The first action to beginning any potential project is to draft a systematic plan, or “protocol”, that will be followed. Investigators should review the OSF Guidance for Writing a Research Protocol for assistance in drafting a sound protocol.

Not Research / Human Subjects Research Determinations

Once the protocol is drafted, the investigator should assess the protocol to determine whether it meets the definition of research and, if so, whether the research involves human subjects. The Office for Human Research Protections (OHRP) provides Human Subject Regulations Decision Charts  to aid investigators in making these preliminary determinations. Investigators may also contact OSF Research Administration for assistance. Making these preliminary determinations will assist the investigator in completing the appropriate application and submission forms and responding to the related questions.

If the investigator concludes that the project is likely not research/human subjects research (NR/NHSR), then it should be submitted directly to the Peoria IRB (PIRB) via IRBNet for a formal determination using the PIRB Determination of Human Subjects Research Form. When submitting to PIRB through IRBNet, share/grant “read only” access with Stephanie Madrigal. OSF permission is not required prior to seeking NR/NHSR determinations from PIRB. However, if the project is determined to be human subjects research, OSF permission will be required as described below.

* CITI training requirements do not apply to projects that are determined NR/NHSR.

New Research Projects

If the investigator concludes that the project is clearly human subjects research, there are two separate processes that are necessary before research can be conducted at an OSF HealthCare location, by or on OSF HealthCare employees, or using OSF HealthCare data.

• The first step is to secure permission from OSF HealthCare to conduct the research. This is done through a research application and evaluation process.
• The second step is to secure approval from an IRB overseeing the research project, which is known as the IRB of record. This is done through a research submission and review process.
  • If an investigator wants to use an IRB of record other than the University Of Illinois College Of Medicine at Peoria’s IRB (PIRB), then permission to use the specified IRB must be obtained. Please contact the OSF Research Administration Department prior to submitting the OSF Research Application to ensure use of the other IRB is permissible.

Step 1: OSF Research Application – Evaluation – Permission Process

The OSF process is intended to ensure organizational, operational and regulatory considerations have been addressed to properly position investigators for successful research projects.

An investigator requesting permission to conduct a new research project at OSF must first send an application to the Research Administration Department via email.

In order to prevent duplicative efforts, and to be fully aware of the information that will be provided to the IRB of record, the OSF Research Application must include all of the documents that will be submitted to the IRB of record.

The OSF Research Application must include the following items:

• Final Protocol
  • If you need assistance writing a research protocol, review the OSF Guidance for Writing a Research Protocol.
• Informed Consent and Assent Forms, if applicable
• OSF Research Application Form 
• Supplemental OSF Research Application Forms, if applicable
  • IND Applicability Form 
  • IDE Applicability Form 
• Contracts and Agreements (e.g. CTA, LOI, MTA), if applicable – available draft versions that have not been provided previously to the Research Projects and Administration Department.
  • Premises Use and Indemnification Agreement 
  • Data Use Agreement 
  • Business Associate Addendum 
• Department, Committee and/or Facility Approvals – those that are obtained prior to sending the application
• *IRB New Research Submission Documents

*New research submission requirements may vary by IRB.

Upon sending a new research application to the Research Administration Department, the application will be screened for completeness and any missing information will be requested from the sender via email.

This screening process includes ensuring the appropriate CITI training courses have been completed by all personnel working on the project. Review the Education & Training page for additional information and resources on research project personnel training required by OSF.

Once deemed complete, the new research application is evaluated by the Research Administration Department.

When the evaluation step is completed and the research project receives permission to proceed from OSF, the study contact will either receive an email from the Research Administration Department giving permission to proceed with submission to the IRB of record, or such permission will be indicated through any electronic signature or submission system used by the IRB of record (e.g. IRBNet).

The amount of time necessary to complete the OSF process can vary widely depending on the type and complexity of the research being applied for, and the committees and/or individuals that must first sign off on the research project.

Overall, the OSF process can be expected to take approximately 2-4 weeks once all the necessary information is received.

Step 2: IRB Submission – Review – Approval Process

The IRB process is intended to ensure the rights and welfare of human research subjects are protected.

Once OSF permission has been secured, an investigator must then request IRB approval to conduct the research project. This is accomplished by following the submission requirements and processes of the IRB of record for the research.

When the IRB of record for the research will be the Peoria IRB (PIRB), all submission forms and requirements can be obtained through PIRB’s electronic submission system, IRBNet.

Instructions for submitting a new research project to PIRB for review through IRBNet can be found on the Protocol Submissions page of PIRB’s website.  

When submitting to PIRB through IRBNet, share/grant “read only” access with Stephanie Madrigal and all department chairs involved in the research project to allow the required signatures from OSF Administration.  

When the IRB of record will be another IRB, then investigators and research staff must become familiar with the specific requirements and process of that particular IRB. This is typically accomplished by reviewing the information made available on the IRB of record’s website, or requesting appropriate training of the research team directly from that IRB.

Additionally, the IRB of record should be instructed to copy the OSF Research Administration Department on all IRB correspondence sent to the investigator. If the IRB of record is not agreeable to this, then the research team will be responsible for forwarding copies of all IRB correspondence to the OSF Research Administration Department.   

IRB new research submission requirements generally include the following items:

• IRB Submission Form
• Final Protocol
• Investigator Brochure / Package Insert
• Device Manual / Device Instructions for Use
• Informed Consent and Assent Forms
• Conflict of Interest Information
• Recruitment Materials
• Study Related Materials not incorporated into the protocol (e.g. surveys, questionnaires, etc.)

The amount of time necessary to obtain IRB review and approval can vary widely depending on the type and complexity of the research being submitted, as well as the submission deadlines and review schedules of the IRB of record. Investigators should inquire directly with the IRB of record for expected review timelines.

Once documented approval of the research protocol, informed consent forms and any other materials that will be presented to subjects has been received from the IRB, the investigator may begin the research project.

The investigator and research team should closely read the approval documentation from the IRB to ensure the IRB’s requirements and policies are followed, including any additional determinations that may have been made specific to the research project.

The IRB approval documentation will also specify how long the research is approved for (no more than 1 year) and when submissions for continuing review reapproval should be made to the IRB.