Health research and the protection of personal information rights in international ethics and human rights law Colin M Harper

1
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

2
International Ethics Codes

• Nuremberg Code
• Helsinki Declaration
• CIOMS Guidelines

3
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.

4
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

5
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

6
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

7
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.

8
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

9
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

10
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)

11
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.

12
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.

13
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.

14
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

15
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)

16
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.

17
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
• individuals physical and social identity
• personal autonomy.

18
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.

19
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.

20
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.

21
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.

22
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.

23
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.

24
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)

25
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.

26
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.

27
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.

28
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?

29
Conclusion

• To promote health research is to protect patient
  rights.
• Patient rights cannot be fully protected without
  health research.