What are the legal requirements for disclosing results from biomedical research?
In Virginia, the legal requirements for disclosing results from biomedical research depend on the scope of the research. Generally, the researcher must follow the regulations established by the Funding Agency (NIH, NSF, etc.) that provided the funding for the research. For research studies that involve human participants, the researcher must seek approval from an Institutional Review Board. An IRB is a committee that evaluates the risks and benefits of the research to assess if the study is ethical and in compliance with the law. The IRB will review the consent form and other documents that describe what information the researcher will collect from participants and how the information will be used. Researchers must also follow their institution’s guidelines for protecting the confidentiality of the research data. Researchers must devise effective ways to protect sensitive information from being disclosed to unauthorized persons. The researcher must also prepare an article to publish the results of the research. The article must adhere to the standards and guidelines of the journal or website that it will be published in. Finally, researchers are expected to share the results of the research with the public, either by presenting their findings in the form of a talk, poster, or online media such as a website. It is also important to share the research results with the participants.
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