The NICHD supports many types of clinical research studies including those that involve researchers who directly observe people, those that collect data to answer scientific or medical questions about the safety or potential benefit of an intervention, such as a medication, device, teaching concept, training method, or behavioral change, and those that examine the dynamics of populations. Federally funded clinical research includes many safeguards to protect those who volunteer to take part in trials and studies. These protections are developed by various organizations and are implemented throughout the research process. Some major organizations with an interest in clinical research regulations are described in the table below; links to any relevant regulatory information, including laws, regulations, policies, and guidances sponsored by the organizations, are also included.
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Each of these organizations is responsible for providing the research community with certain regulatory information, and each has varying levels of authority in clinical research. Some have the ability to develop and implement laws and regulations, which must be followed by investigators, while others can only develop policies and provide guidance(s). The NICHD examined clinical research documents in four areas, defined below.
The tables below summarize the various safeguards which must be considered by all investigators in the clinical research process. Tables are organized by specific topic areas and organizations for each type of regulatory measure (law, regulation, policy and guidance). Specific topic areas include:
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