Bioethics

Dr Mohamed Mosaad Hasan

MD MPH CPHQ CPPS GBSS

Ethics is the branch ofphilosophy which dealswith moral aspects ofhuman behavior

Health ethics is primarilya field of applied ethicsthe study of moral valuesand judgments as theyapply to healthcare

bull A group of guidelines such as the Oath ofHippocrates generally written by physiciansabout the physicianrsquos ideal relationship to hispeers and to his patients

The basic concept of medical ethics is thatthe physician has a moral (and at times legal)obligation to act for the patientrsquos good usingthe most up-to-date information

The question is how to establish that ldquogoodrdquowho defines it and what are the componentsthereof

bull Significant technological and scientificadvances and changes in clinical medicineand research have produced totally newethical dilemmas and exacerbated old ones

bull The change in philosophy from paternalismto autonomy in the physician-patientrelationship

bull The involvement of additional caregivers(various medical specialists a variety ofhealth professionals students administratorsand investigators)

The involvement of society at large (throughthe mass communication media courtslegislators)

Ethical decisions are based on what is best for the common good and generally exceed what is required by law

Legal decisions are based on what is mandated by statutes or case law

bull Scientific and humanistic components mustbe combined

bull The subjective feelings of the patient whichare based on personal social cultural andeconomic value systems must beconsidered

Video Tuskegee Syphilis Project

In 1990 Executive Editor Dr Marcia Angell ofthe New England Journal of Medicinereiterated the journalrsquos position that onlyresearch conducted in accordance with therights of human subjects would be publishedThe results of unethical research would notbe published regardless of scientific merit

The Belmont Report distinguished betweenresearch and practice

Practice includes interventions designed to enhancethe well-being of a patient through eitherdiagnosis or treatment and that have a reasonableexpectation of success

Research was defined as ldquoan activity designed totest a hypothesis permit conclusions to be drawnand thereby to develop or contribute togeneralizable knowledge (expressed for examplein theories principles and statements ofrelationships)

The IRB must

1048697 Identify risks of the research

1048697 Minimize risks as much as possible

1048697 Identify probable benefits

1048697 Evaluate the risks in relation to the benefits

1048697 ensure that research subjects are provided with an accurate and fair description of the risks discomforts and anticipated benefits

(6) ensure that research subjects are offered the opportunity to voluntarily accept or reject participation in the research or discontinue participation without coercion or fear of reprisal or deprivation of treatment to which the patient is otherwise entitled

(8) and (7) determine intervals of periodic review and when necessary determine the adequacy of mechanisms for monitoring data collection

1 Beneficence - a practitioner should act inthe best interest of the patient

2 Non-malfeasance - first do no harm

3 Autonomy - the patient has the right torefuse or choose their treatment

4 Justice - concerns the distribution of scarcehealth resources and the decision of whogets what treatment (fairness and equality)

5 Non discriminatory treatment

6 Dignity - the patient (and the persontreating the patient) have the right to dignity

7 Truthfulness and honesty - the concept ofinformed consent has increased inimportance since the historical events of theDoctorslsquo Trial of the Nuremberg trials andTuskegee Syphilis Study

For example the principles of autonomy andbeneficence clash when patients refuse life-saving blood transfusion and truth-tellingwas not emphasized to a large extent beforethe HIV era

bull The moral obligation to do good for othersand to help them in an active way

bull there are limits to the requirement that oneact to help others at all times These vary withthe degree of need the ease and ability withwhich the help can be rendered and thenature of the relationship between theindividual needing help and the one able toprovide it

Paternalism is an approach in which thephysician chooses the treatment for thepatient because the physicianrsquos professionalknowledge experience and objectivity bestqualify him to judge the ideal treatment forthe patient

bull Autonomy means that only the patient knowswhat is best for him and only he has the rightto decide In order to do so he she needs toreceive from the physician all the appropriateinformation about his condition to permit himto make an informed decision

bull The physicianrsquos values and even less hisprofessional knowledge and experience playno role in the final decision

Traditionally the physicianrsquos role was viewedas giving ldquoordersrdquo to nurses and to patients(eg order-entry physician orders etc) Inthe atmosphere of autonomy physiciansmust use a different language such as adviserecommendation etc

