Standard Operating Procedure (SOP) for Institutional Ethics Committee for Human Research at Jorhat Medical College, Jorhat

1.     Objective

The objective of Standard Operating Procedure (SOP) is to ensure quality and consistency in review of clinical research proposals and to follow the ICMR and national ethical guidelines for biomedical research on human subjects.

2.     Functions of Institutional Ethics Committee (IEC)

IEC should provide independent, competent and timely review of the ethics of proposed studies before the commencement of a study and regularly monitor the ongoing studies.

IEC will review and approve all research proposals involving human participants with a view to safeguard the dignity, rights, safety and well being of research participants irrespective of the source of funding. The goals of research, however important, should never be permitted to override the health and well being of the research subjects.

The IEC will ensure that all the cardinal principles of research ethics viz, autonomy, beneficence, non-maleficence and justice are taken care of in planning, conduct and reporting of a proposed study. It will look into the aspects of informed consent process, risk benefit ratio, distribution of burden/benefit and provisions for appropriate compensations wherever required. It will review the proposals before start of the study as well as monitor the research throughout the study until and after completion of the study through periodic reports, final report and site visits etc. The committee will also ensure compliance with all regulatory requirements, applicable guidelines and laws.

3.     Composition of IEC

IECs shall be multidisciplinary and multisectorial in composition.

The number of members in the committee shall be kept small (7-12 members) as a large committee makes it difficult in reaching consensus and in having the presence of all the members. The external members shall be in majority to ensure the independence of the committee.

The Chairperson of the committee shall be from outside the Institution and not Head/former Head of Jorhat Medical College, Jorhat. The Member Secretary, drawn from Jorhat Medical College, Jorhat itself, shall conduct the business of the Committee. Other members will be a mix of medical and non-medical scientific and non-scientific persons including general public to reflect the differed viewpoints.

The composition may be as follows:-

1.      Chairperson

2.      Basic medical scientists

3.      Clinicians

4.      Legal expert

5.      Social scientist/representative of non-governmental voluntary agency

6.      Lay person from the community

7.      Member-Secretary

IEC shall have majority of its members from other institutions. They could be drawn from any public or private institute from anywhere in the country. There shall be adequate representation of age, gender, community etc. in the Committee to safeguard the interests and welfare of all sections of the society. The Committee can not consist entirely of men or entirely of women.

4.     Constitution of IEC

The Principal, Jorhat Medical College, Jorhat shall constitute the IEC, in consultation with the Academic Board in the following pattern:

1.      Chairperson

2.      Member Secretary from Institute

3.      5-7 members from different specialties as specified above, some of them should be from the Faculty of the Institute.

The committee will be normally reconstituted every 3 years

5.     Membership Duration and Responsibilities

1.    The duration of the membership will be 3 years.

2.     There will be no bar on the members serving for more than one term but it is desirable to have around one third fresh members.

3.     A member can be replaced in the event of long-term non-availability (three consecutive meetings). Authority to replace the member shall be with the Principal, Jorhat Medical College, Jorhat.

4.     Members should maintain confidentiality of all discussions during the meeting and sign a confidentiality form at the start of their term. Each member of the committee will submit a declaration to maintain the confidentiality of the documents submitted to them during their membership period.

5.     Conflict of interest if any shall be declared by members of the IEC at the beginning of every meeting.

6.     Quorum Requirements

A minimum of 5 members including at least three outside members is required for quorum. All decisions should be taken in meetings and not by circulation of project proposals.

7.     Offices/Conduct of the Meeting

The Chairperson will conduct all meetings of the IEC. If for reasons beyond control, the Chairperson is not available, an alternate Chairperson will be elected by the members present from among themselves. The Member Secretary will be responsible for organizing the meetings, maintaining the records and communicating with all concerned. He/she will prepare the minutes of the meetings and get them approved by the Chairperson before communicating to the PI.

8.     Independent Consultants

IEC may call upon subject experts as consultants for review of selected research protocols. 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 not take part in the decision making process.

9.     Application Procedure

1.    All proposals should be submitted in the prescribed application form, copies of which will be available with the Member Secretary.

2.     All relevant documents should be enclosed with application.

3.     The required number of copies of the proposal along with the application and documents in prescribed format duly signed by the PI and Co-investigators/Collaborators should be forwarded by the Head of the Department.

4.     The Member Secretary will acknowledge the receipt and indicate any lacunae. Missing information should be supplied within two weeks.

