PATIENT AUTONOMY

COMPETENT AND INCOMPETENT PATIENT

AND RESEARCH PARTICIPANT TO CONSENT

Soenarto Sastrowijoto, 2009

Center For Bioethics and Medical Humanities
(Pusat Kajian Bioetika dan Humaniora Kesehatan)
Fakultas Kedokteran Universitas Gadjah Mada,
Yogyakarta
 Scandal in Research participant
recruitment
 Nuremberg Turbinal (1947)
Universal Declaration of Human Right (1948) – UN
Declaration of Helsinki I (1964) WMA
Declaration of Helsinki II (Revision 1975, Tokyo)
 The Belmont Report (1979)
Syphilis study, Africa-American (Tuskegee) US
Hepatitis in retarded children (Willowbrook, 1982) US
 WHO and CIOMs (The Council for International
Organization of Medical Sciences, 1993)
International Guiding Principle for Biomedical
Research Involving Human and Animal.
 Ethics
Can be described as a sub-branch of
applied philosophy that seek “what are the
right and the wrong, the good and the bad
set of behaviors in a given circumstance

Bioethics
on the other hand, is a quasi-social
science that offers solutions to the moral
conflicts that arise in medical and
biological science practice
(Sohim Aksoy, 2002)2
 The Belmont Report
The basic moral/ethical principles3,4

 Respect for others (person)

autonomy, dignity, integrity, privacy,, self-
determination.

 Beneficence
 Maximizing - benefits, minimizing-risk
 do no harm (non – maleficence)

 Justice
 treat morally Wright and proper
 Equitable distribution

(Beachamp et al, 2001; Belmont Report, 1979)

 Declaration of Helsinki II
(1975), art 7

State that, no one shall be subjected to

tortue or cruel, in human or degrading
treatment or punishment in particular,
no one shall be subjected without his or
her free consent to medical experiment
 Quality and Standards in
Research 7
1. Scientific validity
2. Ethical Clearance /approval
3. Human or animal research participant
recruitment
4. Informed consent
5. Research protocol, procedure, instrument,
researcher
6. DSMB (Data and Safety Monitoring Board)
7. Quality assurance, to stake holders
8. Publication , authorships
9. Intellectual property right and marketing.
 The Implementation of The Basic
Moral /Ethical Principle

1. Research activity – Research

participant
2. Medical /Health Service – Patients
3. Education activity – Students

All activities should be with Informed

consent
 Informed Consent, some aspects 6

 Philosophical aspect, based on

Hippocrates oath, to help or at least to
do no harm
 Social aspect ,
Respect for others (person), his self-
determination
 Religion aspect
Human being create by our God.
No intervention without his/her consent
 Law aspect

Fail in having consent (in medical service /

research), the intervention is violence

 In having informed consent

the process: 1. Clear information
2. Complete comprehension
3. Voluntariness
 Basic Ethical Principle in
Medical Service 7
 Fundamental Principle :
A clinical intervention is justified if and only if
the expected benefits outweigh the expected
burdens from the perspective of the patients.
 Decision Making
a. Paternalism :
doctor decides everything about what is the
best for the patient.
b. Complete patient autonomy:
doctor explains, but patient (or surrogate)
decides everything.
10
c. Shared decision making:
where the premise is that a good
clinical decision involves two
components
 Determination of goals / values : the
patients (or surrogate) is generally the
appropriate expert and authority on
goals/values.
 Determination of the intervention (if any)
can best achieve these, The doctor is
generally the appropriate expert on these
medical intervention.

11
 Medico-legal perspective

a. A competent patient has the right to

refuse any treatment , even one
necessary to save his /her life.
b. If a patient is not competent, is vary
depend on national or local laws.
 Competent adults have a legal right to
accept or refuse treatment.
 Incompetent adults have the same right
to accept or refuse treatment, which can
exercised by an appropriate surrogate
using “substituted judgment” standard
 Also keep in mind

1. Goods decisions require good date

2. Seek out win-win solution – and be
creative
3. Think about who should decide, as
well as what decision the best.
IN MEDICAL – HEALTH RESEARCH
1. Epidemiology
2. Clinical
3. Basic /Biomedical Molecular
 The Basic principle in having informed
consent is the same
1. Competent research participant
2. In competent research participant
- Children, mentally defect
- Captive group : soldier, prisoner, student
 In collaborative study
Issues should be considered
 MTA (Material Transfer Agreement)
 Publication, authorship
 Intellectual property right and marketing of
product
Some questions related to consent
(UNESCO, 2009)

1. Why is consent a fundamental principle in bioethics?

- Autonomy - Human dignity
- Human right - core value s of democratic
societies.
2. When and how should we seek consent?
- Should be obtained prior to medical or scientific
intervention.
- Dialogue between partners.
3. What are the main element of consent?
- Adequate information
- Adequate understanding.
- Freedom to consent or to refuse.
4. What are the most important aspects of
information provided ?
- Comprehensive, relevant, all to make decision.
- Possible risk and benefits.
- Alternative medical interventions are available.
- Right to freely withdraw at any time, without
consequence.
5. What are the different forms of expressing
consent?
- Writing . - incompetent.
- Oral. - Special bodies supervisor.

