2. Application Submission
The Application to Involve Human
Subjects in Research, (Please see Chapter 12, "Application Forms"
for more information) which includes sample assent form,
consent forms for both medical and non-medical research, adverse
event report forms, the claim of exemption form, and the final
report form, is available from the HSPC support office, the OPRS,
or on the internet at www.oprs.ucla.edu.
The professional OPRS staff are happy to answer any questions you
may have regarding the participation of human subjects in
research or the review of applications by the HSPCs. Any
questions regarding HSPC review or the content of the manual
should be directed to the OPRS.
To contact the individual HSPCs please use the following
telephone numbers and addresses:
General Campus Human Subject Protection Committee:
2107 Peter V. Ueberroth Building
Box 951694
Los Angeles, CA 90095-1694
or Campus Mail Code: 169407
telephone number: 310-825-7122
email address: ghspc@oprs.ucla.edu
Medical Human Subject Protection Committee 1 or 2:
2107 Peter V. Ueberroth Building
Box 951694
Los Angeles, CA 90095-1694
or Campus Mail Code: 169407
telephone number: 310-825-5344
email address: mhspc@oprs.ucla.edu
The Basic
Application
The most common form of HSPC
application for non-medical research consists of three core
documents: 1) the Form HS-1,
Application to Involve Human Subjects in Research; 2) the
informed consent form; and 3) a grant
proposal. The most common form of HSPC application for medical
research consists of five core documents: 1) the Form HS-1, Application to Involve
Human Subjects in Research; 2) the
lay language summary; 3) the informed
consent form; 4) a complete detailed scientific protocol; and
5) a grant proposal. Other documents may be required as part of
the submission depending on the type of research. The following
will help investigators identify the documents required to
complete a submission to the HSPC.
All investigators should carefully review the requirements for
submission of applications to the HSPC. Submission of incomplete
proposals may result in the delay of the review and approval
process. The review process will not be initiated if the proposal
is incomplete and/or does not fulfill the HSPC guidelines.
Investigators should carefully review Chapter
3, The HSPC Review Process of this manual and the
summary guidelines of the application forms for each type of
submission in order to ensure that the appropriate forms are
submitted for HSPC consideration. Application forms are found in Chapter 12 of this manual.
- The HSPC Application Form
HS-1:
The Form HS-1 (4/97), Application
to Involve Human Subjects in Research, is
the legal document requesting HSPC review of your
proposal. Please complete each section as applicable to
your submission. The information you provide in the
application must include sufficient detail to facilitate
an effective review by all members of the HSPC.
- Lay Language Summary:
HSPCs are required by the federal regulations to
include members from various backgrounds, at least one
member from the community-at-large, and at least one
non-scientific member. The lay language summary should
not be more than one page and should explain your
research for the lay reader. The request for a lay
language summary is found in Section
III, of the Form HS-1.
- The Informed Consent
Form/Assent Form:
Sample consent and assent forms are found in Chapter 12 of this manual.
There are sample consent forms for medical research, Form HS-2, and non-medical
research, Form HS-3 and
a sample assent form for research with children between
the ages of seven and 13, known as the Form HS-3a. All
consent/assent forms are required to reflect the HSPC
format and style. (Please refer to Chapter
4, "Informed Consent Requirements," for
information regarding the requirements for informed
consent.) Only UCLA HSPC reviewed, approved, stamped, and
dated consent forms can be used to consent subjects.
- The Research Protocol:
A detailed research protocol is required for the
complete HSPC review of your research. Section IV of the HS-Form 1,
is acceptable in lieu of a detailed scientific protocol
for non-medical research. All submissions should include
a scientific protocol that includes a complete
explanation of the following information:
- Background
- Objectives of the research
- Significance
- Thorough description of how human subjects will
participate in the research
- Eligibility requirements for subjects
- Design/methodology
- Treatment regimen(s) (for medically invasive
research)
- Clinical information (when applicable) (for
medically invasive research)
- Analysis of the collected data
- References
- Grant Proposal:
In order to perform a complete review the HSPCs are
required to examine the grant proposal. Investigators
need not include the funding section or the breakdown of
dispersal of funds unless requested by the HSPC.
Pilot
Studies:
The participation of human subjects in research requires
review by the HSPC or, in the case of Claims of Exemption, by the
OPRS in consultation with the HSPC. The Committee is required to
assess the risks and benefits resulting from human subject
participation in all research. Pilot studies and feasibility
studies, even if they include only one subject, require the same
consideration by the HSPC/OPRS as a project that requests the
participation of 100 or more subjects.
Investigators interested in conducting feasibility or pilot
work should consider contacting the OPRS prior to submitting an
application. The OPRS can advise the investigator on how to
appropriately address issues related to the risks and benefits of
participation. (Please see Chapter 4,
"Informed Consent Requirements" for
additional information.)
Contact OPRS
October 29, 2004
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