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This information should include the profession and institution affiliation of the investigator.
The investigator should respect the child's freedom to choose to participate in the research or not by giving the child the opportunity to give or not give assent to participation as well as to choose to discontinue participation at any time.
Assent means that the child shows some form of agreement to participate without necessarily comprehending the full significance of the research necessary to give informed consent.
As with the child and parents or guardians informed consent requires that the persons interacting with the child during the study be informed of all features of the research which may affect their willingness to participate.
All questions posed by such persons should be answered and the persons should be free to choose to participate or not, and to discontinue participation at any time. INCENTIVES: Incentives to participate in a research project must be fair and must not unduly exceed the range of incentives that the child normally experiences.
Whatever incentives are used, the investigator should always keep in mind that the greater the possible effects of the investigation on the child, the greater is the obligation to protect the child's welfare and freedom. DECEPTION: Although full disclosure of information during the procedure of obtaining consent is the ethical ideal, a particular study may necessitate withholding certain information or deception.
Whenever withholding information or deception is judged to be essential to the conduct of the study, the investigator should satisfy research colleagues that such judgment is correct.
Investigators working with infants should take special effort to explain the research procedures to the parents and be especially sensitive to any indicators of discomfort in the infant.
In spite of the paramount importance of obtaining consent, instances can arise in which consent or any kind of contact with the participant would make the research impossible to carry out. Conceivably, such research can be carried out ethically if it is conducted in public places, participants' anonymity is totally protected, and there are no foreseeable negative consequences to the participant.
In complying with requirements for data sharing, researchers need to carefully consider whether they have provided data which, if combined, risks violating participant anonymity. MUTUAL RESPONSIBILITIES: From the beginning of each research investigation, there should be clear agreement between the investigator and the parents, guardians or those who act in loco parentis, and the child, when appropriate, that defines the responsibilities of each.
The investigator has the obligation to honor all promises and commitments of the agreement.