All new protocols must use the electronic submission process in the eIRB module of eResearch. Investigators benefit from the elimination of all paper documents, the automatic routing of protocols to ancillary committees, the ability to follow the status of each submission as it moves through the approval process and the storage and tracking of all documents.
The IRB does not accept paper applications or materials that are emailed outside of the eIRB system. All applications and supplemental materials to accompany new protocols, amendments, continuing reviews and reportable events must be submitted via the eIRB electronic IRB management system.
See the page on Requirements for Approval for information on the criteria the IRB uses to determine if a study is approvable. And see the page on Naming Documents for guidance on choosing names for study documents.
What type of submission is this?
The investigator must determine which review pathway they believe their research should follow. Human subjects research can be either Exempt from the requirements of 45 CFR 46, it can be eligible for review using Expedited procedures or it can require review by the full board.
Determination of Exemption
Investigators are not permitted to make this determination themselves. The categories are enumerated in 45 CFR 46.101(2)(b)(1 - 6). For more information go to the page titled Exempt Research. Like all submissions, requests for a determination of exemption must be submitted using the eIRB system.
Expedited Review Procedures
Submission qualifying for review using expedited procedures are reviewed on a rolling basis in the order of their arrival in the IRB Office. Approximately 90% of the submissions to the CHOP IRB including new protocols, amendments, continuing reviews and other reports are reviewed using expedited procedures. The categories of research eligible for expedited review are detailed on the webpage Expedited Review and are also listed in on OHRP's website Expedited Review Categories and on.
Full Board Review
Submissions that require full board review are scheduled for the next available IRB meeting. They must be received at least 8 - 10 days prior to the scheduled meeting. This allows time for a thorough pre-review by the IRB Analysts prior to placement on a meeting agenda. The meeting schedule for each of the IRBs is provided below.
Up to 6 new protocols can be reviewed at a convened IRB meeting. When the number of new protocol submissions exceeds this limit, additional submissions go to the next available committee. Some modifications and amendments for approved protocols will need to be reviewed at a convened meeting of the IRB, some will qualify for review using expedited procedures.
Each of the IRB Committees is constituted as a general biomedical committee capable of reviewing any protocol.
IRB Committee Meeting Dates:
- Committee A meets the first and third Wednesday of each month
- The Executive IRB meets on an as needed basis to review urgent matters, possible non-compliance and unanticipated problems involving risks to subjects or others.
What needs to be included in the submission?
The IRB submission consists of the electronic application, a protocol, consent form(s), recruitment materials, a grant (if applicable), financial disclosure statements for the members of the study team, and approvals from ancillary committees. The IRB makes determinations based on the information provided. If information is lacking, the IRB cannot grant an approval. Incomplete information and poorly written protocols are the most frequent causes of delay in approval.
The table below outlines the materials that the IRB needs in order to review a study. The complete listing of the required materials for submission can be found in IRB SOP 301: IRB Submission Requirements and IRB SOP 402: Criteria for Approval. These guidelines below, apply to most research. However, each research study is unique and additional documents may be required in certain situations. The IRB reserves the right to request additional information if needed to conduct a complete review. This happens most frequently with multi-center research when the protocol is written by an outside investigator.
|Required for Submission||Details and Description|
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.
The content of consent documents are specified in the research regulations (DHHS and the FDA) and in the HIPAA Privacy Rule. For more information see the following pages:
The IRB is required to ensure that the work described in the grant application covers the aims of the protocol. The IRB will not accept a grant in lieu of a protocol. For more information see the protocol page for information about the difference between a grant and a protocol.
|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 and approval performed by a duly a registered 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 research team at CHOP must complete a financial disclosure statement. CHOP is transitioning from a paper forms based system to the web-based eCOI portal. More information about Conflict of Interest Reporting is available on the CHOP website. Currently, the paper forms must be signed either with a physical signature or an adobe-validated electronic signature and attached to the eIRB application. The form 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.
In general, anything that is not a protocol, consent document, grant, investigators' brochure or package insert, study instrument, recruitment material, or financial disclosure statement does not need to be submitted.
For example, the IRB does not require the following materials: