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Related Concept Videos

Ethics in Research01:56

Ethics in Research

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.
Drug Regulation01:25

Drug Regulation

Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
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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.
Historical Development of Psychosurgery
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Drug Control Governance: Regulatory Bodies and Their Impact

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 a...
Bioequivalence studies: Biowaivers01:13

Bioequivalence studies: Biowaivers

In certain scenarios, in vitro dissolution tests can replace in vivo bioequivalence studies. This is particularly true when a drug product, though available in varying strengths, maintains proportional similarity in its active and inactive ingredients. In such cases, the need for in vivo bioequivalence studies for lower strength variants may be waived, provided dissolution tests and in vivo studies on the highest strength yield satisfactory results.Bioequivalence can be indicated through...
Pharmacovigilance01:19

Pharmacovigilance

Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
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Related Experiment Video

Updated: May 31, 2026

Working with Human Tissues for Translational Cancer Research
07:48

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Published on: November 26, 2015

Institutional review boards - a mixed blessing.

Taimur Saleem1, Umair Khalid

  • 1Medical College, Aga Khan University, Stadium Road, Karachi 74800, Pakistan. taimur@gmail.com.

International Archives of Medicine
|June 22, 2011
PubMed
Summary
This summary is machine-generated.

Institutional Review Boards (IRBs) are crucial for ethical medical research oversight, especially in developing countries. Reorganizing IRB functions is needed for more efficient and effective research review processes.

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Area of Science:

  • Medical research ethics
  • Clinical trial oversight
  • Global health research governance

Background:

  • Institutional Review Boards (IRBs) are essential for ensuring research integrity and ethical conduct.
  • IRBs face increased relevance in developing countries due to a rise in pharmaceutical-funded clinical trials.
  • Current IRB operations are criticized for bureaucratic inefficiencies and red tape.

Purpose of the Study:

  • To analyze the critical role of IRBs in medical research.
  • To address the challenges and criticisms faced by IRBs, particularly in developing nations.
  • To propose a reorganization of IRB functions for improved efficiency and effectiveness.

Main Methods:

  • Review of existing literature on IRB functions and global clinical trial trends.
  • Analysis of criticisms regarding IRB bureaucracy and delays.
  • Examination of the evolving landscape of medical research.

Main Results:

  • IRBs are vital for transparent, feasible, and ethical scientific investigation.
  • The increasing number of clinical trials in developing countries highlights the need for effective IRB oversight.
  • Criticisms point to unnecessary bureaucracy hindering research progress.

Conclusions:

  • IRBs require functional reorganization to adapt to dynamic research environments.
  • Enhancing IRB efficiency is crucial for timely and ethical medical research.
  • A more judicious and effective approach to IRB operations is necessary.