The main criticism of pure autonomy is thatthe physician has little influence on thepatientrsquos decision which is often based on alack of full understanding of his condition

bull Such a decision may cause unnecessary andavoidable harm to the patient

Respect for autonomy is the basis forinformed consent and advance directives

bull Individualsrsquo capacity for informed decisionmaking may come into question duringresolution of conflicts between Autonomy andBeneficence

is defined as the obligation not to harm others and to remove and prevent potential harm DO NO HARM

bull Thus one must not only prevent intentional harm but must also be appropriately cautious not to cause harm

bull Some interventions undertaken by physicians cancreate a positive outcome while also potentiallydoing harm The combination of these twocircumstances is known as the double effect

bull The most applicable example of thisphenomenon is the use of morphine in the dyingpatient Such use of morphine can ease the painand suffering of the patient while simultaneouslyhastening the demise of the patient throughsuppression of the respiratory drive

Uninformed agent is at risk of mistakenly making a choice not reflective of his or her values

bull The value of informed consent is closely related to the values of autonomy and truth telling

Patient Rights and Responsibilities

Advance Directives Patients can

delegate decision-making authority toanother party If the patient isincapacitated the next-of-kin makedecisions for the incapacitated patient

1048697 Governed at the state level

1048697 Requires a physician order

1048697 Documented in the medical record

1048697 Requires clear policy and procedure

1048697 Documented education of patient family and staff

1048697 Does not require an advance directive as a precondition

This concept is commonlyknown as patient-physicianprivilege

Legal protections preventphysicians from revealingtheir discussions withpatients even under oath incourt

bull Confidentiality is challenged in cases such asthe diagnosis of a sexually transmitteddisease in a patient who refuses to reveal thediagnosis to a spouse or in the terminationof a pregnancy in an underage patientwithout the knowledge of the patientsparents

bull ldquoethical conflicts in medical ethics aretraceable back to a lack of communication

bull Communication breakdowns betweenpatients and their healthcare team betweenfamily members or between members of themedical community can all lead todisagreements and strong feelings

bull Many times simple communication is notenough to resolve a conflict and a hospitalethics committee of ad hoc nature mustconvene to decide a complex matter

bull Permanent bodies ethical boards areestablished to a greater extent as ethicalissues tend to increase These bodies arecomprised of health care professionalsreligious leaders and lay people

Some cultures do not place a great emphasison informing the patient of the diagnosisespecially when cancer is the diagnosis

Physicians should not allow a conflict ofinterest to influence medical judgment

bull In some cases conflicts are hard to avoidand doctors have a responsibility to avoidentering such situations

bull Unfortunately research has shown thatconflicts of interests are very common amongboth academic physicians and physicians inpractice

bull For example doctors who receive income from referring patients for medical tests have been shown to refer more patients for medical tests

Studies show that doctors can be influenced bydrug company inducements including gifts andfood

bull Industry-sponsored Continuing MedicalEducation (CME) programs influence prescribingpatterns

bull A growing movement among physicians isattempting to diminish the influence ofpharmaceutical industry marketing upon medicalpractice as evidenced by Stanford Universitysban on drug company-sponsored lunches andgifts

1048697 Life-sustaining treatment is any treatment that serves to prolong life without reversing the medical condition

1048697 Clear policy and procedure1048697 Examples of such treatment

ndash Mechanical ventilationndash Renal dialysisndash Artificial nutrition and hydrationndash Antibioticsndash Blood products

1048697 Patient must be

ndash Of age

ndash Able to understand the nature of the situation and the consequences of the decision

ndash Able to communicate the wishes to the caregiver

1048697 Capacity normally is determined by the physician

1048697 Capacity is presumed unless there is a reason to question it

1048697 Capacity may come and go so act as close to the time of capacity as possible

1048697 Do not abandon the patient arrange transfer

1048697 Have appropriate policies

1048697 Be sure decisions are based on medical issues not age social status etc

1048697 Avoid court if at all possible

1048697 Negotiate with the patient surrogates and health care providers if necessary

1048697 Use the Ethics Committee

1048697 Chairperson should be well educated or trained in ethical issues

1048697 Appropriate medical and clinical staff should be included

1048697 There should be a clerical representative from the religious community

1048697 A layperson from the community should be a member

1048697 Decisions are nonbinding

1048697 The risk manager should

ndash Be a neutral party during the discussions

ndash Serve as a facilitator

ndash Act as a consultant on legal issues

ndash Develop an ethics consultation mechanism

1048697 Abortion and reproductive rights

1048697 End-of-life or futile care

1048697 Quality of life

1048697 Advance directives

1048697 DNRs

1048697 Staff rights that conflict with patient wishes

The committee that generally is charged withoversight of investigative patient research isthe

A Bioethics Committee

B Institutional Review Board

C Utilization Review Committee

D Quality Improvement Committee

If a patients physician and agent disagree about what course of action is best for the patient the best course of action is to

A Refer the case to the Ethics Committee

B Follow the wishes of the patients agent

C Allow the physician to make the decision

since he is ultimately liable

D Seek guidance from the appropriate court