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Thread: Pharmacogenetic consent and provision of results

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  1. #1

    Pharmacogenetic consent and provision of results

    We are aware of differences between countries with regards to a clinical trial subjects rights to obtain information from pharmacogenetic testing results in clinical trials (i.e., that it is permitted, if specifically requested by the subject, in some countries for the sponsor to provide the results of the analysis, but not in others).

    I am looking for a list or guidance as to where it is permitted, and what information is required to be provided to a subject in the patient information sheet and consent form with regards to their rights to obtain this information.

    If anyone has any specific guidance for the UK, this would be greatly appreciated.

    Many thanks in advance for any advice on this matter.

  2. #2
    I know you asked for a list but I have not come across one- I generally need to look it up on a country by country basis when auditing. I find the OHRP listing from the US Department of Health and Human Services website to be the most comprehensive listing of regulations with direct hyperlinks for about 200 countries. Refer to the "international Compilation of Human Subject Protections" at this link which is updated annually.
    http://www.hhs.gov/ohrp/international/

    Also here is an extract of the requirements for for Hungary in english MOH Decree 35-2005 ( I do not know how to insert a document). Hope this helps

    A. ? (1) If a sample is collected during the clinical trial for human genetic testing, the subject must be informed separately about the procedure. Information must also cover the subject’s right to refuse to give a sample, in which case the genetic data of the subject may not be used even anonymously. Refusal to give a sample will not constitute an obstacle to the subject’s participation in the rest of the clinical trial. Information on and consent to the sampling will be included in a separate document.
    (2) Before collection of a sample for human genetic testing, as part of a genetic consultation, the subject must be advised of
    a) the purpose and quantitative and qualitative details of the sampling,
    b) the risks and benefits of the testing and lack of testing,
    c) the potential consequences of the findings for the subject and his or her family,
    d) the manner and duration of the storage of the genetic sample and data and the various options regarding the identification of the genetic samples and data stored in different forms,
    e) if not specified otherwise in a statement by the subject, the potential transfer of the genetic sample into an archived collection,
    f) the subject’s right to learn about the genetic data generated during the human genetics testing,
    g) the option to decide about depositing the sample in a biobank and about the manner of deposition, including
    (ga) storage with personal identification information,
    (gb) storage with data encryption,
    (gc) storage with pseudonymised data, meaning the code that replaces personal identification information will be known only to the subject,
    (gd) storage with anonymised data, meaning all personal identification information of the subject has been made unsuitable for identification.
    (3) The subject must be informed of the option to include the sample deposited in the biobank for further investigations. In this case, the subject must make a statement regarding whether he or she consents to the use of the sample for diagnostic purposes, research purposes or both, that is for diagnostic and research purposes, depending on the primary purpose of the sampling.
    6/B. ? (1) If a sample is collected during the trial for human genetic testing, a separate informed consent will be prepared.
    (2) The subject’s informed consent will include the following as a minimum:
    a) identifiers of the clinical trial;
    b) name of the health care provider where the clinical trial is to be conducted;
    c) name, position and funcion of the principal investigator and/or the person providing the information;
    d) identifiers of the subject (name, date and place of birth), and, in case of subjects with limited or no capacity to act, also the identifiers of the person authorized to give consent as defined in Section 16 of the Health Care Act (hereinafter referred to as “person authorized to give consent”);
    e) declaration by the subject, or, in the case of subjects with limited or no capacity to act, the person authorized to give consent, that his/her consent to participation in genetic testing for pharmacology purpose was given after accepting or declining the provision of information as specified in Section 6/A, voluntarily and freely, in awareness that it may be revoked any time, either verbally or in writing, without justification;
    f) consent to the collection of sample in the quantity and quality specified in the information and to the use of the data of the subject,
    g) the statement on the storage of samples, with the option to deposit the sample provided by him or her in a biobank in the required manner, including storage in accordance with Section 6/A (2) g).
    h) the statement of the subject regarding the inclusion of the sample deposited in the biobank for further investigations; in this case, the subject must make a statement regarding whether he or she consents to the use of the sample for diagnostic purposes, research purposes or both, that is for diagnostic and research purposes, depending on the primary purpose of the sampling,
    i) disclosure of the results even in the event the subject has no access to them,
    j) consent to or rejection of the possibility of being contacted in the future
    k) date of signature on the informed consent;
    l) signatures of the principal investigator or the person providing the information;
    m) signature of the person giving the informed consent.

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