Research site monitoring for compliance with ethics regulatory standards: review of experience from Uganda

BMC Medical Ethics

Paul Kutyabami³  Frederick Nakwagala⁴  Julius Ecuru²  Joseph Ochieng¹ 

[1] Department of Anatomy, School of Biomedical Sciences, College of Health Sciences, Makerere University, Mulago Hill, P.O Box 7072, Kampala, Uganda;Uganda National Council for Science and Technology, Plot 6 Kimera Road, P.O Box 6884, Kampala, Ntinda, Uganda;Department of Pharmacy, College of Health Sciences, Makerere University, P.O Box 7072, Kampala, Uganda;Mulago Hospital, Mulago Hill, P.O Box 7051, Kampala, Uganda

关键词: Uganda;    Ethics;    Compliance;    Monitoring;    Research;   

Others  :  799941
DOI  :  10.1186/1472-6939-14-23

 received in 2012-10-16, accepted in 2013-05-31,  发布年份 2013

【 摘 要 】

Background

On site monitoring of research is one of the most effective ways to ensure compliance during research conduct. However, it is least carried out primarily for two reasons: presumed high costs both in terms of human resources and finances; and the lack of a clear framework for undertaking site monitoring. In this paper we discuss a model for research site monitoring that may be cost effective and feasible in low resource settings.

Methods

This was a retrospective review of research site monitoring reports covering a period of four years.

Results

The monitoring was conducted by the Uganda National Council for Science and Technology, the National Drug Authority and the National HIV/AIDS Research and Ethics Committee over the period 2007 to 2010.

The monitoring team was usually three members comprising of two experts in research ethics and an assistant. A total of 28 site monitoring visits covering 40 research projects were reviewed. 25% of the site monitoring reports revealed violation of the regulatory requirement for valid ethical approval. 36% of the site reports showed some instances of informed consent violation, 28% showed violation of the rights and welfare of research participants, 38% revealed that sites did not report SAEs to regulatory authorities and many sites lacked adequate GCP and GCLP. However, most of the sites monitored had adequate facilities to conduct the respective studies and good working practices.

Conclusion

This model employed by the monitoring teams to evaluate research compliance is effective in auditing ethical practice. Compliance monitoring is feasible and affordable in a resource limited setting. Research protocol non compliance is still a major problem in Uganda, and there is need for a pro-active approach to this vice by all stake holders if ethical conduct of research is to be achieved.

【 授权许可】

   
2013 Ochieng et al.; licensee BioMed Central Ltd.

【 参考文献 】

• [1]Uganda National Council for Science and Technology: National Guidelines for the Conduct of Research Involving Humans as Participants. 2007. http://www.uncst.go.ug webcite
• [2]World Medical Association: Ethical principles for medical research involving human subjects. Seoul Korea: Declaration of Helsinki 2008. 59th WMA General assembly; 2008. http://www.wma.net webcite
• [3]Belmont Report: Ethical principles and guidelins for the protection of human subjects of research. Report of the National commission for protection of the human subjects of biomedical and behavioral research; 1979. http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html webcite
• [4]International ethical guidelines for biomedical research involving human subjects. Geneva: Concil for international organization of medical sciences (CIOMS) in collaboration with World Medical Organization (WHO); 2002. http://www.cioms.ch/publications/laout_guide webcite 2002/pdf
• [5]Nuffield Council on Bioethics: The ethics of research related to healthcare in developing countries. Nuffield council; 2002.
• [6]Operational guidelines for ethics committees that review biomedical research. Geneva: World Health Organization (WHO); 2000.
• [7]UNAIDS/WHO Guidance document: Ethical considerations in biomedical HIV prevention trials. Joint United Nations Programme on HIV/AIDS (UNAIDS); 2012.
• [8]Convention for the protection of human rights and diginity of the human being with regard to the application of biology and medicine. Oviedo, 4.IV: Convention on human rights and biomedicine; 1997.
• [9]WHO technical report: Guidelines for good clinical practice (GCP) for trials on pharmaceutical products. World Health Organization technical report serries No. 850, 1995, annex 3; 1995.
• [10]Nchangwi Syntia M, Tangwa GB, Chi Primus C, Laurent V, Odile O-M-O-B: Are students kidding with health research ethics? The case of HIV/AIDS research in Cameroon. BMC Med Ethics 2012, 13:12. BioMed Central Full Text
• [11]Mudur G: John Hopkins admits scientist used Indian patients as guinea pigs. BMJ 2001, 323:7323.
• [12]Dyer O: GP suspended for enrolling patients in drug trials without consent. BMJ 2003, 326:304.
• [13]Dyer C: Doctor admits research fraud. Br Med J 1998, 316:645.
• [14]Lenzer J: Secret report surfaces showing that Pfizer was at fault in Nigerian drug tests. BMJ 2006, 332:1233.
• [15]Kovac C: Nigerians to sue US drug company over meningitis treatment. BMJ 2001, 323:592.
• [16]Wise J: Pfizer accused of testing new drug without ethical approval. BMJ 2001, 322:194.
• [17]Ochieng J, Bukuluki P: Perception, Understanding and Practice of Ethics during Research on Humans. East Cen Afr J Surg 2007, 12:1.
• [18]Pickworth E: Should local research ethics committees monitor research they have approved? J Med Ethics 2000, 26:330-333.
• [19]Dickert N, Emanuel E, Grady C: Paying research subjects: an analysis of current policies. Ann Intern Med 2002, 136:368-373.