When PIs Come a'Knockin': Everything Investigators Want to Know but are Afraid to Ask Belmont Report Educational Video Protecting Human Subjects Module 1 Protecting Human Subjects Module 2 Protecting Human Subjects Module 3 General Informed Consent Requirements (video) In this video, all of the characters are fictional. This presentation takes part in two scenes. In the first scene an investigator meets with the IRB Chair to go over some issues for obtaining legally effective informed consent from potential subjects with schizophrenia before submitting her protocol to the IRB. These issues include determining capacity to consent, using a legally authorized representative, and meeting the regulatory requirements for the process of informed consent. In the second scene, Dr. Presley obtains appropriate informed consent from a potential subject, Mr. Smith, who has the capacity to consent. http://www.youtube.com/watch?v=SqRw6FevuXg Research Use of Human Biological Specimens and Other Private Information (video) Mrs. Julie Kaneshiro, OHRP Policy Team Leader, is interviewed and discusses the challenges and complexities of the application of the HHS regulations at 45 CFR part 46 to activities involving biological specimens and other private information. Mrs. Kaneshiro discusses how to assess whether an activity constitutes non-exempt human subjects research. She clarifies when the HHS regulations do and do not apply to an activity and when an institution is engaged in human subjects research. This is an advanced topic video and is best suited to viewing by individuals already possessing a basic understanding of the HHS regulations for the protection of human subjects.