UNIT II
Ethics in all aspects of health care
Medical ethics is a system of moral principles that
apply values and judgments to the practice of medicine. As a scholarly
discipline, medical ethics encompasses its practical application in clinical
settings as well as work on its history, philosophy, theology, and sociology.
A common framework used in the analysis of medical
ethics is the "four principles" approach postulated by Tom Beauchamp
and James Childress in their textbook Principles of biomedical ethics. It
recognizes four basic moral principles, which are to be judged and weighed
against each other, with attention given to the scope of their application. The
four principles are:[6]
Respect for autonomy - the patient has the right to
refuse or choose their treatment. (Voluntas aegroti suprema lex.) Beneficence -
a practitioner should act in the best interest of the patient. (Salus aegroti
suprema lex.)
Justice - concerns the distribution of scarce health
resources, and the decision of who gets what treatment (fairness and equality).
Other values which are sometimes discussed include:
Respect for persons - the patient (and the person
treating the patient) have the right to be treated with dignity.
Truthfulness and honesty - the concept of informed
consent has increased in importance since the historical events of the Doctors'
Trial of the Nuremberg trials and Tuskegee syphilis experiment.
Values such as these do not give answers as to how
to handle a particular situation, but provide a useful framework for
understanding conflicts.
When moral values are in conflict, the result may be
an ethical dilemma or crisis. Sometimes, no good solution to a dilemma in
medical ethics exists, and occasionally, the values of the medical community
(i.e., the hospital and its staff) conflict with the values of the individual
patient, family, or larger non-medical community. Conflicts can also arise
between health care providers, or among family members. Some argue for example,
that the principles of autonomy and beneficence clash when patients refuse
blood transfusions, considering them life-saving; and truth-telling was not
emphasized to a large extent before the HIV era.
Confidentiality is commonly applied to conversations
between doctors and patients. This concept is commonly known as
patient-physician privilege.
Legal protections prevent physicians from revealing
their discussions with patients, even under oath in court.
Confidentiality is mandated in America by HIPAA
laws, specifically the Privacy Rule, and various state laws, some more rigorous
than HIPAA. However, numerous exceptions to the rules have been carved out over
the years. For example, many states require physicians to report gunshot wounds
to the police and impaired drivers to the Department of Motor Vehicles.
Confidentiality is also challenged in cases involving the diagnosis of a
sexually transmitted disease in a patient who refuses to reveal the diagnosis
to a spouse, and in the termination of a pregnancy in an underage patient,
without the knowledge of the patient's parents. Many states in the U.S. have
laws governing parental notification in underage abortion.
Traditionally, medical ethics has viewed the duty of
confidentiality as a relatively non-negotiable tenet of medical practice. More
recently, critics like Jacob Appel have argued for a more nuanced approach to
the duty that acknowledges the need for flexibility in many cases.
Confidentiality is an important issue in primary
care ethics, where physicians care for many patients from the same family and
community, and where third parties often request information from the
considerable medical database typically gathered in primary health care.
Often, simple communication is not enough to resolve
a conflict, and a hospital ethics committee must convene to decide a complex
matter.
These bodies are composed primarily of health care
professionals, but may also include philosophers, lay people, and clergy -
indeed, in many parts of the world their presence is considered mandatory in
order to provide balance.
With respect to the expected composition of such
bodies in the USA, Europe and Australia, the following applies .
U.S. recommendations suggest that Research and
Ethical Boards (REBs) should have five or more members, including at least one
scientist, one non-scientist and one person not affiliated with the
institution. The REB should include people knowledgeable in the law and
standards of practice and professional conduct. Special memberships are
advocated for handicapped or disabled concerns, if required by the protocol
under review. The European Forum for Good Clinical Practice (EFGCP) suggests
that REBs include two practicing physicians who share experience in biomedical
research and are independent from the institution where the research is
conducted; one lay person; one lawyer; and one paramedical professional, e.g.
nurse or pharmacist. They recommend that a quorum include both sexes from a
wide age range and reflect the cultural make-up of the local community. The
1996 Australian Health Ethics Committee recommendations were entitled,
"Membership Generally of Institutional Ethics Committees". They
suggest a chairperson be preferably someone not employed or otherwise connected
with the institution. Members should include a person with knowledge and experience
in professional care, counselling or treatment of humans; a minister of
religion or equivalent, e.g. Aboriginal elder; a layman; a laywoman; a lawyer
and, in the case of a hospital-based ethics committee, a nurse.
The assignment of philosophers or religious clerics
will reflect the importance attached by the society to the basic values
involved.
Bioethics is the study of typically controversial
ethics brought about by advances in biology and medicine. It is also moral
discernment as it relates to medical policy, practice, and research.
Bioethicists are concerned with the ethical questions that arise in the
relationships among life sciences, biotechnology, medicine, politics, law, and
philosophy. It also includes the study of the more commonplace questions of
values ("the ethics of the ordinary") which arise in primary care and
other branches of medicine.
The field of bioethics has addressed a broad swath
of human inquiry, ranging from debates over the boundaries of life (e.g.
abortion, euthanasia), surrogacy, the allocation of scarce health care
resources (e.g. organ donation, health care rationing) to the right to refuse
medical care for religious or cultural reasons.
Bioethicists often disagree
among themselves over the precise limits of their discipline, debating whether
the field should concern itself with the ethical evaluation of all questions
involving biology and medicine, or only a subset of these questions. Some
bioethicists would narrow ethical evaluation only to the morality of medical
treatments or technological innovations, and the timing of medical treatment of
humans. Others would broaden the scope of ethical evaluation to include the
morality of all actions that might help or harm organisms capable of feeling
fear.
The scope of bioethics can expand with
biotechnology, including cloning, gene therapy, life extension, human genetic
engineering, astroethics and life in space, and manipulation of basic biology
through altered DNA, XNA and proteins.These developments will affect future
evolution, and may require new principles that address life at its core, such
as biotic ethics that values life itself at its basic biological processes and
structures, and seeks their propagation.
Historical cases
Historically, Western medical ethics may be traced
to guidelines on the duty of physicians in antiquity, such as the Hippocratic
Oath, and early Christian teachings. The first code of medical ethics, Formula
Comitis Archiatrorum, was published in the 5th century, during the reign of the
Ostrogothic king Theodoric the Great. In the medieval and early modern period,
the field is indebted to Muslim medicine such as Ishaq ibn Ali al-Ruhawi (who
wrote the Conduct of a Physician, the first book dedicated to medical ethics)
and Muhammad ibn Zakariya ar-Razi (known as Rhazes in the West), Jewish
thinkers such as Maimonides, Roman Catholic scholastic thinkers such as Thomas
Aquinas, and the case-oriented analysis (casuistry) of Catholic moral theology.
These intellectual traditions continue in Catholic, Islamic and Jewish medical
ethics.
By the 18th and 19th centuries, medical ethics
emerged as a more self-conscious discourse. In England,
Thomas Percival, a
physician and author, crafted the first modern code of medical ethics. He drew
up a pamphlet with the code in 1794 and wrote an expanded version in 1803, in
which he coined the expressions "medical ethics" and "medical
jurisprudence".However, there are some who see Percival's guidelines that
relate to physician consultations as being excessively protective of the home
physician's reputation. Jeffrey Berlant is one such critic who considers
Percival's codes of physician consultations as being an early example of the
anti-competitive, "guild"-like nature of the physician community.
