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KMTC GATUNDU CAMPUS
ETHICS IN RESEARCH
PRESENTER
HELLEN N MWANGI
Topic Outcomes
• At the end of this topic, you should be able to:
1. Understand the need for research ethics.
2. Highlight key issues in research ethics.
3. Explain fundamental ethical principles, legal and administrative issues in
research.
4. Apply ethical research principles in conducting research.
Topic content
i) The history of Research Ethics
ii) The Importance of Ethics in Research
iii) Ethical Principles in Research
iv) Ethical Clearance to conduct research
v) Logical and Administrative Issues in research
Importances of Ethics in Research
Ethics in research serve many purposes as follows:
a) To ensure high quality research:
• Low quality research is unethical in that it exposes the participants to
the risks or costs of research without the chance of future benefit.
• Similarly, simple duplication or research done elsewhere (for example,
to obtain a degree) may be unethical because it will not lead to new
knowledge or action, even if the research was conducted perfectly.
• However, repeating a research for to verify the findings is acceptable.
This is referred to as replication and is different from duplication
b) To protect the rights of the research subjects from research risks and
abuse:
• Research subjects should therefore be considered in deciding the ethics
of a proposal.
• Although research subjects are more prone to abuse and risks in health
and medical researches, it is important that ethics are adhered to even
for social sciences so that confidentiality and privacy of research
subjects are not interfered with.
c) To ensure fair distribution of potential benefits of the study to the
study subjects:
• For example, the researchers of an intervention study whose results
show positive impact on the study subjects, should ensure that the study
subjects in the control group are also provided to the same benefits as
the intervention group after the completion of the study.
d) Obligations to feedback and publication:
Often forgotten in the rush to produce research reports towards a degree,
is the need for feedback and publication.
• Most ethics review committees will nowadays insist on an acceptable
plan for the dissemination of information gained from research before
approving research proposals.
• Publication in relevant peer-reviewed journals is an obvious way of
doing this, but direct feedback to individuals and communities, or
publication through the media, or to relevant government departments,
is an essential part of an ethical study proposal.
e) Conflict of interests:
• As elsewhere in life, conflicts of interest may occur in research.
• Often this takes the form of sponsorship by a company that has an
interest in a particular outcome of the study, such as in drug trials.
• It is important to ensure absolute independence between the researcher
and the sponsorship for the study to be considered ethically acceptable.
Ethical Principles
The Principle of Justice
1. The concept of justice in research is interpreted to mean a fair
distribution of the benefits of research.
2. For example, though most of the researches on vaccines in HIV and
AIDS are conducted in the developing world, developing countries and
the population originally researched may not be able to afford these
vaccines and will thus not get the benefit of the research.
2. The Principle of Beneficence
• In general, this principle requires that the actions of researchers are
directed at improving the well being of study participants, and they
should not cause harm to the participant.
• While this may sound obvious, there are several important issues in
research that violate or may potentially violate this principle.
• For example, participation in a research may mean offering time
which may result in other priorities not being met. Interviewing rural
women may reduce time they have for child care or to collect firewood
or water.
3. Respect for autonomy
This principle states the requirement that those who are capable of
deliberating personal choices should be treated with respect for their
capacity of self-determination or decision.
On the other hand persons with diminished or impaired autonomy or those
in dependent or vulnerable positions should be protected against harm or
abuse.
4. Voluntary participation
• This principle dictates that all subjects should be recruited into the study upon their
informed consent. Participation should be voluntary and should be free of coercion, and
there should be not be under undue influence, inducement or intimidation. Informed
decision decision-making requires that the information from the investigator be:
– Comprehensive. This should involve; the study procedures, the risks, benefits and
compensation if any.
– Comprehensible (simple language should be used)
– The decision by the subject should be based on competence and the ability to understand.
– Participant should give either verbal or written consent. Those who are illiterate should
give consent based on thumbprint. It is recommended that written or thumb rather than
verbal consent be solicited. Ethical review committees will expect a statement on how
informed consent will be solicited from the prospective study participants
5. Confidentiality
• Participants usually expect the information from them to remain
confidential.
