Which of these statements concerning guidelines for consenting children for research participation are true? (Select all that apply.)
a. No infant or child may be used in research if he or she refuses treatment.
b. Emancipated minors may consent for themselves.
c. Coercion is wrong, but begging a child to participate is acceptable.
d. An 11-year-old should be asked to assent for research participation.
e. If infants and children participate in research, they should sign a consent form.
f. Infants cannot refuse to participate in research if their parents consent.
ANS: B, D, F
The unique vulnerability of children makes the decision to include them as research subjects particularly important. To safeguard their interests and protect them from harm, special ethical and regulatory considerations have been put in place for research involving children. However, the laws defining the minor status of a child are statutory and vary from state to state. Often a child's competency to consent is governed by age, with incompetence being nonrefutable up to age 7 years. Thus, a child younger than 7 years is not believed to be mature enough to assent or consent to research. A child 7 years or older with normal cognitive development can provide assent or dissent to participation in a study, and the process for obtaining the assent should be included in the research proposal. To obtain informed consent, federal regulations require both the assent of the children (when capable) and the permission of their parents or guardians. An infant is not capable of speech or of understanding the purpose of a research study.
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