In 1815, the Apothecaries Act was passed by the
Parliament of the United Kingdom. It introduced compulsory apprenticeship and
formal qualifications for the apothecaries of the day under the license of the
Society of Apothecaries. This was the beginning of regulation of the medical
profession in the UK.
In 1847, the American Medical Association adopted
its first code of ethics, with this being based in large part upon Percival's
work. While the secularized field borrowed largely from Catholic medical
ethics, in the 20th century a distinctively liberal Protestant approach was
articulated by thinkers such as Joseph Fletcher. In the 1960s and 1970s,
building upon liberal theory and procedural justice, much of the discourse of
medical ethics went through a dramatic shift and largely reconfigured itself
into bioethics.
Well-known medical ethics cases include:
Albert Kligman's dermatology experiments
Deep sleep therapy
Doctors' Trial
Henrietta Lacks
Human radiation experiments
Jesse Gelsinger
Moore v. Regents of the University of California
Surgical removal of body parts to try to improve
mental health
Medical Experimentation on Black Americans
Milgram experiment
Radioactive iodine experiments
The Monster Study
Plutonium injections
The Stanford Prison Experiment
Tuskegee syphilis experiment
Willowbrook State School
Greenberg v. Miami Children's Hospital Research
Institute
Since the 1970s, the growing influence of ethics in
contemporary medicine can be seen in the increasing use of Institutional Review
Boards to evaluate experiments on human subjects, the establishment of hospital
ethics committees, the expansion of the role of clinician ethicists, and the
integration of ethics into many medical school curricula.
Negligence
Medical malpractice (also known as medical
negligence) is professional negligence by act or omission by a health care
provider in which the treatment provided falls below the accepted standard of
practice in the medical community and causes injury or death to the patient,
with most cases involving medical error. Standards and regulations for medical
malpractice vary by country and jurisdiction within countries. Medical
professionals may obtain professional liability insurances to offset the risk
and costs of lawsuits based on medical malpractice.
Negligence may be defined as the “breach of a duty
caused by the omission to do something
which a reasonable man, guided by those considerations which ordinarily regulate the conduct of human affairs would
do, or doing something which a prudent and
reasonable man would not do”. A shorter definition is that “negligence
as a tort is the breach of legal duty to
take care which results in damage, undesired by the defendant to the plaintiff”. The definition involves three
constituents of negligence: (1) A legal duty
to exercise the due care on the part of the party complained of towards
the party complaining the former’s
conduct within the scope of the duty; (2) Breach of the said duty; (3) consequential damage.
—In
the leading case Bolam v. Friern Hospital Management Committee [(1957) 2 All
ER,
wherein judge Mc Nair J. has stated as follows:
"………….. where you get a situation which
involves the use of some special skill
or competence, then the test whether there has been negligence or not is
not the test of the man on the top of a
Clapham omnibus, because he has not got this
special skill. The test is the standard of the ordinary skilled man
exercising and professing to have that
special skill. A man need not possess the highest expert skill at the risk of being found negligent.
It is well-established law that it is sufficient
if he exercise the ordinary skill of an ordinary competent man exercising that particular art. Counsel for
the plaintiff put it in this way, that in
the case of a medical man, negligence means failure to act in accordance
with the standards of reasonably
competent medical men at the time. That is a perfectly accurate statement, as long as it is
remembered that there may be one or more
perfectly proper standards; and if a medical man conforms with one of
those proper standards then he is not
negligent. A doctor is not guilty of negligence if he has acted in accordance with a practice accepted
as proper by a responsible body of
medical men skilled in that particular art. Putting it the other way round,
a doctor is not negligent, if he is
acting in accordance with such a practice, merely because there is a body of opinion that takes
a contrary view. At the same time, that
does not mean that a medical man can obstinately and pig-headedly carry on with some old technique if it has been proved
to be contrary to what is really substantially
the whole of informed medical opinion."
Informed consent
1.28
Informed Consent
A
process by which a subject voluntarily confirms his or her willingness to
participate in a particular trial, after having been informed of all aspects of
the trial that are relevant to the subject's decision to participate. Informed
consent is documented by means of a written, signed and dated informed consent
form.
1.26
Impartial Witness
A
person, who is independent of the trial, who cannot be unfairly influenced by
people involved with the trial, who attends the informed consent process if the
subject or the subject’s legally acceptable representative cannot read, and who
reads the informed consent form and any other written information supplied to
the subject.
1.27
Independent Ethics Committee (IEC)
An independent body (a review
board or a committee, institutional, regional, national, or supranational),
constituted of medical professionals and non-medical members, whose
responsibility it is to ensure the protection of the rights, safety and
well-being of human subjects involved in a trial and to provide public
assurance of that protection, by, among other things, reviewing and approving /
providing favourable opinion on, the trial protocol, the suitability of the
investigator(s), facilities, and the methods and material to be used in
obtaining and documenting informed consent of the trial subjects.
The
legal status, composition, function, operations and regulatory requirements
pertaining to Independent Ethics Committees may differ among countries, but should
allow the Independent Ethics Committee to act in agreement with GCP as
described in this guideline.
1.31
Institutional Review Board (IRB)
An
independent body constituted of medical, scientific, and non-scientific
members, whose responsibility is to ensure the protection of the rights, safety
and well-being of human subjects involved in a trial by, among other things,
reviewing, approving, and providing continuing review of trial protocol and
amendments and of the methods and material to be used in obtaining and
documenting informed consent of the trial subjects.
Freely
given informed consent should be obtained from every subject prior to clinical
trial participation.
The IRB/IEC should obtain the following documents:
trial
protocol(s)/amendment(s), written informed consent form(s) and consent form
updates that the investigator proposes for use in the trial, subject
recruitment procedures (e.g. advertisements), written information to be
provided to subjects, Investigator's Brochure (IB), available safety
information, information about payments and compensation available to subjects,
the investigator’s current curriculum vitae and/or other documentation
evidencing qualifications, and any other documents that the IRB/IEC may need to
fulfil its responsibilities.
The
IRB/IEC should ensure that information regarding payment to subjects, including
the methods, amounts, and schedule of payment to trial subjects, is set forth
in the written informed consent form and any other written information to be
provided to subjects. The way payment will be prorated should be specified.
Before
initiating a trial, the investigator/institution should have written and dated
approval/favourable opinion from the IRB/IEC for the trial protocol, written
informed consent form, consent form updates, subject recruitment procedures
(e.g., advertisements), and any other written information to be provided to
subjects.
4.8
Informed Consent of Trial Subjects
4.8.1 In obtaining and documenting informed consent,
the investigator should comply with the applicable regulatory requirement(s),
and should adhere to GCP and to the ethical principles that have their origin
in the Declaration of Helsinki. Prior to the beginning of the trial, the
investigator should have the IRB/IEC's written approval/favourable opinion of
the written informed consent form and any other written information to be
provided to subjects.
4.8.2
The written informed consent form and any other written information to be
provided to subjects should be revised whenever important new information
becomes available that may be relevant to the subject’s consent. Any revised
written informed consent form, and written information should receive the
IRB/IEC's approval/favourable opinion in advance of use. The subject or the
subject’s legally acceptable representative should be informed in a timely
manner if new information becomes available that may be relevant to the
subject’s willingness to continue participation in the trial. The communication
of this information should be documented.
