1. Research ethics

2. Session outline Define ethics Human subject research
The need for a research ethics
The role and purpose of Research Ethics Committees
What is informed consent ?

3. WHAT IS ETHICS ?
The word is derived form the Greek word “ethos” meaning;
“the set of moral principles”

4. What do we mean by ethics?
Morality or ethics represents a code of conduct that governs how people treat each other.
In essence, it is concerned with the way people act or behave.
The term ‘ethics’ usually refers to the moral principles, guiding conduct, which are held by a group or even a profession”
(Wellington, 2000: 54)

5. WHAT IS: ETHICS ?
Ethics are ways of understanding and examining the moral life, or of right and wrong human conduct.
Bioethics is a way of understanding and examining the moral aspects of biomedical research and practice

6. HUMAN SUBJECT RESEARCH
A research Involving living individuals about whom the researcher obtains:
Data through intervention or interaction
Identifiable Human Material +/Private Information
AND OR
The research is considered Human subject research when it involves
Like procedures on Patients or interview
As looking In the medical records

7. Subject Welfare/Rights Advancement of Science
BALANCING TWO GOALS
Protection of
Subject Welfare/Rights
Advancement of Science

8. Types of human participation in research
As research subjects
(on whom experiments, including testing of new drugs, are conducted)
As persons whose body organs or tissues are obtained and/or retained for research
Eg, blood, saliva, urine, biopsy specimens
As research participants from whom information is obtained
Eg, through observation, interviews, focus groups, questionnaires, telephone surveys, psychological or other types of testing

9. Types of human participation in research
As people who might be identified in official documents
Eg, employment records, student records, police records, court documents, medical records.
As people whose information (identified or de-identified) is part of an existing, unpublished source
Eg, a researcher wishing to use all, or part of, an unpublished data-base obtained by another researcher for a different research project

10. The need for a research ethics
Why do we need it?
History tells us that if research is not ethically approved, humans will attempt devastating and immoral practices on the vulnerable to determine outcomes
Past unethical/moral dilemmas highlight this
All research must now go before an ethics committee for approval
Protect the vulnerable – human & animal
Protection of human rights

11. Role of Research Ethics Committees
Research Ethics Committees are the Committees which are convened to provide independent advice to participants, researchers, funders, sponsors, employers, care organisations and professionals on the extent to which proposals for research studies comply with recognised ethical standards.

12. Research Ethics Committees (REC)
The main objectives of a REC are to:
Maintain ethical standards of practice in research
To protect subjects of research and research workers from harm or exploitation
To preserve the subjects rights
To provide reassurance to the public that this is being done.

13. Purpose of a REC
The purpose of a REC is to review a proposed study and to ensure the dignity, rights, safety and well-being of all actual or potential research participants is protected.

14. Ethical guidelines for conduct of research
Nuremburg Code was developed in 1947 following the mistreatment of human subjects by Nazis
The Nuremberg Code (10 principles)
Voluntary informed consent
Likelihood of some good resulting
Based on prior research (animal models)
Avoidance of physical or psychological injury or harm
Benefits should outweigh risks
Proper experience of researcher
Right to withdraw consent
Research must stop if harm is resulting
(no specific mention of children, unconscious people, or others who may not be competent to give consent)

15. What is informed consent ?
Respect for Persons
voluntary decision taken by an individual to participate in research based on understanding the objectives, risks, benefits, and alternatives of the research.
the principal investigator has responsibility to obtain voluntary informed consent (either verbal or written) from all prospective participants or
in the case of individuals who are not capable of giving informed consent, the permission of their legally authorized guardians (proxy consent).
Informed consent is the process whereby human participants in a research project are provided with all the information needed so that they can decide whether to participate. The elements that must be provided are:

16. What is informed consent ?
Respect for Persons
voluntary decision taken by an individual to participate in research based on understanding the objectives, risks, benefits, and alternatives of the research.
the principal investigator has responsibility to obtain voluntary informed consent (either verbal or written) from all prospective participants or
in the case of individuals who are not capable of giving informed consent, the permission of their legally authorized guardians (proxy consent).
Informed consent is the process whereby human participants in a research project are provided with all the information needed so that they can decide whether to participate. The elements that must be provided are:

17. Components of informed consent
Information sheet
seek consent only after the participant has received and adequately understood all necessary information and the consequences of participation as given in the information sheet
if written, the consent form has to be in all three
languages
if written, consent should be obtained by signing on a consent form

18. Informed consent contin..
Information sheet should contain
Self introduction – from where & who you are;
purpose of the research;
description of benefits from participating;
description of risks from participating;
details of time commitment required;
details of any remuneration;
plans to ensure the confidentiality of data;
details about the right to withdraw at any time for any reason;
information about how to communicate a decision to withdraw from the study;
name(s) of investigator(s) contact details.
The wording should suit the individual’s level of understanding