All sections of the consent form, except the "Consent" section, should be written in second person ("You are invited..."). Headers should include “Informed Consent” followed by the title of the study (e.g., the header in this document). Footers should include page numbers.
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.
Informed consent language should be written in the second person (“you”), not in the first person (“I”). Minimize passive voice to the extent possible. Example of passive voice: “A summary of results will be sent to all study participants.” Example of active voice: “We will send you a summary of the results.”
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. This includes both reading level and language (e.g, English, Spanish, French).
How to Write a Consent Letter Title the Letter: Start with a clear title, such as "Consent Letter" or "Permission Letter." Include Your Contact Information: At the top of the letter, include your name, address, phone number, and email address. Date the Letter: Write the date the letter is being written.
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.
Follow these steps to write an effective consent form. 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.
Informed consent documents A statement that the project is research and participation is voluntary, A summary of the research, including: Purpose. Duration. List of procedures. Reasonable, foreseeable risks or discomforts. Reasonable, expected benefits. Alternative procedures or course of treatment, if any.
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 consent letter should include the title, sender and recipient's details, date, statement of consent, relevant details or conditions, acknowledgment of risks (if applicable), and signature.