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.
Why do I have to sign a consent form? The main purpose of the informed consent process is to protect the patient. A consent form is a legal document that ensures an ongoing communication process between you and your health care provider.
Fourth, consent forms are legal documents. Courts have characterized consent forms as establishing contractual relationships between investigators and subjects, which imply legal duties.
To be valid, consent must be voluntary, informed, specific, current, and given by a person with capacity. Unless otherwise indicated, consent can be express or implied, written or verbal.
There are two types of consent that a patient may give to their medical provider: express consent and implied consent. Express consent is typically done in writing, while implied consent is typically conveyed through a patient's actions or conduct.
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.
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.
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.
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.