TITLE ETHICAL CLEARANCE INSTITUTIONAL ETHICAL ACTIVITIES Dr M

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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

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”. •

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,

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

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 •

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

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

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

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 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,

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

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

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

EC Application form 1. Source of population: (a) Ill subjects (b) Non Ill subjects (c) Minors or persons under guardianship Yes Yes No No No

EC Application form(cont). . 2. Does the study involve: a. Physical risks to the

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

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

EC Application form (cont. . ) 3. Does the study involve: (a)Use of records

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

EC Application form (cont. . ) 4. Are subjects clearly informed about: (a) Nature

EC Application form (cont. . ) 4. Are subjects clearly informed about: (a) Nature and purposes of study (b) Procedures to be followed No including alternatives used c) Physical risks (d) Private questions (e) Invasion of the body Yes No Yes No

EC 4. Application form (cont. . ) f) Benefits to be derived g) Right

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

EC Application form (cont. . ) 5. Will sign consent form/verbal consent be required:

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

ERC ABSTRACT: • Abstracts/ summary: is essential • Purpose of the study • Methods

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.

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

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

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

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

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 –

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

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

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 •

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.

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

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

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.