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STANDARD OPERATING PROCEDURES FOR IEC, AIIMS PATNA

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  • SHORT DESCRIPTION OF SOP

    The following may be called as “Standard Operating Procedures for the Institutional ethics committee (IEC) of All India Institute of Medical Sciences, Patna”.

  • ADOPTION OF SOP

    All India Institute of Medical Sciences, Patna herein after referred to as “AIIMS-P” has adopted these written Standard Operating Procedures (SOP) to ensure the protection of the rights and welfare of human participants in biomedical, experimental and behavioral research conducted at AIIMS-P.

  • OBJECTIVES OF SOP

    The objective of this Standard Operating Procedures of the Institutional ethics committee (IEC) of All India Institute of Medical Sciences, Patna is to maintain effective functioning of the AIIMS-P-IEC and to ensure quality and technical excellence and consistent ethical review of all the submitted health and biomedical research proposals and ongoing approved research studies involving human participants in accordance with the ICMR ethical guidelines for biomedical research on human subjects.

  • AUTHORITY FOR CONSTITUTING THE AIIMS-P IEC

    The Dean of Faculty in consultation with the Director, AIIMS-P will appoint the Chairperson and all the committee members based on their competence, experience and integrity by sending an official request letter (Annexure 1A & 1B). Members will confirm their acceptance to the Dean by providing all the required information for membership (Annexure 2). The Chairperson will furnish any information or report to the Dean of Faculty, AIIMS-P when required.

  • ROLE AND RESPONSIBILITIES OF AIIMS- P IEC

    The AIIMS-P-IEC will review all types of research proposals involving human participants with a view to safeguard the dignity, rights, safety and well being of all actual and potential research participants before approving the research proposals. The goals of research, however important, should never be permitted to override the health and wellb eing of the human participants.

    The AIIMS-P-IEC will ascertain whether all the cardinal principles of research ethics viz., Autonomy, Beneficence, Non – maleficence, Respect for Free and Informed Consent, Respect for Human Dignity, Respect for Vulnerable Persons , Respect for Privacy and Confidentiality and Justice are taken care of in planning, conducting and reporting of the proposed research. For this purpose, it will look into the aspects of protocol review, selection of participants, voluntary participation of potential participants, informed consent process, risk benefit ratio, distribution of burden and benefit, maintenance of privacy and confidentiality and provisions for appropriate compensations. It will review the proposals before the commencement of the study as well as review periodically until the completion of the study through appropriate well documented procedures. Such a review may be based on the periodic study progress reports furnished by the investigators and/or monitoring and internal audit reports furnished by the Sponsor and/or by visiting the study sites.

    The mandate of the IEC shall be to review all research projects to be conducted at the Institution involving human beings directly or indirectly, irrespective of whether the research project is funded or non-funded, and if funded, then irrespective of the funding agency.

    AIIMS-P IEC will provide advice to the researchers on all aspects of the welfare and safety of the research participants after ensuring the scientific soundness of the proposed research.

    In case AIIMS-P IEC revokes its approval accorded to a trial protocol, it will record the reasons for doing so and at once communicate such a decision to the Investigator as well as to the Licensing Authority.

    In case of serious adverse event or death occurring to the clinical trial participant, the AIIMS-P IEC shall forward it’s report on the serious adverse event or death, after due analysis, along with its opinion on the financial compensation, if any, to be paid by the sponsor or his representative, whosoever had obtained permission form the Licensing Authority as defined under rule 21(b) for conducting the clinical trial, to the Chairman of the Expert committee constituted by the Licensing authority under Appendix XII (gazette notification 30th January 2013) with a copy of the report to the Licensing Authority within twenty one calendar days of the occurrence of the serious adverse event of death. In case of serious adverse event, other than death occurring to the clinical trial subject, the AIIMS-P IEC shall forward it’s report on the serious adverse event after due analysis along with its opinion on the financial compensation, if any, to be paid by the sponsor of his representative, whosoever had obtained permission from the Licensing Authority for conducting the clinical trial, to the licensing authority within twenty one calendar days of the occurrence of the serious adverse event.

  • COMPOSITION OF AIIMS-P-IEC

    AIIMS-P-IEC will be a multidisciplinary and multisectorial body in composition and independent. The number of members of the Review Board may range from 7 to 15.

