sensitation on training in MAk

1. RESEARCH ETHICS AND INSTITUTIONAL REVIEW
BOARDS / RESEARCH ETHICS COMMITTEE
(IRB/REC):
MAK. PHD STUDENTS’ SENSITIZATION WEBINAR
DR. SADIK KASSIM
DR. DANIEL WAISWA
ASSOC. PROF. AHAMADA ZZIWA
MRS. GORRET NAMUKWAYA KAMOGA

2. OUTLINE
• Welcome Remarks, session objectives: Dr. Sadik Kassim
• Research & Research Ethics: Definition, Importance, Principles and Ethical Issues in
Research: Dr. Daniel Waiswa
• Research Ethics Committee/Institutional Review Board (REC/IRB): A case of CAES-
REC (Functions of REC, Composition of REC, Types of Research Requiring REC
Approval etc) : Prof. Ahamada Zziwa
• REC Approval Process (Application procedures and requirements including fees
structure): Mrs. Gorret Namukwaya Kamoga
• Questions and Answers

3. WELCOME REMARKS AND SESSION OBJECTIVES
Welcome and Introductions

4. WELCOME REMARKS AND SESSION OBJECTIVES
CONT’D
Objectives
i. Create awareness about research and research ethics
ii. Create awareness about CAES-REC and its operations
iii. Get feedback from stakeholders for enhancing operations of CAES-REC

5. RESEARCH: DEFINITION AND PURPOSE
• “Research is a systematic investigation (i.e. the gathering and analysis of information)
designed to develop or contribute to generalisable knowledge”
• “The purpose of research is to enhance society by advancing knowledge through the
development of scientific theories, concepts and ideas. A research purpose is met through
forming hypotheses, collecting data, analyzing results, forming conclusions,
implementing findings into real-life applications and forming new research questions”.
(Source: https://www.discoverphds.com/blog/what-is-research-purpose-of-research)

6. RESEARCH ETHICS: DEFINITION, IMPORTANCE,
PRINCIPLES AND ETHICAL ISSUES IN RESEARCH
• Ethics are broadly the set of rules, written and unwritten, that govern our
expectations of our own and others’ behaviour.
• Research ethics are the set ethics that govern how scientific and other
research is performed and how it is disseminated.
• Research ethics is a core aspect of the research work and the foundation of
research design.

7. IMPORTANCE OF RESEARCH ETHICS
• Promote the aims of research, such as expanding knowledge.
• Support the values required for collaborative work, such as mutual respect
and fairness. This is essential because scientific research depends on
collaboration between researchers and groups.
• Enables researchers to be held accountable for their actions. Many
researchers are supported by public money, and regulations on conflicts of
interest, misconduct, and research involving humans or animals are
necessary to ensure that money is spent appropriately.

8. IMPORTANCE OF RESEARCH ETHICS
• Ensure that the public can trust research: For people to support and fund
research, they have to be confident in it.
• Support important social and moral values, such as the principle of doing no
harm to others.

9. PRINCIPLES OF RESEARCH ETHICS
1. Respect for Persons
 Incorporates two elements about respecting people in regard to research:
People should be treated as autonomous
The term autonomous means that a person can make his or her own decisions
about what to do and what to agree to.
Researchers must respect that individuals should make their own informed
decisions about whether to participate in research.
In order to treat people as autonomous, individuals must be provided with
complete information about a study and decide on their own whether to enroll.

10. People with diminished autonomy should be protected
• Some people in society may not have the capacity to make fully informed decisions about
what they do or what happens to them.
• This could include young children, people who are very ill, or those with mental
disabilities. Such people should be protected and only be included in research under
specific circumstances, since they cannot make a true informed decision on their own.
2. Justice
• This principle deals with the concept of fairness. Researchers should consider what is fair
in terms of recruitment of participants and choice of location to conduct a research. This
encompasses issues related to who benefits from research and who bears the risks of
research.

11. • Principle of justice provides the framework for thinking about these decisions in ways that
are fair and equitable.
• People who are included in research should not be included merely because they are a
population that is easy to access, available, or perhaps vulnerable and less able to decline
participating.
3. Beneficence
• This is an action that is done for the benefit of others.
• The purpose of research is to discover new information that would be helpful to society.
• Researchers are obligated to do their best to minimize all possible risks and to maximize the
benefits for participants.

12. 4. Non-Maleficence
• Is a norm of avoiding deliberate causation of harm.
• One ought not to inflict evil or deliberate harm.
• Research should avoid harming or exploiting the community.

13. ETHICAL ISSUES IN RESEARCH
1. Study design and ethical approval
Good research should be:
 Well-planned
 Appropriately designed
Ethically approved
2. Data analysis
• It is the responsibility of the researcher to analyze the data appropriately.
• To ensure appropriate data analysis, all sources and methods used to obtain and
analyze data should be fully disclosed.

14. ETHICAL ISSUES IN RESEARCH
3. Authorship
• It is generally agreed that the author should have made substantial
contribution to the intellectual content, including conceptualizing and
designing the study, acquiring, analyzing and interpreting the data.
• The author should also take responsibility to certify that the manuscript
represents valid work and take public responsibility for the work.

15. ETHICAL ISSUES IN RESEARCH
4. Conflicts of interest
• This happens when researchers have interests that are not fully apparent and that
may influence their judgments on what is published.
• These conflicts include personal, commercial, political, academic or financial
interest.
• Financial interests may include employment, research funding, stock or share
ownership, payment for lecture or travel, consultancies and company support for
staff. Such interests, where relevant, should be discussed in the early stage of
research.
• The researchers need to take extra effort to ensure that their conflicts of interest do
not influence the methodology and outcome of the research.

