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Toronto Notes 2019 Ethical and Legal Issues in Canadian Medicine Ethical, Legal, and Organizational Medicine ELOM17 Research Ethics
• involvesthesystematicanalysisofethicaldilemmasarisingduringresearchinvolvinghumansubjectsto ensure that:
■ study participants are protected
■ clinical research is conducted to serve the interests of the participants and/or society as a whole
• majorethicaldilemmasarisewhenaphysician’sobligationtothepatientcomesintoconflictwithother
obligations and incentives
• anyexceptionstodisclosurefortherapeuticconsentdonotapplyinanexperimentalsituation
• importantethicalprinciplestoconsiderwhenconductingresearchonhumansubjectsarelaidoutin
the Declaration of Helsinki, the Belmont Report, and the Tri-Council Policy Statement: Ethical Conduct on Research Involving Human Subjects
Table 5. Ethical Principles for Research Involving Human Subjects
Patient’s participation in research should not put them at a known or probable disadvantage with respect to medical care (i.e. cannot deny participants in research ‘known effective care’, such as randomizing patients with depression to a placebo arm with no treatment)
Participant’s voluntary and informed choice is usually required, except in special circumstances (i.e. chart reviews without patient contact, or emergency situations for which there is no accepted or helpful standard of care and the proposed intervention is not likely to cause more harm than such patients already face)
Access to the treatment that is considered standard (i.e. placebo-controlled trials are generally acceptable where patients still receive the standard of care, or, if not, are informed about the placebo arm and what that entails)
Must employ a scientifically valid design to answer the research question (ensured via peer review, expert opinion)
Must demonstrate sufficient value to justify any risk posed to participants
Must be conducted honestly (i.e. carried out as stated in the approved protocol)
Findings must be reported promptly and accurately without exaggeration, to allow practicing clinicians to draw reasonable conclusions
Patients must not be enticed into risky research by financial incentives and investigators must not trade the interests of patients for disproportionate recompense by a sponsor; both participants and investigators are due fair recompense for their time and efforts
Any significant interventional trial ought to have a data safety monitoring board that is independent of the sponsor and can ensure safety of the ongoing trial
Physician-Industry Relations
• healthcaredeliveryinCanadainvolvescollaborationbetweenphysiciansandthepharmaceutical and health supply industries in the areas of research, education, and clinical evaluation packages (i.e. product samples)
• however, unlike physicians, pharmaceutical and health supply industries do not have a fiduciary duty to patients and are profit-driven
■ for example, the dissemination of free product samples by pharmaceutical companies is associated with increased patient preference for new drugs that are often more expensive, thus incurring a greater long-term cost for patients and the healthcare system
■ new pharmaceutical products are not always more effective than previous standard of care and may have less robust safety evidence by virtue of being new drugs
• physiciansmustensurethattheirparticipationinsuchcollaborativeeffortsisinkeepingwiththeir duties to their patients and society; however, physicians often struggle to properly identify situations in which a conflict of interest is present
• evenseeminglyinnocuousgiftsorotherinteractions(penswithpharmaceuticallogo,research honoraria, meals, speaker fees, etc.) can subconsciously influence physician practices and beliefs in favour of promoted products, resulting in the prescription of medications for reasons other than their efficacy and safety profile
• gifts or free products from the pharmaceutical industry are usually inappropriate:
■ sponsorship for travel and fees for conference attendance may be accepted only where the physician
is a conference presenter and not just in attendance
■ physicians receiving such sponsorship must disclose this at presentations and/or in written articles
Resource Allocation
• definition:thedistributionofgoodsandservicestoprogramsandpeople
• physicianshavethedutytoinformpatientsabouttherapeuticoptionseveniftheyarenotavailable
• physiciansmustmakehealthcareresourcesavailabletopatientsinamannerwhichisfairandequitable,
without bias or discrimination
■ need and benefit are morally relevant criteria for resource allocation
■ gender, sexual orientation, religion, level of education, or age alone are morally irrelevant criteria
Guiding Principles for Research Ethics
• Respect for persons: informed consent
• Beneficence: harm vs. benefit
• Justice: avoid exploitation/unjustified
exclusion
Informed Consent for Research
• Purpose of study
• Sum of funding
• Name and probability of harm and benefits • Nature of physician’s participation including
compensation
• Proposals for research must be submitted
to a research ethics board
Randomization is allowed even if there is an efficacious standard if, for example, there
are drawbacks to it (such as it doesn’t work for all, has side effects, and is not tolerated). In such cases, there must be a good safety net established to make sure subjects in the placebo arm do not deteriorate (i.e. there must be a safety monitoring plan for such studies)
CMA and CPSO Guidelines for Ethically Appropriate Physician-Industry Relations • The primary goal should be the
advancement of the health of Canadians
• Relationships should be guided by the CMA
Code of Ethics
• The physician’s primary obligation is to the
patient
• Physicians should avoid any self-interest in
their prescribing and referral practices • Physicians should always maintain
professional autonomy, independence, and commitment to the scientific method
Professional Considerations
Elderly Patient
• Identify their goals of care and resuscitation options
(CPR or DNR), if applicable
• Checkfordocumentationofadvancedirectivesand
POA where applicable
Pediatric Patient
• Identifytheprimarydecision-maker(parents,guardian, wards-of-state, emancipated)
• RegardingcapacityassessmentseePediatricAspects of Capacity, ELOM11
• Bewaryofcustodyissuesifapplicable
Terminally Ill or Palliative Patient
• ConsidertheSPIKESapproachtobreakingbadnews
• Whatarepatient'sgoalsofcare(i.e.diseasevs.
symptom management)?
• Identifyadvancedirectives,POA,orSDM,ifapplicable
(see ELOM10)
• Checkfordocumentationofresuscitationoptions(CPR
or DNR) and likelihood of success
Incapable Patient
• Ifnotalreadypresent,performaformalcapacity assessment and thoroughly document
• IdentifyifthepatienthasanSDMorwhohastheirPOA
• Checkthepatient’schartforanyMentalHealthForms (e.g. Form 1) or any forms they may have on their
person (e.g. Form 42)