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TITLE: ETHICAL CLEARANCE

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TITLE: ETHICAL CLEARANCE & INSTITUTIONAL ETHICAL ACTIVITIES * Dr. M. Nazrul Islam Siddiqui FCPS, MD Associate Professor of Endocrinology Mymensingh Medical College ... – PowerPoint PPT presentation

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Title: TITLE: ETHICAL CLEARANCE


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 patients
    interest...

4
  • Guidelines
  • Nuremberg code 1947
  • Helsinki declaration WMA ? 1964,1975,1983,1989,1
    996,2000
  • 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
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