4.8.3 Neither the investigator, nor the trial staff,
should coerce or unduly influence a subject to participate or to continue to
participate in a trial.
4.8.4 None of the oral and written information
concerning the trial, including the written informed consent form, should
contain any language that causes the subject or the subject's legally
acceptable representative to waive or to appear to waive any legal rights, or
that releases or appears to release the investigator, the institution, the
sponsor, or their agents from liability for negligence.
4.8.5 The investigator, or a person designated by
the investigator, should fully inform the subject or, if the subject is unable
to provide informed consent, the subject's legally acceptable representative,
of all pertinent aspects of the trial including the written information and the
approval/ favourable opinion by the IRB/IEC.
4.8.6 The language used in the oral and written
information about the trial, including the written informed consent form,
should be as non-technical as practical and should be understandable to the
subject or the subject's legally acceptable representative and the impartial
witness, where applicable.
4.8.7 Before informed consent may be obtained, the
investigator, or a person designated by the investigator, should provide the
subject or the subject's legally acceptable representative ample time and
opportunity to inquire about details of the trial and to decide whether or not
to participate in the trial. All questions about the trial should be answered
to the satisfaction of the subject or the subject's legally acceptable
representative.
4.8.8
Prior to a subject’s participation in the trial, the written informed consent
form should be signed and personally dated by the subject or by the subject's
legally
acceptable representative, and by the person who
conducted the informed consent discussion.
4.8.9 If a subject is unable to read or if a legally
acceptable representative is unable to read, an impartial witness should be
present during the entire informed consent discussion. After the written
informed consent form and any other written information to be provided to
subjects, is read and explained to the subject or the subject’s legally
acceptable representative, and after the subject or the subject’s legally
acceptable representative has orally consented to the subject’s participation
in the trial and, if capable of doing so, has signed and personally dated the
informed consent form, the witness should sign and personally date the consent
form. By signing the consent form, the witness attests that the information in
the consent form and any other written information was accurately explained to,
and apparently understood by, the subject or the subject's legally acceptable
representative, and that informed consent was freely given by the subject or
the subject’s legally acceptable representative.
4.8.10 Both the informed consent discussion and the
written informed consent form and any other written information to be provided
to subjects should include explanations of the following:
(a) That the trial involves
research.
(b) The purpose of the trial.
(c) The trial treatment(s) and
the probability for random assignment to each treatment.
(d) The trial procedures to be
followed, including all invasive procedures.
(e) The subject's
responsibilities.
(f) Those aspects of the trial
that are experimental.
(g) The reasonably foreseeable
risks or inconveniences to the subject and, when applicable, to an embryo,
fetus, or nursing infant.
(h) The reasonably expected
benefits. When there is no intended clinical benefit to the subject, the
subject should be made aware of this.
(i) The alternative procedure(s)
or course(s) of treatment that may be available to the subject, and their
important potential benefits and risks.
(j) The compensation and/or
treatment available to the subject in the event of trial-related injury.
(k) The anticipated prorated
payment, if any, to the subject for participating in the trial.
(l) The anticipated expenses, if
any, to the subject for participating in the trial.
(m) That the subject's
participation in the trial is voluntary and that the subject may refuse to
participate or withdraw from the trial, at any time, without penalty or loss of
benefits to which the subject is otherwise entitled.
(n) That the monitor(s), the
auditor(s), the IRB/IEC, and the regulatory authority(ies) will be granted
direct access to the subject's original medical records for verification of
clinical trial procedures and/or data, without violating the confidentiality of
the subject, to the extent permitted by the applicable laws and regulations and
that, by signing a written informed consent form, the subject or the subject's
legally acceptable representative is authorizing such access.
(o) That records identifying the
subject will be kept confidential and, to the extent permitted by the
applicable laws and/or regulations, will not be made publicly available. If the
results of the trial are published, the subject’s identity will remain
confidential.
(p) That the subject or the
subject's legally acceptable representative will be informed in a timely manner
if information becomes available that may be relevant to the subject's
willingness to continue participation in the trial.
(q) The person(s) to contact for
further information regarding the trial and the rights of trial subjects, and
whom to contact in the event of trial-related injury.
(r) The foreseeable circumstances
and/or reasons under which the subject's participation in the trial may be
terminated.
(s) The expected duration of the
subject's participation in the trial.
(t)
The approximate number of subjects involved in the trial.
4.8.11 Prior to participation in the trial, the
subject or the subject's legally acceptable representative should receive a
copy of the signed and dated written informed consent form and any other
written information provided to the subjects. During a subject’s participation
in the trial, the subject or the subject’s legally acceptable representative
should receive a copy of the signed and dated consent form updates and a copy
of any amendments to the written information provided to subjects.
4.8.12 When a clinical trial (therapeutic or
non-therapeutic) includes subjects who can only be enrolled in the trial with
the consent of the subject’s legally acceptable representative (e.g., minors,
or patients with severe dementia), the subject should be informed about the
trial to the extent compatible with the subject’s understanding and, if
capable, the subject should sign and personally date the written informed
consent.
4.8.13 Except as described in 4.8.14, a
non-therapeutic trial (i.e. a trial in which there is no anticipated direct
clinical benefit to the subject), should be conducted in subjects who
personally give consent and who sign and date the written informed consent
form.
4.8.14 Non-therapeutic trials may be conducted in
subjects with consent of a legally acceptable representative provided the
following conditions are fulfilled:
(a) The objectives of the trial
can not be met by means of a trial in subjects who can give informed consent
personally.
(b) The foreseeable risks to the
subjects are low.
(c) The negative impact on the
subject’s well-being is minimized and low.
(d) The trial is not prohibited
by law.
(e)
The approval/favourable opinion of the IRB/IEC is expressly sought on the
inclusion of such subjects, and the
written approval/ favourable opinion covers this aspect.
Such
trials, unless an exception is justified, should be conducted in patients
having a disease or condition for which the investigational product is
intended. Subjects in these trials should be particularly closely monitored and
should be withdrawn if they appear to be unduly distressed.
4.8.15
In emergency situations, when prior consent of the subject is not possible, the
consent of the subject's legally acceptable representative, if present, should
be requested. When prior consent of the subject is not possible, and the
subject’s legally acceptable representative is not available, enrolment of the
subject should require measures described in the protocol and/or elsewhere,
with documented approval/favourable opinion by the IRB/IEC, to protect the
rights, safety and well-being of the subject and to ensure compliance with
applicable regulatory requirements. The subject or the subject's legally
acceptable representative should be informed about the trial as soon as
possible and consent to continue and other consent as appropriate (see 4.8.10)
should be requested.
Mental competence Up – to – date cases
A simple guide to the Mental Capacity Act 2005 in relation to
research
1
Summary
From 1 October 2007, research covered by the Act
cannot include any people who lack capacity to consent to the research unless:
- The
research has the approval of a research ethics committee recognised by
either the Secretary of State or the Welsh Assembly Government, as
appropriate
- The
researcher considers the views of carers and other relevant people
- The
research treats the person’s interests as more important than those of science
and society, and
- The
researcher respects any advance decisions or expressed preferences of a
person who lacks capacity and any objections the person makes during the research
1.1
Timetable
The provisions of sections 30-33 of the Act came
into force on 1 October 2007. Any new research starting on or after 1 October
2007 must have section 30 approval from an NHS REC and comply fully with the
provisions of sections 30-33 if it is “intrusive research” involving one or
more adults unable to consent for themselves.
