Details of the SNU Ethics Committee members for Biomedical and Health Research.

Application procedures

New proposals should be submitted to SNUEC on any working day 3 weeks in advance of scheduled meeting in the prescribed application form along with relevant documents.

Eight (8) hard Copies & soft copy of the proposal along with the application and documents in prescribed format duly signed by the Principal Investigator (PI) and Co-investigators / Collaborators should be submitted to IEC.

Principle Investigators shall be forwarded their application to the Chairperson SNUEC, through Member Secretary and the receipt of the application will be acknowledged by the SNUEC office.

Every application will be allotted an SNUEC registration number to be used for all future correspondence and reference. The date of SNUEC 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. SNUEC can suggest for online meetings and virtual presentations of the investigators in special situations such as COVID-19 pandemic, etc.

If revision is to be made, the revised proposal in required number of copies should be submitted within a stipulated period of time as specified in the communication or before the next meeting.

Details of documents to be submitted for SNUEC review

• Cover letter to the MemberSecretary
• Type of reviewrequested
• Application form for initialreview
• Permission of using copyrighted Proforma /questionnaire
• A completeprotocol
• Approval of the project from institution.
• The correct version of the informed consent document (ICD) in English and the local language(s).
• Case recordform/questionnaire.
• Recruitment procedures: advertisement, notices (ifapplicable)
• Patient instruction card, diary, etc. (ifapplicable).
• Investigator’s brochure (as applicable for drug/biological/devicetrials)
• Details of funding agency/sponsor and fund allocation (ifapplicable)
• Brief curriculum vitae of all the studyresearchers.
• A statement on COI, ifany.
• Good Clinical Practice (GCP) training certificate (preferably within 5 years) of investigators (Sponsored clinical trials)
• Any other research ethics/other training evidence, if applicable as per SNUECSOP.
• List of ongoing research studies undertaken by the principal investigator (ifapplicable)
• Undertaking with signatures ofinvestigators.
• Regulatory permissions (asapplicable).
• Relevant administrative approvals (such as approval for international trials).
• Institutional Committee for Stem Cell Research (IC-SCR) approval (ifapplicable).
• MoU in case of studies involving collaboration with other institutions (if applicable).
• Clinical trial agreement between the sponsors, investigator and the head of the institution(s) (ifapplicable)
• Insurance policy (ifapplicable).

Details of documents to be included in the protocol

The protocol should include the following:

• The first page carrying the title of the proposal with signatures of theinvestigators.
• Brief summary/ lay summary of theprotocol.
• Background with rationale of why a human study is needed to answer the research question.
• Justification of inclusion/exclusion of vulnerablepopulations.
• Clear research objectives and end points / outcome
• Eligibility criteria and participant recruitmentprocedures.
• Detailed description of the methodology of the proposed research, including sample size (with justification), type of study design (observational, experimental, pilot, randomized, blinded, etc.), types of data collection, intended intervention, dosages of drugs, route of administration, duration of treatment and details of invasive procedures, ifany.
• Duration of thestudy.
• Justification for use of placebo, benefit–risk assessment, plans to withdraw and rescue medication. If standard therapies are to bewithheld.
• Procedure for seeking and obtaining written informed consent with a sample of the patient/participant information sheet and informed consent forms inEnglish and local languages. Informed consent for storage of samples; assent; re-consent (if applicable).
• Plan for statistical analysis of thestudy.
• Plan to maintain the privacy and confidentiality of the studyparticipants.
• For research involving more than minimal risk, an account of management of risk orinjury;
• Proposed compensation, reimbursement of incidental expenses and management of research related injury/illness during and after research period and insurance policy.
• Provision of ancillary care for unrelated illness during the duration ofresearch.
• An account of storage and maintenance of all data collected during the trial.
• Plans for publication of results – positive or negative – while maintaining confidentiality of personal information /identity.
• Ethical considerations and safeguards for protection ofparticipants.
• Budget
• Time line / GNATT chart.

Procedure for Document Receipt & Handling:

1. Receiving the Study Documents. The Member Secretary will receive the study documents and other related documents in hard copies at the Ethics Committee office, submitted by the Principal Investigator / Institution / Sponsor / Contract Research Organization (CRO).
2. Checklist for SubmittedDocuments

The Member Secretary will check the following:

• A Submission Letter addressing the EthicsCommittee.
• Total number of copies of alldocuments.

Review Outcome

The Committee will document its view as the following:

1. Approval – Unconditional orConditional
2. Request for Modification orInformation
3. Disapproval
4. Termination/ Suspension of the research proposal / ongoingstudy

Notification of Review Outcome

The outcome of the Committee review will be recorded and conveyed to the Investigator / CRO/Sponsor Within 7 (seven) Working day from the date review.

Approval Period

All projects will be given approval for a period of 1 (one) year from the date on which the project was approved and for the projects continuing for longer than one-year annual renewal will be mandatory.

Title: “Basic Biomedical Ethics, Good Clinical Practice, and Regulatory Guidelines in Clinical Research in India”

Presented by: Indian Society for rational pharmacotherapeutics.

Organized by: Sister Nivedita University, New Town, Kolkata

Venue: Board Room, Sister Nivedita University.

Date: 20.01.2024

Time: 10:00 am-06:00pm (8Hrs.)

Preamble:  

A One day workshop on “Basic Biomedical Ethics, Good Clinical Practice, and Regulatory Guidelines in Clinical Research in India” has been conducted by ISRPT on 20th Jan’24, at Board room of Sister Nivedita University, New Town, Kolkata in order to get fulfil the criteria of SNU Ethics committee registration under I.C.M.R.

This workshop has been sponsored by Sister Nivedita University, New Town, Kolkata.

