Ethics in medical research

1. Ethics in medical research Professor Ayo Ojuawo Deparment of Paediatrics University of Ilorin ayojuawo@yahoo.com

2. Introduction Ethics in research is very critical and must be addressed in proposals. Ethics is about what is morally right and proper in research. Ethics are vital because of past atrocities in research work. Examples are the experiments conducted by the Nazi doctors on Jews, the Tuskegee experiments in the United States etc. While researchers in biological sciences and medicine have always taken ethics seriously, those in the social have not been inclined to do so. Every one is required to address ethics and comply with, and do research in ethically proper way today

3. What is Biomedical Ethics? • Ethics is a philosophical consideration of morals- right or wrong • It is a process of thinking, of morals, of behaviour and intentions • Ethics evolves out of a collective responsibility to humanity • The term “bio-medical ethics” was coined in the early 1970s to refer to the application of moral reasoning to vexing questions at the frontiers of biology and medicine

4. What constitutes a Research? • Sometimes it can be difficult to distinguish research from program evaluation, health care or public health interventions • If the goal is “generalizeable knowledge,” then the activity is research • If the goal is generate knowledge relevant only to a particular individual or program, then it is not

5. Cont’d • All healthy research must be scientifically sound to be ethical • The scientific merit of any research must be matched with the ethical process • Unsound research on human subjects may expose research subjects to risks or inconvenience.

6. The Evolution of Research Ethics • Ethical review and bio-medical ethics evolved in response to a history of medical abuses • Medical abuses by Nazi doctors (Nuremburg Trial and code of 1947) • Publication of article on medical abuses in the New England Journal of Medicine • Public revelation of the Tuskegee syphilis study in 1974

7. The Evolution of Research Guidelines • The various abuses of the dignity and rights of human beings led to the set-up of different commissions to set international standards in Research involving human beings • The Nuremberg Code – outlines permissible medical experimentation on human beings. The first provision of the code requires that “the voluntary informed consent of the human subject is absolutely essential.” The Code also requires that: • the risks to patients be minimized • research be conducted by qualified investigators using appropriate designs • participants always be free to withdraw from participation at any time; and • Any research pursued, have a favorable risk/benefit ratio • The World Medical Association created the Declaration of Helsinki, to guide physicians who become involved in medical research.

8. Ethical Principles Three Basic Ethical Principles AUTONOMY -Respect for persons, community etc BENEFICENCE / MALFICENCE – ensuring that no harm is done JUSTICE- Distributive justice, equality of individuals and that the benefits and risks should be distributed fairly

9. Respect for Persons / Community Respect for persons/community Informed consent of individuals participating will be obtained – orally, through tapes, or in written form (international funding bodies require WRITTEN CONSENT which is a challenge for Nigerian researchers) Provision of consent form

10. Cont’d Respect for persons/community etc Description of entry into homes of respondents and how informed consent will be obtained Same with entry into community Same as the handling of under-aged in studies and how informed consent will be obtained Sharing of outcomes with targeted individuals etc. CONFIDENTIALITY

11. Beneficence Dimension of beneficence DO NO HARM Describing how harm to respondents or targeted community will be avoided at all cost Ensuring full disclosure of the nature of the research with particular reference to harm/ risks and benefits

12. Distributive justice Dimensions of distributive justice Giving every person or community equal chance of participating in the work. Distributing benefits fairly Describing how the conditions of the individuals and community will be ameliorated in the course and after the research

13. UITH ETHICAL REVIEW COMMITTEE • UITH ERC is well established and functional since 1991, current Provost was the 1st Chairman, yours truly, Current Chairman • Thirteen member committee including Laymen and Lawyers • Registered with NHREC and has Federal Wide Assurance FWA certification • Meet bi-monthly

14. UITH ERC ctd • Reviews proposals from Lecturers, Consultants, Residents, Postgraduate students, Undergraduate students etc • Review process – submit 5 copies, takes about 2 weeks for review, Researcher meets with the committee to discuss the proposal, corrections are pointed out to researcher, final paper is reviewed and approval given.

15. UITH ERC ctd • The committee MONITORS the project • Areas of concentration: • Relevant Literature review: citing relevant lite • Aims and objectives • METHODOLOGY • Study population • Sampling technique • Sample size • Inclusion and Exclusion criteria

16. Description of procedures • Data Analysis • INFORMED & UNDERSTOOD CONSENT • Information sheet / Consent form • Information provided in different languages • States the procedure, risk, benefit, confidentiality of information, voluntary withdrawal without penalty • Consent form must be signed / thumb print • ***Consent by proxy (minors, incompetent etc)

17. Concluding Notes Please note that your proposal will be reviewed by your institution’s review board and the NATIONALHEALTH RESEARCH ETHICS COMMITTEE which is based in the Federal Ministry of Health if project involves 3 collaborating centres or more, is a national and/or funded by international agencies Download the document on NHREC from the Internet. It describes process etc for review Check details for the international funding agencies from their web site. Note that there could be long turn around for the review of your proposal

18. Con’td Ethics are not just about the review of your proposal but transcend the entire work. Funding can be terminated if the funding bodies finds ethics are being breached in the course of research Adherence to extant research code and ensuring integrity in research work (e.g., selection of sample/respondents, reporting and analysis of data)

19. THANK YOU