On Improving Oversight and Enhancing Protections

Area of Science:

• Biomedical and behavioral research ethics
• Regulatory science
• Public health policy

Background:

• The U.S. Department of Health and Human Services revised the Common Rule in January 2017.
• Experts in research ethics were invited to comment on significant changes.
• Authors possess extensive experience in institutional leadership, ethics advisory bodies, and Institutional Review Boards (IRBs).

Purpose of the Study:

• To critically evaluate key modifications within the revised Common Rule.
• To address implications of definitional ambiguities and new regulatory requirements.
• To foster discussion on ethical considerations in human subjects research under the updated regulations.

Main Methods:

• Expert commentary and analysis of the revised Common Rule.
• Drawing on practical experience in research ethics and oversight.
• Scholarly review of specific regulatory changes and their potential impact.

Main Results:

• Concerns identified regarding the distinction between research and quality improvement activities.
• Debate on using "generalizable knowledge" to differentiate research from clinical care.
• Ethical and practical issues raised concerning research on and use of posted consent forms.
• Critique of the mandatory single IRB (sIRB) review for multisite studies.

Conclusions:

• The revised Common Rule presents ongoing challenges with definitions and implementation.
• Further examination is needed regarding consent form data utilization and privacy.
• The single IRB mandate requires careful consideration of its impact on multisite research oversight and ethics.