Common rule

Definition

The common rule refers to a set of federal regulations that provide ethical guidelines for the protection of human subjects in research. It establishes standards for informed consent, institutional review board (IRB) processes, and the overall ethical treatment of participants, ensuring their rights and welfare are prioritized in research activities.

5 Must Know Facts For Your Next Test

1. The common rule is formally known as the Federal Policy for the Protection of Human Subjects and is codified in Title 45 of the Code of Federal Regulations.
2. It was first established in 1991 and has undergone revisions, with significant updates in 2018 aimed at enhancing participant protections and streamlining IRB processes.
3. Under the common rule, researchers must obtain informed consent from participants, ensuring they understand the risks, benefits, and nature of the research.
4. The common rule mandates that IRBs must review research studies to assess potential risks to participants and ensure that any potential benefits outweigh those risks.
5. The regulations apply not only to federally funded research but also to research conducted at institutions that receive federal funding for any purpose.

Review Questions

• How does the common rule influence informed consent practices in research involving human subjects?
  • The common rule plays a crucial role in shaping informed consent practices by establishing clear requirements for researchers. It mandates that participants must be provided with sufficient information about the study's purpose, risks, and benefits so they can make an informed choice about their involvement. This ensures that individuals can voluntarily decide whether or not to participate without any coercion, thus upholding their autonomy and rights.
• Discuss the responsibilities of Institutional Review Boards (IRBs) under the common rule and how they contribute to protecting human subjects.
  • Institutional Review Boards (IRBs) have significant responsibilities under the common rule, primarily focused on reviewing research proposals to protect human subjects. They assess the ethical considerations of a study, including potential risks and benefits, ensuring that participants' rights are safeguarded. By evaluating informed consent processes and monitoring ongoing research compliance, IRBs help ensure that researchers adhere to ethical standards and prioritize participant welfare throughout their studies.
• Evaluate the impact of the 2018 revisions to the common rule on research practices involving human subjects.
  • The 2018 revisions to the common rule had a notable impact on research practices involving human subjects by streamlining IRB processes and enhancing participant protections. These changes aimed to reduce regulatory burden while increasing transparency and accountability. For instance, modifications allowed for broader consent options and made it easier for certain low-risk studies to move forward without extensive review, fostering a more efficient research environment while still emphasizing the ethical treatment of participants.

Related terms

Informed Consent: A process through which researchers provide potential participants with clear information about the study, allowing them to make an informed decision about their participation.

Institutional Review Board (IRB): A committee that reviews research proposals to ensure that the rights and welfare of human subjects are protected before a study begins.

Human Subjects Research: Research that involves the collection of data from or about living individuals, requiring adherence to ethical guidelines to protect participants.