Objectives

• To create academic awareness about responsible conduct of research, study, project work, assignment, thesis, dissertation, promotion of academic integrity- and prevention of misconduct including plagiarism in academic writing among students, researchers, faculty- and other members of academic staff as well as any employee of institution.
• To establish institutional mechanism through education and training to facilitate responsible conduct of research, study, project work, assignment, thesis, dissertation, promotion of academic integrity and deterrence from plagiarism.
• To develop systems to detect plagiarism and to set up mechanisms to prevent plagiarism and punish a student, faculty, or staff of institution committing the act of plagiarism.

Ethical guidelines for biomedical research on human subjects

1. Essentiality of the project:

• The objective of the research should be crystal clear, and should only be to improve therapeutic, prophylactic or diagnostic procedures, or for advancement of knowledge of the disease condition. It should be attempted only if considered absolutely essential, after due consideration of all existing alternatives.

2. Informed consent and patient information : (format enclosed)

• Informed consent should be obtained from each human subject/ patient included in the proposed study. The subjects are to be fully apprised or all details of the research activity. The subjects retain the right to abstain from further participation irrespective of any legal or other obligation that may have been entered into by them.

3. Non-exploitation:

• Even though research subjects are in general remunerated for their involvement in research, they should be kept apprised of the possible risk of physica, psychological and moral implications associated with the research study.

4. Privacy and confidentiality:

• The identity and records of the subjects of research needs to be kept confidential, as far as possible.

5. Protocol changes:

• No changes in the protocol of the study will be initiated without prior written approval from the committee, except when necessary to avoid immediate hazards to the subject, or when changes involve only logistical or administrative aspects of the trial. In such cases, any such deviation from the protocol will be promptly reported to the committee.

6. Status (progress) reports:

• In the case of on-going studies of long duration, the principal investigator shall send the progress reports to the committee as specified below:
  • The first report within 30 days of completion of the year following the date of approval.
  • Subsequent reports at one year intervals

Status reports should specify the following:

• Deviation from the protocol of the study affect, if any
• Any increase in risk to the subjects, affecting the conduct of the study
• Any adverse drug reaction, both unexpected and serious.

Risk Minimization

Due care and caution should be taken at all stages of the research to ensure that the subject and those affected by the research are put to the minimum possible risk or suffer from irreversible adverse effects. Risks to subjects can be minimized by using procedures which are consistent with sound research design, and which are already being performed on the subjects for diagnostic or treatment purpose.

STANDARD OPERATING PROCEDURES OF THE MAR BASELIOS COLLEGE INSTITUTIONAL ETHICS COMMITTEE

Name

This committee will be known as Mar Baselios Nursing College Institutional Ethics Committee (MBCN IEC). This name will remain unchanged until the members choose to change it by a vote of three-fourths of the current members of this committee

Purpose

The primary purpose of this committee will be

1. 1. To ensure the protection of the rights, safety and well-being of human subjects involved in a research project.
   2. To provide public assurance of the protection.

Membership

The committee will be an independent body constituted of medical, scientific and lay members. The committee will consist of 10 members  who collectively have the qualifications and experience to review and evaluate the scientific, medical and ethical aspects of a proposed research project. A list of committee members, their qualifications and their affiliations ( eg. Hospitals, universities, clinics, social works religious institutions etc.) will be maintained in the  committee’s records.

Role of Chairman:

• The Chairman will be appointed by the Principal, MBCN.
• The Chairman will be responsible for conducting committee meetings and will lead all discussions and deliberations pertinent to the review of research proposals.
• The Chairman will sign documents and communications related to IEC functioning.
• In case of anticipated absence, the Chairman will nominate a committee member as Acting Chairman and he will have all the powers of the Chairman for that meeting.

Role of Member Secretary:

• To accept research study / project proposals.
• To prepare, maintain and distribute of study files.
• To schedule and organize IEC meetings after consultation with Chairman
• To prepare and maintain meeting agenda and minutes.
• To maintain IEC record and to archive them.
• To sign documents and communications related to IEC functioning.
• To communicate with the IEC members and applicants/ investigators.
• To notify the Principal Investigator regarding IEC decisions related to the submitted research proposal.
• To arrange for training of personnel and IEC members.
• To organize the preparations, review, revision and distribution of SOPs and guidelines.
• To provide necessary administrative support for IEC related activities to the Chairman.
• To provide updates on relevant and contemporary issues to ethics in health research as well as relevant contemporary literature to the committee members.
• To delegate various responsibilities to appropriate and authorized persons.
• Roles and Responsibilities of IEC members:
• To attend IEC meetings and participate in discussions and deliberations for appropriate decisions.
• To review, discuss and consider research proposals submitted for evaluation.
• To monitor Serious Adverse Event reports and recommend appropriate action(s)
• To review the progress reports and monitor ongoing studies.
• To maintain confidentiality of the documents and deliberations of IEC meetings.
• To declare any conflict of interest, if any.
• To participate in continuing education activities in biomedical ethics and biomedical research.
• To provide information and documents related to training obtained in biomedical ethics and biomedical research or any related activities to the IEC secretariat
• To provide an updated CV when requested for by the IEC secretariat
• To carry out the work delegated by Chairman and Member Secretary / Joint Member Secretary o To assist the Chairman and Member Secretary in carrying out IEC work as per SOP

Responsibilities of the Committees:

1. The committee’s primary responsibility will be the protection of safety, rights and confidentiality of the research subjects.
2. The committee will keep all information submitted to them confidential especially the priority information.
3. The committee will review all research proposals submitted to it within specified time limits.
4. The committee will maintain concise but clear documentation of its views on the research proposal.
5. The committee will review the progress of each research project at appropriate and specified intervals, but not less than once a year and will also review the final report of the studies approved by them.
6. The committee will review the qualifications of all investigators participating in the proposed research study.

