5. Principles of health research and methods

Ethical principles of health research

1. Principles of Research Ethics
Dr. Aggrey Dhabangi
Dec 2021

2. Learning Objectives
•Outline (chronology) the major historical
events in research ethics
•Highlight the relevance of ethics to
researchers
•Outline ethical principles that guide
biomedical research process
•Explain vulnerability in research.
•Describe the regulation of research processes
in Uganda.

3. Definition
•Research:
Systematic investigation, testing & evaluation
whose objective is to discover new facts or
information & ↑se the stock of knowledge.
Ethics: = Norms of conduct.
•Research ethics:
norms of research conduct; norms that distinguish
between acceptable and unacceptable behavior or
principles in research.
Research ethics provides guidelines for the
responsible conduct of biomedical research.

4. History of Research Ethics
•1947 - Nuremberg code
•1964 - Helsinki declaration
•1979 - Belmont report
•1991 - Common rule
•1993 - CIOMS
•1996 - ICH / GCP (US, EU,& Japan)
•2002 - International Ethical Guidelines for Biomedical
Research involving Human subjects
•2005 - UNESCO
 Read about the birth of research ethics; pages 3-9 of hand
out, and Module 1 of the online ethics course.

5. Nuremberg code

•The Nuremberg Code consisted of ten basic
ethical principles that the accused physician
violated. The guidelines (10) were as follows:
1. Research participants must voluntarily consent to participate in research
2. Research aims should contribute to the good of society
3. Research must be based on sound theory and prior animal testing
4. Research must avoid unnecessary physical and mental suffering
5. No research project can go forward where serious injury and/or death are
potential outcomes
6. The degree of risk taken with research participants cannot exceed anticipated
benefits of results
7. Proper environment and protection for participants is necessary
8. Experiments can be conducted only by scientifically qualified persons
9. Human subjects must be allowed to discontinue their participation at any time
10. Scientists must be prepared to terminate the experiment if there is cause to believe that
continuation will be harmful or result in injury or death.

6. Rights of Human research participants
Human research participants have a right to:
•Participate in ethically acceptable research
•Be respected (right 2 their autonomy, culture,
beliefs & values)
•Right to information about the research
•Protection against research related injuries, harm,
exploitation or abuse
•Privacy & Confidentiality…….during & after
research
•Decide whether or not to participate, withdraw at
any time

7. Participant rights….cont’d
•Standard of Health care available nationally
•Compensation for research related injuries &
costs
•Report any abuses of ones right & welfare to the
PI, REC/IRC, or UNCST.

8. Basic Research Ethics Principles
(Ensure protection of rights & welfare of research
participants)
1.Respect for persons; respect for autonomy &
protection of vulnerable groups from harm / abuse
2. Beneficence; Research should maximize benefit &
minimize harm
3. Non-maleficence (to do No harm); do no deliberate
infliction of harm.
4. Justice; treat @ person in a way that is morally
right & proper, giving @ what is due to them.

9. Uganda’s Policy on Research
•Policy statement:
Research & dev’t including scientific investigations
& technological trials involving Humans as
research participants shall be conducted for the
benefit of communities in Uganda & abroad,
without causing unnecessary harm to human
research participants and shall not compromise
their rights. (UNCST 2014)

•www.uncst.go.ug

10. Regulatory oversight in Uganda of
research involving Humans
•Done @ 2 levels
1.The institutional level, by the IRC/REC
2.The National level, by the UNCST….& NDA.
UNCST:
Is a semi-autonomous gov’t agency established
in 1990 (CAP 209 of the laws of Uganda).
To: oversee & co-ordinate R&D in Ug, advise
gov’t on policy matters for advancing S&T, &
integrate S&T into the national dev’t process.

11. UNCST Functions
•Act as a clearing house for information on
research & experiments taking place in scientific
institutions.
•Advise & co-ordinate the formulation of a national
policy on S & T
•Co-ordinate all S &T activities, institutions, sector
and organizations
More details, visit: www.uncst.go.ug
N/B:UNCST reserves the right to terminate or revoke
a research permit in the event of gross ethical
misconduct / violation.

12. IRC (Institutional Review Committees)/REC
•They are established by research institutions
•IRC/RECs:
Conduct initial & continuing review & approval of
research studies, with the aim of

Protect the rights & welfare of human research
participants

Monitor research activities to ensure compliance
with scientific ethical requirements.

13. IRC / IRB /REC
•All IRCs operating in Uganda must be
accredited by UNCST

•All IRCs are overseen by UNCST

•Members; consists of 8 – 10 members. Min-5.
(mix; people of varying background, gender
balance, diverse religions, subject experts,
community leaders, religious leaders etc)

14. Functions of IRC
•Maintain ethical standards of practice in research
•Protect research participants & investigators from
harm or exploitation
•Preserve the research participants’ rights &
welfare
•Provide assurance to society of the protection of
rights & welfare of research participants
•Ensure adherence to ethical conduct of research
protocol approved by the IRC
SDL:
Visit; “SOMREC, SOBREC”….1
st
floor CR building

15. DSMB (Data & safety monitoring Board)
•Is a independent group of experts set up by the
study sponsors or PI to review safety, & data
quality during a clinical trail.
•It is established before the commencement of a
clinical trial.
•Ensures that the trial is conducted & data is
handled in accordance with the research
protocol
•Monitors adverse events (safety of participants)
•Its composition is submitted to the IRC & UNCST.

