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This presentation highlights the regulations on Ethical requirements for conducting clinical research in India. This is the guiding regulation for the Ethics Committees in India.

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  1. 1. ETHICAL GUIDELINES FOR BIOMEDICAL RESEARCH ON HUMAN PARTICIPANTS By: Jyothi Bhat 20 Nov 2009 Indian Council of Medical Research, 2006
  2. 2. Definition BIOETHICS = BIO + ETHICS Study of ethical issues and decision-making associated with the use of living organisms Learning how to balance different benefits, risks and duties
  3. 3. Bioethics Started… <ul><li>Started only in 1960’s </li></ul><ul><li>Reason for the creation extraordinary advances in American medicine </li></ul><ul><li>E.g. Organ transplantation, Kidney dialysis, contraceptive pills, abortion… </li></ul>
  4. 4. Indian Council of Medical Research <ul><li>Apex body in India for the formulation, coordination and promotion of biomedical research </li></ul><ul><li>One of the oldest medical research bodies in the world </li></ul><ul><li>In 1911, set up the Indian Research Fund Association (IRFA) with the specific objective of sponsoring and coordinating medical research in the country </li></ul><ul><li>Re-designated in 1949 as the ICMR </li></ul><ul><li>Funded by the Government of India through the Ministry of Health & Family Welfare (MoHF) </li></ul>
  5. 5. The Beginning….. <ul><ul><li>No. of developments in Science and Technology </li></ul></ul><ul><ul><li>Further widening of healthcare between developed and developing nations </li></ul></ul><ul><ul><li>Rapid techniques of diagnosis and therapy are now available through R & D </li></ul></ul><ul><ul><li>Advances in the area of genetics, genomics and molecular biology have grown by leaps and bounds </li></ul></ul><ul><ul><li>Rein in advances with sufficient safeguards to protect the rights and welfare of human participants subjected to biomedical research </li></ul></ul><ul><ul><li>India is being projected as a global hub for clinical trials </li></ul></ul><ul><ul><li>Guidelines for the important for biotechnology areas like stem cell research and stored tissue including DNA banking </li></ul></ul>1980
  6. 6. Bio-Medical Ethics
  7. 7. ICMR Code <ul><li>This statement of Ethical Guidelines for Biomedical </li></ul><ul><li>Research on Human Participants shall be known as </li></ul><ul><li>the ICMR Code and shall consist of the following:- </li></ul><ul><li>Statement of General Principles on Research using Human Participants in Biomedical Research </li></ul><ul><li>Statement of Specific Principles on Research using Human Participants in specific areas of Biomedical Research </li></ul>
  8. 8. GENERAL STATEMENT <ul><li>Medical and related research using human beings as research </li></ul><ul><li>participants must necessarily ensure that: </li></ul><ul><li>PURPOSE: should be directed towards the increase of knowledge </li></ul><ul><li>CONDUCTED: mere means for the betterment </li></ul><ul><li>EVALUATION: at all stages of the proposal </li></ul>These Statements of General and Specific Principles may be varied, amended, substituted and added from time to time.
  9. 9. STATEMENT OF GENERAL PRINCIPLES <ul><li>Principles of essentiality: </li></ul><ul><ul><li>human participants is considered to be absolutely essential </li></ul></ul><ul><ul><li>due consideration of all alternatives </li></ul></ul><ul><ul><li>research has been duly vetted and considered by an appropriate and responsible body of persons who are external to the particular research </li></ul></ul><ul><ul><li>necessary for the advancement of knowledge and benefit of all members of the human species </li></ul></ul>
  10. 10. STATEMENT OF GENERAL PRINCIPLES <ul><li>Principles of voluntariness, informed consent and community agreement: </li></ul><ul><ul><li>Research participants are fully apprised of the research and the impact and risk </li></ul></ul><ul><ul><li>Right to abstain from further participation </li></ul></ul><ul><ul><li>Research entails treating any community or group of persons as a research participant, these principles of voluntariness and informed consent shall apply, mutatis mutandis </li></ul></ul><ul><ul><li>Participant is incapable of giving consent the principle of voluntariness and informed consent shall continue to apply </li></ul></ul><ul><ul><li>Cardinal principles to be observed throughout the research and experiment </li></ul></ul><ul><ul><li>Ethics committee shall decide on the form of consent to be taken or its waiver based on the degree of risk that may be involved </li></ul></ul>
