Studies on informed consent to medical research conducted in low or middle-income settings have increased, including empirical investigations of consent to genetic research. We investigated voluntary participation and comprehension of informed consent among women involved in a genetic epidemiological study on breast cancer in an urban setting of Nigeria comparing women in the case and control groups.
Background: The formulation and implementation of national ethical regulations to protect research participants is fundamental to ethical conduct of research. Ethics education and capacity are inadequate in developing African countries. This study was designed to develop a module for online training in research ethics based on the Nigerian National Code of Health Research Ethics and assess its ease of use and reliability among biomedical researchers in Nigeria.MethodologyThis was a three-phased evaluation study. Phase one involved development of an online training module (...) based on the Nigerian Code of Health Research Ethics (NCHRE) and uploading it to the Collaborative Institutional Training Initiative (CITI) website while the second phase entailed the evaluation of the module for comprehensibility, readability and ease of use by 45 Nigerian biomedical researchers. The third phase involved modification and re-evaluation of the module by 30 Nigerian biomedical researchers and determination of test-retest reliability of the module using Cronbach’s alpha. Results: The online module was easily accessible and comprehensible to 95% of study participants. There were significant differences in the pretest and posttest scores of study participants during the evaluation of the online module (p = 0.001) with correlation coefficients of 0.9 and 0.8 for the pretest and posttest scores respectively. The module also demonstrated excellent test-retest reliability and internal consistency as shown by Cronbach’s alpha coefficients of 0.92 and 0.84 for the pretest and posttest respectively. Conclusion: The module based on the Nigerian Code was developed, tested and made available online as a valuable tool for training in cultural and societal relevant ethical principles to orient national and international biomedical researchers working in Nigeria. It would complement other general research ethics and Good Clinical Practice modules. Participants suggested that awareness of the online module should be increased through seminars, advertisement on government websites and portals used by Nigerian biomedical researchers, and incorporation of the Code into the undergraduate medical training curriculum. (shrink)
This article featuring Nigeria constitutes one of five articles in a collection of essays on local capacity-building in research ethics by graduates from the University of Toronto’s Joint Centre for Bioethics MHSc in Bioethics, International Stream programme funded by the Fogarty International Center for Advanced Study in the Health Sciences (FIC). The first National Health Research Ethics Committee was inaugurated in 2006. Since then, more institutional health research ethics committees continue to be formed. However, research ethics challenges in Nigeria are (...) systemic and require a systems approach to address them effectively. Nigeria requires capacity-building for authentic acculturation of health systems as well as for health research, education, and advocacy within the research community and the general public. Further, it requires relevant legislation and effective regulatory measures. (shrink)
With the completion and the success of the unraveling of the human and some nonhuman genetic codes comes the optimism that science, once again, is at the threshold of transforming human existence in an unprecedented way. The sequencing of the human genome with the science and technology by which it occurs is seen as a potential gateway to man's final conquest of most of the health and health related disorders that have for long plagued the human race.While some developing nations (...) like Cuba, Mexico and India have taken the initiative to be major players in the genomics arena by exploring its potentials towards enhancing improved quality of life for their citizens, the majority of others, especially in Africa, still occupy the spectators' seat. If this apparent lukewarm attitude continues, it implies that the present dependence on the developed nations as remote beneficiaries of gains of scientific breakthroughs will persist. It also means that the expectation that genomics should, among other benefits, re-dress the inequalities of access to health care between the rich and poor nations may be a mirage for a long time to come.The expected benefits from the human genome project and genomics technologies are fascinating and hold the ace for improving the standards of living of the African people. However, these expectations are futuristic, time-dependent and capital intensive. They require commitments of national governments to policy re-orientation about research and development, strategic planning, resource mobilization, priority setting; and establishing, promoting and sustaining enabling environments for scientific and technological breakthrough. No doubt, there is dire need for assistance from the developed and the frontline developing nations in this regard. However, great initiatives and deep commitments to making significant scholarly contributions to the advancement of biotechnology and its potentials in the near future must come from within. (shrink)