Publisher Summary This chapter focuses on issues commonly encountered by, or of concern to, investigators in the clinical research environment. The issues include those related to informed consent for standard and research care, types of advance directives and other surrogate decision-making requirements, the involvement of children in research, maintenance of adequate medical records, protection of confidentiality, liability of clinical researchers, conflicts of interest, and authorship and rights in data. The legal standard for consent to research is not distinct from that required for consent to standard care. Although children may be required to assent to their participation in research, they cannot provide legally valid consent. Determining who has the legal authority to provide consent in the case of a child in foster care, calls for careful investigation. Complete and accurate medical or research records are not only necessary to provide quality care to patients and ensure scientific integrity and verification, but also become the most essential evidence in the event of subsequent litigation, review, audit, or other inquiry. The primary author and the research group ordinarily resolve authorship questions. Although there are no specific legal requirements governing who may or may not claim authorship of a scientific article, professional standards require that the designation of authorship should be based on a substantial contribution