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IRB Submission Form

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The CATS IRB Submission form is where researchers will upload study documents, such as the protocol, consent form, and recruitment materials. Researchers will also provide basic information about the study in the Submission Form.

This guide outlines the different sections of the Submission Form, which becomes available after selecting “Create New Study” in CATS IRB. Before beginning an IRB submission, review the IRB basic steps to make sure that a submission is required for your activity, determine if you have the required training, and gain general knowledge about how to navigate CATS IRB. All submissions will be created in CATS IRB.

Keep in mind that IRB approval cannot be retroactive and that all training must be up-to-date in order for a submission to be approved by the IRB. 

 

TIP: Study staff can “Create a New Study” on behalf of a principal investigator, but only the principal investigator (PI) or PI Proxy can submit the study.

Click on the different sections of the Submission Form listed below to learn more about the information required for each part. 

Protocol

To begin, select the appropriate protocol template from the CATS IRB Library. HPR-591 is the most commonly used protocol. Note that protocol templates may change or be updated as regulations and requirements change. Be sure to use the most recent version of a protocol template. The CATS IRB Library always has the most up-to date version.

Short Title

The short title should include elements that will help the study team identify the protocol. It should be short and unique.

Study Type

Confirm the study type:

  • Single-site: a study in which all research activities occur at one institution, even if the research is conducted or overseen at additional research locations (e.g. schools, nursing homes, etc.)
  • Multi-site: a study in which the study activities are outlined in a single protocol and are carried out at multiple institutions.
  • Collaborative Research: a study in which two or more institutions coordinate to complete a portion of the research outlined in a specific protocol.

TIP: If all of the research is being conducted by one institution, even if multiple locations will be visited, it is a single site study. If you are submitting a study that will be reviewed by an external IRB or is part of a Single IRB application, refer to the page on Single IRBs and IRB AUthorization Agreements. The definition does not apply to research using only de-identified human specimens.

If funded identify:

  • if a proposal has been submitted
  • the source of the funding
  • who/what office will manage the funds

TIP: Include internal and external funding sources. Internal funding sources include any University department.

Confirm the following:

  • All study team members have up-to-date training. Training must be up-to-date prior to approval by the IRB.
  • Conflicts of interest for all study team members are reported.
  • All study team members who will access CATS IRB have a PSU access account.

If necessary, complete HRP-509 – Study Team Member Qualification Template found in the Templates tab in the IRB Library.

HRP-509 is required when:

  • the Principal Investigator (PI) is a student
  • conducting biomedical procedures/clinical investigations in non-clinical environment
  • an Individual Investigator Agreement (HRP-508) is required
  • a visiting scholar is serving as the PI, and/or
  • study work requires special expertise or credentials beyond typical job expectations. 

 

Indicate if there are other research locations outside of the institution where the local PI will conduct research. List the various research locations on the “Research Location” page, which follows the “Study Scope” page.

TIP: This is not the same as the study type (multi, collaborative, single site). Single site studies may have more than one research location.

If answering yes to questions about the use of approved drugs or biologics, food or dietary supplement, or a humanitarian use device, be aware of the corresponding ClinicalTrials.gov Registration requirements.

 

 

  • For single-site studies (study conducted only by Penn State researcher), upload the local site-specific documents
  • For studies in which Penn State is a site in a multi-site study and review is conducted by the Penn State IRB, upload local site-specific documents and study-related documents
  • For studies in which Penn State is a site in a multi-site study and Penn State is serving as the single IRB or Penn State is relying on an external IRB, upload only the local site-specific documents

Participant Facing Materials

Include foreign language versions of all documents, if applicable.

 

  • Consent documents: if applicable; include Study-related documents if Penn State is a multi-site study and a review will be conducted by the Penn State IRB
  • Recruitment Materials: include study-related recruitment materials if Penn State is a site in a multi-site study and a review will be conducted by the Penn State IRB. Important attachments include:
    • Advertisements (printed, audio, and video)
    • Phone screening procedures and screening questionnaires/intake forms
    • Evlaution instruments and surveys

 

Other Attachments

 

  • Data use agreements (all research locations, except Penn State Health)/li>
  • Collaborating approval materials, for example:
    • HRP-901 Human body Fluids for Research Form (Penn State Health researchers only)
    • HRP-902 Use of Human Tissue for Research Form (Penn State Health researchers only)
    • HRP-903 Radiation Review Form (Penn State Health researchers only)
    • HRP-904 Non-Penn State Hershey Researcher Form (Penn State Health researchers only)
    • Scientific Review Memo (Penn State Health researchers only)
    • Certificates of confidentiality from HHS Agency
    • EIM Design Specification Form (primarily for Penn State Health researchers (non- Penn State Health researchers may be asked to complete this form depending on the study)

 

Documents NOT to upload on Local Site Documents

For multi-site studies in which Penn State is serving as the single IRB or Penn State is relying on an External IRB, do not upload study-related documents that are applicable to all sites in a multi-site research study on this page. Those documents must be uploaded on the Study-Related Documents page in the Smartform.

 

See also