RESEARCH AND
HUMAN RESEARCH
ETHICS
PROF. DR. NYI NYI NAING @ SYED HATIM NOOR
1 Chairperson
UniSZA HUMAN RESEARCH ETHICS COMMITTEE (UHREC)
UNIVERSITI SULTAN ZAINAL ABIDIN (UniSZA)
2 INTRODUCTION
Ethics in research is about rules for
distinguishing between right and wrong
“First of all, do no harm” (Hippocratic Oath)
Ethical norms govern conduct of research
Serve the goals of research
Applies to people who conduct scientific
research
Protects all involved in the research such as
the researchers, the participants and
institutions
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One of the essential functions of a university
is the carrying out of research in all areas of
human knowledge and experience
The Universiti Sultan Zainal Abidin (UniSZA)
recognizes its responsibility to researchers
and the wider community to ensure that the
highest standards of integrity and
professionalism are observed in the conduct
of research in human at the University
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The Code of Practice provides guiding
principles and standards of good practice in
research across all subject disciplines and
areas of study related to human at the
University
It applies to all those undertaking research
on the University’s premises using its
facilities
Staff, students, visiting or affiliate staff,
associates, consultants
Most importantly the participants who are
patients or healthy volunteers
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All research at the University shall comply with
the University’s Research Code of Practice and
be guided by the European Commission’s Ethics
for Researchers: Facilitating Research
Excellence in Framework Programme 7 (2013)
Senate of the university, with the assistance from
UniSZA Human Research Ethics Committee
(UHREC), requires that research conducted at
UniSZA complies with human research-related
policies, guidelines and principles published by
internationally recognized organizations
These requirements shall be accessible on the
UHREC’s website in near future
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6 ROLE OF UHREC
The role of UHREC is to facilitate and assist human-
based research conducted by UniSZA researchers to
be ethically right and methodologically sound
All aspects including scientific and statistical validity
related to ethical grounds are screened
Methodological facts and ethical issues go hand-in-
hand
If there are methodological flaws then the study
becomes unethical
It is inappropriate to separate these two issues
A methodologically flawed study cannot be granted
an ethics approval
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PHILOSOPHY OF UHREC
E All human-related research should be Ethically conducted
T All submitted protocols are Timely screened
H The Highest standard of research conduct must be
maintained
I Decisions are made Independently without any influence
C Cumulative assessment is practiced and,
S The whole process for ethical clearance is Systematically
done with standard operating procedures
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UHREC is responsible for assurance on
protection of confidentiality and privacy of:
participants
welfare and rights
freedom to withdraw
selected accessibility of information of the
participants
adequate precaution to be taken to protect
vulnerable participants such as children,
women, mentally impaired, highly dependent
medical care situations, university students
etc.
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PROTOCOLS WHICH NEED
AN ETHICS APPROVAL
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OVERVIEW OF STUDY DESIGNS
10
Systematic review and meta analysis
Intervention [experimental] studies
clinical trials & community trials
Observational/ Analytical Studies:
Cohort studies
prospective, retrospective and historical
Case-Control studies
matched, unmatched and nested
Cross Sectional studies
classical, comparative, diagnostic test, questionnaire
Observational descriptive studies:
population : prevalence, incidence studies
individuals: case reports, case series
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11 Awareness and relevance of ethics should be
priorities in research
Terms of reference of UHREC are to assess and
regulate research proposals on research
involving:
human subjects (patients or normal healthy
individuals)
research involving human samples
human tissue samples
human genetic samples
research involving data derived from humans and
research using products (biological or non-
biological) which are tested on humans
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Research protocols which normally require ethical clearance
from human research ethics committees:
randomized clinical trials
epidemiological research inclusive of both interventional
(clinical and community trials - quasi experimental
studies) and observational studies
laboratory medicine based studies
community-based observational studies
human genetic studies
studies using archived samples
research involving non-human sample such as:
retrospective record reviews, data collection by
interviews, using self-administered or guided self-
administered questionnaires
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Research protocols which normally require ethical
clearance from human research ethics committees
(cont.):
health social science studies
social science studies
focused group discussion and observations
religion-related studies
humanities studies
natural and applied sciences studies
anthropological studies
qualitative research studies.
