Informed Consent in Human Subject Research: A Comparison of Current International and Nigerian Guidelines (original) (raw)
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Implementing National System of Health Research Ethics Regulations: The Nigerian Experience
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Efforts by Nigerian authorities to institutionalize health research dates back to the early 70's with the establishment of the Medical Research Council. Subsequently efforts to strengthen a national health research system in line with the concept of Essential National Health Research (ENHR) were made but albeit un-successfully. This may have been as a result of poor political support, and lack of regulations to promote health research in the country. However little is known about health research regulations and their implementation in Nigeria. Health and health research in Nigeria is not regulated via a set of clearly defined legislation. While the country has developed a regulation document for health research ethics, compliance to this document is likely to be affected by the lack of legislation in for the health system as an entity. In this paper we narrate the developments in health, health research, and health regulations; we describe process for, and extent of implementati...
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The use of human subjects in research comes with lots of ethical challenges. The purpose of this review is to assess the various ethical issues that have been associated with biomedical research in Nigeria. This article also finds out the possible ways of improvement of this scenario. Pubmed/Medline, Google Scholar, JSTOR, and AJOL search were the possible search engine for literature from 2000 to 2020. Key words were used including, ethical issues, biomedical research and Nigeria. Of the 113 publications were found., A total of 18(15.9%) articles fulfilled the study inclusion criteria and were included in this review. Twelve ethical issues were highlighted including Informed consent (12 studies), autonomy and voluntariness (8 studies), beneficence (8 studies), counseling (5 studies), compensation (4 studies), professional behavior and attitudes (2 studies), confidentiality (2 studies), social, cultural and religious practices (2 studies), scientific integrity (1 study), communit...
2014 05 Article-Research-Ethics-J R Soc Med-2014-Zielinski-70-76.pdf
Objective: To describe the state of research ethics policies and practices in health research institutions in sub-Saharan African countries. Design: A structured questionnaire was used to solicit information on research ethics from health research institutions. Setting: Forty-two sub-Saharan African countries. Participants: Key informants from the health research institutions. Main outcome measures: Existence of institutional ethics review policies and mechanisms. Results: About half (51%) of respondent institutions reported having policies on research ethics and 58% had written policies requiring that researchers obtain informed consent of research participants. About one-third of respondent institutions (34%) had established ethics review committees, 42% required that studies went through ethics review committees and 46% had linkages with national or regional ethics organisations. Regarding operating procedures for ethics review committees, 53% had adopted standard operating procedures. Less than one-quarter of respondent institutions reported having policies in place to monitor ongoing research. Of the institutions that monitored ongoing research, 34% did an annual ethical review and 74% required a periodic written report. Only 36% provided any type of ethics training for staff, including those conducting health research and those who were not members of the ethics review committee. Conclusions: There are substantial gaps in the capacity of health research institutions in the WHO African Region to undertake ethical review of studies before, during and after studies conducted. There is a need to strengthen such capacity in order to ensure the wellbeing of individuals enrolled in studies and that of communities that host these studies.
Informed consent in international research: perspectives from India, Iran and Nigeria
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The amount of international biomedical research is increasing and much of this is happening in developing countries. It is important to place adequate focus on the issue of obtaining voluntary informed consent. Researchers need to understand local socio-cultural realities and also respect local cultural beliefs and indigenous research guidelines. Through examples from India, Iran and Nigeria the authors highlight the diversity within and between developing country situations. Emphasis is placed on the importance of informed consent in research as well as clinical practice settings, and the need to be enterprising and innovative in obtaining it.
Applying Research Ethics Guidelines: The View from a Sub-Saharan Research Ethics Committee
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Considerable variation has been demonstrated in applying regulations across research ethics committees (RECs) in the U.S., U.K., and European nations. With the rise of international research collaborations, RECs in developing countries apply a variety of international regulations. We conducted a qualitative descriptive pilot study with members of the national REC in Malawi to determine criteria they use to review research, and their views on international collaborations. Qualitative content analysis demonstrated that international guidelines are interpreted in light of local African conditions such that emphasis is placed on examining benefit to the community and ensuring the informed consent process translates concepts in locally-meaningful ways. Members suggest that RECs often must comply with regulations that do not fit local conditions. Recommendations are provided for improving such international collaborations.