Research starting prior to 1 October 2007 is not
required to comply with sections 30-33 until 1 October 2008, provided it has
ethical approval. Where the research is still underway on 1 October 2008, it
must have section 30 approval from an NHS REC by that date.
2
Remit of the Act
The Mental Capacity Act is relevant to research
involving adults over the age of 16 in England and Wales, except Clinical
Trials of Investigational Medicinal Products (CTIMPs) - the Medicines for Human
Use (Clinical Trials) Regulations 2004 make legal provision for participation
in CTIMPs by adults lacking capacity to consent. In Scotland the Adults with
Incapacity (Scotland) Act 2000 applies. There is no specific legislation in
Northern Ireland. The parts of the Mental Capacity Act that are relevant to
research came into force on 1 October 2007.
The Mental Capacity Act provides the legal
arrangements to enable adults lacking capacity to consent to take part in
research other than CTIMPs (including health and social care research) that
would otherwise require the participant’s consent. The Mental Capacity Act also
enables adults with capacity to make arrangements or make their wishes known in
advance, to deal with future situations where they lack capacity to consent to
take part in research.
3
What is mental capacity?
Mental capacity is the ability to make a decision.
Capacity can only be assessed in relation to a particular decision and a
particular time – a person may have the capacity to make some decisions but not
others, or the capacity may vary over time.
3.1
The two-stage test of capacity
·
Is there an impairment of, or disturbance in, the functioning of
the person’s mind or brain?
If so:
·
Is the impairment or disturbance sufficient to cause the person to
be unable to make that particular decision at the relevant time?
Lack of capacity can be due to a range of causes,
including unconsciousness, dementia, learning disabilities, stroke, head
injuries or mental health problems.
Under the Mental Capacity Act, the following factors
have to be considered when assessing if someone has capacity to make a
decision:
- whether
they are able to understand the information
- whether
they are able to retain the information related to the decision to be made
- whether
they are able to use or weigh that information as part of the process of
making the decision
- whether
they are able to communicate that decision – by any means, including
blinking an eye or squeezing a hand.
3.2
The five core principles
1
A person must be assumed to have capacity unless it
is established that they lack capacity.
2
A person is not to be treated as unable to make a
decision unless all practicable (doable) steps to help them to do so have been
taken without success.
3
A person is not to be treated as unable to make a
decision merely because they make an unwise decision.
4
An act done, or decision made, under this Act for or
on behalf of a person who lacks capacity must be done, or made, in their best
interests.
5
Before
the act is done, or the decision is made, regard must be had to whether the
purpose for which it is needed can be as effectively achieved in a way that is
less restrictive of the person’s rights and freedom of action.
4
Mental Capacity and Research (Sections 30 – 34)
4.1
Ethical approval (Sections 30 - 31)
Any research involving, or in relation to, a person
lacking capacity that would otherwise have required consent from participants may
only be lawfully carried out if an NHS research ethics committee (REC) in
England or Wales has given a favourable opinion. This requirement includes
research that would otherwise fall outside the remit of an NHS REC. The REC can
only approve the research if it meets the following criteria:
- the research must relate to the condition causing
the mind or brain impairment, or to a condition resulting from or
attributed to the mind or brain impairment;
- the research cannot be done as effectively using
people who have mental capacity; and
- the research must produce results relevant to the
condition (or a similar condition) affecting the person and have small
risks or low adverse impact on the person, or it must have potential
benefits to the person without disproportionate risk.
The researcher must stop the research if
at any time they think that one of the above criteria is not met at any time
during the research, unless
withdrawal of any treatment as part of the research would impose a significant
health risk.
4.2
Identifying a consultee (Section 32 - 33)
Where an adult lacks capacity to consent to take part in research,
a consultee should be consulted. A
personal consultee may be a family member, carer, or attorney acting under a
Legal Power of Attorney, as long as they are not paid to look after the person
in question and their interest in the welfare of the person is not a professional
one. If they say that the person who lacks capacity would not have wanted to
take part, or to continue to take part, then this means that the research must
not go ahead.
If there is no such personal consultee
who can be consulted, the researcher must find someone who is not connected
with the research who can fulfil this role instead – a nominated consultee. Where
the research relates to serious medical treatment, the consultee could be an independent mental capacity advocate. Again,
if the consultee says that the person would not have wanted to take part or
continue to take part, the research must not go ahead.
The researcher must provide the
consultee with information about the research, and ask for advice on whether
the person should take part in the research, and what the person’s wishes would
be likely to be if they had capacity.
If the
person shows any signs of resistance or indicates in any way that he or she
does not wish to take part, the person must be withdrawn from the project
immediately, unless withdrawal of any treatment as part of the research would
impose a significant health risk.
In an
emergency, if it is not possible to consult with a consultee in sufficient
time, then the researcher must obtain agreement from an independent registered
medical practitioner or comply with any other requirement of the REC.
Guidance
on nominating a consultee for research involving adults who lack capacity to
consent has been published by the Department of Health (see section 10). The
sponsor or organisation providing care should have a local policy on the
selection and training of the nominated consultees for research taking place
within that organisation.
4.3
Loss of capacity during research (Section 34)
Where
research started before the Act came into force (1 October 2007) and a person
originally had capacity to consent and gave consent before 31 March 2008, research
involving tissue or data collected from that person before a loss of capacity
may continue if the participant later loses capacity before the end of the
project. This research is permitted under the Loss of Capacity Regulations. Such
research must have procedures for dealing with people who lose capacity during
the project that have been approved by the research ethics committee. Approval
for the procedures should be made by submitting a substantial amendment. However,
the research does not need to meet the criteria in section 4.1. When a person
loses capacity during a project, the researcher must seek the views of a
consultee and act in the best interests of the person.
4.4
Research involving human tissue
The
Mental Capacity Act permits the removal of tissue from a person lacking
capacity, if it is in their best interests. The tissue can be stored or used
for research if:
·
The
research is to get information relevant to the health of another individual,
and in the best interests of the person who lacks capacity;
·
The
research is a clinical trial of an investigational medicinal product; or
·
The
research is carried out under the Mental Capacity Act, meets the Acts
requirements and has ethical approval
4.5
Transitional arrangements for research started before 1 October
2007
Research
that started before the Mental Capacity Act came into force and involving
participants who did not have capacity to consent when they entered the study,
must obtain approval from a relevant REC in order to continue under the Act
after 1 October 2008. Application for approval should be made by 1 April 2008. Such
research must meet the requirements of the Mental Capacity Act.
4.6
Research not covered by the Mental Capacity Act
Clinical
trials of investigational medicinal products are not covered by the Mental
Capacity Act because arrangements for participation of adults lacking in
capacity are covered by separate legislation. Other research that does not
require consent does not require specific arrangements for adults lacking
capacity. This includes research involving only:
·
anonymised
data;
·
anonymised
human tissue obtained from the living;
·
human
tissue collected prior to 31 August 2006; or
·
confidential
patient information used under approval of the Secretary of State through the
Patient Information Advisory Group (PIAG).