    The chairperson of the IEC will be from outside the Institution to maintain the independence of the Committee. The Member Secretary will belong to the same Institution and will conduct the business of the Committee. Other members will be a mix of medical / non-medical, legal, scientific and non- scientific persons and may also include members of public to reflect the different points of view.

    There will be representation of age and gender in the Committee to safeguard the interest and welfare of all sections of the society. Member should be aware of local, social and cultural norms, as this is an important social control mechanism. IEC may invite subject experts to take their views, whenever it is needed.

    The AIIMS-P-IEC will include:-

    1. Chairperson –from outside the institute

    2. One or more persons from basic medical science area ( One pharmacologist compulsorily, one female member compulsory)

    3. One or more clinicians

    4. One legal expert or retired judge

    5. One social scientist/ representative of non-governmental voluntary organization/agency

    6. One philosopher/ ethicist/ theologian

    7. One lay person (non-medical background) from the community

    8. Member Secretary – from within the institute

    A Sub-Board of the main IEC may review proposals submitted by undergraduate or post-graduate students or if necessary, an IEC may be separately constituted for the purpose, which will review proposals in the same manner as described above.

  • REQUIREMENTS FOR IEC MEMBERSHIP

    1. All members will serve for a period of 3 years on renewable basis. New members will be Included in the IEC in such a way that there will be a mix of recently included members and members with some years of experience.

    2. During the term, Dean of the Faculty in consultation with the Chairman can disqualify any member if, the contribution is not adequate and/or there is long period of non-availability.

    3. A member can tender resignation of his office of membership from the IEC to the Dean of Faculty through the Chairperson after serving one month advance notice.

    4. Dean can replace the member of IEC as and when required

    5. Each member is required to sign the declaration and confidentiality agreement regarding IEC activities (Annexure 2)

    6. In case AIIMS-P IEC revokes its approval accorded to a trial protocol, it will record the reasons for doing so and at once communicate such a decision to the Investigator as well as to the Licensing Authority.6. Conflict of interest should be declared by members of the AIIMS-P-IEC prior to review meeting.

  • QUORUM REQUIREMENTS

    Minimum of 50% of committee strength and not less than 6 members are required to constitute the quorum for the meeting of which at least one member has to be from outside the institution, and one member will be a non-scientific member & one from opposite gender. All decisions will be taken in meetings and not by circulation of project proposals. Quorum will have 6 members with following representations:

    (a) Basic medical scientists (preferably one pharmacologist).

    (b) Clinician

    (c) Legal expert

    (d) Social scientist / representative of non-governmental voluntary agency / philosopher / ethicist / theologian or a similar person

    (e) Lay person from the community

  • CONDUCT OF AIIMS- P IEC MEETINGS

    The Chairperson will conduct all meetings of the AIIMS-P IEC. In the absence of the Chairperson an alternate Chairperson will be elected from the members by the members present, who will conduct the meeting. The Member Secretary is responsible for organizing the meetings, maintaining the records and communicating with all concerned. He/She will prepare the minutes of the meetings and get it approved by the Chairperson and all the members.

  • INDEPENDENT CONSULTANTS

    The AIIMS-P IEC may call upon subject experts as independent consultants who may provide special review of selected research protocols, if need be. These experts may be specialists in ethical or legal aspects, specific diseases or methodologies, or represent specific communities, patient groups or special interest groups e.g. cancer patients, HIV/AIDS positive persons or ethnic minorities. They will be required to give their specialized views but should not take part in the decision making process which will be made by the members of the AIIMS-P IEC.

  • APPLICATION PROCEDURES

    1. All proposals should be submitted on any working day 2 weeks in advance of scheduled meeting in the prescribed application form, the details of which are given under “XII Documentation”. The applicant may ask for copy of SOP from the IEC, if the same has not been circulated earlier or not available on the website.

    2. All relevant documents should be enclosed with application form. (Documents will be available with Member - Secretary, AIIMS-P IEC and Institutional Website www.aiimspatna.org).

