Ownership and uses of human tissue: Does the Nuffield bioethics report accord with opinion of surgical inpatients?BMJ 1996; 313 doi: https://doi.org/10.1136/bmj.313.7069.1366 (Published 30 November 1996) Cite this as: BMJ 1996;313:1366
- R D Start, lecturer in pathologya,
- W Brown, medical studenta,
- R J Bryant, medical studenta,
- M W Reed, consultant surgeonb,
- S S Cross, senior lecturer in pathologya,
- G Kent, senior lecturer in medical psychologyc,
- J C E Underwood, professor of pathologya
- a Department of Pathology, Sheffield University Medical School, Sheffield S10 2RX
- b Department of Surgery, Royal Hallamshire Hospital, Sheffield S10 2JF
- c Department of Psychiatry, University of Sheffield, Northern General Hospital, Sheffield S5 7AU
- Correspondence to: Dr Cross.
- Accepted 24 September 1996
Objective: To compare opinion of surgical inpatients with the conclusions of the report of the Nuffield Council on Bioethics regarding the ownership and uses of human tissue.
Design: Survey of results of questionnaires completed by patients.
Setting: Large teaching hospital.
Subjects: 384 postoperative adult surgical patients.
Results: There was strong support among patients for the use of tissues in medical education, research, and science with the exception of those tisssues which may transmit disease to others. Few patients (39; 10%) believed that they retained ownership of tissue removed at surgery. Most believed that the tissue belonged to the hospital (103; 27%), to nobody (103; 27%), or to the laboratory (77; 20%). Most patients had not been given any information about the possible uses of their tissues after removal.
Conclusions: Surgical inpatients seem to endorse the conclusions of the Nuffield report regarding the ownership and uses of human tissue. The recommendations regarding patient information and consent procedures should be implemented at the earliest opportunity.
Most surgical inpatients seem to concur with the conclusions and recommendations of the working party regarding the uses of such human tissue
Alterations to patient consent forms and additional patient education represent reasonable requirements for continued and appropriately regulated access to human tissue for the purposes of medical education, research, and audit
The working party of the Nuffield Council on Bioethics, which examined the ethical and legal issues surrounding human tissue, proposed that tissue removed from patients in the course of treatment should be considered abandoned and that the possibility that tissue may be stored, used in the treatment of others, or used in medical education and research should be indicated in general terms in standard consent procedures for medical and surgical interventions entailing the removal of tissue for diagnosis or treatment.1 If patients and the public were to have extremely divergent views from the working party then some of the complex issues surrounding the uses of human tissue would require reconsideration.
We provide the first detailed assessment of opinion of patients in the United Kingdom about the ownership of human tissue removed during treatment and the uses to which that tissue may, can, or should be put.
Patients and methods
Questionnaire design—The questionnaire contained no questions relating to specific research applications or the use of cadaveric, fetal, or reproductive tissue. Respondents were required to tick a box within a limited range of options (see tables 1 and 2). Case records were reviewed to determine the nature of surgical procedures and final histological diagnoses if tissue had been removed. The current hospital consent form contains no reference to the ownership or to the subsequent disposal, storage, or other uses of tissue removed during investigation or treatment, but completed consent forms were examined to determine whether references to such issues had been added during consent procedures.
Questionnaire terminology—Preliminary work clearly indicated that the term “tissue” was poorly understood. The term “diseased part of the body” was found to be an acceptable alternative for tissue within the questionnaire.
Subjects—The survey population consisted of 450 adult patients after they had undergone general surgery or an orthopaedic or urological operation during a seven week period in a large teaching centre. Twenty nine patients were too unwell to participate. Two medical students hand delivered questionnaires with an explanatory letter. The study was approved by the South Sheffield Research Ethics Committee.
RESPONSE RATE AND ANALYSIS
A total of 384 questionnaires were returned (response rate 91%). More respondents were men (58% v 42% women). There were 38 respondents aged between 18 and 34 years; 65 aged between 35 and 49; 119 aged between 50 and 65; 127 aged between 66 and 79; and 35 aged 80 and over. The 60 respondents who had procedures which did not entail the removal of tissue were not excluded from the sample. No consent forms contained any reference to the ownership or to the subsequent disposal, storage, or other uses of removed tissue.
