What studies require IRB approval?

FDA regulations generally require IRB review and approval of research involving FDA-regulated products (e.g., investigational drugs, biological products, medical devices and dietary supplements) (21 CFR Part 56).

Which of the following studies would need IRB approval Citi quizlet?

Which of the following studies would need IRB approval? Studies collecting identifiable information about living individuals.

Which type of IRB review does not require an IRB approval but?

“Exempt” human subjects research is a sub-set of research involving human subjects that does not require comprehensive IRB review and approval because the only research activity involving the human subjects falls into one or more specific exemption categories as defined by the Common Rule.

What is the IRB charged with Select all that apply?

The IRB is charged with the responsibility of reviewing, prior to its initiation, all research (whether funded or not) involving human participants. The IRB is concerned with protecting the welfare, rights, and privacy of human subjects.

What is the IRB charged with quizlet?

The IRB is charged with reviewing all projects involving human subjects for compliance with institutional policies and state, local, and federal laws, as well as the ethical principles contained in the Belmont Report (that is, respect for persons, beneficence, and justice).

Which of the following is something an IRB should do with respect to review of GSD research?

Which of the following is something an IRB should do with respect to review of GSD research? Seek consultants with expertise in specific segments of GSD communities to provide information on research in those communities. What can “gender expression” tell you about a particular subject?

What are some factors that would require the proposed research to be approved by an IRB prior to any data being collected?

Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individual(s) about whom the information is collected.

Why do research proposals need to be reviewed by an IRB?

The IRB reviews the proposals before a project is submitted to a funding agency to determine if the research project follows the ethical principles and federal regulations for the protection of human subjects. The IRB has the authority to approve, disapprove or require modifications of these projects.