Aims: To investigate whether patient opinion about the uses of tissue removed at therapeutic operations has changed since the adverse publicity surrounding the Alder Hey and Bristol Royal Infirmary Inquiries, and to see whether it aligns with the Human Tissue Act 2004.
Methods: A questionnaire was given to 220 postoperative patients in a teaching hospital during an 11 week period. Aggregated responses to each question were ranked in frequency order. Unweighted centroid linkage hierarchical clustering analysis was performed with dendrogram display for the main data on tissue usage.
Results: 203 completed questionnaires were collected (compliance rate 92.3%). 96.3% of patients indicated that they would not object to their tissue being used in research, significantly higher than in the 1996 study (89.1%) with no overlap of the 95% CIs. 29.1% of patients believed that the hospital had ownership of tissue once it has been removed during surgery, 23.2% believed they had ownership, 19.7% believed that the pathology laboratory had ownership, and 15.3% believed that nobody had ownership rights in the case of tissue samples.
Conclusions: This new survey indicates that despite a turbulent decade for those involved in human tissue retention in the UK, public support for a wide range of human tissue based activities, especially biomedical research, has not diminished and that patient opinion aligns well with the Human Tissue Act 2004.
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Most human tissue used in biomedical research and medical education in the UK is derived from tissue which has been removed for a therapeutic purpose, such as excision of a tumour, and which is surplus to diagnostic and prognostic uses (ie after a definitive histopathology report has been issued and the case has been discussed in a multidisciplinary meeting, if appropriate). The retention and use of human tissue for research and other purposes have received considerable media attention following the incidents at Bristol Royal Infirmary and Alder Hey Hospital,1 and new legislation controlling this area has been introduced within the Human Tissue Act 2004. However, attention has largely focused on human tissue that was obtained at postmortem examinations. In 1996 we conducted a survey of patients who had had tissue removed for therapeutic purposes which could potentially have been used in biomedical research or for other applications.2 At that time, 89% of the 358 patients surveyed indicated that they would agree to the tissue removed at their operation being used for medical research. The recent media attention that has been drawn to the potential uses of retained human tissue may have changed the views of this group of potential donors. We have therefore conducted a new survey to assess their views.
PATIENTS AND METHODS
We invited patients recovering from general surgical procedures to complete an anonymous questionnaire in order to ascertain their views and beliefs regarding the uses and ownership of human tissue removed during surgery. The questionnaire was similar to that used in our earlier study,2 and patients were required to tick a box within a limited range of options (see tables 1–5). We invited all patients considered medically well enough to complete a questionnaire to participate in the study. The new survey population comprised 220 postoperative patients during an 11 week period in the same large teaching hospital used previously. Two medical students hand-delivered the questionnaires to general surgical inpatients, together with a patient information sheet inviting the patients to complete the questionnaire following informed consent. The study was approved by the South Sheffield Research Ethics Committee. Data analysis was performed using the Cluster 3.0 software package,3 which developed from the original Cluster program4 to perform unweighted centroid linkage hierarchical clustering analysis, on the responses to the question “If you could decide what happens to the diseased part of your body removed during an operation, which of the following uses would you agree to?”. The resulting dendrogram was displayed in the Java TreeView5 program.
The results are summarised in tables 1–5 and fig 1. A total of 203 completed questionnaires were collected, representing a compliance rate of 92.3%. More respondents were female (61.9%) than male (38.1%). There were 2 respondents aged <18 years, 14 aged 18–34 years, 34 aged 35–49 years, 88 aged 50–65 years, 49 aged 66–79 years, 15 aged ⩾80 years and 1 of unknown age. Ethnic origin was described by 92% of patients as white British, and 3.5% as white Irish; other ethnic origins comprised 4.5% of the total number of respondents. The majority of patients who answered the question “What type of operation did you have?” were able to name their surgical procedure; however, 3.1% of patients did not know what type of surgery they had undergone. Seventy-three per cent of patients stated that the surgeon who performed their operation had given the explanation for that operation to them, 11% the junior doctor on the ward, and 9% both the operating surgeon and junior doctor; 7% did not answer this question.
This study shows that the overwhelming majority of patients who have tissue removed at surgery are willing for any residual tissue, after appropriate histopathological assessment, to be used in biomedical research and medical education. The percentage of patients who would not object to their tissue being used in research is significantly higher in this study (96.3%) than in our 1996 study (89.1%) with no overlap of the 95% CIs. It would appear that the adverse publicity surrounding tissue removed at postmortem examinations has not increased the level of objection to research being performed on tissue that has been therapeutically removed at operation, and indeed appears to have reduced it. This is probably due to the completely different context in which this decision takes place.
An autopsy, especially if on a young child, takes place in the context of marked grief and emotional disturbance where a natural response might be to preserve the integrity of the deceased person. In the context of therapeutic operations the patient has entered into a social agreement with the surgeon which marks the operation as a transition between illness and subsequent potential good health. In many cases the operation will be aimed at complete removal of a cancer and the patient will be relieved to have had the cancerous tissue removed. It is not surprising that in this context the overwhelming majority of patients would wish for residual tissue from their operations to be used in biomedical research and medical education.
