If The Research is Conducted Off Campus
or Recruitment is Performed Off-Campus:
Letters of Compliance/IRB Approval:
The application should include any necessary letters of
compliance or IRB approvals from non-UCLA facilities or agencies
proposed as a research site or source of potential subjects. For
example, letters of compliance are required from facilities such
as nursing homes that do not have a DHHS approved Multiple
Project Assurance and IRB. Letters of compliance are required on
the facility’s letterhead and must contain a statement that
the agency will, "review, abide by and comply with the
procedures approved by the UCLA HSPC." Facilities that do
have a DHHS approved MPA and IRB, such as the Veteran’s
Administration at Wadsworth, must review and approve the project
before the UCLA HSPC will approve the project.
NOTE: Do not wait for the approval of non-UCLA sites before
submitting your proposal to the HSPC. If the HSPC approves the
project prior to your obtaining the letter of compliance or
non-UCLA IRB approval the HSPC approval notice will carry the
following codicil: "This Approval Notice is issued for
administrative purposes only. No subjects may be contacted,
recruited, or enrolled. All related HSPC-approved consent forms
will be held on file with the HSPC until the approval notice from
the IRB of [the name of the facility] is received by the
HSPC."
When Research
Requires the Review of Other Institutional Committees:
Review and Approval of Other UCLA Committees:
Please submit other required institutional review committee
approvals to the HSPC. Though other institutional committees
share the responsibility for following guidelines in our
collective effort to protect human subjects, ultimately the final
authority for participation of human subjects in research falls
on the HSPCs. Other institutional review committees include but
are not limited to the Medical Radiation Safety Committee (MRSC)
and the Jonsson Comprehensive Cancer Center - Internal Scientific
Peer Review Committee (JCCC-ISPRC).
According to the November 8, 1995, memorandum from Assistant
Vice Chancellor-Biomedical Affairs, Barbara A. Levey, to the
National Cancer Institute, all cancer related research is
required to have JCCC-ISPRC review and approval prior to
conducting the study. Please contact the JCCC-ISPRC for more
information.
NOTE: Do not wait for the approval of the other UCLA
institutional review committees before submitting your proposal
to the HSPC. If the HSPC approves the project prior to the
approval of the other committees the HSPC approval notice will
carry the following codicil: "This Approval Notice is issued
for administrative purposes only. No subjects may be contacted,
recruited, or enrolled. All related HSPC-approved consent forms
will be held on file with the HSPC until the [institutional
committee name] approval is received by the HSPC."
If the
Research Involves Advertisements, Posters, Flyers, Press
Releases, etc., to Recruit Subjects:
Contact Documents:
The HSPCs are required to review any advertisements, flyers,
internet postings (with the internet address), etc., for subject
recruitment, correspondence to subjects or other cooperating
individuals such as referring physicians or facilities. In
addition, the Committees review all press releases intended to
facilitate recruitment of subjects. Contact documents are not
approved or valid without an HSPC approval stamp, date, and
number. Only HSPC approved documents may be used in the conduct
of research.
If possible, please include recruitment materials with your
initial application. If the material is not ready at the time of
initial application, investigators may submit the material as an
addendum to an already approved project. Requests for approval of
recruitment materials following initial HSPC review of the
protocol should allow sufficient time to allow for any necessary
revisions prior to publication. Advertisements, press releases,
etc., may qualify for expedited review (Please see Chapter 3, "The HSPC Review
Process," for more information).
For medical studies, contact documents should not make any
claims, either explicitly or implicitly that the research is
superior to any current practice. Please limit advertisements to:
- the name of the investigator and contact information,
including the name of UCLA;
- a simple and concise description of the purpose of the
research;
- general eligibility criteria for participation;
- a truthful description of the possible benefits which may
result from participation in the research. If there are
no benefits, please indicate whether subjects are paid
for their participation or receive free treatment.
If the
Research Includes Surveys, Questionnaires, etc.,
Instruments:
The HSPCs are required to review all research instruments such
as surveys, questionnaires, etc. Please include the instruments,
if available with your initial application. Investigators may
submit draft versions of study instruments for HSPC review. The
HSPCs are required to review any modifications to research
instruments. Please submit an addendum to the Committee when
requesting changes to previously approved instruments. If the
HSPC approves the project prior to the review of the finalized
instruments, the investigator will receive a codiciled approval
notice indicating that the instruments cannot be used until they
are reviewed and approved by the Committee.
Drug and
Device Brochures:
The HSPCs are required to examine the Investigator’s Drug
Brochure and/or device manual in order to adequately assess the
risk/benefit ratio for subjects participating in the research. In
addition, please complete Section IV,
of the HS-Form 1, Investigational Drug Information Record,
for research conducted with non-FDA approved drugs or drugs used
for indications other than those approved by the FDA. (Please see
Chapter 9, "FDA
Requirements," for more information.)
There are special considerations for emergency care and
compensation for injury to subjects participating in privately
sponsored drug and device studies. (Please see Chapter 4, "Informed Consent
Requirements: Description of Informed Consent Forms, Emergency Care and Compensation for
Injury," for more information.)
A claim of exemption means that a research activity does not
require HSPC review and approval. The university, however, is
still obligated to review all such activities, whether funded or
not, and certify that the research meets the federal requirements
for a "Claim of Exemption".
In order to fulfill federal requirements for the proper review of
research, investigators cannot "self-exempt" from HSPC
review. The university has determined that evaluation and
certification of exempt status is performed by the OPRS in
consultation with the HSPC. The Claim of
Exemption does not necessarily mean that the
investigator is exempted from the informed consent requirements. (Please
see Chapter 3, "The HSPC Review
Process" and Chapter 4,
"Informed Consent Requirements" for more
details.)
The following materials are required when submitting a Claim of Exemption:
- Claim of Exemption From HSPC
Review - Form HS-7
- An abstract of the research, purpose and objectives of
the study, and if the applicant is a student, a signature
from a faculty advisor who agrees to sponsor the project;
- Consent forms or a statement indicating that the activity
qualifies for a waiver of informed consent under the
guidelines outlined in Chapter 4, "Informed
Consent Requirements";
- Recruitment materials, i.e., advertisements, flyers,
phone scripts, etc.;
- Approval from participating institutions, i.e., schools
or agencies, if applicable.
Investigators are strongly urged to consult with the OPRS
staff before applying for exemption from Committee review.
(Please see Chapter 3, "The HSPC
Review Process" and the "Claim
of Exemption" Guidelines and Form HS-7 in Chapter 12, "Application Forms"
for more details.)
Contact OPRS
October 29, 2004
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