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THE COMMITTEE ON HUMAN RESEARCH (CHR)
RELYING ON OTHER IRBs
Brief Overview
The purpose of this guidance is
to help UCSF investigators determine in which cases they may rely
on another IRB to review their human
research. Current UCSF policy requires that all faculty and staff
paid by UCSF for greater than 50% of their effort must have UCSF
CHR approval before they begin research using human subjects.
This requirement applies regardless of the source of funding
and even when no funds are involved regardless of the site of
the study activities. (Additional details can be found at Requirements
for UCSF Researchers.) However, there are a few limited exceptions
and these are described below.
The following limited exceptions
have been made in response to requests by investigators for a more
streamlined IRB review for
multi-UC campus research and for research reviewed by the NCI Central
IRB. In the future, and after experience with this initial group
of IRBs, UCSF may consider adding other IRBs to this list.
top of page Definitions
and Responsibilities
Reviewing IRB
- The Reviewing IRB will conduct
initial and continuing reviews, and will review amendments
to approved protocol and unanticipated
problems or adverse events that may arise.
- The Reviewing IRB
will have the authority to suspend the research for failure
to comply with conditions of approval or regulatory
requirements.
- The Reviewing IRB will notify the Relying IRB of any unanticipated problems, suspensions or terminations of research. The Reviewing IRB will notify the federal or funding agencies of these events consistent with their policies and procedures and copy the Relying IRB on any such correspondence.
- The Reviewing IRB will consider conflicts of interest
and confirm, where appropriate, that the application or proposal
for human
subjects research submitted to the federal Department
of Health and Human
Services (HHS) matches the protocol submitted for IRB
approval.
- The Reviewing IRB will serve as the IRB of record.
- Another
IRB may refuse, on a case-by-case basis, to serve as the IRB
of record for another UC location.
Relying IRB
- The Relying IRB will rely on
the IRB review of the Reviewing IRB. It will not rereview the
study.
- Another IRB may refuse, on a case-by-case
basis, to rely on the review another IRB.
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Memorandum of Understanding (MOU) Between Human
Research Protection Programs at University of California Campuses
and UC-Managed Laboratories
for IRB Review of Multi-Campus Human Subject Research for Exempt
and Expedited Categories (April 2006)
This Memorandum of Understanding
(MOU) applies to research eligible for expedited review, i.e.,
research involving no more than minimal
risk to the subject, as well as research that qualifies for exempt certification. When applicable, the MOU will allow research to
be reviewed by the IRB at only one UC location rather than having
to go through the entire IRB process at every UC campus at which
the research will take place.
The MOU became effective March 21,
2006 and will be in place for one year, after which time it will
be reviewed to determine whether
improvements or amendments are needed. Click on Memorandum
of Understanding Between Human Research Protection Programs at
University of California
Campuses and UC-Managed Laboratories for IRB Review of Multi-Campus
Human Subject Research to see the MOU in its entirety.
Conditions of Use:
A PI from UCSF may request
that another UC IRB review his or her application if
a) The research
is not regulated by the FDA and b) Any of the following conditions
are met:
- The research
- will be conducted concurrently at more
than one UC location and/or
- involves
personal identifiable data or samples from more than one
UC location.
- Most or all of the subject contact occurs at another
site.
- Another UC campus is the prime recipient of the funding
award.
- Research has already been approved at one UC campus
or lab and the investigator transfers to another campus.
Procedures for Use:
- PI Notifies the Reviewing and the
Relying IRBs: The PI completes the
Notice
of Intent to Rely on Another UC IRB and
- Sends one completed copy of the
form plus all application materials to the reviewing
UC IRB.
IMPORTANT NOTE: The application materials must
meet all the requirements of the reviewing UC IRB standards
and guidelines.
A link to the
websites of these IRBs can be found at
UC
Office of the President and UC Schools.
Or refer
to UCSF’s web
site
Applying and
Reporting to the CHR
- Sends one completed copy of the form
to his or her own UC IRB. If the PI is a UCSF PI, then
the PI sends a copy of the
form
to CHR, Box 0962.
- Sends one completed copy of the form to all other relying
UC IRBs.
- The Relying and Reviewing IRBs Determine
if Reliance is Acceptable: The Relying IRB needs to determine if reliance
is acceptable.
The Reviewing IRB has to agree to review. Either or both
the relying and the reviewing IRB will notify the PI
if there is
a problem.
Otherwise, the PI can assume the reliance is acceptable.
- Reviewing IRB Notifies PI of Approval: Once the Reviewing
IRB has completed its review and granted approval, the Reviewing
IRB will send a copy of its IRB approval letter to the PI.
- PI Files Approval with All Relying IRBs: The PI must
then send copies of the Reviewing UC IRB Approval and approved
application
and all supporting documents, including the protocol and consent
documents to his or her home IRB and all Relying IRBs. Any
modifications, annual review applications, event reports (adverse
events, violation/incident
reports, concerns/complaints), withdrawal notices and/or termination
notices must also be included with paperwork for the Relying
IRBs.
- Relying IRB Issues Letter of Acknowledgment: The
Relying UC IRBs will issue a letter of acknowledgement to both the
PI and the Reviewing IRB. The PI must keep a copy of this letter
of acknowledgement
in his or her study file in case the study is audited by its
home UC Human Research Protection Program, the federal government,
or
by its funding agency. The UCSF PI will also be able to view
a copy of his or Summary Sheet for this study on Research
Online.
- Additional Notification Requirements for PIs: The
PIs must file an additional Notice of Intent to Rely on Another
UC IRB for each annual review and/or protocol modification, with
any
Relying IRB where the research is continuing to take place.
