45 Code of Federal Regulations 46​

Question 1

45 Code of Federal Regulations Part 46​

Answer 1

Basic HHS Policy for Protection of Human Research Subjects​

​AKA: Public Welfare or Part 46. This policy applies to all research involving human subjects​

It also applies to Federal civilian employees or military personnel​

Inside and Outside the United States​

If a department or agency head determines that the procedures prescribed by the institution afford protections that are at least equivalent, they may approve the foreign procedures in lieu of this policy​

• Consistent with ethical principles of the Belmont Report.

Question 2

3 Major Ethical Principles and Guidelines for Research Involving Human Subjects:

Answer 2

Respect for persons ​

Beneficence ​

Justice

Question 3

The Belmont Report

Answer 3

Created in 1979 to assure that research involving human subjects would be carried out in an ethical manner ​

Ethical principles and guidelines to protect human subjects ​

Created by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research

*Respect for persons ​

*Beneficence ​

*Justice

Question 4

Certification:

Answer 4

notification by the institution to the supporting Federal department or agency component, that a research project or activity involving human subjects has been reviewed and approved by an IRB.

Question 5

45 CFR 46 states that all research involving human subjects conducted, supported, or otherwise subject to regulation by any Federal department or agency includes research conducted by Federal civilian employees or military personnel. It also includes research conducted, supported, or otherwise subject to regulation by the Federal Government only inside the United States.

Answer 5

FALSE​

​

It applies to the Federal Employees OUTSIDE the U.S. as well.

Question 6

Notification by the institution to the supporting Federal department or agency component, that a research project or activity involving human subjects has been reviewed and approved by an IRB is called what?

Answer 6

Certification: notification by the institution to the supporting Federal department or agency component, that a research project or activity involving human subjects has been reviewed and approved by an IRB.

Question 7

Which is deemed NOT to be research?
A. Scholarly or Journalistic Activities that focuses directly on the specific individuals about whom the information is collected​

B. Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority​

C. Collection and analysis of information, biospecimens, or records by or for a criminal justice agency​

D. Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions

Answer 7

ALL

Question 8

What is the minimum number of IRB members required to participate in research approval?​
A) 4​

B) 5​

​C) 6​

D) No minimum

Answer 8

b) Five​

​
Each IRB shall have at least five members, with varying backgrounds. The IRB shall be sufficiently qualified (professional competence), and member diversity with sensitivity to such issues as community attitudes, to promote respect the rights and welfare of human subjects.