5.     The date of meeting will be intimated to the PI who should be available to offer clarifications if necessary.

6.     The decision of IEC 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.

10.  Documentation

All research proposals should be submitted with the following documents:

1.    Title of the project

2.     Names of the PI and Co-investigators with designation.

3.     Name of any other Institute/Hospital/Field area where research will be conducted.

4.     Approval of the Head of the Department.

5.     Protocol of the proposed research.

6.     Ethical issues in the study and plans to address these issues.

7.     Proposal should be submitted with all relevant annexure like proforma, case report forms, questionnaires, follow-up cards, etc. to be used in the study.

8.     Patient information sheet and informed consent form in English/Assamese and local language(s) should be enclosed. The patient information sheet should provide adequate and complete information in understandable language. It should also assure that any new information that becomes relevant during the trial and is related to their participation will be given to them. The consent form should be as per schedule Y published in Gazette of India (2005).

9.     For any drug/device trial, all relevant pre-clinical animal data and clinical trial data from other centers within the country/other countries, if available.

10. Any regulatory clearances required. Copy of clearances if obtained. This is necessary for new drug/device not approved for marketing in India, justification for sending of biological samples outside India and use of radioactive pharmaceuticals in clinical studies.

11.  Source of funding and Budget along with the supporting documents.

12. Indemnity issues including insurance for the compensation to the participants etc.

13. An undertaking to immediately report Serious Adverse Events (SAE) to IEC.

14.  Statement of conflicts of interest, if any.

15. Plans for publication of results-positive or negative-while maintaining the privacy and confidentiality of the study participants.

16.  Any other information relevant to the study.

17.  Agreement to submit annual progress report and final report at the end of study.

18. The PI should provide the details of other ongoing research projects (Title of the project, Date of starting and duration, source and amount of funding).

11.  Review Procedure

1.    Meetings of IEC shall be held on scheduled intervals as prescribed (once in 3 months, for which the dates will be decided at the end of previous meeting). Additional meetings will be held as and when necessary.

2.     The proposals will be sent to members at least 2 weeks in advance.

3.     Decisions will be taken by consensus after discussions, and voting will be done if necessary.

4.     PI should be available during the meeting and may be invited to offer clarifications.

5.     Independent consultants/Experts may be invited to offer their opinion on specific research proposals.

6.     The decisions of the meeting shall be recorded in the minutes book and shall be confirmed during the next meeting with signature of Chairperson at each page.

12.  Element of Review

1.     Scientific design and conduct of the study.

2.     Approval of scientific review committee and regulatory agencies.

3.     Assessment of predictable risks/harms and potential benefits.

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

5.     Management of research related injuries, adverse events and compensation provisions.

6.     Justification for placebo in control arm, if any.

7.     Availability of products to the trial subjects after the study, if applicable.

8.     Patient information sheet and informed consent form in English/Assamese and local language.

9.     Protection of privacy and confidentiality of subjects.

10.  Involvement of the community, wherever necessary.

11.  Protocol and proforma of the study including the consent form.

12.  Plans for data analysis and reporting.

13.  Adherence to all regulatory requirements and applicable guidelines.

14.  Competence of investigators, research and supporting staff.

15.  Facilities and infrastructure.

13.   Expedited Review

Proposals which are recommended for minor revisions will be reviewed by a sub committee appointed by the IEC for clearance and approved by the Chairperson. The approvals will be reported in the next IEC meeting by Member Secretary. The revised form of proposals requiring major changes will be reviewed at the next ethics committee meeting. Rejected proposals may be reconsidered only if a very strong background is there.

14.  Decisions Making

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

2.     Only members will make the decision. The decisions shall be taken in the absence of investigators, representatives of sponsors, consultants.

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

4.     Revised proposals may be subjected to an expedited review.

5.     All approved proposals will be subject to the following standard conditions. Additional conditions may be added by the IEC.

i)      PI should submit annual report of the ongoing project on format prescribed by the Institute, to the IEC.

ii)    The final report of the completed study should be submitted by PI.

iii)   The PI should highlight the changes in the protocols/brochures/informed consent form etc. being amended from the previous documents while submitting amended documents to IEC.

15.  Communicating the Decision

1.    Decision will be communicated to PI by the Member Secretary in writing.

2.     Suggestions for modifications and reasons for rejection shall be communicated to the PI.

16.  Memorandum of Understanding and Indemnity Agreement for Sponsored Drug/Device/Collaborative Trials

After the approval from IEC, the sponsor/CRO will submit the clinical trial agreement/Memorandum of Understanding and Indemnity Agreement document on Rs. 100 stamp paper separately (two copies) to the Institute which will be signed by sponsor and the Principal, Jorhat Medical College, Jorhat with the counter signature of PI. As per existing policy of the Institute, there will be 25% overhead charges to the total cost of the trial/per patient cost.

