Workshop on Health Examination Surveys (HES)

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Workshop on Health Examination Surveys (HES)

• Legal and ethical issues
• Susanna Conti, M. Kanieff, G. Rago
• Istituto Superiore di Sanità (ISS)
• (National Public Health Institute, Italy)

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Introduction

• Two fundamental ethical concerns in performing
  HESs
• Safeguarding of Privacy
• Informed Consent
• Our recommendations focus on these two issues and
  include
• Model of an informed consent form (which contains
  more specific recommendations)

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General considerations on ethical conduct of
research

• Ethical standards are mandated by specific
  legislation.
•  
• Internationally, the Declaration of Helsinki is
  considered to be the pillar of ethical standards.
  
•  
• However, national-level legislation varies by
  individual country.
•  
• This legislation must be consulted when
  planning a HES.
•  

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Ethics committee

• The ethical conduct of research must be
  guaranteed by an ethics committee, whether local,
  regional, or national.
•  
• Approval of all aspects of the research,
  including issues discussed herein
• Safeguarding of privacy
• Informed consent
• Use of data and biological materials (also for
  future analyses)

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Safeguarding of privacy (data protection,
subjects rights) 1

• Every precaution should be taken to respect the
  privacy of the subject and the confidentiality
  of the patient's information.
• Directive 95/46/EC of the European Parliament
  and of the Council of 24 October 1995.
• In individual countries, privacy is safeguarded
  by a Data Protection Act (or Personal Data
  Act)
• Given that HESs include sensitive data regarding
  health, the protocol must comply with the
  specific countrys Data Protection Act.

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Safeguarding of privacy 2

• It must be ensured that Data Protection Act cover
  all aspects, such as
• Access to data
• Exchange of data
• Record linkage
• Anonymisation procedures.

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Informed Consent General considerations

• Concept of obtaining informed consent must be
  clear
•  
• Participants complete understanding of the HESs
  scopes, methods, and use of data.
•  
• Goes beyond signing a form
•  
• Process of communication between individual and
  healthcare professional
•  
• Both an ethical and a legal obligation and
  relevant to both the performance of the study and
  protecting privacy

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Informed Consent Form General considerations
1

• Provision of complete and clear information
  (simple terminology, nothing confusing or
  intimidating)
•  
• Choice of most suitable format, making necessary
  changes (e.g., single signature vs. signature for
  each activity)
•  
• Compliance of informed consent form with national
  legislation (e.g., access to data and storage of
  samples in biobanks).
•  
• Approval by ethics committee

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Informed Consent Form General considerations 2

• Other measures, such as
•  
• Providing descriptive material well before
  requesting consent, allowing for sufficient time
  to understand the implications of participation
•  
• Telephone help-lines
•  
• Translation into other languages.
•  

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• RECOMMENDED ITEMS TO INCLUDE ON AN INFORMED
  CONSENT FORM

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General

• Clear explanation of the HES (mention of
  pertinent public-health benefits)
• Who is conducting the HES and among whom
•  
• How the candidate was chosen (e.g., from
  electoral rolls)
•  
• Explanation of the consent form itself
•  
• Assurance that participation is voluntary, that
  the individual can withdraw at any time, and that
  data will be kept confidential.

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What participation will entail

• Scheduling of visit
• Topics covered on the questionnaire
•  
• Measurements (height, weight, blood pressure)
•  
• Collection of blood/urine/saliva samples
•  
• What tests will and will NOT be performed
• Consideration Participants should be assured
  that samples will not be used for other purposes,
  providing examples (e.g., HIV testing, drug
  testing) DNA testing should be disclosed.

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Time needed to participate

• Time required for interview, measurements, and
  sample taking (number of visits and hours)
• Consideration Important for candidates in
  deciding whether to participate excessive time
  could discourage participation.

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Health risks

•  
• Disclosure of any potential risks related to
  sample taking

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Incentive for participating

• Clear description of compensation, if provided
•  
• Consideration Payment or other forms of
  incentive may not be allowed in certain
  countries.
•  

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Providing results of the tests to participants

• Specific question on whether or not participant
  would like to receive results
•  
• Consideration Must be considered whether
  participant could be upset by any of the results.
  Must be specified if participants general
  practitioner is involved in collecting
  information and providing results.
•  

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Data access, storage, and linkage

• Specification of who will have access to the
  data, of how the data will be stored, and of any
  linkage with other data.
• Considerations
• Data protection laws may vary (e.g., it may be
  legal to provide data to general practitioners or
  insurance companies). The participant must be
  aware of this.
•  
• Laws on the duration of data storage may vary by
  country.
• The participant should be assured that his/her
  data will be anonymous.

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Data confidentiality and privacy

• Description of procedures for maintaining data
  confidentiality.
•  
• Information on what to do if participant feels
  that his/her privacy has been violated.

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Use of data after the study or if participant
withdraws

• Description of how data will be used, emphasising
  confidentiality.
•  
• Statement that participant has the right to
  request that all data be eliminated.
•  
• Consideration Whether or not data from persons
  withdrawing must be discarded may depend on
  specific legislation. 

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Use of biological materials after the study is
completed

• Description of how material will be used,
  including description of biobanks and emphasising
  that samples will NOT be tested for organisms
  such as HIV.
•  
• Consideration There may be legal limitations
  regarding the storage (including duration) and
  use of biological materials.

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Request to contact the participant for future
research

• Participant provided with the opportunity to
  refuse to be contacted for future studies.

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Contact Information

• Information on whom the participant can contact
  for questions or concerns.
• Consideration Important that participant be able
  to clarify questions or doubts, which could
  increase the participation rate.

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Principal Investigator

• Name of Principal Investigator and contact
  information

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• Thank you very much for your attention.