    3. Required number of copies of the proposal along with the application and documents in prescribed format duly signed by the Principal Investigator (PI) and Co-investigators/ Collaborators / Research Scholars shall be guided to the Chairperson AIIMS-P IEC, through member secretary. In his absence via any person nominated by Chairperson, receipt of the application will be acknowledged by the IEC office.

    4. Every application will be allotted an IEC registration number to be used for all future correspondence and reference. The date of IEC meeting will be intimated to the PI to attend the meeting and to make a brief presentation of the proposal and to clarify the points raised by the members.

    5. The decision of the committee on the proposal will be communicated in writing. If revision is to be made, the revised document in required number of copies should be submitted within a stipulated period of time as specified in the communication or before the next meeting.

    6. All research proposals/clinical trials funded/sponsored by Pharmaceutical companies, Agencies, Multinationals etc. will be charged an administrative fee/ processing fee of 5%. Waiver of these fees is permissible for non-funded studies, departmental studies, and studies funded by organizations like ICMR, UGC, DST Government of India, State Science & Technology Department, UNICEF, WHO, USAID, Non Profitable Organizations etc.

  • DOCUMENTATION

    All Research proposals (6 copies along with 1 CD/DVD) shall be submitted along with the information and documents as specified in Annexure-3A, 3B and Annexure 5-7.

  • REVIEW PROCEDURES

    1. The meeting of the IEC will be held on periodic intervals, i.e. 1st Monday o f J a n , M a r c h , M a y, J u l y, S e p , N o v , unless otherwise specified by the member secretary. Additional review meetings can also be held with short notice as and when required. Meetings will be planned in accordance with the need of the work load.

    2. The proposals should be sent to the IEC at least 2 weeks in advance of scheduled meeting.

    3. The IEC’s member-secretary or secretariat shall screen the proposals for their completeness and depending on the risk involved categorize them into three types, namely, exemption from review, expedited review and full review (as described below).

    4. Decisions will be taken by consensus after discussion, and whenever needed voting will be done. Decision of Chairperson will be final.

    5. Researchers will be invited to offer clarifications if need be. The PI / Research Scholar will then present the proposal in person in the meeting. When the PI is not available due to unavoidable reasons the Co-PI will present the proposal.

    6. Independent consultants/experts will be invited to offer their opinion on specific research proposals if needed.

    7. The decisions will be minuted and Chairperson’s approval taken in writing.

    • EXEMPTION FROM REVIEW

      Proposals which present less than minimal risk fall under this category as may be seen in following situations:

      • Research on educational practices such as instructional strategies or effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

      • Exceptions:

      1. When research on 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.

      2. When interviews involve direct approach or access to private papers.

    • EXPEDITED REVIEW

      The proposals presenting no more than minimal risk to research participants may be subjected to expedited review. The Member- Secretary and the Chairperson of the IEC or designated member of the Committee or Subcommittee of the IEC may do expedited review only if the protocols involve -

      1. Minor deviations from originally approved research during the period of approval.

      2. Revised proposal previously approved through full review by the IEC or continuing review of approved proposals where there is no additional risk or activity is limited to data analysis.

      3. Research activities that involve only procedures listed in one or more of the following categories:

      • Clinical studies of drugs and medical devices only when -

      i) Research is on already approved drugs except when studying drug interaction or conducting trial on vulnerable population or

      ii) Adverse Event (AE) or unexpected Adverse Drug Reaction (ADR) of minor nature is reported.

      4. Research involving clinical materials (data, documents, records, or specimens) that have been collected for non-research (clinical) purposes.

      5. When in emergency situations like serious outbreaks or disasters a full review of the research is not possible, prior written permission of IEC may be taken before use of the test intervention. Such research can only be approved for pilot study or preliminary work to study the safety and efficacy of the intervention and the same participants should not be included in the clinical trial that may be initiated later based on the findings of the pilot study.

      a. Research on interventions in emergency situation

      When proven prophylactic, diagnostic, and therapeutic methods do not exist or have been ineffective, physicians may use new intervention as investigational drug (IND) / devices / vaccine to provide emergency medical care to their patients in life threatening conditions. Research in such instance of medical care could be allowed in patients -

      i. When consent of person/ patient/ responsible relative or custodian/ team of designated doctors for such an event is not possible. However, information about the intervention should be given to the relative/ legal guardian when available later;

      ii. When the intervention has undergone testing for safety prior to its use in emergency situations and sponsor has obtained prior approval of DCGI;

      iii. Only if the local IEC reviews the protocol since institutional responsibility is of paramount importance in such instances.

