Informed Consent Process, the Bane of Unethical Clinical Research; a Review (original) (raw)
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Informed consent process, the bane of unethical clinical research
2013
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 docume...
Informed consent for clinical trials: a review
East African Medical Journal, 2010
Objective: To identify and highlight challenges related to informed consent process for clinical trials in sub-Saharan Africa. Data sources: Published original research findings and reviews in the English literature, together with anecdotal information from our current professional experiences with clinical trials. Design: Review of peer-reviewed articles. Data extraction: Online searches were done and requests for reprints from corresponding authors and institutional subscription. Data synthesis: Information categorised accordingly. Results: Informed consent for clinical trials conducted in sub-Saharan Africa (SSA) is not always "truly informed" or "truly voluntary". Guidelines for obtaining informed consent are often difficult to implement because of low literacy levels, socio-economic and cultural factors. The local ethics committees, whose role is critical in informed consent, are weak, ill-equipped or non-existent in some countries. Many participants may have incomplete understanding of the various aspects of the clinical trials due to language barriers, the way information is disclosed or terms used for informed consent documents. In some settings, clinical trials are the only access to health care services for the local population. Further, participants may enroll with perceived notion of cure of their conditions, for monetary or material benefits. Conclusions: There is need for national guidelines on clinical research including ethics review, compensation of subjects, requirements for research investigators, facilities and ethics committees as well as budgetary allocation. These guidelines must not only address specific and unique local circumstances but also meet minimum international clinical research standards. Local bioethics and research capacity should be developed and strengthened with research sponsors contributing towards this. Local research is needed on the validity and reliability of informed consent for clinical trials and factors influencing that in different socio-cultural settings in SSA.
Informed Consent in Clinical Studies
2018
Informed and voluntary consent are important aspects when conducting human research and is an area that is frequently talked about particularly since the atrocities of the World War II. Since, there have been numerous legal additions to safeguard research volunteers and ethics approval also incorporates this process. This is therefore one of the nuts and bolts in research methodology. This article looks at the informed consent process and how this is obtained. It discussed how research informed consent varied from consent for a clinical procedure and looks at occasions when this important aspect can be waived.
Journal of Empirical Research on Human Research Ethics, 2010
informed consent is a basic requirement for the conduct of ethical research involving human subjects. Currently, the Helsinki Declaration of the World Medical Association and the International Ethical Guidelines for Biomedical Research of the Council for International Organizations of Medical Sciences (CIOMS) are widely accepted as international codes regulating human subject research and the informed consent sections of these documents are quite important. Debates on the applicability of these guidelines in different socio-cultural settings are ongoing and many workers have advocated the need for national or regional guidelines. Nigeria, a developing country, has recently adopted its national guideline regulating human subject research: the National Health Research Ethics Committee (NHREC) code. A content analysis of the three guidelines was done to see if the Nigerian guidelines confer any additional protection for research subjects. The concept of a Community Advisory Committee in the Nigerian guideline is a novel one that emphasizes research as a community burden and should promote a form of "research friendship" to foster the welfare of research participants. There is also the need for a regular update of the NHREC code so as to address some issues that were not considered in its current version.
International Journal of Clinical Pediatric Dentistry, 2017
Informed consent in research, clinical trial, and practice is a process in which a patient/participant consents to participate or undergo the proposed procedures after being informed of its procedures, risks, and benefits. Ideally, the patient/participant is expected to give his consent only after fully comprehending the information about the procedures, benefits, and risks involved in research/clinical trial/practice. Thus, many ethical issues are entwined in the process of obtaining a proper informed consent. Certain untoward events in the past led to propose guidelines to prevent exploitations and unhealthy practices in the field of life science. Eventually, the practice of obtaining informed consent was emphasized to make sure that a participant's rights were not in jeopardy. Yet, there are flaws in the practical application of obtaining consent due to lack of understanding, barriers in communication, culture, custom, and various other factors. The present article highlights the need for a complete and comprehensive format of recording informed consent without compromising the rights of an individual and the standards of research or practice on ethical and moral grounds.
Informed consent: still a useful tool in research ethics - DOI: 10.3395/reciis.v2.Sup1.208en
RECIIS, 2008
This article dicusses informed consent (IC): its evolution, its main challenges, and its theoretical assumptions. This process involves the interrelation of IC with the history and evolution of research ethics, and with some abuses committed in biomedical research. The article also presents the objections to IC, especially those related to its implementation in developing countries. It also approaches the epistemological problems and those related to the capacity of acting, given the background conditions in which IC is obtained. Furthermore, the article exposes the traditional justification of IC as conveyed by the Belmont Report, as well as a frequent simplification of this justification that focuses only on the deliberative aspect of IC, in which the emphasis on the autonomy or deliberation supposes an inadequate view of research subjects.
