The Importance of Informed Consent - Modern Changes and Historical Influence

By Elizabeth Smee and Iseult Roche.
 

The April 2008 British Society of Gastroenterologists guidelines on consent has extended informed consent to include information regarding the taking and retention of tissue biopsies.   The views of relatives as well as patients have to be taken into account of if the public confidence in the medical profession is not to be undermined and there is to be true transparency and move to patient centred care.
     

In April 2008 the British Society of Gastroenterologists (BSG) updated their ‘guidance for obtaining a valid consent for elective endoscopic procedures’.   Lack of informed consent is considered to be a breach of patient autonomy and as such can be considered a breach of article 2, 3 or 8 of the Human Rights Act (1998) [1]. Obtaining consent is therefore necessary in order to protect a doctor against charges of battery and is vital in maintaining patient trust in the medical profession.  Gaining informed consent is also an important component in the Global Rating Scale Assessment of UK endoscopy units, and as such influences global opinion on the quality of British endoscopy units. Although this is a single area of medicine, the change reflects society and a fundamental move from the traditional doctor ‘paternalistic’ approach to that of a patient centred approach.

The Schoendorff case

The importance of consent was highlighted in 1914 by Justice Cardozo in the case of Schoendorff vs. society of New York hospital [2] . In this case a patient had a tumour removed despite not having consented to the procedure. Justice Cardozo stated that “Every human being of adult years and sound mind has a right to determine what shall be done with his body” .  Prior to this case it was generally accepted that ‘the doctor knows best’ and that the patients’ role was to be compliant.  Moreover many doctors believed that their duty to ‘do no harm’, as stated in the Hippocratic Oath, included protecting the patient from the harm of a poor prognosis.  Whilst patients were being gradually better informed throughout the 18th and 19th centuries this was largely in order to improve patient compliance and not as a way of establishing patient autonomy [3].
 
The idea that consent should be ‘informed consent’ was established in law in the 1950s, after a patient became hemiplegic following a translumbar aortogram.  The patient was not warned of this rare but recognised risk and the judge ruled that “a physician violates his duty to his patient and subjects himself to liability if he withholds any facts which are necessary to form the basis of an intelligent consent by the patient” [2].

According to BSG guidelines in order to consent to a procedure the patient must be:

• Adequately informed – they must have enough information to understand the procedure, its benefits and potential risks.
• Competent – they must be able to understand, retain, use or weigh up the information needed to make a decision and communicate their wishes.
• Not under duress – not under undue pressure from any external sources, be they friends, family or members of the medical profession.

The BSG guidance continues to clarify what exactly constitutes ‘adequate information’.  One aspect of this is that the “taking and retention of tissue samples” must be mentioned.  In a recent audit into the verbal consent procedure at the Royal London Hospital, Whitechapel, findings suggested this could well be improved upon, with only 6% of observed informed consents for the procedure including the retention of tissue samples (own research – 2008, it should be noted that the taking of biopsies was addressed much more frequently).  These findings support that of previous research in NHS hospitals, indicating that this is a widespread problem, and an ethical issue. For example pre-procedure patient information sheets – which are provided for patients to read before attending the endoscopy unit do not mention tissue sample retention, and this was not consistently explained during verbal consent. This therefore becomes a genuine problem considering the fact that when patients sign the consent form the patient is agreeing to the actual taking and the retention of their tissue samples.  It is vital that the taking of biopsies is addressed during the consenting procedure and that the risks associated with this are mentioned.  It is often not known whether or not a biopsy will be required until during the procedure.  This means that it is sensible to get consent for a possible biopsy in most cases before the procedure takes place regardless of whether or not it later turns out to be needed.  This would prevent the patient from needing to return to the department at a later date in order to have a biopsy taken which is also a cost effective measure as well as, most importantly, potentially far less distressing for patients.  

Full consent in this area will also prevent the temptation to take a biopsy once the patient is already there, even if they weren’t informed about this procedure.  In this situation the patient could sue for battery, or, if there is a complication and the risks of biopsy had not been mentioned then the doctor is open to claims of liability.

The importance of consent and retention of tissue samples

Why is it important to ensure that the retention of tissue samples is consented? In 1995 the Nuffield Council on Bioethics released a report saying that human tissue samples could be used for ethically acceptable purposes without further consent from the patient, as long as the tissue was surplus to diagnostic requirements.  The tissue was considered ‘abandoned’ by the patient making it legally and ethically acceptable to use it without specific consent.

The fact that retained tissues are not considered patient property was established in court in America in 1990 during the Case of John Moore vs. Regents of the University Of California.  Mr Moore had his spleen removed whilst being treated for hairy cell leukaemia.  His doctor went on to use the spleen to make immortal cell lines which he sold to commercial companies.  During this time Mr Moore was told that he needed to continue seeing his doctor, and no other, for routine check ups.  This meant that his doctor had exclusive access to his cells.  When Mr Moore found out that his doctor was profiting from his cells he tried to sue the hospital.  The judge ruled that since the cells were not Mr Moore’s property the doctor had done nothing illegal.

This case raises a number of issues, not least the fact that a doctor intentionally profited from being the sole carer of a particular patient, a matter that should have been raised during the consenting procedure.  The case also clearly demonstrates that removed tissues and organs are not considered the patient’s property. Because conversion of property is strictly regulated in law, courts fear that extending property to include organs would have a detrimental effect on medical research as most labs would not be able to prove how the cell lines they use were created.

