IRB is the acronym for Institutional Review Board for the Protection of Human Subjects. Any institution that receives federal funding to
conduct research with human participants is required to establish an IRB to review all research that directly or indirectly involves human participants, and to set forth institutional policy governing such research.

The UWW IRB has the authority to review, approve, disapprove or require changes in research or related activities involving human participants.  The primary role of the IRB is to ensure the protection of human participants as subjects of research performed by researchers affiliated with the University of Wisconsin - Whitewater.

The UWW IRB requires that all investigators listed on an IRB study application have completed CITI program Social, Behavioral, and Educational (SBE) Human Subjects Protection training.  The courseware is available online and at no charge to persons affiliated to UW-Whitewater at www.citiprogram.org.  Once the training is completed it is valid for 4 years at which time a refresher course is required.

If you have completed the NIH Protecting Human Research Participants course prior to 2017, that will also be accepted for four years
after completion, at which time the CITI SBE Human Subjects Protection Training refresher course must be taken.

If individuals without the required CITI/NIH training are added to a protocol application the submission will be Administratively Withdrawn and returned to the investigator(s) without further review.

Yes, if the study meets the definition for research with human participants, as explained above. UW-Whitewater's Federalwide Assurance (FWA) with the U.S. Department of Health and Human Services states that all research being conducted under the auspices of this institution is subject to
review and approval by the IRB. Written approval from the IRB must be in place before any interventions or interactions with human participants (e.g., recruitment) actually begin.

 Yes, if your research project involves active data collection. Federal regulations and University policy require that ALL research involving intervention or interaction with human participants, regardless of whether or not identifying information is being collected, must be submitted
for review prior to beginning the research study.

However, if your research project involves use of existing information from human participants (e.g., secondary data) that has already been collected, and is a publicly available, then the activity may not require IRB review. Please contact the IRB Administrator for further assistance.

 Yes. Projects conducted by University of Wisconsin - Whitewater undergraduate and graduate students need IRB approval, if the project fits the federal definitions of "research" and "human participants".  This includes
undergraduate research poster projects.

If the project is to be used only in a classroom setting to teach research methods, the project may not constitute human participant research.  However, this means that at no point during or after the conclusion of the course can the results or the data be used for publication, presentation or other research purposes. Therefore, students should discuss these limitations with their instructor or faculty advisor so that they can determine whether IRB review is necessary.  All student projects submitted to the UWW IRB must have a faculty or staff member listed as the Principal Investigator of the study.

No, exempt does not mean exempt from IRB review.  Federal Regulations set certain categories of research exempt from ONGOING IRB review. However, UW-Whitewater policy does not allow investigators to self-exempt their human participant research projects.  Instead, determining if a project is exempt from IRB review is an administrative review process handled by the UWW IRB administrator and/or Board.

If your project meets the criteria for an exemption you will be notified of the exempt approval status and you will not be required to submit your proposal for ongoing continuing review or renewal unless you have made changes to the study.  If changes are made, the protocol should be modified and resubmitted for IRB review.

The IRB CANNOT give retroactive approval to a study that meets the definition of Human Research.  The primary role of the UWW IRB is to administer and monitor the federal protections of participants in research.  The IRB cannot ensure that federal protections have been followed or enforced once the study is underway or has been completed, therefore the federal regulations do not have a provision for retroactive approval.

Fully informing participants of the risks, benefits, and procedures involved in a study is a standard federal requirement in research with human participants.  Ethically and legally, consent is not considered to be "informed" unless the
investigator discloses all the facts, risks, and discomforts that might be expected to influence an individual's decision to willingly participate in a research protocol. This applies to ALL types of research including surveys, interviews, and observations in which participants are identified, and other research experiments.

UW-Whitewater has a number of consent document templates that are fillable, and can be customized to your research project. 

NOTE: We strongly suggest the use of one of our templates which include all elements of consent as required by federal regulations.   The reason most IRB protocols are returned for modification is because not all elements of consent have been covered in customized consent documents.

Whether the consent document requires a signature or just a check mark to agree to consent, the document must be presented to ALL participants before they may participate in the study (e.g.: the first page of an online survey). They must also be given the chance to ask any questions regarding the study at that time.  If you are planning to conduct an online survey or other type of online research, the participant must be given instructions on how/where they can contact a member of the study team prior to participation.

Once the consent form has been completed, the research team must store the documents in the manner in which they have outlined in the study storage data plan in their study application.

If you are planning to use minors in your study (anyone under the age of 18), or persons with diminished decision making capabilities, you are required to get SIGNED parental or guardian consent (check marks are not adequate) and you must also have an assent (agreement to participate) from the participant themselves.   The assent document does not require the participant's signature.  Fillable consent/assent documents are available on our website and through Cayuse IRB submission.

