1. Determine which type of application you need: (1) IRB Application Form (for collecting new data) or (2) IRB Existing Data Form (for an existing data set) (3) IRB Umbrella Course Protocol Form
2. Submit (1) one signed copy of the appropriate application along with all required attachments to irb@uwsp.edu. If it is easier, the cover sheet can be signed and mailed through UWSP postal services.
3. DO NOT begin recruiting participants or collecting data until IRB review is complete and you have received confirmation of approval.
4. To determine if an IRB Application submission is required for quality improvement, quality assessment or program evaluation activities, please submit the following form: IRB Determination of Human Subjects Research.
   

1. IRB Administration performs an initial review to determine that the application is complete and to determine what level of IRB review is required for the project. The type of review required is determined by the level of risk participants are asked to assume when engaging in the research. If risk level is minimal and the research fit into an exempt or expedited review category, the review can be handled by Exempt or Expedited procedures. 

               Average Initial Review Time: 
               Exempt Reviews:  2 weeks
               Expedited Reviews:  4 weeks
               Full Board Reviews:  6 weeks*
                  *The Full Board will to review any research that is deemed more than minimal risk, involves deception, or vulnerable populations.

2. If the reviewers determine changes must be made to your research proposal, you will be contacted directly and the following is required:
1. Provide a written response to each of the stipulations in a cover letter detailing any changes made to the protocol and supporting documents. Submit correspondence to irb@uwsp.edu. 
2. If changes to the consent documents are required, include revised consent/assent forms with changes highlighted.  Include a copy of any documents requested by the committee and highlight any changes made in response to stipulations.
3. You have 30 days after the date of the initial review e-mail from the IRB to respond or request an extension of time and justification for the extension. If not submitted within the deadline, applications may be withdrawn by IRB.
3. When your project is approved, you will receive an approval letter from the IRB. Your project may commence.  Please note any pending items that may be listed on the approval letter.
   
4. Expedited and Full Board IRB projects are valid for a period of one year or less from the approval date, depending on the level of risk determined by the IRB.
5. Exempt protocols automatically expire after 5 years, at which time the PI will be required to submit a new protocol application if they wish to continue the study.
   

1. IRB regulations require at least annual monitoring of all non-exempt human subject research projects which employ more than minimal risk. The IRB may choose to prescribe more frequent monitoring based on risk level.
2. Protocols Requiring Continuing Reivew: Prior to the expiration date of your protocol approval, you will be required to complete an annual Continuing Review Form to provide the IRB with a brief summary of the project. The PI can select whether this project is complete or can request an extension on this form. Due to the Revised Common Rule, most expedited protocols will no longer require continuing review. Upon your anniversary date, your protocol will be transitioned to the New Rule. If your project still requires continuing oversight, you will be notified in writing. Full Board Protocols still require continuing review. 
   
3. An extension request must be approved by the IRB before continuing the study beyond the project approval period.  The IRB requests that these continuing review forms be submitted at minimum 14 days prior to protocol expiration.  Submitting an extension request in sufficient time is the responsibility of the PI.
4. If the protocol expires, all data collection must stop and a new application must be submitted to the IRB for review in order to continue the human subjects research.
5. All Exempt Protocols: Per federal regulations and to help reduce administrative burden, researchers will receive an annual email notification of their ongoing responsibilities to the IRB, and request that PI's update the IRB on the status of their protocol. This includes, but is not limited to: 1) open/closed status, 2) recruitment and data collection, 3) anticipated* changes, 4) adverse events/problems.

*As always, any modifications to a protocol must be submitted to the IRB prior to carrying out said changes.

Exempt protocols automatically expire after 5 years, at which time the PI will be required to submit a new protocol application if they wish to continue the study.

If changes to your research project are requested, you must submit an IRB Modification Request Form. Approval for your modification request must be granted by the IRB before the changes to your protocol can be implemented. Changes to personnel (not including PI and Co-PI) can be made with the Research Personnel Addition Form. All modifications must be submitted to irb@uwsp.edu prior to initiating the proposed changes. 

Researchers (PIs) must close out their IRB protocol once the research project is complete. This includes Exempt research, in addition to Expedited and Full Board research protocols. The IRB office will send out reminder e-mails to PIs at 60 and 30 days prior to protocol expiration.  Protocols can be closed by the PI by submitting the IRB Closure Form to irb@uwsp.edu

Any adverse event or unanticipated problems must be reported to the IRB within 72 hours of the event using the Unanticipated Problem Form or an Adverse Event Form. If a participant or passer-by would like to report a complaint, they may do so by emailing irb@uwsp.edu. IRB is in progress of creating an anonymous reporting method for complaints to be placed on our website.

1. Please contact the HR Office and notify us that you plan to recruit a volunteer for your study.
2. Complete the two required forms below, available from Human Resources:
1. Volunteer Position Description Form
2. Volunteer Agreement Form
3. Return these documents to the HR Office
4. HR will follow up with all parties (supervisor, volunteer, etc.) involved and will determine if a criminal background check is necessary

Submit a copy of the Volunteer Position Description Form and Volunteer Agreement Form to be kept on file with the IRB.