Northwell Health - Human Research Protection Program

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
Study Personnel / Reference: GCP 4.1.1
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
# / Name / Role1 / Can obtain consent?2 / Completed HRPP Education & Registration Requirements? / Date IRB approved / Date IRB removed / Annual COI Disclosure Certified?3 / On File?
CV: Signed & dated within 2 Yrs / License
(If app)
CITI(HSTGCP (3yrs),
COI (4yrs), etc.)
1
2
3
4
5
6
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 continuing review?
If yes, was an amendment submitted to the IRB? / YES NO
YES NO N/A
Department/ Service Line
Institution (specify exact location)
Sponsor Investigator Study?
If yes, does the investigator held IND? / YES NO
YES NO N/A
Sponsor(s)
Funding
(check all that apply) / Industry Government Internal/Department
Foundation Other: ______
Other regulatory requirements that apply / FDA DOD GCP ISO
NIH Other: ______
IRB Review / Northwell Health IRB Central IRB
BRANY Relying on other IRB (specify):______
Review type: Expedited Full Board
IRB Initial Approval Date: ______
Current IRB Expiration Date: ______
Pediatric Risk Category / 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).
(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 form) / # IRB Approved: ______# Enrolled to date: ______
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? / ICH GCP 2.10, 4.9.4, 5.5.6, & 5.5.7
1.2 / If so, what type of regulatory binder is used?
Northwell Health provided version
Northwell Health adapted version
Sponsor provided version
Electronic version
Other: ______
1.3 / (If applicable)
Have the study team ensured all electronically filed documents are available and easily retrievable?
1.4 / Are all CVs & licenses (if applicable) of key personnel on file?
Are CVs signed and dated (within the past 2 years)?
All licenses up-to-date? / ICH GCP 4.1.1, 8.2.10 & 8.3.5
1.5 / Is there a subject screening/enrollment log?
Is the subject screening/enrollment log complete?
# of subjects included? ______
# of subjects excluded? ______/ ICH GCP 8.3.20, 8.3.21,
8.3.22 & 8.4.3
1.6 / Is there an auditing/monitoring log?
(Auditors please sign in on the log)
Is the log complete?
If the study requires monitoring, how frequently do reviews occur?______/ ICH GCP 8.3.10
1.7 / Is there a staff signature log?
Is staff signature log complete?
Is there a staff delegation of responsibility log (can be combined with staff signature log)?
Is the staff delegation log complete? / ICH GCP 4.1.5 & 8.3.24
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

2.1 / YES / NO / N/A / Reference:
All relevant correspondence (e.g. e-mails, submissions, responses, approvals) to and from the HRPP and IRB on file? / ICH GCP 4.4.3, 4.9.4,
8.3.3 & 8.3.19
2.2 / IRB/Institutional HRPP Initial Approval
Final IRB approval & documents approved on file?
List items: / GR056 HS Research Policy: Research with Human Subjects (IRB Approval)
HRPP Policy: Criteria for IRB Approval of Research
ICH GCP 4.4.1 & 8.2.7
InstitutionalHRPP approval & documents approved on file?
List items:
2.3 / Continuing Review
Details / Date Rec’d by IRB / Date approved / IRB approval letter on file?
YES / NO
Continuing Review # 1
Continuing Review # 2
Continuing Review # 3
2.4 / YES / NO / HRPP Policy: Continuing Review
FDA 21CFR 812.150
ICH GCP 4.10.1& 8.3.3
ISO 14155:2011 2.5.2, 4.5.4, 8.2.3, 8.2.4.5, 9.4, 9.8, E.2.21
Was each PR submitted on time?
 If NO:
a)Was there any lapsed period(s) between approval date and expiration date?
b)Was any subject enrolled during this lapsed period?
c)If YES, was a protocol deviation submitted to the IRB? (Please explain in the comments if the deviation was not submitted)
d)Were study activities conducted during this lapsed period?
e)If yes, is there documentation of IRB approval on file?
2.5 / Modifications (Amendments) & Other IRB Notifications Related to Informed Consent and Protocol Changes / GCP 4.5
Change Requested / Date Rec’d by IRB / Date acknowledged/ approved / IRB acknowledgement/ approval letter on file?
YES / NO

1)

List items:

2)

List items:

3)

List items:

4)

List items:

5)

List items:

6)

List items:

2.6 / Reportable Events & Protocol Exceptions / FDA 21CFR312.66; GCP 4.5; GCP 4.11;
HRPP Policy: Protocol Exceptions & Unanticipated Problems Involving Risk to Subjects and Others
Event Type (e.g.: Protocol Deviation, Unanticipated Problem, SAE, Protocol Exception) / Date of Event / Date Rec’d by IRB / Date acknowledged/ approved / IRB acknowledgement/ approval letter on file?
YES / NO
1)
List details:
2)
List details:
3)
List details:
4)
List details:
5)
List details:
6)
List details:
2.7 / 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 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:
2.8 / Any sponsor-approved protocol exceptions? YES NO N/A
 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 protocol version date / On file? / Approved consent version date (with IRB stamp date) / On file? / Approved ASSENT version date if applicable (with IRB stamp date) / On file? / Comments (please describe the differences from the previous version)
2.10 / Who prepares:
(Check all that apply) / PI / Co-I / Coordinator / Other______
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:

1. 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

3.1 / List the types of consent forms used (e.g. healthy volunteers, affected, minor or adult subjects, etc.)
3.2 / Where are the original signed consent forms kept? /

Reference:

ICH GCP 8.2.7, 8.3.3 & 8.3.12
HRPP Policy: Documentation of Informed Consent
3.3 / Where are copies of the signed consent forms kept (e.g. MR, subject file, etc.)?
YES / NO / Reference:
3.4 / Were any invalid consent forms used?
(Includes use of a consent without an IRB approval stamp, expired or incorrect consent)
If yes, was a protocol violation submitted to IRB? / HRPP Policy: Informed Consent
ICH GCP 4.8.8 & 8.3.12
3.5 / For LEP,
If applicable, were translated short forms used?
If Yes, were translated HIPAA forms used?
If No, was a protocol violation submitted to the IRB?
3.6 / Did each subject/LAR sign his/her own consent form?
Did each subject/LAR date his/her own consent form?
List the subject ID#s chosen for consent review:
YES / NO / Reference:
3.7 / Are there enrollment notes written for each subject that were signed and dated by individual who wrote the note?
If so, is a copy of the enrollment note and consent form placed in the subject’s inpatient or outpatient chart (as appropriate)? / HRPP Policy: Informed Consent
3.8 / Did each subject receive a copy of the signed consent form?
Is subject’s receipt of a copy of the signed consent form documented? / HRPP Policy: Informed Consent
ICH GCP 4.8.11
3.9 / 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 affect their willingness to continue OR when their status has changed?
(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)

/ HRPP Policy: Informed Consent
Quality Improvement Recommendation
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

Northwell Health Office of Research Compliance v. January 2017 Page1 of 6