InaS Irabon MD FPOGS FPSRM FPSGE - WordPress

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Ina S. Irabon, MD, FPOGS, FPSRM,FPSGEObstetrics and GynecologyReproductive Endocrinology and InfertilityGynecologic Endoscopy and Hysteroscopy

ReferencesnTextbook of Obstetrics and Gynecology, 3rd ed. Sumpaico, etal.nMethods and principles in biomedical ethics by T LBeauchamp . J Med Ethics 2003;29:269–274nAdinma J. Bioethics in n/221921729nACOG Committee Opinion. Ethical decision making inObstetrics and Gynecology. Number 390. December 2007.

outlinenDefinitionnOrigin: Belmont reportn4 basic bioethical principlesnOther bioethical principles

Bioethics: definitionnBioethics is a subset of ethics that provides reasoned anddefensible solutions that incorporate ethical principles foractual or anticipated moral dilemmas facing clinicians inmedicine and biologynbioethics deals with relationships between practitioners andpatients, practitioners and society, and society and patientsMethods and principles in biomedical ethics by T L Beauchamp . J Med Ethics 2003;29:269–274

Bioethics: the Belmont reportnThe development of the principlesof modern bioethics isinextricably linked to the contentsof the Belmont ReportnThe Tuskegee Alabama publichealth service funded syphilisresearch over the 40 year period,1932 – 1972, involved inhumanexperimentation on 400 indigentblack American malesAdinma J. Bioethics in Obstetrics. https://www.researchgate.net/publication/221921729

Tuskegee Syphilis Study (1933-72)nofficial name Tuskegee Study of UntreatedSyphilis in the Negro MalenAmerican medical research project thatearned notoriety for its unethicalexperimentation on African Americanpatients in Alabamanconducted by the U.S. Public HealthService (PHS) from 1932 to 1972, examinedthe natural course of untreated Syphilisin Afrrican American mennThe research was intended to test whethersyphilis caused cardiovascular damagemore often than neurological damage andto determine if the natural course ofsyphilis in black men was significantlydifferent from that in yphilis-study

Tuskegee Syphilis Study (1933-72)nThe subjects were not told that theyhad syphilis or that the disease couldbe transmitted through sexualintercoursenPenicillin was denied to the infectedmen after that drug became availablein the mid-1940s, and it was still beingwithheld from them 25 years later,nThe Tuskegee syphilis study finallycame to an end in 1972 when theprogram and its unethical methodswere exposed in the Washington Star.A class action suit against the federalgovernment was settled out of courtfor 10 million in hilis-study

Bioethics: the Belmont reportnThe termination of this researchled to the establishment of theUnited States NationalCommission for the Protection ofHuman Subjects of Biomedicaland Behavioral Researchnà published its findings andrecommendations known as theBelmont Report (1979)Adinma J. Bioethics in Obstetrics. https://www.researchgate.net/publication/221921729

Bioethics: the Belmont reportnThe Belmont Report provided ananalytical frame work to guidethe resolution of ethicalproblems arising from researchinvolving human subjects.Adinma J. Bioethics in Obstetrics. https://www.researchgate.net/publication/221921729

Bioethics: definitionnregulates the relationship between the healthcare providerand the beneficiary of healthcare.naddresses ethical issues in clinical practice and healthcare,biomedical research involving humans and animals, healthpolicy and the environmentAdinma J. Bioethics in Obstetrics. https://www.researchgate.net/publication/221921729

The 4 basic BioethicalPrinciples in Health careBeauchamp and Childress (2008)Principle of beneficencePrinciple of nonmaleficencePrinciple of respect for autonomyPrinciple of justice.

1. Principle of BeneficencenPhysician’s obligation to give highest priority to his patient’swelfare and provide competent health care that maximizeshealth benefits for the patientnethical responsibility to do and maximize good.nemphasizes what is best for the patient with respect topreventive and curative healthcare.Methods and principles in biomedical ethics by T L Beauchamp . J Med Ethics 2003;29:269–274

examplenWhen the patient is incapacitated by the grave nature ofaccident or illness, we presume that the reasonable personwould want to be treated aggressively, and we rush toprovide beneficent intervention by stemming the bleeding,mending the broken or suturing the wounded.nin the treatment of suicidal patients who are a clear andpresent danger to themselves. à physician should interveneon behalf of saving the patient's life or placing the patient ina protective environment, in the belief that the patient iscompromised and cannot act in his own best interest at themoment.Methods and principles in biomedical ethics by T L Beauchamp . J Med Ethics 2003;29:269–274

