3.
             4.
             5.
             6.
             7.
             8.
             9.
             10.
              1)   Confirm training and the qualifications of each investigator who is authorized to obtain consent from subjects.
              2)   All individuals involved in research using biological agents must receive the appropriate level based on the type of research involved and 
            Northwell Health Office of Research Compliance v. August 2021                                                                                                 Page 2 of 10
                 should include those involved in the handling and management of biological agents.
            3)   For any investigators with positive COI disclosures requiring a management plan, specify any restrictions noted and review for compliance 
                 with the plan (Check COI Smart).
            Comments:
               1. REGULATORY DOCUMENTATION & RECORD KEEPING
          Reference: FDA 21CFR312.57 & 21CFR312.64; ICH GCP 4.9.4, 5.5.6, 5.5.7, & 8.1-8.4; Northwell Health Research Policy 
          GR042: Maintenance of Human Subject Research Regulatory Documentation 
          Depending on the type of study and sponsor, some studies require different regulatory documents.  Review your 
          regulatory documents and complete this section according to the requirements that apply to your study.  
                                                                                               YES      NO      N/A                  Reference:
          2.1      Does the study team maintain regulatory documents?                           ☐       ☐
                   If so, how are regulatory documents maintained? (check all that apply)
          2.2      ☐ Paper (e.g., regulatory binder)
                   ☐ Electronically (e.g., shared file or system)                                                          ICH GCP 2.10, 4.9.4, 5.5.6, & 5.5.7
                   (If electronic)
          2.3      Has the study team ensured all electronically filed                          ☐       ☐        ☐
                   documents are available and easily retrievable?
          2.4      All CVs & licenses (if applicable) of key personnel on file?                 ☐       ☐
                   All licenses up-to-date?                                                                                  ICH GCP 4.1.1, 8.2.10 & 8.3.5
                                                                                                ☐       ☐
                            Is there a subject screening/enrollment log?                       ☐       ☐
                            Is the subject screening/enrollment log complete?                 ☐        ☐ 
          2.5               # of subjects included? _________                                                                  ICH GCP 8.3.20, 8.3.21,
                                                                                                                                     8.3.22 & 8.4.3
                            # of subjects excluded? _________
                            Is there a subject identification code list?                       ☐       ☐
                            Is there an auditing/monitoring log?                               ☐       ☐
                            Was the log signed by the ORC auditor?                             ☐       ☐
          2.6               Is the log complete/up to date?                                    ☐       ☐                           ICH GCP 8.3.10
                            If the study requires monitoring, how frequently 
                             do reviews occur? ______________
                            Is there a staff signature log?                                    ☐       ☐
                            Is staff signature log complete?                                   ☐       ☐
          2.7               Is there a staff delegation of responsibility log (can             ☐       ☐                       ICH GCP 4.1.5 & 8.3.24
                             be combined with staff signature log)?
                            Is the staff delegation log complete/accurate?                     ☐       ☐
                   (If applicable)
          2.8               Are all versions of the Investigator’s Brochure or                 ☐       ☐        ☐
                             equivalent information on file?                                                                   ICH GCP 7.1, 8.2.1 & 8.3.1
                            Product information sheet on file?                                 ☐       ☐        ☐
          2.9      Are lab tests required?                                                      ☐       ☐
          2.10     If lab results are needed for:                                                                             CLIA Public Law 100-578
          Northwell Health Office of Research Compliance v. August 2021                                                                                  Page 3 of 10
                                                                                      YES     NO      N/A                Reference:
                   eligibility 
                   treatment decisions based on test results 
                   study results that are shared with subjects 
                   treatment providers to alter care,                                                          New York State Public Health Law
                 Are labs done in a CLIA approved or NYS Dept. of Health                                                Article 5, Title V
                 certified lab?                                                        ☐       ☐       ☐
         2.11    Is a copy of normal lab values on file or the values are 
                 documented along with the test results?                               ☐       ☐       ☐             ICH GCP 8.2.11 & 8.3.6
                 Is a copy of the lab certification on file or readily                 ☐       ☐       ☐
                 accessible?                                                                                              CLIA – CMS
         2.12
                 (For research labs where applicable) Is a copy of the Lab             ☐       ☐       ☐             ICH GCP 8.2.12 & 8.3.7
                 Director’s CV on file?
                 Is COI certification completed and up to date for each                                          FDA 21CFR54; Northwell Health
         2.13                                                                          ☐       ☐               Research Policy GR065: Conflicts of
                 investigator?                                                                                        Interest in Research
                 For a sponsor-investigator study,                                                              Northwell Health Research Policy
         2.14    Is Form FDA 1572 ‘Statement of Investigator’ completed                ☐       ☐       ☐       GR097: IND-IDE Sponsor-Investigator
                 and up to date for key study personnel?                                                                Responsibilities
         2.15    All relevant correspondence to and from sponsor and/or 
                 FDA on file (if app)?                                                 ☐       ☐       ☐          FDA 21CFR312; ICH GCP 4.9.4
                         Is this an applicable clinical trial or NIH funded           ☐       ☐                   US Public Law 110-85 (FDA
                          clinical trial?                                              ☐       ☐               Amendments Act of 2007), Title VIII,
         2.16            Is the study registered on clinicaltrials.gov?                                                    Sec.801
                          # NCT_______________________                                                                 ICMJE requirement
                                                                                       ☐       ☐ ☐              Northwell Health Research Policy
                         Is the information up to date?                                                      GR020: Requirements for Registration
                 If the study is a clinical trial conducted/supported by a                                           of Clinical Research at
         2.17    Federal department/agency, does the study team have a                 ☐       ☐       ☐             www.clinicaltrials.gov
                 process/plan for posting a copy of the ICF to                                                        45 CFR 46.116 (h) (1)
                 clinicaltrials.gov or regulations.gov?
                         Is there a Data Safety Monitoring Board/ 
                          Committee/ Plan for this study?
                         If yes, did they adhere to the plan?                         ☐       ☐       ☐              ICH GCP 6.8 & 8.3.18
         2.18            Are all DSMB/C reports and recommendations on                ☐       ☐       ☐
                                                                                       ☐       ☐       ☐          HRPP Policy: Data and Safety
                          file?                                                                                           Monitoring
                         Have all DSMB/C reports been submitted to the                ☐       ☐       ☐
                          IRB?
         2.19    Does the study team have a plan for record retention upon
                 study completion?                                                     ☐       ☐       ☐               FDA 21CFR312.62
          Please use this section to explain any issues with Regulatory Documentation & Record Keeping:
              2. INSTITUTIONAL AND REGULATORY APPROVAL DOCUMENTATION- Relevant to Consent form and 
                   Process Only
          Reference: FDA 21CFR312; ICH GCP 4.4.1 & 4.5.1
          Records                                                             YES      NO      NA                   Reference:
         3.1     All relevant correspondence (e.g., submissions,               ☐        ☐                         FDA 21CFR312. 66
                                                                                                          ICH GCP 4.4.3, 4.9.4, 8.3.3 & 8.3. 19
          Northwell Health Office of Research Compliance v. August 2021                                                                         Page 4 of 10