Human Subjects Review Committee
phone: (714) 834-2034
fax: (714) 834-7644
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New Research Proposals
Preparing a new research proposal for HSRC review
Include the following:
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Provide the name of the study.
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Provide information about the primary researcher and
co-researchers:
· Include a sheet containing the names (with phone numbers and
addresses, credentials, job titles, divisions, and/or agency names)
and signatures of the primary researcher, each co-researcher, and
the appropriate program director).
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State the purpose of the research (e.g., its significance,
expected impact).
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Describe the methodology of the project:
· Describe procedures for subject recruitment, selection, and
screening. Identify the number and characteristics (e.g., age, sex)
of subjects to be included, and any exclusionary criteria.
· Describe all procedures to be performed (i.e., how data will be
collected); describe criteria or procedures for assigning subjects
to different "treatment" groups (e.g., control, experimental).
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Provide expected start and end dates for the project.
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State any risks or benefits to subjects and any potential
benefits for mankind.
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Describe provisions for any medical care required as a result of
participation in the research study.
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Describe procedures for safeguarding confidentiality.
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Describe (if applicable) manner by which subjects are to receive
compensation (e.g., cash, special benefits or services, etc.)
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Develop and provide a consent form (not all projects require
this). To determine if a consent form is necessary, view the DHHS
website.
http://ohrp.osophs.dhhs.gov/humansubjects/guidance/45cfr46.htm -
46.116
· Consent forms must be in language easily understood by the
subject, and must contain all pertinent information in sufficient
detail to allow the subject to make an informed decision to
participate or not to participate in the study.
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Include copies of survey instruments or other forms to be used
in data collection with proposal submission.
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Include a copy of approval from other Human Subject Review
Boards. This is required if study is done collaboratively with a
university or other external institution.
See sample Human Subjects Protocol.
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