Abstract
Quality and ethics need to be embedded into all areas of research with human participants. Good Clinical Practice (GCP) guidelines are international ethical and scientific quality standards for designing, conducting, recording and reporting trials involving human participants. Compliance with GCP is expected to provide public assurance that the rights, safety and wellbeing of participants are protected and that the clinical research data are credible. However, whilst GCP guidelines, particularly their principles, are recommended across all research types, it is difficult for non-clinical trial research to fit in with the exacting requirements of GCP. There is therefore a need for guidance that allows health researchers to adhere to the principles of GCP, which will improve the quality and ethical conduct of all research involving human participants. These concerns have led to the development of the Good Health Research Practice (GHRP) course. Its goal is to ensure that research is conducted to the highest possible standards, similar to the conduct of trials to GCP. The GHRP course provides training and guidance to ensure quality and ethical conduct across all health-related research. The GHRP course has been run so far on eight occasions. Feedback from delegates has been overwhelmingly positive, with most delegates stating that the course was useful in developing their research protocols and documents. Whilst most training in research starts with a guideline, GHRP has started with a course and the experience gained over running the courses will be used to write a standardised guideline for the conduct of health-related research outside the realm of clinical trials, so that researchers, funders and ethics committees do not try to fit non-trials into clinical trials standards.
Highlights
High-quality research is essential to achieving global health goals; to this end, the past few years have witnessed an expansion of health research activities in low- and middle-income countries (LMICs) [1]
Available guidelines and their limitations Biomedical researchers have followed specific guidelines and regulations for many years to ensure the safe and ethical conduct of their research; from the Nuremberg Code written in 1947 following the atrocities committed by the Nazis during World War II, to the World Medical Association’s Declaration of Helsinki (DoH), an international ethical standard applicable to all research on humans most recently updated in 2013 [4]
The group used their collective experience from clinical trials and conducting other health-related research, to develop an outline to ensure that all delegates would, by the end of the course, have a fully developed protocol and associated tools and procedures that would ensure quality of the conduct of the research
Summary
High-quality research is essential to achieving global health goals; to this end, the past few years have witnessed an expansion of health research activities in low- and middle-income countries (LMICs) [1]. There is a need for guidelines that allow health researchers to adhere to the principles of GCP, which will improve the quality and ethical conduct of all research involving human participants These concerns have led to the development of the Good Health Research Practice (GHRP) course. Its goal is to ensure that research is conducted to the highest possible standards, similar to the conduct of trials to GCP The group used their collective experience from clinical trials and conducting other health-related research, to develop an outline to ensure that all delegates would, by the end of the course, have a fully developed protocol and associated tools and procedures that would ensure quality of the conduct of the research. Privacy of the research participants and confidentiality of all data acquired during the study should be duly protected
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