• Efforts to ensure this are essential, such as not obtaining personal
information unless it is absolutely necessary and deleting personal
information as soon as there is no longer need for it.
• This also includes results of any specimens that may have been
collected.
• Researchers should clearly stipulate in the research proposals how
confidentiality will be maintained. The prospective participants should
also be informed how confidentiality will be maintained.
6. Risk of Harm
• Ethical standards also require that researchers not put participants in a
situation where they might be at risk of harm as a result of their
participation.
• Harm can be defined as both physical and psychological.
Ethical Clearance
Even when clear ethical standards and principles exist, there will be times when the need to
do accurate research runs up against the rights of potential participants.
 No set of standards can possibly anticipate every ethical circumstance. Furthermore, there
needs to be a procedure that assures that researchers will consider all relevant ethical issues
in formulating research plans.
To address such needs most institutions and organizations have formulated an Institutional
Review Board (IRB), a panel of persons who reviews grant proposals with respect to ethical
implications and decides whether additional actions need to be taken to assure the safety and
rights of participants.
By reviewing proposals for research, IRBs also help to protect both the organization and the
researcher against potential legal implications of neglecting to address important ethical
issues of participants.
For many journals, a report from an IRB is now mandatory for the publication of any work.
• In Kenya, there are two institutions with
• Ethical Review Committees;
– Kenyatta National Hospital and
– the National Ethical Review Committee at (Africa Medical Research
Foundation).
• These two institutions review proposals by any interested party from
Kenya
Legal &Administrative issues
• Legal Issues in Research
• The following legal issues are pertinent and need to be addressed in
research:
• Intellectual Property (IP): refers to creations of the mind: inventions,
literary and artistic works, and symbols, names, images, and designs
used in commerce.
• IP is divided into three categories:
• Industrial property, Copyrights and Plant Variety Protection Industrial
property, which includes inventions (patents), trademarks, industrial
designs, and utility models
Administrative Issues in Research
. It is a requirement in Kenya and other countries that any research be authorized by an appointed
government department/organization. For academic researches, the Universities have a body
mandated to authorize and give permission for anystudent to conduct research upon submission of
an acceptable research proposal.
 In KMTC , the Research dept. reviews and approves research proposals after which the student
receives a letter of authorization to conduct the research.
 In addition, the student receives a letter to the Ministry of Higher Education Science and
Technology which is mandated by the government to authorize all researches conducted in Kenya.
Having received a Research Permit from the government, the student/researcher should seek further
permission from the administration leaders from where the research is to be conducted. For
example, if the research is to be conducted in a City Council School or Hospital in Nairobi, the
researcher will have to seek and obtain permission to conduct to the research from the Local
Authority Officials in charge of Health and Education in Nairobi.
 In addition, it is also necessary that the researcher informs the local administration such as the
Coounty Officers and Chiefs of their intention to conduct a research in their areas of jurisdiction
TOPIC ASSESSMENT QUESTIONS
1. Why should ethical issues be taken into consideration when planning and
conducting research?
2. Discuss the key ethical issues in research.
3. Giving examples, explain the following research ethical principles:
a. Participant confidentiality
b. Respect for autonomy
c. Voluntary participation
4. What is Intellectual Property?
5. Why should innovators ensure/claim Intellectual Property Rights/Ownership of
their work?
6. Explain the following concepts: Patented Information; Copyright and Plagiarism
LEARNING ACTIVITY
• Draft a verbal consent you would use with your respondents showing
how you would factor in the ethical principle in research
The End
Thank You

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Clinical medicine research and methodology

  • 1. KMTC GATUNDU CAMPUS ETHICS IN RESEARCH PRESENTER HELLEN N MWANGI
  • 2. Topic Outcomes • At the end of this topic, you should be able to: 1. Understand the need for research ethics. 2. Highlight key issues in research ethics. 3. Explain fundamental ethical principles, legal and administrative issues in research. 4. Apply ethical research principles in conducting research.