5
Best interests decisions and acts
The Mental Capacity Act requires any
decision or act made on behalf of a person who lacks capacity to be made in
that person’s best interests. The interests of the person must be assumed to
outweigh those of science and society. The Act does not define best interests
but anyone making such a decision should take into account:
- The persons’
past and present wishes and feelings, including any advance decisions
- The beliefs
and values that would be likely to affect their decision if they had
capacity
- Other
factors that the person might have considered if they were able to do so.
6
Lasting Power of Attorney
Under a Lasting Power of Attorney (LPA)
an individual can, while they still have capacity, appoint another person to
make decisions on their behalf. They can give power to the attorney to make all
decisions or they can choose which decisions they can make. When acting under
an LPA, an attorney has the authority to make decisions on behalf of the person
who made it if they can no longer make these decisions for themselves. In these
cases, an attorney is not there simply to be consulted (although they should
still be consulted if appropriate where other decisions are being made).
Attorneys must act in accordance with the Code of Practice.
7
Advance decisions
An advance decision to refuse treatment
enables an adult to make treatment decisions in the event of their losing their
capacity at some time in the future.
8
Independent mental capacity advocates
The
Mental Capacity Act introduces a duty on the NHS to involve an independent
mental capacity advocate (IMCA) in decisions about serious medical
treatment, when a person who lacks capacity to make a decision has no one who
can speak for them. An IMCA is not a decision maker for the person who lacks
capacity. They are there to support and represent that person and to ensure
that decision making for people who lack capacity is done appropriately and in
accordance with the Act.
9
Children and young people
The Mental Capacity Act does
not usually apply to children younger than 16 who do not have capacity.
Generally, people with parental responsibility for such children can make
decisions on their behalf under common law. For 16 or 17-year-olds who lacks
capacity to consent, the person providing care or treatment must follow the Act’s
principles and act in a way that they reasonably believe to be in the young
person’s best interests. Parents, others with parental responsibility, or
anyone else involved in the care of the young person should be consulted unless
the young person does not want this or this would otherwise breach their right
to confidentiality. Any known views of the young person should also be taken
into account.
(Ref:
www.rdforum.nhs.uk/docs/mca_guidance.doc)
Cloning
Introduction
In early 1997, a research team in Scotland cloned a
sheep, Dolly, by modifying technology developed some decades previously with
amphibians. Then, in July of 1998, researchers at the University of Hawaii produced
mouse clones and developed a process by which mass cloning could occur. The
technique used in both cases, somatic cell nuclear transfer, involves taking a
nucleus from a somatic cell, placing it in an enucleated ovum, and implanting
the ovum into a host uterus.
The cloning of Dolly brought to the forefront a
longstanding debate about cloning human beings. The National Bioethics Advisory
Commission recommended a five-year moratorium on any attempts to create a child
through somatic cell nuclear transfer in the United States and urged the
President to work with all other nations to do the same With the moratorium in
place in the United States, legislative attempts to exercise permanent control
over human cloning, such as the federal “Prohibition of Cloning of Human Beings
Act of 1998,” have been introduced in Congress.
Human cloning is a matter for the medical
profession’s attention since it would involve medical procedures and
technology, and it may result in the creation of new genetic and psychological
conditions that would require professional care. Therefore, the medical profession
must evaluate the ethics of human cloning, and in particular, the potential
role of physicians in the practice. The Council’s purpose here is to consider
whether physicians should participate in human cloning, not to determine
whether it should be legal or illegal.
The Council on Ethical and Judicial Affairs offers
the following report to assess the ethical uncertainties involved in human
cloning. It will address what are currently perceived to be the most widely
discussed applications of human cloning, and it will lay the groundwork for
future reports. Issues involving embryo research, stem cell research, embryo
splitting, embryo twinning, and embryo donor organisms will be addressed in
future reports. A scientific analysis of cloning technology can be found in a
companion report issued by the Council on Scientific Affairs.
Definitions
For the purposes of this report, the term “cloning”
will refer to the production of genetically identical organisms via somatic
cell nuclear transfer.ii “Somatic cell nuclear transfer” refers to the process
in which the nucleus of a somatic cell of an existing (or previously existing) organism
is transferred into an oocyte from which the nucleus has been removed. “Human
cloning” will be used to refer to the application of somatic nuclear transfer
technology to the creation of a human being that shares all of its nuclear
genes with the person donating the implanted nucleus.
Cloning is distinct from techniques such as embryo
splitting and twinning. Human cloning, as defined in this report, does not
include the use of somatic cells to create a pluripotent cell line that could,
for instance, also be used for extra-uterine production of transplantable
tissues without the creation of an entire being. Nor does it include the use of
cloning technology for the production of human tissues or human proteins from
transgenic mammals.
Existing
Limits on Human Cloning
Coverage of advances in cloning, especially in the
popular press, has described the prospects of manufacturing armies of
programmed killers, duplicating sports stars or academic geniuses, and recreating
deceased loved ones.iii Based on the intrinsic limitations of human cloning technology,
some widely mentioned undesirable applications of cloning are impossible, and others,
which may be possible technically, are clearly prohibited by existing law,
public policy, and professional ethical standards. The following sections
describe these issues in more detail. In order to clarify the many
misconceptions about human cloning, physicians should help educate the public
about the intrinsic technical limits of human cloning as well as the ethical
and legal protections that should prevent abuses of human cloning.
A.
Replicating specific persons
The term “cloning” may suggest that one organism is
the exact replica of another. Human clones would be identical insofar as they
would have the same nuclear genes as the donor. However, as observed in natural
monozygotic twins, having identical genes does not result in two indistinguishable
individuals. A clone must— because of the different environment and
circumstances in which he or she creates his or her life story— be a different
person from the person from whom he or she was cloned. Although human cloning
may be thought of as a sort of “delayed twinning,” twins may be more similar
than clones since most twins are conceived and nurtured in the same environment
in utero and often during childhood.
Since environment has a profound influence on
development, human clones likely would be different in terms of personality and
other characteristics. Because cloning would not produce exact replicas,
several applications of human cloning are illogical. In particular, human
cloning would not be a solution to terminal illness or mortality. Children are
already thought of as a way to “soften the blow of mortality,” and clones may
be seen as a more powerful approach since there is no sharing or mixing of
genomes.iv The possibility of having one’s life to live over again, or of
getting back a lost child, might be attractive. But the clone would not be the
same person as the cloned individual. The fact remains that the person does die
and cannot be replaced.
The same reasoning applies to recreating sports
stars, dictators, and geniuses— genetics does not wholly define a person.
Cloning may allow the persistence of certain genotypes and derived phenotypic
traits, but it does not provide individual immortality or replication. A clone
of a sports star will not necessarily be a superb athlete, and even if he or
she did possess keen athletic ability, he or she would not be identical to the
cloned sports star. However, the idea that the clone’s life choices would be
affected by other’s expectations raises additional disturbing possibilities
that are addressed below.
B.
Creating clones without consent
There is some concern that human clones would be
developed from cells obtained without one’s permission since, unlike traditional
procreative methods, isolated somatic cells potentially could yield clones. If
this technique becomes a possibility, the moral foundations of the therapeutic
relationship would have to apply. These include trust, personal respect, and
the healer’s fiduciary obligation to serve the patient’s health interests. Any
attempt to clone a patient involuntarily would violate all three of these fundamental
precepts of medical ethics.
In addition, the doctrine of informed consent would
have to apply if this technique becomes a possibility. In Opinion 8.08,
“Informed Consent,” the Council has recognized that “the patient should make
his or her own determination on treatment.” This includes procedures for reproduction. Few
exceptions exist to this basic social policy. In addition to ethical
safeguards, there are legal protections against procreation without consent.
