INTRODUCTION

Due to rapid developments in science and technology in India, it has become necessary to make adequate specific provisions to meet the ethical challenges posed by these advances on human participants. Our consultants are being involved by globalization in research studies in an increasing manner as is happening in the developing world. The international guidelines released in 2002 by the developed countries focused on observance of ethical norms relevant to different pleuralistic cultural environment in those countries for the protection of the research participants in those regions. In India the challenge faced is to apply universal ethical principles in biomedical research in the multicultural Indian society with a multiplicity of health care systems of varying standards. In keeping with the national policies and the demands of India culture the need was felt of constituting an Institutional Review Board to be in tune with the ICMR guideline, to enable our consultants to avail of the progress in science and be part of the nation's progress by creating skilled manpower for research.

GOVERNING PRINCIPLES

The first international statement on the ethics of medical research using human subjects namely the Nurenberg code was formulated in 1947, which highlighted the essentials of volunteerness and consent. In 1948, the Universal declaration of Human Rights expressed concern about rights of human beings subjected to involuntary maltreatment for purposes of research.

Based on the preliminary efforts of the Council for International organization of Medical Sciences (CIOMS) in 1964 at Helsinki, the World Medical Association formulated general principles and specific guidelines on the use of the human subjects in medical research known as the "Helsinki Declaration", which is revised from time to time.

In November 2006, the Indian Council of Medical Research released a document - Ethical guidelines for Biomedical Research on Human Participants. The Dharamshila Cancer hospital and Research Centre has constituted an IRB guided by the Ethical Principles applied to all research involving human subjects as set forth in the above mentioned ICMR guidelines.

THESE PRINCIPLES ARE ENUNCIATED BELOW

• Principles of Essentiality After due consideration of all alternatives in the light of existing knowledge in the proposed area of research, duly vetted by a responsible body that is the IRB, who are external to the particular research, come to the conclusion that the above research is necessary for the advancement of knowledge for the human species and for ecology and environmental well being of the planet, then only does the DCH & RC - IRB approve of a project.
• Principles of Voluntariness and informed consent are strictly followed, participants are fully apprised of the research, the impact and risks, in the local language as well as English, so that they can make informed choices. When the participant is incapable of giving consent and research is considered essential the principle of voluntariness and informed consent shall also apply and such consent obtained from someone who is empowered under a duty to act on their behalf.
• Principles of non exploitation As a general rule, the IRB ensures that research participants are suitably remunerated. For their involvement in research involving drugs, they are available free of cost, irrespective of the social and economic condition of literacy or educational levels of the participants, who are fully apprised of all the dangers arising in and out of the research. In built mechanism for compensation either through sponsor insurance cover or other appropriate means to cover all foreseeable and unforeseeable risks are in place to provide remedial action and comprehensive aftercare in respect of all affected, if and when necessary.
• Principles of Privacy and Confidentiality The identity and records of the human participants of the research are as far as possible kept confidential and available only to sponsors and regulatory authorities, ensuring that the human participant does not suffer from any form of hardship, discrimination or stigmatization as a consequence of having participated in the research.
• Principles of Precaution and Risk Minimization Due care and caution are taken at all stages of the research, including ensuring design and conduct of the study so that the participants are put to minimum risk and generally benefit from the research. Requisite steps are taken at the appropriate stages to offer specific guidelines in respect of the conduct of the research to the investigators.
• Principles of Professional Competence Adequate care is taken to ensure that research is conducted by competent and qualified persons by reviewing their biodatas and experiences in the conduct of research studies.
• Principles of accountability and Transparency Research is conducted in a fair, honest impartial and transparent manner after full disclosure is made of each aspect of the investigator's interest and any conflict of interest that exist. Subject to principles of privacy and confidently and the rights of the research and participant's full and complete records and data are retained for a reasonable period as may be prescribed or considered necessary for purposes of post research monitoring. Such records shall be available for appropriate legal regulatory and administrative authority when and if necessary.
• Principles of Maximization of public interest Whereas the research and its subsequent applicative use are conducted and used to the benefit of all human kind not for only those who are socially better off but also for the least advantaged and in particular the research participants themselves.
• Principles of Public Domain Whereby the research and any further research or evaluation in response to and emanating from such research is brought into the public domain so that its results are generally known through scientific publications subject to such rights as are available to the researcher under the law in force at that time.
• Principles of Responsibility Whereby the professional and moral responsibility for the due observance of all the principles, guidelines or prescriptions laid down generally devolves on all those directly or indirectly connected with the research, the effect of the research is duly monitored and constantly subject to review and remedial action at all stages of the research and its future use.
• Principles of compliance There is the positive duty on all persons, conducting associated or connected with any research entailing human subjects to ensure that both the letter and spirit of these guidelines as well as other normal, directions, guidelines which have been specifically laid down and which are applicable for that area are scrupulously and duly complied with.

