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IRB Process

The IRB process aims to ensure the appropriate use of human participants. The general procedures for submission, review and approval of documents submitted to the IRB are listed below.

If you have any questions, please contact IRB Administration at irb@uwosh.edu or call (920) 424-3215.

Principal Investigator Eligibility Status

The eligibility status for Principal Investigator (PI) for all research activities at UW Oshkosh has been updated to be congruent with Principal Investigator status for related grant work. Please review SOP #6: Principal Investigator Eligibility.  Current PIs on existing studies who are no longer eligible for PI status under this new policy will be grandfathered in until their project is completed. This policy was put into effect on July 1, 2016.

Submission Process
  1. Determine which type of application you need: (1) IRB Protocol Application for New Projects (for collecting new data), (2) Existing Human Subjects Data Form (for analysis of an existing data set), or (3) Course Umbrella Protocol Application for Class Projects.  To determine if your class project requires IRB review, see SOP #7: Student Class Assignments.
  2. Submit a signed electronic copy with all appendices as a single word or pdf document to irb@uwosh.edu.  
  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 for formal review is required for quality improvement, quality assessment or program evaluation activities, please submit the following form: IRB Determination of Human Subjects Research Form for Quality Improvement/Quality Assessment Activities.
  5. All forms are located on the IRB Forms page.
Review and Approval Process
  1. An IRB staff member 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 based on the federal human subjects research review categories and the 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 category, the review will be handled by Exempt/Limited IRB Review procedures.  Research that meets an Expedited Review Category, will be reviewed following expedited review  procedures.  A list of Exempt and Expedited Review Research Categories  is located on the IRB forms page.

Average Review Time:

Exempt and Limited IRB Reviews:  1-2 weeks

Expedited Reviews:  2-3 weeks

Full Board Reviews:  4-8 weeks

The Full Board will review any research that is deemed more than minimal risk, involves deception, or vulnerable populations.  The committee convenes approximately every 6 weeks during the academic school year.

  1. 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@uwosh.edu and CC: your Faculty Supervisor, if applicable.
    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 original e-mail from the IRB to respond or request an extension of time and justification for the extension.
  2. When your project is approved, you will receive written notification of approval from the IRB. Your project may commence.  Please note any pending items that may be listed on the approval letter.
  3. Please see your approval memo to determine if continuing review is required for your project.  IRB projects requiring continuing review are valid for a period of one year or less from the approval date.  
Continuing Review
  1. To determine if formal Continuing Review is required for your project, please review your most recent IRB Approval Memo and note the protocol expiration date if applicable.
  2. If continuing review is required, you will need to submit an IRB Continuing Review Form, with a brief summary of the project.
    1. If you wish to continue your research, you must request an extension.   An extension request must be approved by the IRB before continuing the study beyond the project approval period.  The IRB requests that 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. 
    2. If your protocol expires, you must stop all human subjects research related to that project.  You have 30 days to submit a continuing review form in order to keep that study open.  Studies not renewed within that 30 day window will be closed administratively and a new application will need to be submitted to the IRB for review in order to continue the human subjects research.
    3. If you have completed your research at the time of continuing review, please submit an IRB Closure Form.
  3.  If continuing review is not required for your project, the IRB will send an annual check-in email.
    1.  If you have completed your research, please submit an IRB Closure Form.
Modifications
  1. 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.
Closures
  1. Researchers (PIs) must close out their IRB protocol once the research project is complete.  The IRB office will send out an e-mail reminder to PIs  to see if they wish to continue the research or close the protocol on an annual basis.  Protocols can be closed by the PI by submitting an IRB Closure Form.
Adverse Event and Problem Reporting
  1. 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
Volunteer Process

Hiring a Volunteer

  1. If you wish to have a non-affiliated person (not associated with an institution of higher education) collaborate on a UW Oshkosh led project, please contact the HR Office and notify them that you wish to hire a volunteer.
  2. Download and complete the two required forms below:
    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.

If the volunteer needs driver authorization, contact the Parking Office at 920-424-4455, visit: https://www.uwosh.edu/riskmanagement/driver-authorization-management

Policies 

Contact IRB

2019-2020 Interim IRB Chair
Melissa Bublitz
bublitzm@uwosh.edu
IRB Administrator
Kelly Schill
(920) 424-3375
IRB Administration
(920) 424-3215
irb@uwosh.edu

Office located in Dempsey Hall Suite 214

IRB Quick Look

IRB Registration:I0RG0004550 
Federal Wide Assurance:FWA00011478 

IRB Process

The IRB process aims to ensure the appropriate use of human participants. The general procedures for submission, review and approval of documents submitted to the IRB are listed below.

If you have any questions, please contact IRB Administration at irb@uwosh.edu or by calling (920)-424-3215.

Principal Investigator Eligibility Status

The eligibility status for Principal Investigator (PI) for all research activities at UW Oshkosh has been updated to be congruent with Principal Investigator status for related grant work. Please see SOP #6: Principal Investigator Eligibility Policy.  Current PIs on existing studies who are no longer eligible for PI status under this new policy will be grandfathered in until their project is completed. This policy was put into effect on July 1, 2016.

Submission Process
  1. Determine which type of application you need: (1) IRB Protocol Application for New Projects (for collecting new data), (2) Existing Human Subjects Data Form (for analysis of an existing data set), or (3) Course Umbrella Protocol Application.  
  2. Submit a signed electronic copy with all appendices as a single word or pdf document to irb@uwosh.edu.
  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 for formal review is required for quality improvement, quality assessment or program evaluation activities, please submit the following form: IRB Determination of Human Subjects Research Form for Quality Improvement/Quality Assessment Activities.
  5. All forms are located on the IRB Forms page.
Review and Approval Process
  1. An IRB staff member 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 Review Time:

Exempt Reviews:  1-2 weeks

Expedited Reviews:  2-3 weeks

Full Board Reviews:  4-8 weeks

The Full Board will to review any research that is deemed more than minimal risk, involves deception, or vulnerable populations.

  1. 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@uwosh.edu and CC: your Faculty Supervisor, if applicable.
    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 original e-mail from the IRB to respond or request an extension of time and justification for the extension.
  2. 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.
  3. Please see your approval letter to determine if continuing review is required for your project.  IRB projects requiring continuing review are valid for a period of one year or less from the approval date.
Continuing Review
  1. IRB regulations require at least annual monitoring of all non-exempt human subject research projects. The IRB may choose to prescribe more frequent monitoring based on risk level.
  2. Prior to the one-year expiration date of your protocol approval, you will be required to complete an annual IRB Continuing Review Form, Found in the forms tab above, 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.
  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.
Modifications
  1. 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.
Closures
  1. Researchers (PIs) must close out their IRB protocol once the research project is complete.  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@uwosh.edu.  
Adverse Event and Problem Reporting
  1. 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
Volunteer Process

Hiring a Volunteer

  1. If you wish to have a non-affiliated person (not associated with an institution of higher education) collaborate on a UW Oshkosh led project, please contact the HR Office and notify them that you wish to hire a volunteer.
  2. Download and complete the two required forms below:
    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.

If the volunteer needs driver authorization, contact the Parking Office at 920-424-4455, visit: https://www.uwosh.edu/riskmanagement/driver-authorization-management

Policies 

Contact IRB

2019-2020 Interim IRB Chair
Melissa Bublitz
bublitzm@uwosh.edu
IRB Administrator
Kelly Schill
(920) 424-3375
IRB Administration
(920) 424-3215
irb@uwosh.edu

Office located in Dempsey Hall Suite 214

IRB Quick Look

IRB Registration:I0RG0004550 
Federal Wide Assurance:FWA00011478