  11. 11. STATEMENT OF GENERAL PRINCIPLES <ul><li>Principles of non-exploitation: </li></ul><ul><ul><li>remunerated for their involvement </li></ul></ul><ul><ul><li>participants kept fully apprised of all the dangers </li></ul></ul><ul><ul><li>human participants should be selected so that the burdens and benefits of the research are distributed without arbitrariness, discrimination or caprice </li></ul></ul><ul><ul><li>in-built mechanism for compensation for the human participants through </li></ul></ul><ul><ul><ul><li>Insurance cover </li></ul></ul></ul><ul><ul><ul><li>providing for remedial action and comprehensive aftercare </li></ul></ul></ul><ul><ul><ul><li>treatment during and after the research </li></ul></ul></ul>
  12. 12. STATEMENT OF GENERAL PRINCIPLES <ul><li>Principles of privacy and confidentiality: </li></ul><ul><ul><li>identity and records of participants are kept confidential </li></ul></ul><ul><ul><li>cannot be disclosed without consent in writing of the human participant concerned, or someone authorised on their behalf </li></ul></ul><ul><li>Principles of precaution and risk minimisation </li></ul><ul><ul><li>due care and caution is taken at all stages </li></ul></ul><ul><ul><li>research participant are put to the minimum risk </li></ul></ul><ul><ul><li>no known irreversible adverse effects, and generally, benefit </li></ul></ul><ul><ul><li>both professional and ethical reviews of the research are undertaken at appropriate stages </li></ul></ul>
  13. 13. STATEMENT OF GENERAL PRINCIPLES <ul><li>Principles of professional competence: </li></ul><ul><ul><li>conducted at all times by competent and qualified persons </li></ul></ul><ul><ul><li>act with total integrity and impartiality </li></ul></ul><ul><ul><li>aware of, through training preferably, the ethical considerations to be borne in mind </li></ul></ul><ul><li>Principles of accountability and transparency </li></ul><ul><ul><li>experiment will be conducted in a fair, honest, impartial and transparent manner </li></ul></ul><ul><ul><li>full and complete records of the research inclusive of data and notes are retained for the purposes of post-research monitoring, evaluation of the research, conducting further research scrutiny by the appropriate legal and administrative authority, if necessary </li></ul></ul>
  14. 14. STATEMENT OF GENERAL PRINCIPLES <ul><li>Principles of maximisation of the public interest and of distributive justice: </li></ul><ul><ul><li>benefit all human kind and not just those who are socially better off but also the least advantaged </li></ul></ul><ul><li>Principles of institutional arrangements </li></ul><ul><ul><li>all the procedures required to be complied with and all institutional arrangements required to be made in respect of the research and its subsequent use or application are duly made in a bonafide and transparent manner </li></ul></ul>
  15. 15. STATEMENT OF GENERAL PRINCIPLES <ul><li>Principles of public domain: </li></ul><ul><ul><li>results are generally made known through scientific and other publications </li></ul></ul><ul><li>Principles of totality of responsibility </li></ul><ul><ul><li>professional and moral responsibility </li></ul></ul><ul><ul><li>effect of the research is duly monitored and constantly subject to review and remedial action at all stages of the research and experiment and its future use </li></ul></ul>
  16. 16. STATEMENT OF GENERAL PRINCIPLES <ul><li>Principles of compliance: </li></ul><ul><ul><li>general and positive duty on all persons, conducting, associated or connected with any research to ensure that both the letter and the spirit of these guidelines, as well as any other norms, directions and guidelines </li></ul></ul><ul><ul><li>12 principles under Statement on General Principles are common to all areas of biomedical research </li></ul></ul>
  17. 17. ETHICAL REVIEW PROCEDURES <ul><li>Emphasized under the Statement of General Principles at item no. 5 ( precaution and risk minimization) </li></ul><ul><li>mandatory that all proposals on biomedical research involving human participants should be cleared </li></ul><ul><li>BASIC RESPONSIBILITIES </li></ul><ul><li>ensure competent review of all ethical aspects of the project proposals </li></ul><ul><li>provide advice to the researchers on all aspects of the welfare and safety of the research participants </li></ul><ul><li>dual responsibility of review of both, the scientific content and ethical aspects </li></ul>
  18. 18. BASIC RESPONSIBILITIES <ul><li>advisable to have separate Committees </li></ul><ul><li>specify in writing the authority under which the Committee is established </li></ul><ul><li>Special situations </li></ul><ul><li>Small institutions could form alliance with other IECs or approach registered IEC </li></ul><ul><li>the institutional policy should be same </li></ul><ul><ul><li>To protect the dignity, rights and well being </li></ul></ul><ul><ul><li>To ensure that universal ethical values and international scientific standards are expressed in terms of local community values and customs. </li></ul></ul><ul><ul><li>To assist in the development and the education of a research community responsive to local health care requirements. </li></ul></ul>
