Ames

Question 1

why are ethics committees important

Answer 1

1. conflict of values and interest
2. insight of multiple, experienced perspectives
3. value of communication and consensus building
4. Requirement of governing codes ( joint commission and code of federal regulation)
5. Need for oversight and accountability

Question 2

Nuremberg Code

Answer 2

Participation in medical research on human subject must be voluntary, and has the right to bring experiment to the end

Question 3

International Covenant on Civil and Political Rights

Answer 3

No one shall be subjected to torture or to cruel, inhumane or degrading treatment or punishment. In particular, no one shall be subjected without his free consent to medical or scientific experimentation

Question 4

Helsinki

Answer 4

Clinical care and research may overlap, and patient’s care takes presidence

Question 5

Tuskegee and the Belmont report

Answer 5

Syphilis infection purposefully.  
1. Respect for Persons
2. Beneficence
3. Justice (emphasis)
Application
1. Informed consent
2. Assessment of Risks and Benefits
3. Selection of Subjects

Question 6

Common Rule

Answer 6

Protecting those who are marginal.

1. risks to subjects is minimal
2. risks are reasonable
3. selection of subjects is equitable
4. informed consent
5. informed consent documented
6. research plan makes adequate provision for monitoring data
7. adequate provisions for protecting privacy

Question 7

COIMS International Guidlines

Answer 7

To protect subjects out of controversy

Question 8

Principles of ethical clinical research

Answer 8

1. Value: contributes general knowledge that improves health
2. Validity: sound research design ensuring valid conclusions
3. Fair subject selection: statistically valid, nondiscriminatory , benefits participants
4. Favorable risk/benefit ratio
5. Independent review: for adherence to ethical guidlines
6. Informed consent: clear processes and documented voluntary participation
7. Respect for participants: during and after study

Question 9

Coma

Answer 9

pathological state of eyes-closed unresponsiveness in which the patient has neither awareness nor wakefulness and from which the patient cannot be aroused to awareness or wakefulness by vigorous stimuli

Question 10

Vegetative state

Answer 10

disorder of consciousness in which wakefulness is retained but awareness of self and environment is entirely absent… may be a transient stage during spontaneous recovery from coma to awareness, or it may be a chronic, unchanging state

Question 11

Minimal conscious state

Answer 11

disorder of altered consciousness characterized by a profound lack of responsiveness but partial or intermittent evidence of awareness of self and environment

Question 12

Locked-in Syndrome

Answer 12

a state of profound paralysis, is not a disorder of consciousness but may be mistaken for one

Question 13

Brain Death

Answer 13

irreversible cessation of all clinical brain functions

Question 14

Report of Ad Hoc

Answer 14

1. unresponsiveness to ext stimuli
2. no spontaneous movements or breathing
3. no reflexes to light
4. documentation of no cortical activity: EEGs 24hr
5. exclusion of mimics such as hypothermia or drug sedation

Question 15

Uniform Determination of Death Act

Answer 15

establishing alternatives formulations (cardiopulmonary or whole brain)

Question 16

President’s commission

Answer 16

death is fundamentally philosophical but based on physiological permanent cessation of all brain function

Question 17

How is death determined

Answer 17

1. Preconditions showing irreversibility: all necessary
2. Signs showing complete cessation of all clinical brain functions: all necessary
3. Confirmatory tests: optional, neuroimaging preferred