Bittel Bioethics of Human Subjects research Flashcards
Define bioethics
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
Define Institutional Review Board (IRB)
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
Define research misconduct
a fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results
Define serious adverse event
any experience that suggests a significant hazard, contraindication, side effect, or precautions that develops during a clinical trial
Define informed consent
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
Define autonomy
capacity of an individual to make an informed uncorked decision
Define clinical trial
the systematic investigation of the side effects of materials or methods on a disease state conducted according to a formal study plan
Define good clinical practice
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
Who was James Lind?
1747 The FIRST clinical trial in the navy; scurvy
Who was Dr. John Haygarth?
Tractor dude, first guy to recognize the placebo effect in 1799
Describe the Biologics Control Act
1902
Regulated the production of vaccines and anti-toxins
Describe the Pure Food and Drug act
1906 required medications to report their ingredients
response to the jungle
Describe the therapeutics trail committee
created by the medical research council of great britain in 1931
considered applications by companies for trials of new products
Describe the Tuskegee Syphilis Study
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
Describe the Nazi medical experiment
1933
victims included the mentally ill, physically impaired, Jews, Poles, Russians, and Gypsies
experiments included hypothermia, heating, genetics
Describe the Nuremberg code
1947
16 doctors found guilty of war crimes and crimes against humanity
7 doctors executed
What are the 10 basic points of the nuremberg code
- voluntary consent
- possibility of important results
- justifiably based on knowledge
- avoid unnecessary suffering
- can’t do it if you think the pt’s will die
- more benefit than risk
- protect the patients from death
- conducted by qualified people
- right for patient to withdraw
- doctor must discontinue trial if new info shows harm
Describe the willow brook study
1963; mentally ill children were injected or orally exposed to hepatitis
Parents GAVE consent
Doctors wanted to learn about the natural history of hepatitis
Describe the Jewish Chronic Disease Hospital Study
1963
injection of liver cancer cells into patients with chronic diseases
how quickly can they reject the cancer cells ?
Describe the declaration of Helsinki
1964; developed by the world medical association, outlines the Ethical Principles of Medical research
What are the basic principles of the declaration of helsinki?
- Doctor protects patient
- Research needs to be reviewed
- Benefit > Risk
- Patients must volunteer
- Assent if minors
What led to the creation of the belmont report?
The tuskegee syphilis study and the National Research act of 1974
Define the Belmont report
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
Define Respect for persons
autonomy for individuals
Define beneficence
Do no harm
Maximize the benefits and minimize the risks
Define justice
benefits and risks must be equally distributed
What is the function of the Office of Research Integrity? ORI?
prevent research misconduct
Describe the safe medical devices act
required manufacturers of devices to create a method of tracking
Describe HIPAA
Health Insurance Portability and Accountability Act
make insurance portable
patient information is private and secure
reduce health care fraud
Describe the IRB
reviews and monitors biomedical research involving humans
under FDA
review informed consent
risks to the individual should be outweighed by the benefit of society
What would “count” as human research?
bodily materials
diagnostic specimen
private information
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?
Nah
What are the 3 levels of IRB review; briefly describe
Full board- more than min risk for the subjects
Expedited- not greater than min risk
Exempt-less than min risk, there is no identifying
