search this site.
Showing posts with label Clinical Medicine: ethico-legal-fiqhi issues 2019. Show all posts
Showing posts with label Clinical Medicine: ethico-legal-fiqhi issues 2019. Show all posts

191110P - HOW TO RESOLVE ETHICAL ISSUES IN PRACTICE

Print Friendly and PDFPrint Friendly

Presentation at a Clinical Ethics Course held at Princess Nourah bint Abdulrahman University, Riyadh on 10 November 2019. By: Professor Omar Hasan Kasule Sr. MB ChB (MUK). MPH (Harvard), DrPH (Harvard) Chairman of the Ethics Committee King Fahad Medical City.

 

THE LEARNING OBJECTIVES / OUTCOMES:

}  Understand the methods and processes of clinical ethics consultation.

}  Analysis of case scenarios with ethical dilemmas.

 

WHAT IS AN ETHICAL DILEMMA?:

}  A problem with two or more competing solutions.

}  No fixed or unanimous rules and regulations.

}  Whatever solution is adopted has practical, ethical, and legal implications.

 

ASK YOUR HEART?:

}  Humans were created with the innate ability to feel ‘right’ from ‘wrong’ – ask your heart first.

}  In most cases the rational = the moral.

}  In a few cases human rationality fails and higher moral guidance needs to be invoked.

 

AUTHORITATIVE SOURCES: AT THE NATIONAL/INTERNATIONAL LEVELS:

}  The Mufti of the Kingdom of Saudi Arabia and the Grand Ulama Authority.

} The Fiqh Academy of the Organization of the Islamic Conference.

}  The Fiqh Academy of the World Muslim League.

}  Other Fiqh Academies.

 

AUTHORITATIVE SOURCES: LOCAL LEVEL:

}  Ethics Committee in the Hospital

}  Local Scholar or religious guide

 

EXISTING LAWS AND REGULATIONS:

} Code of Medical Ethics by the Saudi Council for Health Specialties.

} Health Professions Practice Regulations by the Ministry of Health.

 

SOLUTION USING THE 4 ETHICAL PRINCIPLES:

}  Patient autonomy = patient decides

}  Beneficence = bring benefit

}  No maleficence = cause no harm

}  Justice = treat all with equity

 

SOLUTIONS USING MAQASID AL SHARI'AT:

}  Protection of ddiin (morality).

}  Protection of life (life and health), hifdh al nafs.

}  Protection of progeny (family and procreation), hifdh al nasl.

}  Protection of the mind (psyche) hifdh al ‘aql.

}  Protection of wealth (resources), hifdh al mal.

 

SOLUTIONS FROM PRINCIPLES OF THE LAW, QAWAID AL FIQH:

}  The Principle of Intention, qa’idat al qasd: we consider the underlying intentions.

}  The Principle of Certainty, qaidat al yaqeen: evidence based decisions.

}  The Principle of Injury, qaidat al dharar: cause no harm; balance benefit vs injury.

}  The Principle of Hardship, qaidat al mashaqqat: exceptions in cases of necessity.

}  The Principle of Custom or Precedent, qaidat al urf: follow the procedures.

 

SCENARIO 1:

} An 80-year fully conscious and competent old man with advanced incurable cancer needed palliative chemotherapy.

}  The family objected when the doctor wanted to obtain informed consent from the patient because that would involve disclosing the diagnosis which would make the patient very sad and depressed.

}  The family wanted to make the decision without informing the patient.

}  What should the doctor do? Provide your moral reasoning.

 

SCENARIO 2:

}  A 30-year-old woman presented with classical signs of acute appendicitis.

}  She consented to an operation to open the abdomen and remove the inflamed appendix.

}  The surgeon found a previously undiagnosed ovarian cyst and decided to remove it as well

}  The removal was a simple and safe procedure that would not increase the duration of the operation.

}  The head nurse refused because the patient had not given consent.

}  What should the surgeon do? Provide your moral reasoning.

 

SCENARIO 3:

}  A 90-year-old in ICU with stage 4 widely metastasized cancer and multi-organ failure was told by the doctors that there was nothing they could do to reverse the course of the disease and that they could only provide symptomatic treatment.

}  He asked to be discharged to die at home. His children objected saying that he needed complex nursing that they could not provide at home.

}  What should healthcare workers do? Provide your moral reasoning.

 

SCENARIO 4:

}  The thoracic surgeon wanted to carry out a de-bulking operation to decrease lung cancer mass to enable the patient to breathe easier and he told the patient of the high risk of death from hemorrhage.

}  The patient 85-year-old patient was drowsy because of medication and was suspected of suffering from dementia.

}  The doctor was not sure whether the patient was capable of understanding the explanations given and making serious decisions about the operation and he had no relatives nearby.

