Patient’s Rights

Universal Declaration of Human Rights

Article 25
1 Everyone has the right to a standard of living adequate for the health and well-being of himself and of
his family, including food, clothing, housing and medical care and necessary social services, and the right
to security in the event of unemployment, sickness, disability, widowhood, old age or other lack of
livelihood in circumstances beyond his control.

US Patients’ Bill of Rights

1. Information Disclosure.
2. Choice of Providers and Plans.
3. Access to Emergency Services.
4. Participation in Treatment Decisions.
5. Respect and Nondiscrimination.
6. The Right to Privacy and confidentiality of Health Information.
7. Complaints and Appeals.

THE PATIENT'S CHARTER (Malaysian Medical Association)

I. RIGHT TO HEALTH CARE AND HUMANE TREATMENT

 Every individual shall have access to competent health care and treatment regardless of age, sex,
ethnic origin, religion, political affiliation, economic status or social class.
 Health care services shall be available on the basis of clinical need regardless of the ability to pay
and it shall be the responsibility of the Government to ensure that every person has access to
essential health services.
 Every patient shall be treated with care, consideration, respect and dignity without discrimination
of any kind.
 All drugs dispensed shall be of acceptable standards in terms of quality, efficacy and safety as
determined by the Drug Control Authority of Malaysia.
 Every individual shall have the right to prompt emergency first aid treatment from the nearest
government or private medical and health facility.
 Patients shall be interviewed and examined in surroundings designed to ensure reasonable privacy
and shall have the right to be chaperoned during any physical examination or treatment, except in
cases of emergency where such conditions may not be possible.
  A child admitted to hospital shall, whenever possible, have the right to the company of a parent or
guardian.

II. RIGHT TO CHOICE OF CARE

 A patient has the right to a second opinion at any time.

 A patient shall have the right to know the investigations conducted, the results of these
investigations and a copy of the medical reports and have them explained. The patient shall also
have the right to authorise in writing another health professional to obtain a copy of the same and
inform him or her of what they contain.
 A patient shall, whenever possible, have the right to be treated at a hospital of choice and to be
referred to a consultant of choice.
 A patient who has received adequate information about his or her condition during consultation
shall have the right to accept or to refuse treatment.
 If a patient's health professional refuses to allow another health professional to be called in, or
breaches any other provisions of this charter, the patient shall have the right to discharge that
health professional and seek the services of another.

III. RIGHT TO ACCEPTABLE SAFETY

 Before any treatment or investigation, a patient shall have the right to a clear, concise explanation
in lay terms of the proposed procedure and of any available alternative procedure. Where
applicable the explanation shall incorporate information on significant risks, side-effects, or after-
effects, problems relating to recuperation, likelihood of success, risks thereof, and whether the
proposed procedure is to be administered by or in the presence of students. A patient may refuse
any treatment or investigation.

IV. RIGHT TO ADEQUATE INFORMATION AND CONSENT

 A Patient shall have the right to know the identity and professional status of the individuals
providing service to the patient and to know which health professional is primarily responsible for
the patient's care.
 A patient shall have the right to information regarding all aspects of medication, including :
 The right to adequate and understandable information on prescribed and purchased
medicines.
  The right to the most effective and safe medicines. Safety must be ensured by the
manufacturers and by legislative control.
 The right to convenient access to medicines.
 The right to choose among competitive products.
 All medicines shall be labelled, and shall include the international non-proprietary name (INN) of
the medicine, the dosage and how often the medicine has to be taken. In addition, the patient shall
be informed about medication, including the following :-
 The purpose of the medicine
 The possible side effects
 The avoidance of any food, alcoholic beverages or other drugs
 The duration necessary for any medication prescribed
 The measures to be taken if a dose is forgotten or if an overdose is taken.
 A patient shall have the right to an itemized account after any treatment or consultation and to have
this explained.
 If a patient is in hospital or any health care facility, the patient shall,unless unconscious be
consulted about any decision to discharge or transfer the patient to another facility.
 Where it is appropriate to a patient's condition or treatment, the patient shall be given advice about
self-care, drugs administration, special precautions, which may be necessary or desirable, and the
existance of special associations, facilities, aids or appliances which may be of assistance.
 A patient's consent shall be required before any procedure is carried out and in the case of a minor
the consent shall first be obtained from the parent or guardian. If a patient is unconscious and delay
would be dangerous, a doctor is entitled to carry out any necessary treatment or operation.
 A patient's consent shall be required for the inclusion of a patient in any research. The patient shall
be adequately informed of the aims, methods, anticipated benefits and potential hazards of the
study and the discomfort it may entail. The patient shall be informed that he or she is at liberty to
abstain from participation in the study and that he or she is free to withdraw his or her consent to
participation at any time. To ensure that the informed consent is not obtained under duress or from
a patient in a dependent relationship to the health professional, the informed consent shall be
obtained by a health professional who is not engaged in the investigation and who is completely
independent of the official relationship between the patient and the health professional. In the case
of a child the informed consent shall be obtained from the parent or guardian.
 A patient shall have the right to have the details of the patient's condition, treatment, prognosis and
all communication and other records relating to the patient's care to be treated as confidential,
unless :
  authorised in writing by the patient
 it is undesirable on medical grounds to seek a patient's consent but it is in the patient's own
interest that confidentiality should be broken.
 the information is required by due legal process.

