What is the name of the specific regulations that offer additional protections for children involved as subjects in research?

Study for the CITI Research Methods Test. Engage with flashcards and multiple-choice questions. Each question offers hints and explanations. Get ready for your exam!

The specific regulations that provide additional protections for children involved in research are referred to as Subpart D: Additional Protections for Children. This section of the Code of Federal Regulations is designed to ensure that research involving children is conducted ethically, taking into account their vulnerability and the need for extra safeguards. Children are considered a protected population in research settings due to their developmental stage and often limited ability to provide informed consent.

Subpart D mandates that researchers consider the best interests of child participants, ensuring that any research involving them is both necessary and poses minimal risk. This includes requirements for obtaining assent from children, when appropriate, and consent from parents or guardians. This structure is crucial because children may not fully understand the implications of their participation in research, which is why the regulations are particularly stringent in this area.

The other regulations mentioned address different vulnerable populations or general research requirements, but Subpart D specifically targets the unique issues related to children, making it the correct choice for this question.

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