CITA ROSITA SIGIT PRAKOESWA
Faculty of Medicine, Universitas Airlangga
Dr. Soetomo General Academic Hospital
Ethical Aspect:
Human Subject Research
OUTLINE
ETHICS & ETHICAL REVIEW
(Medical Service & Clinical Research)
ETHICAL ISSUE IN ETHICAL REVIEW
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IMPLEMENTATION OF ETHICAL REVIEW PROCESS
ETHICS & ETHICAL REVIEW
(Medical Service & Clinical Research)
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Better Research = Better Health
Good Research
Good Evidence
Evidence-Based Healthcare
Better health status
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CURRENT
SITUATION
Lawsuit Target
Hospitals
Doctors
Nurses, Midwives
Dentists
As legal subjects, doctors, nurses, midwives have been targeted for lawsuits over health services that are considered detrimental to patients.
CLINICAL PROBLEMS
Pure Ethics
Ethico-legal
Profession
Legal
Legal Sectors
Suit to applicable regulations
ADMISSION
OUT
General
Consent
Patient & Family Right
Education
Protection
Security and safety
Patients and Belongings
Protection
Patient’s
Privacy and Secret
Informed
Consent
DNR
Life End
Patient & Family Right
Clinical Trial
Screening
registration
Initial assessment
(Medical-nursing-discharge plan
Pain-fall-special risk)
Follow up plan
Summary
Education
Intervention / Procedure
Integrated Patient Services
Hospital Service Process
IMPLEMENTATION of
3 PRINCIPLES
7 ETHICAL STANDARDS
in The Ethical Review Process
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HISTORY
R
B
J
Beneficence
Respect for persons
Ethical Principles
Researchers must respect human rights and dignity as subjects, give their best and act fairly
Justice
Recognize 3 ethical principles, 7 WHO ethical standards & 25 WHO-CIOMS ethical guidelines
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Guidelines
Social
vs Clinical value
Scientific Validity
Fair Subject Selection
Favorable Risk-Benefit Ratio
Privacy & Confidentiality
Seven Principles of Good Ethics
Seduction / Persuasion
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1. SOCIAL VALUE/ CLINICAL VALUE
THERE IS NOVELTY
In the study, there is a novelty value, namely there is at least one of the following 3 characteristics:
a. Potential to generate valid information |
b. Have meaningful relevance to health problems |
c. Contribute to a creation/benefit in evaluating policy interventions, or as part of implementing activities that promote individual or community health |
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2. SCIENTIFIC VALUE
Research design follows scientific logic :
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3. BALANCING BURDEN & BENEFIT
Subjects are selected based on scientific considerations, not recruited based on socioeconomic status, on the basis of authority, or ease of manipulation
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4. POTENTIAL BENEFIT & RISKS
The key: lies in the HREC, the decision is based on a balance of careful, fair judgment “Lay person” considerations
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5. PERSUASION
It is ethically acceptable to compensate for the costs of participating in research, including transportation costs, lost income, replacing time spent participating in research 🡪 Fair
Avoid suspicion of “exploitation” claims
Caution 🡪 subject recruitment with low socioeconomic, benefits researchers, sponsors incur lower costs
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6. PRIVACY & CONFIDENTIALITY
Violation of the privacy and confidentiality of research subjects is disrespectful to the subject and can lead to social stigma
Research using medical records, does it violate ethics?
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7. INFORMED CONSENT
Communication process
The principle of respect for each individual
Consent is given by competent individuals who have received information, understood and made decisions without coercion, persuasion, or intimidation
Viewed as a process rather than document preparation
Informed consent
1. Scientific value, social value, and respect
2. Conducting research in health facilities
3. Distribution of benefits and burdens in the selection of research subjects
4. Benefits and risks of research
5. Selection of controls in clinical trials
6. Attention to the health of research subjects
7. Interest in society
8. Collaboration and research capacity building
9. Individual capacity of informed consent
10. Modification of informed consent
11. Collection, storage and use of biological materials
12. Collection, storage and use of data in health research
13. Reimbursement and compensation for research participants
14. Reimbursement and compensation for hazardous events in research
15. Vulnerable persons
16. Adult participants are unable to give informed consent
17. Children and youth participants
18. Female participant
19. Pregnant and breastfeeding participants
20. Disaster and outbreak research
21. Randomized cluster test
22. Use of online data and digital tools in health research
23. Requirements for establishing an ethics committee and reviewing protocol
24. Public accountability in health research
25. Conflicts of interest
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RESEARCH
New Discoveries
No matter how good the results in the laboratory
or in animals, if the effect is not seen in HUMANS
MAN IS THE FINAL TEST TUBE
ETHICS
These findings have no clinical benefit
!