V. RIGHT TO REDRESS OF GRIEVANCES

 A patient shall have access to appropriate grievance redressal mechanisms.

 A patient shall have the right to seek legal advice as regards any alleged malpractice by the
hospital, the hospital staff or by a doctor or other health professional.
 A patient shall have the right to recover damages for injury or illness incurred or aggravated as a
result of the failure of the health professional to exercise the duty and standard of care required of
him or her while treating the patient.

VI. RIGHT TO PARTICIPATION AND REPRESENTATION

 A patient shall have the right to participate in decision-making affecting the patient's health :
 with the health professionals and personnel involved in direct healthcare:
 through consumer and community representation in planning and evaluating the system of
health services, the types and qualities of service and the conditions under which health
services are or were delivered.

VII. RIGHT TO HEALTH EDUCATION

 Every individual shall have the right to seek and obtain advice with regards to promotive,
preventive and curative medicine, and rehabilitation to maintain or regain good health and a
healthy lifestyle.

VIII. RIGHT TO A HEALTHY ENVIRONMENT

 Every individual shall have the right to an environment that is conducive to good health. This
includes and extends to a healthy and safe work environment, a healthy and safe home
environment, and a healthy and safe environment at the place where he gets his medical care and
treatment.
 Informed Consent
What is informed consent?
"Consent given by a competent individual who:
- Has received the necessary information (verbally and in writing).
- Has adequately understood the information.
- After considering the information, has arrived at a voluntary decision without having been subjected to
undue influence or inducement, or intimidation."
Creation of Informed Consent Documents
• Use local language

• Write to appropriate reading level

• Illustrate with appropriate concepts, drawings, images or videos

• In cases of emergency, interventions to save the life of the patient can be done without the
patient’s consent.

Essential Elements of Informed Consent

Procedure Description
• The procedure to be done

• Objectives of the procedure

• Expected responsibilities

• Steps involved
Alternatives
• Alternative procedures

• Advantages and disadvantages of each

• Availability
Benefits
• Reasonably expected

• Not exaggerated

• Duration
Risks
• Anticipated

• Physical, social, psychological

 • Likelihood, severity, duration
Confidentiality
• Degree of confidentiality

• Indicate persons or organizations which will have access to the information

• Anticipated future use of data or samples

Voluntary approval or refusal
• Absolutely voluntary

• Has the right to refuse at any time

• No penalty for refusal

Documentation
• Part of the informed consent process

• Signatures: Person, Guardian, Legal representative, Witness

• Ethics committee review and approval

Contact Persons
• Member of the medical or surgical team

• Special groups

Patient Rights in Medical Research

NUREMBERG CODE (1947)
1. Voluntary consent of the human subject
2. Fruitful results for the good of society
3. Based on the results of animal experimentation
4. Avoid all unnecessary physical and mental suffering and injury
5. No experiment should be conducted where there is an a priori reason to believe that death or disabling
injury will occur.
6. The degree of risk should never exceed that determined by the humanitarian importance of the problem

7. Proper preparations
8. Scientifically qualified persons
9. The human subject should be at liberty to bring the experiment to an end
10. The researcher can terminate the experiment at any stage
Ethical principles that guide research on human subjects:
Belmont Report (The National Commission for the Protection of Human Subjects of Biomedical and
Behavioral Research 1979) and WHO Guidelines 1991
1. Autonomy (Respect for persons)
Each individual:
* Is unique and free.
* Has the right and capacity to decide.
* Has value and dignity.
* Has the right to informed consent.

2. Non Maleficence/Beneficence
Research must:
* Protect physical, mental and social well-being.
* Reduce risks to a minimum.
* Retain the community perspective.
3. Justice
Research must:
* Conduct equitable recruitment of research participants.
* Ensure a fair distribution of risks and benefits.
* Provide special protection for vulnerable groups.

