Human Research Protection Program
Institutional Review Board
External IRB Submission Policy
Scope
MMC HRPP requires all industry sponsored studies to be reviewed by an external IRB,
(Chesapeake IRB, other). This policy also provides instructions for local IRB requirements
when utilizing other External IRB models such as NCI IRB and IRBShare.
It is not permissible for an investigator to submit a study not approved by one IRB to the
other IRB. In addition, it is not permissible for a study to be submitted to both the MMC IRB
and an external IRB, with the intent of withdrawing the submission from one of the IRBs.
Please note: The Clinical Trial Agreements (CTA) or Oncology Group Agreements will
remain between the sponsor and MMC. If IRB fees apply they will be invoiced directly
between the external IRB and sponsor.
1. POLICY
The details of this policy apply to each study that a Principal Investigator intends to submit to
an External IRB (i.e. Chesapeake, other) or External IRB model (NCI IRB, IRBShare).
Please see the separate instructions that pertain to the selected external IRB/external model.
MMC Internal Procedures
The External IRB Submission Form needs to be submitted to the MMC IRB along with
supporting documents to verify eligibility for external review. The MMC IRB staff will
perform a pre-screen of the submitted documents to verify that all required institutional
committee approvals have been received and to record the study in the MMC IRB database
as an external review.
1.1 MMC Process for External IRB Submission
The Principal Investigator (PI) must certify that s/he has read and understands the
external IRB submission policy and requirements and has reviewed them with the
research team; this is documented by signing the MMC External IRB Submission
Form. The Principal Investigator is to retain all original signed forms, letters, etc., in
his/her study file.
Please submit electronic documents to accompany the External IRB Submission
Form to the MMC IRB at mmcirb@mmc.org:
a) A completed External IRB Submission Form signed by the PI and
Department Chair/Division Chief/Practice Administrator, as appropriate.
b) Documentation of review from the Radiation Safety Committee and/or
Institutional Biosafety Committee (and recommended language for
inclusion into the ICF, if applicable).
c) MMC IRB does not require a copy of the IRB application used for
external submission.
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Effective Date 11/04/2015
Supersedes 03/06/2014
Human Research Protection Program
Institutional Review Board
External IRB Submission Policy
1.2 Required Internal Services/Committee Reviews
As with all studies submitted to the MMC IRB, approval from the following
required applicable institutional committees must be obtained by the PI prior to
submission of the application to the MMC IRB office:
Radiation Safety Committee (RSC): Approval is required if the study involves
research-related ionizing radiation exposure. If subjects will be exposed to
ionizing radiation as a result of study participation interdepartmental sign off from
this committee with the accompanying language to be incorporated in the ICF
must be submitted to the MMC IRB with the External IRB Submission Form. The
PI is to submit an electronic copy of committee review letter and submit it as
noted above. The PI is to retain documentation in his/her study file.
Institutional Biosafety Committee (IBC): Approval is required if the study
involves biohazardous materials that include pathogenic microorganisms,
infectious materials, biological toxins, recombinant DNA, and select agents.
After review and approval from the IBC, an approval letter will be provided to the
PI by the IBC as confirmation of approval. PI is to submit an electronic copy of
committee review letter and submit it as noted above. The PI is to retain
documentation in his/her study file.
MMC IRB will maintain an electronic copy of the original External IRB Submission
Form signed by the IRB office staff person. A signed copy will be sent to the PI/
research team. This should be considered confirmation that the MMC internal IRB
process is complete. Once your study is approved by the external IRB your review
will be complete.
1.3 The Principal Investigator assumes responsibility for the accuracy of
information submitted on the External IRB Submission Form. Documents requiring
the Principal Investigator’s signature that have been signed by someone other than the
Principal Investigator will be returned to the Principal Investigator. Applications
submitted with missing, inaccurate, or inconsistent information would be returned to
the Principal Investigator.
1.4 The MMC HRPP requires communication and collaboration with all
ancillary departments that are included or impacted by your participation in a
research project. These departments must be aware and agree to participate as
described in the project. MMC IRB does not require written approvals from these
departments prior to completing their review for external IRB submission*.
However, Good Clinical Practice in Research requires the inclusion, education
and collaboration of each applicable department. It is the responsibility of the
Principal Investigator for ensuring internal ancillary departments are prepared and
overseen according to FDA regulations. Ancillary departments, which are
included or impacted by study participation, include but are not limited to:
Pharmacy, Radiology, Nordx, IV therapy, other clinical departments (Emergency
Medicine, Cardiology).
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Institutional Review Board
External IRB Submission Policy
1.5 The PI/research staff must follow the MMC requirements for training and
education.
*Ancillary department sign offs should be obtained and kept with the study NOT submitted with the
External IRB form.
1.6 The PI/research staff must follow Maine Medical Center COI policy;
complete their disclosures via the online COI website. MMC Research COI
Committee and the MMC IRB Chair, will approve the management plan, if
applicable, and share that plan with the External IRB.
