ministry of ethics
TRANSCRIPT
Contact Details:
Mark Baxter
Email: [email protected]
Unfortunately, our video content was too large to upload to the internet, so I have included a screenshot of each video along with a youtube link and case notes to accompany each video.
Introduction to our Project
http://www.youtube.com/watch?v=iHwz5sSOeXk
Example Topic 1: Organ Donation
http://www.youtube.com/watch?v=EbObZ8zs82E&feature=player_embedded
Case Notes:
LEARNING OBJECTIVES
o The significance and limits of respect for patient autonomy
o Proxy consent
o Best interests of patients who lack capacity
o Local, national and international prioritization in relation to clinical decisions
LEGAL ASPECTS OF CASE
A healthcare professional should try and find out if a patient has indicated if they wish to donate their organs. This can be done by checking the Organ Donor Register, looking for an organ donor card on the person, or checking the patient's medical records. If this is the case, organ donation can then go ahead, legally.
The Human Tissue Act 2004 details the guidelines for which organ donation can occur.
If the patient has indicated their wish for organ donation, but their family objects to it, then legally under the Human Tissue Act 2004, the family cannot veto this consent. In practice th ough, few surgeons would consider carrying out organ retrieval over the family's wishes.
If the patient has not indicated their wish for organ donation before their death, consent can be given posthumously, by a person in a 'qualifying relationship' (Human Tissue Act 2004). The Human Tissue Act actually ranks people who could be in a 'qualifying relationship' with the patient, as to who can give consent first.
ETHICAL ISSUES RAISED
In posthumous donation, a dead person lacks capacity to consent. So by giving 'treatment'- ventilating them, are you acting in the patient's best interests? But does a dead person have any interests anyway?
Consent to 'treatment' by another adult is not allowed in all other branches of medicine, unless the patient has created a lasting power of attorney. Why should it be different here?
Which organs are being donated? Should all the organs be used for donation to maximise the benefit from one donor?
IN CLINICAL PRACTICE
Organs and tissues suitable for transplantation:
Organs: kidney, heart, lung, liver, pancreas, small bowel
Tissues: cornea, bone, tendon, skin, heart valve.
Families must never feel under any pressure to agree to donation, and must be assured that their decision will be respected.
The NHSBT (NHS Blood & Transplant) service has strict rules for the subsequent organ allocation. This system aims to treat patients equally, to ensure that organs are allocated fairly according to patients' needs, and to achieve the best possible match between donors and recipients.
REFERENCES1. Human Tissue Act 2004
http://www.hta.gov.uk/legislationpoliciesandcodesofpractice/legislation/humantissueact.cfm2. Organ Donor Register
http://www.uktransplant.org.uk/ukt/how_to_become_a_donor/how_to_become_a_donor.jsp
Example Topic 2: Ethics of Medical Audit and Research
http://www.youtube.com/watch?v=o2_EOEdLp_o&feature=player_embedded
Case Notes:
LEARNING OBJECTIVES
o Confidentiality for publications/case reports/audits
o The purposes and differences between research and audit
o Ethical, professional and legal considerations involved in medical research and audit
o National/Local ethics committee
o Ethical and legal issues in conducting and reporting clinical trials
LEGAL ASPECTS OF THE CASE
It is vital to define research adequately to follow the appropriate guidelines.
Informed consent must be obtained from all participants. This includes adequately providing information of the benefits and risks involved. The only exception to this is if the patient has impaired mental capacity.
Clinical research must be approved at national and local levels by ethics committees. The NHS site (R&D department) must also be made aware of, and approve any projects or investigations.
ETHICAL ISSUES RAISED
Doctors have a duty to do good for their patients: the principle of beneficence. Medical research (involving patients directly or indirectly) is vital to promote and improve existing healthcare in the present and also in discovering therapies and treatments.
Patients' autonomy must be respected. 'The relationship between a doctor and a patient is based on trust, and the participants' rights to make a decision on their involvement in any research must be protected'.[1] Hence, any participants must be informed if they are to be involved in any research, in order to get consent.
