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Resources :: Guide :: Vulnerable and risk sensitive participants :: Risk-sensitive populations :: Including abused adults in a study

Including Abused Adults with Diminished Capacity in a Study

Any adult who has lost (or in some cases never had) the ability to consent due to their mental capacity belongs in this category. Often these adults are under the care of a family member and/or live in a care facility. These individuals are vulnerable to abuse because they are either unable to advocate for themselves or unwilling because the abuser is also their caregiver.  Issues such as consent become more complex (do you seek consent from the care giver who might be the potential abuser?) and talking to the adult about his or her situation may be upsetting (or even impossible depending on the capacity of the adult). If the adult is still in the care of the abuser, the adult may be in a harmful and possibly life threatening situation.  Depending on your relationship with the participant, you may be legally obligated to report any abuse, which will also compromise confidentiality. When you construct your study, it is important to think through every detail and to carefully weigh the impact you will have on the adult’s life.

Consent Process
For studies involving adults with diminished capacity to consent, it is important to verify first that the adult does not have the capacity to consent. Review the Assessing Capacity to Consent section for more information. If the adult does not have the capacity to consent, they will need a surrogate to consent. This individual is a legally authorized representative (LAR) and has the permission to make decisions for the adult. Even though the adult doesn’t have the capacity to consent, you should still ask their permission to participate by using an assent form, where appropriate. Please see Participants with Diminished Mental Capacity in the Consent section.

It is important for the Board to have a clear understanding of all the players involved in the adult’s life. Who is the caregiver? Is the caregiver the abuser? Does the participant still live with the abuser? Is the caregiver the LAR? Developing the consent process may be challenging and it is important that the process protects the participant and that they are properly advocated for, as well as receive the full opportunity to assent, where possible. As you develop your consent documents, make sure that they provide the participant and the surrogate with accurate and useful information that will help them understand the scope and nature of their participation. 

Confidentiality Issues
Understanding the abused adult’s situation will help you to anticipate how to protect his or her confidentiality. For some abused adults, their abuser may still be in their lives and if the abuser found out about the abused adult participating in a study about abuse, it may incite further harm to the adult. It is important that you consider how to approach the abused adult (which can only occur after the LAR gives permission) about the study, where the study will take place, and how the data are collected and stored so that confidentiality will be protected. Even providing the participant with a pamphlet about the study may not be wise if it could be linked to the participant.

There may be instances in which confidentiality has to be compromised. If you learn of new instances of abuse, you may be legally obligated to report the abuse.

As mentioned in the previous section, you will need to obtain consent from a legally authorized representative and assent from the abused adult. Templates for these documents are found in the Forms: Consent section and information about this process can be found in the Adults with Diminished Capacity to Consent section. If the potential exists that you may have to compromise confidentiality, you should provide this information in the consent form in the “Confidentiality” section; provide the participants with specifics about what would prompt you to break confidentiality and what information will be shared. For example, see the sample text below:

Consent form text (please modify so that it is appropriate for the participants’ reading level): I have ethical obligations to report suspected abuse and to prevent others from carrying out threats or doing serious harm to you.  If keeping information obtained in this study private would immediately put you in danger, I will release that information to protect you.

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