A consideration of ethical and legal issues in multi-site studies
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AbstractSignificant ethical and legal issues may arise in conjunction with the conduct of multi-site studies. For example, different cultures may have varying concepts of personhood. The United States, for instance, places significant emphasis on the autonomy of each individual, while many other societies rely to a greater degree on defining an individual with reference to his or her roles or relationships to others. These differing orientations may have implications for informed consent procedures and for the design of procedures to maintain confidentiality of the data and privacy of the participants. The development of procedures for the maintenance of confidentiality and privacy must also consider any differences in reporting requirements between the sites that relate to sexually transmitted diseases and child abuse. The implications of such differences for the conduct of multi-site studies are examined.