Common Rule

Definition

The Common Rule is a federal policy that governs the ethical conduct of research involving human subjects in the United States. It establishes the basic requirements for obtaining informed consent, ensuring privacy, and maintaining ethical standards in research practices. This rule is pivotal in safeguarding the autonomy of participants, protecting their confidentiality, and ensuring that research institutions have the proper review mechanisms in place to oversee research ethics.

5 Must Know Facts For Your Next Test

1. The Common Rule applies to all federally funded research in the U.S., requiring institutions to adhere to its guidelines for protecting human subjects.
2. Informed consent under the Common Rule must be documented, detailing risks, benefits, and the right to withdraw from the study at any time.
3. The rule mandates that researchers minimize risks to participants while maximizing potential benefits, creating a balance between scientific advancement and ethical responsibility.
4. An important feature of the Common Rule is its provision for expedited review processes for certain types of research that involve minimal risk.
5. Institutions are required to have an Institutional Review Board (IRB) that reviews research protocols and ensures compliance with the Common Rule before studies can commence.

Review Questions

• How does the Common Rule influence the process of informed consent in research involving human subjects?
  • The Common Rule significantly influences the process of informed consent by establishing clear guidelines that researchers must follow to ensure that participants fully understand their rights and the nature of the study. It requires that consent forms be informative and accessible, outlining potential risks, benefits, and the voluntary nature of participation. By mandating these requirements, the Common Rule aims to protect participant autonomy and ensure they can make informed decisions about their involvement in research.
• Discuss how the Common Rule ensures privacy and confidentiality for research participants.
  • The Common Rule ensures privacy and confidentiality by mandating that researchers implement measures to protect sensitive information about participants. This includes requirements for data de-identification and secure storage of personal data. Researchers must also inform participants about how their data will be used and shared, which helps build trust and encourages participation while safeguarding individual privacy rights as outlined by ethical standards.
• Evaluate the role of Institutional Review Boards (IRBs) in upholding the principles of the Common Rule within research institutions.
  • Institutional Review Boards (IRBs) play a crucial role in upholding the principles of the Common Rule by reviewing research proposals to ensure they meet ethical standards. IRBs assess potential risks to participants, evaluate the adequacy of informed consent processes, and ensure that researchers have implemented measures to protect participant confidentiality. By serving as a gatekeeper for ethical research practices, IRBs help maintain public trust in research and contribute to the protection of human subjects as mandated by the Common Rule.

Related terms

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

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

Human Subjects Research: Research involving living individuals from whom data is obtained through intervention or interaction or identifiable private information.