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Explaining Risk in a Protocol

The Board will need to know the various harms that might be encountered by participants, the likelihood that the harm will occur, and how you will both reduce the potential for harm and assist participants who have experienced harm as the result of participating in the study. Regardless of the risk level in your study, it is important that you accurately describe this information in your protocol. Consider the following checklist before you submit your protocol for review:

  • Clearly outlined recruitment and consent procedure: From the IRB’s perspective, one of the best ways to protect a participant is to ensure that a participant is able to protect themselves.  Ultimately, the person that will make the best decision about a tolerable level of risk is the individual consenting to participate.  The Board and the researchers work together to create the kind of environment where this is possible, allowing participants to act out of their own best interests. Some participants are not able to sign a consent form because of their age and/or mental competency. Please see Vulnerable and Risk Sensitive Populations for more information.
  • Identify all risks in the study: The Board will review a study for possible “red flags”, elements in the study that will likely cause concern for a participant.  For example, questions about personal behaviors such as sexuality, drug use, political views, etc, may make a participant uncomfortable and should be specified in the consent form.  Possible injuries, potential emotional distress, or offensive material should be included as well.  Be particularly sensitive regarding children and provide ample information to parents about what their child will do. The consent form should inform participants about all of the probable risk factors; don’t include improbable, ridiculous, and/or outlying risk factors that will only stress a participant. Some participants, because of their lifestyle, relationships, health conditions, etc, may be more susceptible to risk and need extra precautions. Please see Vulnerable and Risk Sensitive Populations for more information.
  • Describe what you will do to minimize risks: The Board will not allow unnecessary risk and will want assurance that you have minimized risk in the study. One of the benefits of the review is that the Board members may have suggestions of ways you can reduce risk in your study, providing alternative, safer methods for collecting the same data. 
  • Include a detailed plan for an undesirable event: If something goes wrong, what will you do?  The Board wants to know that you are prepared to handle a situation should it arise.  For example, if a participant indicates that they are suicidal on a questionnaire, how will you handle this situation? In your protocol, you need to develop a plan that is specific to your study and will best benefit your participants. If you need help, consult with a faculty advisor, colleague, and contact our office. Should an incident occur, our office is required to follow specific procedures in the event of an unexpected event; for more information, please see Undesirable Events.

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