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Presentation at a Course on Bioethics Alfaisal University on 2 December 2018 by Professor Omar Hasan Kasule Sr. MB ChB (MUK). MPH (Harvard), DrPH (Harvard) Chairman of the Ethics Committee King Fahad Medical City.
Ethical Issues in Research: Maqasidi and Qawaid Perspectives
• Introduction
• Research ethics from maqasid al shari’at
• Research ethics from qawa’id al fiqh
• The shari’at basis for informed consent
• Research publication
• Research on animals
Ethical Issues in Clinical Research
• Ethical obligation to do research
• Risk vs benefit consideration in searching for new treatments
• Informed consent
• Information given for informed consent
• Other considerations: randomization, patients under the stress of disease may not fully understand the study and therefore their consent is not free, failure to stop the study when harmful/beneficial effects appear
Case Scenario - 1
• The commander of an army brigade asked the brigade physician to undertake research on causes of very high sick leaves. The physician took blood from all soldiers to look for their immune profiles. When some soldiers protested that they were not asked for consent he told him he was following military orders.
Case Scenario - 2
• A physician was recruiting patients for a large multi-center study of myocardial infarction. The informed consent sheet was 10 pages long because there were many procedural details and adverse effects to disclose. Most of the subjects were bored reading through or listening to the details and were ready to sign because they trusted the physicians doing the study.
Case Scenario - 3
• A new drug that had proved efficacy against leukemia in invitro, animal and phase 2 trials was submitted for human trials. Its risk profile was not well understood from earlier studies. It was to be tested against a placebo. There was no known effective treatment for this disease.
Case Scenario - 4
• A multi-center trial of a new medication was carried out at a local hospital; the hospital was among the last to join the 5-year trial. Local results showed that the drug was effective and patients were satisfied. Interim analysis of the data by the sponsor showed the superiority of the new drug. The sponsor also noticed that if the results of the local hospital were eliminated, the sample size of the remaining sites would be adequate. He therefore decided to terminate the study at the hospital prematurely and cut off the supply of the drug.
Ethical Issues in Public Health Research
• Ethical approval
• Individual vs. Community rights
• Benefits vs. Risks
• Informed consent
• Privacy and confidentiality
• Conflict of interest
• Study interpretation and communication: controversial findings
Case Scenario - 1
• A community randomized study was needed to establish whether adding multivitamin tablets to food served in public restaurants would help reduce cardiovascular risk. Permission was obtained from the mayor of the city since it was not possible to get consent from each individual participant.
Case Scenario - 2
• A new vaccine against flu was found effective overseas. The Ministry of Health wanted to test its efficacy by a randomized study. Because of a negative media campaign, there were no volunteers for the study. The Ministry decided to force all hospital employees above 50 years to enter the study in the next winter season.
Ethico-Legal Issues in Grant Writing and Publication - 1
• Issues
o Introduction to research malpractice: prevalence and attitudes
o Introduction to research malpractice: causes
o Investigators and authorship
o Originality
o Plagiarism: definition
Ethico-Legal Issues in Grant Writing and Publication - 2
• Issues
o Protecting your ideas from plagiarists
o Confidentiality and privacy
o Informed consent
o Disclosure
o Financial integrity / COI
o Regulatory affairs
Case Scenario - 1
• A professor of cardiology conducted a well-designed post marketing survey of a drug that had been marketed recently in Saudi Arabia but had been marketed for over 10 years in the US and EU. Preliminary results were against what many researchers had published and seemed even illogical to him. He told the team of researchers to keep this information secret until the study was completed. Analysis of the complete data confirmed the preliminary analysis. The professor decided not to submit the results for publication for fear of his reputation and also not to disturb other cardiologists in the country who were satisfied with the drug.
The Institutional Review Board (IRB): Structure and Functions - 1
• IRB
o Definitions: IRB, investigator, investigations in humans & investigational product,
o Review and reviewer
o Roles of IRB: overview, procedures of assuring objectives, assurance of patient protection
o Assurance of data accuracy
o Membership: quorum, meetings of the IRB
The Institutional Review Board (IRB): Structure and Functions - 2
• IRB
o Types of submissions for review, documents submitted to IRB
o Criteria of review for initial approval: criteria for reviewing a protocol, criteria for reviewing the qualifications of the investigator, criteria of review for continuing approval, criteria for auditing, monitoring, and inspections
o IRB records 16
Case Scenario - 1
• A very experienced professor of surgery wanted to undertake research comparing two surgical approaches that he has been using alternately over the past 15 years. He reviewed the Nuremberg and Helsinki declarations as well as the ICH-GCP guidelines and the Saudi regulations on research. He made sure he fulfilled all stipulations of these documents in his research and saw no reason to seek the approval of the local IRB that in his view consisted of young inexperienced members most of whom had been his students. (SCHS)
Case Scenario - 2
• A physician was given a fat grant to study a new drug. The sponsor provided a well written and detailed protocol. Implementation of the protocol was difficult in the local circumstances: the informed consent information was too much and the subjects could not adhere to the visit dates fixed in the protocol. The physician made alterations in the protocol that he thought were simple and did not affect study validity or patient safety and saw no reason to inform IRB/REC. The sponsor sent monitors who discovered the discrepancy. The physician ignored their observations and continued the study without documenting the changes he had made. (SCHS)
Case Scenario - 3
• A physician in a local hospital agreed to be an investigator of a multi-center international trial sponsored by the pharmaceutical company. He regularly completed and sent CRFs to the sponsor overseas. On one occasion the sponsor questioned the data submitted and insisted that the original patient’s chart be shipped to him for inspection and verification. (SCHS)
Conflict of Interest in Research
• COI
o What is conflict of Interest (COI)?
o What is a non-financial conflict of Interest?
o Examples of COI
o How does an IRB member deal with his/her COI?
o How does an investigator deal with his/her COI?
o Some questions used to assess potential COI
Case Scenario - 1
• The IRB of a major hospital sat to consider a proposal sponsored by a multi-national pharmaceutical firm and all 5 members declared their interests. The Chairman has been engaged as a temporary consultant for the firm over the past 5 years mainly to give lectures on drug development processes to potential researchers. The son in law of the deputy chairman had shares worth SAR1000 in the firm acquired during course training course on stock investment. One member was the brother in law of the principal investigator. The principal investigator a member for 6 years had not attended the meeting. Only one member had no interests to declare. The committee proceeded to consider the proposal because everybody’s interests were now known. (PEER Handbook SCHS 2014)
Case Scenario - 2
• The hospital received a big grant from a pharmaceutical company to do a post marketing survey on a new analgesic. After trial initiation it was discovered that the physicians in the hospital rarely prescribed the drug. The principal investigator called a meeting of all physicians in the outpatient clinic and asked them to start prescribing the drug so that the hospital would not lose the grant. He explained that the drug had already been found to be effective and was safe. (PEER Handbook SCHS 2014)