Your study application is essentially an agreement with the IRB on the terms of which you intend to conduct your research.  If you need to make changes to specific items on your protocol (e.g.: add/change investigators, add more or different participants or study locations, change in data collection methodologies etc.), then you must submit a modification to the UWW IRB.  You cannot implement the requested changes until they have been approved by the IRB Administrator or Board.

Serious Incidents:

If a serious incident such as a life-threatening illness, injury, or death occurs during the course of the study, the study investigators must immediately seek the appropriate medical treatment for the participant(s) and cease all study activities, unless stopping activities will be life-threatening to participants.  The incident must be reported to the UW-Whitewater IRB via the Cayuse IRB Incident report within three (3) days.  The IRB will assign an investigator to the incident who may contact the P.I. for additional information. A determination will be made on the proper procedures for next steps.  Federal Guidelines require that serious incidents may need to be reported to the OHRP (Office for Human Research Protections) and any research sponsors.  Research activities may not resume until notified by the UW-Whitewater IRB and may be terminated or suspended indefinitely as a result of the incident.

Non-Serious Incidents:

In the event of a non-serious incident, the study may continue but must be reported to the UW-Whitewater IRB within seven (7) days via the Cayuse IRB incident report.  The IRB Administrator and IRB Chair will review the incident report and depending upon the incident and severity, determine if the entire IRB needs to be consulted and if an investigator needs to be assigned to the incident for further review. They will also determine if the study needs to be suspended until the investigation has been completed.  No studies will be suspended if suspension will create further complications for the participants.  The investigators will be instructed on how to proceed and given deadlines as appropriate for changes and corrections. 

UW-Whitewater policy requires that you submit a closure report when you have finished or are ending an approved research protocol.  The closure report can be completed through the Cayuse IRB application.

The Cayuse program can be accessed on the ORSP home page or using the icon above.

Log in with your Net - ID Login.  This should be all lower case even if there are capital letters in your net ID.

The main reason that a person will not be able to access Cayuse IRB is because CITI training has not been completed.

If you have completed CITI training, sign back into CITY and make sure that you have UW-Whitewater as your affiliation.  Then CITI will notify us with the courses you have completed.  If they are the correct courses (see requirements on our Training & Workshops page), you will be granted access to the IRB portion of Cayuse.

Anyone with "No CITI" can not be on an IRB protocol until they have completed the required human research training through CITI.  If they are going to participate on the protocol, they must completed the required training before the protocol is submitted.

 We require that the Informed Consent form be the first page of a survey because many researchers are either:

     1.  Not providing the signed consent form to the participants (even though a copy of a consent form was submitted with the protocol)

     2.  The wording on the consent for is changed or essential elements of informed consent on the first page of the survey are eliminated when given to the participants

We require that the survey be submitted exactly as it will be given to the participant to assure that basic and federally required IRB regulations will be followed.  Consent forms and IRB protocols will be randomly selected for internal compliance audits.

A continual problem for the IRB is who "owns" the protocol.  Some faculty/staff want the students who entered the protocol to be responsible for any reports, modifications, renewals etc.  There are also students who do not know what is expected of them or what they needed to do when submitting to the IRB (despite the fact that they have completed the required research training).

The certification is meant to show that everyone on the protocol is responsible for what happens during the research.  The certification is the same for all protocols and needs to be read at least once to remind researchers that the rules of research must be followed, and in the event there are any potential issues, they could be held personally liable.  This is very important and covered in Cayuse IRB training. 

In the event that the "standard" certification needs to be changed, there will be notifications to users of IRB and also notices on our website.

In your professional profile, check the "People" tab to verify that the "Principal Investigator" box is checked under the eRA Role.

If your research involves working with humans or animals, you are required to complete training through CITI.  UWW subscribes to this service and CITI notifies our department when training is completed.  This type of training is required for all research at all universities.  Training does not have to be done all at once.  There are sections and you are able to go back into the site until the complete course has been finished with a passing grade.  The time it takes from completion of the course with a passing grade to being able to submit a protocol is 48-60 hours. 

If you have training through another institution within the last four years, please add the certificate to your user profile in Cayuse 424 and send a copy to Donna Kempf.

No research with humans or animals that will be shared can be done without an approved IRB protocol on file with the Office of Research and Sponsored Programs. 

NEEDED FOR HUMAN RESEARCH:

The CITI course that is required is "Social, Behavioral, & Educational (SBE) Sciences - All Researchers"

NEEDED FOR ANIMAL RESEARCH:

There is a minimum of two CITI courses needed for animal research:

     1.  "Working with the IACUC Course"

     2.  One or more of the "Species Appropriate" modules depending on the animals in your research.

We also encourage but do not require the "Minimizing Pain and Distress" applicable to your research.  This does not count toward the mandatory two courses needed before doing animal research.

For instructions to sign into CITI, click here.