The drug trial shall be started by the PI after the agreement is signed by both the parties as well as DCGI and required regulatory approvals are available for the concerned trial.

17.  Follow up Procedures

1.   Annual report should be submitted by the PI on prescribed format along with comments.

2.   Final report should be submitted at the end of study on prescribed format including a copy of the report which has been sent to sponsoring agency.

3.   All SAEs and the interventions undertaken should be intimated immediately to IEC. The PI should submit the SAEs reported by other centers from time to time to the Member Secretary for information to IEC along with comments if any action is required in the current study.

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

5.   Any amendment to the protocol should be submitted for approval.

6.   Any new information related to the study should be communicated to IEC.

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

8.   Change of investigators should be done with the approval of IEC.

18.  Record Keeping and Archiving

1.     Curriculum Vitae (CV) of all members of IEC.

2.     Minutes of all meetings duly signed by the Chairperson. Copy of all correspondence with members, researchers and other regulatory bodies.

3.     Copy of existing relevant national and international guidelines on research ethics and laws along with amendments.

4.     All study related documents (study protocols with enclosed documents, progress reports, and SAEs.) should be archived for minimum of five years after the completion of study. A copy of filled CRF shall remain with the PI for minimum of ten years.

5.     Final report of the approved projects.

19.  Updating IEC Members

1.    All relevant information on ethics will be brought to the attention of the members of IEC by the Member Secretary.

2.     Institute Members will be encouraged to attend national and international training programs/ conferences/ seminars in the field of research ethics to help in improving the quality of research protocols/ ethics committee submissions and review.

ANTI RAGGING COMMITTEE

As per guideline of the Medical Council of India, New Delhi to curb the menace of ragging in JMCH, Jorhat a full- fledged Anti Ragging Committee is hereby constituted superseding all the previous ones with following members.

Functions of Anti-Ragging Committee:

1.            To strictly monitor and implement discipline of students inside the college campus.

2.            To strictly implement guidelines, as directed by the Hon’ble Supreme Court of India regarding ragging in educational institutions and notified by MCI as regulations.

DISCIPLINARY ACTION COMMITTEE

A Disciplinary Action Committee of Jorhat Medical College is hereby constituted with the following officers for such proceedings at Jorhat Medical College, Jorhat.

1.      Dr. P Biswanath                                                                             Chairperson

      Prof. & HoD, Paediatrics

2.      Dr.B.R. Das

      Prof. & HOD, Community Medicine                                           Member

3.      Dr.T.K Das

      Prof. & HOD, Anatomy                                                               Member

4.      Dr. Deep Kumar Roy

      Prof. & HOD, Radiology                                                              Member

5.      DrA.K Sen

      Prof. & HOD, Medicine                                                               Member

INSTITUTIONAL ETHICS COMMITTEE

FOR BIOMEDICAL RESEARCH ON HUMAN PARTICIPANTS

1.      Prof. (Dr.)  Pradyot Kr. Thakur                                                              Chairperson

Formerly Prof. & HoD,

Department of Physiology,

AMCH, Dibrugarh

Gayan Gaon Old, Tarajan,

Jorhat :-785001

Mob. No.  9864254862

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2.      Dr. Saurabh Borkotoki                                                                                Member

Prof. & HOD,                                                                                       (Basic Medical Scientist)

Deptt. of Biochemistry

Jorhat Medical College & Hospital, Jorhat

Mob. No.9864022132

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3.      Dr. Meghali Chaliha                                                                                      Member

Prof. & HOD,                                                                                        (Basic Medical Scientist)

Deptt. of Pharmacology,

Jorhat Medical College & Hospital, Jorhat

Mob. No.- 99544-31380

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4.      Dr. Anju L.Saikia                                                                             Assistant Member Secretary

Deptt. of Pharmacology,                                                                     (Basic Medical Scientist)

Jorhat Medical College & Hospital, Jorhat

Mob. No.- 73990-17497

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5.      Dr. Atul Baro                                                                                                   Member

Prof. & HOD,                                                                                                  (Clinician)       

Deptt. of Surgery,

Jorhat Medical College & Hospital, Jorhat

Mob. No.- 94351-05372

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6.      Dr. P. Bishwanath                                                                                            Member

Prof. & HOD,                                                                                                   (Clinician)

Deptt. of PAediatrics,

Jorhat Medical College & Hospital, Jorhat

Mob. No.- 94354-76119

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7.      Dr. Usha Rani Pegu                                                                                          Member

Associate Professor                                                                                         (Clinician)

Deptt. of Medicine

Mob. No.- 94351-30402

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8.      Sri Sudipta N Goswami                                                                                      Member