  • 3. Topic content i) The history of Research Ethics ii) The Importance of Ethics in Research iii) Ethical Principles in Research iv) Ethical Clearance to conduct research v) Logical and Administrative Issues in research
  • 4. Importances of Ethics in Research Ethics in research serve many purposes as follows: a) To ensure high quality research: • Low quality research is unethical in that it exposes the participants to the risks or costs of research without the chance of future benefit. • Similarly, simple duplication or research done elsewhere (for example, to obtain a degree) may be unethical because it will not lead to new knowledge or action, even if the research was conducted perfectly. • However, repeating a research for to verify the findings is acceptable. This is referred to as replication and is different from duplication
  • 5. b) To protect the rights of the research subjects from research risks and abuse: • Research subjects should therefore be considered in deciding the ethics of a proposal. • Although research subjects are more prone to abuse and risks in health and medical researches, it is important that ethics are adhered to even for social sciences so that confidentiality and privacy of research subjects are not interfered with.
  • 6. c) To ensure fair distribution of potential benefits of the study to the study subjects: • For example, the researchers of an intervention study whose results show positive impact on the study subjects, should ensure that the study subjects in the control group are also provided to the same benefits as the intervention group after the completion of the study.
  • 7. d) Obligations to feedback and publication: Often forgotten in the rush to produce research reports towards a degree, is the need for feedback and publication. • Most ethics review committees will nowadays insist on an acceptable plan for the dissemination of information gained from research before approving research proposals. • Publication in relevant peer-reviewed journals is an obvious way of doing this, but direct feedback to individuals and communities, or publication through the media, or to relevant government departments, is an essential part of an ethical study proposal.
  • 8. e) Conflict of interests: • As elsewhere in life, conflicts of interest may occur in research. • Often this takes the form of sponsorship by a company that has an interest in a particular outcome of the study, such as in drug trials. • It is important to ensure absolute independence between the researcher and the sponsorship for the study to be considered ethically acceptable.
  • 9. Ethical Principles The Principle of Justice 1. The concept of justice in research is interpreted to mean a fair distribution of the benefits of research. 2. For example, though most of the researches on vaccines in HIV and AIDS are conducted in the developing world, developing countries and the population originally researched may not be able to afford these vaccines and will thus not get the benefit of the research.
  • 10. 2. The Principle of Beneficence • In general, this principle requires that the actions of researchers are directed at improving the well being of study participants, and they should not cause harm to the participant. • While this may sound obvious, there are several important issues in research that violate or may potentially violate this principle. • For example, participation in a research may mean offering time which may result in other priorities not being met. Interviewing rural women may reduce time they have for child care or to collect firewood or water.
  • 11. 3. Respect for autonomy This principle states the requirement that those who are capable of deliberating personal choices should be treated with respect for their capacity of self-determination or decision. On the other hand persons with diminished or impaired autonomy or those in dependent or vulnerable positions should be protected against harm or abuse.
  • 12. 4. Voluntary participation • This principle dictates that all subjects should be recruited into the study upon their informed consent. Participation should be voluntary and should be free of coercion, and there should be not be under undue influence, inducement or intimidation. Informed decision decision-making requires that the information from the investigator be: – Comprehensive. This should involve; the study procedures, the risks, benefits and compensation if any. – Comprehensible (simple language should be used) – The decision by the subject should be based on competence and the ability to understand. – Participant should give either verbal or written consent. Those who are illiterate should give consent based on thumbprint. It is recommended that written or thumb rather than verbal consent be solicited. Ethical review committees will expect a statement on how informed consent will be solicited from the prospective study participants
  • 13. 5. Confidentiality • Participants usually expect the information from them to remain confidential. • Efforts to ensure this are essential, such as not obtaining personal information unless it is absolutely necessary and deleting personal information as soon as there is no longer need for it. • This also includes results of any specimens that may have been collected. • Researchers should clearly stipulate in the research proposals how confidentiality will be maintained. The prospective participants should also be informed how confidentiality will be maintained.
