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Presentation at a ‘Basic Quantitative Nursing Research Course’ held at King Fahad Medical City, Riyadh on 11 September 2019; by Professor Omar Hasan Kasule Sr. MB ChB (MUK), MPH (Harvard), DrPH (Harvard) Chairman, Institutional Review Board - KFMC
DEFINITION: IRB
• In An independent body reporting directly to the CEO through a report once or twice a year.
• Members from diverse disciplines including non-health professionals.
• Main function is the protection of the rights and welfare of research subjects and assures the public that this role is carried out well.
• Works mainly to review and approve research protocols, investigator qualifications, and methods of informed consent.
• Follow up / monitor ongoing research for adverse effects, protocol adherence.
DEFINITION: Investigator
• A qualified person who is responsible for the conduct of research.
• Sub-investigators assist the investigator in all aspects of the study.
• The investigator or sub-investigator may be or may not be a staff member at KFMC.
• The investigator / sub-investigator may be a student, a health professional, or any other profession if the project has a health-related component.
DEFINITION: Investigations in Humans & Investigational Product
• Investigation is research undertaken for purposes of studying the absorption, distribution, metabolism, efficacy, and safety of an investigational product.
• Investigational product is a pharmaceutical form of an active ingredient or placebo being tested in a clinical study.
DEFINITION: Review and Reviewer
• Review is a rigorous and systematic process of assessing a research project regarding its scientific merit, validity and reliability of the research methodology, qualification of the investigators, research subject rights and safety, and other ethical considerations.
• A Reviewer is a person with specialist knowledge in a field of medicine, healthcare, and research methodology asked to review a research project and recommend to IRB its approval, modification, or rejection.
ROLES OF IRB 1: Overview
• The primary role of the IRB is protecting the rights, safety, and welfare of the subject/patient.
• The secondary role is assuring that data from a study will be accurate, reliable, and accurate.
ROLES OF IRB 2: Procedures of Assuring Objectives:
• Review and approval of the protocol.
• Assessing the qualifications of the investigator.
• Assuring that methods and materials for informed consent are appropriate.
• Reviewing financial aspects to ensure no conflicts of interest.
• Monitoring the conduct of the study.
• IRB shall operate according to written SOPs.
ROLES OF IRB 3: Assurance of Patient Protection:
• Independent review and monitoring of the protocol to ensure a favorable risk-benefit ratio.
• Putting patient interests before public interest.
• Assuring informed consent.
• Conducting the study according to the protocol.
• Making sure that the study is carried out by qualified personnel.
ROLES OF IRB 3: Assurance of Data Accuracy:
• Monitoring reports.
• Auditing reports.
• Inspection reports.
MEMBERSHIP:
• IRB shall consist of at least 5 members representing various disciplines of science, medicine, and ethics.
• KFMC IRB has 18 members including the chairman and a non-medical community representative.
• At least one member must be a non-scientist and one must be a lay community representative.
• Alternate members shall attend and vote if principal members notified the chairman of their absence.
• Members shall be independent of the sponsor and the investigator to avoid potential conflict of interests.
• Members are appointed on the basis of their expertise and not as representatives of their departments or units.
QUORUM:
• The quorum shall be half of the members and decisions shall be carried by a simple majority.
• Members shall sign an attendance roster indicating the time of arrival and if the time of departure if they do not sit throughout the meeting.
• If members do not attend the whole session a notation must be made in the minutes on what protocol discussions they missed.
MEETINGS OF THE IRB:
• IRB shall meet once every 4-6 weeks unless an emergency meeting is necessary.
• The meeting dates and venues are advertised 6 months in advance.
• Members receive the agenda and documents relating to the meeting 10 days in advance.
• The chairman designates 1-2 members to make a detailed analysis of each submission and report to the meeting.
• The agenda includes the following sections: follow-up of previously approved studies, safety reports, amendments, and new studies for approval (exempt, expedited, and full review).
TYPES OF SUBMISSIONS FOR REVIEW:
• Exempt, expedited, and full review submissions for projects to be carried out at KFMC that have a KFMC staff member as an investigator or a co-investigator.
• Exempt, expedited, and full review submissions of projects to be carried out at KFMC by external investigators.
• At its discretion the IRB shall review (a) exempt projects carried out in other institutions if they have a KFMC staff as an investigator or a co-investigator. (b) projects carried out at other institutions without a KFMC staff member as an investigator or co-investigator. At its discretion, IRB may charge for this service.
DOCUMENTS SUBMITTED TO IRB:
• Exempt studies: IRB application form, protocol/research proposal, informed consent material if applicable, data collection instruments if applicable, current curriculum vita(e) of the researcher(s).
• Clinical research either expedited or full review: protocol and its amendments, written information provided to the research subjects and the informed consent form (ICF), the case report form (CRF), the investigator brochure (IB), study recruitment
CRITERIA OF REVIEW FOR INITIAL APPROVAL:
• Risks are minimal and are reasonable in relation to the anticipated benefits.
• Consent is informed and is properly documented.
• Provisions are adequate to ensure privacy and confidentiality.
• The research plan contains adequate provisions for monitoring the data to ensure safety.
• Subject selection is equitable.
• There are adequate safeguards to protect vulnerable subjects (children, pregnant women, mental patients etc.).
CRITERIA FOR REVIEWING A PROTOCOL:
• Simple and logical eligibility and exclusion.
• Objective and easy to assess outcome measures.
• Proper subject selection and randomization.
• Simple intervention is not likely to be mistaken.
• Adequate sample size and power to detect a difference.
• Low risk of missing important data by too short a follow-up.
• Overall reliability of the trial results.
CRITERIA FOR REVIEWING THE QUALIFICATIONS OF THE INVESTIGATOR:
• Education.
• Training.
• Experience.
• Familiar with the investigational product.
• Knowledge of GCP guidelines.
• Has time to devote to the study.
• Has sufficient qualified staff.
CRITERIA OF REVIEW FOR CONTINUING APPROVAL:
• Reports of adverse effects.
• Protocol amendments / violations / deviations.
• Patient recruitment.
• Any special problems.
CRITERIA FOR AUDITING, MONITORING, AND INSPECTIONS:
• Compliance with the protocol.
• Submission of necessary reports.
• Safety reporting.
• Termination or suspension.
• Final report/closeout.
IRB RECORDS:
• All documents submitted by the PI, IRB correspondence, and IRB minutes are part of IRB official records.
• IRB official records must be kept for a minimum of 3 years after the end of the study.