However, informed consent is only valid if patients are given honest information about the research and are informed fully about all the benefits and risks.
The principle of non-maleficence must also be adhered to. As mentioned, the primary aim of research is not intended to directly benefit the current participants, and so they may not get any benefits from it. BUT, measure must be taken to ensure that all risks are minimised- and again, patients are informed of this when you get consent.
IN CLINICAL PRACTICE
Defining Clinical Research
4 key discriminants are, as laid out in 'Defining Research (2010)' by the National Research Ethics Service (NRES): intent, treatment/service, allocation and randomisation. [2]
i. Intent. The primary aim of research is to derive new knowledge2, which is beneficial to future patients and the wider population. This is different to service evaluations or clinical audits, where the aims are to judge and evaluate current standards of care.
If a project has multiple intentions, it may be harder to define what it is. In this case it may necessary to seek clarification and judgement, either from a Research Ethics Committee (National or Local), or even the Research and Development office located at the NHS site where the project is taking place.
ii. Treatment/Service. "Neither audit nor service evaluation uses an intervention without a firm basis of support in the clinical or health community." (Defining Research, 2010) [2]
iii. Allocation. Allocation of Treatment follows protocol and a defined framework in research. In audits and service evaluations, no allocation takes place. Treatment is chosen jointly by the patient/clinician before either take place.
iv. Randomisation. Research may use randomisation. Audits and Service Evaluations do not.
Applying for Research Approval:
After the project is designed and informed consent is obtained, the following procedure needs to be followed to obtain approval:
o Applications need to be made using the Integrated Research Applications System- IRAS (https://www.myresearchproject.org.uk/).
o Applications then need to be booked in for review with an appropriate REC, either to via the central allocation system, or directly via the local allocation service. Once a booking is
made, the application and supporting documents need to be submitted to the allocated REC within 4 days.
o Once a valid application is received, the REC has 60 days to return an opinion on whether the research complies with the current ethical regulations.
REFERENCES
1. General Medical Council: http://www.gmc-uk.org/guidance/ethical_guidance/research.asp2. 'Defining Research': National Research Ethics Service, 2010.
Example Topic 3: Conflicts of Interest with Financial Incentives
http://www.youtube.com/watch?v=5kXtecrSUuU&feature=player_embedded
Case Notes:
LEARNING OBJECTIVES
o Respect for the role, responsibilities and requirements of the GMC and its primary concern to promote the health and safety of patients
o Importance of trust, integrity, honesty and good communication in professional relationships
o Accepting personal responsibility and be aware of limitations and seeking appropriate help.
o Professional boundaries with patients.
o Conflicts of Interest
o Responding to clinical errors and reporting adverse incidents
o Legal and ethical responsibilities for protecting patients
LEGAL ASPECTS OF THE CASE
NHS General Medical Services Contract (2004)
Schedule 5A GP may not accept a fee from an NHS patient for services unless they are specifically outlined in the above document. This particular arrangement is not mentioned and thus the doctor may not demand payment for it.
Schedule 6 Paragraph 124GPs must keep a register of all gifts from patients and outside parties above the value of £100. This register must be made available to the PCT on request. Thus in this situation, if he accepts a monetary or non-monetary gift of value greater than £100 for his endorsement, it must be recorded.
GP Partnership Agreement
Each GP practice has a Partnership Agreement (essentially a constituition) outlining financial policy. If, in this policy, extra earnings are shared communally between partners, the GP must ensure that his partners are happy to endorse the dvd as well because by accepting payment, their endorsement is implied.
ETHICAL ISSUES RAISED
Is this GP qualified to assess the quality of the product?
From the GMC Good Practice Guidance [2] "64. you must always be honest about your experience, qualifications and position.." It is not unreasonable to question the expertise of a GP in the area of sports science. It is unlikely that the GP will have the appropriate depth of knowledge in this area.
