Policies, Guidance, and Forms
UNA IRB Submission Checklist: This should be the cover page for all submissions to the IRB.
- Research Application and Protocol Form
- Modification of Approved Protocol Form (please submit via the Canvas IRB course)
- Continuing Review Form (please submit via the Canvas IRB course)
- Unanticipated Problems and (Reportable) Adverse Event Report Form
- Non-compliance/Protocol Deviation Report Form
- Completion/Termination Report Form
- Research Dissemination
- UNA is not currently equipped to conduct genetic research. If UNA were to participate in such research it would likely be as a sub-grantor, in which case policies of the grantor would be followed. A link to the University of Alabama at Birmingham genetic research policy is provided here as reference. http://www.uab.edu/medicine/genetics/research
- HIPPA Application in UNA Human Subject Research
- HIPAA Training
- Institutional Review Boards and the HIPAA Privacy Rule (DHHS Policy) http://privacyruleandresearch.nih.gov/irbandprivacyrule.asp
- Protecting Personal Health Information in Research: Understanding the HIPAA Privacy Rule (DHHS Policy) http://privacyruleandresearch.nih.gov/pr_02.asp
- Research Repositories, Databases, and the HIPAA Privacy Rule (DHSS Policy) http://privacyruleandresearch.nih.gov/research_repositories.asp
- Council for International Organizations of Medical Sciences International Ethical Guidelines for Biomedical Research Involving Human Subjects http://www.cioms.ch/publications/layout_guide2002.pdf
- DHHS OHRP Compilation of International Standards
http://www.hhs.gov/ohrp/international/index.html
- See also Recruitment section under Internet-Based Research
- Recruiting Material
- For additional information see DHHS Guidance on Reporting Unanticipated Problems and Adverse Events - http://www.hhs.gov/ohrp/policy/advevntguid.html