Practical problems with clinical staff obtaining consent for use of residual tissue removed for therapeutic or diagnostic purposes.

When interpreting the results given below please note that in reported series where informed consent is requested for the research use of ‘residual’ surgically resected tissue, it is typical that over 97% of patients give consent. In one report in the British Medical Journal, 99% of 3,000 patients gave consent despite the request being to pass the residual tissue to a commercial company for research (Jack & Womack, BMJ 327: 262-262, 2003).

The problem is not that patients object to this use; it is that the clinical staff will not ask, as they are busy, it takes time to explain and they perceive this as a problem which is not relevant to them.

Compared to post-mortem tissue, the problem is huge; about 3 million solid tissue samples and well over 100 million blood samples.

The laboratory staff, who under this Bill will have to have such consent, are in no position to ask as they do not have patient contact.

If patients are not asked, their wishes cannot be respected.

Examples

1 At Aintree University Hospital, Dr Ian Watson reports that the clinical chemistry department has accumulated a pile of paper reports almost three feet high, on blood samples where the requesting doctor did not even provide enough information for the result to be returned to a responsible clinician. If such basic information cannot be provided consistently, what chance is there of laboratories obtaining reliable consent information from the clinical staff?

2 The hospital at High Wycombe introduced ‘tick boxes’ on their histopathology request forms, with separate boxes to indicate whether the patient consented or objected to the teaching and research use of any material which was surplus after tests were complete. An audit performed after a publicity campaign within the hospital showed that 68.4% of request forms were submitted to the laboratory with none of the boxes marked. This audit considered only solid tissue samples, which one might expect to be more emotionally important than blood or urine..

3 In Leeds, a section was introduced into the surgical consent form where the patient was asked to indicate consent or objection to the subsequent use of any residual material for research or teaching. An audit showed that only 48% of specimens received in the laboratory had traceable consent forms. Of those which were found, 40% did not have the ‘tissue’ section completed. This method does not address blood samples, where explicit consent for taking the sample is not recorded.

Interestingly, of the completed forms, only 0.8% objected to research use, but 8% objected to use in ‘public health monitoring’. This apparent contradiction suggests serious deficiencies in the quality of information provided to patients by the surgeons. (Agarwal, Sugden & Quirke. Introduction of consent for surgically removed tissue. J Pathol 2003;201(Supp.):49A). Consent which is not adequately informed is not valid and therefore cannot be ‘appropriate’.

4 In Southampton a new surgical consent form, incorporating consent for teaching and research use, was implemented in early 2003. Over 10,000 surgical and biopsy specimens that were received in the 5 months from April to August 2003 were audited. Of these, only 40% had consent forms attached and of those consent forms 23.9% did not make any indication of refusal or consent for tissue usage for teaching or research, or withheld consent. Thus 67.3% of the cases being accumulated in Southampton archives at the moment would not be available for teaching or research. Again, blood samples were not included in the scheme.

5 In Leicester, consent was sought for research use of residual samples and clinical data from 159 renal transplant patients. An approved information sheet and consent form were clipped to the front of the clinical casenotes before relevant patients attended the renal transplant clinic. The Professor of Transplant Surgery supported the project. All the staff in the transplant clinic had to do was hand the papers to the patients, with a few words of explanation. After 6 months, only 33 forms had been returned. Investigation showed that, despite an instruction from the Professor of Transplant Surgery, the forms were being ignored by the staff in the outpatient clinic. They claimed they were too busy.

6 A Breast Cancer Research Unit wanted to obtain ‘normal’ breast tissue as a control for its tissue culture work. This can be obtained from breast reduction operations, which are preformed on a small number of young women each year. The surgeons recognized the importance of the work being undertaken, but this coincided with the introduction of the new NHS surgical consent forms. Both the plastic surgeons and – remarkably – the breast surgeons decided that they did not have the time to spend explaining research use of residual resected tissue to their patients. Despite the small number of patients involved, consent was not requested and research was blocked.

7 In November 2001 the Department of Health published its ‘Good practice in consent’ guidance which indicated that all Trusts should inform all patients that any residual tissue might be used in teaching and / or quality control. Patients should be given the opportunity to object to such use. To have any effect, this system of implied consent requires the existence of a database or other system by which objections can be recorded and retrieved.

At a meeting of academic pathologists in Bristol in July 2003 members of the audience (about 50 people) were asked to raise a hand if they worked in a trust where such a system had been implemented. Not one hand was raised.

Despite this, the Department of Health seems to believe that such systems have been implemented throughout the NHS (Explanatory Notes to the Human Tissue Bill).

8 As part of the QUASAR multi-centre study of colorectal cancer, a questionnaire was sent to GPs asking their attitudes to seeking consent from their patients for the research use of archival tissue samples. About 20% of GPs replied. Of those who replied, GPs either refused to help or said they would expect payment for the work. A typical fee expected was £50 per patient. (Information from Professor P. Quirke. A further questionnaire to patients indicated that they did not wish to be asked, and the study was allowed to proceed without consent).

It is worth noting that in its present form, the Bill would make most teaching of cervical cytology illegal without consent, as a cytological opinion requires histological confirmation of the diagnosis, so the diagnostic process must be complete. Such consent would have to be requested by GPs.

8 It is widely known that the rate of ‘relative’s consent’ post-mortems has plummeted since the tissue retention scandals were publicised. The reason for this is less widely known. An audit in Leicester showed that the proportion of relatives who gave consent hardly fell at all, from 51% of those asked to 48% of those asked between 1999 and 2001. So the fall in the PM rate was due almost entirely to clinical staff not asking the relatives for permission. Informal discussion with clinical staff indicated that one of the main reasons for this is the time taken to guide grieving relatives though the much - expanded consent processes which were (necessarily) introduced between these two time points.

A requirement for consent is actually a prohibition unless there is a mechanism to request, record and retrieve that consent.

Professor Peter Furness

23^rd January 2004