S.L. 483.1 Art. 9Consent.

An establishment shall, in relation to the procurement of human tissues or cells:

(a) give all prospective donors of tissues or cells, their relatives or any other person granting consent on behalf of donors, information in accordance with guidelines and authorization requirements as established by the Authority;

(b) obtain from all persons who are willing to donate tissues or cells, their relatives or any other person granting consent on behalf of donors, information in accordance with guidelines and authorization requirements established by the Authority;

(c) put and keep in place procedures for the evaluation of donors in accordance with the requirements set by these regulations and schedules and any amendments thereto;

(d) apply eligibility criteria for all donors of tissues and cells;

(e) maintain records of the results of donor evaluations and report to donors any relevant abnormal findings from the evaluations;

(f) ensure that:

(i) an examination of the donor, including an interview, is carried out before any donation of tissues or cells,

(ii) a qualified health professional is responsible for giving to and gathering from donors the information which is necessary to assess their eligibility to donate, and

(iii) on the basis of that information, a qualified health professional assesses the eligibility of all donors to donate;

(g) encourage voluntary and unpaid tissue and cell donations with a view to ensuring that tissues and cells are, in so far as possible, provided from such donations; and

(h) the tissues and cells are procured, packaged and transported in accordance with the requirements set by these regulations and any schedules and any amendments thereto.