oa Reconciling Multiple Standards

Stem cell research by Weill Cornell Medical College in Qatar (WCMC-Q) is subject to the ethical standards of both the Qatar Supreme Council of Health (SCH) and the National Academies of Sciences (NAS) in the United States (US). The authors examined their personal experiences with the policy-making process in Qatar and the ethical review process in both Qatar and the US. The objectives of this examination were to characterize different approaches to ethical oversight of stem cell research; consider factors underlying the different approaches; identify advantages and shortcomings of the approaches;and suggest areas where the approaches could enrich each other.

The authors identified two different approaches. First, Top-down, in which a centralized agency passes a set of regulations, often drawn from different international experiences and intended to be complete and stable. This is the model followed in Qatar. Secondly, Bottom-up, in which various agents (researchers, universities, funders, and others) reach a level of consensus and produce non-mandatory guidelines including a set of principles and accompanying specific points. Institutions later adopt the guidelines. This is the approach of the NAS.

Each approach results from the interplay of several factors, including Local experience, Organization of the state, and Political culture.

Top-down is rapidly available and provides a clear, monolithic framework, generally with few internal contradictions.

However, speed and consistency may limit flexibility. There may not be room for ethically acceptable alternative solutions if the framework poses scientific or practical difficulties. Top-down regulation runs the risk of rapid obsolescence in a dynamic field.

Bottom-up, being the product of deliberation, tends to be more flexible. However, this approach risks being hijacked by interminable discussions. Guidelines are not always immediately available. In a decentralized environment, competing guidelines may emerge. Approaches can enrich each other by establishingbasic guiding principles to inform detailed rules; avoiding too much detail that will be difficult to change; maintaining a mix of guidelines and regulation to provide certainty and flexibility while avoiding arbitrariness; adjusting according to experience of and feedback from stakeholders; and accepting imperfection in details and implementation.