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Informed Consent materials
The Informed Consent file should be considered a living document that will and is intended to evolve over time. The dynamic version numbering and process for presenting, enabling assent, creating and preserving evidence of agreement to the terms is a key feature to allow participants to remain informed and actively involved in the process of consent. As more details emerge and future versions of the Informed Consent file and method are are expected to adapt over time.
Below are relevant resources related to Informed Consent in the context of research studies conducted in Denmark.
APPROVING AUTHORITY: Danish Data Protection Agency (DPA): http://www.datatilsynet.dk/english/
LEGISLATION: The Act on Processing of Personal Data (Act No. 429) (2007): http://www.datatilsynet.dk/english/the-act-on-p
GUIDELINES: DCE: Protection of Sensitive Personal Information http://www.etiskraad.dk/sw314.asp Other guidelines can be accessed at: http://www.privireal.group.shef.ac.uk/content/dp/denmark.php
European Commission - Research Directorate-General
Directorate L - Science, Economy and Society
Unit L3 - Governance and Ethics
ftp://ftp.cordis.europa.eu/pub/fp7/docs/informed-consent_en.pdf
The Informed consent form must contain adequate information to meet the necessary requirements. In most cases, an information sheet should be attached.
Consent should be a continuing process, especially in long-term trials or projects, researchers should foster a continuous dialogue with participants and inform them of anything new related to the trial.
[Include the following]
A statement that the study involves research subjects and an explanation of the purposes of the research.
The expected duration of the subject's participation.
A description of the procedures to be followed/ of the medicine that is going to be tested, and an identification of any procedures which are experimental.
A statement that participation is voluntary.
Information about who is organising and funding the research.
A description of any reasonably foreseeable risk, discomfort or disadvantages.
A description of any benefits to the subject or to others which may reasonably be expected from the research avoiding inappropriate expectations.
A disclosure of appropriate alternative procedures for treatment/diagnosis if any, that might be advantageous to the subject
A statement describing the procedures adopted for ensuring data protection/confidentiality/privacy including duration of storage of personal data.
A description of how incidental findings are handled.
A description of any planned genetic tests.
For research involving more than minimal risk, an explanation as to whether there are any treatments or compensation if injury occurs and, if so, what they consist of, or where further information may be obtained. Insurance coverage should be mentioned.
A reference to whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject.
A statement offering the subject the opportunity to ask questions and to withdraw at any time from the research without consequences.
An explanation of what will happen with the data or samples at the end of the
research period and if the data/ samples are retained or sent/sold to a third party for further research.
Information about what will happen to the results of the research
EuroPriSe Privacy Trustmark Criteria Under EU Privacy Directive
www.european-privacy-seal.eu
2.1.1.1 Processing [Personal Data] on the Basis of Consent
(Article 7(a) of Directive 95/46/EC)
Relevant Questions:
• Does the consent (as expressed by the data subject) meet the legal requirements on consent?
o Is the consent unambiguous and sufficiently specific, by setting out the purpose of the various phases of the processing?
o Is it obtained under some form of duress / an offer of advantage / threat of disadvantage? Does any of this invalidate the consent?