"Good Clinical Practice" (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible. The International Conference on Harmonization developed the Good Clinical Practice Guideline which was adopted by Health Canada's Therapeutic Directorate Products (TDP).
The GCP is important to prevent unethical research practices! These ethical guidelines evolved from the Nuremburg code, which was created as a result of the atrocious unethical practices that occurred during WWII. Other examples of unethical practices include the Tuskegee syphilis trial (1932-1972), in which over 600 African American men were used to study the progression of syphilis, and were not treated even after a proven treatment, penicillin has become known. Unethical practices have even occurred as recently as 2012, when a Rotavirus clinical study was conducted on 6800 infant. In the randomized double blind study, only 1/3 of the infants were administered vaccination for the rota virus!
THE FUNDAMENTAL STEPS BEFORE A STUDY CAN BEGIN:
- Research Question
- Study Team (principle investigator, research staff, funding source, etc.)
- Study Protocol (objectives, design of study, methods and procedures, proposed sample size and target population, statistical analysis)
- Informed Consent
- Recruitment material
- Ethics Approval (REB)
- Operational and Administrative Approvals
- Research Agreement
WHAT IS INFORMED CONSENT?
To set up a study, each recruited patient must be fully informed and voluntarily consent to participate. Informed consent is an on-going process that starts with the researcher's first contact with the individual and continues until the study is complete or the participant withdraws.
The elements of an informed consent form include:
- Objective of study
- Design and length of study
- Sample size
- Risks and benefits
- Statement of privacy and confidentiality
- Freedom to withdraw participation
- Compensation and/or treatment for any incurred injury during study
- Research team contact information