After Submitting the Proposal and Approval is Granted

Any and all changes to an approved research study must be submitted for review and approval prior to implementing the change(s) into the research study (e.g., additional surveys/questionnaires, additional participants, a different participant population, a title change, change in principal investigator, change of funding source, increased time for participant participation, etc.).

No. The expiration date of the original approval is not changed by the review and approval of a modification.

Modifications to studies that were originally submitted and approved in paper must be submitted via the Modification Request Form located on the Modifications page.

Modifications to studies that were submitted via the eSubmission process in PRAMS must be submitted via PRAMS (http://www.prams.psu.edu). Modification Request Forms submitted for studies approved via the eSubmission process will be returned.

Any supporting documents (i.e., recruitment materials, informed consent forms, data collection instruments) that have been revised must also be submitted for review and approval.

The information must clearly describe the proposed changes/additions to the research study.

It is the responsibility of the principal investigator (PI) to ensure continued approval of his or her human participant research study. As a courtesy, approximately 75 days prior to the approval expiration date, the Office for Research Protections will send an email to the principal investigator, any co-investigators, an advisor (if the PI is a student), and project coordinators alerting them to the impending approval expiration. If a response is not received, another reminder will be sent to the same individuals approximately 45 days prior to the approval expiration date. If no response is received to the reminders, a notice indicating the approval for the study expired will be sent the morning after the approval expiration date.

Continuing Reviews for studies that were originally submitted and approved in paper must be submitted in paper via the Continuing Progress Report (CPR) form that will be attached to the email notification. Signatures are no longer required on these forms. Therefore, the CPR form and supporting documents, if applicable, may be sent as email attachments to ORProtections@psu.edu.

Continuing Reviews for studies that were submitted via the eSubmission process in PRAMS must be submitted via PRAMS (http://www.prams.psu.edu).

Requests for continuing reviews should be submitted at least three (3) weeks prior to the approval expiration date. If approval is allowed to expire, all research on the study must cease until renewed approval is granted.

Yes. As a result of the IRB's investigation of the unanticipated problem, revisions to the approved research study and the informed consent form may be requested.

An MTA outlines the terms of use of tangible research materials. While terms may vary from one agreement to the next, the most commonly negotiated elements include: rights and ownership of intellectual property and data, publication rights, liability and governance. MTAs cover a wide array of materials, including, but not limited to, animals, reagents, cell lines, devices, software and data. MTAs allow researchers to share tangible materials as well as receive tangible materials without necessarily having to purchase them.

An MTA is required when:

1. Penn State owned tangible research materials including, but not limited to, animals, reagents, cell lines, devices, software and data are being sent to another academic institution, research institution or company.
2.  A Penn State researcher will receive tangible research materials including, but not limited to, animals, reagents, cell lines, devices, software and data from another academic institution, research institution or company.  If the materials are being shipped to Penn State, Penn State often uses the company/institution’s agreement.

For all University locations other than the Hershey Medical Center/College of Medicine:

Penn State’s Office of Technology Management (OTM) processes all MTAs for materials being shipped from Penn State and materials being shipped to Penn State from another academic institution, research institution or company.  

Many of Penn State’s Colleges also have their own checklist completion requirements and/or other approval requirements for MTAs.  Researchers should consult with their College’s Research Office regarding any additional MTA requirements or may contact the OTM for additional information.

If biological materials are being sent or received, the Uniform Biological Materials Transfer Agreement (UBMTA) can be used if the other institution/company has signed the Master UBMTA. You can check the list of entities that have signed the Master UBMTA as well as download the UBMTA for completing here. The UBMTA should still be sent through the OTM for execution on behalf of Penn State.

The OTM coordinates with Penn State's Office for Research Protections (ORP) to verify that all necessary research oversight committee (i.e. IRB, IACUC, IBC and UIC) approvals are in place for all materials listed on the MTA. If materials are being received from or shipped outside of the United States, the OTM also completes an export review to ensure that there is no export control on the materials.

The OTM will prepare and forward the MTA for appropriate signatures by the other company/institution and/or PSU. Once the agreement is fully executed, a signed copy will be sent to the other institution/company and the OTM will notify the Penn State researcher and the College so that arrangements can be made to send/receive the materials. (Please note: All incoming and outgoing animal shipments must be coordinated through Penn State’s Animal Resource Program.  When shipping hazardous materials, researchers must adhere to Penn State Policy SY34, Hazardous Material Shipping.)

The MTA execution process can sometimes take one to two weeks to complete.

Any questions regarding an MTA should be directed to the OTM (814-865-6277 or otminfo@psu.edu).