- Post Approval Event Reporting for PIs: The PI should
follow the standards and guidelines of the Reviewing IRB for
the reporting
of any post approval events. These include adverse events,
other safety information, and/or protocol violations or incidents.
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Memorandum of Understanding (MOU) Among the
Human Research Protection Programs at the University of California
at Berkeley, Lawrence Berkeley National Lab (LBNL), UC Davis
and UC San Francisco for IRB Review of Multi-Campus Human Subject
Research for All Categories (April 2006, Revised November 2007)
This Memorandum of Understanding
(MOU) applies to all categories of human research including research
that requires full committee
review (that is, studies involving more than minimal risk) as well
as studies eligible for expedited
review (that
is, research involving no more than minimal risk to the subject)
and research that qualifies
for exempt certification. When applicable, the MOU will allow research
to be reviewed by the IRB at only one UC location rather than having
to go through the entire IRB process at UC Berkeley, LBNL, UC Davis and/or
UCSF.
Conditions of Use:
A PI from UCSF may request
that only UC Berkeley, LBNL, UC Davis, or UCSF review his or her application
if
- The research
- will be conducted concurrently at more
than one UC location and/or
- involves personal identifiable data
or samples from more than one UC location.
- Most or all of the subject contact occurs at one
UC location.
- UC Berkeley, LBNL, UC Davis or UCSF is the prime recipient
of the funding award.
- Research has already been approved at one UC campus
and the investigator transfers to another campus.
- San Francisco Veterans Affairs Medical Center (SFVAMC) cannot be a site.
Procedures for Use (Decision Tree):
- PI From the Reviewing Campus Notifies the Reviewing IRB: The Reviewing PI submits his/her IRB Application and includes the completed Notice
of Intent to Rely on Another UC IRB.
- The Reviewing and Relying IRBs Determine
if Reliance is Acceptable: The Reviewing IRB has to agree to review.The Relying IRB needs to determine if reliance
is acceptable.
Either or both
the relying and the reviewing IRB will notify the PI
if there is
a problem.
Otherwise, the PI can assume the reliance is acceptable.
- Reviewing IRB Notifies PI and Relying IRB of Approval: Once the Reviewing
IRB has completed its review and granted approval, the Reviewing
IRB will send a copy of its IRB approval letter and the submitted Notice
of Intent to Rely on Another UC IRB both the PI and Relying IRB.
- Relying IRB Issues Letter of Acknowledgment: The
Relying UC IRBs will issue a letter of acknowledgement. The Relying PI must keep a copy of this letter
of acknowledgement
in his or her study file in case the study is audited by its
home UC Human Research Protection Program, the federal government,
or
by its funding agency. The UCSF PI will also be able to view
a copy of his or Summary Sheet for this study on Research
Online.
- Additional Notification Requirements for PIs: The
PIs must file the existing or an additional Notice
of Intent to Rely on Another UC IRB with each annual review and/or protocol modification, with
the Reviewing IRB.
- Post Approval Event Reporting for PIs: The PI should
follow the standards and guidelines of the Reviewing IRB for
the reporting
of any post approval events. These include adverse events,
other safety information, and/or protocol violations or incidents.
Decision Tree - The Process for Relying on and Points to Consider When Determining Which UC IRB Should Provide Review.
IMPORTANT NOTE: Faculty with Joint Appointmetns or UC students:
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National Cancer Institute Central IRB
(NCI CIRB) Initiative for
Adult and Pediatric Human Research (July
2006)
Memorandum of Understanding (MOU) Between the Human Research Protection Programs (HRPP) at Community Medical Centers in Fresno and UC San Francisco for IRB Review of all Categories of Human Subject Research funded through UCSF and Conducted at Community Medical Centers (September 2007)
This Memorandum of Understanding (MOU) applies to all categories of human research (that is, Full Committee, Expedited, and Exempt). When applicable, the MOU allows research to be reviewed only by the Community Medical Centers IRB rather than having to also be reviewed by the UCSF IRB.
Conditions of Use:
To be eligible for this Memorandum of Understanding, the following conditions must be met:
Procedures for Use:
- The UCSF Principle Investigator submits an application to the Community Medical Centers’ IRB according to that IRB’s guidelines. The PI should indicate to the Community Medical Centers’ IRB that the study is funded through UCSF.
- The UCSF Principle Investigator should follow the standards and guidelines of the Community Medical Centers’ IRB for the reporting of any post approval events. These include adverse events, other safety information, and/or protocol violations or incidents.
- The UCSF Principle investigator should follow the standards and guidelines of the Community Medical Centers’ IRB for submitting amendments and renewal applications.
- The Community Medical Centers’ IRB notifies the UCSF HRPP of approvals which fall under this MOU, and forwards a copy of their approval letter and the approved application packet to the UCSF HRPP.
- The Community Medical Centers’ IRB is the IRB of Record for studies reviewed under this MOU and is responsible for continuing review as well as review of subsequent amendments and serious adverse events.
- The UCSF Fresno Grants and Research Office is responsible for comparing grant applications with corresponding CMC IRB applications.
- The UCSF Fresno Grants and Research Office is responsible for collecting and forwarding financial disclosure documents to the UCSF COIAC.
- The UCSF HRPP will record approvals taking place under this MOU in Research Online and maintain copies of the approval packets.
IMPORTANT NOTE: The UCSF HRPP will not issue approval letters for studies reviewed under this MOU. Investigators should use the approval letter from the Community Medical Centers’ IRB and/or the Summary Sheet in Research Online to document IRB approval.
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