Jail Road, Jorhat                                                                                               (Legal Expert)

Mob. No.- 98640-79192, 94350-50121

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9.      Sri Pranab Kr.Saikia                                                                                           Member

HOD, Deptt. of Sociology                                                                                             (Social Scientist)

CKB College, Teok, Jorhat

Mob. No.- 99570-33186

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10.   Sri Dilip Mudoi                                                                                                 Layman Member

Meleng Lohkor Gaon

P.O.- Lahdoigarh, Jorhat

Mob. No.- 99574-56671

11.   Dr. Bishnu Ram Das                                                                                        Member Secretary

Prof. & HOD

Deptt. of Community Medicine

Jorhat Medical College & Hospital, Jorhat

Mob. No.- 94350-20324

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            Functions of the institutional ethics committee for Biomedical Research on Human Participants is to review and approved all type 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.The goals of research, however important, should never be permitted to override the health and well being of the research subjects.

INSTITUTIONAL LOCAL RESEARCH COMMITTEE

HOSPITAL INFECTION CONTROL COMMITTEE

Chairperson                                  : Prof. (Dr.) R.K. Bhattacharyya, Medical Superintendent

Deputy Chairperson                      : Dr. Reema Nath, Prof. & HOD, Microbiology

Secretary                                      : Dr. Purnima Barua, Associate Prof., Microbiology

Representative of                          : Dr. Uttara Borkotoki, Associate Prof., Microbiology

Microbiology/ Virology           

Representative of Medicine           : Dr. A.K.Sen, Prof. & HOD, Medicine

Representative of Surgery             : Dr. Atul Ch. Baro, Prof. & HOD, Surgery

Representative of Pediatrics           : Dr. P. Biswanath, Prof. & HOD, Pediatrics

Representative of O&G                 : Dr. H.K.Sarma, Prof. & HOD, O&G

Representative of ICU                   : Dr. Lily Das,  Prof. & HOD, Anesthesiology

Representative of Nursing Supdt.  : Mrs. Biju Moni Bhuyan Saikia, Nursing Supdt.

Representative of General             : Dr. Sadhan Borah, Deputy Superintendent

or Supdt.

CSSD Supervisor                                 

Pharmacy                                      : Dr. Bobyjeet Goswami, Asso.Prof. Physiology

Epidemiologist                              : Dr. B.R. Das, Prof. & HOD, Community Medicine

HICOs                                          : Dr. Nilotpal Bhattacharya, Assistant Prof. Surgery

                                                    : Dr. Angshurekha Das, Assistant Prof., Microbiology

HICN                                           : Mrs. Purabi Kalita, Asst. Nursing Superintendent

Functions:-

1)     Formulate guidelines for the use of Antimicrobials in JMCH, Jorhat.

2)     Formulate principles to be followed to ensure the safe, effective and rational prescribing of antimicrobial drugs by the doctors and faculty of the JMCH, Jorhat with consideration to routes, dose and duration of administration and biochemical monitoring (when appropriate) including taking of microbiological samples (under the ‘Policy for the Prudent Use of Antimicrobial Drugs’ which is part of the ‘Clinical Governance Policies and Procedures for the Medical Colleges of Assam’.

3)     Investigate all hospital infection of JMCH, Jorhat

4)     Establish surveillance programme.

5)     Provide leadership and guidance in prevention and control of hospital infection.

GENDER  HARASSMENT COMMITTEE

            In compliance of the Hon’ble Supreme Court of India/ UGC/ MHRD/ Govt of India Regulations, the Gender harassment Committee of Jorhar Medical College, Jorhat is hereby reconstituted with the following officers for the purpose of preventing gender and sexual harassment.

CURRICULUM COMMITTEE: JORHAT MEDICAL COLLEGE

             A curriculum Committee is hereby re-constitute with the following faculty members for implementation of  ATCOM and CBME Module in Jorhat Medical College, Jorhat.

CURRICULUM COMMITTEE: JORHAT MEDICAL COLLEGE

             A curriculum Committee is hereby re-constitute with the following faculty members for implementation of  ATCOM and CBME Module in Jorhat Medical College, Jorhat.

LIBRARY COMMITTEE

            The JMC Library Committee is hereby reconstituted with the following faculty for smooth functioning of the Central Library of Jorhat Medical College, Jorhat. The scope of function of the Committee shall be:-

a)     To recommended the books and Journals for purchase as and when required.

b)     Calling for tenders for Books, Indian, International and current Journals with terms and conditions to be incorporated in the Tender Schedule.

c)     The committee shall sit together with in the 1^st week of every month for review of the functioning of the central Library.