These are the basic elements that need to be included in a consent form, as required by Federal Regulations:
- A sentence that the study involves research and explains the purpose of the study.
- A description of what you will be asking the subject to do and how much time they will spend participating in the study.
- If appropriate, an explanation if any of the procedures are experimental.
- A description of any anticipated risks, harms, discomforts, and inconvenience for the subject.
- A description of any possible benefits to the subject, or society, from the study.
- If appropriate, a disclosure of any alternative procedures or treatments instead of the study that would be helpful.
- If appropriate, a description of any compensation or medical treatments available if the subject is injured while participating in the study.
- A statement explaining how you will keep their information confidential.
- A statement that taking part in the study is voluntary, and there will be no penalty or loss of benefits if they don’t want to participate.
- A statement that they can stop participating at any time, and there will be no penalty or loss of benefits if they decide to stop. If necessary, include information that alerts subjects to any consequences to them should they withdraw while dependent on some intervention to maintain normal function.
- Name and phone number or email of the person(s) the subject can contact if they have any questions about the study or if there is a research-related injury or adverse event
- Name and email of the HSRO Associate Director if they have any questions about their rights or if there is an adverse event.
The IRB may impose additional requirements that are not specifically listed in the regulations to ensure that adequate information is presented in accordance with institutional policy and local law.
The words you use should be appropriate for the subject population so they can easily understand what you wrote, and you should explain any complex ideas or large words.
Unless otherwise requested, Exempt category research does not require a signature line. All other research categories should include a line for the subject to sign, and a line for the date.
A copy of the form MUST be given to the subject (or representative).