Informed Consent Process, the Bane of Unethical Clinical Research; a Review
Clinical Research is a branch of medical science that experiments new drug, medical device or biological on human subjects prior to approval. For the study to be credible, unbiased and generally applicable, all ICH-GCP regulations, other international and local regulations governing ethical clinical research studies should strictly be adhered to. The current regulations for clinical research are based on a combination of ethical thoughts and history. Ethics is different from law and regulation, both of which mandate a certain way of acting. The United States regulations for the protection of human subjects and other regulatory agencies from different countries have provided minimum baseline with which everyone must comply in operating an institutional review board (IRB), obtaining informed consent from research subjects and conducting research in an ethical manner. The challenge, especially in a practical environment such as clinical research, is to translate these regulatory documents, provisions and different ethical principles into action. In clinical research, the consent of the research participants should be received before they are enrolled for trial. Many years after the document governing ethical principles of clinical research was developed and addressing three major areas: respect for persons, beneficence and justice, abuse of informed consent process has been a major ethical problem in most clinical research conducted across the globe and especially those conducted in Africa. Is informed consent process well administered? Do these patients have a good comprehension of the entire research process? Is informed consent a mere signing of a paper to participate in a trial, or a continuous process?. Is there a better way of administering informed consent to achieve a better research outcome that will benefit all? This review shall focus on recalling history of abuses of informed consent process and ways to correct the unethical practice shall be discussed.
INFORMED CONSENT PRACTICES IN NIGERIA
Developing World Bioethics, 2008
Most writing on informed consent in Africa highlights different cultural and social attributes that influence informed consent practices, especially in research settings. This review presents a composite picture of informed consent in Nigeria using empirical studies and legal and regulatory prescriptions, as well as clinical experience. It shows that Nigeria, like most other nations in Africa, is a mixture of sociocultural entities, and, notwithstanding the multitude of factors affecting it, informed consent is evolving along a purely Western model.Empirical studies show that 70–95% of Nigerian patients report giving consent for their surgical treatments. Regulatory prescriptions and adjudicated cases in Nigeria follow the Western model of informed consent. However, adversarial legal proceedings, for a multiplicity of reasons, do not play significant roles in enforcing good medical practice in Nigeria. Gender prejudices are evident, but not a norm. Individual autonomy is recognized even when decisions are made within the family. Consent practices are influenced by the level of education, extended family system, urbanization, religious practices, and health care financing options available. All limitations notwithstanding, consent discussions improved with increasing level of education of the patients, suggesting that improved physician's knowledge and increasing awareness and education of patients can override other influences.Nigerian medical schools should restructure their teaching of medical ethics to improve the knowledge and practices of physicians. More research is needed on the preferences of the Nigerian people regarding informed consent so as to adequately train physicians and positively influence physicians’ behaviors.
Journal of Empirical Research on Human Research Ethics: An International Journal, 2011
we assessed the extent of research ethics approval and informed consent reporting in publications emanating from Cameroon and indexed in PubMed from 2005-2009. In our review of 219 fulllength articles, we found that 57.53% reported ethics approval, 70.78% informed consent, and 50.68% both ethics approval and informed consent. Reporting these procedures was more common in randomized clinical trials than in other study designs. Also, 59.52% of the articles on vulnerable populations documented ethics approval and 76.19% documented informed consent. This study also identified some structures for ethics review and recommends some next steps for research on the quality of ethics review in Cameroon.
Informed consent of human subjects: a review
Bangladesh Journal of Bioethics, 2014
Informed consent is a vital part of the research process, and as such entails more than obtaining a signature on the consent form. Researchers or investigators must educate potential subjects to ensure that they can reach a truly informed decision about whether or not to participate in the research. Their consent must be given freely, without coercion, and must be based on a clear understanding of what participation involves. Only then it can be regarded as 'informed consent'. Although a relatively recent phenomenon, the role of informed consent in human research is central to its ethical regulation and conduct. However, guidelines often recommend procedures for obtaining informed consent (usually written consent) that are difficult to implement in developing countries. This paper reviews the guidelines for obtaining informed consent and also discusses prevailing views on current controversies, ambiguities and problems with these guidelines and suggests potential solutions.