Ch 2 Ledford

Question 1

The Public Health Services Act (1993)

Answer 1

sponsoring institutions must ensure the rights of research participants are protected

Question 2

Well designed applied research studies allow for

Answer 2

A) study of behaviors in the typical environments
B) evaluation of a new intervention or innovation
C) replication of findings from other studies under similar and novel conditions

Question 3

Institutional Review Board (IRB)

Answer 3

committees responsible for reviewing proposed research studies

Question 4

The National Research Act led to

Answer 4

the development for the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in 1974

Question 5

Belmont Report

Answer 5

provides guidelines to improve the protection of human participants in research studies:
- respect for the persons
- beneficence
- justice

Question 6

respect for persons

Answer 6

highlights the importance of voluntary involvement in research and explaining the purpose of a study and corresponding procedures as well as the protection of vulnerable populations

Question 7

beneficence

Answer 7

focuses on the rules of “do no harm” and “maximize possible benefits and minimize possible harms”

Question 8

justice

Answer 8

highlights the importance of fairness, especially the recruitment of participants and treatment of those from vulnerable or underrepresented populations

Question 9

Federal Policy for the Protection of Human Subjects

Answer 9

• aka Common Rule
• published in 1991
• further specified the application of the principles of the Belmont Report in applied research

Question 10

minimal risk

Answer 10

the same risk that a person would encounter in daily life or while performing routine physical or psychological examinations

Question 11

human subjects reviews

Answer 11

• requires an abbreviated version of the written thesis research proposal
• focuses on 2 questions:
  1) What will happen to the participants?
  2) What will happen to the data?

Question 12

to minimize the potential of loss of confidentiality, you should

Answer 12

A) describe how participants will be coded
B) verify that the researcher will be the sole holder of the code
C) state where the code will be stored

Question 13

critical elements of informed consent

Answer 13

• procedures must be described fully, including purpose and expected duration
• potential risks and benefits should be discussed
• consent can be revoked at any time and participants are free to withdraw from participation
• consent form and description of the study must be communicated in simple (8th grade) language
• info on who to contact with questions during the study should be shared