Have a balanced role in enforcing research ethics
RESEARCHER
REVIEWER (Human Research Ethics Committee)
Research’s Ethics
Proposal
Protocol
A written plan of research proposals that is compiled systematically
The research operational guidelines that explained each step of the research in detail
RESEARCH PROTOCOLS
Online
HEALTH RESEARCH ETHICS COMMITTEE
(KEPK)
KEPK
HOW THE RESEARCH ETHICS REVIEW IS IMPLEMENTED?
The profile
Health Research Ethics Committee
Dr Soetomo General Academic Hospital
(HREC-DSGAH)
Academic Medical Center Standards�Human Subject Research Program
Coord Research & Development
Coord Medical Service
Coord Education & Training
Health Research Ethics Committee
Researcher
Director
Human Subjects (Patient)
Medical Staff Group
Sponsor &
Research Contract
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What, who, why, when, where & How
Health Research Ethics Committee Dr Soetomo General Academic Hospital
is an independent committee which conducting ethical review for every protocol of researches which will be done by civitas hospitalica & academica of DSGAH
The members are from internal and external institution, lay persons and administration staffs
to ensure that human subject research in DSGAH would be studied in accordance with ICH-GCP (International Convention on Harmonization of GCP) principles, refer to WHO-CIOMS guidelines
HREC-SGAH start on 2005
Jl. Prof. Dr. Moestopo No 6-8 Surabaya
How to contact :
Hotline : Whatsup - 082143729965, Phone number - 031 550 1164, Link Web KEPK : http://komiteetik-rsudrsoetomo.com
The History �of HREC Dr Soetomo General Academic Hospital
199x
2005
2008
2018
2019
April 2020
Fac of Med Unair
+ DSGAH
Guidelines book of HREC DSGAH
Separated from HREC of FM
Unair
Online ethics submission was started
Renewed guideline of HREC
Online ethics submission was revised referred to FERCAP
standard
Only Human Research Subject that must submit ethical clearance approval
All researches should submit ethical clearance approval
Organization Chart of HREC
Panel 1
Panel 2
Panel 3
Panel 4
Chairman
Prof Dr Hendy Hendarto dr SpOG(K)
Vice chairman
Dr Dominicus Husada dr MCTM SpA(K)
Secretary (2)
Dr Achmad Suryawan dr SpA(K)
Dr Laksmi Wulandari dr SpP(K) FCCP
Male Female Senior
EC Composition | | ||||||||||
Name | Profession & Credentials | Field Med Non-Med | Affiliation Yes No | Gender M F | | ||||||
Joni Wahyuhadi | Advisor / Director | | ☐ | | ☐ | | ☐ | | |||
Cita Rosita SP | Advisor / Director | | ☐ | | ☐ | ☐ | | | |||
Hendy Hendarto | Gynecologist | | ☐ | | ☐ | | ☐ | | |||
Dominicus Husada | Pediatrician | | ☐ | | ☐ | | ☐ | | |||
Ahmad Suryawan | Pediatrician | | ☐ | | ☐ | | ☐ | | |||
Laksmi Wulandari | Pulmonologist | | ☐ | | ☐ | ☐ | | | |||
Elizius Hanindito | Anesthesiogist | | ☐ | | ☐ | | ☐ | | |||
Tri Wahyu Martanto | Orthopedic Surgeon | | ☐ | | ☐ | | ☐ | | |||
Fany Arsyad | Research Development | ☐ | | | ☐ | | ☐ | | |||
Imam Mu’if | Research Development | ☐ | | | ☐ | | ☐ | | |||
Ferdiansyah | Orthopedic Surgeon | | | ☐ | | ☐ | | ☐ | | ||
Siti Farida | Pharmacist | ☐ | | | ☐ | ☐ | | | |||
Arie Utarianie | Anesthesiogist | | ☐ | | ☐ | ☐ | | | |||
Damayanti Tinduh | Physic & Rehabilitation | | ☐ | | ☐ | ☐ | | | |||
Endang Martiniani | Pharmacist | ☐ | | | ☐ | ☐ | | | |||
Alpha Fardah | Pediatrician | | ☐ | | ☐ | ☐ | | | |||
Evelyn Komaratih | Ophthalmologist | | ☐ | | ☐ | ☐ | | | |||
Septiana Widyanta | Dermatologist | | ☐ | | ☐ | ☐ | | | |||
Eddy Bagus Wasito | Microbiologist | | ☐ | | ☐ | | ☐ | | |||