Figure 1 shows that the three patients who would object to their tissue being used in research would also object to this tissue being used for other purposes, including, in two cases, making a histopathological diagnosis which would be likely to be of direct immediate benefit to them in planning further treatment. This study did not include any follow-up, such as selective interviews, so we do not know anything about the beliefs or demographics of the few objectors. It is possible that they might hold religious beliefs that dictate that the whole of a person’s body should be available for burial when they die, or similar secular or cultural attitudes. The fact that the vast majority of patients would consent to research on their tissues should not affect the rights of the few who would not and appropriate systems need to be designed to accommodate this. The majority in favour of research suggests that such a system should be based on an opt-out, rather than opt-in, basis.6 7
We investigated patients’ beliefs regarding who might examine their tissue removed during surgery; table 3 lists the responses to this question. Interestingly, the majority of patients thought that a research scientist or pathologist might examine the tissue (72.4% and 67% respectively), while half (50.2%) of all patients thought that the surgeon might also perform this task. The majority of patients correctly recognised that other members of staff, such as nurses and radiologists would not examine their tissue. These results may have implications for patient information and consent procedures; more explicit information about the process by which excised tissues are examined histologically may be beneficial.
The question regarding ownership of the removed tissue resulted in a range of responses from a patient sample (table 4). Similar proportions of patients believe that the hospital (29.1%), the patients themselves (23.2%), or the laboratory (19.7%) have ownership of tissue once it has been removed during surgery. Interestingly, however, only 15.3% of patients correctly identified that nobody actually has ownership rights in the case of tissue samples.11 There was a significant rise in the number of patients who believed that they themselves owned the tissue (rising from 10% to 23.3%); this may be related to the publicity surrounding Alder Hey or possibly just an increase in patient advocacy and self-determination during that period. It would appear that most patients have gained insight into what happens to diseased tissue removed during surgery from various aspects of the media, with a total of 108 patients (53.2%) stating that television, radio, or the written media have informed them regarding these issues, while only 59 patients (29.1%) had gained information from a hospital doctor. This is a surprising result given the current emphasis on appropriate consent within clinical medicine. It is also noteworthy that 18 patients (8.9%) indicated that their own personal experiences had informed them about what happens to diseased tissues removed during surgery. Thirty-five per cent of patients stated that they were aware before their operation that the removed diseased parts of the body might be used for medical research; however 60% of patients said they were unaware of this, and 5% of patients did not answer this question.
The data on the views on the use of tissue for transplantation or production of hormones in this study are not reliable since the majority of patients realised that the tissue that had been removed from them would not be suitable for such purposes. Many of the patients indicated this in the free text comments on the questionnaires. These data should therefore not be taken as an accurate indication of patient opinion on transplantation.
We concluded the questionnaire by inviting patients to enter any comments they may have had regarding what happens or should happen to diseased parts of the body removed during an operation, or any regarding the influence of any recent events in the media on answers to any of the questions outlined above. Twelve patients (5.9%) directly mentioned events at Alder Hey and controversies regarding retained organs in their open responses.
The proportion of patients who would not object to their removed tissues being used in medical research in this study is higher than in the study of Goodson and Vernon.8 However, it is not entirely clear whether their questionnaire was asking people to consider whether they would consent to medical research on tissues removed during a therapeutic operation or at autopsy. The title of their paper clearly states that it is a study of public opinion on the use of tissue samples from living subjects for clinical research. However, their questionnaire included specific sections on tissues such as the eyes, heart, bone and brain, which are far more likely to pertain to autopsies, and ignored the most common surgically-removed tissues such as the gastrointestinal system and skin. Their questionnaire, as reproduced in their publication, does not specify that the questions are for tissues from living subjects, and the respondents, without further information, were far more likely to deduce that the question concerned tissue removed at autopsy; this study is therefore not directly comparable with our own. The study by Jack and Womack9 on tissue donated to a commercial tissue bank does produce a similar result to this study, with 98.8% of patients consenting to this use. Hoeyer et al10 surveyed a Scandinavian population on the use of biobank material in genetic research and found that 71% accepted this use. It is not clear what the study population were told about the origin of the material in the hypothetical biobank, so again it is difficult to compare with our study.
The Human Tissue Act 200411 arose from the public inquiries into events at Bristol Royal Infirmary and Alder Hey which showed that storage and use of human tissue without consent was commonplace. The basic tenet of the Human Tissue Act 2004 is that living patients must consent to retention and use of their organs and tissue for particular purposes beyond their diagnosis and treatment. However, in order to ensure that unnecessary restrictions would not be placed on bona fide research, Sections 1(8) and 1(9) allow the use of anonymised archival residual tissue from operations in biomedical research without specific patient consent provided that this research has received appropriate ethics committee approval. Similarly, consent is not required for the use of surplus tissue from the living for the purposes of audit, education, public health monitoring or quality assurance. The sample of public opinion in this survey would appear to align closely with this legislation.
In conclusion, this new survey clearly indicates that despite a turbulent decade for those involved in human tissue retention in the UK, public support for a wide range of human tissue based activities has not diminished and is likely to be strengthened by new legislation.
Ninety-six per cent of patients in this survey indicated that they would not object to their tissue being used in research, a higher figure than in our survey in 1996.
These patients’ views accord with the legislation of the Human Tissue Act whereby anonymised archival surgical material may be used in research with appropriate ethics committee approval but without specific patient consent.
There is still a great deal of uncertainty about the ownership of human tissue among inpatients who have had operations in which tissue has been removed.
There is still a significant percentage of patients who are unclear about what happens to tissue that has been removed at operation; this could be improved by better explanations at the time of consent.
We are grateful to all 220 patients in this study who considered completing a questionnaire. We are also grateful to Messrs Ackroyd, Cameron, Harrison, Thomas, and Wyman, Prof. Majeed, Mrs Chandran and Ms Wyld, for allowing us access to their patients for this project. We also thank Prof. Sir James Underwood and Shirley Harrison, Chair of the Human Tissue Authority, who made some very helpful comments on the manuscript.
Funding: No funding was received for this study. The minimal costs of questionnaire production were met from non-specific departmental budgets.
Competing interests:None declared.
Ethics approval: This study was approved by the South Sheffield Research Ethics Committee 04/Q2305/190.
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