Question

For research that does not entail a demonstration project conducted by or subject to the approval of state or local government officials, an IRB may waive or alter the regulatory elements of informed consent if it finds and documents a number of items, including: The research could be carried:

Answer 1

Answer:

An institutional review board (IRB), also known as an independent ethics committee (IEC), ethical review board (ERB), or research ethics board (REB), is a type of committee that applies research ethics by reviewing the methods proposed for research to ensure that they are ethical.

Explanation:

• Conducting initial and continuing review of research;
• Reporting findings and actions to the investigator and the institution;
• Determining which projects require review more often than annually;
• Determining which projects need verification from sources other than the investigator that no material changes have occurred since previous IRB review;
• Ensuring prompt reporting to the IRB of proposed changes in a research activity, and ensuring that changes in approved research, during the period for which IRB approval has already been given, may not be initiated without IRB review and approval except where necessary to eliminate apparent immediate hazards to the human subjects;
• Ensuring prompt reporting to the IRB, appropriate institutional officials, any department or agency head and OHRP for research conducted or supported by HHS, and the FDA for FDA-regulated research of:
• Any unanticipated problems involving risks to human subjects or others;
• Any instance of serious or continuing noncompliance with the applicable HHS and FDA regulations or the requirements or determinations of the IRB; Any suspension or termination of IRB approval.

HHS and FDA regulations do not provide additional detail on the content of IRB written procedures, which gives IRBs the flexibility to establish procedures best suited to their own operations.