The OPRR was organized in the NIH in accordance with this regulation. Policy on the Human Care and Use of Laboratory Animals and other HHS regulations. Thus, OPRR is acting as an official safeguard for ethics not only in industry-sponsored clinical trials regulated by the FDA but also in all biomedical research with governmental support. The MHW only regulates clinical trials for new drug applications or post-marketing surveillances, which are supported by the pharmaceutical or medical device industries. Respect for persons refers to respect for self-determination including voluntary informed consent.
Beneficence refers to the ethical obligation to maximize benefits and to minimize risks.
Justice is the fair and equal distribution of both the benefits and the burdens of participation in research. The last three resources will be helpful to study coordinators who write protocols and informed consent documents or to members of IRB establishing their institutional standard procedures and templates. Items in this section are selected for publication and edited by the editorial office at their discretion.