Ethics of medical research

Question 1

How does the scientific method provide scientific evidence to improve health care?

Answer 1

By providing knowledge and info on the usefulness and effectiveness of diagnostic, therapeutic and preventive procedures

Question 2

What does biomedical research contribute to?

Answer 2

It contributes to increase our understanding of the etiology, pathophysiology and risk factors of diseases

Question 3

What is biomedical research?

Answer 3

It’s the careful, meticulous, systematic, diligent inquiry or examination of current knowledge, undertaken to establish facts or principles

Question 4

What is the aim of researchers by developing biomedical research?

Answer 4

Researchers strive to better understand the causes of disease, expand knowledge to discover better ways to prevent ill health, and to develop beneficial medications, and procedures to diagnose, treat and cure diseases and conditions that cause illness and death.

Question 5

Biomedical research should be considered

Answer 5

A moral obligation for all physicians and health professionals.

Question 6

What does ethical biomedical research encompasses?

Answer 6

The attainment of moral aims or purpose
The application of morally acceptable means to obtain them

Question 7

Scientific rigor characteristics as a condition

Answer 7

It is a necessary condition but not a sufficient one; not all what is scientifically feasible may be acceptable from an ethical standpoint.

Question 8

When did documental ethical guidelines develop?

Answer 8

In the mid-twentieth century, after a series of well-publicized ethical breaches and war crimes.

Question 9

Ethical breaches and war crimes that lead to the development of documented ethical guidelines

Answer 9

World War II: Nazi scientists launched a series of studies designed to test the limits of human exposure to the elements with the final aim of better preparing German soldiers —> Nüremberg Code (1947)

1932: U.S. Public Health Service started the “Tuskegee Study”, an experiment on black men in the late stages of syphilis

Question 10

What did the Tuskegee Syphilis Study lead to?

Answer 10

U.S. Congress passed the National Research Act in 1974

Question 11

What did the National Research Arch create?

Answer 11

The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research

Question 12

What did the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research consider?

Answer 12

1. The boundaries between biomedical and behavioral research and the accepted and routine practice of medicine
2. The role of assessment of risk-benefit criteria in the determination of the appropriateness of research involving human subjects
3. The establishment of appropriate guidelines for the selection of human subjects for participation in such research
4. The nature and definition of informed consent in various research settings

Question 13

The work of the National Commission led to

Answer 13

The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research

Question 14

When was the Belmont Report published?

Answer 14

In 1979

Question 15

What does the Belmont Report state?

Answer 15

“persons are treated in an ethical manner not only by respecting their decisions and protecting them from harm, but also by making efforts to secure their well being”

Question 16

What did the Belmont Report summarize and define?

Answer 16

The basic ethical principles of respect, justice and beneficence, thereby representing the origins of modern research ethics.

Question 17

Basic ethical principles

Answer 17

Principle of autonomy
Principle of justice
Principle of beneficence

Question 18

What does the principle of autonomy recognize?

Answer 18

The rights of individuals to self-determination

Question 19

The respect for persons incorporates at least 2 ethical convictions

Answer 19

Individuals should be treated as autonomous agents
Persons with diminished autonomy are entitled to protection

Question 20

What does respect autonomy mean?

Answer 20

To give weight to the person’s autonomous considered opinions and choices while refraining from obstructing their actions unless they are clearly detrimental to others

Question 21

Capacity of self-determination

Answer 21

Not every human being is capable of self-determination.

This capacity matures during an individual’s life, while some individuals lose it wholly or in part as a consequence of illness, mental disability, or circumstances that severely restrict liberty

Question 22

What does the respect for persons demand?

Answer 22

That subjects enter into the research voluntarily and with an adequate info (informed consent)

Question 23

What does the principle of justice refer to?

Answer 23

It refers to the ethical obligation of fairness and equality in health resources and treatment

Question 24

The conception of justice is especially relevant to

Answer 24

Protect vulnerable groups:

• It should be determined whether some classes are being systematically selected simply because of their easy availability, compromised position or manipulability
• When research leads to the development of therapeutic devices and procedures, these do not provide advantages only to those who can afford them
• Research should not unduly involve persons from groups unlikely to be among the beneficiaries of subsequent applications of the research

Question 25

What does the principle of beneficence mean?

Answer 25

It means the obligation to act in the best interest of patients maximizing possible benefits and minimizing possible harms

Question 26

The principle of beneficence establishes the need to

Answer 26

Carefully evaluate the risk-benefit relation; learning what will in fact be beneficial may require exposing persons to risk

Question 27

What is the imperative posed by the principle of beneficence?

Answer 27

To decide when it is justifiable to seek certain benefits despite the risks involved, and when the benefits should be foregone because of the risks

Question 28

What does the principle of beneficence imply?

Answer 28

The professional competence of the researchers involved to warrant maximization of benefits and the reduction of risk that might occur from the investigation.

Question 29

Concept of non-malificece

Answer 29

It is more important not to harm your patient, than to do them good; “primum non nocere”, “first, do no harm”.

Question 30

What does the Declaration of Helsinki represent?

Answer 30

One of the most relevant documents in the history of research ethics as the first significant effort of the medical community to regulate research itself

Question 31

Primary purpose that led to the Declaration of Helsinki

Answer 31

To set international ethical principles for research involving human participants the World Medical Association (WMA)

Question 32

The Declaration of Helsinki was originally enacted in

Answer 32

1964

Question 33

Most recent revision of the Declaration of Helsinki

Answer 33

At the General Assembly in October 2013

Question 34

Aspects that include the Declaration of Helsinki

Answer 34

The duty of physicians expands not only to promote and safeguard health but also well-being.

Articles pertaining to vulnerable populations have been changed to better capture several important ethical principles

2013:
Appropriate access of underrepresented groups to
participation in medical research

The need for compensation for study participants who are inadvertently harmed

Attempts to further clarify the role of placebos

The need to register every study involving human subjects in a publicly accesible database before recruitment of the first subject

Provision for post-trial arrangements in advance of study start

The ethical obligation to publish and disseminate the study results, even if they are negative or inconclusive.

Question 35

Other relevant documents apart from Declaration of Helsinki

Answer 35

Declaration of Geneva
Declaration of Tokyo
Declaration of Taipei

Question 36

Declaration of Geneva

Answer 36

Modern version of the Hippocratic Oath

Question 37

Declaration of Tokyo

Answer 37

Guidelines for Physicians to Prevent Torture

Question 38

Declaration of Taipei

Answer 38

Research on Health Databases, Big Data and Biobanks

Question 39

When can we use placebo?

Answer 39

When we don’t have a treatment that we already know it’s effective

Question 40

Potential vulnerable groups and individuals

Answer 40

Soldiers
Prisioneros
Pregnant
Psychiatric patients
Children
Elderly
Patients in coma