GCP Clinical Research aims to create generalizable knowledge that advances human biology knowledge or human health. Clinical research participants enable the preservation of that knowledge. One way to determine their safety or efficacy is by testing new medications or treatments on willing patients.
Clinical research, however, has the potential to take advantage of patient volunteers by putting some people at risk of harm for the benefit of others. The goal of ethical standards is to safeguard both patient volunteers and the scientific method — it is the major element of the Basics of Good Clinical Practice.
Common Ethical Codes that Guide Good Clinical Practice (GCP) Study:
- Nuremberg Code,
- Declaration of Helsinki,
- Belmont Report,
- CIOMS and,
- US Common Rule.
By thoroughly studying these ethical codes, seven principles are proposed to guide the conduct of ethical research:
Social and Clinical Significance:
Research studies are conducted to find out the answers to a particular problem or subject of interest. In the case of the Good Clinical Practice (GCP) Study, the answer should be scientifically valid and valuable enough to justify the participation of subjects and risking their lives for the betterment of a community.
Scientific Facts:
GCP clinical research should be designed in a way that validates the questions asked. The objectives should be clear and understandable.
Fair Subject Selection:
Participants should be chosen in a way that minimizes the risks and adds value to the Good Clinical Practice (GCP) Study. Minorities and people from diverse backgrounds should not be excluded from getting the benefits of a clinical study without a substantial reason.
Risk-Benefit ratio:
It is important to weigh the risks and benefits before conducting GCP Clinical Research as it helps to maintain the safety of the participants.
Independent Review:
Before the commencement of a Clinical Trial, it should be reviewed by a neutral regulatory body. In this case, Institutional Review Board (IRB) reviews all the materials.
Informed Consent:
To keep the research within the ethical parameters, most agree that the participants should make an informed decision regarding participation in the Clinical Trial.
Consideration for Enrolled Participants:
Respecting a participant’s decision to take part in a Clinical Trial is important. They should be valued and respected from the day they enter into the Clinical Trial till the end of the trial. Respecting their privacy and protecting their information, acknowledging their right to change their mind in between the trial, and keeping a check on their well-being during the trial is proof of successful GCP Clinical Research. Most of the monitors take care of these points but are reluctant in sharing the study results with the participants.