  • 14. 6. Risk of Harm • Ethical standards also require that researchers not put participants in a situation where they might be at risk of harm as a result of their participation. • Harm can be defined as both physical and psychological.
  • 15. Ethical Clearance Even when clear ethical standards and principles exist, there will be times when the need to do accurate research runs up against the rights of potential participants.  No set of standards can possibly anticipate every ethical circumstance. Furthermore, there needs to be a procedure that assures that researchers will consider all relevant ethical issues in formulating research plans. To address such needs most institutions and organizations have formulated an Institutional Review Board (IRB), a panel of persons who reviews grant proposals with respect to ethical implications and decides whether additional actions need to be taken to assure the safety and rights of participants. By reviewing proposals for research, IRBs also help to protect both the organization and the researcher against potential legal implications of neglecting to address important ethical issues of participants. For many journals, a report from an IRB is now mandatory for the publication of any work.
  • 16. • In Kenya, there are two institutions with • Ethical Review Committees; – Kenyatta National Hospital and – the National Ethical Review Committee at (Africa Medical Research Foundation). • These two institutions review proposals by any interested party from Kenya
  • 17. Legal &Administrative issues • Legal Issues in Research • The following legal issues are pertinent and need to be addressed in research: • Intellectual Property (IP): refers to creations of the mind: inventions, literary and artistic works, and symbols, names, images, and designs used in commerce. • IP is divided into three categories: • Industrial property, Copyrights and Plant Variety Protection Industrial property, which includes inventions (patents), trademarks, industrial designs, and utility models
  • 18. Administrative Issues in Research . It is a requirement in Kenya and other countries that any research be authorized by an appointed government department/organization. For academic researches, the Universities have a body mandated to authorize and give permission for anystudent to conduct research upon submission of an acceptable research proposal.  In KMTC , the Research dept. reviews and approves research proposals after which the student receives a letter of authorization to conduct the research.  In addition, the student receives a letter to the Ministry of Higher Education Science and Technology which is mandated by the government to authorize all researches conducted in Kenya. Having received a Research Permit from the government, the student/researcher should seek further permission from the administration leaders from where the research is to be conducted. For example, if the research is to be conducted in a City Council School or Hospital in Nairobi, the researcher will have to seek and obtain permission to conduct to the research from the Local Authority Officials in charge of Health and Education in Nairobi.  In addition, it is also necessary that the researcher informs the local administration such as the Coounty Officers and Chiefs of their intention to conduct a research in their areas of jurisdiction
  • 19. TOPIC ASSESSMENT QUESTIONS 1. Why should ethical issues be taken into consideration when planning and conducting research? 2. Discuss the key ethical issues in research. 3. Giving examples, explain the following research ethical principles: a. Participant confidentiality b. Respect for autonomy c. Voluntary participation 4. What is Intellectual Property? 5. Why should innovators ensure/claim Intellectual Property Rights/Ownership of their work? 6. Explain the following concepts: Patented Information; Copyright and Plagiarism
  • 20. LEARNING ACTIVITY • Draft a verbal consent you would use with your respondents showing how you would factor in the ethical principle in research

Editor's Notes

  • #2: Key Result areas i. Quality Training ii. Research, Innovation and Consultancy iii. Digital Transformation iv. Institutional Sustainability Quality training strategic objectives i. Expanding transformative opportunities for students and graduates ii. Enhancing innovation in teaching and learning iii. Maintaining accreditation iv. Skilling, reskilling and retooling faculty v. Establishment of Centres of Excellence vi. Modernization of infrastructure for teaching and learning
  • #3: While mentoring relationships are primarily one-way helping relationships, peer relationships offer a higher degree of mutual assistance, with both individuals giving and receiving support. Peers facing similar challenges related to their disabilities can share strategies to overcome disability-related barriers.