  19. 19. COMPOSITION <ul><li>multidisciplinary and multi-sectorial in composition </li></ul><ul><li>Independence and competence are the two hallmarks </li></ul><ul><li>number of persons should be kept fairly small (8 - 12 members </li></ul><ul><li>minimum of five persons is required to form the quorum </li></ul><ul><li>Chairman should be from outside the Institution </li></ul><ul><li>Member Secretary should be from the same Institution </li></ul><ul><li>Others: mix of medical/non-medical, scientific and non-scientific persons </li></ul>
  20. 20. COMPOSITION <ul><li>1. Chairperson </li></ul><ul><li>2. One - two persons from basic medical science area </li></ul><ul><li>3. One - two clinicians from various Institutes </li></ul><ul><li>4. One legal expert or retired judge </li></ul><ul><li>5. One social scientist/ representative of non-governmental </li></ul><ul><li>voluntary agency </li></ul><ul><li>6. One philosopher/ ethicist/ theologian </li></ul><ul><li>7. One lay person from the community </li></ul><ul><li>8. Member Secretary </li></ul>
  21. 21. COMPOSITION Judge Clinician Social worker Philosopher Layman Chairman Secretary
  22. 22. COMPOSITION <ul><li>As per revised Schedule Y of Drugs & Cosmetics Act, 1940, </li></ul><ul><li>amended in 2005 the quorum should have at least one </li></ul><ul><li>representative from the following groups: </li></ul><ul><ul><li>One basic medical scientist (preferably 1 pharmacologist). </li></ul></ul><ul><ul><li>One clinician </li></ul></ul><ul><ul><li>One legal expert or retired judge </li></ul></ul><ul><ul><li>One social scientist/ representative of non-governmental organisation/philosopher/ ethicist/ theologian or a similar person </li></ul></ul><ul><ul><li>One lay person from the community </li></ul></ul><ul><li>Adequate representation of age and gender and member from </li></ul><ul><li>specific patient groups if required </li></ul>
  23. 23. TERMS OF REFERENCE <ul><li>Terms of Appointment </li></ul><ul><li>duration of the term </li></ul><ul><li>policy for removal, </li></ul><ul><li>replacement, </li></ul><ul><li>resignation procedure, </li></ul><ul><li>frequency of meetings, and payment of processing fee </li></ul><ul><li>honorarium/ consultancy to the members/ invited experts etc. </li></ul><ul><li>All these should be specified in a written and documented </li></ul><ul><li>SOP. Periodic updation of the SOP must also be undertaken. </li></ul>
  24. 24. <ul><li>appointment of members could be extended for another term </li></ul><ul><li>defined percentage of members could be changed on regular basis </li></ul><ul><li>appoint persons trained in bioethics or persons conversant with ethical guidelines and laws of the country </li></ul><ul><li>Substitute member may be nominated </li></ul><ul><li>criteria for number of missed meetings may be defined in the SOP </li></ul>TERMS OF REFERENCE
  25. 25. TRAINING <ul><li>encouraged to keep abreast of all national and international developments in ethics </li></ul><ul><li>regular training so that they become aware of their role and responsibilities </li></ul><ul><li>in GCP for drug trial review </li></ul><ul><li>change in the regulatory requirements should be brought to their attention and they should be aware of local, social and cultural norms </li></ul>
  26. 26. REGULATION <ul><li>IECs register under Biomedical Research Authority </li></ul><ul><li>REVIEW PROCEDURES </li></ul><ul><li>review every research proposal before initiation </li></ul><ul><li>scientific evaluation has been completed before ethical review is taken up </li></ul><ul><li>member-secretary or secretariat to screen the proposals for their completeness and categorise them based on the risk involved into </li></ul><ul><ul><li>exemption from review </li></ul></ul><ul><ul><li>expedited review </li></ul></ul><ul><ul><li>full review </li></ul></ul>
  27. 27. REVIEW PROCEDURES <ul><li>Exemption from review </li></ul><ul><ul><li>Proposals which present less than minimal risk </li></ul></ul><ul><ul><ul><li>Research on educational practices such as instructional strategies or effectiveness of or </li></ul></ul></ul><ul><ul><ul><li>comparison among instructional techniques, curricula, or </li></ul></ul></ul><ul><ul><ul><li>classroom management methods. </li></ul></ul></ul><ul><ul><li>Exceptions </li></ul></ul><ul><ul><ul><li>use of educational tests, survey or interview procedures, or observation of public behavior can identify the human participant directly or through identifiers, and the disclosure of information outside research could subject the participant to the risk of civil or criminal or financial liability or psychosocial harm </li></ul></ul></ul><ul><ul><ul><li>interviews involve direct approach or access to private papers </li></ul></ul></ul>
