TITLE: ETHICAL CLEARANCE & INSTITUTIONAL ETHICAL ACTIVITIES

1. TITLE: ETHICAL CLEARANCE & INSTITUTIONAL ETHICAL ACTIVITIES

2. Dr. M. Nazrul Islam Siddiqui FCPS, MD Associate Professor of Endocrinology Mymensingh Medical College & Hospital • .

3. Ethical principles • “The health of my patient will be my first consideration”. • “A physician shall act only in the patient’s interest…..”.

4. Guidelines • Nuremberg code: 1947 • Helsinki declaration : WMA  1964,1975,1983,1989,1996,2000 • Belmont report : 1979 • International ethical guidelines: CIOMS – 1982,1993,2002.

5. 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.

6. Islam & Ethical Principles Basic life support • Organ transplantation • Reproductive health • Genetics • etc. • Needs application of basic principles of Islam

7. Islam & Ethical Principles “and he makes for them good things lawful & bad things forbidden” – • Surah no.7, Ayet no. 157.

8. Animal Experiment & Ethics • Medical research • Laboratory animals • Proper handling • Rationality of animal experiment • IRB • AEEC

9. Ethical Issues Important Fields • Ethics in health care • Ethics in medical education • Ethics in health administration • Ethics in health research • etc.

10. 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.

11. Ethical Clearance Categories of research/ studies • Survey • Research studies involving invasive methods, trials, experiments etc. • Policy Issues

12. Ethical Clearance APPLICATION FORM • Principal Investigator (s) • Co- Investigators • Place of study/ Institution • Title of study

13. EC Application form (cont..) • Type of study • Duration • Total cost • Funding Agency

14. EC Application form 1. Source of population: • Ill subjects Yes No • Non Ill subjects Yes No • Minors or persons Yes No under guardianship

15. EC Application form(cont).. 2. Does the study involve: • Physical risks to the subject Yes No • Social risks Yes No • Psychological risks Yes No • Discomfort to subjects Yes No

16. EC Application form (cont..) 2. • Invasion of the body Yes No • Invasion of privacy Yes No • Disclosure of information Yes No damaging to subject or others

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

18. 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

19. EC 4. Application form (cont..) • Benefits to be derived Yes No • 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

20. EC Application 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

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

22. Abstract/ Summary Points to be illustrated: • Rationale of using a special group . • Potential risks: physical, psychological, social, legal etc. • Protection against risks. • Safeguarding confidentiality

23. 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

24. 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.

25. 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.

26. 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

27. 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

28. 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

29. IEA (cont..) Number of members: at least 7 – 9. • One chairman • One member secretary • Quorum: By simple majority

30. 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

31. MMC • ERC Members: • 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

32. MMC ERC • First meeting: 30 March 2006 • Resolutions: • To form scientific review committee • Thesis protocol: Needs Ethical clearance • Seminar on: Ethics in Medical Research

33. 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.

34. Thank you