Submissions for a Determination

The IRB not only reviews and approves human subjects research subject to the federal regulations, it also review several other types of applications for activities that do not require IRB approval. While not approving these activities, the IRB does acknowledge that they agree with the investigator's determination that the research does not require IRB review and approval.

Not Human Subjects ResearchMany activities that take place at CHOP and similar institutions is not research or if it is research, does not meet the definition of human subjects research.

HIPAA Attestations HIPAA permits the use of personal health information without requiring an authorization for Work Preparatory to Research and for research limited to the use of Decedents. Investigators must submit an attestation to the IRB prior to beginning either type of work.

Exempt Research Human subjects research in several categories, that has minimal risk is exempt from the research regulations. At CHOP, the IRB is required to review applications for Exempt research and to make a determination that it agrees (or not) with the investigator's own determination.

Summary:

The IRB is frequently consulted regarding studies that do not meet the definition of research or research that isn't human subjects research . At CHOP, there is no obligation to consult the IRB regarding this category of research. This page discuss activities that are not research and research that isn't human subjects research.

Summary:

HIPAA permits investigators to use Personal Health Information (PHI) for two activities without IRB review or approval. The investigator must submit an attestation to the IRB prior to embarking on the work. After submitting the attestation, the investigator may proceed with their work. The HIPAA regulation does not specify what the IRB is to do with the attestations. At CHOP, the IRB screens the submissions to ensure that they meet the requirements of HIPAA and acknowledges receipt.

Summary:

Some minimal risk human subjects research is exempt from the regulations at 45 CFR 46. When research is exempt, that means that the federal regulations do not apply. The research is still considered human subjects research but the IRB does not provide oversight. The CHOP Office of Research Compliance may still review exempt studies.

Top