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.
A document with important information about a medical procedure or treatment, a clinical trial, or genetic testing. It also includes information on possible risks and benefits. If a person chooses to take part in the treatment, procedure, trial, or testing, he or she signs the form to give official consent.
I participant name, agree to participate or agree to participation of my child participant name in the research project titled project title, conducted by researcher(s) name who has (have) discussed the research project with me. I have received, read and kept a copy of the information letter/plain language statement.
Examples of giving nonverbal consent may include: Head nod. Thumbs up. Pulling someone closer. Nodding yes. Making direct eye contact. Actively touching someone. Initiating sexual activity.
Basic Elements of Informed Consent Purpose of the Research. Description of the Research. Risks. Benefits. Alternatives to Participation.
It should be a concise document; the length and design should encourage a potential participant to read it in full. A brief introduction; for example: Before you decide to take part in this study it is important for you to understand why the research is being done and what it will involve.
It must be obvious that the individual has consented, and what they have consented to. This requires more than just a confirmation that they have read terms and conditions – there must be a clear signal that they agree. If there is any room for doubt, it is not valid consent.
I participant name, agree to participate or agree to participation of my child participant name in the research project titled project title, conducted by researcher(s) name who has (have) discussed the research project with me. I have received, read and kept a copy of the information letter/plain language statement.
If you prefer to write your own consent document, you may do so, but be sure to include all required elements of informed consent.