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Commonly Asked Questions
Who are the members of the HSRC Committee?
The Human Subjects Review Committee consists of qualified members
from all five of the following categories:
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Health Care Agency Public Health Services
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Health Care Agency Behavioral Health Services
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Health Care Agency Medical & Institutional Health Services
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Health Care Agency’s Office of Quality Management
-
Outside
agency or department
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Do I need to have my research proposal reviewed by the HSRC?
All research, sponsored either directly or indirectly by the
Health Care Agency, in which human subjects are utilized must be
reviewed by the Human Subjects Review Committee. Furthermore, any
proposal for such an activity must be reviewed and approved by the
committee before it can be undertaken, and annually until
completion.
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Are there any other steps I need to follow before I submit my
research proposal to the HSRC?
Submit the research proposal to the Deputy Agency Director of the
Health Care Agency program involved in the research. The director
must sign the Research Propo
sal Signature form.
Download form
Deputy Agency Director, Public Health
Bldg. 38X
(714) 834-3155
Deputy Agency Director, Behavioral Health
Bldg. 38X
(714) 834-6032
Deputy Agency Director,
Medical and Institutional Health Services
Bldg. 38X
(714) 834-2021
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To whom do I submit my research proposal after the Research
Proposal Signature form is signed?
Mail to:
Office of Quality Management
405 W. 5th Street, Suite 458
Santa Ana, CA 92701
Attention: Curtis Condon, Ph.D
OR
Send by pony to: Bldg. 38-S
Attention: Curtis Condon, Ph.D
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How will I know if my proposal has been approved?
An official approval form signed by the Chair of the HSRC will
be sent to the primary investigator or designee.
Download form
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How long does it take for the HSRC to review the research
proposal?
Approximately two weeks.
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Annual Approval Process:
How often do I need to follow renewal procedures for my study?
Annually, until the project is completed (unless otherwise
specified by the HSRC).
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What steps do I need to follow?
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Complete the HSRC Status Report form.
Download form If
another form is used the same information must be included:
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Name of primary investigator, title of research, project start
and anticipated end date, number of subjects accrued to date and
expected total number of subjects.
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Brief project summary
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Progress of the project
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Adverse events (if any) encountered in the course of the
research
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Recent literature (if any) associated with research project
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Current copy of consent form and any changes made to consent
form after initial approval by HSRC.
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Signature of primary investigator, (and typed name), date of
signature and telephone number where investigator may be reached.
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Provide copy of updated IRB approval if study is affiliated with
a university or other external institution.
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Final Report
What does the HSRC require if the study is terminated or has been
completed?
Complete the HSRC Final Report form.
Download form
If
another form is used the same information must be included:
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Name of primary investigator and title of research. project
start and end date, and number of subjects.
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Summary of project.
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Findings/conclusions.
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Benefits derived from the study (for the subjects and in
general).
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Any adverse events encountered during the course of the
study. Signature of primary investigator, (and typed name), date of
signature and telephone number where investigator may be reached.
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