SCOPE AND PURPOSE
INSTITUTIONAL REVIEW BOARD (IRB)
IRB Composition
- External Reviewers
- Membership Term of Appointment
- Members Non-Disclosure and Conflict of Interest
Subject to reappointment, each IRB member may be appointed to the Board for 2 consecutive terms (4 years). IRB members and External Reviewers respect the confidentiality of the IRB deliberations and findings and do not disclose them until the Principal Investigators have been formally notified by the IRB of their decision. All members of the IRB are responsible for disclosing any potential or perceived conflict of interest in relation to membership on the board and on any projects reviewed by the board.
Listed on the project, or will be included (or reasonably expected under academic standards to be included) as a co-author on a publication of the project's results;. Having financial interests in a company that supports or facilitates the project being investigated, or the interest is in a company that is known to an IRB member to own or license rights to the technology. After publication, participate in any discussion or decision in the board regarding the research project.
Be part of the quorum when the decision is to be voted on; or. Any IRB Member who becomes aware of a conflict of interest of another IRB Member, and the other IRB Member has not identified this conflict of interest, is required to raise the matter at the next IRB meeting.
IRB’s Roles and Responsibilities
They are required to self-identify conflicts of interest and refrain from participating in the discussion and refrain from voting on research activities. Limit, suspend or terminate an approval of a research project that does not comply with the requirements or that has been associated with an unexpected serious adverse event for the subjects. Review of required documentation of informed consent from human subjects except to the extent waived in accordance with the applicable policies and procedures.
Notify the Principal Investigator in writing of his decision regarding a submitted research project or of any change necessary to obtain its final approval. Participation in conferences, workshops, online courses, seminars or lectures related to human subjects research for development.
RESEARCH ETHICS TRAINING
IRB REVIEW
- Determination of ‘Human Subject Research’
- Proposals and Documents to be submitted
- IRB Criteria for Review
- Types of Review
- Exempt Review
- Full Board Review
- Risk/Benefit Analysis
- Informed Consent
- Waiver of Informed Consent
- Data Protection
The risks to the participants are acceptable in relation to the anticipated benefits and the importance of the knowledge that can reasonably be expected to result. Research involving the use of educational (cognitive, diagnostic, ability, achievement) tests, survey procedures, interview procedures, or observation of public behavior, unless: (a) the information obtained is recorded in such a way that human subjects can are identified directly or through identifiers associated with subjects; and (b) any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or harm the subjects' financial condition, employability, or reputation. The IRB is responsible for assessing potential risks and the forms they may take (Appendix B) and weighing the probability of the risk occurring and the magnitude of harm that could result.
A statement that the research involves, an explanation of the purpose of the research and the expected duration of the subjects' participation, and a description of the procedures to be followed. If the participant cannot read or understand written or spoken English, the consent form must be translated into an alternative language (eg Bangla), then a translated version of the Informed Consent Form and all accompanying information must be given to that individual become When children (<14 years old) are involved in research, it is required to have the consent of the child or minor and the consent of the parent(s)/guardian(s), instead of the consent of the subjects .
The consent form must clearly state what form of compensation will be provided, the amount or value of the compensation, and the timing of the compensation. The omission or modification will not adversely affect the rights and welfare of the subjects.
Renewal of IRB Review
Ensure identifiers, data and keys are placed in separate, password protected/encrypted files and each file is stored in a different secure location. Ensure that authentication and authorization are required for those accessing sensitive data by providing firewalls, data encryption and password protection.
PRINCIPAL INVESTIGATOR RESPONSIBILITIES
Project Changes
If a project is changed in such a way that subjects are treated differently than described or described in the original proposal, a research project change form (Appendix A-V) describing such changes must be submitted to the IRB for approval.
Adverse Events
Addition or Deletion of Investigator(s)
MEETING PROCEEDINGS
A list of total board reviews with the respective information: Actions taken and decisions made by the board, including refusals; Voting on those actions (including the number of members voting for, against and abstaining); Grounds for requiring changes to the research proposal or consent documents or for rejecting the research proposals.
COMMITTEE RECORDS
REVIEW OF THE GUIDELINES
Will members of the research team have a financial interest, receive personal compensation, or hold a position in an industry sponsoring this project or have a potential conflict of interest related to the development of this project. Provide a brief summary below (ie 300 words maximum) of the purpose of the project in general terms, including background information as needed, the research questions and most importantly, an explanation of why this research is needed. Provide a description below of the research design (including steps and methodology), what types of data will be collected, details on primary outcome measures, and anticipated follow-up procedures or actions.
Note: Must be designed or developed using appropriate methods to achieve the goals of the research proposal. Exemption is granted only when the proposed research meets one or more of the categories mentioned in the Institutional Review Board Policy. Members of the research team will have a financial interest in, receive personal compensation from, or hold a position in an industry sponsoring this research or have a potential conflict of interest related to the conduct of this research.
Please provide below a short summary (i.e. 300 words or less) of the purpose of the project in general terms, including if necessary background information, research question(s) and, most importantly, an explanation of why this research is necessary. YES NO People who are illiterate YES NO Researchers' own students YES NO Other IUB students YES NO Please provide details. If non-Bangla speakers or poor level of Bangla language knowledge is expected, consent information should also be attached in the language of the proposed subjects.).
How you will protect the confidentiality of the collected data and protect against risks of breach of confidentiality or invasion of privacy. State your plans for de-identifying or maintaining the anonymity of the data, especially if audio/video recordings or images will be collected. I confirm that all investigators involved in this research project have completed the required ethics approval training and that each of the co-investigators has accepted their role in this project.
This consent form, a copy of which will be given to you, is only part of the informed consent process required by the IUB Institutional Review Board (IRB) Committee. The IRB must also consider whether the research design can be modified so that it can be carried out without invading the privacy of the subjects.
