Common Rule

Definition

The Common Rule refers to the federal policy in the United States that governs the ethical principles and guidelines for conducting research involving human subjects. This set of regulations ensures that participants are treated ethically and protects their rights, connecting closely to the concepts of informed consent and patient autonomy, emphasizing the necessity of voluntary participation and adequate information before individuals agree to partake in research activities.

5 Must Know Facts For Your Next Test

1. The Common Rule was first published in 1991 and has been revised multiple times, most recently in 2018, to enhance protections for human subjects in research.
2. It applies to all federally funded research involving human subjects, including studies conducted by universities, hospitals, and other institutions.
3. Under the Common Rule, researchers must obtain informed consent from participants before enrollment, ensuring they understand the research's purpose, procedures, risks, and benefits.
4. The regulations require researchers to minimize risks to participants while ensuring their autonomy is respected throughout the research process.
5. Certain categories of research may qualify for expedited review or exemption from full IRB review under the Common Rule, based on specific criteria related to risk.

Review Questions

• How does the Common Rule ensure informed consent among research participants?
  • The Common Rule mandates that researchers provide comprehensive information about the study's purpose, procedures, potential risks, and benefits before obtaining informed consent. This process ensures that participants make educated decisions about their involvement in research. By emphasizing transparency and voluntary participation, the Common Rule reinforces the importance of informed consent as a fundamental ethical principle in protecting human subjects.
• Discuss the role of Institutional Review Boards (IRBs) in relation to the Common Rule.
  • Institutional Review Boards (IRBs) play a critical role under the Common Rule by reviewing research proposals to ensure compliance with ethical standards. They assess the potential risks to participants and whether adequate measures are in place to protect their rights and welfare. IRBs also evaluate the informed consent process to confirm that it meets regulatory requirements. By providing oversight, IRBs help uphold the ethical principles outlined in the Common Rule.
• Evaluate the impact of recent revisions to the Common Rule on the ethical conduct of research involving human subjects.
  • Recent revisions to the Common Rule aim to strengthen protections for human subjects while facilitating valuable research. Changes include enhancing informed consent requirements and establishing a new framework for managing risk levels in research studies. These revisions reflect a balance between promoting ethical considerations and encouraging innovation in research practices. By adapting to contemporary issues in ethics and technology, the revised Common Rule enhances accountability and reinforces trust between researchers and participants.

Related terms

Informed Consent: A process through which researchers ensure that participants understand the nature of the research, its risks and benefits, and their right to withdraw at any time before agreeing to participate.

Institutional Review Board (IRB): A committee that reviews and approves research proposals to ensure that they comply with ethical standards and protect the rights and welfare of human subjects.

Beneficence: An ethical principle that requires researchers to maximize potential benefits and minimize any possible harm to participants in research studies.