      iv. If Data Safety Monitoring Board (DSMB) is constituted to review the data;

      b. Research on disaster management

      A disaster is the sudden occurrence of a calamitous event at any time resulting in substantial material damage, affecting persons, society, community or state(s). It may be periodic, caused by both nature and humans and creates an imbalance between the capacity and resources of the society and the needs of the survivors or the people whose lives are threatened, over a given period of time. It may also be unethical sometimes not to do research in such circumstances. Disasters create vulnerable persons and groups in society, particularly so in disadvantaged communities, and therefore, the following points need to be considered when reviewing such research:

      i. Research planned to be conducted after a disaster should be essential culturally sensitive and specific in nature with possible application in future disaster situations.

      ii. Disaster-affected community participation before and during the research is essential and its representative or advocate must be identified.

      iii. Extra care must be taken to protect the privacy and confidentiality of participants and communities.

      iv. Protection must be ensured so that only minimal additional risk is imposed.

      v. The research undertaken should provide direct or indirect benefits to the participants, the disaster- affected community or future disaster- affected population and a priori agreement should be reached on this, whenever possible, between the community and the researcher.

      vi. All international collaborative research in the disaster-affected area should be done with a local partner on equal partnership basis.

      vii. Transfer of biological material, if any, should be as per Government rules taking care of intellectual property rights issues.

      6. Expedited review may also be taken up for nationally relevant proposals requiring urgent review.

    • FULL REVIEW

      All research presenting with more than minimal risk, proposals/ protocols which do not qualify for exempted or expedited review and projects that involve vulnerable population and special groups shall be subjected to full review by all the members.

      While reviewing the proposals, the following situations may be carefully assessed against the existing facilities at the research site for risk/benefit analysis:

      a. Collection of blood samples by finger prick, heel prick, ear prick, or venipuncture:

      i. From healthy adults and non-pregnant women who weigh normal for their age and not more than 500 ml blood is drawn in an 8 week period and frequency of collection is not more than 2 times per week;

      ii. From other adults and children, where the age, weight, and health of the participants, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected has been considered and not more than 50 ml or 3 ml per kg, whichever is lesser is drawn in an 8 week period and not more than 2 times per week.

      iii. From neonates depending on the hemodynamics, body weight of the baby and other purposes not more than 10% of blood is drawn within 48 – 72 hours. If more than this amount is to be drawn it becomes a risky condition requiring infusion/blood transfusion;

      iv. Prospective collection of biological specimens for research purposes by noninvasive means. For instance:

      1. Skin appendages like hair and nail clippings in a non-disfiguring manner;

      2. Dental procedures - deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction of permanent teeth; supra and sub-gingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth;

      3. Excreta and external secretions (including sweat);

      4. Uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gum or by applying a dilute citric solution to the tongue;

      5. Placenta removed at delivery;

      6. Amniotic fluid obtained at the time of rupture of the membrane prior to or during labor;

      7. Mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings;

      8. Sputum collected after saline mist nebulization and bronchial lavages.

      b. Collection of data through noninvasive procedures routinely employed in clinical practice. Where medical devices are employed, they must be cleared/ approved for marketing, for instance

      i. physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the participant or an invasion of the participant's privacy;

      ii. Weighing or testing sensory acuity;

      iii. Magnetic resonance imaging;

      iv. Electrocardiography, echocardiography; electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, Doppler blood flow,

      v. Moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.

      c. Research involving clinical materials (data, documents, records, or specimens) that will be collected solely for non-research (clinical) purposes.

      d. Collection of data from voice, video, digital, or image recordings made for research purposes.

      e. Research on individual or group characteristics or behavior not limited to research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.

  • ASPECTS CONSIDERED DURING REVIEW OF RESEARCH PROPOSAL

    1. Scientific design and conduct of the study.

    2. Approval by appropriate scientific review committees / Research committee, if any.

    3. Examination of predictable risks/harms

    4. Examination of potential benefits.

    5. Procedure for selection of subjects including inclusion / exclusion, withdrawal criteria and other issues like advertisement details.

