Historical Background

Question 1

What does IRB stand for?

Answer 1

Institutional Review Board

Question 2

True or False: IRBs are primarily concerned with the welfare of human subjects in research.

Answer 2

True

Question 3

In what year was the Belmont Report published?

Answer 3

1979

Question 4

What are the three primary ethical principles outlined in the Belmont Report?

Answer 4

Respect for persons, beneficence, and justice

Question 5

Multiple Choice: Which legislation led to the establishment of IRBs in the United States? A) National Research Act B) Belmont Report C) Common Rule

Answer 5

A) National Research Act

Question 6

Fill in the blank: The __________ established the requirement for IRB review of research involving human subjects.

Answer 6

National Research Act

Question 7

What is the primary role of an IRB?

Answer 7

To review research protocols for ethical considerations

Question 8

True or False: IRBs can only be found in the United States.

Answer 8

False

Question 9

What federal agency is responsible for overseeing IRBs in the United States?

Answer 9

Office for Human Research Protections (OHRP)

Question 10

Short Answer: Name one historical event that prompted the establishment of IRBs.

Answer 10

The Tuskegee Syphilis Study

Question 11

Multiple Choice: Which of the following is NOT a function of an IRB? A) Approving research B) Monitoring ongoing research C) Conducting the research themselves

Answer 11

C) Conducting the research themselves

Question 12

Fill in the blank: The __________ was a landmark report that highlighted ethical issues in human subjects research.

Answer 12

Belmont Report

Question 13

What is the Common Rule?

Answer 13

A federal policy regarding human subjects research

Question 14

True or False: IRBs must include at least one member who is not affiliated with the institution.

Answer 14

True

Question 15

Short Answer: What is informed consent?

Answer 15

A process to ensure that research participants understand the study and its risks.

Question 16

Multiple Choice: What type of research does an IRB review? A) Only medical research B) Only social science research C) All research involving human subjects

Answer 16

C) All research involving human subjects

Question 17

Fill in the blank: The __________ sets the ethical standards for research involving human subjects.

Answer 17

Belmont Report

Question 18

What is the role of the IRB chair?

Answer 18

To lead the review process and ensure compliance with regulations

Question 19

True or False: IRBs can disapprove research studies if they do not meet ethical standards.

Answer 19

True

Question 20

Short Answer: What is the purpose of a risk-benefit analysis in IRB review?

Answer 20

To assess whether the potential benefits of research outweigh the risks to participants.

Question 21

Multiple Choice: In what decade did the U.S. government begin to require IRB review for federally funded research? A) 1960s B) 1970s C) 1980s

Answer 21

B) 1970s

Question 22

Fill in the blank: The __________ Act was enacted in response to ethical violations in research.

Answer 22

National Research Act

Question 23

What is the definition of ‘vulnerable populations’ in research ethics?

Answer 23

Groups that may be at increased risk of coercion or undue influence

Question 24

True or False: IRB review is optional for private research institutions.

Answer 24

False

Question 25

Short Answer: Name one type of research that may require additional protections from an IRB.

Answer 25

Research involving children or prisoners