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Ethics in Research01:56

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Today, scientists agree that good research is ethical in nature and is guided by a basic respect for human dignity and safety. However, this has not always been the case. Modern researchers must demonstrate that the research they perform is ethically sound.
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Psychosurgery, the surgical alteration or permanent removal of brain tissue to alleviate severe psychological conditions, stands as one of the most radical and controversial treatments in the history of mental health care. Its development and application have evolved significantly, marked by dramatic shifts in scientific understanding and ethical perspectives.
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Drug control governance involves the oversight and regulation of pharmaceuticals to ensure their safety and efficacy while preventing illegal drug use and trafficking. Regulatory bodies, including the US Food and Drug Administration (FDA) and the European Union's European Medicines Agency (EMA), play a central role in this process. These agencies evaluate the safety and efficacy of drugs before they can be marketed. They fund clinical trials and assess the benefits and risks associated with...
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Institutional Review Boards: Purpose and Challenges.

Christine Grady1

  • 1Department of Bioethics, Clinical Center, National Institutes of Health, Bethesda, MD.

Chest
|June 5, 2015
PubMed
Summary

Institutional Review Boards (IRBs) ensure human subject protection in research. Current systems face challenges with efficiency and consistency, prompting reforms and the need for evidence-based models.

Area of Science:

  • Bioethics
  • Regulatory Science
  • Clinical Research Administration

Background:

  • Institutional Review Boards (IRBs) are critical for protecting human research participants through ethical review.
  • IRBs have been regulated in the US for over 30 years and are globally mandated.
  • The evolving research landscape necessitates adaptation of IRB review and oversight systems.

Purpose of the Study:

  • To examine the current state of IRB review and oversight.
  • To address growing dissatisfaction with IRB system inefficiencies and inconsistencies.
  • To explore the need for evidence-based reforms and adaptable models for current and future research.

Main Methods:

  • Review of existing literature on IRB functions and challenges.
  • Analysis of proposals for IRB reform and alternative oversight models.

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  • Examination of regulatory changes impacting IRB operations.

    • Main Results:

    • Evidence suggests inconsistencies in IRB review and regulation application, leading to dissatisfaction.
    • Concerns exist regarding the time burden and unproven effectiveness of current IRB processes.
    • Centralized and shared review models are gaining traction but require further evidence.

    Conclusions:

    • The current IRB system requires significant updates to address efficiency and effectiveness concerns.
    • Developing and testing new, adaptable review models is crucial for participant protection.
    • Further data and resourcefulness are needed to ensure robust and respectful oversight in human research.