The importance of careful tissue examination to the diagnosis and management of cancer and other diseases was well understood (table 1, items 1, 2, 4, and 5). Most respondents believed that their tissue could be used in medical research and in undergraduate and postgraduate medical education (items 3, 6, and 7). Few respondents thought that tissue would be either preserved and kept or thrown away immediately after the operation (items 10 and 11). Transplantation and the preparation of hormones were not commonly considered to be uses for tissue removed at surgery (items 12 and 13), and many respondents commented that their tissue would be diseased and therefore unsuitable for such uses. Strong support was observed for most of the suggested uses for tissue with exceptions of transplantation and hormone preparation (table 2, items 9 and 10).
In total 104 respondents believed that the hospital owned the tissue, but a similar proportion thought that nobody owned it (103). Fewer patients believed that the laboratory owned the tissue (77) and fewer still that they themselves owned the tissue (37). The sex of the patient (2 8.2; 5 df; P>0.05), the site of surgery (26.4; 20 df; P>0.05), the removal of tissue (8.3; 5 df; P>0.05), and malignant diagnoses (5.8; 5 df; P>0.05) were not related to views on the ownership of tissue, but patients aged under 65 years were more likely to believe that the hospital owned the tissue than those aged over 65 (12.5; 5 df; 0.01<P<0.05).
Of those patients who believed that they owned the tissue themselves, 30 still supported its use in teaching and research. No significant differences in the level of support for these and the other suggested applications were identified between those patients who believed that they owned the tissue themselves and the other respondents. Many respondents indicated that proper use of the tissue was more important than who owns it. One hundred and thirty four respondents stated that they were not aware of having ever received any information regarding the ownership and uses of human tissue removed during surgery.
Human tissue is often removed from the body in the course of diagnosis or treatment, and there may be tissue left over after sufficient has been sampled for diagnostic purposes. Such left over tissue and any material archived during the course of diagnosis and treatment has in the past been made available for the purposes of medical research, education, and audit without the specific consent of the patient from whom the tissue has been removed.
Legislation governing the removal and use of cadaveric human tissue has been in existence for many years, but the lack of systematic review of the uses of human tissue removed from living patients has created problems. The working party of the Nuffield Council on Bioethics was timely in its examination of the relevant ethical and legal issues in relation to the human tissue not covered by specific recent legislation or regulation.1 The working party concluded that tissue removed with consent during the course of treatment should be regarded as having been abandoned and that the possibility that tissue may be stored, archived, and subsequently used in the treatment of the patient or others, or in medical research and education, should be indicated in general terms in standard consent procedures.
The difficulties in determining the ownership of tissue removed with consent during the course of treatment (or even whether property rights should apply to human tissue as implied by the use of the term “abandoned”) are emphasised by our observations which support the conclusions of the working party regarding abandonment. Most patients believed that such tissue comes into the possession of the hospital authority or that it ceases to belong to any individual or institution. A much smaller proportion concurred with the view of some commentators that the tissue remains the property of the patient.2 The applications for which tissue might be used seemed to be more important to respondents than the issue of ownership.
Our results also support the working party's conclusions that consent to treatment is inevitably general but should always refer to the possibility that removed tissue may be discarded or stored and, if stored, that it may at some time be used for diagnosis, further treatment, research, teaching, or study. Most patients in this study supported the use of their tissue in most areas of medical education and research with the exception of those applications which could transmit disease to others. Individual consent for specific uses would seem unnecessary and impracticable, particularly in relation to material stored anonymously in pathological archives and increasingly in residual tissue banks. The specifics of future research applications are not known at the time of storage and therefore the use of such material cannot sensibly be subject to specific informed consent.
Although 90% of the respondents in this study believed that removed tissue belonged to others or to no one, a considerable minority believed that they retained ownership of removed tissue. To clarify the situation for all patients we would support the recommendation that consent forms and explanatory material for patients should be modified so that hospitals inform patients that consent for investigation or treatment also covers any acceptable further uses of tissue. Many consent forms, including our own, do not contain any reference to the subsequent use of removed tissue except for the description of the operation, investigation, or treatment which is completed by the attending clinician.3
Many factors may have combined to produce the high response rate in this study; including genuine patient interest in the subject, the simple design of the questionnaire, and the personal delivery and collection of the questionnaires. Another factor may have been that participation provided patients an opportunity to demonstrate gratitude towards those concerned in the therapeutic process. In this respect postoperative patients may represent a biased group of subjects, and the study is weakened by the absence of appropriate controls. Further studies may be necessary to confirm these findings in other groups. We would also emphasise that our observations and conclusions, like those of the Nuffield working group, may not represent those of societies outside of the United Kingdom. Cultural and religious influences may severely restrict the use of human tissue in some countries.
We thank Dr T J Stephenson for advice and all of the patients who kindly participated in the study.
Conflict of interest None.