    6. Management of research related injuries, adverse events.

    7. Compensation provisions.

    8. Justification for placebo in control arm, if any

    9. Availability of products, benefits to subjects after the study is completed if applicable.

    10. Patient information sheet, informed consent form in English and in local languages.

    11. Protection of privacy and confidentiality.

    12. Involvement of the community, wherever necessary

    13. Plans for data analysis and reporting.

    14. Adherence to all regulatory requirements and applicable guidelines.

    15. Competence of investigators, research and supporting staff.

    16. Facilities and infrastructure of study sites.

    17. Criteria for withdrawal of patients, suspension or premature termination of a study in AIIMS-P.

  • DECISION-MAKING

    1. Members will discuss the various issues before arriving at a consensus decision. When consensus is not arrived at, the decision will be made by voting procedure.

    2. A member should withdraw from the meeting during the decision procedure concerning an application where a conflict of interest arises and this should be indicated to the chairperson prior to the review of the application and recorded in the minutes.

    3. Decision will be made only in meetings where quorum is complete.

    4. Only the members can make the decisions. The expert consultants will only offer their opinions.

    5. Decision may be to approve, reject or revise the proposals. Specific suggestions for modifications and reasons for modifications and reasons for rejection will be given.

    6. In cases of conditional decisions, clear suggestions for revision and the procedure for having the application revised will be specified.

    7. Modified proposals will be reviewed by an expedited review through identified members.

    8. Procedures for appeal by the researchers will be clearly defined.

  • COMMUNICATING THE DECISION

    1. Decision of the meeting on the proposals will be communicated by the Member Secretary/secretariat in writing to the PI / Research Scholar within two weeks after the meeting at which the decision wastaken in the specified format. All the approvals will be valid for one year or for the duration of the project whichever is less. Investigator has to get his or her project re- approved after one year, where required.

    2. The communication of the decision will include:

    a. Name and address of IEC.

    b. The date, place and time of decision.

    c. The name and designation of the applicant.

    d. Title of the research proposal reviewed.

    e. The clear identification of protocol no., version no., date, amendment no., date.

    f. Along with protocol, other documents reviewed- Clear description of these documents along with Version No. and Date.

    g. List of EC members who attended the meeting- clear description of their role, affiliation and gender.

    h. A clear statement of decision reached.

    i. Any advice by the IEC to the applicant including the schedule / plan of ongoing review by the AIIMS IEC

    j. In case of conditional decision, any requirement by IEC, including suggestions for revision, and the procedure for having the application re-reviewed.

    k. In case of rejection of the proposal, reason(s) for the rejection will be clearly stated.

    l. Signature of the member secretary with date.

  • FOLLOWING UP PROCEDURES FOR APPROVED PROPOSALS BY PI / SPONSOR

    1. IEC will review the progress of all the studies for which a positive decision has been reached from the time of decision till the termination of the research.

    2. Progress of all the research proposals will be followed at a regular interval of at least once a year. But in special situations, IEC will conduct the follow up review at shorter intervals basing on the need, nature and events of research project.

    3. Periodic status report of study should be submitted at prescribed intervals for review, along with information and documents as specified in Annexure-4A, 4B 4C & 7 based on the safety concerns and this prescribed interval should be specified in the Letter of Communication of Decision to the PI from the IEC.

    4. Final report should be submitted at the end of study.

    5. Following instances and events will require the follow-up review/ Renewed Approval:

    a. Any protocol amendment likely to affect rights, safety or well-being of research subject of conduct of study.

    b. Serious or unexpected ADR related to study or product, action taken by Investigator, Sponsor and Regulatory Authority.

    c. Any event or information that may affect the benefit/risk ratio of the study.

    6. Protocol deviation, if any, should be informed with adequate justifications.

    7. Any new information related to the study should be communicated.

    8. Premature termination of study shall be notified with reasons along with summary of the data obtained so far.

    9. Change of investigators/sites must be informed to the office of IEC.

    10. Monitoring: Oversight mechanism will be in place to monitor the approved studies. Actual site visits can be made especially in the event of reporting of adverse events or violations of human rights and appropriate action will be taken when required and communicated to the applicant indicating modification/suspension/termination /continuation of the project. In case the IEC desires so, reports of monitoring done by the sponsor and the recommendations of the DSMB may also be sought.

