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Health research and the protection of personal information rights in

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Health research and the protection of personal
information rights in international ethics and human
rights law
Colin M Harper
Promoting Health Research and Protecting Patient Rights
Irish Data Protection Commissioner
29 November 2006
International Ethics Codes
• Nuremberg Code
• Helsinki Declaration
• CIOMS Guidelines
Nuremberg Code (1947)
• Aimed at outlawing gross abuses of human
beings in medical research for �public good’.
• Emphasis upon necessity of gaining consent of
the human subject for all participation in
research.
• No explicit reference to use of personal
information constituting research, but not
excluded either.
• �Prevention of �unnecessary mental suffering’
might be interpreted broadly enough to cover
use personal of information even after
anonymisation.
World Medical Association
Declaration of Helsinki (1964/2004)
The World Medical Association has developed
the Declaration of Helsinki as a statement of
ethical principles to provide guidance to
physicians and other participants in medical
research involving human subjects.
Medical research involving human subjects
includes research on identifiable human material
or identifiable data.
Para. 1
World Medical Association
Declaration of Helsinki (1964/2004)
It is the duty of the physician in medical
research to protect the life, health, privacy,
and dignity of the human subject.
Para. 10
World Medical Association
Declaration of Helsinki (1964/2004)
The right of research subjects to safeguard their
integrity must always be respected. Every
precaution should be taken to respect the
privacy of the subject, the confidentiality of the
patient's information and to minimize the impact
of the study on the subject's physical and mental
integrity and on the personality of the subject.
Para. 21
World Medical Association
Declaration of Helsinki (1964/2004)
• Explicitly includes the research on �identifiable
data’ under its ethical protections.
• Emphasizes the principles of consent and the
primacy of the person.
• It sets no limits on the ability of a person to
restrict the use of their �identifiable data’ for
medical research.
• Makes connection between privacy,
confidentiality and �physical and mental integrity’
and �personality’ of the research subject.
CIOMS International Ethical Guidelines for
Biomedical Research Involving Human Subjects
(2002)
Patients have the right to expect that their physicians
and other health-care professionals will hold all
information about them in strict confidence and disclose
it only to those who need, or have a legal right to, the
information, such as other attending physicians, nurses,
or other health-care workers who perform tasks related
to the diagnosis and treatment of patients.
A treating physician should not disclose any identifying
information about patients to an investigator unless each
patient has given consent to such disclosure and unless
an ethical review committee has approved such
disclosure.
Guideline 18
CIOMS International Ethical Guidelines for
Biomedical Research Involving Human Subjects
(2002)
For [epidemiological] studies it is usually
impracticable to obtain the informed
consent of each identifiable patient; an
ethical review committee may waive the
requirement for informed consent when
this is consistent with the requirements of
applicable law and provided that there are
secure safeguards of confidentiality.
Guideline 18
UN Human Rights Instruments
• Universal Declaration of Human Rights (1948)
• International Covenant on Civil and Political Rights
(1966)
• UN Convention on the Rights of the Child (1989)
• UN Declaration on Bioethics and Human Rights (2005)
Article 12 of the Universal Declaration of
Human Rights (UDHR) (1948)
No one shall be subjected to arbitrary
interference with his privacy, family, home
or correspondence, nor to attacks upon his
honour and reputation. Everyone has the
right to the protection of the law against
such interference or attacks.
Article 17 of the International Covenant on Civil
and Political Rights (ICCPR) (1966)
1. No one shall be subjected to arbitrary or
unlawful interference with his privacy,
family, home or correspondence, nor to
unlawful attacks on his honour and
reputation.
2. Everyone has the right to the protection
of the law against such interference or
attacks.
Article 16 of the UN Convention on the
Rights of the Child (1989)
1. No child shall be subjected to arbitrary
or unlawful interference with his or her
privacy, family, home or correspondence,
nor to unlawful attacks on his or her
honour and reputation.
2. The child has the right to the protection
of the law against such interference or
attacks.
Article 9 UN Declaration on Bioethics
and Human Rights (2005)
The privacy of the persons concerned and the
confidentiality of their personal information
should be respected. To the greatest extent
possible, such information should not be used or
disclosed for purposes other than those for
which it was collected or consented to,
consistent with international law, in particular
international human rights law.
Article 9
Regional European Standards
• European Convention on Human Rights (1950, as amended)
• European Convention on Human Rights and Biomedicine (1999)
• Additional Protocol to European Convention on Human Rights and
Biomedicine on Biomedical Research (2005, not yet ratified)
• Directive 95/46/EC of the European Parliament and of the Council of
24 October 1995 on the protection of individuals with regard to the
processing of personal data and on the free movement of such data
(Data Protection Directive)
• European Standards on Confidentiality and Privacy in Healthcare
(2006)
Council of Europe Convention on
Human Rights (ECHR)
Article 8 of the Convention reads as follows:
1. Everyone has the right to respect for his private and
family life, his home and his correspondence.
