Graduates of a research and development program can work in many different areas of the pharmaceutical industry. Whether working in a testing laboratory or for a pharmaceutical company, it’s important that any research you conduct adheres to the standards laid out by the Good Clinical Practice (GCP) guidelines.
GCP guidelines are set out by the International Council on Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). These international quality standards govern the designing, conducting, and reporting of clinical trials that involve human subjects.
With its roots in the Declaration of Helsinki and the Belmont Report, GCP guidelines have undergone many changes over the last century, but their central purpose remains the same: to protect the rights, safety, and well-being of the human subjects involved in research.
Here’s why these guidelines are so important.
GCP Guidelines Protect the Rights and Safety of Research Subjects
The old Hippocratic Oath of ancient Greece, which stated that any physician needs to be mindful of the well-being of their patient over anything else, is still binding today. This extends to those involved in any field of health and health research, including pharmaceutical researchers.
The central purpose of the GCP guidelines is to protect the rights, safety, and well-being of human subjects used in research. It’s inevitable that human subjects need to be occasionally used in research, but by adhering to these protocols, potential harm can be greatly minimized.
Professionals with pharmaceutical training know the ways in which the GCP guidelines help to safeguard against unethical research. Briefly, these relate to ideas such as:
- Voluntary participation: subjects should not participate against their will
- Informed consent:subjects should be aware of what the research will entail, and what potential harm could come to them, as much as possible within reason
- Confidentiality:the privacy of research subjects should be protected as much as possible
After Pharmaceutical Training, GCP Helps Ensure Your Research Is Consistent and Reliable
Aligning your research with the GCP guidelines shows that it is conducted ethically, safely, and credibly Additionally, the GCP guidelines help make sure that research is going to be beneficial and worthwhile, by weighing the potential harm against the overall potential benefits of the study.
Students in pharma courses will learn the protocols of followingGCP guidelines.This helps to guard the safety of research subjects, but also makes sure the research is fair and just. Adhering to these ethical guidelines:
- increases the quality of research
- makes sure that it is compliant with the accepted scientific norms
- ensures that it is consistently and accurately reported
Coordinate Research Standards on an International Scale
What makes the GCP guidelines so important and effective is that they are applicable on an international scale. Aligning your research with them will standardize your ethical protocols globally. No matter where in the world your research is conducted, other researchers will understand its credibility if it is explicitly aligned with the GCP standards.
One of the central issues with international research efforts, especially that which is conducted in the Global South, is the lack of standardization. Different ethical protocols in different places makes it difficult to align research efforts on a global scale. By adhering to the GCP guidelines, researchers can be certain that their protocols are understood by different scientific communities throughout the world.
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