The World Health Organization Guiding Principle 1 of the Guiding Principles on Human Cell, Tissue and Organ Transplantation requires consent from the donor to organ removal for the purpose of transplantation. Guiding Principle 10 requires traceability of organ transplants. Guiding principle 11 requires that donation activities be transparent and open to scrutiny.
These obligations belong to jurisdictions which are responsible for the donation activities. According to the World Health Organization, each jurisdiction is to determine the means of implementing the Guiding Principles.
Jurisdictions may claim compliance with these Guiding Principles. Yet, doubts may arise whether those claims are well founded. The international community needs to address the question how claims of compliance can be assessed.
The purpose of this paper is to attempt to answer that question. China, about which doubts of compliance with the Guiding Principles have been raised, is used as a case study.
Traceability, transparency and openness to scrutiny are three different principles. First, traceability differs from either transparency or openness to scrutiny.
Traceability helps transparency and scrutiny. However, it is possible to introduce a system of traceability without transparency or openness to scrutiny, if the traceability exists only behind closed doors. As the World Health Organization Guiding Principles indicate, ideally there should be all three, transparency, openness to scrutiny, and traceability. Traceability is not the substitute for either transparency or openness to scrutiny.
Transparency and openness to scrutiny are also different, although there is some overlap. Transparency means we can see right away what we want to see. All we have to do is look. Openness to scrutiny means that to see what we want to see requires scrutiny, and that scrutiny is permissible, even welcome.
Transparency may not give us an immediate answer to every question because what we see requires some analysis and probing. Openness to scrutiny means that, in addition to providing access to all relevant records, the record keepers must be open to answer probing questions about those records.
The two principles of transparency and openness to scrutiny each raise a similar question. What should transparency allow us to see? What should be open to scrutiny?
Without answering those questions comprehensively, this much is clear. Transparency should allow us to see the sourcing of organs to determine whether the consent required by Guiding Principle 1 has been obtained. Openness to scrutiny means that we should be able, with scrutiny, to determine whether the requisite consent has been obtained.
We need to know not just whether the requisite consent has been obtained now, but also whether it had been obtained in the past. Guiding Principle number 1 does not just refer to present and future consent. It also refers to past consent.
The World Health Organization has never suggested that extraction of organs without donor consent was at one time acceptable. Because the principle of consent refers to past consent as well as present and future consent, the principles of transparency and openness to scrutiny apply to past records as well as present and future records, to determine whether there has been that past consent.