Bittel Bioethics of Human Subjects research

Question 1

Define bioethics

Answer 1

the study of the ethical issues emerging from advances in biology and medicine

includes morals

ethical questions that are involved in the sciences, biotechnology, medicine, etc

Question 2

Define Institutional Review Board (IRB)

Answer 2

independent body made up of medical, scientific, and nonscientific members, whose responsibility it is to ensure the protection of the rights, safety and well-being of human subjects involved in a trail by among other things, reviewing, approving, and providing continuing review of trials, of protocols and amendments, and of the methods and materials to be used in obtaining and documenting informed consent of the trial subjects

Question 3

Define research misconduct

Answer 3

a fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results

Question 4

Define serious adverse event

Answer 4

any experience that suggests a significant hazard, contraindication, side effect, or precautions that develops during a clinical trial

Question 5

Define informed consent

Answer 5

consent to participate in a medical experiment by a subject after achieving understanding of what is involved. Essential to be entirely voluntary and can withdraw at any time without any impact on patient care

Question 6

Define autonomy

Answer 6

capacity of an individual to make an informed uncorked decision

Question 7

Define clinical trial

Answer 7

the systematic investigation of the side effects of materials or methods on a disease state conducted according to a formal study plan

Question 8

Define good clinical practice

Answer 8

a standard by which clinical trials are designed, implemented, and reported to assure that the data are scientifically sound and that the rights of the subjects are protected

Question 9

Who was James Lind?

Answer 9

1747 The FIRST clinical trial in the navy; scurvy

Question 10

Who was Dr. John Haygarth?

Answer 10

Tractor dude, first guy to recognize the placebo effect in 1799

Question 11

Describe the Biologics Control Act

Answer 11

1902

Regulated the production of vaccines and anti-toxins

Question 12

Describe the Pure Food and Drug act

Answer 12

1906 required medications to report their ingredients

response to the jungle

Question 13

Describe the therapeutics trail committee

Answer 13

created by the medical research council of great britain in 1931

considered applications by companies for trials of new products

Question 14

Describe the Tuskegee Syphilis Study

Answer 14

United States
399 African men with syphilis
Given daily treatments
a lot of deaths and infection of wives and children, led to the Belmont report in 1972
Participants and families were rewarded money for the sketchiness of the study

Question 15

Describe the Nazi medical experiment

Answer 15

1933
victims included the mentally ill, physically impaired, Jews, Poles, Russians, and Gypsies

experiments included hypothermia, heating, genetics

Question 16

Describe the Nuremberg code

Answer 16

1947
16 doctors found guilty of war crimes and crimes against humanity
7 doctors executed

Question 17

What are the 10 basic points of the nuremberg code

Answer 17

1. voluntary consent
2. possibility of important results
3. justifiably based on knowledge
4. avoid unnecessary suffering
5. can’t do it if you think the pt’s will die
6. more benefit than risk
7. protect the patients from death
8. conducted by qualified people
9. right for patient to withdraw
10. doctor must discontinue trial if new info shows harm

Question 18

Describe the willow brook study

Answer 18

1963; mentally ill children were injected or orally exposed to hepatitis
Parents GAVE consent

Doctors wanted to learn about the natural history of hepatitis

Question 19

Describe the Jewish Chronic Disease Hospital Study

Answer 19

1963
injection of liver cancer cells into patients with chronic diseases

how quickly can they reject the cancer cells ?

Question 20

Describe the declaration of Helsinki

Answer 20

1964; developed by the world medical association, outlines the Ethical Principles of Medical research

Question 21

What are the basic principles of the declaration of helsinki?

Answer 21

1. Doctor protects patient
2. Research needs to be reviewed
3. Benefit > Risk
4. Patients must volunteer
5. Assent if minors

Question 22

What led to the creation of the belmont report?

Answer 22

The tuskegee syphilis study and the National Research act of 1974

Question 23

Define the Belmont report

Answer 23

1979
Created by the national Commission for the protection of human Subjects of biomedical and Behavioral Research

told what the IRB needs to review 
Set of ethical guidelines; 
3 principles 
1. respect for persons 
2. beneficence
3. Justice

Question 24

Define Respect for persons

Answer 24

autonomy for individuals

Question 25

Define beneficence

Answer 25

Do no harm

Maximize the benefits and minimize the risks

Question 26

Define justice

Answer 26

benefits and risks must be equally distributed

Question 27

What is the function of the Office of Research Integrity? ORI?

Answer 27

prevent research misconduct

Question 28

Describe the safe medical devices act

Answer 28

required manufacturers of devices to create a method of tracking

Question 29

Describe HIPAA

Answer 29

Health Insurance Portability and Accountability Act

make insurance portable
patient information is private and secure
reduce health care fraud

Question 30

Describe the IRB

Answer 30

reviews and monitors biomedical research involving humans
under FDA
review informed consent
risks to the individual should be outweighed by the benefit of society

Question 31

What would “count” as human research?

Answer 31

bodily materials
diagnostic specimen
private information

Question 32

If there is a study that is using tissue samples that were collected for different reasons and the researchers are not able to identify the subjects, is this a human subject study?

Answer 32

Nah

Question 33

What are the 3 levels of IRB review; briefly describe

Answer 33

Full board- more than min risk for the subjects
Expedited- not greater than min risk
Exempt-less than min risk, there is no identifying