Informed consent: Issues and challenges
Journal of Advanced Pharmaceutical Technology & Research, 2013
Informed consent is an ethical and legal requirement for research involving human participants. It is the process where a participant is informed about all aspects of the trial, which are important for the participant to make a decision and after studying all aspects of the trial the participant voluntarily confirms his or her willingness to participate in a particular clinical trial and significance of the research for advancement of medical knowledge and social welfare. The concept of informed consent is embedded in the principles of Nuremberg Code, The Declaration of Helsinki and The Belmont Report. Informed consent is an inevitable requirement prior to every research involving human being as subjects for study. Obtaining consent involves informing the subject about his or her rights, the purpose of the study, procedures to be undertaken, potential risks and benefits of participation, expected duration of study, extent of confidentiality of personal identification and demographic data, so that the participation of subjects in the study is entirely voluntary. This article provides an overview of issues in informed consent: The obligations of investigator, sponsor and Institutional Review Board to protect rights and welfare of human research subjects. It discusses about the basic elements of informed consent and the process to be followed while obtaining informed consent. Some of the circumstances under which informed consent can be waived and ethical challenges faced by physicians in obtaining informed consent from subjects are also highlighted in this article.
Understanding Informed Consent for Participation in International Health Research
Developing World Bioethics, 2009
To participate in health research, there is a need for well-administered informed consent. Understanding of informed consent, especially in international health research, is influenced by the participants' understanding of information and the meaning attached to the information communicated to them regarding the purpose and procedure of the research. Incorrect information and the power differential between researcher and participants may lead to participants becoming victims of harmful research procedures. Meningitis epidemics in Kano in early 1996 led to a response from drug companies, especially Pfizer, as well as humanitarian workers from Médecins Sans Frontiers, which resulted in an unethical trial. Pfizer's drug trial during the epidemics has left a lasting controversy, which has yet to be resolved. This paper examines the key issues surrounding the controversy, discusses the context of informed decision-making, the ethical issues and implications of the incident, and concludes with some recommendations. Relevant texts, journals, Internet materials, newspaper articles and documentary materials on the conduct of the Pfizer's Trovan trial have been consulted. Four types of action (act intuitively, act rationally, act ignorantly, and act contextually-based on information provided) are identified as possible options for decision making. Participants most likely acted in ignorance due to poor understanding of the information contained in the verbal informed consent administered, thereby raising ethical issues. It is concluded that health research ethics committees have an important role to play nationally and locally in overseeing research, and in avoiding future occurrences.
Ethics of Clinical Research-Potential and Enrolled Subjects' Protection
Texila International Journal of Clinical Research, 2019
This paper examined the ethics of Clinical Research and the protection of potential and enrolled human subjects. Clinical research is a lengthy and costly process. Subject recruitment and retention are an essential step to help lowering the cost and the length of clinical trials. Good quality research is crucial for determining the clinical and cost effectiveness of health care systems, at the same time recruitment of sufficient participants is a cornerstone for good quality research that tests hypotheses with confidence and minimizes bias. In this paper, I had the opportunity to highlight some ethical concerns and considerations that are related to recruiting human subjects in clinical research. The purpose of ethical guidelines is both to protect patient volunteers and to preserve the integrity of the science. This report serves as guidance for biomedical and behavioural researchers to find a summary of the basic ethical principles to protect human subjects basically: beneficence, justice, and respect for individuals. The existing literature on the subject was reviewed all along to contextualize the study. I have used observation during the field trips and hands on knowledge of recruiting human subjects carried in my job. The process of informed consent is crucial in achieving these principles. In order to protect human subjects, the informed consent process involves the verbal discussion with the possible subject along with the paper document. Finding revealed that by placing some people at risk of harm for the good of others; clinical research has the potential to exploit patient volunteers. Undue inducement could be eliminated by careful assessment of risks, paying attention to eligibility criteria, collecting an informed and voluntary consent of research subjects. We should continually strive to bring in interactive learning opportunities for clinical researchers, ethics committee members, scientists, biomedical researchers and all other personnel involved in clinical development and translational research.
THE CONSENT PROCESS IN CLINICAL RESEARCH: AN INSIGHT INTO DEVELOPING COUNTRIES
the rights of research participants. However, the recommendations for obtaining consent differ according to cultural context. This paper has discussed some of the disputed aspects of informed consent and has proposed some recommendations. Finally, it is concluded that a relational autonomy model is an appropriate choice to obtain a culturally relevant consent in developing countries rather than a formal written consent.