workshop on health examination surveys (hes) legal and ethical issues susanna conti, m. kanieff, g....
TRANSCRIPT
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)
HES Workshop, Luxembourg, 9-11 April 2008
Introduction
Two fundamental ethical concerns in performing HESs:
Safeguarding of PrivacyInformed 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
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
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 privacyInformed consentUse of data and biological materials (also for future analyses)
HES Workshop,Luxembourg, 9-11 April 2008
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]
It must be ensured that Data Protection Act cover all aspects, such as:
Access to dataExchange of dataRecord linkageAnonymisation procedures.
HES Workshop,Luxembourg, 9-11 April 2008
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]
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]
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.
RECOMMENDED ITEMS TO INCLUDE ON AN INFORMED
CONSENT FORM
HES Workshop,Luxembourg, 9-11 April 2008
HES Workshop,Luxembourg, 9-11 April 2008
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.
HES Workshop,Luxembourg, 9-11 April 2008
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 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
Disclosure of any potential risks related to sample taking
HES Workshop,Luxembourg, 9-11 April 2008
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
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
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
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
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
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
Participant provided with the opportunity to refuse to be contacted for future studies.
HES Workshop,Luxembourg, 9-11 April 2008
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
Name of Principal Investigator and contact information
HES Workshop,Luxembourg, 9-11 April 2008
Thank you very much for your attention.