Examples:You save a patient’s life despite the circumstances in thesesituations .nA patient who comes to the emergency room, bleedingprofusely from a gunshot wound, lost consciousness due tomassive blood loss, with no other relatives seenaccompanying the patient .nA man came to the emergency room at 2 am, needingemergency treatment from a hacking wound to the face andhead, and massive bleeding. You learned that this patient isthe same suspect who killed a close relative a few days ago Methods and principles in biomedical ethics by T L Beauchamp . J Med Ethics 2003;29:269–274

Examplesngiving of episiotomy to a parturient woman to prevent a thirddegree laceration of the perineumAdinma J. Bioethics in Obstetrics. https://www.researchgate.net/publication/221921729

2. Principle of Non-MaleficencenRefers to the ethical duty of the health practitioners to do noharm or cause pain to the patientnPhysician recommends treatment option which poses minimalor no harm to his patientsnThe Hippocratic imperative to physicians, “Bring benefit anddo no harm”nExample:1.Sensitivity test prior to IV drug administration2.Prescribing oral antibiotics for which the patient has noknown allergy to3.giving and suturing of episiotomy without local anesthesia(?!!) in a parturient woman (violation of principle!)Methods and principles in biomedical ethics by T L Beauchamp . J Med Ethics 2003;29:269–274Adinma J. Bioethics in Obstetrics. https://www.researchgate.net/publication/221921729

Examples4.Performing ceasarean section on a term pregnant patientfor no medical indications ( physician or patient’sconvenience? à violation)5.Referring the patient to a specialist who can adequatelymanage your complicated case, instead of managing thepatient on your own6.Referring patient to other competent healthcare providers,when you refuse to perform a requested medicalprocedure.Adinma J. Bioethics in Obstetrics. https://www.researchgate.net/publication/221921729

2. Principle of Non-maleficenceAccording to Beauchamp and Childress, the principle ofnonmaleficence supports a number of more specific moralrules, including the following:nDo not kill.nDo not cause pain or suffering.nDo not incapacitate.nDo not cause offense.nDo not deprive others of the goods of life.Methods and principles in biomedical ethics by T L Beauchamp . J Med Ethics 2003;29:269–274

3. Principle of Respect for AutonomyAccording to Beauchamp and Childress, the principle of respectfor autonomy supports a number of more specific rules, includingthe following:nTell the truth.nRespect the privacy of others.nProtect confidential information.nObtain consent for interventions with patients.nWhen asked, help others make important decisions.Methods and principles in biomedical ethics by T L Beauchamp . J Med Ethics 2003;29:269–274

3. Principle of Respect for Autonomy Requires the physician to respect the rights of patients tomake independent decisions as an expression of their selfdetermination basis for the practice of "informed consent" in thephysician/patient transaction regarding health care.Methods and principles in biomedical ethics by T L Beauchamp . J Med Ethics 2003;29:269–274

Examples nTerminal patients with painful gastrointestinal obstructiondue to stage 4 cancer, who choose to forego chemotherapyor CPRnTerminal cancer patient from a poor family, decides to foregolife-sustaining medical technology (breathingsupport/apparatus)nInforming the patient about his prognosis, or disclosing alldetails of treatment he will undergonA VIP patient requests that his case not be divulged to mediaor his relatives

4. Principle of JusticenJustice in health care is usually defined as a form of fairness,or as Aristotle once said, "giving to each that which is hisdue.”nethical responsibility to uphold fairness and equity inmedical care. It refers to the equitable distribution ofpotential benefits and risks.nThe question of distributive justice also seems to hinge onthe fact that some goods and services are in short supply,there is not enough to go around, thus some fair means ofallocating scarce resources must be determined.Methods and principles in biomedical ethics by T L Beauchamp . J Med Ethics 2003;29:269–274

4. Principle of JusticenJustice is the principle of rendering to others what is due tothem.nIt is the most complex of the ethical principles to beconsidered because it deals not only with the physician’sobligation to render to a patient what is owed but also withthe physician’s role in the allocation of limited medicalresources in the broader community.ACOG Committee Opinion. Ethical decision making in Obstetrics and Gynecology. Number 390. December 2007.

4. Principle of Justicenunderlies concerns about how social benefits and burdensshould be distributed.nFor example, is it fair that two patients, otherwise similarlysituated, are treated disparately by the health care systembecause one is rich and the other is indigent?Methods and principles in biomedical ethics by T L Beauchamp . J Med Ethics 2003;29:269–274

4. Principle of JusticenSubdivided in to 3 categories:1.Distributive justice: fair distribution of scarce resources2.Rights-based justice: respect for people’s rights3.Legal justice: respect for morally acceptable lawsExample:Equal access to treatmentDilemma: reproductive technologies (IVF) not equally available toallMethods and principles in biomedical ethics by T L Beauchamp . J Med Ethics 2003;29:269–274

