Common Rule

Definition

The Common Rule refers to a set of federal regulations that govern the ethical conduct of research involving human subjects in the United States. It is designed to protect the rights and welfare of research participants, ensuring that their participation is voluntary and informed, while also emphasizing the importance of oversight through Institutional Review Boards (IRBs). This regulatory framework establishes key principles and procedures that researchers must follow when conducting studies involving human subjects.

5 Must Know Facts For Your Next Test

1. The Common Rule was first established in 1991 and has been revised several times to adapt to changing ethical standards and research practices.
2. It applies to research funded by federal agencies such as the National Institutes of Health (NIH) and the Department of Health and Human Services (HHS).
3. Key principles include respect for persons, beneficence, and justice, guiding researchers in their interactions with participants.
4. Under the Common Rule, institutions are required to have IRBs that review research protocols to ensure ethical compliance before studies can begin.
5. The rule also mandates ongoing monitoring of research to address any emerging ethical concerns throughout the study's duration.

Review Questions

• How does the Common Rule impact the design and conduct of research involving human subjects?
  • The Common Rule impacts research design by establishing ethical guidelines that researchers must incorporate into their protocols. It requires obtaining informed consent from participants, ensuring their understanding of the study's risks and benefits. Additionally, it mandates review by an IRB, which evaluates whether the proposed research adheres to ethical standards, thereby safeguarding participant rights and welfare throughout the research process.
• Discuss the role of Institutional Review Boards (IRBs) in the context of the Common Rule and their importance in protecting human subjects.
  • IRBs play a critical role in implementing the Common Rule by reviewing research proposals involving human subjects before they can commence. They assess potential risks to participants, evaluate informed consent procedures, and ensure that researchers uphold ethical standards. By serving as a safeguard against unethical practices, IRBs help maintain public trust in research and promote the responsible conduct of science.
• Evaluate the effectiveness of the Common Rule in addressing contemporary ethical issues in human subjects research, considering recent changes and challenges.
  • The effectiveness of the Common Rule in addressing contemporary ethical issues can be evaluated through its recent updates aimed at enhancing protections for participants in light of emerging technologies and data use. However, challenges remain, such as ensuring compliance across diverse research settings and keeping pace with rapidly evolving methodologies like big data analysis. Continuous dialogue among stakeholders is crucial for adapting regulations to address these complex issues while maintaining participant rights and promoting ethical research practices.

Related terms

Institutional Review Board (IRB): A committee established to review and approve research involving human subjects, ensuring that ethical standards are met and participant rights are protected.

Informed Consent: A process by which researchers provide potential participants with comprehensive information about a study, allowing them to make an educated decision about their involvement.

Human Subjects Research: Research that involves collecting data from or about individuals through intervention or interaction, or obtaining identifiable private information.