Is there any clinical evidence supporting/opposing the methods in the DVD?
GMC Good Practice Guidance [2] "65. You must do your best to make sure any documents you write or sign are not false or misleading. This means you must take reasonable steps to verify the information in the documents and that you must not deliberately leave out relevant information."
The GP must make an informed decision on the merits of the exercise programme. He must differentiate between a medical and personal endorsement - if there is supporting research it is a medical endorsement, if not it is only a personal endorsement. He must take steps to ensure a personal endorsement is not mis-leadingly portrayed as a medical one. This is further compounded by the GMC Good Practice Guideline "63. You must be honest and trustworthy when writing reports..."
Ethically the GP must declare any financial interest he has in an enterprise to his patients when recommending the product.
GMC Guidance [2] states "before taking part in any discussions about buying or selling goods or services you must declare any relevant financial or commercial interest that you or your family might have in the transaction."
IN CLINICAL PRACTICE
Will the Dr-Patient Relationship by affected?
By entering into a financial agreement with the patient the GP is putting his professional relationship with the patient at risk.
From the GMC Guidance "Maintaining Boundaries" (2006);."In most successful doctor-patient relationships a professional boundary exists between doctor and patient. If this boundary is
breached, this can undermine the patient's trust in their doctor, as well as the public's trust in the medical profession."
Also, "The doctor-patient relationship may involve an imbalance of power between the doctor and the patient." In this case, by accepting payment from a patient the balance of power may shift towards the patient, which could cause difficulties for the GP in the future when dealing with this man, or his family. This is of particular concern in this scenario, where the patient has long-standing mental health issues which the GP is supporting him with.
Will the public's trust in the Dr be affected?
GMC Guidance states; "you must make sure that your conduct at all times justifies your patients trust in you and the publics trust in the profession."
The GP should consider that by endorsing a commercial product of this nature he may be seen to be "selling-out". This may cause patients to question his judgment and clinical decision making. If in the future the DVD is proved to be unsafe/inadequate this may also undermine patient confidence in his practice.
Would this scenario be more acceptable if the GP did not receive payment for his endorsement?
REFERENCES
1. NHS General Medical Services Contract (2004)2. GMC: Duties of a Doctor3. GMC: Conflicts of Interest (September 2008)4. Medical Act (1983)5. Public Interest Disclosure Act (1998)6. Health Service Circular (1999/198)7. GMC: Maintaining Boundaries - Guidance for Doctors (November 2006)
Example Topic 4: Dealing with Authorities and Confidentiality
http://www.youtube.com/watch?v=IkA_YzEPvrQ&feature=player_embedded
Case Notes:
LEARNING OBJECTIVES
o Informed consent, voluntariness and disclosure of diagnosis
o Recognition of the legal and ethical boundaries of the clinical discretion to withhold information
o When it is legally, professionally and ethically justifiable or mandatory to breach confidentiality (balance of public interests)
o Conflicts of interest
LEGAL ASPECTS OF THE CASE
Good Medical Practice (2006) :-
"Patients have a right to expect that information about them will be held in confidence by their doctors"
There are serious repercussions for the doctor who discloses confidential information ranging from disciplinary GMC hearings, civil proceedings and criminal proceedings.
The patient's basic contact details is confidential information along with their medical information.
Data Protection Act (DPA), section 29, paragraph 3 :-
Personal data is exempt from non-disclosure provisions for prevention or detection of crime. So the police can request for personal data to be disclosed in certain circumstances.
However, despite the fact that the DPA releases the data holder from obligation to protect data, it does not require the holder to disclose it. In this case, the clinician must decide if the circumstances are serious enough and in the public interest to disclose the information.
Prevention of Terrorism Act 2000 :-
If the doctor is suspicious that an act of Terrorism might take place, it is his legal duty to report this to the police.
ETHICAL ISSUES RAISED
Under what circumstances is it alright for a doctor to breach patient confidentiality? There are guidelines from the GMC which defines serious crimes as a possible reason to disclose information. However they do not list what types of crimes are involved.
