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Closing Studies

When a principal investigator terminates employment or other association with UCLA, he or she is obligated to submit a termination report to the HSPC or transfer the protocol to another principal investigator via an amendment which is reviewed and approved by the HSPC and Department or Division head.

NOTE: As a general rule, change of key personnel in federally funded or FDA-regulated research requires prior approval of the funding agency and/or FDA.

Final Reports are required because of the serious risks to research subjects that may arise when research activities are terminated without HSPC knowledge. For example, if a study is closed or HSPC approval has lapsed, then ethically or medically indicated follow-up procedures may not be available. (Please see Appendix 12, "Application Forms," Form HS-8)

Research activities may be closed by the HSPC without investigator approval if it is determined that the investigator is no longer affiliated with UCLA.

Conflicts of Interest

Sponsored Research is responsible for administration of conflict of interest policies. On September 26, 1995, the UCLA Office of Contracts and Grant Administration (now called Sponsored Research) issued a memorandum outlining new requirements of the National Science Foundation and the Public Health Service regarding an "investigator’s sponsored project obligations and personal financial interests or obligations" which may result in a conflict of interest. (The FDA has published proposed regulations but they have not been issued in final form).

The HSPC also is concerned about the potential for abuse when investigators have a financial obligation or interest that may pose a conflict of interest. The HSPC requires that investigators disclose within their application all potential financial conflicts of interest and explain how the potential conflict of interest will be minimized or resolved. In these situations, the HSPC may require disclosure of conflicts of interest in consent forms.