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PP122 Strengthening Ethics Compliance In A Large Research Program: Uganda
- Sylvia Nabukenya, Barbara Castelnuovo, Andrew Kambugu, Maimouna Kayaga, Bruce Opio, Richard Orama, Stephen Okoboi
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- Journal:
- International Journal of Technology Assessment in Health Care / Volume 33 / Issue S1 / 2017
- Published online by Cambridge University Press:
- 12 January 2018, p. 129
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- Article
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- You have access Access
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INTRODUCTION:
The infectious Diseases Institute (IDI) is a research institute at the College of Health Sciences, Makerere University. Over the years, the number of research studies has greatly increased with an average of fifty active studies per year. Because of the voluminous study activities, investigators were faced with inadvertences of ethical approval deadlines (1). In 2015, a centralized electronic Regulatory Affairs Information System (RAIS) was developed and piloted to track the regulatory process of the entire research projects. RAIS is a web-based system, developed using a Net framework and runs on any operating system using a web browser such as “Google Chrome” and “Mozilla Firefox”.
METHODS:A signed approval letter from an accredited Research Ethics Committee, National Drug Authority and Uganda National Council of Science and Technology, the reviewed protocol, consent forms and data collection tools are uploaded electronically into the RAIS with study staff contact information, CVs and Good Clinical Practice (GCP) certificates. RAIS sends automatic “no reply” emails to the investigators and research administration notifying for the need of annual renewal 56, 28 and 14 days before the expiry date of the approvals. The investigator or designated person prepares the application package which is then forwarded to the Research Regulatory Officer for review and submission to the regulatory authority.
RESULTS:From January 2015 to November 2016, fourty-three ongoing studies were uploaded to the RAIS of which eleven were clinical trials, twenty-one observational studies, seven diagnostic and four implementation studies. Studies that obtained their annual approvals before the expiry date was 90.7 percent, compared to 29 percent that had reported early submission for annual renewal between January 2013 and December 2014. RAIS has enabled continuity of study activities with timely annual renewed approvals, supported the tracking of staff GCP certificates and populated timely notifications to investigators, resulting in submission of annual application packages on time.
CONCLUSIONS:RAIS has strengthened ethical regulatory compliance and provided an effective platform for tracking regulatory processes, thus enabled continuity of study activities with timely annual renewal approvals and greatly supported the tracking of staff GCP certificates.
17 - HIV/AIDS
- from Section 4 - Major common infections
- Edited by David Mabey, London School of Hygiene and Tropical Medicine, Geoffrey Gill, University of Liverpool, Eldryd Parry, Martin W. Weber, Christopher J. M. Whitty, London School of Hygiene and Tropical Medicine
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- Book:
- Principles of Medicine in Africa
- Published online:
- 05 March 2013
- Print publication:
- 02 January 2013, pp 195-231
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- Chapter
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Summary
In 1982, physicians in South West Uganda noticed a new disease with prominent symptoms of weight loss and diarrhoea, known locally as slim disease, and in 1983 patients with opportunistic infections and Kaposi's sarcoma (KS) were identified in hospitals in Rwanda and Zaire. These observations were made shortly after reports of clusters of unusual diseases associated with profound immunosuppression among men who had sex with men in the United States. These reports were the first to draw public attention to the acquired immunodeficiency syndrome (AIDS), initially as an unusual new disease, and now undoubtedly the greatest challenge to global public health in recent years.
The problem in Africa
The global burden of HIV disease continues to fall most heavily in sub-Saharan Africa, home to around two-thirds of the 33.3 million people estimated to be living with HIV/AIDS in 2010 (Fig. 17.1) (UNAIDS). Since 2000, the global epidemic has stabilized and HIV prevalence is declining in many countries. The number of new HIV infections in African countries peaked in the mid-1990s, and has subsequently declined. AIDS-related mortality in Africa has also declined since 2004, at least partly attributable to remarkable achievements in expansion of access to effective treatment with antiretroviral therapy (ART). In 2009, nearly 37 per cent of people in Africa needing ART received it. Wider coverage of ART is now reducing adult mortality at population level (Floyd et al., 2010), but HIV continues to be a major cause of death among young adults: AIDS remains the largest cause of maternal mortality in South Africa. The principal challenges remain to reduce the number of new cases of HIV infection occurring, and to deliver effective care for the millions already living with the virus.