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Medical jurisprudence > Bioethics > Flashcards

Bioethics Flashcards

1
Q

The study of ethical and moral implications of

medical research and practice

A

BIOETHICS

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2
Q

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

A

ETHICS

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3
Q

2 general ethical principles

A
  1. Respect for autonomy
  2. Protection of persons with impaired or diminished
    autonomy
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4
Q

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

A

Respect for autonomy

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5
Q

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

A

Protection of persons with impaired or diminished

autonomy

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6
Q

their job is to review drugs that are not yet

released in the market

A

Ethical Committee

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7
Q

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

A

Nursing Homes

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8
Q

4 Research Hierarchy

A
  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
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9
Q

Paying someone to join a study is ____

A

unethical

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10
Q

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

A

Beneficience

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11
Q

Soundness of research design, must be technically

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

A

ethically sound

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12
Q

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

A

WVSU Ethics committee

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13
Q

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

A

Remdesivir

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14
Q

Solidarity trial sites in the Philippines

A

Cebu – Chong Hua Hospital and WVSU Medical Center

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15
Q

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

A

Justice

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16
Q

Justice in research ethics is often referred to as

A

distributive justice

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17
Q

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

A

distributive justice

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18
Q

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

A

Fetal-maternal conflict

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19
Q

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

A

Prenatal diagnosis

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20
Q

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

A

End of life issues

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21
Q

An example is resuscitation on a terminally ill

patient.

A

END OF LIFE ISSUES

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22
Q 
is often based on best
interest principle (chance of survival, pain of attempted resuscitation, subsequent benefits or burdens).
A

DECISION TO RESUSCITATE A NEONATE

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23
Q

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

A

STEM CELL THERAPY

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24
Q

5 COMMON ETHICAL ISSUES IN PRACTICE

A
  1. Fetal maternal conflict
  2. Prenatal diagnosis
  3. End of life issue
  4. Decision to resucitate a neonate
  5. STEM cell therapy
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25
Q

7 Ethical issues in medical research

A
  1. validity and scientific soundness
  2. Informed consent
  3. Confidentiality
  4. Voluntariness
  5. Compensation
  6. Vulnerable population
  7. Equitable distribution of burdens and benefits
26
Q

Research not scientifically sound is not ethical

A

validity and scientific soundness

27
Q

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

A

INFORMED CONSENT

28
Q

can informed consent be translated?

A

There is a translation for informed consent

29
Q

Questions often asked about confidentiality

A

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

30
Q

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

A

Voluntariness

31
Q

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

A

Compensation for injuries

32
Q

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

A

COMPENSATION FOR INJURIES

33
Q

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

A

Vulnerable population

34
Q

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

A

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

35
Q

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

A

inducement

36
Q

Reasonable compensation is not more than Php____

37
Q

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

A

EQUITABLE DISTRIBUTION OF BURDENS AND BENEFITS

38
Q

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

A

SULFINAMIDE DISASTER

39
Q

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

A

Nuremberg code

40
Q

The Thalidomide tragedy led to the formation of

A

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

41
Q

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

A

Nuremberg Code

42
Q

Three key/salient principles of Nuremberg Code

A
  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.
43
Q

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

A

Declaration of Helsinki

44
Q

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

A

Declaration of Helsinki

45
Q

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

A

Declaration of Helsinki

46
Q

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

A

Principle 6 of the Declaration of Helsinki

47
Q

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”

A

Principle 11 of the Declaration of Helsinki

48
Q

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

A

HELSINKI CONTENTS

49
Q

Good clinical practice certification is one of the many in the

A

Helsinki Content

50
Q

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”

A

GOOD CLINICAL PRACTICE GUIDELINES

51
Q

7 CONTENTS OF GOOD CLINICAL PRACTICE GUIDELINES

A
  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
52
Q

5 EMPHASIS OF GOOD CLINICAL PRACTICE GUIDELINES

A
  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;
53
Q

3 WHO STANDARDS AND OPERATIONAL

GUIDANCE

A
  1. Research ethics review system
  2. Research ethics committees:
  3. Researchers and their obligations
54
Q

SCOPE OF HEALTH-RELATED RESEARCH

A

Biomedical, Behavioral, Social Science, and

Epidemiologic

55
Q

3 SYSTEMS APPROACH FOR THE PARTICIPANTS AND PROTECTION PROGRAMS

A
  1. Monitor quality research
  2. Make iperation transparent
  3. Comply with national government
56
Q

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

A

BELMONT COMMISSION

57
Q

3 principles of belmont Commission

A
  1. Respect for person
  2. Beneficience
  3. Justice
58
Q

Requirement to acknowledge autonomy

Requirement to protect those with diminished
autonomy

A

Respect for persons

59
Q

Do not do harm

Maximize possible benefits and minimize
possible harm

Sometimes expressed as a separate principle,
nonmaleficence (do no harm)

A

Beneficience

60
Q

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

Medical jurisprudence (14 decks)

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