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FDA update – February 23, 2011

IRB receives warning letter

The FDA has issued a warning letter to a Californian IRB Napoli LLC, collocated with West Coast IVF Clinic on January 21st 2011.

The Two Reasons behind this warning letter are as follows:

  1. Failure to have at least five members
  2. A lack of written procedures i.e. failure to have adequate written procedures governing the functions and operations of the IRB.

According to 21 CFR part 56- IRB, an IRB must be composed of at least 5 members. There must be at least one IRB member whose primary concerns are in nonscientific areas. No IRB may have a member participate in the IRB’s initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB. 

An IRB must prepare, maintain, and follow written procedures that describe the IRB's functions and operations. The IRB has no written procedures for the following:

  • A procedure for ensuring that the IRB reviews proposed research at convened meetings at which a majority of the members are present, including at least one member whose primary concerns are in nonscientific areas. 
  • A procedure for reporting all IRB findings and actions to the investigator and the institution.
  • A procedure for determining which studies require review more often than annually and which projects need verification from sources other than the investigator that no material changes have occurred since previous IRB review.
  • A procedure for 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 subjects.
  • A procedure for ensuring prompt reporting to the Food and Drug Administration of any unanticipated problems involving risks to human subjects or others, and any instance of serious or continuing noncompliance with regulations or the requirements or determinations of the IRB.
  • A procedure for ensuring prompt reporting to the IRB, appropriate institutional officials, and the FDA of any instance of serious or continuing noncompliance with the regulations or the requirements or determination of the IRB.
  • A procedure for ensuring prompt reporting to the IRB, appropriate institutional officials, and the FDA of any suspension or termination of IRB approval.

These are serious issues that all IRBs need to understand and know to avoid problems.

For more information on this issue and IRB rules you can contact mdi at the following link: info@mdiconsultants.com