Cloning a patient involuntarily would likely violate the patient’s existing
constitutional rights to privacy and reproductive freedom.vi Therefore, under
no circumstances should cloning occur without an individual’s permission.
C.
Respecting the rights of clones
Many of the other unrealistic applications of human
cloning, such as creating armies of clones or creating human organ factories,
stems from the underlying fear that clones would be denied the same rights as other
individuals in society. Children are entitled to the same protections as every
other individual in society. The fact that a human clone’s nuclear genes would
derive from a single individual rather than two parents does not change its
moral standing. This standard should be applied to every supposed use of clones.
The
Realistic Uses of Human Cloning
A.
Assisted Reproduction
There are some realistic applications for cloning
technology in the medical arena. One of the most likely uses is as a method of
assisted reproduction. To the benefit of many patients, the widespread
introduction of assisted reproductive technologies has resulted in a great
number of pregnancies and births that otherwise could not have occurred. The
use of in-vitro methods of fertilization, donor eggs, donor sperm, and/or
surrogate mothers have proved to be effective treatments for infertility.
Assisted reproductive technologies are also attractive options to individuals
or couples who do not choose to reproduce by traditional means. Cloning
technology might allow any couple or individual to reproduce with minimal genetic
input from another party.
Because of the prevalence of assisted reproductive
technologies and the rapid rate of technological development in this arena,
cloning rarely would be the only reproductive option available to prospective parents.
For example, scientists recently have pioneered a technique in which DNA is
transferred from an infertile woman’s oocyte to a viable donor oocyte.vii In
addition, the development of somatic cell gene therapy and other technologies
may allow for the treatment of genetic disorders— an alternative to avoiding
all genetic contribution from a partner with a disease gene. One issue for this
report is whether it would be justifiable to make cloning available to
individuals who could use existing or alternative options.
Many of the issues that arise in the context of
cloning, for example with respect to medical, psychological, or social harms,
can be compared to issues that arise in the use of other assisted reproductive
techniques. Generally speaking, the medical profession should be satisfied that
the benefits of commonly used reproductive interventions outweigh the risks to
individuals, families, and their offspring enough to justify medical
cooperation with informed patient requests for these services. Evaluating
whether or not this calculus has been done for all of the currently used
reproductive technologies is beyond the scope of this report. Regardless, cloning
should be subject to such a balancing.
In considering cloning as another reproductive
health tool, the profession should evaluate whether the ethical concerns
introduced by assisted reproductive technologies will be exacerbated in the
case of cloning to the point where they outweigh potential benefits to
individuals, families, and their offspring. For example, human cloning appears
to represent a significant step toward turning children into “products of human
will and design,” a situation that many find problematic.viii Determining the
balance of possible harms and benefits will require further investigation and
discussion regarding human cloning with consideration given to the points
raised in the next section.
Individuals do not have a right to demand that
physicians participate in human cloning. Before physicians would be justified
in participating in human cloning, the harms and benefits need to be evaluated
further with some of the issues requiring discussion on a societal level. Until
these issues are brought closer to resolution and benefits clearly outweigh
harms, it would be inappropriate for physicians to participate in human
cloning. Cloning technology also potentially may be used to create a person
with tissues immunologically matched to an existing individual. If the
technology uses somatic nuclear transfer for cell or tissue production without
creating a human being, then this is not human cloning by the definition used
here. One scenario that has been discussed in the context of human cloning is
the possibility of manufacturing “donor organisms.” In this context, donor
organisms are humans in early stages of development created for the sole
purpose of harvesting their organs.ix The creation of human embryo or fetal
donor organisms will be addressed in a future report.
Legal and ethical protections already preclude the
use of cloned children as discardable donor organisms. Medical ethics is
grounded in the principle of nonmaleficence, or the avoidance of harm. Any involvement
by a physician in the deliberate sacrifice or harm of children in order to
harvest organs would violate this axiom. Further, this practice would be
considered murder. Even where the clone would not be destroyed, the ethical
prohibition against using human beings merely as means rather than as ends in
themselves makes the possibility of using human cloning to create an organ
donor controversial. Nevertheless, even without human cloning, the practice of
having children in order to create matching tissue for an older sibling already
occurs. One couple unable to find a matching donor for their first child’s bone
marrow transplant decided to have a second child on the chance that he or she
would also have the rare marrow type. Notably, the couple indicated that they
had wanted another child and that they would care for the resulting child
irrespective of his or her marrow type. In this situation, hoping the child had
the same marrow type as its sibling did not preclude the couple from valuing
the child for its own sake. xi A cloned person, however, would be born with
assurance of tissue compatibility, and perhaps with the expectation of tissue
donation.
There are limits on the types of procedures to which
parents can consent. In a previous report, “The Use of Minors as Organ and
Tissue Donors,” the Council has described the standards that proxies should use
when making a decision to donate a minor’s organs.xii One of the standards the
Council recommends is a “best interests test” based on the principles of
beneficence and nonmaleficence in which the proxy “attempts to ascertain what
would bring the most good to the person… and at the very least… do no harm to
that person.” Physicians can help parents with the calculus of determining the
best interest of the child.
Technological advances in organ and tissue research
might alleviate the need to develop a human being in order to produce a
matching organ. For example, somatic cell nuclear transfer may be used to
produce only the matching, transplantable tissues. Improved pharmaceutical interventions
to lower the rate of organ and tissue rejection could also reduce the need for
tissue compatibility
Ethical
Concerns Regarding Human Cloning
Physicians have an ethical obligation to consider
the harms and benefits of new medical procedures and technologies. In weighing
the harms and benefits, physicians should consider the possible implications of
human cloning. Potential physical harms, psychosocial harms, adverse effects on
familial relations, and changes to the gene pool are all legitimate issues.
Compared to other technologies that might be used to address reproductive
limitations and organ and tissue shortages, these potential harms of human
cloning appear to outweigh the potential benefits at this time.
A.
Physical harms introduced by cloning
While the Council will address the harms and
benefits of embryo research in a future report, it is important to note that
techniques used for cloning humans could potentially endanger the developing individuals.
The Human Embryo Research Panel of the National Institutes of Health (NIH), in
its 1994 study, advised that embryos should be transferred to a woman’s uterus
only when “there is reasonable confidence that any child born as a result” will
not be harmed.xiii At present, this cannot be assured with any degree of
certainty with human cloning. Somatic cell nuclear transfer has not yet been
refined and its long-term safety has not yet been proven. The possibility of
genetic or cellular conditions, and perhaps an array of illnesses associated
with cloning, is of great concern. While the demise of countless amphibian, lamb,
and mouse fetuses may be disturbing, similar wastage and mortality among human
fetuses is unacceptable. Moreover, we might have significant concerns about
offering such technology to women as a mechanism to facilitate reproduction
given the potential harms from the expected high miscarriage rate. The risk of
producing individuals with developmental anomalies is serious and precludes
human cloning for the time being. Producing disabled human clones would give
rise to an obligation to seek better understanding of— and potential medical
therapies for— the unforeseen consequences that could arise from human cloning.
B.
