10 Basic Principles of the Nuremberg Code of 1947
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1. Voluntary consent of human subjects
2. Results for good of society
3. Designed and based on results of animal experimentation and
knowledge of disease/condition under study.
4. Designed to avoid unnecessary physical and mental suffering.
5. No experiments to be conducted when there is expectation of death or
disabling injury
6. Degree of risk should never exceed humanitarian importance of the
, problems to be solved by the experiment
7. Proper facilities provided to protect subject against injury, disability or
death
8. Experiment should be conducted only by scientifically qualified person
9. Subject should be at liberty to end the experiment if he has reached the
state where continuation seems impossible
10. Scientist in charge must be prepared to terminate the experiment if
continuation of the experiment is likely to result in injury, disability or death.
Termination can occur after IND remains inactive for ______.
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5 years
A sponsor who determines any unanticipated AE that presents unreasonable risk,
termination shall occur within ______ and not later than ______ after sponsor first received
notice of effect.
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5 working days
15 working days
IRB can waive consent requirements
21 CFR 50.24
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, 21 CFR 50.24 can be invoked for emergency research in which it is not
feasible to obtain informed consent and prospective subjects
- Life threatening situations - no available treatments available
- Patients won't be able to consent due to medical condition
- Needs to be administered ASAP - no time to review with LAR
- No way to prospectively determine patients' likeliness to participate
- Direct benefit to subject
- Evidence to support potential of intervention to provide direct benefit
- Attempt to contact LAR within specified period of time
-Children
-Pregnant Women
-Prisoners
-Handicapped
-Mentally Disabled
-Educationally disadvantaged
-Economically disadvantaged
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Vulnerable Populations
Phase 2 Study
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Evaluate effectiveness of drug in a specific population
Dose finding
Includes several hundred patients
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1. Voluntary consent of human subjects
2. Results for good of society
3. Designed and based on results of animal experimentation and
knowledge of disease/condition under study.
4. Designed to avoid unnecessary physical and mental suffering.
5. No experiments to be conducted when there is expectation of death or
disabling injury
6. Degree of risk should never exceed humanitarian importance of the
, problems to be solved by the experiment
7. Proper facilities provided to protect subject against injury, disability or
death
8. Experiment should be conducted only by scientifically qualified person
9. Subject should be at liberty to end the experiment if he has reached the
state where continuation seems impossible
10. Scientist in charge must be prepared to terminate the experiment if
continuation of the experiment is likely to result in injury, disability or death.
Termination can occur after IND remains inactive for ______.
Give this one a try later!
5 years
A sponsor who determines any unanticipated AE that presents unreasonable risk,
termination shall occur within ______ and not later than ______ after sponsor first received
notice of effect.
Give this one a try later!
5 working days
15 working days
IRB can waive consent requirements
21 CFR 50.24
Give this one a try later!
, 21 CFR 50.24 can be invoked for emergency research in which it is not
feasible to obtain informed consent and prospective subjects
- Life threatening situations - no available treatments available
- Patients won't be able to consent due to medical condition
- Needs to be administered ASAP - no time to review with LAR
- No way to prospectively determine patients' likeliness to participate
- Direct benefit to subject
- Evidence to support potential of intervention to provide direct benefit
- Attempt to contact LAR within specified period of time
-Children
-Pregnant Women
-Prisoners
-Handicapped
-Mentally Disabled
-Educationally disadvantaged
-Economically disadvantaged
Give this one a try later!
Vulnerable Populations
Phase 2 Study
Give this one a try later!
Evaluate effectiveness of drug in a specific population
Dose finding
Includes several hundred patients
