Institutions receiving funding from the U.S. Public Health Service (PHS), primarily through the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC), are required to comply with various regulations and policies aimed at protecting human subjects in research, promoting responsible conduct of research, and ensuring appropriate use of funds. Key requirements include:
Institutional Review Board (IRB) review: All research involving human subjects must be reviewed and approved by an IRB to ensure the ethical and safe treatment of participants.
Informed Consent: Researchers must obtain informed consent from participants, providing them with information about the research, potential risks and benefits, and their right to withdraw.
Conflict of Interest management: Institutions must have policies and procedures in place to identify, manage, and mitigate conflicts of interest for researchers.
Animal Welfare: If research involves animals, institutions must comply with the Animal Welfare Act and PHS policies on humane care and use of laboratory animals.
Financial Conflict of Interest (FCOI) Disclosure: Researchers must disclose significant financial interests that could potentially bias their research.
Responsible Conduct of Research (RCR) training: Individuals involved in research must receive training on the responsible conduct of research, covering topics like data management, authorship, and plagiarism.
Data Management and Sharing: Institutions may be required to have plans for managing and sharing research data.
Research Misconduct policies: Institutions must have policies and procedures for addressing allegations of research misconduct, such as fabrication, falsification, and plagiarism.
These requirements are crucial for maintaining the integrity of research and protecting the rights and welfare of participants. Failure to comply can result in penalties, including loss of funding.
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