Legal Review of Non-Research Biohacking Waiver for Compliance with 45 CFR Part 46

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We are a Bay Area startup developing a non-invasive sleep optimization device and seek an experienced lawyer to review and refine our “Voluntary Sleep Hacking Agreement” waiver. This waiver governs a private, non-published project involving 10 participants testing our device in at-home settings. Our goal is to ensure the project is not classified as “human subjects research” under 45 CFR Part 46 and to minimize liability for our C-Corp and its agents, except in cases of gross negligence or intentional misconduct. We will provide a detailed draft waiver (2 pages) outlining the project as a personal biohacking experiment, with anonymized data and no research intent. Your role is to: - Verify the waiver’s language and structure prevent the project from being deemed “human subjects research” (§46.102(d), §46.102(f)), focusing on non-systematic data use, no generalizable knowledge, and anonymized data handling. - Ensure liability protections are robust, shielding our C-Corp and agents from claims (per non-exculpatory standards, §46.116) unless gross negligence occurs. - Confirm compliance with related federal (e.g., FDA device regulations) and California privacy laws to avoid regulatory scrutiny. - Provide practical guidance on implementing the waiver (e.g., signing process, participant screening, data storage) to maintain non-research status and reduce legal risks. Deliverables: - Finalized “Voluntary Sleep Hacking Agreement” (PDF document) with revisions to strengthen non-research framing, liability protection, and regulatory compliance. - A one page memo summarizing key revisions, potential legal risks (e.g., FDA, participant claims), and actionable steps for using the waiver with participants (e.g., notarization, data anonymization protocols). Required Skills and Experience: - Expertise in U.S. federal human subjects research regulations (45 CFR Part 46), including exemptions and non-research classifications. - Experience with medical device or neurotechnology legal frameworks, particularly FDA investigational device requirements. - Knowledge of California privacy laws (e.g., CCPA) and personal liability protections for startups. - Proven track record drafting waivers or consent forms for high-risk or experimental projects (e.g., biohacking, wellness tech). - Familiarity with C-Corp liability structures and non-exculpatory language standards. - Ability to translate complex legal risks into practical guidance for a lean startup team. Preferred Qualifications: - Prior work with biohacking, quantified self, or neuromodulation projects. - Experience advising startups on low-budget, high-impact legal strategies. Budget: $500, negotiable based on experience and turnaround time. Expected Delivery: Finalized waiver and memo within 7 business days from project start. Note: This is a one-time project with potential for future collaboration as we scale to IRB-approved studies.

Keyword: Project Consultant

Price: $500.0

Legal Consulting Contract Drafting