Chapter 7 - Experimental Aspects of Human Experimentation Flashcards Preview

PHAR3006 Drug Design & Development > Chapter 7 - Experimental Aspects of Human Experimentation > Flashcards

Flashcards in Chapter 7 - Experimental Aspects of Human Experimentation Deck (17):

Why are animal models flawed?

not appropriate is the new treatment is a device e.g. pacemaker, hip replacement
2. Pathophysiology model is wrong i.e. how relevant is any short term animal model to long term human diseases
3. dose or timing of drug administration differs
4. effect or toxicity of therapy is species specific


name 3 diseases where there an animal model doesnt exist

1. cystic fibrosis
2. asthma
3. chronic obstructive lung disease


give 5 disorders where human experimentation has delivered progress

2. cervical cancer
3. breast cancer
4. erectile dysfunction
5. rheumatioid arthritis


what was unethical about J. Marion Sims

1840's - Performed surgical experiments on enslaved african women with anaesthesia.
many of the women died from infections from the experiments


what was unethical about Dr. leo Stanley

1913-1951 - performed experiments on prisoners at san quentin. Many experiments involved testicular implants where testicals of executed prisoners or animals were implanted into living prisoners


name 4 experiments conducted by Nazi researchers

mustard gas


describe elements of the Tuskegee syphilis study

1932-1972 - 399 african-american males were denied treatment for syphilis programms
- a leaked file to the press resulted in the study's termination
-by this time 28 had died from syphilis and 100 more had died from medical complications related to syphilis
-40 wives of the participants had been infected with syphilis, 19 children had contracted the disease at birth


what happened at camp 22 prison

2004 - families of 3/4 were used as experimental subjects of poison gas, suffocation gas and blood experiments


what motivations are there for research misconduct?

power/ fame
poor judgement/ ignorance
amorality, sadism
coercion, obedience


what are the differences between research and medical practice

1. clinical practice intends to do whats best for the patient
in research, the intent is to use the patient to find some truth about a condition for the potential benefit of all patients
2. volunteers are at risk of being exploited for the greater good in research
3. there is an unknown risk of the experiment itself in research


list the 6 essential requirements for human experimentation set by the nuremberg code

1. research should be based on prior animal work
2. research must be conducted by qualified scientists
3. the risks should be justified by the anticipated benefits
4. physical and mental suffering must be avoided
5. research in which death or disabling injury is expected should not be conducted
6. informed consent is essential


give the three principals of ethical review for all human research

1. assessment of the quality of the science and the data
2. assessment of the risk to the volunteer
3. assessment of informed consent


what four questions need to be answered to make sure there is a high quality of science in human experiments

1. will the experimental design answer the research question
2. are the investigators competent and experienced
3. will they collect the data accurately and truthfully
4. will the researchers have enough data?


what are the two types of research on humans?

1. non-interventional
2. interventional studies


what is non-interventional studies

surveys, questionnaires, blood samples


what is interventional studies

volunteers take a drug, change their lifestyle or have a device implanted


what 3 questions need to be asked regarding risk of an interventional study

1. how safe is the intervention being tested?
2. what are the procedural risks to the volunteer during the study e.g radiation
3. will volunteers be denied usual therapy