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THE COMMITTEE ON HUMAN RESEARCH (CHR)
UCSF RECHARGE FOR CHR PROTOCOL REVIEW
UCSF CHR POLICY AND RATES FOR RECHARGE
OF IRB REVIEWS
(Revised September 2006)
UCSF CHR POLICY
In September 1, 2000, the UCSF Committee on
Human Research began charging for the review of the following types
of human research protocols:
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Protocols funded by private industry |
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Protocols submitted on behalf
of UCSF-affiliated institutions (e.g., NCIRE, the Gallo Center,
the Gladstone Institutes) |
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Protocols submitted on behalf
of non-UCSF organizations (e.g., the San Francisco Department
of Public Health, the Blood Centers of the Pacific) |
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UCSF CHR RECHARGE RATES
The following rates are in effect beginning
October 20, 2006. The rates have not gone up since September of
2000. The new rates reflect the actual and current costs of review
and post approval monitoring by the Human Research Protection Program.
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Initial Full Committee Review
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Renewal of Full Committee Reviews (Continuing
Review) |
Initial Expedited Review |
Renewal of Expedited Review
(Continuing Review)
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Modification
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Exempt Certification
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| Protocols funded by private industry |
$1600 |
$450 |
$300 |
$300 |
no charge |
no charge |
Protocols submitted on behalf of
UCSF affiliated
institutions
i.e.,
• Gallo
• Gladstone
• NCIRE |
$2200 |
$600 |
$450 |
$450 |
no charge |
no charge |
Protocols submitted on behalf of
non-UCSF organizations i.e.,
• Blood Centers of the Pacific
• SFDPH |
$2200 |
$600 |
$450 |
$450 |
no charge
|
no charge
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| Important Note:
There will be no charge for adverse event reports submitted
to the CHR for review and processing. For additional information
please review the Frequently Asked Questions below. |
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FREQUENTLY
ASKED QUESTIONS ABOUT THE CHR CHARGE FOR REVIEW
The following questions are the most common ones that have been asked
about the recharge for CHR review for industry-sponsored studies and studies
being conducted by the affiliated institutes.
What is the start date for these revised charges?
The start date will be October 20, 2006 for all revised
charges. That is, these charges will apply to any study received
in the CHR office October 20, 2006 or after.
When will the Principal Investigator be charged?
Individual investigators will be charged after CHR review has occurred,
whether or not the study is finally funded.
- Internal UCSF Investigators will be charged through a journal
recharge.
- External investigators will be charged through an invoice
sent directly to the institution.
Important Note: For both UCSF-affiliated institutions and
non-affiliated institutions or organizations, Stephen Dorsey at 502-2180,
Assistant to the HRPP Director, bills the institutions directly, not the individual
PIs.
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What happens if the contract is not approved?
If the CHR review has already taken place, the investigator
or the institute will still be charged.
How are investigators expected to cover the
extra costs of these charges?
Investigators should list the expense for IRB review as a budget line item
as part of the start up costs.
When current studies are renewed after the October
20, 2006 rate increase, will the new rates
be used or can the previous rates apply?
The revised rates will apply.
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Will there be a charge for modifications of existing studies?
Yes and No.
No - There will be no extra charge for modifications or administrative
changes, as long as they do not require full committee review.
Those costs are included in the charge for initial and continuing reviews.
Yes - However,
if a modification is a major modification and requires full committee
review and is, therefore, reviewed as a renewal as well, then the
renewal rates for a full committee renewal will apply.
Will there be a charge for submitting adverse event reports or incident reports?
No, there will be no charge for either action.
Will there be a charge for Exempt Certifications?
No, there will be no charge for exempt certifications.
Will there be a charge for Single Project Assurances?
No, as of this time, there will be no charge for Single Project Assurances.
A charge for this activity may occur in the future.
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Are there any exemptions to these charges?
Yes, a junior investigator (Assistant Professor) who is submitting his or her
first industry-sponsored clinical trial will not be charged. In order to
receive a waiver, however, the investigator must submit a written request
for an exemption attached to the application.
Are there any other cases in which waivers
for the charge may be granted?
In general, no. However, if an investigator believes
there are special circumstances, he or she may request a waiver in writing.
Approvals for waivers will be rare and will be approved by the
Director of the Human Research Protection Program in consultation, as needed,
with the Associate Vice Chancellor for Research
.
For Gallo, Gladstone and NCIRE, and other affiliated and non-affiliated institutions,
will there be a charge for each protocol reviewed or only those funded by
private industry?
All CHR reviews will be recharged. The rate for initial full committee study
review is $2200. Renewals of full committee studies will be reviewed at the rate of $600. The rate
for initial and renewal expedited studies is $450.
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Is there any plan to expand this charge
to NIH-funded studies or to studies funded by foundations?
There are currently no plans to expand this recharge.
However, the NIH is considering adding a line item in its budget
for IRB review.
Is UCSF unusual in charging for IRB review?
No, many other academic medical centers throughout the country charge for IRB
review and many other institutions are considering doing so.
Are the charges at UCSF in line with these
other institutions?
Yes, the charges are in line with other academic institutions and
certainly lower than private IRBs.
How were the charges determined?
The amount of recharge was determined based on cost according
to University procedures and was reviewed and approved by the UCSF
Budget Office. The charge for affiliated institutes is higher because an
indirect cost charge is added to these as mandated by the Budget Office,
in accordance with University policy.
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Why were the charges raised at this time?
Since the time of the original calculations of the costs for IRB
review, the unit has been restructured to become an accredited UCSF Human
Research Protection Program. The CHR has added two IRB panels. An entirely
new unit, the Quality Improvement Unit, has been added to the Program to conduct
post-approval auditing and education and to help review and handle adverse
event reporting and incident reporting. Additional staffing has been added
to help handle the steadily increasing volume as well as the increasing complexity
of the research as well as the additional regulatory requirements.
What if I don't know my funding source?
The funding section of the CHR Cover Page must be completed
before CHR review can occur. If you are unsure how to complete
the funding section of the CHR application, please call the CHR
office at 415-476-1814 and ask to speak with Stephen Dorsey or
the Analyst of the Day.
What if I have additional questions?
Call Stephen Dorsey at 415-502-2180 about billing, or
Sharon
Friend at 415-476-9839 with other questions.
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