Get Flexibility In The Regulations Flexibility In The Regulations - Academics - Academics Ochsner

This guide provides a clear and supportive approach to filling out the Flexibility In The Regulations form designed for academic purposes at Ochsner. Whether you are new to the process or need a refresher, this step-by-step guide will assist you in completing the document accurately online.

Follow the steps to effectively complete the form online.

1. Click the 'Get Form' button to access the Flexibility In The Regulations document and open it for editing.
2. Begin by reviewing the introductory sections for a comprehensive understanding of what qualifies as research and human subjects research.
3. Answer the essential questions regarding your project: Does it meet the definition of research? Is it human subjects research? Determine if it is exempt, expedited, and whether waivers of consent or documentation can be granted.
4. Provide a brief description of your research, including background information and the rationale behind it. Be specific about the subject population and the type of data or specimens to be studied.
5. Evaluate whether your research involves any FDA-regulated items, as this will affect your exemption criteria.
6. Complete the sections regarding possible waivers of consent. Answer questions to confirm whether your research poses more than minimal risk to subjects and assess if the waivers would adversely affect their rights and welfare.
7. If applicable, indicate if the Ochsner IRB is not the IRB of record.
8. Review your entries for accuracy and completeness, and finalize your form. You can then save your changes, download a copy, print it for your records, or share it as needed.

Start filling out your form online today to streamline your research process.