DECLARATION OF HELSINKI (1964)

1. Research must conform to generally accepted scientific principles and based on adequately performed
laboratory and animal experimentation
2. The design and performance of research should be under supervision of appointed committee
independent of the investigator and the sponsor.
3. Research should be conducted only by scientifically qualified persons.
4. The importance of the objective is in proportion to the inherent risk to the subject.
5. Research should be preceded by careful assessment of predictable risks in comparison with foreseeable
benefits
6. The research should respect the privacy of the subject and to minimize the impact of the study on the
subject’s physical and mental integrity
7. Physicians should cease any investigation if the hazards are found to outweigh the potential benefits.
8. The physician is obliged to preserve the accuracy of the results.
9. The subject must be adequately informed .The physician should then obtain the subject’s freely-given
informed consent, preferably in writing.
10. The informed consent should be obtained by a physician who is not engaged in the investigation.
11. In case of legal incompetence, informed consent should be obtained from the legal guardian.

Human Genome and Human Rights

What are the purposes of human genetic research?

Human genetic data and human proteomic data may be collected, processed, used and stored only for the
purposes of:
1. Diagnosis and health care, including screening and predictive testing
2. Medical and other scientific research, including epidemiological, especially population-based genetic
studies, as well as anthropological or archaeological studies
3. Forensic medicine and civil, criminal and other legal proceedings

Why human genetic data have a special status?

1. They can be predictive of genetic predispositions concerning individuals
2. They may have a significant impact on the family, including offspring, extending over generations, and
in some instances on the whole group to which the person concerned belongs
3. They may contain information the significance of which is not necessarily known at the time of the
collection of the biological samples
4. They may have cultural significance for persons or groups.

Universal Declaration on the Human Genome and Human Rights

(General Conference of UNESCO 1997, endorsed by the General Assembly 1998)
Purpose: to protect the human genome from improper manipulations that may endanger the identity and
physical integrity of future generations.
* It recognizes the human genome as “the heritage of humanity”
* It declares practices“contrary to human dignity” such as human cloning and germ-line interventions
* It prevents genetic discrimination, and any use of genetic information that would be contrary to human
dignity and human rights. Genetic discrimination occurs when people are treated differently by their
employer or insurance company because they have a gene mutation or differences in their DNA that
increase their risk of getting a certain inherited disease
* Informed consent is required for all genetic research
* Confidentiality in dealing with research and results.
* Just reparation for any damage sustained as a direct and determining result of an intervention affecting
his or her genome.
* Solidarity and international co-operation

International Declaration on Human Genetic Data 2003

This document sets out a number of rules for the collection, use and storage of human genetic data.
* Informed consent
* The right to decide whether or not to be informed about research results
* Change of purpose (epidemiological studies, or public health purposes population-based genetic studies)
* Privacy and confidentiality
* Anonymization of personal genetic information
* Non-discrimination and non-stigmatization
* Treatment of biological samples for forensic medicine or in civil, criminal and other legal proceedings
according to law
* Apply mutatis mutandis to stored biological samples used to produce human genetic data for forensic
medicine
* Genetic counselling should be made available
* International solidarity in genetic research, and benefit sharing

Patient’s Responsibilities

1. The patient shall ensure that he or she knows and understands what a patient's rights are and shall
exercise those rights responsibly and reasonably.
2. The patient shall keep appointments and shall inform the health professional if unable to do so.
3. The patient shall provide accurate and complete information which the health professional requires
about his or her health and ability to pay for health services.
4. The patient shall inform the health professional if he or she is currently consulting with or under
the care of another health professional or provider of traditional health care in connection with the
same complaint or any other complaint.
5. The patient shall ensure that he or she understands the purpose and cost of any proposed
investigation or treatment before deciding to accept it. The patient shall insist upon explanations
until adequately informed and consult with all relevant persons before reaching the decision.
6. The patient shall accept all the consequences of the patient's own informed decisions.
7. The patient shall establish a stable relationship with and follow the treatment determined by the
health professional primarily responsible for the patient's care.
8. The patient shall so conduct himself or herself so as not to interfere with the well being or rights of
other patients or providers of health care.
9. Every individual has a responsibility to maintain his or her own health and that of society by
refraining from indulging in :-
o unhealthy food consumption;
o addiction forming substances such as dadah, tobacco and alcohol;
o lifestyles that have an adverse impact on health such as sexual promiscuity, reckless activities,
and physical inactivity; and,
o contamination of the environment.
10. Every individual has a responsibility to accept all preventive measures sanctioned by law.
11. A patient is encouraged to have a family doctor, dentist and pharmacist to ensure that there is
continuing health care for the patient and the patient's family.
12. Every individual has the responsibility to ensure that resources are spent wisely on on social and
health services.