Informed Consent Resource Guide Requirements, examples, and templates IRC Biosafety Committee Resource Guide For studies using biological samples IRB Common Rule & Reliance Agreement Guide Guidance on collaboration with other institutions’ IRBs When PIs Come a 'Knockin': Everything Investigators Want to Know but are Afraid to Ask Offers guidance for Principal Investigators on IRB expectations, responsibilities, and best practices for maintaining compliance throughout the research process Belmont Report Educational Introduces the foundational ethical principles of human subjects research (Respect for Persons, Beneficence, and Justice) based on the Belmont Report Protecting Human Subjects Module 1 Provides an overview of key ethical standards, informed consent requirements, and the historical background of human subjects protection Protecting Human Subjects Module 2 Explains researcher responsibilities, IRB roles, and specific considerations for vulnerable populations in human subjects research Protecting Human Subjects Module 3 Focuses on practical applications of ethical principles, including risk-benefit analysis, confidentiality, and ongoing participant protections during the study General Informed Consent Requirements 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. Research Use of Human Biological Specimens and Other Private Information 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. Need Help? If you have questions about which guide to use or how to complete your materials, contact: Dr. Jennifer Bail, IRB Chair irb@uah.edu Include “IRB Application Question” in your subject line.