Eddy Rahardjo | Anesthesiogist | | ☐ | | ☐ | | ☐ | | |||
Aryati | Clinical Pathologist | | ☐ | | ☐ | ☐ | | | |||
Jusak Nugroho | Clinical Pathologist | | ☐ | | ☐ | | ☐ | | |||
Doddy M Soebadi | Urologist | | ☐ | | ☐ | | ☐ | | |||
Gatot Soegiarto | Internist | | ☐ | | ☐ | | ☐ | | |||
M Arifin Parenrengi | Neurosurgeon | | ☐ | | ☐ | | ☐ | | |||
Yulianto Listiawan | Dermatologist | | ☐ | | ☐ | | ☐ | | |||
Suharjono | Pharmacist | ☐ | | | ☐ | | ☐ | | |||
Agus Santoso Budi | Plasticsurgeon | | ☐ | | ☐ | | ☐ | | |||
Awalia | Internist | | ☐ | | ☐ | ☐ | | | |||
Khairina | Psychiatrist | | ☐ | | ☐ | ☐ | | | |||
Lindawati Alimsardjono | Microbiologist | | ☐ | | ☐ | ☐ | | | |||
Margarita M Maramis | Psychiatrist | | ☐ | | ☐ | ☐ | | | |||
Iswinarno | Plasticsurgeon | | ☐ | | ☐ | | ☐ | | |||
Andi Darma | Pediatrician | | ☐ | | ☐ | | ☐ | | |||
Dwi Reno Pawarti | ENT doctor | | ☐ | | ☐ | ☐ | | | |||
Christijogo Sumartono | Anesthesiogist | | ☐ | | ☐ | | ☐ | | |||
Hardiono | Anesthesiogist | | ☐ | | ☐ | | ☐ | | |||
Christinari Ratih | Dentist | | ☐ | | ☐ | ☐ | | | |||
Tutik Rahayu Ningsih | Lay person | ☐ | | ☐ | | ☐ | | | |||
Prilian Cahyanai | Lay person | ☐ | | ☐ | | ☐ | | | |||
Meigire Triassunu | Lay person | ☐ | | ☐ | | | ☐ | | |||
Dwi Novi Kartika K | Lay person | ☐ | | ☐ | | ☐ | | | |||
Astri Nur Amalia | Lay person | ☐ | | ☐ | | ☐ | | | |||
Zahra Fatimah Yuniar | Lay person | ☐ | | ☐ | | ☐ | | | |||
Dien Mardiyah | Lay person | ☐ | | ☐ | | ☐ | | | |||
Fuad Hasan | Lay person | ☐ | | ☐ | | | ☐ | | |||
Eys Dedeh Herawati | Secretary staffs | ☐ | | ☐ | | ☐ | | | |||
Lintang Ayu Prayogi | Secretary staffs | ☐ | | ☐ | | ☐ | | | |||
Wini Damayanti | Secretary staffs | ☐ | | ☐ | | ☐ | | | |||
Dyah Adriyani | Secretary staffs | ☐ | | ☐ | | ☐ | | | |||
Syailendra Balindo | Secretary staffs | ☐ | | ☐ | | | ☐ | | |||
: 25
: 25
: 20
Junior : 30 Medical staffs : 32
Non Medical staffs : 18
- R&D
SAE point persons
Member of
Health Research Ethics Committee Dr Soetomo General Academic Hospital 2021
Website - HREC Review
Panel of
Health Research Ethics Committee Dr Soetomo General Academic Hospital
Flowchart of Ethics Submission (New Version)
Researcher
Verificator / Adminatrator Classificator / Secretary Chief
Reviewer
Filling the research protocol form
Application submission
Document check
Forwarding to Classificator/Secretary
Document correction / completion
Classify the Application
Choose reviewers
Choose lay person
Asking Chief approval
Reviewing Protocol
Not complete
Complete
Exempted
Expedited
Pleno
Letter of Exemption
Preparing Board Meeting
Document correction / completion
Resubmission
Need correction
Approved
Ethical Clearance
Pleno
Exempted
Expedited
Major Revision
Resubmission check
Minor Revision Correct
Board Meeting
Board Meeting
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&
ETHICAL ISSUE
IN
ETHICAL REVIEW
Ethical Aspects of Clinical Research �Vulnerable subjects, RESPECT FOR PERSONS- AUTONOMY
RECRUITMENT | Was a representative sample of patients included in the study at the same time in the disease course (usually early)? | Are the diagnostic tests carried out covering the entire spectrum of patients (as would be used in practice)? | Does the subject represent? |
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Inability to protect yourself can be caused by:
Respecting the autonomy of the subject
Ethical Aspects of Clinical Research �BENEFICENCE & NON MALEFFICIENT
BENEFIT
For the subjects
Free health care (physical examination, laboratory, X-ray, etc.)
