Specific guidance on informed consent Sample Clauses

Specific guidance on informed consent. The following principles should be considered in relation to achieving informed consent from users participating in the project; see also Appendix C for quality guidance, a generic template and some examples from local pilots:  Each potential subject must be appropriately informed about the study design, the aims, methods, anticipated benefits and potential problems / difficulties in participating in the Project, and any discomfort it may entail.  Any documentation given to potential participants should be timely, clear and comprehensive. There should be an opportunity for them to raise any issues or concerns, and ask for advice.  Informed consent should be required, preferably in writing, and records of consent should be maintained. It is strongly recommended to retain in a file all refusals and the related reasons.  Potential participants must be informed that they are free to withdraw consent to participate at any time. Withdrawal should be easy.  At the end of the evaluation, all participants will be informed about the results / outcomes of the project, whether positive (successful) or not.  There should be a procedure for making complaints, and participants should be made aware of this.  All participants should be volunteers. It should be made clear that refusal to participate will not lead to any adverse consequences; for example, users of care service providers must be assured that any decision not to participate will not prejudice or affect in any way the services they currently receive. Considerable care should be taken where consent is sought from those in a dependent position or suffering from cognitive impairments.  Informed consent must be obtained from a legal guardian in the case of subjects who do not have the legal competence to give informed consent.  Any inducement offered to participants should be declared, and should be in accordance with appropriate guidelines. Some project participants may be unable to consent when the pilot starts, or in the course of the piloting activity. In such a case, other safeguards need to be in place. There may be many reasons why an individual may not be able to provide consent. If this situation occurs, the assessor should consider the following:
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