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14 The types of research vary from:
researcher initiated research (sponsored by institutional
research grants, national grants, international grants or
without grants)
post-graduate research
undergraduate research
contract research with pharmaceutical companies
contract research with industries
research conducted with other institutions, other ministries
such as Ministry of Health, Ministry of higher education,
Ministry of women children and family development
multi-centered centered research
research conducted with other countries
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15 A GLANCE ON CURRENT SITUATION OF
ETHICAL ISSUE AWARENESS IN HUMAN-
RELATED RESEARCH AT UniSZA
Traditionally majority of applications for human ethics
approval come from Faculty of Medicine, Faculty of
Health Sciences and Faculty of Pharmacy at UniSZA
However majority of human related research require
ethical clearance
It is very much improved that there are many more
applications from other faculties which are involved in
research tested on human
There is a significant proportion of human based
research may not have gone through proper
procedure to have obtained an ethics approval
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It was reported that an ethics approval was sought
from UHREC retrospectively by a number of
researchers only when they were asked to produce
evidence of an ethics approval by the journals for
scientific publications
It was clear that some human-based research studies
were conducted at UniSZA without an ethics approval
Retrospective ethics approvals for publication
purposes are not valid, unprofessional and stringently
an ethics approval cannot be granted
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All human-based researchers about serious
awareness on ethical issues in their studies is
necessary
Not eligible to proceed at UHREC for an ethics review
in granting an ethics approval if a study has already
been conducted at the time of application to UHREC
Majority of post-graduate studies in human research
need ethical clearance from UHREC
Submission of thesis requires to include an evidence
of ethical clearance
Notice of submission (NOS) without an ethics
approval (if applicable) would not be accepted by the
graduate school
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18 ROLE OF FACULTIES AND CENTRES
OF EXCELLENCE (COEs) IN
OBTAINING ETHICAL APPROVAL
Research committees of faculties and COE are responsible for
screening research protocols before submitting them to
UHREC.
All research proposals inclusive of researcher-initiated
research, post-graduate research, undergraduate research,
contract research with companies or industries, research with
researchers from other ministries, with non-governmental
organizations and with other countries are necessary to be
screened for plausible methodology in view of the scope and
objectives of the studies.
Research proposals without being vetted at faculties and COEs
will not be accepted by UHREC for an ethics approval (an
evidence of scrutinizing the proposal at faculty level is
compulsory to proceed for an ethics review at UHREC)
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19 TERMS OF REFERENCE
Terms of Reference were approved by
Mesyuarat Senat kali ke 141 Bil.11/2019
held on 30th October 2019.
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20 TERMS OF REFERENCE
1) Consider human-related research protocol approvals
from faculties and COEs within UniSZA, from other
institutions, companies, agencies and organizations,
etc. outside UniSZA.
2) Ensure that all human-related research studies which
ethically approved by UHREC are conducted based on
international research ethics guidelines.
3) Recommend that all human-related research activities
conducted at any premises (example hospital, clinic,
etc.) of UniSZA are ethically approved by UHREC.
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21 TERMS OF REFERENCE (cont.)
4) Consider an ethics approval for human research
related Intellectual Properties (IP) applications for
commercialization submitted to UHREC from faculties
and CoEs from within or outside of UniSZA.
5) Appoint independent assessors to evaluate research
activities if any serious adverse events (SAEs) occur in
clinical and community trials.
6) Inform Research Management Office to advise UniSZA
staff or students who conduct human-related research
to obtain an ethics approval.
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22 TERMS OF REFERENCE (cont.)
7) Inform Research Management Office to consider
termination of research activities with immediate effect if
UniSZA staff or students are found to have deviated from
the approve research protocol.