16. Functions of DSMB
•Ensure safety of study participants

•Preserve credibility & integrity of the clinical trial

•Ensure availability of definitive & reliable results
in a timely manner

•Make decisions related to safety, based on the
results & adverse events and recommend
whether the study should continue or not.

17. Informed consent (IC)
•Background:
The ethical principle = respect for persons requires
that research participants (RP) be given the
opportunity to make choices about what should be
done to them.
Thus consent is not just a signature, but a process of
information exchange between research & research
participant on the whole research process.

 Information should be adequate, clearly understood
by the subject with “decision making capacity” & the
subject voluntarily decides to participate.

18. Requirements for IC process
•RP gets adequate understanding of the relevant facts
& consequences of participating
•Prospective RP given sufficient opportunity to
consider whether or not to participate w no coercion
or undue influence.
•The information given to RP be in a language & form
understandable to the RP or their representative.
Implication; use simple English or translate into the
local language.
•IC can be written (or verbal)
•IC process starts before the research is initiated &
continues through out the study duration of the
study.

19. Definition of Informed consent
•IC is thus a legal document between RP &
researcher, given by a competent subject who has;
Received necessary information about the study
Adequately understood the information about the
study
After considering the info and has arrived at a
decision (minus coercion, undue influence,
inducement or intimidation) to participate.

20. Elements of IC form (what must be well stated in it)
•A statement that this is a research / study rather
than provision of routine care
•Research description; objective, expected
responsibility, procedures, study duration, n…
•Foreseeable risks or discomforts
•Benefits to the RP
•Disclosure of alternatives
•Extent of Privacy & Confidentiality of RP
•Compensation for participation
•Extent of Investigators’ responsibility

21. Elements of IC form cont’d
•Names & contact details of PI (2 answer Qns)
•A statement that participation is voluntary,
…..can withdraw at anytime..
•The sponsor & institutional affiliations,
collaborations of PIs
•A statement that RP will get feedback on the
findings of the study
•A statement that the study has been
approved by a Ugandan based IRC.

22. Assent
•Where RP are Children aged ≥ 8yrs, but <18yrs;
 It is an ethical obligation to have them agree to
participate in research.
But they are not yet of legal age to……., and so;

They assent, then full IC is then provided by the
parent / guardian, aged > 18yrs

23. Vulnerable groups in research
•What defines vulnerability;
They are groups of people who are relatively (or
absolutely) incapable of protecting their own
interests.

Such groups may have; insufficient power,
intelligence, education, strength, etc to protect
their own interests.

They also may have limited capacity or freedom
to consent or decline consent.

24. Vulnerable groups (VGs)
•They include (Examples);
Children
Mature & emancipated minors (e.g 16yr mother)
Street children
Prisoners
The Homeless
Substance abusers
Handicapped (mentally & Physically)
Armed forces
Pregnant women.

25. Vulnerable groups contd.
•In some cases their “willingness” to participate
in research is unduly influenced by expectation of
benefits associated or fear of retaliation from
interested senior members in case of refusal to
participate.
•Therefore research among VGs require additional
attention, and justification to ensure their
protection.
•How:
REC approval is stringent
Special requirements for research among VGs

26. Common terms used in Research
•Research participant: A living individual from
whom the researcher obtains data.
•Investigator: A person responsible for
conducting the study.
•Principal Investigator (PI): The responsible /
overall leader of the team
•Sponsor: individual, company, institution or
Organization that takes responsibility for the
mgt or financing of the study
•Clinical trial: Type of research study, experi-
mental in design (eg. comparing drug A vs B).

27. Common terms…..
•Adverse events: Any untoward medical event
in the subject who has received a test,
procedure or test drug that may or may not
have a causal r/ship with this Rx
•Study Protocol: a document that describes
the objective, design, methodology, statistical
consideration, & organization of a study.
•SOPs(Standard operating procedures):
detailed, written instructions of the
performance of a specific procedure, to
achieve uniformity.

28. Common terms contd.
•IRC/ IRB/REC:
•CRF (case report form): is where gathered
research informatn is captured for data mgt.
•Blinding / masking: A procedure in which one
or more parties to a clinical trail are kept
unaware of the treatment assignment(s). Can
be single or double blinding….
•Randomization: the process of assigning
subjects to treatment or control groups, using
an element of chance to determine the
assignment in order to reduce bias.

29. Online Ethics course

https://elearning.trree.org/enrol/index.php?id=2htt
ps://elearning.trree.org/enrol/index.php?id=2

30. Create / open account
•Go to link, above
•Create your account (Provide all details)
•Confirmation sent to your e-mail
•Activate account, via link sent to your e-mail
•Start course…..

31. Window of your Account……

32. Quiz; examples

34. Required Modules
•Module 1: Introduction to Research Ethics

•Module 2.1: Research Ethics Evaluation

35. Certificates

36. References
•Council for International Organizations of Medical Sciences.
(2002). International ethical guidelines for biomedical
research involving human subjects. Bulletin of medical ethics,
(182), 17.
•Emanuel, Ezekiel J., David Wendler, and Christine Grady.
"What makes clinical research ethical?." Jama 283.20 (2000):
2701-2711.
•Emmanuel, E. J. (2004). What makes clinical research in
developing countries ethical? The benchmarks of ethical
research. JID, 189, 930-937.
•www.uncst.go.ug