Monday, March 10, 2008

Medical Ethics - Master of Hospital Administration (MHA)

Introduction to issues in medical ethics

V Raman Kutty

Professor, AMC

Medical Ethics
[vs. Professional ethics]

Principals to guide physicians in their relationships with others

Ethical dilemma is a predicament in which there is no clear course to resolve the problem of conflicting moral principles

Dynamic environment/evolving field

Principles

Autonomy

Beneficience

Nonmaleficence

Justice

Autonomy

Right to self-determination

Requires decision making capacity

Lack should be proven not assumed

Competence – legal determination

Liberty – freedom to influence course of life/treatment

Preservation of Autonomy

Advance Directives

A document in which an individual either states preferences or designates decision maker

Living Will

Takes effect when terminally ill and lacking decision making capacity

Preserving Autonomy

Surrogate Decision Makers

Represents patients interest

Best identified before critical illness

In absence of specific advanced directives should use substituted judgement

Preservation of Autonomy

The primary responsibility of the physician is to serve the patients interest

The patient self determination act of 1990

At the time of admission information re: the patients’ right to refuse care or create an advance directive must be dispensed

Informed Consent

Requirements

Decision making capacity

Volutariness

Reasonable person standard

Present all alternatives f/b recommendation

Respect refusal

All surgical and experimental procedures

Implied Consent

Invoked when true informed consent not possible

Emergency situations when harm would result without urgently needed intervention

Disclosure

Truth telling on part of physician is an integral part of patient autonomy

Paternalism

Justifiable if patient at risk of significant preventable harm, paternalistic action will prevent harm, benefits outweigh risks and the least autonomy-restrictive course of action is used

Confidentiality

Obligation of physician to maintain information in strict confidence

Exceptions if failure to release data to data to appropriate agencies may result in greater societal harm

Futility

Unilateral decision made on part of physician to withold or withdraw medical intervention based on predictable futile outcome

Physiologic futility

Medical futility – none of last 100 cases like this…

Beneficience

Obligation to preserve life, restore health, relieve suffering and maintain function

To do “good”

Nonabandonment – obligation to provide ongoing care

Conflict of interest – must not engage in activities that are not in patients best interest

Nonmaleficence

“Do no harm, prevent harm and remove harm”

Impaired Physician

Physicians have the obligation to report impaired behavior in colleagues

Principle of Double Effect

Act must be morally good

Actor intends good effect

Good effect outweighs bad effect

Bad effect not means to good effect

Justice

Allocation of medical resources must be fair and according to need

Physicians should not make decisions regarding individuals based upon societal needs

DNR

DNR orders affect CPR only

Other therapies should not be influenced by DNR order

Should be reviewed frequently

Rationale should be in medical record

Withdrawing of Support

Brain death is not required

Same as not initiating

Does not conflict with basic principles

Persistent Vegetative State

Uncnsciousness/ loss of self awareness lasting more than weeks

Death

Irreversible cessation of circulatory and respiratory function

Irreversible cessation of all brain function (including brainstem)

The Nuremberg Trials

Nuremberg Code (1947)

“The voluntary consent of the human subject is absolutely essential.”

“This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice … and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision. This latter element requires that before the acceptance of an affirmative decision by the experimental subject there should be known to him the nature, duration and purpose of the experiment; the methods and means by which it is to be conducted; all inconveniences and hazards reasonably to be expected; and the effects upon his health or person which may possibly come from his participation in the experiment.”

RESEARCH ETHICS CODES

DECLARATION OF HELSINKI – 1964 (revised in 1975, 1983, 1989, 1996, 2003)

Issues addressed include:

Research with humans should be based on the results from laboratory and animal experimentation

Research protocols should be reviewed by an independent committee prior to initiation

Informed consent from research participants is necessary

Research should be conducted by medically/scientifically qualified individuals

Risks should not exceed benefits

ICMR guidelines

Recently developed by ICMR (available on website)

All medical research in India mandated to follow guidelines

Implications

Informed consent requirements should be carefully followed

IRB mandatory in large institutions- otherwise, can request other institutions’ IRB to review proposals

Collaborative research should be approved by IRBs of all institutions