Psychosocial harms introduced by cloning
Human cloning has the potential to introduce
psychosocial harms to individuals. If a person with known genetic
predispositions and conditions is cloned, the cloned child’s genetic predispositions
and conditions will, due to the very nature of cloning, also be known to a
certain extent. For the most part, environment will also play a significant
role. Presently, a child’s genetic predispositions can be predicted to varying degrees
if the parent’s genetic predispositions have been determined. Knowledge of a
child’s genetic predispositions raises concerns about the autonomy and best
interests of the child. The Council has urged caution in this area in its
ethical Opinion 2.138, “Genetic Testing of Children.” Knowledge of genetic information holds great
significance to an individual. The harm of preempting the child’s future choice
in knowing or forgoing knowledge of his genetic status and the danger of abrogating
the child’s right to privacy with respect to this status must be weighed
carefully.
Foregoing choice in learning one’s genetic
predispositions may seem trivial compared to the concerns about identity raised
with human cloning. If raised by the clone-parent, a clone-child could see what
he or she has the potential to become. In this respect, human clones would
differ dramatically from monozygotic twins who develop simultaneously. The
timing of development is a key difference between monozygotic twins and human
clones. Having insight into one’s potential may cause enormous pressures to
live up to expectations (or inappropriately relieve pressure to do so), even
more so than those generally experienced by children.
Presumably, a person would clone him or herself or
another individual because that person has desirable characteristics that would
be reflected in the clone. For example, the person who cloned a sports star presumably
would hope that the clone-child develops into another sports star. A sports
star’s clone-child unable to live up to these expectations could be dubbed a
failure unable to capitalize on his or her genetic gift. Moreover, although the
clone-child of a sports star might feel more confident of his or her abilities from
the outset, other clone-children may feel limited by their genetic lot. If a
clone-child saw that he or she was likely to develop certain diseases or had
failed at certain tasks, his or her undertakings might be bounded by what the
clone-parent had done. Therefore, cloning might limit the clone-child’s
perception of self and increase external pressures. Human cloning may diminish,
at least psychologically, the seemingly unlimited potential of new human beings
and may exacerbate disturbing motivations for having children.
C.
The impact of human cloning on family and society
In addition to concerns about individual privacy and
identity, the implications of cloning for family and broader social
relationships remain uncharted. What would be the consequence to, say, the
fatherdaughter relationship if the daughter and wife were genetically
identical? Would a woman have a normal mother-daughter relationship with her
clone?xv These examples illustrate that the family unit might be quite
different with the introduction of cloning. As one philosopher wrote: “cloning
shows itself to be a major violation of our given nature as embodied, gendered,
and engendering beings— and of the social relations built on this natural
ground.” Additionally, some problems are technical and legal in nature. For instance,
birth cousins could be genetic siblings, and this might result in a need to
revisit laws governing marital eligibility. Also, the courts have had
difficulty sorting out parental rights in cases of assisted reproduction. In
one case, a court found a child conceived using assisted reproductive
technologies to have no parents despite having eight individuals from which to
choose.
While discussion and resolution of these issues is
not the province of physicians, the impact of human cloning on family and
society is an important factor for physicians to consider when weighing the
costs and benefits of cloning. Until more thought is given on a societal level
regarding how to construct familial relations in this context, physicians
should not participate in human cloning.
D.
The effects of human cloning on the gene pool
Although not the most imminent threat, human cloning
has the potential to alter the gene pool. In order for human cloning to have a
significant effect on the gene pool, cloning would have to be widespread, and clones
would have to reproduce. If cloning became widespread, human genetic diversity
would decrease. Over time, the benefits of genetic diversity, from having individuals
with disease immunity to fostering a population with a wide variety of talents,
have helped human beings survive and succeed. Like other interventions that can
change individuals’ reproductive patterns and the resulting genetic characteristics
of a population, human cloning raises the specter of eugenics.The possibility
that physicians might play a part in deciding which persons are or are not “worthy”
of cloning is contrary to professional medical values by all respectable
accounts. For the most part, those individuals thought to possess desirable
characteristics or lack undesirable ones would be cloned. In addition, as is
the worry with many assisted reproductive technologies, only those who have the
ability to pay or are members of favored social groups will have access. This
would have the potential to skew the gene pool in the direction of favored
social groups and whatever characteristics are thought to be advantageous at
the time, even though the long-term desirability of the characteristics is
unknown. The possibility that physicians might be the agents of a social policy
that make such judgments is contrary to professional medical values. The
application of cloning for eugenic or discriminatory practices is incompatible
with the ethical norms of medical practice.
In addition, since the somatic cell from which
clones originate likely will have acquired mutations, serial cloning would
compound the accumulation of mutations that occur in somatic cells. Although
these mutations might not be apparent at the time of cloning, genetic problems
could become exacerbated in future generations. These possibilities need to be
investigated further before physicians participate in human cloning.
The
Need for International Regulations
Even if the United States developed sound ethical
guidelines and well-crafted regulations to address the practice of human
cloning, some fear that human cloning would simply be forced into other
locales. Individuals could travel to other countries where human cloning would
be available and potentially unregulated. Because cloning technology is not
limited to the United States, physicians should help establish international
guidelines regarding human cloning.
Human embryos and IVF Shared responsibilities
for decisions and the understanding of risk
At first glance, the case for federal funding of
embryonic stem-cell research seems too obvious to need defending. Why should
the government refuse to support research that holds promise for the treatment
and cure of devastating conditions such as Parkinson's disease, Alzheimer's
disease, diabetes, and spinal cord injury? Critics of stem-cell research offer
two main objections: some hold that despite its worthy ends, stem-cell research
is wrong because it involves the destruction of human embryos; others worry
that even if research on embryos is not wrong in itself, it will open the way
to a slippery slope of dehumanizing practices, such as embryo farms, cloned
babies, the use of fetuses for spare parts, and the commodification of human
life.
Neither objection is ultimately persuasive, though
each raises questions that proponents of stem-cell research should take
seriously. Consider the first objection. Those who make it begin by arguing,
rightly, that biomedical ethics is not only about ends but also about means;
even research that achieves great good is unjustified if it comes at the price
of violating fundamental human rights. For example, the ghoulish experiments of
Nazi doctors would not be morally justified even if they resulted in
discoveries that alleviated human suffering.
Few would dispute the idea that respect for human
dignity imposes certain moral constraints on medical research. The question is
whether the destruction of human embryos in stem-cell research amounts to the
killing of human beings. The “embryo objection” insists that it does. For those
who adhere to this view, extracting stem cells from a blastocyst is morally
equivalent to yanking organs from a baby to save other people's lives.
Some base this conclusion on the religious belief
that ensoulment occurs at conception. Others try to defend it without recourse
to religion, by the following line of reasoning: Each of us began life as an
embryo. If our lives are worthy of respect, and hence inviolable, simply by
virtue of our humanity, one would be mistaken to think that at some younger age
or earlier stage of development we were not worthy of respect. Unless we can
point to a definitive moment in the passage from conception to birth that marks
the emergence of the human person, this argument claims, we must regard embryos
as possessing the same inviolability as fully developed human beings.
But this argument is flawed. The fact that every
person began life as an embryo does not prove that embryos are persons.
Consider an analogy: although every oak tree was once an acorn, it does not
follow that acorns are oak trees, or that I should treat the loss of an acorn
eaten by a squirrel in my front yard as the same kind of loss as the death of
an oak tree felled by a storm. Despite their developmental continuity, acorns
and oak trees are different kinds of things. So are human embryos and human
beings. Sentient creatures make claims on us that nonsentient ones do not;
beings capable of experience and consciousness make higher claims still. Human
life develops by degrees.