Bristol heart and Alder Hey scandals

This means that the 1995 Nuffield guidance raises some problems, including the fact that patients may have a genuine concern that they are being used and taken advantages of. In the UK this guidance left the door open for the Bristol heart scandal and the Alder Hey organ scandal in 1999, whereby the organs of dead children were retained without consent, (and sometimes against the specific wishes of the parents).  The report following the Bristol heart scandal described the NHS as ‘cavalier’ in its attitude towards seeking consent to retain tissues of patients who had died [7] .

Publicity regarding the retention of organs removed post-mortem, especially following the Bristol heart and Alder Hey scandals, has led to reappraisal of the circumstances under which it is ethical to use human tissues for teaching, lab quality assurance and biomedical research [8].  
This has led to the Human Tissue Act (2004) which states that “even common interventions such as mucosal biopsy and polypectomy must be specifically consented.  The consent obtained must also explicitly cover the retention of any tissue” [9].

Human Tissue Act (2004) consequently means that most biomedical research requires explicit consent to use tissue samples.  However, it is possible to use tissues without consent for lab quality assurance or for research if it is not linked to the patient it came from.  Despite these exceptions it is often necessary to prove consent in order to get ethical approval for research – and rightly so.  If consenting for the retention of tissue samples is not done at the time of the procedure consent has to be sought retrospectively at a later date.  

Furness & Nicholson (2004) [6] found that it was extremely difficult to attempt to trace patients in order to get consent at a later date. It identified that 26% of the patients they tried to contact had still not been found after a year.  Not only does this significantly reduce the pool of available tissues that can be utilised for research but it also increases the cost of the research and the time it takes.
 
Studies have found that just 1-3% of patients object to the use of their tissues for research [6,8].  This reflects the fact that most members of the public consider ‘surplus’ therapeutically excised tissue as having little or no emotional value [10] .  This has resulted in the argument that consent should not be mandatory when using surplus therapeutically excised tissue [6].  However, this is in stark contrast to the emotional value placed on the organs and tissues of deceased relatives.  It is, therefore, often for the relatives benefit, and not that of the patient, that fully informed consent is required.  

What constitutes informed consent in practical terms?

The more practical aspect of what constitutes informed consent is also a problem.  It is completely impractical to inform the patient about all possible research that may be carried out on a tissue.  Especially given the fact that it is impossible to predict what research the tissue may be used for.  Is it still to be considered ‘informed consent’ if you tell them that the tissue may be used for research but do not specify in what capacity?

The immortal cell line HeLa was developed in the 1950s from the cervical cells of Henrietta Lacks, who died in 1951 from cervical cancer.  Neither her consent, nor that of any relatives was gained and although she originally remained anonymous it was only a few years after her death that the media found and published her real name.  This must have been very distressing for her family, who discovered that the doctor treating Ms Lacks had profited by selling the patent to her immortalised cells.  This was not, however, illegal as at the time any tissues taken from a patient were considered ‘abandoned’ and therefore no longer the patient’s property.    

Ms Lack’s case exemplifies why it is important to gain consent even when using tissues from a living patient.  Whilst the surplus tissue may not be of much importance to a living patient, if they subsequently pass away the relatives may be upset to know that it is being used without anyone having been told about it.  Ms Lack’s case also indicates how hard it can be to maintain anonymity and so reinforces the fact that it is important to consent all patients regarding the retention of tissue so that preventing linkage is not such a problem.  Finally, the media attention which these sorts of cases attract undermines public confidence in the medical profession as a whole and will inevitably lead to more and more stringent practices in the future.       

Conclusion

In conclusion, while many may feel that these new regulations are excessive and a waste of time they are important in maintaining good patient – doctor relations.  It takes very little time to verbally consent a patient to take and retain a biopsy and makes little time difference to the overall consenting procedure. By including this information in the majority of cases you prevent the risk of having to delay a biopsy just because it was not consented for.  It will also save time and money for researchers who won’t have to try and trace the patients for each tissue sample they wish to use.  

Furthermore it will maintain the ethical moral code of good research and prevent scandals like Alder Hey and Ms Lacks case from reoccurring, thus helping to maintain public confidence in the medical profession.  Any further scandals will inevitably lead to stricter regulations regarding the taking and retention of tissue samples.  This could have a huge detrimental impact on research and would probably increase the time and protocols required to obtain consent.

References:

1.    “Guidance for obtaining a valid consent for elective endoscopic procedures” British Society of Gastroenterology; Dr H Shepard & Dr D Hewett; April 2008
2.    Schoendorff v society of New York Hospital, 1912
3.    J. Wayne, D. Rex, & C Williams; Colonoscopy; 2003, Blackwell publishing
4.    “Experiences from the front-line routine consenting of surplus surgically removed tissue: without investment by the NHS fully informed consent is not available” Wheeler et al; J Clin Pathol; 2007; Apr; 60(4):351-4
5.    “Ethical issues in the collection, storage and research use of human biological materials” Meskin & Quair; J Lab Clin Med; 2004 Nov; 144(5);229-34
6.    The retention & storage of pathological records and archives (3rd edition, 2005) Royal College of Pathologists
7.     BBC News Online, "NHS 'cavalier' over organ consent", 21st September 1999, http://news.bbc.co.uk/1/hi/health/background_briefings/the_bristol_heart_babies/392437.stm
8.    “Obtaining explicit consent for the use of archival tissue samples: practical issues” Furness & Nicholson J Med Ethics 2004; 3
9.      www.hta.gov.uk
10.    “Public perceptions of the collection of human biological samples” London medical research council, 2001
11.    “Medical research under threat after Alder Hey scandal” Mark Hunter, BMJ 2001 Feb 24; 322 (7284):448

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