What should come first: the doctor's duty to an individual patient, or the duty to the public and in this case, public safety?
By withholding information, is the doctor potentially withholding information that could help protect someone else? After all, the police could just get a court order to request the information later on anyway.
IN CLINICAL PRACTICE
The clinician has obligations to their patient to keep their information confidential, including their contact details.
No one outside the healthcare team should see their medical files; nor should anything about the patient be discussed by anyone outside the medical team, unless the patient consents.
The clinician should attempt to follow the "Caldicott Principles", which set out a way in which the DPA can be followed within the framework of the NHS.
If the clinician is unsure as to what to do, they can contact the NHS Trust Caldicott Guardian, who can advise in situations where confidentiality is at risk of being breached; or alternatively, contact their medico-legal team.
REFERENCES
1. Data Protection Act 1998, section 292. Caldicott Principles3. Caldicott Guardian
Example Topic 5: The Whistleblower
http://www.youtube.com/watch?v=XuugG0WWAAg&feature=player_embedded
Case Notes:
LEARNING OBJECTIVES
o The role, responsibilities and requirements of the GMC in whistleblowing
o The importance of trust, integrity, honesty and good communication in all professional relationships
o The need to know how and where to seek appropriate help
Students should be able to:
o Respond appropriately clinical errors
o Follow procedures for reporting adverse incidents
o Adhere to legal and ethical responsibilities that protect patients
LEGAL ASPECTS OF CASE
Is Dr A legally protected if she makes a complaint? The Public Interest Disclosure Act 1998 (PIDA), states that "The disclosure must relate to raising genuine concerns about risks to patients, financial malpractice, or other wrongdoing from the following categories:
a criminal offence;
breach of any legal obligation
miscarriage of justice
danger (or potential danger) to the health and safety of an individual
damage (or potential damage) to the environment; and
the deliberate concealing of information about any of the above."
PIDA gives right not only to full time staff but also to locums, students and contractors. This was designed to protect employees by protecting anybody who informed the authorities from being victimised or dismissed. Therefore, in this case, the doctor is legally protected as her registrar may be endangering his patients.
What action can the GMC take? The GMC has a set out a list of what they can and they can't take action against. They can take and have taken action against:
Misconduct
o E.g. misuse of alcohol/drugs, sexual advances, treating without consent
Deficient performance
o E.g. not examining properly, serious/repeated mistakes
A criminal conviction
Physical or mental illness
A decision by a regulatory board in the British Isles or overseas
When fitness to practice is found to be impaired, the possibilities include suspension, removal/imposing conditions of a doctors registration. A warning can also be issued if it is not believed that fitness to practice is not impaired but there has been a significant departure from the principles set out in the GMCs Guidance for Doctors: Good Medical Practice.
In this case, the Registrar, is guilty of misconduct with alcohol. Further investigation to elucidate if this was a onetime occurrence, or a recurring problem is necessary. His/her performance should be evaluated, to ensure patient care has not been compromised.
What is the correct reporting procedure to follow? The first port of call in this situation is the consultant. After this, the PCT should be informed.
Ideally the following information should be provided in writing, so that an investigation can begin:
The doctor's full name, or surname, initials and reference number
The doctor's address, or the address of the hospital/practice where they work
A full account of the events or incidents that concern you, with dates, if possible
Copies of any relevant papers and/or any other evidence you have
Details of any action you have taken already - for example, if you have spoken to the doctor, or made a complaint to the doctor's employer
Details of anyone else who will support your complaint.
If a doctor is concerned that by providing information they will be breaching patient confidentiality they may wish to take advice from the GMC or their defence organisation.
ETHICAL ISSUES RAISED
Is the Registrar putting his patient's interests first? In this case, the Registrar would not be able to make his patient his first concern since alcohol will impair his decision making. The GMC Guidance also states that 57 "You must make sure that your conduct at all times justifies your patients' trust in you and the public's trust in the profession." Obviously, practising medicine whilst under the influence of alcohol does not promote public trust in the profession.
