Law, ethics and research ethics committees

Area of Science:

• Bioethics
• Medical Law
• Research Governance

Background:

• The UK Research Ethics Committee (REC) system operates under specific management views regarding application rejections.
• A key contention is that RECs should not reject applications based purely on legal grounds.
• This stance is supported by arguments concerning the distinction between legality and ethics, and perceived REC limitations in legal expertise.

Purpose of the Study:

• To critically examine the UK REC system's operational management view that legal grounds alone are insufficient for application rejection.
• To evaluate the implications of this view on ethical review processes and research integrity.
• To assess the authority and remit of RECs concerning legal considerations in research ethics.

Main Methods:

• Analysis of the operational management's arguments against rejecting applications on purely legal grounds.
• Review of published guidance and official authority basis for REC decision-making.
• Examination of REC capacity to obtain legal advice and the ethical implications of their remit.

Main Results:

• The view that RECs may not reject applications on purely legal grounds is contrary to published guidance and REC's official authority.
• Permitting RECs to disregard legal conformity is unethical and politically imprudent, as legal compliance is a necessary condition for ethical approval.
• RECs possess the capacity to obtain legal advice, and applying law falls within their ethical remit, despite departmental shortcomings.

Conclusions:

• The integrity of the UK's ethical review system is questionable, particularly concerning the management's stance on legal considerations.
• Guidance on advising researchers regarding breaches of confidence, coupled with the management's view, raises serious concerns.
• The agreement by MREC Chairmen not to consider the Data Protection Act 1998 exemplifies systemic issues in ethical review.