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ICMR guidelines for IEC - an overview

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ICMR guidelines for IEC - an overview

  1. 1. INSTITUTIONALETHICS COMMITTEE (IEC)  Independent body constituted of medical, non- medical, scientific and non-scientific members  whose responsibility is to ensure the protection of the rights, safety and well-being of human subjects involved in the trial  by, among other things, reviewing, approving & providing continuing review of trial protocol &
  2. 2. ICMR GUIDELINES FOR IEC- AN OVERVIEW PROF. Dr. V.SATHYA NARAYANAN M.D., PROFESSOR OF PHARMACOLOGY SRM MCH & RC
  3. 3.  the apex body in India for the  formulation,  coordination and  promotion of biomedical research.  one of the oldest medical research bodies in the world.  funded by the Government of India through the Department of Health Research, Ministry of Health & Family Welfare The Indian Council of Medical Research (ICMR)
  4. 4.  Structure of Institutional Ethics Committee  Functioning of IECs  Review procedures  Steps towards IEC Meetings I ( 1- 4 )  Steps towards IEC Meetings II ( 5-10 )  Responsibilities of IEC members  conclusion OUTLINE
  5. 5.  At the end of the session participants be able to  Describe the structure of an IEC  Describe the review process from within the IEC  Describe the responsibilities of an IEC member Objectives
  6. 6. Composition:  Multidisciplinary and multisectorial in composition  Number of persons – 5/7 – 12/15 Structure of IEC
  7. 7.  Chair should preferably be from outside the Institution and not head of the same  Institution to maintain the independence of the Committee.  Member secretary, from same institution  should conduct the business of the Committee Specific members of IECs
  8. 8.  Chair  1-2 basic medical scientists  1-2 clinicians from various institutes  One legal expert or retired judge  One social scientist/representative of NG voluntary agency  One philosopher/ethicist/theologian  One lay person  Member Secretary  If required, subject experts could be invited to offer views Members of IEC
  9. 9. Described in terms of; Review procedures Decision making processes Documentation requirements Functioning of IECs
  10. 10.  Scientific evaluation should be completed before ethical evaluation  Evaluate possible risks to the subjects with proper justification  Expected benefits Review Procedures
  11. 11.  Adequacy of documentation for ensuring privacy, confidentiality and justice issues  The ethical review should be done through formal meetings and should not resort to decisions through circulation of proposals  Decisions are preferably arrived at by consensus Review Procedures
  12. 12. 1. Prefixed dates for routine IEC meetings 2. Submissions made by researchers in keeping with the requirements of the IEC’s SOP 3. Finalising primary and secondary reviewers 4. The proposals circulated to members giving sufficient time for review Steps towards the IEC meeting - I
  13. 13. 5.The members undertake the review 6.The meeting of the IEC 7.Discussions at the IEC 8.Decisions made 9.The process and decisions are documented 10.These decisions and the reasons are communicated to the researchers Steps towards the IEC meeting - II
  14. 14. Preparatory phase: steps 1-4
  15. 15.  Need to be finalised in advance  This helps researchers develop, finalise the materials  Plan in advance Step 1. Prefixed dates
  16. 16.  Knowledge of the dates facilitates timely submissions Step 2.Submissions to the IEC
  17. 17. SUBMISSION OF APPLICATION 1. The title with signature of Principal Investigator (PI) and Co-investigators as attestation for conducting the study. 2. Clear research objectives and rationale for undertaking the investigation in human participants in the light of existing knowledge. 3. Recent curriculum vitae of the Investigators indicating qualification and experience. 4. Participant recruitment procedures and brochures, if any. 49
  18. 18. 5. Inclusion & exclusion criteria for entry of participants. 6. Precise description of methodology of the proposed research, including sample size (with justification), type of study design, intended intervention, dosages of drugs, route of administration, duration of treatment and details of invasive procedures if any. 7. Plan to withdraw or withhold standard therapies in the course of research. 8. Plan for statistical analysis of the study. 50 SUBMISSION OF APPLICATION
  19. 19. SUBMISSION OF APPLICATION 9. Procedure for seeking and obtaining informed consent with sample of patient information sheet and informed consent forms in English and local languages. 10. Safety of proposed intervention and any drug or vaccine to be tested, including results of relevant laboratory, animal and human research. 11. A statement on conflict-of-interest (COI), if any. 54
  20. 20.  The secretariat of the IEC sorts through the proposals,  allocates primary and secondary reviewers for the proposals that need full review Step 3. Primary and secondary reviewers
  21. 21. Proposals are mailed to all members Step 4. Sending of proposals
  22. 22. The Review Phase: Steps 5-9
