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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 – PowerPoint PPT presentation

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Title: Ethics in medical research


1
Ethics in medical research
  • Professor Ayo Ojuawo
  • Deparment of Paediatrics
  • University of Ilorin
  • ayojuawo_at_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
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.

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
  • 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

10
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

11
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

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 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

18
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)

19
  • THANK YOU
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