Examples nWho should get a priority in organ transplant?nShould it be on a “First come- first served basis”?, ORnCase to case basis? (re: ensure that limited resources are used sensiblyand fairly)EX:2 patients need to have kidney transplant: one is a 24 yr old withkidney failure due to chronic glomerulonephritis; 2nd px is an 80yr old man with stage 4 kidney cancer .WHO WOULD YOUPRIORITIZE?nShould you recruit poor patient for your research because theybadly need the monetary compensation?Methods and principles in biomedical ethics by T L Beauchamp . J Med Ethics 2003;29:269–274

Examples nDuring the COVID pandemic, where the number of severe COVIDpatients needing ventilator machines overwhelmed the capacityof the hospitals to provide for patients nHOW DO YOU DECIDE WHICH PATIENTS WILL BE GIVEN THEVENTILATOR?nWHO DECIDES?nISSUE: Allocation of scarce resources in crisis situations / scarceresource situationsàcrisis standards of careàMedical futilityMethods and principles in biomedical ethics by T L Beauchamp . J Med Ethics 2003;29:269–274

nIn crisis standard of care, the goal is to provide the BESTpossible CARE to the population as a wholenA designated hospital panel (with recommendations fromthe health care team) make the choice to provide a particulartherapy to a patient, under the crisis standard of care.

Other BioethicalPrinciples

5. Principle of Human Dignityn Requiresthat all health care decisions must aim topromote human dignity, and result not only inphysical health, but also satisfy the patient’spsychological, social, spiritual and cultural needsas an individual, and as member of the communityhe belongs.n Examples:nPatient has the right to choose or refuse treatmentdepending on his preference/culture/religionTextbook of Obstetrics and Gynecology, 3rd ed. Sumpaico, et al.

6. Principle of Free andInformed Consentn Derivedfrom the basic principle of respect forautonomyn Thisis the concrete expression of respecting thepatient’s autonomyn21.levels:autonomy of capable persons which upholdspatient’s right to voluntary informed consent, andchoice based on comprehension of availableoptions.nEx: patient’s right to family size determination.Adinma J. Bioethics in Obstetrics. Textbook of Obstetrics and Gynecology, 3rd ed. Sumpaico, et al.

6. Principle of Free andInformed Consentn2. The second level: protection of personsincapable of autonomy.n the unconscious, the mentally sub-normal andthe child – all of whom require the protection oftheir autonomy.n Ex: the decision on the treatment of anunconscious pregnant woman; genitalmutilation of an infant.Adinma J. Bioethics in Obstetrics. https://www.researchgate.net/publication/221921729

6. Principle of Free andInformed Consentn Elementsof a “valid” informed consent:1.Competence of patient2.Adequate information3.Comprehension and understanding of informationpresented4.Free, voluntary consentAdinma J. Bioethics in Obstetrics. https://www.researchgate.net/publication/221921729

6. Principle of Free andInformed Consentn Theinformation that should be included inrecommending a diagnostic/therapeuticprocedure for a patient are:1.Complete description of the procedure2.Reason for the proposed procedure3.Benefit/s of the procedure4.Risk/s of the procedure5.Alternative diagnostic/therapeutic options6.Freedom to ask questionsAdinma J. Bioethics in Obstetrics. https://www.researchgate.net/publication/221921729

6. Principle of Free andInformed ConsentnIn cases of incompetent patients who cannot provide consent,proxy decision-makers (husband, parents, relatives, guardians)should make the decision according to the patient’s bestinterestnWHO ARE THE INCOMPETENT PATIENTS INCAPABLE OFAUTONOMY?1.unconscious2.mentally sub-normal/ mentally challenged3.child / minorAdinma J. Bioethics in Obstetrics. https://www.researchgate.net/publication/221921729

6. Principle of Free andInformed Consentnprotection of the INCOMPETENT requires either;1.the presence of a living will especially in the case of theunconscious patient2.OR obtaining of consent from the surrogate/ proxy decisionmakers (husband, parents, relatives, guardians)3.or if option #2 is not feasible: a clergyman, or the ethicalcommittee of a health institution4.or as a last resort, the law court.Adinma J. Bioethics in Obstetrics. https://www.researchgate.net/publication/221921729

6. Principle of Free andInformed Consentnthe attending physician can invoke “therapeutic privilege” andgive consent based on his obligation to provide health careExample: ruptured ectopic pregnancy in shock with noavailable relativesAdinma J. Bioethics in Obstetrics. https://www.researchgate.net/publication/221921729

6. Principle of Free andInformed Consentn Medicalpaternalism refers to the overriding ofautonomy.n Strong paternalism is the overriding of theautonomy of a capable person, and is not ethicallypermissible.n Weak paternalism is the overriding of the autonomyof an incapable person which is permissible ifperformed for the overall well-being of the person.Adinma J. Bioethics in Obstetrics. https://www.researchgate.net/publication/221921729

