Whether a researcher, clinician, participant, or advocate, your voice matters in shaping the future of ethical, science-based research. Here’s how to make an impact:

1. Contact Your Representatives: Congressional leaders need to hear from constituents who value research integrity and participant protection. Encourage them to:

• • Oppose broad deregulation efforts that could weaken key regulations under Title 21 and Title 45
  • Support risk-based, science-driven regulatory reform
  • Ensure transparency and stakeholder input in any proposed rule changes

Useful Resources:

• Find your House representative
• Contact your Senators
• Call the Capitol Switchboard: 202-224-3121

2. Send an Email or Letter: Subject: Preserving Research Integrity During HHS Deregulation Efforts

Dear [Congressmember’s Name],

I am writing as a member of the clinical research community to express concern about the ongoing deregulation efforts being conducted by the U.S. Department of Health and Human Services (HHS) under Executive Orders 14192.

We fully support efforts to reduce unnecessary administrative burdens, particularly those that impact healthcare providers such as nurses and physicians, who need more time to focus on patient care. However, we are alarmed by proposals that could result in the repeal or weakening of regulations that are foundational to the safety, ethics, and scientific rigor of medical research. In particular, the concept of eliminating 10 regulations for every new one introduced appears to prioritize quantity over thoughtful reform. It promotes a broad removal of regulation rather than the carefully planned approach that should guide true modernization.

Title 21 and Title 45 of the Code of Federal Regulations must remain intact. These regulations:

• Protect the rights and safety of clinical trial participants
• Ensure the integrity of scientific data
• Uphold public trust in the drug and device approval process
• Provide the legal framework for conducting ethical human subjects research in the United States

Dismantling these protections without deliberate and transparent replacement mechanisms would put both safety and innovation at risk.

We urge Congress to support the following principles:

• A science-based, nonpartisan approach to regulatory reform
• Public comment and expert input on any regulation under consideration for repeal
• Investment in harmonization and streamlining of guidance, rather than removal of core regulations
• A clear distinction between administrative burden in healthcare delivery and the regulatory framework necessary for ethical, evidence-based research

The research community stands ready to contribute constructively to this conversation. We have submitted formal feedback to HHS and respectfully ask that you help ensure any regulatory changes proceed transparently and with full stakeholder engagement. As with FDA draft guidances, we believe any proposed repeals should be made available for public comment.

Thank you for your attention to this important matter and for your continued support of ethical, science-driven research policy.

Sincerely,
[Your Name]
[Your Affiliation, if applicable]
[Contact Information]

3. Make a Phone Call

Here is a brief script you can use:

“Hi, my name is [Your Name], and I live in [City, State]. I’m calling to urge [Representative/Senator Name] to oppose efforts under Executive Order 14192, ‘Unleashing Prosperity Through Deregulation,’ that threaten essential clinical research protections. Regulations like Title 21 and Title 45 safeguard participant safety, scientific integrity, and public trust. Please support science-based, transparent reform, not broad deregulation that puts ethical research at risk. Thank you.”

4. Engage your network

Encourage colleagues, patient communities, and professional organizations to take part in this effort. Share this message, coordinate outreach, and raise awareness through social media, and professional forums.