THE OFFICE OF RESEARCH
RESEARCH INVESTIGATOR HANDBOOK
3. OBTAINING REGULATORY COMMITTEE APPROVALS
3.9 Involving human subjects in your research
• Does my study require human subject research review and approval?
• Who do I contact?
• What types of approvals do I need to work with human subjects?
• What training is required?
• Is auditing or monitoring required?
• What are my additional responsibilities
for clinical research?
• Top Tips to speed up approval and prevent problems
• Relevant polices, procedures, and ethical statements
Does my study require human subject research review and approval?
Any research that involves either the participation
of human subjects or the use of human biological specimens, medical charts,
with information about humans is considered to be human
subject research and requires review. Full information on when human subject protocol review is required is available at Applying and Reporting to the CHR.
on Human Research (CHR) reviews human subject research
to ensure the ethical and equitable treatment of those
subjects under federal and state laws.
The CHR is part of the Human Research
Protection Program (HRPP) in the Office of Research.
The CHR is UCSF’s
federally mandated Institutional Review Board (IRB).
Who do I contact?
The main number for the CHR is (415) 476-1814. The HRPP front desk will
answer routine questions. Complex questions are referred to an “analyst
of the day”. See also the
Contact Information and the main
HRPP web site.
What types of approvals do I need to work
with human subjects?
You need Committee
on Human Research (CHR) approval. All research on
human subjects (including the use of biospecimens,
medical charts, and data) must be submitted to the CHR for review and
approval prior to any
contact with human subjects or any use of their specimens,
records, or data. Depending on the nature of your research, you may
There are three types of CHR review, with separate application formats.
The type of application needed depends on the degree of risk to
Committee: more than minimal risks to subjects, reviewed by one of four full
|| Expedited: no more than minimal
risks, reviewed by a subcommittee of the CHR
exempt from the need for CHR review, but requires
submission and review of a form for certification
of exempt status
Approval turnaround time: Full Committee
and Expedited approvals usually take from 2 weeks to
8 weeks depending on the type of human research,
the level of risk, and the complexity of ethical or
technical questions that arise during review. Exempt
certifications usually can be issued
within a week. You should allow extra time during holiday
and vacation periods.
Expiration date: Most human research
projects are given approval for one-year but some may
receive a shorter term of approval based on the CHR’s
perception of the need for more frequent review. The
expiration date is absolute, and by federal law, the
CHR cannot grant an extension. You must obtain approval
of your renewal before the expiration date.
(Continuing Review Application)
If your approval expires, you
must stop your research until you receive a new CHR
approval. However, if it would jeopardize subjects
to suspend ongoing treatment or follow-up tests,
you must continue activities needed to ensure
the safety of the subjects
Modifications: You cannot modify CHR
approved procedures without prior review and additional approval from
the CHR. You need CHR approval for
additions, deletions, or substitutions to your research
protocol, informed consent documents, recruitment procedures, questionnaires,
or other previously
approved documents. Failing to follow your approved
protocol or using documents altered without approval is a serious violation
Authorizations or approvals may
also be required from the
Committees: biologicals (
RUA for Humans) and/or controlled substances (
If human stem cells, either embryonic
or adult, will be used in the study,
Stem Cell Application must be submitted with the
CHR application. Human stem cell research is carefully
regulated and may require additional approvals.
Stem Cell web site for
UCSF guidance and policies.
Cancer Center, Clinical Research Centers:
PCRC, and the
Affairs Medical Center also have review requirements.
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What training is required?
Investigators who will work with human subjects must
complete the CITI On-line Human
Subjects Protection Training before the CHR
gives final approval. The CHR tracks this online
training to document compliance with Federal training
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Is auditing or monitoring required?
All human subjects studies at UCSF are subject to auditing
The UCSF Human Subjects Protection Program includes
Improvement Unit (QIU) that provides quality assurance, quality
educational activities to:
||monitor the conduct of clinical
research to ensure the rights and welfare of human
|optimize compliance with federal,
state, and institutional regulations and policies.
Audit types include both for-cause audits and random
quality improvement assessments (not-for-cause audits). Other groups
to UCSF that may audit your research are:
External audits also may be done as
part of federal, university, or sponsor programs.
If you receive adverse findings from an outside auditor,
you should notify the CHR immediately.
If needed, the CHR and UCSF Legal Counsel can
assist in the preparation of a response. Failing to
respond properly may jeopardize your and UCSF’s
human research programs. External groups that may audit
your research may include (but are not limited to)
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What are my additional
responsibilities for clinical research?
Additional institutional requirements that may apply
are described at the following sites:
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Top Tips to speed up approval
and prevent problems:
||Use iMedRIS for human subject and human stem cell application.
||Remember that chart reviews,
studies of specimens (even anonymous ones), and
use of information about humans from clinical or
research databases all require CHR review or formal
||Do not change your study procedures
or documents without CHR approval.
||Be sure that your protocol
and consent form clearly explain how what happens
subjects in the study will be different from what
happens to people
who decline participation.
||All documents and sections of
the application should be consistent; in particular
check the purpose, significance, procedures, benefits,
and alternatives in both the protocol and the consent
form; use the same name for the drugs throughout
the protocol and consent form.
||Use non-technical, everyday
language in the consent form. Avoid all
||Do not use acronyms in either
the protocol or the consent form without first
||Keep track of the approval expiration
date and submit your renewal application in time
to receive a new approval before the study expires.
Allow four to six
| Get separate CHR approval for
each discrete study. Do not group
related studies into a complicated application.
You may have several CHR applications for a single
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procedures, and ethical statements:
Human subject research is regulated by federal, state,
university, and affiliate regulations, guidance, policies,
and practices. You
are encouraged to follow the guidance found at UCSF’s HRPP web
site, which consolidates the requirements into consistent guidelines.
By following the web site’s guidance, a researcher will automatically
comply with numerous regulations. For reference, major
federal regulations and ethical statements are listed
below. Additional links can be found
at the UCSF Human Research Protection Program website.