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Initial Submission Types
Published on Jun 14, 2022 · Last Updated 1 month 2 weeks ago
Learn more about the initial submission types in the CHOP electronic IRB submission system (eIRB) and how investigators can decide which type of submission is right for their project.
Research Study Involving Human Subjects (Exempt, Expedited, Full Board Review) oversight by CHOP IRB
For all studies involving human subjects research that will be submitted for 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
For studies that involve a single subject (such as an emergency IND or IDE) that CHOP will have time to review.
Research Study involving CHOP reliance on an outside reviewing IRB
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. Learn more about 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. Learn more about 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 information about coded and de-identified datasets, review. what needs to be reviewed by the IRB and sharing data and biospecimens. If determined to not be human subjects research, the investigator will receive a determination letter within the eIRB system.
HIPAA Attestations
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. Learn more about HIPAA Attestations.
Grant/Contract Only
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.
The IRB submission consists of the electronic application, and as applicable, a protocol, consent form(s), recruitment materials, and other relevant documents. The IRB makes determinations based on the information provided. If information is lacking, the IRB cannot make a determination or grant approval. Required review and approval from ancillary committees (e.g. COI, Pharmacy, IBC, Contracting/Budgeting, etc.) will be sought concurrently.
The table below outlines the materials that the IRB may need in order to review a study. The complete listing of the required materials for submission can be found in 301: Research Submission Requirements and 402: Criteria for Initial IRB Approval. The guidelines below, apply to most research. However, each research study is unique and additional documents may be required in certain situations. For some submissions, a protocol may not be required. The IRB reserves the right to request additional information if needed to conduct a complete review.
| Required for Submission | Details and Description |
|---|---|
| Protocol |
The protocol is the most important component of an IRB submission. It describes the science behind the study, the detailed plan for executing the study and discusses the research ethics issues related to human subject participants. The IRB provides four protocol templates that can be adapted to meet the needs of virtually any study. The protocol templates should serve as a starting point; they are intended to be adapted to meet the requirements of the study design and not to be followed to the letter.
|
| Consent Documents |
The content of consent documents is specified in the research regulations (DHHS and the FDA) and in the HIPAA Privacy Rule. For more information see the following pages: |
| Investigational Agent Information |
The Investigators' Brochure is required for all investigational drugs and biologics. If the drug is marketed, the Package Insert may be substituted. Sponsor-supplied information sheets for investigational devices or the devices instructions (for approved devices) are required. |
| Scientific Review |
Scientific review and approval performed by an approved Scientific Review Committee (SRC) is required for all prospective studies that have not been through an external review process (e.g., NIH, AHA, industry sponsor, etc.) prior to IRB submission. The SRC review form and the investigator's responses to any issues raised by the SRC, must be attached to the eIRB application. See Scientific Review for more detailed information. |
| Financial Disclosure Statements |
To satisfy CHOP Research Institute Policies, every member of the CHOP research team who is listed in eIRB must complete a study-specific financial disclosure statement via the eResearch eCOI portal. More information about Conflict of Interest Reporting is available on the CHOP website. The disclosure has a dual purpose; it allows the CHOP Conflict of Interest Committee to have a consistent means for assessing potential conflicts of interest and provides assurance that all members of the study team are aware of their involvement in the study. |
| Other Required Documents |
The following materials also require submission to the IRB:
|
| Materials that are Not Required |
While incomplete submissions delay review of research, submissions that include extraneous materials also unnecessarily extend review time. For example, the IRB generally does not require the following materials:
Note: Safety-related information always needs to be submitted. In addition, if the sponsor requires submission of the document(s), the IRB will review them. |