Posts Tagged ‘research ethics’


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

New open-access Research Ethics Committee Assessment Toolkit now available for use!

Monday, August 21st, 2017

The Research Ethics Committee Assessment Toolkit (RECAT) is designed to facilitate evaluation of the operational needs of Research Ethics Committees (RECs) globally to inform local quality assurance and quality improvement efforts. The toolkit is published open-access for non-commercial use and now availble for download.

 

The RECAT was developed by the African Bioethics Consortium (ABC) whose members include the Johns Hopkins University-Fogarty African Bioethics Training Program, the University of Zambia School of Medicine, the University of Botswana Office of Research & Development, and the Makerere University College of Health Sciences.

 

Financial support to develop the RECAT was provided to Johns Hopkins University Bloomberg School of Public Health and Berman Institute of Bioethics though a US National Institutes of Health, Fogarty International Center and National Institute of Allergy and Infectious Diseases supplemental grant under Award No. R25TW001604. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Congratulations Nancy Kass on Global Forum on Bioethics in Research Award!

Monday, November 7th, 2016

Dr. Nancy Kass received the Global Forum Award for her contributions to progress in international research ethics at the 2016 Global Forum on Bioethics in Research in Buenos Aires, Argentina.

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.

 

Silent voices: Current and future roles of African research ethics committee administrators

Thursday, November 3rd, 2016

Efforts to strengthen the capacity of research ethics committees in Africa to date have largely targeted their chairs and members, neglecting an explicit focus on research ethics committee administrators, who often manage the reviews and the review committees. The concept of an administrator as a key role player in research ethics review in Africa is only now emerging. No empirical studies have been conducted to describe their position, roles, and responsibilities or their potential to affect positively the quality and responsiveness of ethics review. This questionnaire-based study found that research ethics committee administrators vary greatly in expertise and responsibilities, identifies the administrators’ potential to improve research ethics review performance in Africa, and outlines specific requirements to realize this potential.

Genomics Research Meeting at the University of Botswana

Thursday, November 3rd, 2016

genome-adventures

On Oct 14, 2015, UB hosted a Human Genomics Research Plenary Meeting, focusing on ethical and regulatory issues surrounding bio-banking and genomics research in Africa, attended by 70+ individuals.  Our annual ABC meeting was held the next two days, during which each institution provided updates on work plans and activities, trainees’ practicum projects, and future goals. We also spent time discussing the future of the consortium.  On Oct 17, UB hosted a consortium benchmarking activity around IRB best practices and resource sharing, with a focus on improving efficiency and quality of the IRBs.

 

Ethical challenges in designing and conducting medicine quality surveys

Wednesday, April 27th, 2016

Objectives

 

To identify and discuss the main ethical challenges related to the conduct of surveys and make suggestions on how to address them.

Method

 

Most evidence-based information regarding medicine quality derives from surveys. However, existing research ethical guidelines do not provide specific guidance for medicine quality surveys. Hence, those conducting surveys are often left wondering how to judge what counts as best practice. A list of the main ethical challenges in the design and conduct of surveys is presented.

Results and conclusions

 

It is vital that the design and conduct of medicine quality surveys uphold moral and ethical obligations and analyse the ethical implications and consequences of such work. These are: impact on the local availability of and access to medicines; the confidentiality and privacy of the surveyors and the surveyed; questions as to whether outlet staff personnel should be told they are part of a survey; the need of ethical and regulatory approvals; and how the findings should be disseminated. Medicine quality surveys should ideally be conducted in partnership with the relevant national Medicine Regulatory Authorities. An international, but contextually sensitive, model of good ethical practice for such surveys is needed.

Engaging with research ethics in central Francophone Africa: Reflections on a workshop about ancillary care

Thursday, November 7th, 2013