This page briefly describes the initial submission types in the CHOP electronic IRB submission system (eIRB) and provides links to additional information to help investigators decide which type of submission is right for their project.
Research Study Involving Human Subjects (Exempt, Expedited, Full Board Review) oversight by CHOP IRB
Select this option for all studies involving human subjects research that will be submitted for Exempt, Expedited or Full Board review. For guidance on which review pathway the project may qualify, see the webpages on Exempt Research, Expedited Review, and Full Board Review.
Clinical Investigation involving a single human subject (e.g. emergency IND or IDE); CHOP IRB has time to review
Select this option for studies that involve a single subject (such as an emergency IND or IDE) that CHOP will have time to review. For guidance, see the webpage on Emergency Use and Single Subject INDs.
Research Study involving CHOP reliance on an outside reviewing IRB
Select this option for all studies where another IRB will serve as the IRB of record for CHOP (i.e. studies where a cooperative agreement or an authorization agreement will be used) or for Oncology studies where the NCI PCIRB will be the IRB of record. Do not choose this if you are doing a multi-center study where the CHOP IRB will have oversight of CHOP. An Outside IRB of Record means that one IRB agrees to review the study in place of another IRB to avoid duplication of effort. This is not for studies where both IRBs will maintain local oversight. Further guidance is available on the webpage describing Multicenter Research/Single IRB.
Emergency Use of Investigational Agent (CHOP IRB does/did not have time to review)
This option serves two purposes:
- The emergency use has already occurred (choose the first option: 5 day follow-up report after use of test article): If an investigational agent (drug, biologic, device) was used in an emergency situation, the submission allows an investigator to comply with the FDA's requirement to notify the IRB within 5 days after use of test article. The investigator will receive an acknowledgement letter within the eIRB system.
- The emergency use has not yet occurred (choose the second option: Initial report prior to use of test article): If required by the manufacturer providing the agent for emergency use, a submission will provide an official IRB correspondence prior to emergency use. The investigator will receive an acknowledgement letter within the eIRB system.
'Emergency' means the use of an unapproved test article (drug, biologic or device) with a human subject in a life-threatening situation in which no standard acceptable treatment is available. In addition to being an emergency there must be insufficient time to obtain IRB approval. If time permits, the investigator needs to contact the IRB chair or vice-chair (e.g. via email) prior to us to determine whether the IRB has sufficient time to review.
An investigator may use an unapproved test article once without prospective IRB review, provided that the use qualifies as emergency use. Any subsequent use of the unapproved test article at CHOP must have prospective review and approval by the IRB unless requiring such prospective review would inappropriately deny emergency treatment to a second individual. For further guidance, see the webpage on Emergency Use.
Request for Determination of the Need for IRB Review
Choose this option for situations where investigators are uncertain whether or not the proposed activities constitute human subjects research. A determination may also be obtained to satisfy a granting agency or to obtain documentation for study files. This is not the right option if the research is sponsored by the NIH and the CHOP PI is the overall PI on the grant, or a sponsor requires an IRB approved protocol. In those cases, submission of a 'Research Study Involving Human Subjects (Exempt, Expedited, Full Board Review) oversight by CHOP IRB' is likely required.
Research is defined as "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge."
Human subject means a living individual about whom an investigator conducting research obtains (1) Data through intervention or interaction with the individual, or (2) Identifiable private information. For further guidance, see the webpages on What needs to be reviewed by the IRB and Sharing-Data-and-Biospecimens for information about coded and de-identified datasets. If determined to not be human subjects research, the investigator will receive a determination letter within the eIRB system.
Choose this option before starting work preparatory to research or research with decedents data or specimens. 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 IRB will review the attestations for completeness and to ensure that they comply with the requirements of HIPAA. The investigator will receive an acknowledgement letter within the eIRB system. For further guidance, see the webpage on HIPAA Attestations.
Administrative review by the IRB is required for certain types of grants, cooperative agreements, and contracts that (1) have been submitted with the knowledge that human subjects may be involved within the support period, but definite plans were not included in the application/proposal (45 CFR 46.118) or (2) involve research undertaken without the intention of involving human subjects but it is later proposed to involve human subjects (45 CFR 46.119), or (3) support more than one human subjects research protocol. The investigator will receive an acknowledgement letter within the eIRB system.