Human Research Protection Program Sample Clauses

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. [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. 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. (a) Sponsor 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. (b) During, and for a period of 2 years after completion of the study, Sponsor shall report to the investigator promptly (and no later than 30 days) any information that could directly affect the health or safety of past or current study subjects or influence the conduct of the Study, including but not limited to the Study results and information in site monitoring reports and data safety monitoring committee reports as required by the Protocol. In each case, the Investigator and/or Stony Brook University will communicate these findings to the IRB of record for a determination of need to notify past or current study subjects. (c) Where the University receives any such information or Study results from Sponsor that impact participant safety or medical care, the University will, to the extent possible, send Study participants a written communication about the results.

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. 6.2 In furtherance of Institution’s HRPP, Sponsor agrees: (a) to promptly notify the Principal Investigator and/or the IRB directly, of (i) non-compliance with the study protocol in Exhibit A or applicable laws, particularly those laws related to human research subjects, that could impact the safety or welfare of participating subjects, (ii) serious adverse events that have been reported to the FDA or other governmental agency in relation to the Study at Institution or any other site, (iii) unanticipated problems in the Study at Institution or any other site that could relate to risks to participating subjects, and (iv) circumstances that could affect subjects’ willingness to continue to participate in the Study or the IRB’s continuing approval of the Study, and (b) to develop a plan of communication to subjects with the Principal Investigator that is acceptable to the IRB when new findings or results of the Study might impact the willingness of subjects to continue to participate in the Study or directly affect their current or future safety or medical care. 6.3 Sponsor agrees to provide Institution with any data and safety monitoring reports related to the Study. Institution agrees that such reports will be submitted to the IRB as required. During the Study and for at least two (2) years following the completion of the Study at all sites, Sponsor shall promptly provide Institution and Principal Investigator with the written report of any routine monitoring findings in site monitoring reports and data safety monitoring committee reports including, but not limited to, data and safety analyses.

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. 19.2 In furtherance of STANFORD’s HRPP, SPONSOR agrees: (a) to promptly notify the Principal Investigator and/or the IRB directly, of (i) non- compliance with the study protocol in Exhibit A or applicable laws, particularly those laws related to human research subjects, that could impact the safety or welfare of participating subjects, (ii) serious adverse events that have been reported to the FDA or other governmental agency in relation to the Clinical Trial at Stanford or any other site, (iii) unanticipated problems in the Clinical Trial at Stanford or any other site that could relate to risks to participating subjects, and

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.