    11. Applicant must inform the time of completion of study and must send the result summary to IEC. IEC must receive a copy of final summary of study completed from the applicant.

  • RESPONSIBILITIES OF SPONSOR/INVESTIGATOR
    • Responsibilities of Sponsor

      (i) The clinical trial Sponsor is responsible for implementing and maintaining quality assurance systems to ensure that the clinical trial is conducted and data generated, documented and reported in compliance with the protocol and Good Clinical Practice (GCP) Guidelines issued by the Central Drugs Standard Control Organization, Directorate General of Health Services, Government of India as well as with all applicable statutory provisions. Standard operating procedures should be documented to ensure compliance with GCP and applicable regulations.

      (ii) Sponsors are required to submit a status report on the clinical trial to the Licensing Authority at the prescribed periodicity.

      (iii) In case of studies prematurely discontinued for any reason including lack of commercial interest in pursuing the new drug application, a summary report should be submitted within 3 months. The summary report should provide a brief description of the study, the number of patients exposed to the drug, dose and duration of exposure, details of adverse drug reactions (Annexure 8), if any, and the reason for discontinuation of the study or non-pursuit of the new drug application;

      (iv) Any report of serious adverse event of death occurring in clinical trial, after due analysis shall be forwarded by the sponsor to chairman of the ethics committee and chairman of the expert committee constituted by the licensing authority as defined under rule 21(b) under appendix XII of gazette notification dated 30th January 2013 with a copy of the report to the Licensing authority and the head of the Institution where the trial has been conducted within ten calendar days of occurrence of serious adverse event of death. The report of the serious adverse event other than death, after due analysis, shall be forwarded by the sponsor to the Licensing authority, Chairman of the Ethics Committee and the head of the Institution where the trial has been conducted within ten calendar days of occurrence of the serious adverse event. (See Annexure 8).

      (v) In case of injury or death occurring to the clinical trial subject, the sponsor (whether a pharmaceutical company or an Institution) or his representative, whosoever had obtained permission from the Licensing Authority for conduct of the clinical trial, shall make payment for medical management of the subject and also provide financial compensation for the clinical trial related injury or death in the manner as prescribed in Appendix XII of gazette notification dated 30th January 2013.

      (vi) The sponsor (whether a pharmaceutical company or an institution) or his representative, whosoever had obtained permission from the Licensing Authority for conduct of the clinical trial, shall submit details of compensation provided or paid for clinical trial related injury or death, to the Licensing Authority within thirty days of the receipt of the order of the Licensing Authority.

    • Responsibilities of the Investigator(s)

      (i) The Investigator(s) shall be responsible for the conduct of the trial according to the protocol and the GCP Guidelines and also for compliance as per the undertaking given in Appendix VII of schedule Y. Standard operating procedures are required to be documented by the investigators for the tasks performed by them. During and following a subject’s participation in a trial, the investigator should ensure that adequate medical care is provided to the participant for any adverse events. Investigator(s) shall report all serious and unexpected adverse events to the Licensing Authority defined under clause (B) of rule 21 (Schedule Y and Gazette notification 30th January 2013), the sponsor or his representative, whosoever had obtained permission form the licensing authority for conduct of the clinical trial, and the ethics committee that accorded approval to the study protocol, within twenty four hours of their occurrence. The report of the serious adverse event of death, after due analysis shall be forwarded by the investigator to Chairman of the ethics committee and Chairman of the Expert Committee constituted by the Licensing authority under Appendix XII with a copy of the report to the Licensing Authority and the head of the institution where the trial has been conducted within ten calendar days of occurrence of the serious adverse event of death. The report of the serious adverse event other than death, after due analysis shall be forwarded to the Licensing Authority, Chairman of the Ethics Committee and the Head of the Institution where the trial has been conducted within ten calendar days of occurrence of the serious adverse event.

