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Carefully Consider the Risks to the Participants

When the IRB reviews your protocol, we look at the risks in the study, or the potential for harming participants in the study.  The Board will weigh the benefits of the study against the risks in the study and will determine if the risks are acceptable or if modifications need to be made in order for the study to go forward.  There are some populations that the Board routinely identifies as “risky” because of the nature of their situations.  For example, patients with a disease that may ostracize them from a community if that disease is known (i.e. AIDS or HIV positive status), persons who work in illegal trades, victims of crime or victimizers, illegal immigrants, etc., these participants would be considered risk-sensitive participants if made the target of a study.

In addition, the federal regulations define a special category of participants who are more likely to be at risk because of their inability to consent to a study.  These participants are called vulnerable participants and include children, prisoners, adults with diminished capacity to consent, etc.  Some participants may be in a situation where they could be coerced or feel coerced into participating in a study; for example, a student may feel pressured to participate in a study conducted by his teacher in order to get a good grade in the class.  When you construct your study, you need to consider the participants’ situations, ability to consent, and how participating in the study may affect their lives.  You should construct a study that minimizes the risks to the participants; if you need suggestions, talk to your faculty sponsor and/or contact our staff. 

For some risk-sensitive and vulnerable populations, the Board will be reluctant to allow you to collect identifiable data from these populations unless you have the training, experience, and support to conduct such a study.  For new or inexperienced researchers, this doesn’t mean that you cannot address these topics in a study.  For example, instead of talking to HIV patients directly, you can interview doctors and nurses about their experiences working with these patients.  You can develop an anonymous survey to distribute to the patients that can be discreetly returned in the doctor’s office.  In general, it is important for you to carefully consider the risks that your study may pose to the participants involved and to address these risks in the protocol.  The Board will want to see that you have a plan in place to handle a situation should something arise. 

On the flip-side, it isn’t necessary to overreact to this section as well.  If you are doing an anonymous survey of healthy adults, most likely your risks are minimal and it is okay to declare that there are no risks in your study.  Also, don’t overstate the risks in the consent form as you don’t want to alarm your participants unnecessarily.

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