Exam II Lecture 14 and 15 IRB, Case Studies, Responsibilities

Question 1

What are the main federal guidelines governing human subjects research?

Answer 1

.

Question 2

Which three things immediately require oversight by a committee?

Answer 2

Biohazard
Recombinant DNA
Radiation
Controlled substance

Question 3

What are the main components of the informed consent process?

Answer 3

Legal capacity to give consent

Exercise free power of choice

Sufficient knowledge and comprehension of the study.

Question 4

Which three things immediately require oversight by a committee?

Answer 4

Biohazard
Recombinant DNA
Radiation
Controlled substance

Question 5

What did the belmont report establish?

Answer 5

Respect for persons (informed consent and additional protections)

Beneficence: Maximize benefits while minimizing risks

Justice: Fair distribution of risks and benefits of research.

Question 6

What did the belmont report establish?

Answer 6

Respect for persons (informed consentand additional protections)

Beneficence: Maximize benefits while minimizing risks

Justice: Fair distribution of risks and benefits of research.

Question 7

Risk involves which two dimensions?

Answer 7

Magnitude of harm (severity and duration)

Probability of harm

Question 8

Does a true case report require an IRB?

Answer 8

No, the IRB will not review a case report because it does not meet the definition of research.