Bioethics of Human Subjects Research

Question 1

What is bioethics?

Answer 1

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

Question 2

What is the institutional review board (IRB)?

Answer 2

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

Question 3

What is research misconduct?

Answer 3

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

Question 4

What is serious adverse event (SAE):

Answer 4

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

Question 5

What is informed consent?

Answer 5

consent to participate in a medical experiment by a subject after achieving an understanding of what is involved. It is essential that participants understand that participating in a research study is completely voluntary; they can withdraw from the study at any time or choose not to participate without it having any impact on their clinical care

Question 6

What is autonomy?

Answer 6

the capacity of an individual to make an informed uncoerced decision

Question 7

What is a clinical trial?

Answer 7

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

Question 8

What is 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

Describe the work of Dr. James Lind

Answer 9

1747: published one of the first widely known clinical trials to help treat scurvy. Citrus fruit helped cure it

Question 10

Describe the work of Dr. John Haygarth

Answer 10

1799: One of the first demonstrators of the placebo effect

Question 11

What is the biological control act?

Answer 11

1902: regulated the production of vaccines and antitoxins. Came from in 1901 when 13 children died in St Louis from diphtheria antitoxin that was contaminated with tetanus spores

Question 12

What is the pure food and drug act?

Answer 12

1906: required medications to report their ingredients, in response to The Jungle, banned selling of impure food

Question 13

What is the therapeutics trials committee?

Answer 13

considered applications by companies for trials of new products

Question 14

What is the Tuskegee syphilis study?

Answer 14

Researchers told 399 African American men with syphilis that they would treat them for “bad blood” but ended up not ever treating them for the disease

Question 15

What is the nuremberg code?

Answer 15

Nuremburg Military tribunal’s decision about the Nazi medical experiments
16 doctors found guilty of war crimes and crimes against humanity
7 doctors executed

Question 16

What is the nuremberg code 10 points?

Answer 16

1. Consent must be voluntary
2. possibility of important results; with no other means to get information
3. trial must be justifiably based on past knowledge
4. avoid all unnecessary physical and mental suffering
5. no trial can be conducted where reason to believe that death or disabling injury will occur
6. trial must be of more benefit than risk
7. provisions must be made to protect patients from injury or death
8. trial conducted by scientifically qualified persons
9. right to patient to withdraw from study
10. doctor must discontinue trial if new information suggests probable cause that trial could result in injury, disability or death

Question 17

Describe the Willowbrook study

Answer 17

Doctors infected mentally ill children with hepatitis to see how it works in 1963. Parents gave consent for the study because if they didn’t, their children would not be treated by the hospital

Question 18

Describe the Jewish Chronic Disease Hospital Study

Answer 18

1963; injection of live cancer cells into patients with various chronic illnesses, doctors did not tell parents that they were injecting cancer cells

Question 19

What is the declaration of Helsinki?

Answer 19

1964: developed by the World Medical Association
outlines the ethical principles of medical research
Basic principles: doctors duty to protect the life, health, privacy and dignity of patient, research much be reviewed by independent committee, Benefit > risk, patients must volunteer, assent much be obtained from minors if capable

Question 20

What is the national research act?

Answer 20

1974; created the national commission for the protection of human subjects of biomedical and behavioral research
group was formed to write basic ethical principles for research

led to creation of Belmont report

Question 21

What does the National Commission for the protection fo human subjects of biomedical and behavioral research do?

Answer 21

publish on children, established rationale for pediatric research (1977)

Question 22

What is the Belmont report?

Answer 22

ethical principles and guidelines for the protection of human subjects

Question 23

What are the three fundamental principles of the Belmont report?

Answer 23

respect for persons
beneficence
justice

Question 24

Describe respect for persons

Answer 24

autonomy of individuals

persons with diminished autonomy are entitled to protection

Question 25

Describe beneficence

Answer 25

do no harm | maximize the benefit and minimize the risks

Question 26

Describe justice

Answer 26

benefits and risks must be distributed equally

Question 27

Describe clinical practice?

Answer 27

interventions designed solely to enhance the well being of the individual and that have a reasonable expectation of success

Question 28

Describe research

Answer 28

activity designed to test a hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalized knowledge

Question 29

The national institute of health (NIH) craned the ______ to develop policies, procedures, and regulations to detect, investigate and prevent ________

Answer 29

office of research integrity (ORI), research misconduct

Question 30

What are the goals of HIPAA?

Answer 30

make health insurance portable anywhere in the country make patient information private and secure reduce health care fraud and abuse

Question 31

What does the privacy rule require providers to comply with?

Answer 31

- develop notices informing patients of their privacy rights and provider practices regarding PHI - prepare authorization forms for release of PHI - implement policies and procedures to protect patient medical records - train office and clinical staff in privacy rule standards and their institution's privacy practices

Question 32

How does the IRB describe human subjects?

Answer 32

living persons about whom an investigator obtains specimens or data through direct interaction or intervention or through identifiable, private information.

Question 33

What is individually identifiable?

Answer 33

describes private information regarding the identity of human subjects that an investigator may ascertain directly or through a coding system. If identity is knowable, the study is considered to be human subjects of research

Question 34

What does the IRB do?

Answer 34

formally review and monitors biomedical research involving humans under oversight of the FDA

Question 35

The NIH will consider your research to involve human subjects unless it meets both of the following conditions:

Answer 35

- you are not collecting samples by interacting or intervening with living people, TISSUES COLLECTED FOR OTHER REASONS - none of the investigators or collaborators listed in the application can identify the subjects through coded private information or specimens

Question 36

What is a investigator initiated clinical trial?

Answer 36

a trial run by a clinical sponsor (institution, investigator, collaboration) but without a company take the role as a sponsor

Question 37

What is the Havasupai genetic study?

Answer 37

blood was collected from the Havasupai tribe to determine why there was such high cases of type II diabetes Researches then ended up using blood for other studies without the tribes permission