title: Development of the Good Health Research Practice course: ensuring quality across all health research in humans.
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.
authors.affiliation: London School of Hygiene and Tropical Medicine, London, United Kingdom.
authors.forename: Patricia
authors.initials: P
authors.lastname: Henley
authors.affiliation: Freelance Consultant, Chennai, India.
authors.forename: Varalakshmi
authors.initials: V
authors.lastname: Elango
authors.affiliation: Institute of Public Health, University of Heidelberg, Heidelberg, Germany.
authors.forename: Olaf
authors.initials: O
authors.lastname: Horstick
authors.affiliation: Center for Tropical Medicine, Faculty of Medicine, Universitas Gadjah Mada, Gedung PAU, Jl, Teknika Utara, Barek, Yogyakarta, 55281, Indonesia.
authors.forename: Riris Andono
authors.initials: RA
authors.lastname: Ahmad
authors.affiliation: World Health Organization, Geneva, Switzerland.
authors.forename: Christine
authors.initials: C
authors.lastname: Maure
authors.affiliation: UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases, Geneva, Switzerland.
authors.forename: Pascal
authors.initials: P
authors.lastname: Launois
authors.affiliation: London School of Hygiene and Tropical Medicine, London, United Kingdom.|UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases, Geneva, Switzerland.
authors.forename: Corinne
authors.initials: C
authors.lastname: Merle
authors.affiliation: Freelance Consultant, Heidelberg, Germany.
authors.forename: Jamila
authors.initials: J
authors.lastname: Nabieva
authors.affiliation: Center for Tropical Medicine, Faculty of Medicine, Universitas Gadjah Mada, Gedung PAU, Jl, Teknika Utara, Barek, Yogyakarta, 55281, Indonesia. yodi_mahendradhata@yahoo.co.uk.
authors.forename: Yodi
authors.identifier: http://orcid.org/0000-0002-4522-1785
authors.initials: Y
authors.lastname: Mahendradhata
mesh_terms: D035843:Biomedical Research / Q000193:education* / Q000592:standards; D003479:Curriculum; D004501:Education, Medical; D006805:Human Experimentation / Q000592:standards*; D006801:Humans; D010865:Pilot Projects; D017410:Practice Guidelines as Topic; D011364:Professional Practice / Q000592:standards; D011787:Quality of Health Care
keywords: Capacity building; Developing Countries; Ethics; Quality; Training