Bioethics

Question 1

The study of ethical and moral implications of

medical research and practice

Answer 1

BIOETHICS

Question 2

A branch of philosophy
Rules of behavior based on ideas about what is
morally good and bad

Answer 2

ETHICS

Question 3

2 general ethical principles

Answer 3

1. Respect for autonomy
2. Protection of persons with impaired or diminished
   autonomy

Question 4

Requires that those who are capable of deliberation
about their persona; choices should be treated with
respect for their capacity for self-determination

Answer 4

Respect for autonomy

Question 5

prominent in cases with clinical trials, vulnerable
population. Requires that those who are dependent or vulnerable be afforded security against harm or
abuse

Answer 5

Protection of persons with impaired or diminished

autonomy

Question 6

their job is to review drugs that are not yet

released in the market

Answer 6

Ethical Committee

Question 7

What place where administrator is the one who asks for consent: a question of ethics

Answer 7

Nursing Homes

Question 8

4 Research Hierarchy

Answer 8

1. Animal study
2. Stage 1: 10-20 healthy participants, dosages
3. Stage 2: 300-800 patients with disease for efficacy
4. Stage 3: more than a thousand participants

Question 9

Paying someone to join a study is ____

Answer 9

unethical

Question 10

Ethical obligation to maximize benefits and minimize harms Gives rise to norms requiring that the risks of research be reasonable in the light of the expected benefits

Answer 10

Beneficience

Question 11

Soundness of research design, must be technically

sound. If not technically sound, it’s not ___

Answer 11

ethically sound

Question 12

Fully recognized ethics
committee by the Philippine Ethics Board, Forum for
Ethical Review for Asia and Western Pacific

Answer 12

WVSU Ethics committee

Question 13

drug with minimal harm, minimal side
effects (nausea, headache, vomiting), but must undergo
another trial for covid-19; cost – 8,000 per dose, 3 doses
per day for 10 days = 240 000 for free for each patient

Answer 13

Remdesivir

Question 14

Solidarity trial sites in the Philippines

Answer 14

Cebu – Chong Hua Hospital and WVSU Medical Center

Question 15

Obligation to treat each person in accordance to what is morally right and proper. To give each person what is due him/her

Answer 15

Justice

Question 16

Justice in research ethics is often referred to as

Answer 16

distributive justice

Question 17

Philippines was chosen to be a testing site yet

the company decides not to market the drug in the Philippines. (Unethical) is an example of

Answer 17

distributive justice

Question 18

any situation wherein the pregnant woman’s interests or well-being contradicts the interests or benefit of the fetus, as defined by the physician.

Answer 18

Fetal-maternal conflict

Question 19

testing for any abnormalities in the
fetus before birth. Ethical issues may arise when complications are present and decisions have to be made regarding the fate of the
fetus

Answer 19

Prenatal diagnosis

Question 20

involve the amount of care or medical attention that should be given to terminally ill
patients

Answer 20

End of life issues

Question 21

An example is resuscitation on a terminally ill

patient.

Answer 21

END OF LIFE ISSUES

Question 22

is often based on best
interest principle (chance of survival, pain of attempted resuscitation, subsequent benefits or burdens).

Answer 22

DECISION TO RESUSCITATE A NEONATE

Question 23

Embryos are destroyed in the process of stem cell line derivation used for stem cell therapy that is usually given to adults.

Answer 23

STEM CELL THERAPY

Question 24

5 COMMON ETHICAL ISSUES IN PRACTICE

Answer 24

1. Fetal maternal conflict
2. Prenatal diagnosis
3. End of life issue
4. Decision to resucitate a neonate
5. STEM cell therapy

Question 25

7 Ethical issues in medical research

Answer 25

1. validity and scientific soundness 2. Informed consent 3. Confidentiality 4. Voluntariness 5. Compensation 6. Vulnerable population 7. Equitable distribution of burdens and benefits

Question 26

Research not scientifically sound is not ethical

Answer 26

validity and scientific soundness

Question 27

Patients or participants should be given appropriate information about the treatment so they may make a voluntary choice to accept or refuse it.

Answer 27

INFORMED CONSENT

Question 28

can informed consent be translated?

Answer 28

There is a translation for informed consent

Question 29

Questions often asked about confidentiality

Answer 29

→ Who will have access to the information gathered? → How long will the information be kept? → What is the method of destruction?

Question 30

Information provided by the participants should be kept private and the anonymity of the subjects must be respected.

Answer 30

Voluntariness

Question 31

Just compensation must be provided to participants who suffered injury as a result of participating in the study.

Answer 31

Compensation for injuries

Question 32

For example, subject met an injury on the way to the place where the study will be conducted. Researcher must pay for medical expenses.

