Posts Tagged ‘IRB/REC’


Research Ethics Committees in Nigeria: A Survey of Operations, Functions, and Needs

Thursday, August 31st, 2017

Abstract: Heightened global commitment to research on diseases such as HIV/AIDS, tuberculosis, and malaria has led to increased research over the past decade in many African countries, including Nigeria. This increase in research has led to debates about the ethics of health research in resource-poor or developing countries and has drawn further attention to existing ethical review processes. This study was undertaken to describe and benchmark the operational and organizational structures as well as functions of research ethics committees (RECs) in Nigeria. The article explores the factors that contribute to REC conformity with the Nigerian National Ethics Code and World Health Organization (WHO) guidelines for RECs. Data were collected using a self-administered, semistructured questionnaire. A descriptive analysis was conducted, and Fisher’s exact tests performed to assess associations between selected REC characteristics and the degree of conformity to applicable national and international requirements. Eighty percent of RECs (20 out of 25) had standard operating procedures, while 68% (17 out of 25) met at least quarterly and provided final review determinations within three months. RECs with committee chairs who had prior bioethics training were more likely to have operations conforming to the WHO and the Nigerian ethics guidelines. Overall, this study suggests that there is variability in the degree to which operations and functions of RECs in Nigeria conform to the Nigerian National Code and WHO guidelines.

 

Research Ethics Committees in Nigeria: A Survey of Operations, Functions, and Needs,. Aminu A. Yakubu, Adnan A. Hyder, Joseph Ali, and Nancy Kass. IRB: Ethics & Human Research. 2017. May-June 2017 Volume: 39, Issue: 3

FABTP awarded NIH G-11 grant for IRB strengthening in Zambia

Friday, November 4th, 2016

The National Institutes of Health (NIH) has awarded the FABTP and University of Zambia a G-11 grant to improve the University of Zambia Biomedical Research Ethics Committee(UNZABREC).  The project has the goal of Enhancing Management and Performance of the Office and Work of the Ethics committee for Research (EMPOWER) in Zambia.

The FABTP EMPOWER project to strengthen UNZABREC capacity in both ethical quality and administrative efficiency builds on and complements the strong research presence of Johns Hopkins University (JHU), not only in bioethics related collaborations but working on research projects more broadly in Zambia. There are at least eleven different HIV-related studies, and multiple additional studies on other topics, on which JHU collaborates with colleagues in Zambia. These studies each require efficient and high quality, local ethics review – a goal our Zambian colleagues agree is both critical but currently only variably realized.   There are three co-Principal Investigators (co-PIs) for this work: Drs. Nancy Kass and Adnan Hyder from JHU and Dr. Charles Michelo from UNZA. The three co-PIs will have shared responsibility for oversight of all aspects of training, capacity development and budget and will together serve as the Executive Committee for EMPOWER.

The NIH funding will allow the EMPOWER project to carry out several core program activities. EMPOWER will support one UNZABREC member or staff to attend a one month intensive program at JHU each year; this will be in addition to one person from UNZA supported by FABTP annually.  EMPOWER will also support system evaluation, seminars and webinars.

 

New NIAID online database compares research regulations across countries

Wednesday, September 17th, 2014

NIAID has launched the ClinRegs website, a public online database of country-specific regulatory information on clinical research. ClinRegs is designed to allow researchers to plan international clinical trials more efficiently by consolidating regulatory requirements in one place and enabling comparisons across select countries.


Access the site here: http://clinregs.niaid.nih.gov

Impact of Three Years Training on Operations Capacities of Research Ethics Committees in Nigeria

Monday, October 14th, 2013