Final answer:
Federal regulations mandate that research involving human subjects require informed consent, risk minimization, and privacy protection. Oversight by Institutional Review Boards (IRB) and Institutional Animal Care and Use Committees (IACUC) is mandatory to ensure the ethical treatment of human and animal participants.
Step-by-step explanation:
Federal regulations governing the use of humans in research always require key protections to ensure the safety and ethical treatment of participants. Research involving human subjects must adhere to strict guidelines which include ensuring that risks to participants are minimized and reasonable in comparison to the benefits. Researchers must obtain informed consent, clearly explaining the risks involved to the study subjects. Once informed, subjects must demonstrate their understanding and agreement by providing written consent. Moreover, privacy protections are mandatory, requiring researchers to uphold confidentiality and safeguard personal information, regardless of any external pressures.
In addition to human subject protections, there are also regulations for animal research. The Animal Welfare Act (AWA) and the Public Health Service Policy (PHS Policy) are key federal regulations applying to institutions engaging in biomedical research using animals. These regulations ensure that institutions have oversight committees such as the Institutional Animal Care and Use Committee (IACUC) to oversee the ethical treatment and use of animals. For instance, the committee ensures that research proposals meet basic standards, justify the use of animals, do not duplicate existing research, and minimize animal pain and distress.
Understanding the historical context, such as the Tuskegee syphilis study, underscores the necessity for the robust ethical guidelines we now have in place. Today, research institutions establish oversight committees like the Institutional Review Boards (IRB) to review all studies involving human subjects to ensure compliance with federal regulations and ethical standards.