  23. 23.  The members review the proposal keeping in mind the subjects (vulnerability, etc),  the process(consent, requirements for privacy and confidentiality etc),  the study requirements (risks/benefits etc)  Seeks and obtains clarifications if necessary Step 5. The review
  24. 24. TYPES OF REVIEW
  25. 25. FULLREVIEW All research proposals presenting with more than minimal risk.  Projects that involve vulnerable population (children, psychiatric patients etc.,)  Full review is carried out in cases involving  (a) collection of blood samples  (b) Prospective collection of biological specimens eg. Skin appendages, excreta saliva, placenta, amniotic fluid, sputum etc
  26. 26. EXPEDITED REVIEW • Those with no more than minimal risk to research participants may be subjected to this review Ex: clinical studies of drugs and medical devices the research involves already approved drugs when a adverse event or unexpected adverse reaction is reported
  27. 27. EXEMPTED FROM REVIEW Proposals with less than minimal risk Ex: research on educational practice, • instructional technics, curricula, • classroom management methods
  28. 28.  Presided over by the chair  The members have done their homework!  Attend meeting and engage in discussion  If further clarifications needed, ask for the PI to be present  Discuss and discuss and discuss Step 6. The IEC meeting
  29. 29.  The various members raise concerns regarding aspects of proposal  Many of the issues are clarified by within group discussions  Usually the guidance from the ICMR guidelines and the various govt. regulations are referred to already by specific members when there are contentious issues  In case these are not adequate, the members also use other guidelines and use scholarly journals for additional support for decisions Step 7. The discussions
  30. 30.  Usually all concerns are adjusted into the decision by way of recommendations to be taken into account before giving clearance  In case the requirements are trivial, the MS is authorised to obtain clarifications and give clearance  In case additional information is needed or the clarifications need further review, a sub-committee may be appointed or resubmission recommended Step 8. The decision
  31. 31.  The member secretary keeps track of the discussions and decisions  Compiles the minutes and has them sent to all members present for corrections if any  Once these are returned, s/he prepares the minutes for approval by Chair Step 8. Documenting the decisions
  32. 32.  The MS communicates these decisions to the researchers and also  advices them on what is necessary in case of any recommendations that call for changes Step 9. The communication with the researchers
  33. 33. The Final Phase: The decision
  34. 34.  Outright approval (at most, only very minor changes are suggested. The application contained all necessary information.)  Approval with modifications (there is enough information to judge the study, but clarification or changes are needed)  Resubmit with more information (there is not enough information to judge the application appropriately)  Outright disapproval (there is no way the researcher can ethically do study) Step 10. The decision:
  35. 35.  Meetings must be minuted and approved and signed by chair  Strict confidentiality  All documentation, including final reports of the study, microfilms, CDs and video recordings need to be kept safe for about 15 years (currently revised to a minimum of 3 years) Documentation requirements
  36. 36. Responsibilities of IEC Members
  37. 37. 1. To provide competent review of all ethical aspects of the project 2. Undertake review free from bias and influence 3. Provide advice to the researchers on all aspects of welfare and safety of research participants Responsibilities of IEC Members
  38. 38.  Undergo appropriate training to enhance competence  To maintain confidentiality of documents obtained and discussions during the review process  To allocate time for reviewing the proposals 1. To provide competent review of all ethical aspects of the project
  39. 39.  Need to put on record various interests, financial or otherwise to avoid conflict of interest  Reflexivity about the nature of engagement with protocols  Non-judgmental and unbiased decision making 2. Undertake review free from bias and influence
  40. 40. CONFLICT OF INTEREST  A conflict of interest is a set of conditions in which professional judgment concerning a primary interest (such as a patient’s welfare or the validity of the research) tends to be unduly influenced by a secondary interest (such as financial gain)
  41. 41.  Need to build capacity of researchers  Provide ongoing review  Monitor the taking of consent  Ensure that the guidance from the ERB is actually followed  Keep oneself informed of the research process and re-review whenever necessary 3. Provide advice to the researchers on all aspects of welfare and safety of research participants
  42. 42.  Discussed the structure and functions of IEC  Described the review process  Explained the responsibilities of members of the IEC  I hope you have a productive time discussing the proposals CONCLUSION
  43. 43. A QUOTE ON ETHICS
  44. 44. THANK YOU..

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