      (ii) The investigator shall provide information to the clinical trial subject through informed consent process as provided in Appendix V of Schedule Y about the essential elements of the clinical trial and the subject’s right to claim compensation in case of trial related injury or death. He shall also inform the subject or His/ Her nominee(s) of their rights to contact the sponsor or his representative whosoever had obtained permission from the Licensing Authority for conduct of the clinical trial for the purpose of making claims in the case of trial related injury or death.

  • RECORD KEEPING AND ARCHIVING AT THE OFFICE OF AIIMS IEC

    1. All the documents and communications of IEC will be dated, filed and archived in a secure place.

    2. Only the member secretary or persons, who are authorized by the Chairman of IEC will have the access to the various documents.

    3. All the documents related to research proposals will be archived for a minimum period of 3 years in the Institute, following the completion /termination of the study.

    4. No document (except agenda) will be retained by any IEC member.

    5. At the end of each meeting, every member must return the CD/DVD containing all the researchproposals and documents to IEC office staff. They will archive one copy in IEC office and other copies will be destroyed after one year.

    6. Following documents will be filed and archived with proper label on the top of file for easy identification

    a. Constitution and composition of AIIMS-P IEC

    b. Curriculum Vitae (CV) of all members of AIIMS-P IEC with records of training in Human ethics if any.

    c. Standard Operating Procedures of AIIMS-P IEC.

    d. Annual reports

    e. A record of all income and expenses of the EC, including allowances and reimbursements made to the secretariat and EC members;

    f. The published guidelines for submission established by the EC.

    g. Copy of all study protocols with enclosed documents, progress reports, and SAEs.

    h. Agendas and Minutes of all IEC meetings duly signed by the Chairperson / Member secretary.

    i. Copy of all existing relevant national and international guidelines on ethics and laws along with amendments.

    j. Copy of all correspondence with members, Principal Investigators and other regulatory bodies.

    k. Record of all notification issued for premature termination of a study with a summary of the reasons;

    l. Final report of the approved projects, including microfilms, CDs and Video recordings.

  • UPDATING AIIMS-P IEC MEMBERS

    1. All relevant new guidelines should be brought to the attention of the members.

    2. The IEC members should be encouraged to keep abreast of all national and international developments in ethics through orientation courses on related topics by its own members or regular training organized by constituted body/ bodies, so that they become aware of their role and responsibilities. For drug trial review it is preferable to train the IEC members in Good Clinical Practice. Any change in the regulatory requirements should be brought to their attention and they should be aware of local, social and cultural norms, as this is the most important social control mechanism. This is needed for maintaining quality in ethical review

  • TERMS OF REFERENCE

    Terms of reference will be maintained in the office of AIIMS-P IEC. This includes:-

    A. Membership Requirements

    B. Terms of Appointment with reference to the duration of the term,

    C. The policy for removal, replacement, resignation procedure,

    D. Frequency of meetings, and

    E. Payment of processing fee to the IEC for review, honorarium/ consultancy to the members/ invited experts etc.

    The SOPs will be updated periodically based on the changing requirements. The term of appointment of members could be extended for another term and a defined percentage of members could be changed on regular basis. Preferably, IEC would appoint persons trained in bioethics or persons conversant with ethical guidelines and laws of the country. Substitute member may be nominated if meetings have been continuously missed by a member due to illness or other unforeseen circumstances.

  • ADMINISTRATION AND MANAGEMENT

    A full time secretariat and space for keeping records is required for a well-functioning IEC. The members could be given a reasonable compensation for the time spared for reviewing the proposals. Reasonable fees can be charged to cover the expenses related to review and administrative processes for any third party (protocols submitted by researchers not employed by AIIMS-P) submission as described in section XI Point No 6. There should be provision for allocating reasonable amount of funds for smooth functioning of the IEC.

  • SPECIAL CONSIDERATIONS / PROTECTION OF VULNERABLE POPULATION

    While all the above requirements are applicable to biomedical research as a whole irrespective of the specialty of research, there are certain specific concerns pertaining to specialized areas of research which require additional safe guards / protection and specific considerations for the IEC to take note of. Examples of such instances are research involving children, pregnant and lactating women, vulnerable participants and those with diminished autonomy besides issues pertaining to commercialization of research and international collaboration. The observations and suggestions of IEC will be given in writing in unambiguous terms in such instances. ICMR guidelines as applicable will be followed for protection of vulnerable population.