Those who view embryos as persons often assume that
the only alternative is to treat them with moral indifference. But one need not
regard the embryo as a full human being in order to accord it a certain
respect. To regard an embryo as a mere thing, open to any use we desire or
devise, does, it seems to me, miss its significance as potential human life.
Few would favor the wanton destruction of embryos or the use of embryos for the
purpose of developing a new line of cosmetics. Personhood is not the only
warrant for respect. For example, we consider it an act of disrespect when a
hiker carves his initials in an ancient sequoia — not because we regard the
sequoia as a person, but because we regard it as a natural wonder worthy of
appreciation and awe. To respect the old-growth forest does not mean that no
tree may ever be felled or harvested for human purposes. Respecting the forest
may be consistent with using it. But the purposes should be weighty and
appropriate to the wondrous nature of the thing.
The notion that an embryo in a petri dish has the
same moral status as a person can be challenged on further grounds. Perhaps the
best way to see its implausibility is to play out its full implications. First,
if harvesting stem cells from a blastocyst were truly on a par with harvesting
organs from a baby, then the morally responsible policy would be to ban it, not
merely deny it federal funding. If some doctors made a practice of killing
children to get organs for transplantation, no one would take the position that
the infanticide should be ineligible for federal funding but allowed to
continue in the private sector. If we were persuaded that embryonic stem-cell
research were tantamount to infanticide, we would not only ban it but treat it
as a grisly form of murder and subject scientists who performed it to criminal
punishment.
Second, viewing the embryo as a person rules out not
only stem-cell research, but all fertility treatments that involve the creation
and discarding of excess embryos. In order to increase pregnancy rates and
spare women the ordeal of repeated attempts, most in vitro fertilization
clinics create more fertilized eggs than are ultimately implanted. Excess
embryos are typically frozen indefinitely or discarded. (A small number are
donated for stem-cell research.) But if it is immoral to sacrifice embryos for
the sake of curing or treating devastating diseases, it is also immoral to
sacrifice them for the sake of treating infertility.
Third, defenders of in vitro fertilization point out
that embryo loss in assisted reproduction is less frequent than in natural
pregnancy, in which more than half of all fertilized eggs either fail to
implant or are otherwise lost. This fact highlights a further difficulty with
the view that equates embryos and persons. If natural procreation entails the
loss of some embryos for every successful birth, perhaps we should worry less
about the loss of embryos that occurs in in vitro fertilization and stem-cell
research. Those who view embryos as persons might reply that high infant
mortality would not justify infanticide. But the way we respond to the natural
loss of embryos suggests that we do not regard this event as the moral or
religious equivalent of the death of infants. Even those religious traditions
that are the most solicitous of nascent human life do not mandate the same burial
rituals and mourning rites for the loss of an embryo as for the death of a
child. Moreover, if the embryo loss that accompanies natural procreation were
the moral equivalent of infant death, then pregnancy would have to be regarded
as a public health crisis of epidemic proportions; alleviating natural embryo
loss would be a more urgent moral cause than abortion, in vitro fertilization,
and stem-cell research combined.
Even critics of stem-cell research hesitate to
embrace the full implications of the embryo objection. President George W. Bush
has prohibited federal funding for research on embryonic stem-cell lines
derived after August 9, 2001, but has not sought to ban such research, nor has
he called on scientists to desist from it. And as the stem-cell debate heats up
in Congress, even outspoken opponents of embryo research have not mounted a
national campaign to ban in vitro fertilization or to prohibit fertility clinics
from creating and discarding excess embryos. This does not mean that their
positions are unprincipled — only that their positions cannot rest on the
principle that embryos are inviolable.
What else could justify restricting federal funding
for stem-cell research? It might be the worry, mentioned above, that embryo
research will lead down a slippery slope of exploitation and abuse. This
objection raises legitimate concerns, but curtailing stem-cell research is the
wrong way to address them. Congress can stave off the slippery slope by
enacting sensible regulations, beginning with a simple ban on human
reproductive cloning. Following the approach adopted by the United Kingdom,
Congress might also require that research embryos not be allowed to develop beyond
14 days, restrict the commodification of embryos and gametes, and establish a
stem-cell bank to prevent proprietary interests from monopolizing access to
stem-cell lines. Regulations such as these could save us from slouching toward
a brave new world as we seek to redeem the great biomedical promise of our
time.
The issue of IVF treatments and the supposed “right
to a child” raises some complex ethical issues. Compare these two comments:
"Being denied appropriate fertility treatment can have a devastating
consequence on patients’ lives, effectively denying them the right to a
family." (Dr Sue Avery of British Fertility Society). Dr Andrew Davies,
chair of Warrington Health Consortium, said: "While we fully understand
infertility is a condition that causes great distress to couples, it does not
affect general physical health or life expectancy." Here are the main
points to consider: (click read more below)
1. Issues of what a “right to a family” actually
means. Arguably you cannot have a “right” unless someone else has an obligation
to protect and uphold that right. There is no right to free speech if you never
allow me to speak, so in the case of IVF treatments, who is obliged to provide
that treatment? If it is the taxpayer who pays for it, then should the taxpayer
be required to pay for every woman below a certain age to have this treatment?
2. Issues of which family unit qualifies. At present
every woman applying for NHS treatment is screened by the ethics committee of
the local hospital trust. Occasionally women are denied treatment as
“unsuitable”. But what of gay couples? Should they have the absolute right to a
surrogate child? Should they have exactly parallel rights to heterosexual
couples?
3. Issues of justice. It depends where you live how
many treatments, if any, you can have funded by the taxpayer. Of course, those
rich enough can have any number of treatments, with an age restriction that
depends on the country where you have the treatment. 60% of IVF treatment is
privately funded. In the UK that age limit is currently 42. Is this fair?
4. Issues of need. Infertility isn’t an illness as
the Doctor from Warrington points out above. If I spend £8,000 on an IVF
treatment, this money cannot be spent screening 55 year olds for prostate
cancer, which kills 11,000 men every year. How many lives could be saved if the
£60m spent last year on IVF treatments was directed elsewhere?
5. Issues of wastage. We know that the money spent
on IVF cycles will be wasted in 75% of cases, with the utilitarian disadvantage
that any woman experiencing IVF treatment and failing to succeed is likely to
suffer acute disappointment. In a perverse way, it may be that aggregate
happiness might be higher if no-one had treatment at all. But there again, what
of the joy of the 25% and their very wanted child? It’s always hard to balance
utility and disutility on the scales of social happiness.
But there again, if we universalise infertility, it
is highly likely that I would want treatment should I be unfortunate to have
problems conceiving. For this reason a Kantian might well argue strongly for
IVF treatment. But is the child then born a means to an end - the end being the
sense of happiness and fulfilment of the parents?
Embryo wastage occurs because many eggs are
fertilised and the healthiest are then implanted. Sometimes two or more are
implanted, and one may then later be removed. Those who argue for the sanctity
of embryonic life find this wastage of live embryos ethically unacceptable. We
are back at the base point we encountered with abortion: what exactly is the
moral status of an embryo or foetus, and in the end, is this a metaphysical
question about beliefs rather than something resolvable by science?