UNDER 21 CFR 56.108
"IRB functions and operations"

• Requires written procedures for "prompt" reporting of "any unanticipated problems involving risks to subjects or others"
• Described reporting is to: "the IRB, appropriate institutional officials, and the Food and Drug Administration"

ACTUAL TEXT:

21 CFR 56.108 IRB functions and operations. In order to fulfill the requirements of these regulations, each IRB shall:
(a) Follow written procedures:

1. For conducting its initial and continuing review of research and for reporting its findings and actions to the investigator and the institution;
2. For determining which projects 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;
3. For ensuring prompt reporting to the IRB of changes in research activity; and
4. 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 human subjects.
   

(b) Follow written procedures for ensuring prompt reporting to the IRB, appropriate institutional officials, and the Food and Drug Administration of:

1. Any unanticipated problems involving risks to human subjects or others;
2. Any instance of serious or continuing noncompliance with these regulations or the requirements or determinations of the IRB; or
3. Any suspension or termination of IRB approval.
   

UNDER 45 CFR 46.103
"Assuring Compliance"

• Requires written procedures for "prompt" reporting of "any unanticipated problems involving risks to subjects or others"
• Described reporting is to: "the IRB, appropriate institutional officials, and the Department or Agency head"
• The reporting obligation is institutional

ACTUAL TEXT:

45 CFR 46.103(b): Assurances applicable to federally supported or conducted research shall at a minimum include:

(4) Written procedures which the IRB will follow (i) for conducting its initial and continuing review of research and for reporting its findings and actions to the investigator and the institution; (ii) for determining which projects require review more often than annually and which projects need verification from sources other than the investigators that no material changes have occurred since previous IRB review; and (iii) for ensuring prompt reporting to the IRB of proposed changes in a research activity, and for ensuring that such 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 when necessary to eliminate apparent immediate hazards to the subject.

(5) Written procedures for ensuring prompt reporting to the IRB, appropriate institutional officials, and the Department or Agency head of (i) any unanticipated problems involving risks to subjects or others or any serious or continuing noncompliance with this policy or the requirements or determinations of the IRB; and (ii) any suspension or termination of IRB approval.