At Last! Aye, and There's the Rub

Area of Science:

• Biomedical and Behavioral Research Ethics
• Regulatory Science
• Public Health Policy

Background:

• In 1981, a commission recommended adopting uniform federal regulations for human subjects research.
• The goal was to ease administration, reduce burdens, and improve research efficiency.
• A 180-day target for implementation proved unrealistic, leading to delays.

Purpose of the Study:

• To analyze the challenges in implementing uniform federal regulations for human subjects research.
• To evaluate the effectiveness of comprehensive regulatory revisions versus incremental changes.
• To propose a better process for updating research regulations.

Main Methods:

• Historical analysis of regulatory development processes.
• Review of the implementation of the Common Rule.
• Critique of the 2017 final rule revision process.

Main Results:

• The initial 180-day target for uniform regulations was not met, taking 10 years for the Common Rule.
• Subsequent attempts at revision, like the 2011 ANPRM, led to comprehensive, lengthy processes.
• The 2017 final rule process involved discarding or inadequately vetting many proposed changes.

Conclusions:

• The difficulties in issuing the initial Common Rule suggest a need for a different approach.
• Comprehensive regulatory revisions are prone to delays and inadequate vetting.
• An incremental process with ongoing public involvement through advisory bodies is recommended for regulatory updates.