Responsible Conduct of Research Human Subjects …：人类受试者的研究的负责行为….pptVIP

PI - Informed Consent Process Simply having a signed, acceptable form is not sufficient evidence that informed consent has been secured. Subjects must understand what the form says. They must have been given a reasonable amount of time to read the form and an opportunity to ask questions about the proposed research. In short, informed consent is actually an on-going process, which is documented through use of an informed consent form. It is recommended consent forms be written at no more than an 8th grade reading level. In some cases, due to language barriers or other circumstances, the elements of informed consent may be presented orally. In those cases, the IRB must receive a written summary of what is to be communicated orally and a witness must be present at the oral presentation. The subject may then sign a “short” consent form. Contents PI - Informed Consent Process (Continued) If the subject is potentially “vulnerable,” (elderly, cognitively impaired, or economically or educationally disadvantaged), extra care must be taken to be sure they are truly giving their informed consent. There are additional regulatory requirements if research involves women, human fetuses, neonates, prisoners or children. . If the subjects have legal guardians or legal representatives, those representatives must participate in the informed consent process and their signatures also must be secured. Subjects (and their representatives) should be given a copy of the signed form. In some cases, the IRB may allow for alterations to the normal consent form elements or waive the the consent form requirements. However, the IRB can grant waivers only under special circumstances and it is not required to do so. Contents Institutional Review Board (IRB) - Members Requests for Approval of Protocols and informed consent forms are reviewed by an institution’s Institutional Review Board (IRB). The 1971 federal regulations required institutions to create IRBs with specific membe