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Ethic is a branch which specializes in the morality of what we do and what we are. It studies the norm of an acceptable human behaviour which requires a morality (good actions; avoiding acting badly) A/ There are 4 fundamental principles and 1 non universal principle guiding Ethic in clinical research: 1) Autonomy This principle implies that a person should be able to act and take decisions without constraint or influence (from third parts, money of pharmaceutical groups, etc). NB: This authority is often diminished or in-existent among a certain group of people (minors; mentally handicapped; incapacitated; prisoners, etc…) 2) Beneficence This principle implies to do good, and to benefit participants of a research trials. The aim of the trial should be to maximize the benefice which must be superior to the risks taken by participants of the trial. 3) Non maleficence This principle implies to avoid doing bad or harming participants of a research trial. The aim of the trial should be to minimize the nuisance for the participants of the trial and the drive of the study should be first and foremost “not to harm”. NB: It is possible to harm without hurting or injuring. 4) Justice This principle is derived from human right whereby “we should do to others what we would expect others to do to us if they were in our shoes and us in theirs” 5) Cultural aspect The cultural aspect is particularly important in Africa due to the fact that the trials lead there will be dealing with individuals raised in a community with peculiars norms, conceptions, and perceptions of things which should be taken in consideration prior to any intervention. B/ Aim of the CERSSA (Congolese Ethic Comity) The aim of CERSSA is to give their ethical view and to examine: - The content of the project, - The informed consent process: the participant must be informed, should understand the implication of his participation, and should agree to participate without any form of constraint: moral or economical from anybody; the consent forms should be translated in national and local languages understandable by primary school students. - The respect for the confidentiality of the participants - The risk and damages for the participants and study team (accidental infections…) - The benefits; treatment; free medical care; protection of participants - The infrastructure, ect… C/ Management of samples Countries of the South should not be transformed in samples collectors. The participation of African experts should be sought and they should be consulted, informed and implicated in decision making regarding transportation of samples, samples collection, etc… In case of lack of qualified laboratories in Africa to analyse these samples locally, it is necessary to ensure their traceability: Where are they going? What will they be used for? Have they been genuinely destroyed after analysis? IN CONCLUSION: it is important to know that ETHIC is a MUST for every research conducted on HUMAN SUBJECT
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Frida OYAKHIROMEN
25 Aug 2011
Dear Innocent, thank you for your question. Though I forwarded your question to Prof. Tsiba for a more elaborate/appropriate answer, I would like to refer you also to our course on "Introduction to Clinical Research" in the e-learning module of this website, in particular to the sections titled "What Are The Main Principles Of Research Ethics (b)"? and "What Is Informed Consent and Why Is It Needed (e)" where we learn about The Council for International Organisations of Medical Sciences (CIOMS) 2002 'International Ethical Guidelines for Biomedical Research Involving Human Subjects' which highlights the importance of cultural aspects while running an ethical research study and states:
‘The challenge to international research ethics is to apply universal ethical principles to biomedical research in a multicultural world with a multiplicity of health-care systems and considerable variation in standards of health care. Research involving human subjects must not violate any universally applicable ethical standards, but the guidelines acknowledge that, in superficial aspects, the application of the ethical principles, e.g. in relation to individual autonomy and informed consent, needs to take account of cultural values, while respecting absolutely the ethical standards.’
The course also relates practical examples whereby the culture of the study population lead to an amendment of a clinical research protocol whereby the informed consent should be presented in form of a written document signed by the participant. The reason being that in that particular region (highland in Peru), the population was mostly illiterate and suspicious to sign a document they were unable to read because they had lost land through signing a document; In this case, the 2002 CIOMS guidelines state that:
“Informed consent should be obtained according to the legal requirements and cultural standards of the community in which the intervention is carried out.”
I Hope this helps... -
ALI Innocent
5 Aug 2011
Hi,
While admitting that it is important to consider cultural aspects when doing research in a community I need more clarification on how the cultural aspect of a research protocol became another pillar of ethics in science.