The Common Rule is a set of regulations established by the Department of Health and Human Services (HHS). It provides essential protections for human research subjects, such as informed consent to participate in studies and protection of their data. In addition to these general requirements, there are several additional regulations that supplement and further specify the conditions of the Common Rule.
Research Involving Human Genes and DNA
The Common Rule was amended in 2009 to include explicit protections for research involving human genes and DNA. This amendment requires that researchers obtain prior written consent from research subjects prior to using their DNA in research studies. It also prohibits the sale and commercialization of human genes and DNA without prior written consent.
Medical and Health Research
In addition to the Common Rule’s provisions for informed consent in medical or health research, HHS has imposed additional regulations to ensure that research participants are adequately informed about the procedures, risks, and benefits of proposed research projects. Such additional requirements include providing research participants with detailed information about the experimental design, risks of harm, and potential benefits of participating in the research.
Research Involving Human Embryos
The Common Rule prohibits research involving human embryos unless the research is conducted in accordance with strict ethical guidelines. Specifically, research involving human embryos must be approved by an institutional review board (IRB), and research participants must provide informed consent prior to participating in the research. In addition, the research must be conducted in accordance with local laws and regulations.
Research Involving Minors
When conducting research involving minors, researchers must obtain the informed consent of both the minor and his or her parent or legal guardian. In addition, depending on the nature of the research, researchers may be required to obtain an additional form of consent from either the minor’s parent or legal guardian or from a third-party organization such as a school or daycare.
Conclusion
The Common Rule is an important set of regulations that provide essential protections for human research subjects. In addition to the requirements of the Common Rule, several additional regulations supplement and further specify the required conditions for certain types of research. By following these additional regulations, researchers can ensure that their research studies are conducted in an ethical and responsible manner.