7. Principle of a Well-formedconsciencen Requiresthat physicians, as responsible healthcare providers, have the following obligations:Inform themselves as fully as possible about evidencebased medical facts and ethical norms2. Form a morally certain judgment of conscience based onabove information3. Make health care decisions according to this fully informedconscience4. Accept responsibility for their actions1.Textbook of Obstetrics and Gynecology, 3rd ed. Sumpaico, et al.Adinma J. Bioethics in Obstetrics. https://www.researchgate.net/publication/221921729

8. Principle of Totalityn Requiresthat all persons should develop, use, carefor and preserve all his physical functions in such away that lower functions are never sacrificed,except for the better functioning of the wholeperson, or to preserve lifen Example:1.Atonic uterus causing heavy postpartum bleeding may beremoved to preserve the life of the patient2.A gangrenous foot may be amputated to prevent spread ofinfectionTextbook of Obstetrics and Gynecology, 3rd ed. Sumpaico, et al.

9. Principle of ProfessionalCommunicationn Requiresthat health professionals have thefollowing responsibilities:1.Establish and preserve trust in their patients2.Share medical facts they possess that are legitimatelyneeded by patients to have an informed conscience3.Refrain from lying or providing misinformation4.Keep secret information not legitimately needed by othersthat if revealed will harm patients or destroy patient’s trustTextbook of Obstetrics and Gynecology, 3rd ed. Sumpaico, et al.

10. Principle ofConfidentialityn Requiresthe physician to keep the privacy ofpatients about those aspects of life which do notdirectly affect othersn Notabsolute à may be broken by the need toprotect the patient or others from harmTextbook of Obstetrics and Gynecology, 3rd ed. Sumpaico, et al.

11. Principle of Double Effectn Derivedfrom the basic principle of “nonmaleficence”n Refersto actions which may have both good and badeffects.n4conditions that must be fulfilled for the principle tobe allowed are the following:1.The action must not be intrinsically contradictory to one’sfundamental commitment to God and neighbor the actionmust be good or at least indifferent2.The intention of the agent must be directed towards thebeneficial effect, the harmful effect is only allowed, neverdirectly intendedTextbook of Obstetrics and Gynecology, 3rd ed. Sumpaico, et al.

11. Principle of Double Effect3. The foreseen beneficial effects must be greater than orequal to the harmful effects4. The beneficial effect must proceed from the action aheador simultaneous with the harmful effectIt is important to note that in general the mother should beof prime consideration and therefore decision on her wellbeing takes precedence over that of the foetus.Textbook of Obstetrics and Gynecology, 3rd ed. Sumpaico, et al.

Principle of Double EffectExample:Breast cancer patient who is pregnant (25 weeks AOG),given chemotherapyCervical cancer patient(stage 2B), pregnant 28 weeks,undergoes CS and hysterectomy thereafter

12. Principle of Stewardshipn Refersto man’s limited dominion over nature andhis own life.n Thesethings were entrusted to him to care for andimprove as responsible stewardn Healthprofessionals have ethical responsibilitiesto use intelligence and available technology toprevent and cure diseasesTextbook of Obstetrics and Gynecology, 3rd ed. Sumpaico, et al.

13. Principle of Fidelitynrefers to the ethical responsibility of the health practitionersto carry out whatever promises made to a patient in relationto activities for which he or she has been employed. \nEx: pregnant woman used for the purpose of a clinicalexamination for professional medical students’ exams mayhave been promised free further antenatal care and delivery.Adinma J. Bioethics in Obstetrics. https://www.researchgate.net/publication/221921729

14. Principle of Scientific Validitynmedical practitioners have responsibility to ensureprofessional competence and scientific soundness in theconduct of medical care or research on patient.Adinma J. Bioethics in Obstetrics. https://www.researchgate.net/publication/221921729

15. Principles of veracitynenjoins health practitioners to tell the truth - explaining thepotential benefits and risks alike involved in whatevertreatment being giving to, and procedure being carried outon the patient.Adinma J. Bioethics in Obstetrics. https://www.researchgate.net/publication/221921729

Summary4 basic principlesOther bioethical principlesnPrinciple of human dignitynPrinciple of beneficencenPrinciple of Free and Informed consentnPrinciple of nonmaleficencenPrinciple of Well-formed consciencenPrinciple of respect forautonomynPrinciple of TotalitynPrinciple of Professional communicationPrinciple of justice.nPrinciple of confidentialitynPrinciple of Double effectnPrinciple of StewardshipnPrinciple of FidelitynPrinciple of Scientific validitynPrinciple of Veracityn

3. Principle of Respect for Autonomy According to Beauchamp and Childress, the principle of respect for autonomy supports a number of more specific rules, including the following: nTell the truth. nRespect the privacy of others. nProtect confidential info