8) Inform Research Management Office to consider
termination of research activities by UniSZA staff or
students found to have any occurrence of unfavorable
circumstances such as Serious Adverse Events (SAEs)
leading to disabilities or death.
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23 TERMS OF REFERENCE (cont.)
9) Inform Research Management Office to consider
suspension or termination of human related research
activities by UniSZA staff or students if any case of
misconduct proven to have been committed.
10) Inform Research Management Office to reject registration
of IP involving application to human subjects submitted
from faculties and COEs from within or outside of UniSZA
if it is deemed unethical.
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24 TERMS OF REFERENCE (cont.)
11) Recommend that all research protocols submitted by
undergraduate/ postgraduate candidates conducting human
research studies have obtained an ethics approval before
commencing research, except for Faculty of Medicine,
Faculty of Health Sciences and Faculty of Pharmacy where
it is mandatory.
12) Recommend that all thesis submitted by postgraduate
candidates conducting human-related research studies
have obtained an ethics approval before being accepted by
the Graduate School of UniSZA for Notice of Submission
(NOS), except for Faculty of Medicine, Faculty of Health
Sciences and Faculty of Pharmacy where it is mandatory.
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25 MEMBERS OF UHREC
Helsinki Declaration (1964,1975,1983, 1989, 1996,
2000, 2002, 2004, 2008, 2013) developed by World
Medical Association was applied in structuring the
committee.
A total of 25 members includes 23 academics of different
disciplines form all faculties, an legal expert and a
layperson who are not associated with UniSZA
The secretariat includes an assistant registrar, a clerical
staff and a lecturers who is a member of UHREC
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a = Medical, Health Sciences, Pharmacy and other sciences; b = Non-science based; c = Community representative
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Composition of UHREC based on Disciplines and Faculties
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UHREC Members 2023
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PROTOCOL REVIEW
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The UHREC chairperson classifies the study protocol review
pathway as either Expedited Review or Full Committee Review
filtered through the following criteria:
Expedited Review Full committee review
• The research poses no more than minimal risk • Studies which involve randomized control trials of
new drug/treatment/procedure
• The study does not involve vulnerable populations • Studies which are randomized community trials or
quasi-experimental studies
• The study does not involve the collection of • Observational studies either descriptive or analytical
stigmatizing information
• The study uses anonymized or archived samples • Research which involves questionnaires or survey to
vulnerable groups
• Continuing review of studies previously classified • Genetic and/or genomic studies
under expedited review
• Study protocol amendments that are administrative in • Any other study not fulfilling expedited review criteria
nature and do not affect the study protocol.
• Undergraduate research protocols.
• Applications which have
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other IRBs.
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FLOW CHART - APPLICATION
SUBMISSION OF FULL
COMMITTEE REVIEW
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FLOW CHART -
APPLICATION SUBMISSION
OF EXPEDITE REVIEW
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32 OVERVIEW FLOWCHART
* If the application hasn’t gone through other IRBs, then application must
go through Faculty’s committee (Chairman – either Dean of Faculty/
Director of CoE)
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SOPs AND FORMS OF UHREC
33 Structure
Review process
SOPs Approval
Documentation
• Application
Archiving
• Patient information sheet (BM & BI)
• Consent form (BM & BI)
• CV of applicants
• Assessment forms
• Interventional studies (Clinical
Submission forms trials/community trials)
• Observational studies
• Undergraduate research
• Contract research
• Genetic study
Forms • From other institutions
▪ Amendment form
▪ Final report forms
(Interventional/observational)
Post approval forms ▪ Non-compliance form
▪ Termination form
▪ Site visits report form
▪ Serious adverse report form
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UHREC STUDY PROTOCOL FORMS
Compulsory Documents (if applicable)
34 1. Checklist Form (UniSZA-PTPIP-42-GP 001-BR 003(01)
2. Form A: Application Form (UniSZA-PTPIP-42-GP 001-BR 004(01)
3. Form B: Research Proposal (UniSZA-PTPIP-42-GP 001-BR 005(01)
Form C1: Research Information Sheet
4.
