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Thread: Volunteers attending screening but not consenting

  1. #1

    Volunteers attending screening but not consenting

    Hi I'm looking for advice how volunteers who attend the screening visit but decide not to consent (before being seen by the Physician) should be handled? Should they still go through the consent process and indicate on the ICF they do not wish to take part in the trial or would they be allowed to leave the site? Also are they still eligible to receive the screening compensation?

    If allowed to leave, should their attendance be documented anywhere? Screening/Enrollment Log etc?

    Another question is for volunteers who are obviously not within inclusion/exclusion criteria, for example clearly not within the protocol required age range but did not disclose the information at the recruitment stage.
    Are they entitled to screening compensation? Should they still be consented and subsequently screen failed?

  2. #2
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    Consent is always required to be gained before performing any study specific screening activity, tests, assessments, questionnaires, scales, etc. Study staff cannot screen the potential subjects before they have given their written informed consent (ICH E6 4.8.8; 4.8.11; 5.18.4(e)). Without written informed consent the study staff do not have the permission of the subject to perform study related screening assessments. Also it is difficult for the subject to identify what is study specific screening and refuse to participate in the study (including screening) if they have not had the full study explained to them and consented in writing. To perform screening without documented consent would be a breach of their rights. UK law (UK SI 2004/1031 Schedule 1 Part 1 para 3(1) & Article 3 of EU Directive 2001/20/EC) specifically requires consent before trial specific screening of subjects. The MHRA GCP Guide (11.4.1) gives a useful definition of pre-screening:- "pre-screening may take the form of reviewing the subject’s hospital notes ... No additional trial specific screening activities ... must8 take place until informed consent to participate in the trial is obtained from the subject".

    There are a very large number of international inspection findings and warning letters based upon the fact that some sort of study specific assessment was conducted on subjects before gaining full written informed consent. Many of these are readily available.

    All sponsors I have heard of, start the study (including any study specific screening) with requiring that investigators obtain the written informed consent of each subject beforehand. This safeguards the subject, the investigator and the sponsor.

    The RQA (formally BARQA) GCP Committee has provided a useful Q & A on the RQA website:- "Q: What is pre-screening and what are the limits?
    Answer: Consent is always required to be gained before performing any study specific screening activity, tests, assessments, questionnaires, scales, etc. Study staff cannot screen the potential subjects before they have given their written informed consent, therefore they cannot administer a primary outcome or screening measure even if it is as simple as a pain scale. Although there is no formal definition of “pre-screening” it is logically anything that happens before consent as anything after consent is either screening or other parts of the study. Before gaining the written informed consent of the potential subject, the investigators may:- 1. Advertise for subjects using IRB/IEC approved materials (ICH GCP 3.1.2; 8.2.7); 2. Ascertain if he/she has sufficient numbers of subjects (ICH GCP 4.2.1), provided that the IRB/EC has no objection to this review of subject’s information prior to consent; 3. Fully inform the subject about the study (ICH GCP 4.8.5). As a consequence of informing potential subjects, they may decide to “self screen”. For instance, they may realise that the study is too involved for them or that they definitely do not have the attributes that the protocol will be screening for at the screening visit. Research staff or call centre staff should ideally inform the potential subject about the study using IRB/IEC approved scripts and information. Part of the consent form details the subject’s agreement for the sponsor and investigator to process their personal data for the purposes of this specific study. Consequently it would be against Data Protection regulations to record any personal data on subjects gained specifically for this study, before gaining their written informed consent to process their data. However, data from previously performed routine assessments may be collected, provided that the IRB/IEC approved protocol stipulates what is acceptable (type of measure and timing of assessments) and that these data have been collected as part of routine care and not specifically for this study. As stated above, any study specific assessments must be preceded by written informed consent. At all times data that would identify potential subjects and subjects that have given consent, should remain confidential and at the investigator’s site. Investigators may provide anonymised and aggregated information on their retrospective data (ICH GCP 4.2.12) that the monitor may review (ICH GCP 5.18.4.b). Sponsor’s representatives (i.e. monitors & auditors) can only view personal data at site, for subjects that have given consent. 15th October 2007".

    Getting the consent of the subject at an early stage eliminates the problem of them being screened without consent.

    Documentation of the attendance of all patients and subjects would be in the hospital/clinic notes for that person. All subjects that consent would be included in the screening log.

    All subject should be able to leave as soon as they either refuse to consent or withdraw consent. To suggest that there might be any hindrance to their freely withdrawing, would be GCP non-compliant and possibly illegal.

    Compensation in terms of travel expenses would probably be expected by such subjects. Payment for any assessments, after consent, would presumably be on a pro-rata basis. There should be on undue influence, where the withdrawal of the subject would adversely affect them.

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