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It is illegal to conduct research with children without informed consent through parental approval, al- though there are variations on the policy. National Institutes of Health (NIH) policy (NOT-OD-18-116) requires individuals of all ages, including children, to be included in NIH-supported research unless there is a scientific or ethical reason not to include them. There are also specific requirements that apply to research involving chil- dren in 45 CFR 46 Subpart D. NIH defines a child as an individual under the age of 18. Note that “children” is defined in 45 CFR 46 Link to as “persons” who have not attained the legal age for consent to “treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted.” Important points from 45 CFR 46 regarding research with children: Exemption 2 does not apply to research with children except for research involving observations of public behavior when the investigator(s) do not participate in the activities being observed. Research with children may require assent from the child in addition to permission from a parent(s). Research involving greater than minimal risk is permitted with children only under specific conditions, and re- quirements depend on the prospect or absence of direct benefit to the individual participants. When children are wards of the State or other agency/institution/entity, an advocate may be required in addi- tion to an individual acting on behalf of the child as a guardian or in loco parentis. The federal regulations list eight required elements of informed consent. These are the following: 1.Purpose and procedures—You must tell a prospective participant that the study involves research, explain the purpose of the study and the length of time you expect the person to participate, describe the proce- dures to be followed, and identify any experimental procedures. 2.Risks—You must describe any reasonably foreseeable risks or discomforts to the prospective participant. 3.Benefits—You must describe any benefits to the prospective participant or to others which may reasonably be expected from the research. 4.Alternatives—You must disclose any appropriate alternative procedures or courses of treatment that might benefit the prospective participant. 5.Confidentiality—You must tell prospective participants whether their records will be kept confidential and, if so, explain the level of confidentiality. 6.When there is greater than minimal risk—You must tell prospective participants whether they will receive any compensation and/or medical treatments if injury occurs and, if so, what compensation or treatment will consist of, or where to obtain further information.