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Related Concept Videos

Clinical Trials01:16

Clinical Trials

Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
Clinical Trials: Overview01:11

Clinical Trials: Overview

Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
Bioavailability Study Design: Healthy Subjects Versus Patients01:15

Bioavailability Study Design: Healthy Subjects Versus Patients

Bioavailability studies are essential for evaluating a drug's therapeutic efficacy and understanding its absorption patterns under various physiological conditions. Conducting such studies on target patient populations provides more relevant data by simulating real-world disease states. However, practical challenges often necessitate the use of young, healthy adult volunteers as study subjects.Patients may exhibit altered drug absorption patterns due to the effects of the disease itself,...
Nurses' Legal Responsibilities I01:27

Nurses' Legal Responsibilities I

In healthcare, informed consent is a crucial process that involves thoroughly communicating medical treatment options to patients, including benefits, risks, potential side effects, and alternatives. This process enables patients to make well-informed decisions about their care, ensuring they understand the implications of their choices before consenting to or refusing treatment.
The legal responsibilities of a nurse regarding informed consent include the following:
Preclinical Development: Overview01:28

Preclinical Development: Overview

Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...
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.

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Working with Human Tissues for Translational Cancer Research
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[The informed consent in international clinical trials including developing countries].

Alexander Montenegro Surís1, Magda Elaine Monreal Agüero

  • 1Centro Nacional Coordinador de Ensayos Clínicos. alexander@cencec.sld.cu

Cuadernos De Bioetica : Revista Oficial De La Asociacion Espanola De Bioetica Y Etica Medica
|April 12, 2008
PubMed
Summary

Informed consent in developing countries requires community input and culturally appropriate communication. Documentation and local oversight are crucial for ethical clinical trials, ensuring volunteer protection.

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Area of Science:

  • Clinical Research Ethics
  • Global Health Trials
  • Informed Consent Procedures

Context:

  • Ethical considerations in international clinical trials, particularly in developing nations.
  • The informed consent process is a significant point of ethical debate in global health research.
  • Challenges in applying standard informed consent protocols in diverse cultural and socioeconomic settings.

Purpose:

  • To outline recommendations for improving the informed consent process in clinical trials conducted in developing countries.
  • To highlight key considerations for ethical research conduct in resource-limited settings.
  • To address the unique challenges of obtaining voluntary informed consent from participants in developing nations.

Summary:

  • A literature review identified critical aspects for informed consent in developing countries, emphasizing community involvement.
  • Effective informed consent requires culturally adapted communication methods, local translation, and may necessitate alternatives to traditional signed forms.
  • Documentation of consent should be carefully considered, moving beyond simple signing and dating of forms.

Impact:

  • Enhancing participant protection and ethical standards in clinical trials conducted globally.
  • Promoting culturally sensitive and effective communication in international health research.
  • Informing the development of pragmatic research to ensure voluntary participation and ethical conduct in diverse settings.