6. Are consent procedures different in various

circumstances of application?
- Practice : preventive , diagnostic, therapeutic of
medical intervention.
- Scientific research.
- Competent and incompetence patient or research
participant
- Different social economy & cultural context.
7. What are the most important features of consent
in clinical practice?
- Requisite sine qua non.
- Form - quality of relationship
- invasive character of procedure.
- potential benefit and possible side-
effect
- Considention of tocit agreement.
8. What are the most important feature of the
consent in biomedical/ clinical research?
- Healthy volunteers, direct or indirect benefits.
- Written consent; ethical approval of consent
forms and information sheets.
- Civil status and capacity to consent.
9. Are there exception to consent procedures in
epidemiological research?
- Use already collected data/ material, review board/
professional societies – should establish specific
regulations waive the individual consent (?)
- Protect their right.
- Innless the data / material is irretrievably unlinked
to the participant.
10. What are the examples of public health interventions
that are carried on without consent of individual?
- PH intervention aim at preventing a problem of
important for the whole of population.
- Protection of the rights and freedom of others – serious
PH consequences of individual.
- Carantine – spread of plague.
immunization – categories of population
hospitalization – mental illness.
11. What are the most importance feature of consent in
emergency situation?
- Save the patient life - appropriate representative.
- affairs the consent before
going further treatment.
- Research project – differently is different countries.
12. What are the most important feature of consent in
organ, tissue, cell donation?
- Post-mortem donation - every deceased person is
a potential donor.
- had expressly stated the
opposite.
- Living donation - autonomy can be compromised
- quarantine - adverse effect &
long term
consequences.
- emotional pressure
– no compromised.
- without inducement
with financial or
other personal gain.
13. What procedures should be followed when dealing
with person unable to consent?
- Person who do not have the capacity to consent
to research and medical practice:
- Mentally ill.
- Children.
- Confuses elderly.
- In conscious people.
- if there is evidence, to decide for them self.
- According to their - age, nativity, degree capacity.
- who be a legitimate
representative; legal, social
and cultural feature.
14. Is scientific research on persons unable to consent
justifiable ?
- Will bring them direct benefit.
- No comparable study.
- Minimal risk and minimal burden.
- Contribute to the health benefit of other person.
15. How does the practice of consent depend on the
economic context?
- Disadvantaged economic context – high demand
for treatment (lack of health care professional,
infrastructure, drugs, training, ect)
- Such difficulties should not be used as an
agreement.
16. How do social and cultural context in influence
consent?
- Keeping in mind - interest of the person
- respect for the will
- promote education, autonomy
and individual responsibility.
- Communal decision making may prevail-conflict
of communal and individual decision. Values
should not infringe upon fundamental freedom.
- Constrained individuals should be taken into
particular consideration, could be subject to
pressure of circumstances to give “free” consent –
particularly in research.
“ The voluntary consent of the human
subject is absolutely essential ”

(International legal consent)

References
1. Emanuel, E.J. et al, 2004 Ethical and Regulatory Aspects of Clinical research :
Reading and Commentary- The Jonh Hopskins Unive. Press, Baltimore and
London.
2. Jenie, UA 2006 Bioetika : Pengertian, Prinsip dan KBN. Kajian Politik Lokal dan
Sosial Humaniora. Renai Tahun VI, No. 1, hal 7 - 13
3. Beanchamp, T.T. and Childress, J.P., 1994. Principle of Biomedical Ethics. Fourth
Ed. Oxford University Press, N.Y.
4. Kushe H and Singer P, 2004 A Companion to Bioethics – Reprinted Block Well
Publishing Ltd. Australia.
5. Sastrowijoto S, 2008 Etika Penelitian dan Publikasi Kedokteran – Kesehatan dan
Modul Pelatihan WHO: Perkembangan Etika Penelitian Kesehatan, tingkat
institusi, nasional dan global Ed. I. FK UGM Yogyakarta Hal 3 – 9
6. Ismail D, 2008 Etika Penelitian dan Publikasi Kedokteran – Kesehatan dan Modul
Pelatihan WHO : Informed Consent di bidang penelitian Ed. I. FK UGM
yogyakarta, Hal 35 -39
7. Farrow, L. Z and M and Baden L., 1999 Clinical Ethics for the Medical House
officer : general Principles and Cases Third Printing, January Roschester, NY
8. UNESCO, 2009 Report of the International Bioethics (IBC) on Consent.
SHS/EST/C/B 08-09/i