International Council on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines are considered the global standard for all types of clinical research. Compliance with GCP is seen as a challenge by Indian academic clinical researchers, as they are under the impression that adherence to ICH GCP is mandatory for all types of clinical research. However, compliance with ICH GCP standards is mandatory for pharmaceutical companies intending to submit clinical data to regulatory authorities for supporting new drug approvals. For other types of clinical research, e.g. academics — which could impact the safety and well-being of human participants — ICH GCP recommends that principles of this guideline may be applicable.
The Indian scenario for compliance with scientific and ethical guidelines for research is quite complex. Compliance with Indian GCP is mandatory for clinical trials of new drugs as defined in New Drugs & Clinical Trials Rules 2019. However, for Biomedical and Health Research and academic clinical trials, conformity with ICMR 2017 National Ethical Guidelines is a must. For studies in alternative systems, GCP for ASU -Ayurveda, Siddha, Unani is recommended. These multiple guidelines have overlapping and conflicting provisions. Although there is an urgent need for a revamp of diverse Indian guidelines, these are unlikely to be changed or diluted in the near future. For the academician’s personal research, putting principles of ICH GCP in practice is the best option.
GCP is a continuum which should be implemented across all stages of clinical research – design, conduct, analyses, reporting, and documentation. The foundation of GCP compliance rests on ensuring human protection and data integrity. The principles of GCP embody science – scientifically sound protocol, ethics – EC approval, voluntary informed consent, trained competent clinical researchers, medical care – and accurate documentation of clinical research conduct. However, there are significant GCP compliance issues in clinical research conduct in India. ECs comply with the letter, but not the spirit of GCP guidelines! The quality of informed consent – especially from vulnerable populations, continues to be a concern. Deviations and violations of protocol requirements and study conduct procedures are not uncommon.
The major roles and responsibilities of the clinical researcher during the conduct of research are of 1) protective physician and 2) responsible researcher. He should ensure that the research team is qualified and trained to implement procedures to ensure the integrity of the study tasks and data, and maintain adequate and accurate source documents and trial records. Documentation in clinical research is critical as it is the foundation of quality and essential for demonstration of compliance, and provides evidence for publication. The documentation should support all protocol procedures and decisions taken by the clinical researcher. The researcher should develop his own SOPs for the conduct of clinical research. Finally, the academic researcher should ask himself: Is my clinical research practice good enough to comply with current standards of ethics and science?
An attitudinal shift from compliance to regulations to self-regulation is vital to put in practice the principles of GCP.