IRBMED AND CHESAPEAKE IRB General Procedures for Ceding IRBMED Oversight Procedures Specific to...

IRBMED AND CHESAPEAKE IRB

• General Procedures for Ceding IRBMED Oversight• Procedures Specific to Chesapeake IRB

Medical SchoolInstitutional Review Board (IRBMED)

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Introductions

Representatives Chesapeake IRBMED


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What is a central IRB?

Central IRB – A single IRB that provides regulatory and ethical review services for multiple sites participating in a research study

A central IRB may be independent (sometimes called commercial) or institutional Independent IRB – Chesapeake IRB Institutional IRB – University/Hospital IRB


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What does it mean to cede oversight?

Ceding is a legal agreement that transfers responsibilities from one entity to another

To cede oversight of the ethical review of research, IRBMED must agree to relinquish certain responsibilities and Chesapeake IRB (for example) must agree to assume those responsibilities IRB Authorization Agreement – IRB regulatory terms Master Service Agreement – All other contractual terms

and responsibilities


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What are the benefits to ceding IRB oversight? FDA, OHRP, NIH, and U-M all support the use of central IRBs to

improve the efficiency of conducting multi-site trials

Enhance research partnerships Industry - sponsored research Cooperative group research Inter-institutional academic relationships

Ensure consistency between investigative sites by utilizing a single IRB

Avoid individual reviews by local IRBs

Respond to faculty needsMedical SchoolInstitutional Review Board (IRBMED)

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U-M Plans and Roll-out

The process is in early stages of roll-out Completed roll-out in approximately 6 months

U-M plans to seek Master Service Agreements with appropriately qualified central IRBs Each central IRB may have slightly different procedural elements

relationships The first application for each new central IRB will take add’l time

A new eResearch application type was developed for use by the UMHS/medical school community Guidance materials are in development


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How do study teams at U-M utilize a central IRB?1) As part of the PAF Application, indicate from the drop-down listing which central IRB will be used to ensure that appropriate contractual terms are added

2) Complete the eResearch application “Requesting Review by a Non-UM IRB” (aka Ceding)

3) The ceding application will be reviewed by the ancillary committees and acknowledged by IRBMED


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Generic Workflow


Identify the

Central IRB in the PAF

Initiate a U-M IRBMED Ceding

Application

UM Ancillary Committee

Reviews

IRBMED Acknowledgement

Submit the Central IRB application

Initiate the Central IRB application

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Secti

ons

of th

e Ce

ding

App

licati

on 1 General Study Information2 Sponsor Information3 UM Study Functions4-3 Requesting Review by Non-UM IRB5-2/4 Research Design6-2 Benefits and Risks 7-3 Special Considerations8 Subject Participation9-3 Subject Populations10-6 Informed Consent11 Confidentiality/Security/Privacy13 Subject Payment14 Health Care Treatments and Procedures


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Terms of the Master Agreement

UM Conflict of Interest Investigational Drug Service RDRC/SHUR CRAO Protocol Review Committee

(Cancer Center) IRBMED Acknowledgement

Chesapeake IRB IRB Application Protocol Informed consent Recruitment All other relevant materials


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THANK YOU!

Additional questions will be answered following the Chesapeake IRB presentation


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Questions & Answers

How long will it take for ancillary committee review to be completed? Ancillary review remains unchanged.

How long will it take for an IRBMED acknowledgement letter to be issued? Following review by ancillary committees, IRBMED acknowledgement should take approximately 2 business days.

Should the ceding application be used for NCI-cIRB instead of the facilitated review applications? This will be permitted within the next month. Continue to use facilitated review applications until otherwise indicated.


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Questions & Answers

If my central IRB is not on the list in the PAF or the IRB application, how can it be added? Contact the IRBMED to request consideration of the new IRB.

What central IRBs may be used at this time? Currently, U-M has agreements with Chesapeake IRB and NCI. If you would like to use a different central IRB, it requires negotiation via our normal IRB review and ceding procedures. As other central IRB agreements are finalized, IRBMED will the notify the research community.


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Questions & Answers

Why does U-M have an agreement with Chesapeake IRB? Chesapeake IRB is accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP) and has a strong FDA compliant track-record.

Is the process different when working with another University/Institutional IRB? Yes, as UM is able to work individually with other institutions to create IRB Authorization Agreements through a less formal contractual process.


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Questions and Answers

Is there a fee associated with using a central IRB? Independent IRBs will charge a fee which is usually paid by the research sponsor. The process for payment will vary depending on the Master Agreement with the independent IRB. Work with your sponsor to determine how the fee will be incorporated into your study budget.

University/Institutional IRBs may not charge a fee.

I am uncertain as to how to answer some of the questions in the new eResearch ‘ceding’ application. Help text is being written and will be posted as soon as it is available.


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U-M Contacts

IRBMED 763-4768Joe Austin ([email protected])

Diana Miller ([email protected])

Georgia Marvin ([email protected])

Judy Birk ([email protected])

Consult with the IRBMED early in the application process if you wish to use a Central IRB!


IRBMED AND CHESAPEAKE IRB General Procedures for Ceding IRBMED Oversight Procedures Specific to...

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