(UniSZA-PTPIP-42-GP 001-BR 006(01)
5. Form C2: Maklumat Kajian (Malay) (UniSZA-PTPIP-42-GP 001-BR 007(01)
Form D1: Informed Consent Form (English)
6.
(UniSZA-PTPIP-42-GP 001-BR 008(01)
Form D2: Borang Keizinan Subjek (Malay)
7.
(UniSZA-PTPIP-42-GP 001-BR 009(01)
Form E: Curriculum Vitae (CV) of researchers (excluding post/ undergraduate student)
8.
(UniSZA-PTPIP-42-GP 001-BR 010(01)
9. Research Tools (e.g. Data Collection Forms, Questionnaires)
10. Approval Letter from the Faculty/ Institute Research Committee
Additional Documents (if applicable)
1. Other Institutional Ethics Approval (e.g. NMRR)
2. Approval Letter from related agencies/ institution
3. Investigator’s Brochure
4. Statement Insurance and/or Indemnity Coverage
An appointment letter as the contract researcher from companies/ industries with related
5.
multi-centered and multi-national trial document
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6. Other Related Documents
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TOTAL NUMBER OF UHREC APPROVAL
NO. YEAR NO. OF APPROVAL
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1. 2012 10
2. 2013 14
3. 2014 23
4. 2015 39
5. 2016 43
6. 2017 38
7. 2018 71
8. 2019 75
9. 2020 68
585
10. 2021 90
11. 2022 154
12. 2023 (until 20th 127
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TOTAL 636
DURATION OF APPLICATION PROCESS 2018
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Figure 1: Overall mean of application process (days) in 2018
Mean (SD): 81.76 (22.58) days
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DURATION OF APPLICATION PROCESS 2019
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Figure 2: Overall mean of application process (days) in 2019
Mean (SD): 92.98 (39.26) days
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DURATION OF APPLICATION PROCESS 2020
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Figure 3: Overall mean of application process (days) in 2020
Mean (SD): 58.88 (28.83) days
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DURATION OF APPLICATION PROCESS 2021
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Figure 4: Overall mean of application process (days) in 2021
Mean (SD): 109.18 (48.47) days
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DURATION OF APPLICATION PROCESS 2022
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Figure 5: Overall mean of application process (days) in 2022
Mean (SD): 87.15 (42.98) days
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EXAMPLES OF UHREC APPROVAL LETTERS
UHREC Approval letter (with grant) UHREC Approval letter (without grant)
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43 UHREC WEBSITE
https://www.unisza.edu.my/uhrec/
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44 ACKNOWLEDGEMENT
European Commission’s
Ethics for Researchers:
Facilitating Research
Excellence in Framework
Programme 7 (2013)
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World Medical Association’s
Helsinki Declaration (1964,
1975, 1983, 1989, 1996,
2000, 2002, 2004, 2008,
2013)
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46 CONTACT US
UniSZA Human Research Ethics Committee (UHREC)
Block E, Level 1, UniSZA, Gong Badak Campus
Secretariat:
1) Encik Nur Amatur Rahman bin Abd Razak, Pegawai
Tadbir (N44)
Tel No.: 09-6687757
2) Cik Baheyah binti Sanat, Penolong Pegawai Tadbir
(N32)
Tel No.: 09-6688309
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Unethical research misconduct is because of two
proven theories.
One is “Bad apple theory” – committed because
morally corrupted and economically desperate.
The other theory is “Stressful or imperfect theory” –
committed because of institutional pressures, career
ambitions (promotion), pursuit of profit or fame,
improper supervision of post-graduate candidates.
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However, many of the deviations in conduct of
research occur because researchers simply do not
know or have never thought seriously about some of
the ethical norms of scientific research in human.
The heavily tasked UHREC is committed to lead
UniSZA researchers adhered to UniSZA’s Human
Research Code of Practice and human research
ethics guidelines to safeguard researchers be neither
“a bad apple” nor “a stressful”, ‘In Shaa Allah’.
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THANK YOU
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