Common use of Human Research Protection Program Clause in Contracts

Human Research Protection Program. [47]Company acknowledges that Institution has a human research protection program (“HRPP”) established in accordance with the principles and standards of the Association for the Accreditation of Human Research Protection Programs that is applicable to all research involving human subjects, including the Research Program, that includes: (i) submittal for prospective and continuing review to Institution’s institutional review board (“IRB”) under the federal regulations governing the protection of human research subjects, (ii) obtaining consent from human research subjects as specified in those regulations, (iii) conducting the research in accordance with ethical standards such as the Belmont Report. [47] Some institutions do conduct FDA related clinical trials. A separate type of agreement is used for these. Section 10.4 contemplates the use of human subjects for other than FDA related purposes.