Appendix P: Four-Part Human Participant Training Tutorial

Part I of the online training module, “History of Human Subjects Protections” introduces researchers to events that have had significant influence upon federal regulations for the protection of human research subjects.  Eighteen slides present information about events such as the Nazi experiments, the Thalidomide tragedy, and the Tuskegee Syphilis Study, along with brief descriptions of research ethics milestones such as the Nuremberg Code of 1947; amendments to the Food, Drug, and Cosmetics Act of 1962; the Belmont Report of 1979; and the Common Rule of 1991.

Part II, “Ethics and Federal Regulations” consists of fifty eight slides presenting details about federal regulations and the University’s institutional rules concerning human subjects’ protections.  The definition of terms including “research,” “participant,” and “human research” is made with reference to specific federal regulations [45 CFR 46.102; 21 CFR 50.3(g); and 21 CFR 56.102(e)].  Investigators’ responsibilities for (a) the design of research that identifies and minimizes possible risks to human participants; (b) the reporting of conflicts of interest to the IRB; (c) the equitable selection and recruitment of participants; (d) obtaining IRB approval; (e) following approved informed consent procedures; (f) reporting unanticipated problems, and (g) monitoring the rights and welfare of participants throughout a research project are discussed.  Other topics addressed include:  required elements of the informed consent document and process; requirements and procedures for the protection of participants’ privacy and data confidentiality; inclusion of underrepresented populations in research; identification of vulnerable populations as research subjects; and the use of deception in research.

Part III of the training module, “Human Subjects Approval at UT Austin” focuses on the University’s IRB application processes.  Opening slides identify persons who may be primary investigators involved in research at the University (faculty, staff, and students are all eligible), and persons who may be involved in the review and approval of such research (faculty sponsors, department review chairpersons, Office of Research Support staff, and IRB members).  Subsequent slides describe the UT Austin IRB’s responsibility to determine and certify that all human subjects research conducted at UT conforms to federal guidelines for the conduct of ethical research and complies with DHHS regulations regarding the health, welfare, safety, rights and privileges of human subjects.  Qualifications for exempt, expedited, and full board studies are presented.  Essential elements of the UT Austin IRB application materials are listed, and the ORS research review and approval process is described.  Requirements for the submission of continuing review applications, amendment applications, and unanticipated problem reports are presented in detail.  Finally, procedures for the online submission of an IRB application via the IRBaccess system are described.

Part IV of the training module, “The Belmont Report,” links researchers to the DHHS online copy of the report, available at http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm.

Finally, once the online four-part human participant training tutorial is completed, investigators are required to document their training within IRBaccess or their application will not be approved.  Training is valid for 3 years.

To learn more about human participant training visit our Four-Part Human Participant Training Tutorial page.