45 Code of Federal Regulations 46 Flashcards
45 Code of Federal Regulations Part 46
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.
3 Major Ethical Principles and Guidelines for Research Involving Human Subjects:
Respect for persons
Beneficence
Justice
The Belmont Report
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
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.
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.
FALSE
It applies to the Federal Employees OUTSIDE the U.S. as well.
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?
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.
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
ALL
What is the minimum number of IRB members required to participate in research approval?
A) 4
B) 5
C) 6
D) No minimum
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.
Is collection and analysis of biospecimens, or records by or for a criminal justice agency considered research?
No. There is an ethical conflict as well as barriers to approved research design.
The registration information for an IRB must be updated within X days after changes occur regarding the contact person who provided the IRB registration information or the IRB chairperson.
90 days
We know that the IRB may waive informed consent in certain circumstances.
Can they waive an informed consent if the risk to the subject presents no more than minimal risk of harm to subjects?
Yes
Even if research doesn’t use human test subjects do they still need IRB approval?
No.
For Federal Studies ONLY the IRB can approve or reject a research application
True or false?
False.
On the basis of evaluation, the department or agency head may approve or disapprove the application or proposal in or outside us
If the research holds out the prospect of direct benefit solely to the fetus then the consent of the pregnant woman soley is obtained in accord with the informed consent provisions.
True or False
False.
If the research holds out the prospect of direct benefit solely to the fetus then the consent of the pregnant woman and the father is obtained in accord with the informed consent provisions
Which condition is incorrect?
Nonviable neonates. After delivery nonviable neonate may not be involved in research covered by this subpart unless all of the following additional conditions are met:
(1) Vital functions of the neonate must be artificially maintained
(2) The research will not terminate the heartbeat or respiration of the neonate
(3) There will be no added risk to the neonate resulting from the research
(4) The purpose of the research is the development of important biomedical knowledge that cannot be obtained by other means
(5) The legally effective informed consent of both parents of the neonate is obtained
Nonviable neonates. After delivery nonviable neonate may not be involved in research covered by this subpart unless all of the following additional conditions are met:
(1) Vital functions of the neonate will not be artificially maintained
