TITLE: ETHICAL CLEARANCE & INSTITUTIONAL ETHICAL ACTIVITIES

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 FORM1. Principal Investigator (s)

2. Co- Investigators

3. Place of study/ Institution

4. Title of study

ECApplication form (cont..)

5. Type of study

6. Duration

7. Total cost

8. Funding Agency

EC

Application form1. Source of population:

(a) Ill subjects Yes No

(b)Non Ill subjects Yes No

(c)Minors or persons Yes No

under guardianship

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 Yes No

f. Invasion of privacy Yes No

g. Disclosure of information Yes No

damaging to subject or others

EC

Application form (cont..) 3. Does the study involve:

(a)Use of records Yes No

(hospital, medical,

death, birth or other)

(b) Use of fetal tissues Yes No

or abortus

(c) Use of organs or Yes No

body fluids

EC

Application form (cont..)

4. Are subjects clearly informed about:

(a) Nature and purposes of study Yes No

(b) Procedures to be followed Yes No

including alternatives used

c) Physical risks Yes No

(d) Private questions Yes No

(e) Invasion of the body Yes No

EC

4. Application form (cont..) f) Benefits to be derived Yes No

g) Right to refuse to participate Yes No

or to withdraw from study

h) Confidential handling of data Yes No

i) Compensation where there are Yes No

risks or loss of working time or

privacy is involved in any

particular procedure

ECApplication form (cont..)5. Will sign consent form/verbal

consent be required: (a) From subjects Yes No (b) From parent or guardian Yes No

(if subjects are minors) 6. Will precautions be Yes No

taken to protect anonymity

of subjects

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

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

MMCMMC

MMC ERC Members:1. Prof. Dr. Saiyeedur Rahman

2. Prof. Dr. Md. Akram Hossain

3. Prof. Majahed Uddin Ahamed

4. Prof. Dr. Md. Anwar Hossain

5. Prof. Dr. Md. Manirul Islam

6. Dr. Kamrun Nahar

7. Dr. Md. Azizul Haque

8. Dr. Md. Nazrul Islam Siddiqui

9. 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.