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Application for IRB Review for Digital Health Products and AI in Healthcare

Purpose

This application form is designed for the ethical and regulatory review of digital health products and AI applications in healthcare within the Sultanate of Oman.

Scope

Projects involving the development, testing, or implementation of digital health technologies or AI algorithms in a healthcare setting fall within the scope of this application. This includes but is not limited to mobile health apps, wearable devices, telemedicine platforms, AI-powered diagnostic tools, and predictive analytics models.

Submission

Complete all relevant sections of the application form. Include supporting documents such as research protocols, informed consent forms, data management plans, and any other relevant materials. Submit the completed application and supporting documents to the IRB/Ethical Committee secretariat.

Expedited Review (Minimal Risk) Application Guidelines

Comprehensive Review (Requiring informed consent) Application Guideline and Template

Review Process

The review process typically takes 4-8 weeks for expedited review and 8-12 weeks for comprehensive review. The committee may request additional information or clarifications during the review process.

Contact

For any inquiries or assistance, please contact the IRB/Ethical Committee secretariat at [Email Address] or [Phone Number].

Attestations

Accuracy

I certify that all information provided in this application is accurate and complete to the best of my knowledge

Data Sharing

I agree to share the final results including detailed analysis of this research/project with the Ministry of Health, Oman.

Publication Rights

I acknowledge that the Ministry of Health, Oman reserves the right to publish or disseminate the results of this research/project.

Proposal Submission

I have reviewed the guidelines and template (Link) provided and have completed the needful.

I am ready to attach my proposal in both PDF and DOCX formats.