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THE COMMITTEE ON HUMAN RESEARCH
ABOUT THE COMMITTEE ON HUMAN RESEARCH
WHO MUST
HAVE CHR APPROVAL BEFORE ENROLLING HUMAN SUBJECTS IN RESEARCH (Revised
October 2004, Revised March 2008)
 • Types
of Research Covered
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Requirements for UCSF Researchers
• Researchers
Paid > 50% Time by UCSF
• Researchers Paid < 50% Time by UCSF
• Funding Awarded Through UCSF
• Post Docs, Student Research, and House Staff
• Researchers at Other Institutions for Which the CHR is the
IRB
• Research
at UCSF Involving UCSF Facilities, Patients or Employees Not
Conducted under the Aegis of UCSF
• Research Conducted by UCSF Emeritus Professors
Types of Research
Covered
The following requirements apply to all types
of research involving human subjects, including chart reviews, retrospective
studies, access to UCSF data banks and repositories, collection and/or
use of human biological specimens and, of course, research involving direct
contact with human subjects, including compassionate use protocols and
emergency use requests. Human research that is exempt from review under
Federal regulations must be submitted to the CHR for formal certification
of exemption.
Requirements
for UCSF Researchers
UCSF-affiliated researchers using human subjects must receive prior approval
from the CHR if any of the following circumstances apply:
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Researchers
Paid > 50% Time by UCSF
All faculty and staff paid by UCSF for greater than 50% of
their effort must have 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,
and regardless
of the site of the study activities.
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Researchers Paid < 50% Time
by UCSF
If researchers are paid by UCSF for less than 50% of their effort,
they need not obtain CHR approval for human research, unless
one of the following conditions applies: |
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The funding is granted to or applied for through
UCSF, or |
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Subjects will be recruited at UCSF, SFGH,
or the SFVAMC, or |
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The research will take place at a UCSF, SFGH
or SFVAMC facility. |
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A UCSF-affiliated institution
holds an FWA that identifies the UCSF CHR as the
IRB of record for all its human research. |
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If the above conditions apply,
researchers must arrange for an eligible faculty member
(PI
eligibility requirements at UCSF or the PI eligibility requirements of the
various affiliates) to serve as the Principal Investigator for
the study, or they may obtain a
waiver from the Department Chair.
This is because researchers paid less than 50% time are not typically
eligible to serve as Principal Investigator at UCSF nor are they
eligible to have research reviewed by the CHR. |
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Important Note: Even if CHR review
is not required, any investigator holding a UCSF appointment
must obtain approval from another Institutional Review Board
(IRB) before conducting human research. Anyone accepting the
privilege of a UCSF faculty title must also assume the duty of
obtaining prior approval from a duly-constituted IRB in order
to conduct human research.
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Funding Awarded Through UCSF
If the human research is supported either by extramural funds
granted to (or applied for through) the Regents of the
University of California or by University funds, CHR review
is required.
If UCSF is the primary recipient of a grant, then the UCSF
PI must obtain CHR approval, even if only for the scope of
the work if the research is being conducted elsewhere. If multiple
sites are involved, the CHR will require evidence of the various
and relevant IRB approvals at all subcontracted sites.
If UCSF has been awarded a subcontract, and is not the prime
recipient of the grant, then the CHR need review only the subcontracted
portion of the study that will be completed by the UCSF researcher.
Post Docs, Student Research and House Staff
Postdoctoral Fellows are allowed to serve as PIs on CHR applications if the following two conditions are met:
- A UCSF faculty member who would otherwise qualify as a Principal Investigator is identified as the Co-PI on the application, and
- A cover letter from the Co-PI faculty member is attached to the application stating that he or she agrees to serve as faculty support and/or a mentor to the Postdoctoral Fellow.
Because neither students nor house staff are eligible to
serve as PIs, they are required to seek the sponsorship of
a UCSF
faculty member. These studies are often smaller scale unfunded
studies and, with an appropriate PI, are eligible for CHR
review.
Short-term students, for example those in the Summer Research
Training Program in the School of Medicine, may not need individual
approvals from the UCSF IRB if they already have an IRB approval
from their own institution and if they are not accessing UCSF
facilities, medical records, patients or personnel. If they
are accessing any of these, they will need individual UCSF
CHR approval with a qualified UCSF faculty member to serve
as the PI.
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Researchers from Other UCSF-Affiliated Institutions
for which the CHR Is the IRB
Several institutions have signed agreements and Federal
Wide Assurances designating the UCSF CHR as the institution’s IRB (e.g., SFGH, SFDPH, SFVAMC, Gladstone
Institutes, Gallo Institutes). Researchers working under the auspices of those
institutions must obtain CHR approval for human research as required by individual
institutional policies, and are eligible to obtain CHR review as determined by
UCSF institutional policies.
IMPORTANT NOTE: Investigators
who wish to use facilities, involve patients or employees, or recruit
subjects from any UCSF-affiliated institution must contact each
institution to see what if any their additional requirements are.
For example, the San
Francisco Veterans Affairs Medical Center (SFVAMC) has its own set of requirements.
Research Not Being Conducted by a UCSF Principal Investigator but Accessing
UCSF Facilities, Patients or Personnel
All human subjects research conducted at UCSF facilities or
involving UCSF patients or employees (including students, faculty and staff)
must either identify a UCSF faculty member to serve as the Principal
Investigator
for the project or submit their research proposal to the CHR for
an administrative review using the form called UCSF
CHR Administrative Review for Human Research
Studies Not Being Conducted by a UCSF Principal Investigator But
Accessing UCSF Facilities, Patients or Personnel Form. Review
of this form will help determine the following:
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Whether
the study must have a UCSF faculty member serve as the PI,
or |
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Whether the study can be certified
as exempt according to federal regulations and UCSF policies,
or |
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Whether the study will require
an additional review and approval by the Office of the Associate
Vice Chancellor for Research. |
Important Note: This policy applies to
the use or collection of human biological specimens or the
review of medical records for research purposes as well as
the recruitment or direct involvement of patients, staff, or
faculty.
Important Exception to
the Policy: An exception to the requirement
for administrative review for research being conducted by outside
faculty or groups is a survey of faculty by their professional
organizations. These do not require administrative approval.
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Research Conducted by UCSF Emeritus Professors
Emeritus Professors may ask that the UCSF CHR review their studies,
provided any funding is brought through UCSF, if there is funding.
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