investigator (PI) has an IRB or OPO ethical oversight board, or equivalent, education and experience Evidence that the PI has a process for maintaining the security of files, and/or human within the area of research as materials, provided by the OPO for the proposed research, and that the protected stated in the study design. health information of the donor and any involved recipients will remain confidential, and Evidence that the project has That the OPO communicates to the PI that the first priority for the deceased donor, and been subjected to ethical organs and/or tissues, are to provide transplants and transplant therapy before being oversight either by an designated for research purposes. Institutional Review Board (IRB) if appropriate (i.e. living subjects involved in the research) or an OPO ethical oversight process. Ethical oversight will also demonstrate donor and recipient confidentiality of protected health information. Evidence that priority is reserved for organs and tissues (if applicable to the research request) to be transplanted or used for medical therapy before being designated for research purposes. RS 1.3 Minimum information disclosed by The survey team will review OPO approved research protocols involving deceased each PI: The OPO shall obtain donors over the OPO three year accreditation period and verify the full name, all PI’s minimum information from each PI applicable sponsors of the research intervention, PI contact information, details of the who is approved for a deceased intervention, title of the protocol, an objective method for determining the protocol end donor research intervention to date. include: full name, all applicable PI’s sponsors of the research intervention, PI contact information, details of the intervention, full title of the protocol, an objective method for determining the protocol end date (i.e. specific month, day and year; number of specimens, etc.). RS 1.4 RESEARCH INTERVENTION COMMUNICATIONS: RS 1.4.1 The OPO must have a policy and The survey team will ask the OPO what authorization is required by the state’s UAGA procedure for systematically
investigator (PI) has education and experience within the area of research as stated in the study design. Evidence that the project has been subjected to ethical oversight either by an Institutional Review Board (IRB) if appropriate (i.e. living subjects involved in the research) or an OPO ethical oversight process. Ethical oversight will also demonstrate donor and recipient confidentiality of protected health information. Evidence that priority is reserved for organs and tissues (if applicable to the research request) to be transplanted or used for medical therapy before being designated for research purposes. an IRB or OPO ethical oversight board, or equivalent, Evidence that the PI has a process for maintaining the security of files, and/or human materials, provided by the OPO for the proposed research, and that the protected health information of the donor and any involved recipients will remain confidential, and That the OPO communicates to the PI that the first priority for the deceased donor, and organs and/or tissues, are to provide transplants and transplant therapy before being designated for research purposes. RS 1.3 Minimum information disclosed by each PI: The OPO shall obtain minimum information from each PI who is approved for a deceased donor research intervention to include: PI’s full name, all applicable sponsors of the research intervention, PI contact information, details of the intervention, full title of the protocol, an objective method for determining the protocol end date (i.e. specific month, day and year; number of specimens, etc.). The survey team will review OPO approved research protocols involving deceased donors over the OPO three year accreditation period and verify the PI’s full name, all applicable sponsors of the research intervention, PI contact information, details of the intervention, title of the protocol, an objective method for determining the protocol end date. RS 1.4 RESEARCH INTERVENTION COMMUNICATIONS: RS 1.4.1 The OPO must have a policy and procedure for systematically The survey team will ask the OPO what authorization is required by the state’s UAGA
PROPOSED_REVISIONS_REDLINE_AOPO_Standards_and_Guidelines_2015-07-28.docx