2. There shall be no interference by a public authority with
the exercise of this right except such as is in accordance
with the law and is necessary in a democratic society in
the interests of national security, public safety or the
economic well-being of the country, for the prevention of
disorder or crime, for the protection of health or morals,
or for the protection of the rights and freedoms of
others”.
Definition of �Private life’ in European
Convention on Human Rights (ECHR)
• �gender identification, name and sexual orientation and
sexual life’;
• �right to identity and personal development’;
• �right to establish and develop personal relationships
with other human beings and the outside world’;
• �physical and psychological integrity’;
• �the development without outside interference of the
personality’;
• �moral integrity’;
• �preservation of mental stability’;
• �individual’s physical and social identity’;
• �personal autonomy’.
EU Directive on the protection of individuals with regard to
the processing of personal data and on the free movement
of such data
• A Directive is a piece of European Union
legislation which is addressed to Member
States.
• Once such legislation is passed at the European
level, Member States must ensure that it is
effectively applied in their domestic legal system.
• The Directive prescribes an end result. The form
and methods of the application is a matter for
each Member State to decide for itself.
Aim of the Data Protection
Directive
Directive 95/46/EC on data protection aims to
enable the free flow of personal data from one
Member State to another for the purposes of the
internal market, whilst at the same time ensuring
that fundamental rights and freedoms of
individuals (in particular, privacy) are
safeguarded by ensuring a high level of
equivalent protection of these rights and
freedoms in all the Member States.
Article 8 of Directive 95/46/EC
• Deals with the processing of special categories of data,
including data concerning health.
• Member States must prohibit the processing of those
special categories of data.
• Except in certain situations, including those (a) �where
the data subject has given his or her explicit consent’; (b)
�where the processing is necessary to protect the vital
interests of the data subject or of another person where
the data subject is physically or legally incapable of
giving his consent’ (Art. 8/2).
• Directive 95/46/EC is thus broadly in keeping with other
international and European norms in this area.
Data Protection Directive Article 8 (3)
Paragraph 1 shall not apply:
• where processing of the data is required for the
purposes of preventive medicine, medical diagnosis, the
provision of care or treatment or the management of
healthcare services,
AND
• where those data are processed by a health professional
subject under national law or rules established by
national competent bodies to the obligations of
professional secrecy or by another person also subject
to an equivalent obligation of secrecy.
European Convention on Human Rights and
Biomedicine (1997/99)
Article 10 �Private life and right to information’:
1. Everyone has the right to respect for private life
in relation to information about his or her health.
2. Everyone is entitled to know any information
collected about his or her health. However, the
wishes of individuals not to be so informed shall
be observed.
3. In exceptional cases, restrictions may be placed
by law on the exercise of the rights contained in
paragraph 2 in the interests of the patient.
European Convention on Human Rights and
Biomedicine
Article 26 Limitations on the right to privacy
1. No restrictions shall be placed on the exercise
of the rights and protective provisions contained
in this Convention other than such as are
prescribed by law and are necessary in a
democratic society in the interest of public
safety, for the prevention of crime, for the
protection of public health or for the protection of
the rights and freedoms of others.
Comparison of the limitations on right to
privacy in ECHR and ECHRB
•
•
•
•
•
•
in the interest of national security
in the interest of public safety
the economic well-being of the country
the prevention of disorder or crime
the protection of [public] health or morals
the protection of the rights and freedoms of
others
(Italicised items not in ECHRB)
Additional Protocol to European Convention on
Human Rights and Biomedicine on Biomedical
Research (2005/awaiting ratification)
Article 25 – Confidentiality
Any information of a personal nature
collected during biomedical research shall
be considered as confidential and treated
according to the rules relating to the
protection of private life.
Key difficulty for health sector
Understanding the complex set of
interlocking norms which protect patient
information:
• ethics;
• data protection law;
• human rights law; and
• law of confidentiality.
Difficulties in protecting patient
rights?
• Ethics places greater importance upon gaining consent
for research use of information than human rights law.
• Human rights law seeks a balance between privacy
rights of the research subject, specified public interests
and the rights and freedoms of others.
• Status of consent for information use remains a disputed
issue between ethics and human rights law.
• Increasing convergence apparent international
instruments, but unclear how this will ultimately impact
on practice.
Difficulties in promoting health
research?
Health research is perhaps itself an ethical
and legal obligation:
An indispensable condition for fulfilment of
the right to health?
An ethical obligation on researchers and
healthcare professionals to discover new
and improve existing treatments?
Something all of us are ethically obliged to
participate in?
Conclusion
To promote health research is to
protect patient rights.
Patient rights cannot be fully
protected without health research.
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