How to Sign an Application in KC 5.2.1
Jamie Van Natta
Last modified 1/15/2016
Version 3.0 – include Search Protocols instructions
Contents
How to Process an Application Approval Request in KC 5.2.1 ................................................................................................ 1
Overview: ................................................................................................................................................................................ 1
Step 1: Search for the approval request using your Action List ............................................................................................. 2
Step 2: Review protocol application. ..................................................................................................................................... 3
Step 3: Approve or Disapprove the protocol application. ..................................................................................................... 3
Approve ............................................................................................................................................................................... 3
Disapprove .......................................................................................................................................................................... 4
Overview
As a PI on a research project, a department chair or in some cases, the college dean, you are responsible for the conduct
and oversight of the project. Formerly, on the paper application, you were required to sign the attestation section of
the application to indicate acceptance of your responsibilities or your approval of the application. In KC, this signature
process is electronic.
Step 1: Search for the protocol you need to approve
1. Login to the system: https://myorca.utoledo.edu using your UTAD username and password. You will land on a
page that looks like this:
Navigate to the Submitted Protocol Application
To find the currently approved protocol:
1. Click on the “Search Protocols” link in the IRB Protocols box of the Researcher landing page (upper box, middle
column.
2. Using the Protocol # field, type your protocol number in the format *2#####* in the box.
a. If you do not know your protocol number, you can use any of the other fields such as Title or
Investigator (PI).
b. Always remember to use * character before and after your search criteria
3. Hit the enter key or click the “Search” button
4. Scroll down to see your results.
NOTE: If the Protocol Status says “Pending/In Progress” then it’s not ready for a signature yet.
5. Click the “Edit” link in the far left column of the results, if you do not have an “edit” link, click the “view” link.
a. If your results do not show the protocol you are looking for, it is possible that your permissions are
incorrect. Contact the Research Systems Team at 419-383-6651 or email Jamie.VanNatta@utoledo.edu.
Step 2: Review protocol application.
As with the paper application, all the content of the electronic application should be reviewed by the PI, or Department
Chair or College Dean. A quick description of the contents of each tab follows. For more detailed information on the
contents of each tab and what is entered on them, see the instructions for submitting a new application on the IRB KC
Instructions webpage.
Protocol Tab: Contains meta-data about the application. Here you will find the title and PI, additional information like
identifiers or keywords, the list of performance sites and external locations associated with the project, a list of any
funding sources, and the vulnerable populations.
Personnel Tab: Contains the list of personnel associated with the project.
Questionnaire Tab: Contains all the application questions, the meat of the application. Here is where the background,
significance, procedures, consent information, subject population information, etc are found.
Notes and Attachments Tab: Here is where all the additional application materials can be found. Consent forms,
advertising materials, COI forms, Protocol Narrative, Data Collection tool, Surveys etc are included in attachments.
Once you have completed your review of the application, you are ready to make a determination.
Step 3: Approve or Disapprove the protocol application.
1. Go the
tab.
2. At the bottom of the page, you will see a row of buttons. A description of each button follows.
Send Notification means you wish to send a system message to someone. It is unlikely you will ever need to use this
button.
Send Ad Hoc Request will allow you to send an approval request to another person. For example, if you are not the
department chair, and feel that he or she should also sign off on this project, then you would use this button to generate
an approval request for them. Again, this will be rare, and if you need assistance, please refer to the “Submit an
Application” document on the IRB KC Documentation page, or call your IRB Administrator for assistance.
Reload simply refreshes the webpage.
Close simply closes the protocol for consideration later.
Recall removes the protocol from workflow. Please do not use the recall button.
Approve indicates that you have reviewed the application and believe it to be sound and complete. It also indicates
you understand your roles and responsibilities with regard to the study as noted below.
Principal Investigator’s Assurance Statement:
 I certify that the information provided in this application is complete and accurate.
 I understand that as Principal Investigator, I have the ultimate responsibility for the protection of the rights and
welfare of human subjects, and the strict adherence to any study-specific requirements required by the IRB.
 I agree to comply with all IRB and Institutional policies and procedures, as well as with all applicable Federal, State,
and local laws and regulations regarding the protection of human subjects in research and the conduct of research.
 I also agree to the following:
1. to accept responsibility for the scientific and ethical conduct of this research study,
2. to obtain prior approval from the Institutional Review Board before amending or altering the research protocol or
implementing changes in the approved consent form, study sites or study personnel, recruitment procedures,
3. to immediately report to the IRB any serious adverse reactions and/or unanticipated problems related to subjects
which may occur as a result of this study,
4. to train study personnel in the proper conduct of human subjects research,
5. to assure that the personnel approved to explain and obtain consent have read the protocol, understand the study,
and are fully knowledgeable of ALL details of the protocol and are able to answer ALL questions from research
subjects such as risks and alternatives, and if applicable, all alternate treatments and therapies.
6. to obtain IRB approval through the Continuing Review process until data analysis is complete,
7. to complete the Final Report Forms required by the UT IRB,
For Biomedical studies:
8. to adhere to the standards of Good Clinical Practice (GCP)*, developed by the International Conference on
Harmonization (ICH).
Department Chair & Dean’s Assurance Statement:
1. I have reviewed this application, and I believe that the benefits of the proposed research outweigh the risks to the
study subjects.
2. The Principal Investigator has appropriate training, experience, and expertise to conduct this study.
3. The Principal Investigator has adequate staff and facilities to conduct the project.
4. If I become aware of any factors which have the potential to adversely affect the risk/benefit ratio for study
subjects, or any issues that may reflect noncompliance with UT policies, or federal regulations regarding research
with human subjects, I will immediately report these to the UT IRB.
Disapprove indicates that you found some fault with the application and wish to make changes before the final
submission to the IRB for review. When you click the disapprove button, you will be asked to confirm your action and
will be provided with a text area in which to write your reasons for disapproval. Upon completing the reason, click the
“Yes” button to complete the disapproval. This will return the protocol to an editable state, where you or the
submitting investigator can make corrections before resubmitting.
Once you have chose either “Approve” or “Disapprove” you have completed the approval request. Congratulations!
The item will now disappear from your Action List.