The possibility that the drug or treatment studied is beneficial to cure their disease
Special attention
from doctors
For others/ society:
New knowledge
Example: Giving rewards to the subject
Excluding benefits because it can be manipulated to balance the risk-benefit considerations
Classified as research incentive
Intended to replace the time loss, transport costs and inconveniences
High honorarium should not be used as rewards for research with high risk
Various efforts to reduce the risk on the research subject
Good research methods
Competency / qualification of the research team
Approval of the Ethics Committee
Research place facilities
Sequential analysis for large studies
Security monitoring
Terminations research
Subject’s termination of participation
Inclusion and exclusion criteria
Design and methodology
Research rationale
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Various efforts to reduce the risk on the research subject
Good Monitoring of Adverse Events (AE)
Maintaining the confidentiality of the subject’s data
Give freedom to the subject to refuse in taking part and withdrew from the study
Avoid a repeat study
Anticipating the potential side effects
Avoid coercion
Preparing for help if side effects occur
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Anticipating the potential side effects
For the drug research, potential side effects can be expected i.e by seeing the structure of the molecule, therapeutic class, toxicity data on experimental animals
Termination of research due to risk-benefit considerations
Large and planned research that take a long time sometimes to be stopped early because one treatment is far superior → other group is disadvantaged
Ethical Aspects of Clinical Research �JUSTICE
1. RECRUITMENT | Was a representative sample of patients included in the study at the same time in the disease course (usually early)? | Are the diagnostic tests carried out covering the entire spectrum of patients (as would be used in practice)? | Does the subject represent? |
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2. ALLOCATION | How is the patient treated? If there are subgroups with different prognoses, are adjustments made for important prognostic factors? | | Is the placement of intervention and control groups hidden? so the intervention and control groups were comparable at the start of the study? |
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3. MAINTENANCE | Was the group status maintained commensurate with the same management and adequate follow-up? | Is a standardized final test applied to all subjects? | Did the groups get the same co-intervention? Is there sufficient follow-up? |
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Ethical Aspects of Experimental Research
Population of patients with condition
Sample
OUTCOME
OUTCOME
Time
RECRUITMENT
Benefecience
Non Maleficience
Autonomy
Justice
MEASUREMENT
RANDOMIZATION
Experimental
Intervention
Comparison
Intervention
HARM/RISK
Non malefecience
Ethical Aspects of Experimental Research
Population of patients with condition
Sample
OUTCOME
OUTCOME
Time
RECRUITMENT
Benefecience
Non Maleficience
Autonomy
Justice
MEASUREMENT
RANDOMIZATION
Experimental
Intervention
Comparison
Intervention
HARM/RISK
Non malefecience
Ethical Aspects of Experimental Research
Population of patients with condition
Sample
OUTCOME
OUTCOME
Time
RECRUITMENT
Benefecience
Non Maleficience
Autonomy
Justice
MEASUREMENT
RANDOMIZATION
Experimental
Intervention
Comparison
Intervention
HARM/RISK
Non malefecience
Ethical Aspects of Experimental Research
Population of patients with condition
Sample
OUTCOME
OUTCOME
Time
RECRUITMENT
Benefecience
Non Maleficience
Autonomy
Justice
MEASUREMENT
RANDOMIZATION
Experimental
Intervention
Comparison
Intervention
HARM/RISK
Non malefecience
Medical personnel of a Class A hospital
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Profile of handwashing behavior
Is this research ethically worthy?
Problem statement .
Handwashing profile of a class A hospital medical personnel is unclear.
Case Example (1)
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Covid-19 patients
New Antiviral (X)
Standard of Care (Y)
Clinic
Laboratory
Is this research ethically worthy?
Problem statement .
Benefits of new antiviral (X) in patients with Covid-19 in improvement of clinical & laboratory parameter is not yet clear
Case Example (2)
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Elderly who suffer from Bronchial asthma
Sport (exercise)
No sport (exercise)
Clinical improvement
Is this research ethically worthy?
Problem statement .
The effect of exercise in the elderly who suffer from
Bronchial asthma is unclear.
Case Example (3)
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In all areas of research and therapy,
nuanced consideration & discussion of the best translational pathways, as viewed by ethics as well as science, will play a vital role in balancing hope and hype now and in the future,
as the field continues its rapid progress
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Thank YOU