AUTHORITY - All members of the IRB draw their authority from the Chairman who has appointed them for a specific period of time.

RESPONSIBILITY - All members of the Board have the responsibility of giving inputs to the decisions of the Board by voting for or against approval of a project and maintain confidentiality for decisions of the Board.

ORGANIZATIONAL ETHICS - The institution shall organize and make available space, time and storage for the researchers to complete their projects on time.

PATIENTS RIGHT - The main responsibility of the board is to ensure the well being and safety of the human subjects enrolled in a trial and ensure their remuneration from sponsors / or Insurances organized by the sponsors in case of a trial related injury on a case by case basis. Confidentiality of data would be maintained and Informed consent of the subjects / patients or authorized person in case of children or when patients cannot decide for themselves due to illness / disease.

Information & consent should be in the understandable language of the patient with translation and back translation available.

MANAGEMENT PROCEDURES OF IRB - For review of each protocol, the quorum should be at least 5 members.

APPOINTMENT & DUTY OF IRB MEMBERS - The Executive Director DCH & RC will nominate the chairperson & the members of the IRB who have qualifications and experience to review and evaluate the science, medical aspects and ethics of proposed studies and shall appoint the Chairperson from amongst the members who is outside the Institution, according to ICMR guidelines.

CHAIRPERSON - The Chairperson is responsible for conducting all committee meetings and leads discussions and deliberations pertinent to the review of the research proposals. He presides over all administrative matters pertinent to the function of the ethics committee.

In case of anticipated absence, the chairperson nominates a committee member as Acting Chairperson who will have all the powers of the Chairman for that meeting.

MEMBERS & MEMBER SECRETARY

The Executive Director appoints the member secretary from amongst the members of the committee. In consultation with the chairperson the member secretary will be responsible for the following functions : -

• Receiving all research proposals
• Forwarding all material to the Committee Members for Review and ensuring that the Research projects carried out in DCH & RC are :
  • Sound in design, have statistical validity and are conducted according to the parameters of ICH - GCP and Schedule Y.
  • Do not compromise safety of patients
  • Are conducted under the supervision of medical persons with required expertise.
  • Include only patients who have given voluntary written informed consent.
  • The Committee will review approved Research Projects every 6 months and a final report on completion of study / trial. It will maintain a list of projects, submitted, approved / disapproved and outcome.
  • A report of each SAE when observed be informed to the Board.
  • Inform the board of amendments to study related documents and get them approved.
  • Investigators to inform of study discontinuation or death, with reasons.

Projects received will be reviewed by Member Secretary within 2 weeks of receipt and if incomplete, sent back to the investigator for the clarifications required and for completeness.

The projects then will be sent to all members of the Ethics Committee and they given 2 weeks for pursuing & reviewing, subsequently the IRB meeting would be fixed by Member Secretary in consultation with the Chairperson.

Decisions will be made by voting by the members present at a particular meeting. A written opinion on the project from those who are absent will be obtained. IRB will meet bimonthly and / or earlier as required.

Agenda will be sent to members at least 2 weeks before the meeting

• Member secretary will take the minutes of a meeting or any member designated by the Chairman.
• The applicant of a proposal will submit the following documents
  • Protocol
  • Investigators brochure
  • Informed Consent and information sheet in English and Local Language with back translation certificates
  • CV of investigator and co investigators
  • Permission from DGDCI or copy of request letter to the DGDCI
  • Compensation and financial details
  • Be available for any clarifications.
  • Undertaking by PI to follow ICH & GCP guidelines.

A meeting for approval of projects will be generally called within 4 weeks of the receipt of a proposal and study related documents.

The Board will give its opinion on the project in writing as follows

• Documents pursued
  • Protocol
  • Investigators brochure
  • Informed Consent and information sheet in English and Local Language with back translation certificates
  • CV of investigator and co investigators
  • Permission from DGDCI or copy of request letter to the DGDC
  • Compensation and financial details
• Approved
• Disapproved
• Modifications before approval
• Discontinuation of previously approved project.

Should an amendment to a study related document be administrative in nature and not involving any safety criteria, it may be provisionally approved in writing by the chairperson of the Board without calling a full meeting.

The Chairman will inform other members of the committee of the amendment and his / her decision. The decision will be ratified at the next meeting of the IRB and will be recorded.

All documents pertaining to the ethics committee will be held in the office of the Institutional ethical review board.

Expedited review and approval can also be done as required for exceptional situations for a particular clinical trial.