Human Research Protection Program. Company acknowledges that Stanford 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 Stanford’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.
Human Research Protection Program. (HRPP) is defined as the overarching program at an Accessing Institution charged with the responsible oversight of human subjects research and compliance with federal regulations (e.g., the Federal Policy for the Protection of Human Subjects (45 CFR 46) by Users from that institution
Human Research Protection Program. Company acknowledges that NEOMED 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 NEOMED’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.
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.
Human Research Protection Program. (a) Company acknowledges that Stony Brook University (“University”) 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 clinical research studies, including the Study, that includes: (i) the University’s submittal of clinical studies for prospective and continuing review to the IRB as required by the FDA regulations governing the protection of human research subjects, (ii) obtaining of consent from human research subjects for participation in the clinical studies as required by the FDA regulations governing the protection of human research subjects, and (iii) conducting clinical studies in accordance with ethical standards such as the Belmont Report.
Human Research Protection Program. Pursuant to HMH’s Human Research Protection Program, clinical trial agreements are required to include language which obligates sponsors to promptly inform HMH of serious study related events that could pose risks to human research subjects in a clinical trial; develop a plan of communication to provide HMH with information of new findings or results which might impact the willingness of human subjects to participate in a clinical trial; and provide HMH with relevant study safety information for a certain period of time after the clinical trial has been terminated.
Human Research Protection Program. 1 Sponsor acknowledges that AIR 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 clinical research studies, including the Study, that includes: (i) their submittal for prospective and continuing review to the Institutional Review Board ("IRB") as required by the FDA regulations governing the protection of human research subjects, (ii) obtaining of consent from human research subjects as required by the FDA regulations governing the protection of human research subjects, (iii) conducting them in accordance with ethical standards such as the Belmont Report.
Human Research Protection Program. 19.1 SPONSOR acknowledges that STANFORD 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 clinical research studies, including the Clinical Trial, that includes: (i) their submittal for prospective and continuing review to STANFORD’s institutional review board (“IRB”) as required by the FDA regulations governing the protection of human research subjects, (ii) obtaining of consent from human research subjects as required by the FDA regulations governing the protection of human research subjects, (iii) conducting them in accordance with ethical standards such as the Belmont Report.
Human Research Protection Program. 6.1 Sponsor 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 clinical research studies, including the Study, that includes: (i) their submittal for prospective and continuing review to Institution’s institutional review board (“IRB”) as required by the FDA regulations governing the protection of human research subjects, (ii) obtaining of consent from human research subjects as required by the FDA regulations governing the protection of human research subjects, (iii) conducting them in accordance with ethical standards such as the Belmont Report.
Human Research Protection Program. In the event that MMC does not hold the contract for a given clinical study and the Principal Investigator is not an employee of MMC, however, the Investigator wants to engage the services of a float pool study coordinator and/or grant accountant, a separate Letter of Agreement shall be developed between MMCRI and the Investigator and/or his Practice and will include language to the effect that the Investigator will abide by MMC’s Human Research Protection Program and that the study will be reviewed by MMC’s IRB.