IEC REGISTRATION POLICY

• IEC Date Fixed
• Submission made by researchers
• Decide Primary & Secondary review
• Sending proposals
• IEC Review
• IEC Meeting
• The Discussions
• The Decisions
• Documentations
• Communication
• Review

RESEARCH ECHOSYSTEM AT MAR BASELIOS COLLEGE OF NURSING

CUSTODIAN OF POLICY

Custodian of Policy Principal, Mar Baselios college of Nursing reviews the recommendations discussed in the SRC & IEC and updates the research policy. The Principal Mar Baselios college of Nursing will be the custodian of the research policy.

UNDERTAKING RESEARCH

Faculty members and UG students of Mar Baselios college of Nursing can undertake research activities leading to scientific publications, presentations in National/International conferences, generation of Intellectual property with potential for commercialization, which is beneficial for the society. Research Management Overall management of research activities will be coordinated by the Principal Mar Baselios college of Nursing. IEC and SRC committees shall be responsible for the overall functioning of research activities .Each department’s research activities are coordinated by the head of each department.

CODE OF ETHICS FOR RESEARCH

• All students pursuing research in the college are expected to maintain high standards of integrity, honesty and professionalism in respect of all the work undertaken by them.
• An ethics committee has been constituted and a Standard Operating Procedures (SOP)is adopted for monitoring research activities of the college.
• Since the college is affiliated to KUHS, the college follows the regulations of the University regarding plagiarism and malpractice in research.
• Whenever a paper is to be published in peer reviewed journals, the journal will normally have a committee to check the originality in the content.
• An ethics committee has been constituted and a standard operating procedures (SOP) is adopted for monitoring research activities of the college.

ETHICAL GUIDELINES

All research involving human participants should be conducted in accordance with the basic and general ethical principles. The researcher and the team are responsible for protecting the dignity, rights, safety and well-being of the participants enrolled in the study. Registration policy for IEC It is ensured that EC processes are in place to safeguard the quality of ethical review as well as compliance with national/international and applicable regulations. Efforts are made to seek recognition/certification/accreditation from recognized national/international bodies and kept updated on a continuing basis.

PATIENT INFORMATION, INFORMED CONSENT AUTHORISATION TO ACCESS MEDICAL RECORDS

Title of the study

Chief Investigator

Sponsor of the study if any

1. Introduction : what does this document contain?

Brief description of the study, possible risks and potential benefits, confedntiality of participation, voluntariness of participation, authorization for access to study records.

1. Purpose of study
2. Brief description of study

Personal/ life-style restrictions, if participating

Duration of study

Procedures done before participation in study: medical history, including diseases and drugs, physical examination, lab tests.

1. Possible discomforts/ risks, associated with the study:

Known side effects of drugs, other risks like donating blood samples, acquiring infections

1. Study related injuries/ risks and reimbursement
2. Potential benefits of study to the participant: not guaranteed
3. Cost of treatment during study period: will not be changed
4. Early discontinuation of participation in study: voluntary discontinuation, other reasons
5. Voluntary participation
6. Confidentiality and authorization to access medical records
7. Ethical considerations and IEC approval

Informed consent/ authorization

1. I confirmed that i have read and understood the information sheet dated …… for the study or it was read to me, and have had the opportunity to ask questions and have received satisfactory answers. I understand the possible risks and benefits of this study.
2. I understand that my participation in this study is voluntary, and that i am free to withdraw any time, without giving any reason, without my medical care or legal rights being affected.

APPLICATION FOR APPROVAL OF RESEARCH PROJECT BY THE INSTITUTIONAL ETHICS COMMITTEE

• Title of the research project:
• Principal investigator-particulars
  • Name, designation and address:
  • Contact number
• Guide-particulars
  • Name, designation and address:
• Co-investigators
  • Name, designation and address:
• Department or institution where
  • Research being carried out
• Collaborating departments, if any
• Funding agency, if any-
  • Name and address.
• Research scheme-particulars
  • Duration of the study
  • Objectives/aims of study
  • Brief outline of methodology

LIST OF DOCUMENTS TO BE SUBMITTED ALONG WITH APPLICATION FOR THE IEC REVIEW

• Project submission application form duly filled
• Letter to member secretary/ chairperson
• IEC application fee
• Summary of protocol (in not more than 500 words)
• Protocol
• Informed consent document in English
• Informed consent document in Regional language
• Patient/ Subject questionnaire/s
• Signed and dated brief current curriculum vitae of the study team members ( principal investigators, co-investigator, study coordinator)
• All proposal should be submitted in the prescribed application form, copies of which will be available from the member secretary
• All relevant documents with check list should be enclosed with application form
• Eight copies of the proposal along with the application and documents in prescribed format duly signed by the principal investigator and co-investigators/ collaborators should be forwarded by the head of the department

MISCONDUCT IN RESEARCH

The following practices will be considered as research misconduct since they violate the principles and practices of research. Such offences are serious and subject to strict disciplinary action.

• Data fabrication,
• Research falsification
• Plagiarism , abuse of confidentiality
• Dishonesty in publication,
• Misuse of research funds, etc.

Research misconduct does not include honest error or honest differences in interpretations or judgments of data

MAR BASELIOS COLLEGE OF NURSING, KOTHAMANGALAM

Communication of Decision of the Institutional Ethics Committee (IEC)

Please note:

• Inform IEC immediately on case of any adverse events and serious adverse events.
• Inform IEC in case of any change of study procedure, site and investigator.
• The permission is only for period mentioned above. Annual report to be submitted to IEC.
• Members of IEC have right to monitor the trial with prior intimation.

     Secretary                                                                                    Signature of Member 

        IEC