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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
Reference: GCP 4.1.1
Study Personnel Northwell Health Research Policy GR085: Training in the Conduct of Human Subject Research &
GR065: Conflicts of Interest in Research; HRPP Policy Criteria for IRB Approval of Research

Completed HRPP Education & On File?


Registration Requirements? Annual COI CV: Signed &
Can obtain CITI (HST & GCP (3yrs), Date IRB Date IRB Disclosure dated within 2 License
# Name Role1 consent?2 COI (4yrs), etc.) approved removed Certified?3 Yrs (If app)
1

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1) Confirm training
2) Confirm the qualifications of each investigator who is authorized to obtain consent from subjects.
3) For any investigators with positive COI disclosures requiring a management plan, specify any restrictions noted and review for compliance with
the plan (Check COISmart).
Study Staff changes since last
YES NO
continuing review?
If yes, was an amendment submitted
YES NO N/A
to the IRB?
Department/ Service Line

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Institution (specify exact location)
Sponsor Investigator Study?
YES NO
If yes, does the investigator held
YES NO N/A
IND?
Sponsor(s)
Funding Industry Government Internal/Department
(check all that apply) Foundation Other: ______________
Other regulatory requirements that FDA DOD GCP ISO
apply NIH Other: ______________
Northwell Health IRB Central IRB
BRANY Relying on other IRB (specify):________________
IRB Review Review type: Expedited Full Board
IRB Initial Approval 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 signed a consent # IRB Approved: ________ # Enrolled to date: ________
form)
Comments:

1. REGULATORY DOCUMENTATION & RECORD KEEPING

Reference: Northwell Health Research Policy GR042: Research Regulatory Binder; ICH GCP 4.9.4, 5.5.6, 5.5.7, &
8.1-8.4; FDA 21CFR312.57 & 21CFR312.64

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:
1.1 Do you maintain regulatory documents?
If so, what type of regulatory binder is used?
Northwell Health provided version
Northwell Health adapted version ICH GCP 2.10, 4.9.4, 5.5.6, & 5.5.7
1.2
Sponsor provided version
Electronic version
Other: ________________
(If applicable)
Have the study team ensured all electronically
1.3
filed documents are available and easily
retrievable?

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Are all CVs & licenses (if applicable) of key
personnel on file?
1.4 Are CVs signed and dated (within the past 2 ICH GCP 4.1.1, 8.2.10 & 8.3.5
years)?
All licenses up-to-date?
Is there a subject screening/enrollment log?
Is the subject screening/enrollment log
1.5 complete? ICH GCP 8.3.20, 8.3.21,
8.3.22 & 8.4.3
# of subjects included? _________
# of subjects excluded? _________
Is there an auditing/monitoring log?
(Auditors please sign in on the log)
1.6 Is the log complete? 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?
1.7 Is there a staff delegation of responsibility log ICH GCP 4.1.5 & 8.3.24
(can be combined with staff signature log)?
Is the staff delegation log complete?
Please use this section to explain any issues with Regulatory Documentation & Record Keeping:

2. IRB DOCUMENTATION – Relevant to Consent Form and Process Only

Reference: ICH GCP 4.4.1 & 4.5.1


YES NO N/A Reference:
All relevant correspondence (e.g. e-mails,
2.1 ICH GCP 4.4.3, 4.9.4,
submissions, responses, approvals) to and 8.3.3 & 8.3.19
from the HRPP and IRB on file?
IRB/Institutional HRPP Initial Approval
Final IRB approval & documents approved on GR056 HS Research Policy: Research with Human
file? Subjects (IRB Approval)
HRPP Policy: Criteria for IRB Approval of Research
2.2 List items: ICH GCP 4.4.1 & 8.2.7
Institutional HRPP approval & documents
approved on file?
List items:
Continuing Review

Date Rec’d Date IRB approval letter on file?


Details
by IRB approved YES NO
2.3 Continuing Review # 1

Continuing Review # 2

Continuing Review # 3

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YES NO
Was each PR submitted on time?
 If NO:

a) Was there any lapsed period(s) between


HRPP Policy: Continuing Review
approval date and expiration date?
b) Was any subject enrolled during this FDA 21CFR 812.150
lapsed period?
2.4 ICH GCP 4.10.1& 8.3.3
c) If YES, was a protocol deviation submitted
to the IRB? (Please explain in the
ISO 14155:2011 2.5.2, 4.5.4, 8.2.3,
comments if the deviation was not 8.2.4.5, 9.4, 9.8, E.2.21
submitted)
d) Were study activities conducted during
this lapsed period?
e) If yes, is there documentation of IRB
approval on file?
Modifications (Amendments) & Other IRB Notifications
GCP 4.5
Related to Informed Consent and Protocol Changes
Date IRB acknowledgement/
Date Rec’d approval letter on file?
Change Requested acknowledged/
by IRB
approved YES NO
1)
List items:
2)
2.5 List items:
3)
List items:
4)
List items:
5)
List items:
6)
List items:
FDA 21CFR312.66; GCP 4.5; GCP 4.11;
Reportable Events & Protocol Exceptions HRPP Policy: Protocol Exceptions & Unanticipated Problems Involving Risk to
Subjects and Others
Event Type Date IRB acknowledgement/
Date of Date Rec’d approval letter on file?
(e.g.: Protocol Deviation, Unanticipated acknowledged/
Event by IRB
Problem, SAE, Protocol Exception) approved YES NO
1)
List details:
2)
2.6 List details:
3)
List details:
4)
List details:
5)
List details:
6)
List details:

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Any reportable events not reported to the IRB (or HRPP for external IRBs)?
Have any of the following issues been reported by PI:
 New information that might adversely affect the safety of the subjects or
2.7 the conduct of the clinical trial
 Any changes significantly affecting the conduct of the clinical trial or
increasing risk to subjects
If Yes, provide details and recommendation:
Any sponsor-approved protocol exceptions? YES NO N/A
2.8
 If YES, have they been approved by the IRB prior to implementation? YES NO
2.9 IRB Approved Protocol and Consent Versions GCP 4.4, 4.8, 4.9, 8.2.2, 8.2.7
Approved ASSENT
Approved Approved consent version date if Comments (please describe
protocol version version date (with applicable (with IRB the differences from the
date On file? IRB stamp date) On file? stamp date) On file? previous version)

2.10 Who prepares:


PI Co-I Coordinator Other___________
(Check all that apply)
Progress report to the IRB?

SAE/AE reports?
Modifications?
Any quality recommendations for the protocol /consent documents?

Please use this section to explain any issues with IRB Documentation:

3. INFORMED CONSENT PROCESS & DOCUMENTATION

Reference: ICH GCP 4.8, 4.9, FDA ALCOAC Standards; GR010 Northwell Health Research Policy: Informed
Consent; Northwell Health Policy 100.23 Informed Consent and LEP
List the types of consent forms used
3.1 (e.g. healthy volunteers, affected,
minor or adult subjects, etc.)
Where are the original signed consent Reference:
3.2
forms kept? ICH GCP 8.2.7, 8.3.3 & 8.3.12
Where are copies of the signed consent HRPP Policy: Documentation of Informed
3.3 Consent
forms kept (e.g. MR, subject file, etc.)?
YES NO Reference:
Were any invalid consent forms used? HRPP Policy: Informed Consent
3.4
(Includes use of a consent without an IRB approval

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stamp, expired or incorrect consent) ICH GCP 4.8.8 & 8.3.12

If yes, was a protocol violation submitted to IRB?


For LEP,
If applicable, were translated short forms used?
3.5
If Yes, were translated HIPAA forms used?
If No, was a protocol violation submitted to the IRB?

Did each subject/LAR sign his/her own consent form?


3.6
Did each subject/LAR date his/her own consent form?
List the subject ID#s chosen for consent review:

YES NO Reference:
Are there enrollment notes written for each subject
that were signed and dated by individual who wrote
the note?
3.7 HRPP Policy: Informed Consent
If so, is a copy of the enrollment note and consent
form placed in the subject’s inpatient or outpatient
chart (as appropriate)?
Did each subject receive a copy of the signed consent
form? HRPP Policy: Informed Consent
3.8 ICH GCP 4.8.11
Is subject’s receipt of a copy of the signed consent
form documented?
For studies with multiple visits (if app):
As informed consent is an ongoing process, is there
documentation (e.g. notes or re-consent when
necessary) of the subject’s willingness to continue,
when new information becomes available and may
HRPP Policy: Informed Consent
3.9 affect their willingness to continue OR when their
status has changed? Quality Improvement Recommendation
(It is also recommended that the following assessments are
documented:
 How the subject is doing on study
 Clinician’s recommendation for continuation or
discontinuation of participation)
Roles & Responsibilities PI Co-I Coordinator Other: ____________
Who obtains informed consent?
Who completes enrollment/
progress notes?
Please use this section to explain any issues with the Informed Consent Process:

Exit Interview: Documentation of Discussions

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