Answer 32

COMPENSATION FOR INJURIES

Question 33

In the case of research involving minors, parent or guardian should sign the consent form while minors can sign assent form:

Answer 33

Vulnerable population

Question 34

15-18 yrs. old → 12-14 yrs. old → 8-12 yrs. old

Answer 34

Should sign the assent form; Should sign less detailed assent form; No assent form but should be consulte

Question 35

Impoverished population is prone to _____ Since they agree to participate because they are given money.

Answer 35

inducement

Question 36

Reasonable compensation is not more than Php____

Answer 36

1500

Question 37

If both male and female are tested, both should also receive the benefits of the study

Answer 37

EQUITABLE DISTRIBUTION OF BURDENS AND BENEFITS

Question 38

Sulfanilamide drug was usually given in powder form. They thought it would yield better results in elixir form. Solvent used for making the elixir caused the adverse effects of the drug

Answer 38

SULFINAMIDE DISASTER

Question 39

which is a set of ethical principles for medical studies using human subjects.

Answer 39

Nuremberg code

Question 40

The Thalidomide tragedy led to the formation of

Answer 40

Kefauver-Harris Amendments” or the Drug Efficacy Amendment of 1962

Question 41

first international guideline to be produced, and a key document on which many subsequent regulations have been based

Answer 41

Nuremberg Code

Question 42

Three key/salient principles of Nuremberg Code

Answer 42

1. Subjects should give their voluntary consent 2. Experiments should be as such as to yield fruitful results for the good of society 3. Participants should be protected and experiment should avoid all unnecessary physical and mental suffering and injury.

Question 43

Adopted by the World Medical Association (WMA) in 1964 in response to the findings of the Nuremberg Trials

Answer 43

Declaration of Helsinki

Question 44

Statement of ethical principles for medical research involving human participants, including identifiable human material and data

Answer 44

Declaration of Helsinki

Question 45

Purpose: Understand Disease, improved interventions. Human Participant necessary. Primacy of Patient’s best interest: health, well-being rights

Answer 45

Declaration of Helsinki

Question 46

holds that “Well-being of research participants should take precedence over the interests of science and society”

Answer 46

Principle 6 of the Declaration of Helsinki

Question 47

holds that “It is the duty of the researcher to protect the life, health, dignity, right to self-determination, privacy, and confidentiality of the research participants and to safeguard scientific integrity”

Answer 47

Principle 11 of the Declaration of Helsinki

Question 48

Covers every aspect of clinical research since its purpose is to protect the rights of every subjects

Answer 48

HELSINKI CONTENTS

Question 49

Good clinical practice certification is one of the many in the

Answer 49

Helsinki Content

Question 50

Provides public with assurance that “the rights and safety and well-being of trial participants are protected and that the data and results are credible”

Answer 50

GOOD CLINICAL PRACTICE GUIDELINES

Question 51

7 CONTENTS OF GOOD CLINICAL PRACTICE GUIDELINES

Answer 51

1. Principles 2. Research ethics committees 3. Investigator 4. Sponsor 5. Clinical trial protocol and amendments 6. Investigator’s brochure 7. Essential documents for the conduct of a clinical trial

Question 52

5 EMPHASIS OF GOOD CLINICAL PRACTICE GUIDELINES

Answer 52

1. Follows ethical standards 2. Information on protocol, investigators, and product are adequate and available 3. Product manufactured handled and stored appropriately 4. Protocol compliance 5. Conduct recorded and reported accurately;

Question 53

3 WHO STANDARDS AND OPERATIONAL | GUIDANCE

Answer 53

1. Research ethics review system 2. Research ethics committees: 3. Researchers and their obligations

Question 54

SCOPE OF HEALTH-RELATED RESEARCH

Answer 54

Biomedical, Behavioral, Social Science, and | Epidemiologic

Question 55

3 SYSTEMS APPROACH FOR THE PARTICIPANTS AND PROTECTION PROGRAMS

Answer 55

1. Monitor quality research 2. Make iperation transparent 3. Comply with national government

Question 56

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

Answer 56

BELMONT COMMISSION

Question 57

3 principles of belmont Commission

Answer 57

1. Respect for person 2. Beneficience 3. Justice

Question 58

Requirement to acknowledge autonomy Requirement to protect those with diminished autonomy

Answer 58

Respect for persons

Question 59

Do not do harm Maximize possible benefits and minimize possible harm Sometimes expressed as a separate principle, nonmaleficence (do no harm)

Answer 59

Beneficience

Question 60

o To each person an equal share o To each person according to individual need o To each person according to individual effort o To each person according to societal contribution o To each person according to merit

Answer 60

Justice