Term of Reference – IJN Research Ethics Committee…
The primary purpose of the IJNREC, a subcommittee of Research Committee, is to protect the rights and welfare of human subjects involved in research activities being conducted in Institut Jantung Negara (IJN).
Responsibilities of IJNREC :
Advocate and encourage ethical standards of practice in research; protect subjects of research from unnecessary harm; preserve the subjects’ rights and provide reassurance to the public that best practice is being applied.
Review proposals for research to be carried out in or by IJN, its staff and members.
Have authority to approve (with or without modification) or reject proposals for research, on the basis of ethical considerations only.
To request for progress reports from the investigators.
To oversee the conduct of the study once study is approval
To suspend of terminate approval study.
To place restrictions on studies.
Frequency of Meetings
IJNREC Committee shall meet at least four (4) times a year.
Additional meetings will be scheduled as necessary.
IJNREC reports to the Chairman, IJN Research Committee.
An annual report of the Committee’s activities shall be submitted to the Chief Clinical Officer (CCO) who chair the Professional and Advisory Committee (PAC) and Chief Executive Officer (CEO) or to Deputy Chief Executive (DCEO) and CEO.
Membership Composition and Terms of Office
Chairman, IJN Research Committee, shall be responsible for the constitution of IJNREC and has a minimum number of eight (8) members and maximum of fifteen (15) members.
The composition of the IJNREC shall include:
Members are appointed for a period of two years and may serve consecutive terms at the discretion of the Chair.
A member is expected to attend all scheduled IJNREC meeting, however a member shall notify the Chairman or Secretary in case member unable to attend. The Chairman has an authority to accept the excuse and qualify member to remain in IJNREC. Should a member fail to do so, the Chairman should address this with the member concerned.
Member may resign from the IJNREC at any time upon giving notice in writing to the Chairman.
Disqualification of a member from the IJNREC is at the discretion of the Chairman, with the approval by the Research Committee. Grounds for disqualification include, but are not confined to, disruptive behavior at meetings, failure to declare conflicts of interest and breach of the code of confidentiality.
Members who are not staff of IJN may be offered an honorarium for each attendance at a committee meeting. The value of the honorarium will be determined from time to time by IJN.
IJN will maintain appropriate insurance cover, and will indemnify all members of the IJNREC, against any claims made against them which arise in respect of their membership of the IJNREC, provided that they have acted in good faith in reaching the decisions made.
Members must be willing to have their name, profession and affiliation published on the IJNREC page of the IJN website, and take part in education training appropriate to their role on the IJNREC.
Members are expected to treat as confidential all applications, meeting deliberations, information on research participants and related matters.
Declaration of interest
When a IJNREC member believes they have an interest in relation to an application for ethical review or any other matter for consideration at the meeting that may compromise their ability to make an impartial decision, they should declare that interest to the IJNREC. Such a declaration may be made orally at the meeting, prior to the matter being considered, or in writing to the Chairman prior to the meeting.
Where the member concerned is the Investigator or another sub-investigator/collaborator named on the application form, the IJNREC has the following :
The member should leave the meeting room during discussion and voting session.
In the event, Chairman of IJNREC serve as Principal Investigator, Director of Clinical Research will sign the correspondence letter.
In the case of any other declared interest, the IJNREC should collectively consider whether or not it is appropriate for the member concerned to take any part in the review of the application. Account should be taken of the closeness of the member’s interest in the application and the potential for a conflict of interest. In some cases, the declaration of the interest may in itself be sufficient to ensure that the decision of the IJNREC is not unduly influenced. The IJNREC has the following :
The member should leave the meeting room during discussion and voting session.
If Chairman has conflict of interest, one of IJNREC member will chair the discussion and decision.
Failure to declare a known interest in an application for ethical review will result in disqualification of a member from the IJNREC.
Roles and Responsibilities
To call meetings of the IJNREC and prepare and disseminate the meeting agenda and other meeting materials to IJNREC members
To ensure minutes of IJNREC meeting are recorded, distributed and maintained
To provide annual report to the Research Committee which include the activities of the committee and outcomes of the initiatives undertaken in the year under review
To recommend new member of the committee as required and obtain approval from the CEO
Committee Members (including Chair)
To decide, independently, the conduct of research proposal submitted to the IJNREC will protect the rights and welfare of participants involved in human subject research
Preparation and maintenance of meeting agenda and minutes
Organizing the preparation, review, revision and distribution of SOPs
Providing updates on relevant and contemporary issues related to ethics in health research, as well as governance and guideline related
Responsible for the administrative aspect of the IJNREC
Work in unity with the EC members and the investigators to reduce the turn-around time of the study proposals sent to the IJNREC for review
Organizing IJNREC meetings regularly
Receive and check for the completeness of the documents for review by the IJNREC
Preparation and maintenance IJNREC related files
To maintain confidentiality regarding reviewed protocols
Unaffiliated members were intended to have no formal ties to the IJN other than IJNREC membership. Thus, enabling them to provide the IJNREC with unbiased view, to increase funding or approve particular research.
Non-scientific members were to provide the IJNREC with expertise in such nonscientific areas such as law, religion, education or ethics and thus act as surrogate for participants and non-research values.
Review and Amendments
This Term of Reference shall be reviewed at least three years and may be amended as necessary
A minimum of five (5) members of the IJNREC are required to be present at a meeting held to determine an opinion in relation to an application for ethical approval.
There must be a reasonable representation of member categories in any quorum, including at least the following:
One lay person
Where a quorum is not present, the meeting may not commence, continue or conclude any discussion with the purpose of determining the opinion on an application for ethical review.
Where a quorum is not present for all or part of a meeting, the IJNREC may proceed with any other business on the agenda, provided that the Chairperson is present.
Governance and Decision Making
IJNREC reviews and assesses each application in accordance with the statement on the ethical conduct in human research and other relevant guidelines.
IJNREC shall make one the following decisions:
To approve the project as being ethically acceptable, with and without conditions
To provide provisional approval to the project with requested modifications, this may then be reviewed for final approval by the IJNREC Chair
To defer making a decision on the project until the clarification of information or the provision of further information to the IJNREC
To not approve the proposal
IJNREC shall reach a decision by unanimous agreement. Where a unanimous decision is not reached, the decision is considered to be carried by a majority of the members who reviewed the application.
IJNREC may consult any persons for advice and opinion in the review of any related matters, subject to that such person a) must have no conflict of interest, b) required to provide an undertaking confidentiality, and c) shall not entitled to vote.
The review of proposals deemed to be of “minimal risk to participants” may be through an expedited review process between scheduled meetings at the discretion of the Chair. The Chair may seek advice from other committee members as appropriate before making a decision. If approval granted, such approval shall be notified at the next committee meeting.