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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). Introduction. Two fundamental ethical concerns in performing HESs: Safeguarding of Privacy

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workshop on health examination surveys hes

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)

introduction
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)

HES Workshop, Luxembourg,

9-11 April 2008

general considerations on ethical conduct of research
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.

HES Workshop,Luxembourg,

9-11 April 2008

ethics committee
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)

HES Workshop, Luxembourg,

9-11 April 2008

safeguarding of privacy data protection subjects rights 1
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 country’s Data Protection Act.

HES Workshop,Luxembourg,

9-11 April 2008

safeguarding of privacy 2
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.

HES Workshop,Luxembourg,

9-11 April 2008

informed consent general considerations
Informed Consent: General considerations

Concept of obtaining informed consent must be clear:

Participant’s complete understanding of the HES’s 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

HES Workshop,Luxembourg,

9-11 April 2008

informed consent form general considerations 1
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

HES Workshop,Luxembourg,

9-11 April 2008

informed consent form general considerations 2
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.

HES Workshop,Luxembourg,

9-11 April 2008

slide10

RECOMMENDED ITEMS TO INCLUDE ON AN INFORMED CONSENT FORM

HES Workshop,Luxembourg,

9-11 April 2008

general
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 withdrawat any time, and that data will be kept confidential.

HES Workshop,Luxembourg,

9-11 April 2008

what participation will entail
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.

HES Workshop,Luxembourg,

9-11 April 2008

time needed to participate
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.

HES Workshop,Luxembourg,

9-11 April 2008

health risks
Health risks

Disclosure of any potential risks related to sample taking

HES Workshop,Luxembourg,

9-11 April 2008

incentive for participating
Incentive for participating

Clear description of compensation, if provided

Consideration: Payment or other forms of incentive may not be allowed in certain countries.

HES Workshop,Luxembourg,

9-11 April 2008

providing results of the tests to participants
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 participant’s general practitioner is involved in collecting information and providing results.

HES Workshop,Luxembourg,

9-11 April 2008

data access storage and linkage
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.

HES Workshop,Luxembourg,

9-11 April 2008

data confidentiality and privacy
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.

HES Workshop,Luxembourg,

9-11 April 2008

use of data after the study or if participant withdraws
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.

HES Workshop,Luxembourg,

9-11 April 2008

use of biological materials after the study is completed
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.

HES Workshop,Luxembourg,

9-11 April 2008

request to contact the participant for future research
Request to contact the participant for future research

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

HES Workshop,Luxembourg,

9-11 April 2008

contact information
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.

HES Workshop,Luxembourg,

9-11 April 2008

principal investigator
Principal Investigator

Name of Principal Investigator and contact information

HES Workshop,Luxembourg,

9-11 April 2008

slide24
Thank you very much for your attention.

HES Workshop,Luxembourg,

9-11 April 2008