Participant’s Profile:

A total of 28 delegates from different department attended this workshop along with all members of Ethics Committee.

Description about the Program:

Workshop started with welcome address by Prof. Kuntal Mandal and Dr. Dhrubojyoti Chattopadhyay, Vice-Chancellor, S.N.U. felicitated our guests. The resource persons of this workshop were Dr. Sandeep Kaushal,Dean Academics, Professor and Head, Pharmacology, General Secretary, ISPRT and Dr. Sandip Mukhopadhyay, Course in Public Health Policy, Management & Leadership (AIIMS-Jodhpur), Scientist E-ICMR & Vice-President, IMPA.

Our resource persons delivered their lectures on different aspects of biomedical ethics, good clinical practice, and regulatory guidelines in clinical research, informed consent, patient information sheet, role of different stakeholders, NDCT rules 2019, formation, registration and functioning of IEC, Research misconduct, safety monitoring and S.A.E. and compensations in clinical trials in India.

The entire session was an interactive session and the speakers answered many queries raised by the participants. Dr. S.S. Tomar, Deputy Registrar, S.N.U was also present and a brief explanation was given to all about the role of the administrator to fulfil the requirements of Ethic Committee.

 Prof. Kuntal Mandal, proposed vote of thanks. The entire programme was co-ordinated with the support of the Principal, and faculty of the nursing department of S.N.U.

Expenditure: The total expenditure for this workshop was-    Rs. 72,777/- 

Feedback: Overall the programme was successful.

Report Submitted by:

Prof. Kuntal Mandal, Professor Nursing Department, S.N.U.

1^st Ethics committee meeting was held on 30.08.23 at board room of Sister Nivedita University. The minutes of the meeting –

Formation of rules and regulations

1. Members of the Ethics Committee recommended to follow the ICMR protocol which includes-

• Format for application
• Format for protocol submission
• Consent form(Hindi, Bengali & English)
• Patient information sheet (Hindi, Bengali & English)
• Parent information sheet (Hindi, Bengali & English)
• Child Information sheet and consent form (Hindi, Bengali & English)
• Checklist for submission of proposal
• Continue review application form
• Study completion form

2. Members of the Ethics committee agreed that students have to follow certain guidelines for the approval from the Ethics Committee.

• Student need to submit the proposal within 1^st week of month
• Meeting will be called on 3^rd week of month according to the availability of date from the members of Ethics Committee.
• Student along with guide need to present their topic in front of Ethics committee on the said date.

3. Ethics Committee members recommended that Bio-Technology and animal ethics also need to incorporate under this umbrella.

• In a view to maintain safety related to Bio-Hazards, standardized rules and regulations need to develop and suggested to include members from Bio-Technology Department.

• Focused on safe disposal of Bio medical waste. Also the committee suggested to develop standard protocol on Bio- medical waste management.

4. Ethics Committee members suggested that permission to be accorded from client / hospital authority / concerned authority whichever is applicable related to thesis / project and copy of the same to be submitted to the Ethics Committee.

5. Ethics Committee members also recommended that –

• Standardized format need to develop for proving certificate.
• to be prepared for Ethics Committee.
• Provision for online submission need to develop.
• Proper record section for documentation is required.

• Any other matter

Suggestions:

• Need to attend ICMR seminar and conferences by the members to keep them updated.
• Next meeting can be planned at the end of Sept’23 regarding development of standardized format.

Second SNU Ethics Committee meeting was held on 11.10.2023 at the conference room of Vice Chancellor, Sister Nivedita University. The minutes of the meeting are:

• Registration of the Ethics committee at ICMR
• Formation of rules and regulations
• Additional members for specialized area
• Any other suggestions

The resolutions are-

1. Registration of Ethics Committee

• Ms. Sangita Banik will create password and ID.
• Deputy registrar will help in registration.
• Application had been given to Vice Chancellor, Sister Nivedita University for approval of registration at ICMR and formation of ID and password on behalf of the institution.

      2. Formation of rules and regulations

• Members of the Ethics Committee recommended the following formats to standardize the functions during submission of proposal and progress of the study to ethics committee-

• Format for application
• Format for protocol submission
• Consent forms (Hindi, Bengali & English)
• Patient information sheet (Hindi, Bengali & English)
• Parent information sheet (Hindi, Bengali & English)
• Child Information sheet and consent form (Hindi, Bengali & English)
• Checklist for submission of proposal
• Continue review application form
• Study completion form

• Members of the Ethics committee agreed that investigators have to follow certain guidelines for the approval from the Ethics Committee.

• Investigator need to submit the soft copy of the proposal to the member secretary within 1^st week of month. Member secretary will circulate the mail to all members of ethics committee.
• Meeting will be called on 3^rd week of month according to the availability of the date from the members of Ethics Committee.
• Principal investigator or guide need to present their topic in front of Ethics committee on the said date.
• Ethics Committee members suggested that written ethical permission to be procured from concerned authority for each and every project and copy of the same to be submitted to the Ethics Committee

    3. Additional members for specialized area

• For biotechnology discipline - Dr. Rajat Pal and
• For veterinary discipline – Dr. Soumi Shukla
• Dr. Balay Bhattacharya and Dr. Rajat Pal will look for the work of ethics committee related to get permission for Institutional ethics committee from the statutory body i.e. CPCSEA)/Committee for Control and Supervision of Experiments on Animals (CCSEA).
• It was also suggested that to take consent from Dr. Soumi Shukla (Veterinary) to include in this committee as veterinary doctor.

Suggestions:

• Need to organize seminar/conference/workshop for the members of the ethics committee to update themselves regarding ICMR guidelines and protocols preferably online.
• Next meeting can be planned at the end of puja vacation to get the feedback of the progress of the work.