Investigator’s Manual for
the Protection of Human Subjects
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Chapter 7: Responsibilities of Principal Investigators

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:

  1. the primary appointment of the principal investigator is with the other institution
  2. UCLA is not the primary recipient of funding, and
  3. 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 facility’s 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 investigator’s 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.

 


Investigator’s Manual for
the Protection of Human Subjects
Table of Contents
Last Chapter | Next Chapter
Last Section | Next Section
Chapter 7: Responsibilities of Principal Investigators
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October 29, 2004
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