1.7 The external IRB may ask questions of the PI with regard to the
submission for review. The PI or his/her designee is to address these questions
directly with the external IRB.
1.8 The external IRB will send all approvals to the PI.
PLEASE REMEMBER, you cannot begin your study at MMC until a fully executed
Clinical Trial Agreement/ Contract /Master Agreement or Cooperative Agreement is
sent to you.
Post External IRB approval
If the external IRB approval is granted, the PI and research team members are to
communicate directly with the external IRB regarding the study and will submit all
future documents (e.g. advertisements, amendments/revisions, continuing review,
AEs/SAEs, unanticipated events, protocol deviations/violations, non-compliance,)
directly to them for review/approval without submitting copies to the MMC IRB
office.
Changes among research team members must still be submitted to the MCC IRB office
using the External IRB Amendment Form (FO 306B). In addition all unanticipated
deaths of MMC/MMP subjects that are determined by the PI to be attributed to the
items/procedures that are being studies must be submitted to the MMC IRB within 48
hours of becoming aware. The SAE Reporting and Early Reporting of Death or SAE
form should be used to report these events (RR404B). All research activities at MMC will
follow MMC HRPP requirements and policies pertaining to education, monitoring, research
record retention, COI and consenting practices.
MMC IRB will work in collaboration with the external IRB regarding any reported noncompliance. Reports of non-compliance or continuous non-compliance will be reported
to and reviewed by the local MMC IRB, subsequent actions will be determined according
to the MMC IRB Standard Operating Procedures. Determination to notify the Office of
Human Research Protection (OHRP), US Food and Drug Administration (FDA), sponsor,
and other federal agencies will be addressed by MMC IRB according to IRB policy.
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Human Research Protection Program
Institutional Review Board
External IRB Submission Policy
Chesapeake IRB Addendum
Applicable Pharmaceutical Studies
Phase I/Ib, II, IIa, IIb, III, or IV protocols undertaken at Maine Medical Center (MMC) or
Maine Medical Partners (MMP) may be eligible for submission to an external IRB for review
and approval. All industry sponsored or non-federally funded foundation sponsored, multicentered, sponsor initiated (defined as sponsor created, designed, and developed) studies are
eligible for external review.
If the study involves a test article that has been issued an IND or IDE number, the IND or
IDE number must be issued to the industry sponsor of the study and not an investigator. If a
determination must be made by the IRB regarding the need for an IND or IDE for a test
article (21 CFR 312 or 21 CFR 812) the study will not be eligible for external review and will
remain with MMC IRB.
NCI IRB Addendum
Applicable NCI Studies (CIRB)
The National Cancer Institute (NCI) Central Institutional Review board (CIRB) is designed
to help reduce the administrative burden on local IRB’s. The CIRB enables an investigator to
enroll patients into NCI-sponsored clinical trials significantly faster than when employing the
method of traditional IRB review.
The NCI CIRB uses an independent model. Maine Medical Center has shared the local
context considerations which include but are not limited to state and local laws, conflict of
interest policies, boilerplate language for inclusion in the consent document and any other
institutional requirements. Local PI’s have provided the NCI CIRB with resources available
to support research, extent of existing research responsibilities, informed consent process
information, including descriptions of vulnerable populations eligible for enrollment and
safeguards used to protect those populations. Privacy and confidentiality protections, in
addition to any unique study-specific considerations, are also reviewed by the NCI CIRB as
part of local context.
The CIRB agreement states that Individual adverse event reports are to be submitted for
review and analysis to a monitoring entity [e.g., the research coordinating group, program,
or network, the coordinating or statistical center, or a Data and Safety Monitoring
(DSMB)] so a contextual view of adverse events occurring on a specific trial is obtained.
The adult and pediatric CIRB’s require the Study Chair to provide current minutes from
most recent DSMB meeting and study report of adverse events at the time of continuing
review.
IRBShare Section Addendum
Applicable IRBShare Studies
IRBshare system is a shared IRB review model for multi-site studies comprised of
participating institutions utilizing Shared Review Documents, a Shared Review Model, a
centralized secure web portal, and an IRBShare Master Agreement. Maine Medical Center
has signed an IRBShare Master Agreement and has agreed to participate in this shared IRB
review model to ensure compliance with the Common Rule (45 CFR Part 46).
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Effective Date 11/04/2015
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Human Research Protection Program
Institutional Review Board
External IRB Submission Policy
The MMC IRB may rely on a participating institution ONLY for the initial review of a full
board study. MMC IRB will be responsible for all matters other than initial review pertaining
to the study including but not limited to review of local research context issues under the
Common rule, continuing reviews, amendments, adverse events/unanticipated problems,
noncompliance with the protocol and protocol deviations.
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Effective Date 11/04/2015
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