Human tissue must only be used with consent, say new guidelines

The commercial use of archived human tissue should only occur with the explicit consent of the patient it belongs to or their…

The commercial use of archived human tissue should only occur with the explicit consent of the patient it belongs to or their next of kin, according to new ethical guidelines for doctors.

The guidelines, published yesterday, have been drawn up by the Medical Council, which said it was important safeguards were put in place for the handling of this type of material.

It said the council had studied the matter in detail as concern had been expressed regarding the customary handling of archived tissue in recent years, following the postmortem organ-retention controversy.

"In order to diagnose and treat illness, it is frequently necessary to remove tissue from a patient for the purpose of laboratory analysis. This removed tissue may be a blood sample, a biopsy or part or all of an organ that is affected by a disease such as cancer. After laboratory analysis has been carried out, it is customary to store any remaining tissue in case further analysis is necessary. This stored tissue is referred to as archived human tissue," the Council said in a statement.

READ MORE

"As well as re-analysis, this archived tissue has, for many decades, been used for other purposes such as the training of doctors and laboratory staff, audit, continuing education, quality control, quality assurance and biomedical research.

"It has not been the custom to seek consent for these further uses as it has always been considered that patients would not in general have been interested in further ownership of the tissues and the research and other uses to which the tissue was being subjected was in the interests of maintaining laboratory and medical standards and advancing methods of diagnosis, treatment and other aspects of patient care," it added.

The statement said this practice should continue as it believed it would be "impractical to routinely seek consent for future use of these tissues that, in reality, would amount to millions of specimens".

However, where archived tissue samples were used for research or education, it said, they should be anonymised so that patient confidentiality was maintained. And any research undertaken should be approved in advance.

Meanwhile, medical council president Dr John Hillery told a press briefing he was concerned that junior doctors in their intern year continue to work without adequate supervision in a number of hospitals.