Research Performed at Non-UCLA Sites
Research
Conducted at other Institutions with an OPRR Approved MPA
If the research is conducted at another institution with an
OPRR approved MPA, the UCLA HSPC will not perform a dual review
provided that all of the following conditions are met:
- the primary appointment of the principal investigator is
with the other institution
- UCLA is not the primary recipient of funding, and
- the research is conducted entirely at the other site.
If any of the aforementioned conditions is not met, the
research proposal has to be submitted to the UCLA HSPC for review
and approval. UCLA does not currently have OPRR approved
cooperative agreements with any institutions.
Research
Conducted at a Site Without an OPRR Approved MPA
When UCLA accepts the responsibility for review of research
that is conducted at a site without a MPA, the HSPCs require that
the director of the facility (clinic, hospital, institution,
school, etc.) provide a Letter of Compliance. Such letters must
be on the facilitys letterhead and contain the assurance
statement that the agency will "abide and comply with the
UCLA HSPC requirements for the protection of human research
subjects."
Research
Conducted at a Foreign Site
When research is to be conducted at a foreign site and it is
in receipt of DHHS funding (such as NIH, CDC, HRSA, ACHPR and
Fogarty Grants, but not NSF), the investigator is required to
obtain a Single Project Assurance (SPA) from the responsible
institution at the foreign site. This assurance demonstrates that
the ethical principles of that culture will be considered in the
design and conduct of the research as well as appropriate federal
regulations (whichever is more stringent). The HSPC/OPRS does not
administer these assurances, but will alert the investigator to
the need to contact his or her funding officer who, in
cooperation with the NIH/OPRR, will assist in this process.
Regardless of funding, the HSPC will pay close attention to
the protocol and the investigators understanding and
awareness of possible cultural vulnerabilities within the
population to be studied. In addition, the HSPC is required to
scrutinize the protocol according to the ethical principles
articulated in the Belmont
Report and 45
CFR 46.
Contact OPRS
October 29, 2004
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