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Completing the Flexibility in the Regulations form is essential for researchers to navigate the requirements while protecting research subjects. This guide provides clear, supportive instructions for filling out the form effectively and understanding its components.

Follow the steps to complete the Flexibility in the Regulations form online.

1. Press the ‘Get Form’ button to retrieve the Flexibility in the Regulations form and open it in the editor.
2. Begin by reviewing the questions regarding the project. Determine if the project meets the definitions of research and human subjects research. This section helps clarify whether the project is exempt or eligible for an expedited review.
3. Assess if a waiver of consent can be granted. If applicable, consider whether a waiver of documentation of consent can also apply. Take note of the conditions that allow for these waivers.
4. If conducting a quality improvement project, clarify the intent to implement practices aimed at enhancing patient care. If the intent meets the criteria, the project does not qualify as research and should not proceed.
5. Complete the sections on data or specimen collection. Evaluate if the purpose contributes to generalizable knowledge and if there is a hypothesis involved. Proceed only if the response is affirmative.
6. Identify whether your study involves interventions, access to identifiable private information, or the receipt of identifiable data/specimens. Clarify the agreements and protections to ensure compliance with regulations.
7. Provide a brief description of your research, including background information and rationale. Specify the subject population and any special considerations, such as research involving prisoners or children.
8. Determine if your research involves FDA regulated items. Be mindful of the additional restrictive criteria relevant to such research.
9. Clarify the risk level in your application. If applying for expedited review, ensure you define minimal risk clearly. The IRB will make the final determination on the application.
10. If not the IRB of record, make the appropriate selection in the form. Utilize available resources, educational materials, and decision trees to guide you through completion.
11. Review your entries for accuracy before saving the changes. You can choose to download, print, or share the completed form as needed.

Start completing your Flexibility in the Regulations form online today for a seamless research process.