}  What should the doctor do? Provide your moral reasoning.

 

SCENARIO 5:

}  A patient presented to the clinic with vague complaints in the abdomen and worries about cancer.

}  Physical examination and investigations revealed no pathology.

}  The doctor was angry with the patient for wasting clinic time when he was in good health. 

}  As the patient was leaving he told the doctor that his uncle had died the week before of stomach cancer. The doctor did not respond.

}  What should the doctor have done? Provide your moral reasoning.

 

SCENARIO 6:

}  A young man sent for a pre-employment examination filled out a health questionnaire and mentioned no health problems at all.

}  Physical examination revealed a severely dislocated shoulder and an unhealed acromial fracture.

}  When asked about them he admitted that they caused him pain from time to time but that he was patient and did not care much about them.

}  What should the examining doctor report? Provide your moral reasoning.

 

SCENARIO 7:

}  An 80-year-old diabetic man, whose son had died last year from a transfusion of mismatched blood, was admitted to the same hospital for observation after falling at home.

}  He insisted that no procedure be done without written approval by his physician son whom he wanted to sit by his bedside all the time.

} Nurses were inconvenienced by having to get written permission for routine monitoring of vital signs and insulin injections.

} The nurses refused to comply with his wishes and he refused to cooperate leading to a stand-off.

} What should the doctor in charge do? Provide your moral reasoning.

 

SCENARIO 8:

}  A young neurosurgeon planned to operate on a patient with a lumbar spinal injury that had a 5-10% chance of success.

}  He was perplexed about taking informed consent.

}  If he informed the patient that the operation could go wrong and result in paraplegia with a 90% chance the patient would refuse the operation.

}  If the operation was not carried out there was a 95% chance of further deterioration leading to paraplegia after a few months.

}  What should the neurosurgeon do? Provide your moral reasoning.

 

SCENARIO 9:

}  A 30-year-old patient with multiple sclerosis who had 5 years while in good health designated her husband as the decision maker.

} When she lost consciousness the doctors needed a decision whether to put her on life support.

}  The husband who had by that remarried and lived in a separate house decided against life support because it would prolong her suffering.

}  Her father intervened and decided on life support because that would be in her best interests.

} What should healthcare workers do? Provide your moral reasoning.

 

SCENARIO 10:

} A university professor with previous episodes of transient stroke had written a directive and had it witnessed that if he lost consciousness he would not like to be resuscitated.

} Years later he was brought to the hospital unconscious from head injuries sustained in a car accident.

}  The doctors reading his directive in his shirt pocket decided not to resuscitate him but his wife insisted that he be resuscitated.

}  What is the right course of action for the doctors? Provide your moral reasoning.

 

191106P - ETHICS IN NURSING RESEARCH

Print Friendly and PDFPrint Friendly

Presentation at an Ethics in Nursing Research held at King Fahad Medical City, Riyadh on 06 November 2019. By Professor Omar Hasan Kasule Sr. MB ChB (MUK). MPH (Harvard), DrPH (Harvard) Chairman, Institutional Review Board - KFMC

 

 

Special Issues in Nursing Research:

}  The nurse as a research subject.

}  Quality Improvement vs research: consent and IRB approval.

}  The nurse investigator and voluntary patient consent.

}  Issues of validity in qualitative research: sampling and data collection.

 

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.

}  Privacy and confidentiality.

 

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:

}  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 - 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 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

§  Introduction to research malpractice: prevalence and attitudes.

§  Introduction to research malpractice: causes.

§  Investigators and authorship.

§  Originality.

§  Plagiarism: definition.

§  Plagiarism: detection and avoidance.

 

Ethico-Legal Issues in Grant Writing and Publication - 2:

§  Protecting your ideas from plagiarists.

§  Confidentiality and privacy & Disclosure.

§  Informed consent.

§  Financial integrity / COI.

§  Regulatory affairs: IRB.

 

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 to only 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

§  Definitions: IRB, investigator, investigations in humans & investigational product.

§  Review and reviewer.

§  Roles of IRB: overview, procedures of assuring objectives, assurance of patient protection.

§  Assurance of data accuracy.

§  Membership: quorum, meetings of the IRB.

 

The Institutional Review Board (IRB): Structure and Functions - 2:

}  IRB

§  Types of submissions for review, documents submitted to IRB.

§  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.

§  IRB records.

 

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

§  What is conflict of Interest (COI)?

§  What is a non-financial conflict of Interest?

§  Examples of COI.

§  How does an IRB member deal with his/her COI?

§  How does an investigator deal with his/her COI?

§  Some questions used to assess potential COI.

 

Case Scenario - 1:

}  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)