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Presentation to course for clinical research coordinators held on May 10, 2020 by Prof. Omar Hasan Kasule Sr. MB ChB (MUK), MPH (Harvard) DrPH (Harvard) Chairman, Institutional Review Board
Basic Terminology
• Institutional Review Board (IRB) is a body constituted by the institutional highest authorities but works independently to make ethical reviews and approve proposed research as well as following up the implementation of the research.
• Research is systematic collection and analysis of empirical data to describe a phenomenon or to establish causal linkages between and among phenomena.
• Clinical research is research carried out on patients and healthy volunteers to test new treatment modalities.
Basic Terminology (cont.)
• Informed consent is agreement of the research subject to participate in research after full disclosure and explanation of details pertaining to the research.
• Research Subject is an individual patient or healthy volunteer who consents to participate in research. Research submissions will be classified as exempted, expedited, or full review.
Risk (A potential harm or the potential of an action or event to cause harm).
• Minimal risk is no greater than the risk encountered in normal day to day activities or during routine physical or psychological examinations.
• Low Risk - Involves a minor increase over minimal risk- the intervention or procedure presents experiences that are reasonably commensurate with those inherent in actual or expected medical, dental, physiological, social or educational situations.
• Moderate Risk - Risks are reasonable in relation to anticipated benefits, if any, to subjects and the importance of the knowledge that may reasonably be expected to result.
• High Risk - Involves greater than minimal risk with no prospect of direct benefit to individual subjects, but is likely to yield generalized knowledge about the subject’s disorder or condition. Studies that are of high levels of risk may result in permanent physical and/or mental changes, hospitalization, and/or death.
Types of Review
• Exempt research is approved without review by the full IRB data abstraction from charts. It poses no risk to humans.
• Expedited research is approved by the Chair with information to the IRB later. It involves minimal risk such as drawing blood.
• Full Review research involves intervention on the human y drugs or devices and must be approved by the full IRB committee.
Adverse Event
• Definition: Any untoward or unfavorable medical occurrence in a human study participant, including any abnormal sign (e.g. abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participants’ involvement in the research, whether or not considered related to participation in the research.
• Serious Adverse Events: Any adverse event that: results in death, is life threatening, or places the participant at immediate risk of death from the event as it occurred, requires or prolongs hospitalization, causes persistent or significant disability or incapacity, results in congenital anomalies or birth defects.
• Unanticipated Problem: is defined as any incident, experience, or outcome that meets all of the following criteria: unexpected, related/possibly related to the research, and places research participants at greater risk of harm.
Authorization
• Research involving human subjects must be reviewed and approved by an Institutional Review Board (IRB) prior to any research intervention with participants.
• The Institutional Review Board (IRB) of King Fahad Medical City is the body responsible for ethical approval and regulation of all research proposals and protocols on humans in the institution that have ethical implications to ensure that the highest research ethical standards and assure the safety of research subjects and protect the institution and its staff from ethical violations.
Scope of Research: IRB covers the following types of research:
• Research by clinical observation
• Controlled clinical comparative research
• Laboratory research
• Epidemiological research
• Genetic research
• Qualitative research
Core Functions of IRB
• Assessing and approving research on patients, volunteers, and human tissues.
• Assessing any research involving access to medical records with a potential to breach confidentiality.
• Monitoring the conduct of research to detect any ethical violations.
• Assuring protection of research subjects’ physical and mental well being as stipulated in the Helsinki Declaration.
• Protection of the researchers and the institution in which they work by advising them about ethical conduct so that they do not commit mistakes that will lead to criminal prosecution.
Membership of the IRB
• Membership is designed in such a way that all professional and technical competences needed for proper evaluation of a research proposal are included.
• Members represent the major medical and surgical specializations practiced in KFMC including physicians, nursing staff, general practitioners, pharmacists, statisticians, ethicists, and lay persons from the community who have no connection with medical work.
• The period of service on the committee is renewable and is usually three years.
Diversity and Independence of IRB
• Selection of members ensures representation of the population subgroups by gender, age groups, ethnic, and socio-economic background.
• Members are selected on their own personal merit as people with knowledge, skills, and sound judgment and not as members or advocates of any profession or organization.
IRB Operational Policy Guidelines
• Balance between research and care delivery research such that research that is a departure from the commonly accepted treatment does not affect the patient’s treatment adversely.
• Equity and justice in research to ensure that recruitment into studies should reflect the community’s ethnic, gender, and age distribution since results of an unbalanced study may not be applicable to all groups.
• The source of funding of research should not in an indirect and discreet way influence the conduct of research and the report of its findings thus leading to lack of objectivity.
IRB Operational Policy Guidelines (cont.)
• Research malpractice is prevented and if it occurs is detected early. Examples of malpractice include cooking or doctoring data, selective reporting of data, suppression of negative information, and ‘stealing’ others’ work.
• Expedited review procedures can also be used to review minor changes in previously approved research during the period (of one year or less) for which approval is authorized.
IRB Procedures
• The Principal Investigator dialogues with applicable departments that will be involved in the proposed study prior to the submission of a research proposal to the KFMC IRB.
• The Principal Investigator submits the KFMC IRB research application package in standard format for IRB review including the following information.
• IRB committee Requests a quorum of at least half of the members for holding a meeting. Members who cannot attend can send written comments and can vote.
IRB Procedures (cont.)
• Proposals, protocols, and reports to be tabled are sent to the members in advance so that they have a chance to study them.
• IRB meets in private to preserve confidentiality.
• IRB Committee Member excuses himself/herself if a project is for review that they are associated with.
IRB uses the following criteria of Assessing Research
• Full disclosure to research subjects of the objectives of the study and of their rights to participate, abstain, or withdraw from the study.
• Research objectives that are clearly stated and are attainable }Research design and statistical methods judged adequate to produce clinically and scientifically useful results.
• Comparison of the scientific merit and benefit of the research against risks and costs to patients.
IRB uses the following criteria of Assessing Research (cont.)
• Investigators are qualified and competent to undertake the research successfully.
• Research facilities are adequate.
• Details on how confidentiality and security of the data will be assured.
• Designated IRB members review the application and present their report to the IRB Committee (Appendix G Template for Reviewer’s Report).
Follow-up of Research Implementation
• IRB monitors progress of the research and receives reports of all adverse reactions whether related to the drug tested or not.
• IRB makes on-site inspections to ensure the approved protocol is adhered to and to inspect research documents and records as per IRB audit and monitoring procedures.
• IRB holds regular monitoring meetings to review the progress of recruitment of research subjects, changes to the protocol, adverse reactions, the process of informed consent, refusals and withdrawals, and case record forms.
Roles of the Principal Investigator (PI)
• Submits the required documents through the Research Center to the Saudi Food and Drug Administration if applicable to research CPP 1435-20).
• Submits the study documents along with IRB approval letter to the Ministry of Health for approval to send tissue abroad for research (CPP 1432-86).
• Submits annual continuation requests to the Chair IRB.
• Submits an Adverse Events Report as per policy to the IRB Chair.
• Submits a study status report (Appendix I) to the Chair IRB.
Roles of the Principal Investigator (PI) (cont.)
• Submits a Progress Report Protocols Approved by Expedited Review to the Chair IRB.
• Submits a Final Report for IRB Study Completion or Study Termination to the Chair IRB.
• Declares conflict of interest.
• Keep full records of all its actions.
• Ensures secure location for records (locked door, password protected computer).
• Submits an annual report listing all proposals considered in the past year, the number approved, and any matters that deserve attention from higher authorities.