Certain populations are considered “vulnerable” due to their members’ possible lack of autonomy or capacity to make informed decisions regarding their own participation. For JWU’s purposes, these populations include children, prisoners, pregnant women, fetuses, neonates, and individuals participating in some AIDS-related studies.
Other populations may also be vulnerable. These include educationally or economically or educationally disadvantaged individuals, individuals with impaired decision making abilities, individuals who are illiterate or have low fluency in the research study’s language, or students or employees of the institution(s) involved in the research.
Researchers must take special care when considering how to engage, and obtain informed consent from, members of these populations. For example:
- When the participant is a minor, space for the minor’s signature and the parent/guardian’s signature should be provided.
- In the case of child participants, two consent forms are required: parent/guardian consent form and a separate child assent form (in language appropriate for age and reading ability).
- When working with children as participants, a statement must be included in the consent form under the confidentiality section that the law mandates reporting instances of physical and sexual abuse. The statement must be to the following effect: No information about you or your family will be given to anyone outside the study personnel, except, as federal and state law mandates, for example in the case of a child who is being abused or who is in imminent danger.