Key Points 3-4m

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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 meds").
  • 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 participation.
  • Describe the payment method for subjects, if any.
  • Do not make payment an inducement, only a compensation for expenses and inconvenience.
  • 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.