16. ETHICAL ISSUES IN RESEARCH
5. Redundant publication and plagiarism
• Redundant publication occurs when two or more papers, without full cross
reference, share the same hypothesis, data, discussion points, or conclusions.
• However, previous publication of an abstract during the proceedings of
meetings does not preclude subsequent submission for publication, but full
disclosure should be made at the time of submission.

17. ETHICAL ISSUES IN RESEARCH
6. Research Methods
Key questions can help us find the right approach for our studies:
i. Which methods most effectively fit the aims of your research?
ii. What are the strengths and restrictions of a particular method?
iii. Are there potential risks when using a particular research method?
7. Voluntary Participation and Consent
• An individual should at no point feel any coercion to participate in a study.
• Informed consent states that an individual must give their explicit consent to
participate in the study.

18. ETHICAL ISSUES IN RESEARCH
8. Validity
• The research design must address specific research questions.
• The conclusions of the study must correlate to the questions posed and the results
• Research ethics demands that the methods used must relate specifically to the research
questions
9. Sampling
• Sampling is the first step in research design.
• There is need to explain the particular group of participants needed
• If the sample includes children or special needs individuals, there is need have additional
requirements to address like parental permission.

19. ETHICAL ISSUES IN RESEARCH
10. Risk of Harm
• Participants should be protected from the risk of harm at all times and focus
should be put on the risk to benefit ratio.
• If risks outweigh the benefits, there is need to abandon or redesign the study.

20. RESEARCH ETHICS COMMITTEE /
INSTITUTIONAL REVIEW BOARDS (REC/IRB):
A CASE OF CAES-REC
• RECs are established organizations that conduct initial and continuing review of research projects with the
primary goal of protecting rights, values and welfare of research participants.
• There are 34 RECs in Uganda accredited by the Uganda National Council for Science and Technology
(UNCST).
• The College of Agricultural and Environmental Sciences Research Ethics Committee/Institutional Review
Board (CAES-REC/IRB) is accredited and certified by the UNCST to conduct initial and continuing review
of research projects with the primary goal of protecting the rights and welfare of research participants.
• CAES-REC evaluates and approves research proposals and monitors research progress to lend credibility to
the research activities, output and outcomes in compliance with ethical standards.

21. FUNCTIONS OF REC
1. To maintain ethical standards of practice in research.
2. To protect research participants and researchers from harm or exploitation.
3. To preserve the research participants’ rights and welfare.
4. To provide assurance to society of the protection of rights and welfare of
research participants.
5. To ensure adherence to ethical conduct of research protocols approved by
the Research Ethics Committee.

22. COMPOSITION OF REC
• RECs are composed of multidisciplinary team of qualified and experienced in Research
Ethics.
• Members are appointed on individual merit by the organizations. Members serve a
maximum of three years and each member is eligible for reappointment.
• Adequate representation of age, gender and cultural background is encouraged.
• Maximum of 15 members are recommended

23. TYPES OF RESEARCH REQUIRING REC APPROVAL
• A Clinical Trial of an Investigational Medicinal Product (CTIMP) (with the exception of
Phase 1 trials in healthy volunteers taking place outside the NHS)
• A Clinical Investigation or other study of a Medical Device
• A combined trial of an Investigational Medicinal Product and an Investigational Medical
Device
• A Clinical Trial to study a novel intervention or randomized Clinical Trial to compare
interventions in clinical practice

24. TYPES OF RESEARCH REQUIRING REC APPROVAL
CONT’D
• A basic science study involving procedures with human participants
• A study administering questionnaires/interviews for quantitative analysis,
or using mixed qualitative/quantitative methodology
• A study involving qualitative methods only
• A study limited to working with human tissue samples (or other human
biological samples) and data (specific project only)
• A study limited to working with data (specific project only).

25. REC APPLICATION AND APPROVAL PROCESS
1. Submission of protocol
a). Types of submission
• New/Initial application to conduct research
• Request for amendment
• Request for renewal
• Submission of serious adverse event reports
• Submission of protocol violations & protocol deviations
• Submission of a study close out/end report

26. REC APPLICATION AND APPROVAL PROCESS
b). How to submit a protocol
• All submissions are made via https://nrims.uncst.go.ug
• Create an account
• Fill in the online form
• Upload the following documents
CVs of the research team
Proposal/Protocol
HSP/GCP certificate

27. REC APPLICATION AND APPROVAL PROCESS
b). How to submit a protocol continued
Data collection tool
Translation of the data collection tool
Informed consent
Translation of the informed consent
Admission letter
Proof of payment of REC fees
Data transfer agreement in case of a collaboration

28. REC APPLICATION AND APPROVAL PROCESS
• Make final submission
2. REC Review
a). Types of review
• Regular review
• Expedited review
• Fast track
3. Responding to REC Review comments
• Compliance report
• A revised proposal/protocol with track changes
• A clean copy of the revised proposal/protocol

29. THANK YOU
FOR ANY ADDITIONAL INFORMATION, PLEASE CONTACT:
MRS. GORRET NAMUKWAYA KAMOGA
CAES-REC ADMINISTRATOR
TEL. 0775471980 EMAIL.: rec.caes@mak.ac.ug