Our Clinical Research 101 series takes an in-depth look at key steps and tips for navigating the clinical research process. The second installment in our Clinical Research 101 series is by Leslie Love, Senior Project Manager at CHÉOS, on the importance of Good Clinical Practice (GCP) guidelines.
Ms. Love is a certified clinical research professional with over 20 years of experience in a variety of research settings. Her primary role is to provide project management support to CHÉOS and Canadian HIV Trials Network-supported investigators, as well as develop research training materials and programs. Ms. Love is one of many project managers who work for CHÉOS. The Centre’s project managers are experts in the regulatory, policy, budgeting, and implementation requirements for clinical research studies, and can be contacted for consultation by completing our Service Request Form.
Good Clinical Practice (GCP) is an international standard for the design, conduct, performance, recording, analyzing, and reporting of research that involves human participants. Ultimately, GCP is in place to protect the rights, safety, and welfare of humans participating in research, and to assure the quality, reliability, and integrity of data collected. All members of the research team (investigators, sponsors, and Research Ethics Boards) are required to follow GCP.
The topic of research ethics in clinical research came to public attention after World War II, when it was discovered that the Nazis had conducted experiments on humans, without their consent, and that these experiments often led to serious complications and even death.
At the subsequent Nuremberg trials, these experiments were declared a crime against humanity, and a document was created defining ten points for undertaking legitimate medical research (the Nuremberg Code). These standards included: the requirement to have a valid reason for the research, that all participation is voluntary and requires informed consent, a requirement to minimize risks, and that the participant may end their participation at any time. These standards were developed further and expanded upon by other organizations (e.g. the World Medical Association’s Declaration of Helsinki, the Belmont Report on research in the U.S., and the Tri-Council Policy Statement in Canada). In 1996, regulatory and pharmaceutical companies from the U.S., Japan, and Europe, with observers from Canada, Australia, the Nordic countries, and WHO, met to develop detailed GCP guidelines as a unified international standard for clinical trials that should also be applied to all types of clinical research.
Whenever clinical research is conducted in Canada or internationally, GCP must be followed. Study team members are often asked by their institution or the sponsor of the study to complete training on GCP before undertaking any clinical studies. The ethical conduct of research is not only obeying the regulations, but taking responsibility for what happens during a study in which a researcher or their team is involved.
Fortunately, while outright misconduct in clinical research is rare, regulatory agencies including Health Canada will consider errors made due to lack of knowledge of the standards as a reportable offense during inspections.
- International Conference on Harmonization (ICH): Good Clinical Practice
- ICH Guidance E6: Good Clinical Practice: Consolidated Guidelines
- The Nuremberg Code
Still have questions?
If you have any questions on the details of GCP in a clinical research study, please contact researchsupport[at]cheos.ubc.ca and we can assist you.