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.
The consent form should describe if/when identifiable data will be destroyed and how such data will be protected and how it will be used or shared. Language - Consent forms should be written in the 2nd person (i.e., "you are") and in a language that is clear, concise, and understandable to the subject population.
I understand that my participation is voluntary and that I may withdraw my participation at any time without penalty. I voluntarily agree to participate in this study. __ I do __ I do not give you permission to make audio/video recordings of me during this study (if applicable).
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.
The consent form should describe if/when identifiable data will be destroyed and how such data will be protected and how it will be used or shared. Language - Consent forms should be written in the 2nd person (i.e., "you are") and in a language that is clear, concise, and understandable to the subject population.
State the Purpose: Mention the letter's purpose and what you consent to. Be specific about the details. Provide Details: Include any relevant details about the consent, such as dates, locations, and conditions. Sign and Date: End with your signature and date.
If you plan to use an electronic consent process, you will need to explain the process of documenting consent in your protocol and provide a copy of the electronic consent form. An electronic consent form needs to cover all the required consent information as provided in the Electronic Consent Template.
Drafting tips for preparing consent forms: Use words familiar to the non-medical reader. If possible, keep words to 3 syllables or fewer. Write short, simple, and direct sentences. Keep paragraphs short and limited to one idea. Use active verbs.
4-Step Guide: How to Make a Consent Form Choose a sample consent form to customize. To begin, choose from a selection of sample consent forms and customize them easily to suit your specific needs. Adjust the form's design. Publish your form online. Get consent and print the documents if needed.
How to write a consent form: A step-by-step guide Step 1: Title and introduction. Step 2: Description of the activity. Step 3: Risks and benefits. Step 4: Confidentiality and data handling. Step 5: Voluntary participation and withdrawal. Step 6: Consent statement. Step 7: Signature and date. Step 8: Contact information.