Applicable Regulation or Guidance
The FDA and the HHS have regulations that contain provisions for data monitoring and auditing of protocols involving human subjects.
Provisions for Data Monitoring
Federal regulations give the IRB responsibility for ensuring that research protocols include an ongoing monitoring program to protect research subjects. Specifically, HHS regulation 45 CFR 46.111(a)(6) and FDA regulation 21 CFR 56.111(a)(6) state that IRBs must approve research only when “the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.”
Audit Systems
HHS regulation 45 CFR 46.109(e) and FDA regulation 21 CFR 56.109(f) state: “An IRB shall conduct continuing review of research covered by this policy at intervals appropriate to the degree of risk, but not less than once per year, and shall have authority to observe or have a third party observe the consent process and the research.” Institutions that hold an approved OHRP federalwide assurance are required to ensure that they have procedures that “include formal mechanisms for monitoring compliance with human subject protection requirements.”
The following links provide access to the specific federal regulations:
- The Common Rule 45 CFR 46.111(a)(6) and FDA 21 CFR 56.111(a)(6) (Criteria for IRB Approval of Research)
- The Common Rule 45 CFR 46.109(e) and FDA 21 CFR 56.109(f) (IRB Review of Research)
The following links provide additional interpretive guidance from the FDA and the DHHS: