ARTICLE XIV RESEARCH 14.1. General: (a) All research involving human subjects (sponsored or non-sponsored) will be conducted in a manner that minimizes risks to the welfare, health, and safety of the participants. Patient’s rights, including the right of privacy, will be preserved, and an informed consent form will be obtained from the patient, or his or her authorized representative, prior to such participation. (b) The TCHIRB is designated to oversee research on subjects conducted by the administration, nursing, medical and resident staff, or involving nonpublic information held by the Hospital. The purpose of the TCHIRB is to protect the rights and welfare of human subjects participating in research and to ensure that the human research conducted under this Article complies with all federal regulations, including those promulgated by the Department of Health and Human Services and the Food and Drug Administration at 45 C.F.R. §46 and 21 C.F.R. §§50, 56 and 812, and conforms to federal and state laws and the Hospital’s policies. The ethical principles are based on the Nuremburg Code, the Declaration of Helsinki, the Belmont Report, and the International Conference on Harmonization (Good Clinical Practices). (c) The President & Executive Officer is responsible for the appointment of members of the TCHIRB and the oversight of the TCHIRB. The Hospital may not approve research covered under this Article if it has not been approved by the TCHIRB; however, the Hospital administration may decline to conduct research previously approved by the TCHIRB. Investigators may not begin research involving human subjects until the TCHIRB has approved the study or has determined that it is exempt. 14.2. Prior Review of Proposed Research Projects: (a) The Administration of the Hospital will assist in determining the feasibility of protocols or proposals for research. Prior review of any proposed research project involving human subjects will be obtained from the appropriate service line executive medical director (and division chief, if applicable) to include assurances that: (1) the principal investigator has appropriate training and expertise, adequate resources and sufficient time allocation to conduct the research;
ARTICLE XIV RESEARCH 14.1. General: (a) All research involving human subjects (sponsored or non-sponsored) will be conducted in a manner that minimizes risks to the welfare, health, and safety of the participants. Patient’s rights, including the right of privacy, will be preserved, and an informed consent form will be obtained from the patient, or his or her authorized representative, prior to such participation. (b) The TCHIRB is designated to oversee research on subjects conducted by the administration, nursing, medical and resident staff, or involving nonpublic information held by the Hospital. The purpose of the TCHIRB is to protect the rights and welfare of human subjects participating in research and to ensure that the human research conducted under this Article complies with all federal regulations, including those promulgated by the Department of Health and Human Services and the Food and Drug Administration at 45 C.F.R. §46 and 21 C.F.R. §§50, 56 and 812, and conforms to federal and state laws and the Hospital’s policies. The ethical principles are based on the Nuremburg Code, the Declaration of Helsinki, the Belmont Report, and the International Conference on Harmonization (Good Clinical Practices). (c) The President & Executive Officer is responsible for the appointment of members of the TCHIRB and the oversight of the TCHIRB. The Hospital may not approve research covered under this Article if it has not been approved by the TCHIRB; however, the Hospital administration may decline to conduct research previously approved by the TCHIRB. Investigators may not begin research involving human subjects until the TCHIRB has approved the study or has determined that it is exempt. 14.2. Prior Review of Proposed Research Projects: (a) The Administration of the Hospital will assist in determining the feasibility of protocols or proposals for research. Prior review of any proposed research project involving human subjects will be obtained from the appropriate service line executive medical director (and division chief, if applicable) to include assurances that: (1) the principal investigator has appropriate training and expertise, adequate resources and sufficient time allocation to conduct the research;
Rules%20Regulations%20041817.DOCX