Ethics in medical research

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Ethics in medical research

• Professor Ayo Ojuawo
• Deparment of Paediatrics
• University of Ilorin
• ayojuawo_at_yahoo.com

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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

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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

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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

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Contd

• 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.

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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

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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.

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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

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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

• Respect for persons/community

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Contd

• 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

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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

• Dimension of beneficence

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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

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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

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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.

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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

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• 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)

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Concluding Notes

• Please note that your proposal will be reviewed
  by your institutions 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

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Contd

• 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)

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• THANK YOU