TITLE: ETHICAL CLEARANCE &
INSTITUTIONAL ETHICAL
ACTIVITIES
Dr. M. Nazrul Islam Siddiqui
FCPS, MD
Associate Professor of
Endocrinology
Mymensingh Medical College &
Hospital
•.
Ethical principles
• “The health of my patient
will be my first
consideration”.
• “A physician shall act only
in the patient’s interest…..”.
Guidelines
• Nuremberg code: 1947
• Helsinki declaration : WMA 
1964,1975,1983,1989,1996,2000
• Belmont report : 1979
• International ethical guidelines:
CIOMS – 1982,1993,2002.
Guidelines (Cont..)
• Guidelines for good clinical practice
for trials on pharmaceutical
products: WHO – 1995
• Universal Declaration on Human
Genome & Human Rights: UNESCO –
1997
• Operational Guidelines: WHO – 2000
• Surveying & Evaluating Ethical
Review Practice: WHO – 2002.
Islam & Ethical Principles
Basic life support
• Organ transplantation
• Reproductive health
• Genetics
• etc.
–Needs application of basic
principles of Islam
Islam & Ethical Principles
“and he makes for them good
things lawful & bad things
forbidden” –
–Surah no.7, Ayet no. 157.
Animal Experiment & Ethics
•
•
•
•
•
•
Medical research
Laboratory animals
Proper handling
Rationality of animal experiment
IRB
AEEC
Ethical Issues
Important Fields
•
•
•
•
•
Ethics in health care
Ethics in medical education
Ethics in health administration
Ethics in health research
etc.
Ethical Review Committee (ERC)
• BMRC ERC  NCE
• Each & every project  SRC 
ethical clearance
• ERC provides clearance for:
– BMRC funded research projects
– Project founded by organizations
– Research studies leading to
postgraduate degrees.
Ethical Clearance
Categories of research/ studies
• Survey
• Research studies involving
invasive methods, trials,
experiments etc.
• Policy Issues
Ethical Clearance
APPLICATION FORM
1.
2.
3.
4.
Principal Investigator (s)
Co- Investigators
Place of study/ Institution
Title of study
EC
Application form (cont..)
5.
6.
7.
8.
Type of study
Duration
Total cost
Funding Agency
EC
Application form
1. Source of population:
(a) Ill subjects
(b)Non Ill subjects
(c) Minors or persons
under guardianship
Yes
Yes
Yes
No
No
No
EC
Application form(cont)..
2. Does the study involve:
a. Physical risks to the subject
Yes
No
b. Social risks
Yes
No
c. Psychological risks
Yes
No
d. Discomfort to subjects
Yes
No
EC
Application form (cont..)
2.
e. Invasion of the body
f. Invasion of privacy
g. Disclosure of information
damaging to subject or others
Yes No
Yes No
Yes No
EC
Application form (cont..)
3. Does the study involve:
(a)Use of records
(hospital, medical,
death, birth or other)
(b) Use of fetal tissues
or abortus
(c) Use of organs or
body fluids
Yes
No
Yes
No
Yes
No
EC
Application form (cont..)
4. Are subjects clearly informed about:
(a) Nature
and purposes of study
(b) Procedures to be followed
including alternatives used
c) Physical risks
(d) Private questions
(e) Invasion of the body
Yes No
Yes No
Yes No
Yes No
Yes No
EC
4. Application
form (cont..)
f) Benefits to be derived
g) Right to refuse to participate
or to withdraw from study
h) Confidential handling of data
i) Compensation where there are
risks or loss of working time or
privacy is involved in any
particular procedure
Yes
Yes
No
No
Yes
Yes
No
No
EC
Application form (cont..)
5. Will sign consent form/verbal
consent be required:
(a) From subjects
(b) From parent or guardian
(if subjects are minors)
6. Will precautions be
taken to protect
anonymity
of subjects
Yes No
Yes No
Yes
No
ERC
ABSTRACT:
• Abstracts/ summary: is
essential
• Purpose of the study
• Methods
• Procedure
Abstract/ Summary
Points to be illustrated:
1. Rationale of using a special
group .
2. Potential risks: physical,
psychological, social, legal etc.
3. Protection against risks.
4. Safeguarding confidentiality
Abstract/ summary (cont..)
5. When potential risks/Question of
privacy  needs signed informed
consent:
(a) If signed consent will not be taken –
why ?
Provide altenative procedure e.g –
verbal.
(b) If information is withheld – justify.
( c) In case of potential risks/ loss of
work time – cpmpensation
Abstract/ summary (cont..)
6. If study involves interview: time. place &
context
7. Benefits to the subjects, society &
favorable risk – benefit ratio.
8. If experimental drugs: status of
registration in BD & developed countries
9. Experimental ‘new drugs’ : toxicity
studies should be annexed.
Abstract/ summary (cont..)
10. If placebo is used: justify
11. If experimental ‘new drug’:
sponsorship & its conditions
12. Use of records: hospital, medical,
birth, death etc.
Other materials: organs, tissues,
body fluids, fetus, abortus etc.
ERC
Check documents:
 Umbrella proposal
 Proposal summary
 Abstract for ethical Review committee as per
attachment (Obligatory)
 Informed consent form for subjects
 Informed consent form for parent or guardian
 Verbal consent form for subject
 Procedure for maintaining confidentiality
 Questionnaire or interview schedule
MMC
Institutional Ethical Activities
• Ethical Review Committee:
– Operational guidelines, WHO,2000
– BMRC
• Clause no. 4.1:
– Academic council
– Consensus of the members
– Rotation of membership
IEA (cont..)
Clause no. 4.2:
– Duration of appointments: at least 1 yr.
– Renewal of appointment
– In case of resign or transfer
Clause no. 4.4:
– Clearly defined office
– Adequate staff support
IEA (cont..)
Number of members: at least 7 – 9.
–One chairman
–One member secretary
• Quorum: By simple majority
MMC
Ethical Review Committee
• Decision in the Academic Council:
29 January 2006
• Ethical Review Committee was formed
Structure: 11 members
• Chairman: Prof. Dr. Nurul Islam
• Member secretary: Dr. Feroza Parveen
MMC
ERC Members:
1.
2.
3.
4.
5.
6.
7.
8.
9.
Prof. Dr. Saiyeedur Rahman
Prof. Dr. Md. Akram Hossain
Prof. Majahed Uddin Ahamed
Prof. Dr. Md. Anwar Hossain
Prof. Dr. Md. Manirul Islam
Dr. Kamrun Nahar
Dr. Md. Azizul Haque
Dr. Md. Nazrul Islam Siddiqui
Dr. U.K. Taufiqun Nessa
MMC
ERC
• First meeting: 30 March 2006
• Resolutions:
– To form scientific review committee
– Thesis protocol: Needs Ethical
clearance
– Seminar on: Ethics in Medical
Research
SUMMARY
• Biomedical research is the key of
development
• Research should be problem based with
favourable risk benefit ratio
• Ethical research leads to a healthy out
come
• All research activities should be conducted
by ethical guidelines
• All research activities must have clearance
from ERC.