The Final Rule: When the Rubber Meets the Road.

Area of Science:

• Biomedical and Social Sciences Research Ethics
• Regulatory Compliance in Human Subjects Research

Background:

• The original Common Rule (1991, amended 2005) requires updates to reflect advancements in research methodologies.
• The research landscape has evolved significantly, necessitating a modernized regulatory framework.

Purpose of the Study:

• To outline key revisions in the updated Common Rule effective January 19, 2018.
• To guide Human Research Protection Programs (HRPPs) in understanding and implementing the final rule.
• To highlight critical changes impacting research protocols and institutional policies.

Main Methods:

• Analysis of the final Common Rule published in the Federal Register.
• Identification of substantial changes requiring HRPP attention.
• Review of specific revisions including exempt research, continuing review, informed consent, and single IRB review.

Main Results:

• The revised Common Rule introduces significant modifications to research oversight.
• Key changes include expanded exempt research categories and revised continuing review requirements.
• Implementation necessitates updates to policies, procedures, and workflows for HRPPs.

Conclusions:

• The final Common Rule aims to modernize and improve the applicability of regulations for human subjects research.
• HRPPs must proactively plan for implementation, focusing on areas like informed consent and single IRB utilization.
• Successful adaptation will ensure continued protection of human research participants within an evolving research environment.