  28. 28. <ul><li>Expedited Review </li></ul><ul><ul><li>no more than minimal risk </li></ul></ul><ul><ul><li>Minor deviations from originally approved research during the period of approval (usually of one year duration). </li></ul></ul><ul><ul><li>Revised proposal previously approved or continuing review of approved proposals where there is no additional risk </li></ul></ul><ul><ul><li>Involve procedures listed in one or more of the following categories : </li></ul></ul><ul><ul><ul><li>a. Clinical studies of drugs and medical devices only when - </li></ul></ul></ul><ul><ul><ul><ul><li>research is on already approved drugs except when studying drug interaction or conducting trial on vulnerable population or </li></ul></ul></ul></ul><ul><ul><ul><ul><li>adverse Event (AE) or unexpected Adverse Drug Reaction (ADR) of minor nature is reported. </li></ul></ul></ul></ul>REVIEW PROCEDURES
  29. 29. <ul><li>Expedited Review </li></ul><ul><ul><li>Research involving clinical materials collected for non-research (clinical) purposes </li></ul></ul><ul><ul><li>in emergency situations like serious outbreaks or disasters prior written permission of IEC may be taken before use of the test intervention. Only for pilot study or preliminary work to study the safety and efficacy of the intervention </li></ul></ul>REVIEW PROCEDURES
  30. 30. <ul><li>Full Review </li></ul><ul><ul><li>more than minimal risk </li></ul></ul><ul><ul><li>involve vulnerable population and special groups </li></ul></ul><ul><ul><li>do not qualify for exempted or expedited review </li></ul></ul><ul><ul><li>following situations may be carefully assessed </li></ul></ul><ul><ul><ul><li>Collection of blood samples by finger prick, heel prick, ear prick, or venipuncture: from healthy adults not more than 500 ml blood is drawn in an 8 week period frequency of collection is not more than 2 times per week </li></ul></ul></ul><ul><ul><ul><li>prospective collection of biological specimens like hair and nail clippings, excreta and external secretions, placenta removed at delivery </li></ul></ul></ul><ul><ul><ul><li>Collection of data </li></ul></ul></ul><ul><ul><ul><li>Research involving clinical materials collected solely for non-research (clinical) purposes </li></ul></ul></ul>REVIEW PROCEDURES
  31. 31. Decision making process… <ul><li>Decision by consensus, to be communicated in writing, and in detail </li></ul><ul><li>Conflicts of interest to be addressed, if any </li></ul><ul><li>Reasons for decision ( positive of negative) to be recorded </li></ul><ul><li>Reversing a decision or discontinuing a trial possible, if good & sufficient reasons exist. </li></ul><ul><li>Consider any amendments to protocol, adverse events, new information likely to influence study etc </li></ul><ul><li>Investigator &/or patient /interested parties may be asked for inputs </li></ul><ul><li>Subject experts may be invited, and opinions recorded. </li></ul><ul><li>Decisions to be taken only in the absence of non-members. </li></ul><ul><li>Minutes </li></ul>
  32. 32. <ul><li>How & When? </li></ul><ul><li>Each IEC to decide for itself, the procedure & mechanism </li></ul><ul><li>Why? </li></ul><ul><li>To re-examine a proposal </li></ul><ul><li>To check if there is any valid scientific or ethical reason to suspend or terminate a study </li></ul><ul><li>Expedited Review </li></ul>Interim Review
  33. 33. <ul><li>Documents to be dated, filed & preserved </li></ul><ul><ul><li>Constitution & composition of the IEC </li></ul></ul><ul><ul><li>CVs of all members </li></ul></ul><ul><ul><li>SOPs of the IEC </li></ul></ul><ul><ul><li>National & International Guidelines </li></ul></ul><ul><ul><li>Copies of protocols submitted to IEC </li></ul></ul><ul><ul><li>All correspondence with IEC members & investigators reg: application, decision and follow-up </li></ul></ul><ul><ul><li>Agenda of all IEC meetings </li></ul></ul><ul><ul><li>Minutes of all IEC Meetings with Chairperson’s signature </li></ul></ul><ul><ul><li>Copies of decisions communicated to applicants </li></ul></ul><ul><ul><li>Record of notifications issued for premature termination of a study with reasons </li></ul></ul><ul><ul><li>Final Reports of studies with microfilms, CDs and video recordings. </li></ul></ul><ul><ul><li>Records to be maintained for at least 15 years ( if not permanently), after completion/termination of study. </li></ul></ul>Record Keeping