As the Consultant is not there, is the Registrar leading the team appropriately? GMC Guidance: Management for Doctors sets out what is expected of a Doctor in a position of leadership, which in this case in the absence of the Consultant is the Registrar. In particular the following are relevant to this case: 20. "Whether you have a management role or not, your primary duty is to your patients. Their care and safety must be your first concern." And 21. "Management involves making judgements about competing demands on available resources." In this case, by drinking the Registrar is impairing his ability to do either of the above.
Is a Doctor responsible for a colleague's performance? GMC Guidance: Good Medical Practice 43. states that "If you have concerns that a colleague may not be fit to practice, you must take appropriate steps without delay, so that the concerns are investigated and patients protected where necessary. This means you must give an honest explanation of your concerns to an appropriate person from your employing or contracting body, and follow their procedures". In this case, if the reporting doctor ignores this incident, she is neglecting her duty and would be in breach of the Good Medical Practice Guidelines.
Is the health of the Registrar affecting his ability? GMC Guidance: Good Medical Practice 79. "...if your judgement or performance could be affected by a condition or its treatment, you must consult a suitably qualified colleague. You must ask for and follow their advice about investigations, treatment and changes to your practice that they consider necessary. You must not rely on your own assessment of the risk you pose to patients." Also relevant here is GMC Guidance, Management for Doctors, 58. "Doctors should also protect those they manage from risks arising from a colleagues health and respond constructively to signs that colleagues have health problems, in particular mental health problems, depression and alcohol and drug dependence."
IN CLINICAL PRACTICE
Ever since the Bristol Heart Case, where a number of operations were performed on children with sub-optimal results. Legislation has been put in place so that poor clinical practise can be reported without repercussion. Currently it is thought that there are various inequalities in how whistleblowers are treated in the NHS, as well as a lack of adequate protection.
Andrew Lansley (Health Secretary of the UK) realised that the NHS Constitution should more accurately reflect whistleblowing culture to counteract the culture of silence and fear within the working environment. He has established a NHS Constitution consultation paper.
The paper states that dismissal of a whistleblower would be considered unfair if they are dismissed for making a protected disclosure as defined by PIDA 1998.
At the time of writing this, the paper is still undergoing review.
REFERENCES
1. GMC Guidance: Good Medical Practice2. NHS Department of Health: The NHS Constitution and Whistleblowing (A paper for
consultation)3. Antecedents and Outcomes of Retaliation Against Whistleblowers: Gender Differences and
Power Relationships by Michael T Regh, Marcia P. Miceli, Janet P. Near, James R. Van Scotter in Organization Science Vol.19, No. 2, March-April 2008, pp. 221-240
4. The key to effective whistleblowing is interprofessional collaboration. BMJ 2009;339:b3055
Example Topic 6: A Case of Pre-Eclampsia
http://www.youtube.com/watch?v=0iC2Xbgm8p0&feature=player_embedded
Case Notes:
LEARNING OBJECTIVES
o Maternal-fetal conflicts of interest
o Ethical, legal and professional aspects of termination of pregnancy
o Human Fertilisation Embryo Act 1998, Abortion act
LEGAL ASPECTS OF THE CASE
Under the Abortion Act 1967 :-
Justification for medical termination of pregnancy include:
The pregnancy does not surpass 24 weeks, and that continuation of the pregnancy would entail greater risk (to the mental/physical health of the pregnant lady or any existing children of her family) than if the pregnancy were terminated.
Severe permanent injury to the physical or mental health of the pregnancy lady would be prevented by termination of the pregnancy.
The risk to the life of the pregnancy lady would be greater by continuation of pregnancy than if it were terminated.
if the child were born, there is considerable risk that it will suffer from physical or mental abnormalities, as to be significantly handicapped.
In this case point 3 and 4 would justify termination of pregnancy.
