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At a minimum, a counseling informed consent form should include: Limitations and guidelines regarding confidentiality. Purpose and description of the group. Suggested length of the group. Costs, copays, and any fees. Clients right to refuse services at any time. The role of the therapist as the group facilitator.
Considerations in preparing the informed consent document: Elements of consent present. Complete explanations. Lay language. Protection of confidentiality. No unproven claims of effectiveness. Device studies include a statement that the study includes an evaluation of the safety of the test article.
Drafting tips for preparing consent forms: If possible, keep words to 3 syllables or fewer. Write short, simple, and direct sentences. Divide sentences into two when necessary. Keep paragraphs short and limited to one idea.
I consent to participate in the research project and the following has been explained to me: the research may not be of direct benefit to me. my participation is completely voluntary. my right to withdraw from the study at any time without any implications to me.
Instructions for Developing an Informed Consent Document General Information. Describe the purpose(s) of this research study in lay terms. Purpose of the Study. Procedures. Risks. Benefits. Compensation, Costs and Reimbursement. Withdrawal or Termination from Study. Confidentiality.
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