HUMAN RESEARCH. The Grantee agrees that all human subject research (which includes but is not limited to the researcher obtaining identifiable private information or data through intervention or interaction with an individual) shall be prohibited unless the Grantee also certifies that prior written approval of its own or another Institutional Review Board (IRB) has been obtained or the research has been exempted, subject to all applicable laws, including but not limited to: 42 U.S. C. Section 3515(b) (relating to prohibitions on funding certain experiments involving human participants) and the regulations there under. Voluntary, informed consent of each subject shall be obtained. If the subject is a minor, or incompetent, the voluntary, informed consent of his or her legal guardian shall be required. The Grantee shall inform each potential subject prior to his or her consent that refusal will not result in the loss of any benefits to which the subject is otherwise entitled from the Federal government, the Commonwealth, the Grantee, any sub-grantee, or any third party insurer. Additionally, the Grantee agrees that all human subject research funded under this grant shall be submitted for review and approval to the Department of Health IRB on form number HD 1013F prior to the onset of research.
HUMAN RESEARCH. The Contractor agrees that all human subject research (which includes but is not limited to the researcher obtaining identifiable private information or data through intervention or interaction with an individual) shall be prohibited unless the Contractor also certifies that prior written approval of its own or another Institutional Review Board (IRB) has been obtained or the research has been exempted, subject to all applicable laws, including but not limited to: 42 U.S. C. Section 3515(b) (relating to prohibitions on funding certain experiments involving human participants) and the regulations there under. Voluntary, informed consent of each subject shall be obtained. If the subject is a minor, or incompetent, the voluntary, informed consent of his or her legal guardian shall be required. The Contractor shall inform each potential subject prior to his or her consent that refusal will not result in the loss of any benefits to which the subject is otherwise entitled from the federal government, the Commonwealth, the Contractor, any subcontractor, or any third party insurer. Additionally, the Contractor agrees that all human subject research funded under this grant shall be submitted for review and approval to the Department of Health IRB on form number HD 1013F prior to the onset of research.
HUMAN RESEARCH. Any activity that either:
2.4.1 Is Research as Defined by DHHS and involves Human Subjects as defined by DHHS, or
2.4.2 Is Research as Defined by FDA and involves Human Subjects as defined by FDA.
HUMAN RESEARCH. You and your supervisor will complete this section to indicate the duties you have been trained to perform as they relate to a human research study. Duties (Section A: Human Research) Employee Supervisor
HUMAN RESEARCH. Anytime human subjects may be used, the Partner shall comply with Department of Health and Human Services (DI-IHS) policies and regulations on the protection of human subjects (45 CFR 46, as amended) and with any terms of approval imposed by the District’s Internal Review Board (“IRB”) on the Use of Humans as Experimental Subjects. In all cases, the Partner agrees to adhere to the study protocol approved by the IRB, to assure that any legal or IRB requirements for the informed consent process are met and are appropriately documented, and to report to the District’s authorized representative (a) any adverse events or unexpected problems, and (b) any proposed changes to the study protocol or informed consent process. If the Partner has its own approved Institutional Review Board, then the project shall also be submitted to that board for approval and the Partner shall provide verification that the approval has been granted. If applicable, the verification shall state the date when the project must be resubmitted for continuing review.