The following key points should be considered when authoring the risks and benefits section.
- Explain risks, hazards, or discomforts, including the likelihood of the risk with fairly low probabilities. Be honest and accurate.
- If there are significant physical or psychological risks (such as stress or invasion of privacy) to participation, tell the subject under what conditions the researcher will terminate the study.
- Identify the risks of being in the placebo group (e.g., "off
- Describe any benefits to the subject or others that may reasonably be expected from the research.
- If there is no benefit to the subject, say so.
- If there is the possibility of injury as a result of the research, include information as to the medical treatment and compensation.
- If there is an inducement or a reward for participation, specify terms
of disbursement on the document.
- FDA regulations require that payment to subjects be prorated over
time, so that in the event a subject withdraws from a study, prior to
termination of the research, he/she receives some compensation for
- Describe the payment method for subjects, if any.
- Do not make payment an inducement, only a compensation for expenses
- If the subject is a student who receives class credit or some other
token, include that information under benefits. If a person is to receive
some money or other token to participate, explain when it will be paid and
any conditions of full or partial payment.
- State the alternative treatments for the subject and the risks and
benefits of alternatives. Use a table, if necessary.