Under the HFEA 1990 Act, it amends the Abortion Act 1967 to allow abortions where there is a serious risk of foetal handicap upto birth.
ETHICAL ISSUES RAISED
The rights of the mother and the interests of the foetus to life.
The rights of that father and his wishes.
At which point does the foetus attains human rights?
Which is more important, the life of the mother or the life of the unborn foetus? How do you decide? In reality, the obstetrician is more concerned about the life of the mother. However the mother has been trying for so long to get pregnant, this baby is very special to her, and therefore she is less willing to terminate the pregnancy.
Psychological trauma to the mother and her husband need to be considered as they have to choose between the life of the mother and the life of a baby. Also if she terminates the pregnancy, she may not be successful in getting pregnancy again.
IN CLINICAL PRACTICE
Incidence of preeclampsia is 5% (range 5 - 10%) of all pregnancies. Maternal complications of preeclampsia include:-
o HELLP (10-20%)
o Pulmonary oedema (2-5%)
o Acute renal failure (1-5%)
o Placental abruption (1-4%)
o Eclampsia (<1%)
These risks increase in those < 33wk gestation.
The importance of recognising early stages of pre-eclampsia.
A recent study in the UK amongst medical student showed that 62% were pro-choice and 33% pro-life and 7% was undecided. This was comparably a lower pro-life percentage than a similar survey of GPs, the authors were unsure whether this was a societal change to abortion, or because doctors become more pro-choice as they develop.
REFERENCES
1. Abortion Act 19672. HFEA 1990 Act3. Medical students' attitudes towards abortion: a UK study J Med Ethics 2008;34:783-787
Example Topic 7: Child Protection and Non-Accidental Injury
http://www.youtube.com/watch?v=krEM-6_0-AQ&feature=player_embedded
Case Notes:
LEARNING OBJECTIVES
o Rights and Interests of children
o Capacity of young people to consent to and refuse treatment
o Role of parents/guardians/HCP/courts in decisions about treatment of children
o Ethical & legal issues in child protection
o Application of the duty of confidentiality to young people
LEGAL ASPECTS OF THE CASE
Children Act 1989 and 2004 :-
The Act outlines that the child's welfare is of paramount importance when making decisions
Based on the Children Act, local authorities have a "duty to investigate ... if they have reasonable cause to suspect that a child is ... likely to suffer significant harm" (section 47)
Medical practitioners have a duty of care towards their patients, which means that when abuse is suspected, there is a legal imperative to report this suspicion to the relevant authorities
If a child states that they have been the victim of abuse, these claims should be investigated. In these cases, parental consent is not required to conduct a formal investigation
Protection orders :-
Protection orders are given out when a doctor believes that the children is at risk of significant harm.
EPOs (Emergency protection orders) are used to prevent significant harm and/allow investigation.
If it is a true emergency, the police may issue a PPO (Police Protection Order) which lasts for 72 hours.
If the child is not at immediate risk then an CAO (Child Assessment Order) is given
ETHICAL ISSUES RAISED
When child abuse is suspected, it may be acceptable to speak to and examine the child without the parents' consent. This is especially true of sexual abuses when the perpetuators may try and silence the child.
Should the doctor break the child's confidentiality? He is 12. If confidentiality is broken, the child may not trust this doctor again. Causing possible even more harm?
Again, comes back to Children Act 1989 - taking into account views of children, treating them with respect and taking their own wishes into account.
Doctors have a duty of confidentiality to patients. However, this can be breached in the public interest (which includes prevention of crime, including abuse)
IN CLINICAL PRACTICE
There is little likelihood that different clinical conclusions would be found in this case In general, child abuse should be suspected if presentation of injury is disproportionate to its
"history" In clinical situations, parents would likely be discussed with before a protection order is
issued Would he be willing to talk to the Police and make a formal statement about this issue. If not
... what should happen? Issues which might come into play include children with learning difficulties - are they at
more risk of abuse?
REFERENCES
1. Children Act 1989 and 2004