Step-by-step guides for completing IRB forms, informed consent, and IRB reliance agreements. The UAH IRB Committee has developed a series of Resource Guides to help you through every step of the IRB application process. These guides provide step-by-step support for completing forms, understanding requirements, and navigating the review process. Begin with the IRB Overall Process Resource Guide. This guide explains: The steps to submit an IRB application Which forms are required What CITI training certificates you will need How the review process works after submission How to submit an extension (Form 5) for an already approved study Below are the available guides and examples to assist with your submission: Application Process & Forms IRB Overall Process Resource Guide Provides an overview of the entire IRB submission process, including required forms, CITI training, and how applications are reviewed and approved. Form 1 Resource Guide Explains how to complete the main IRB application form, with four approved examples to help you prepare strong, well-written submissions. Four approved examples to help you write strong applications Form 2 Resource Guide Form 3 Resource Guide Covers how to request exemption from IRB review, with guidance on determining whether your study qualifies for exempt status. Form 6 Resource Guide Provides instructions for studies involving minors (under 18 years old), including consent and assent requirements. Form 8 Resource Guide Guides you through submitting an adverse event or unanticipated problem report related to an approved IRB study. Form 9 Resource Guide Explains how to report protocol deviations or violations, ensuring compliance and participant safety. Form 10 Resource Guide Describes the process for study closure, including when and how to submit a final report once research activities are complete. Form 11 Resource Guide Covers how to request amendments or revisions to an already approved IRB protocol, including required documentation and review procedures. Supporting Guidance Informed Consent Resource Guide Requirements, examples, and templates IRC Biosafety Committee Resource Guide For studies using biological samples Submitting a Revision to an Approved Study Guide Instructions for amendments 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.