Submit a Human Subject Research Protocol

If conducting human subject research, a protocol must be submitted in WVU+kc to the WVU Institutional Review Board for review. Start a new protocol document by clicking on the Create IRB Protocol link located in the IRB menu bar of the WVU+kc dashboard.  

Required fields to Save

The Protocol page is the first page of the document and collects general information about the protocol. There are six required fields that must be completed in order to save your protocol:

• Description: provide the short title of the project in the Description field, which has a 40 character limit

• Protocol Type: use the Protocol Type Decision Tool to determine protocol type. Then select the anticipated level of review the protocol will likely require from the drop-down list. Keep in mind that the final review determination will be made by the Office of Human Research Protections (OHRP). Selecting the wrong type may result in providing too much or not enough information about your protocol.

• Title: enter the full title of the project in the Title field, which has a 2000 character limit

• Principal Investigator: indicate the person who will have absolute responsibility for the overall conduct of the research

• Lead Unit/ Department: select the primary department of the PI in the Lead Unit/Department field

Although they are not required to save the document, you should complete as many other fields as possible on the Protocol page if the information is available. ECOG, RTOG, COG, or other numbers can be added in the Additional Information section of the page. If you are submitting a Full Board (Clinical Trial) protocol, you will be required to enter at lease one Other Identifier in the Additional Information section.

Once all required fields have been completed, click the Save button or navigate to the next page (tab) in the Protocol document to prompt the WVU+kc system to save the protocol.

Add Personnel

The Personnel page is where you will specify the other individuals (besides the PI) who will be working on this protocol or require access to the WVU+kc protocol document. The PI that was selected on the Protocol page will be automatically added to the personnel page in an expandable information section. A summary of the PI Qualifications must be provided for all PIs in the Person Details section. The qualifications should be a few sentences stating the PI's current position at WVU, years of experience, and any previous experience in this study's field of research.

To add personnel to the protocol:

1. Click the search icon (magnifying glass) in the Person field at the top of the page to open the WVU Employee/Student Search screen.

   • If the person you need to add is not a WVU employee or student, click the Non-WVU Person Search to check if that peson has been added to the database. If not, you can add them to the WVU+kc address book by clicking the link at the bottom of the search area (Can't find what you're looking for? Click here to add a new Rolodex Entry) to create a record for this person.

   • If the non-employee will need access to edit the protocol and they were not already in the database of non-employees, you will need to submit a WVU Login Special Account Request on their behalf to grant such access.

2. Enter part or all of the person's name in the search field. You can search by first or last name, or conduct a wildcard search by using an asterisk (*) to replace some letters in the name.

3. After you have found the correct person in the search results, click the Return Value link next to their name to pull their information into the Add Person form.

4. Click the drop-down in the Protocol Role field to choose this person's role.

5. Click Add Person to insert a new section for this individual on the page below.

A details drop-down will be inserted on the Personnel page for each individual you add to the protocol. Click the Show button to display each sub-section for their personnel details.  

Note: The PI and all Co-I's must have an Up to Date Conflict of Interest Disclosure status (viewable in the Person Details area) in order to submit the Protocol. Users will not be able to submit the Protocol successfully if this requirement isn’t fulfilled.  Learn more about Conflict of Interest Disclosure.

To delete any person from the protocol

1. select the checkbox in the tab area at the top of the Person Details section (next to their name).

2. Then click the Delete Selected button at the bottom of the page.

Permissions

The Permissions page can be used to assign editing (Aggregator) or view-only (Viewer) rights on a protocol. The Assigned Roles section will display all of the people who can currently view or edit the protocol. The Users section will allow you to change each person's access permissions.

To edit permissions for someone who is already on the protocol:

1. Click the Edit Role button in the row with their name under the Users section.

2. Click the checkbox(es) for the role(s) you would like to add or remove for this person.

3. Click Save to apply the new roles.

To add a new person who should have access to this protocol:

1. In the Add row at the top of the Users section, click the Search icon (magnifying glass) in the User Name field to search for a WVU employee or student.

2. Enter part or all of the person's name in the search field. You can search by first or last name, or conduct a wildcard search by using an asterisk (*) to replace some letters in the name.

3. After you have found the correct person in the search results, click the Return Value link next to their name to pull their information into the Add Person form. The name and department details for that person should now appear in the Add row.

4. Click the drop-down in the Role field to choose which role to assign for this person.

5. Click Add to complete adding the new person to the protocol.

To delete a role:

1. Click the Delete button in the Users section row for that person.

2. Click Yes to confirm that this person's access role should be deleted.

3. Click the Reload button at the bottom of the WVU+kc page to refresh the list.

Protocol Details / Questionnaire

The Questionnaire page is where the bulk of the information about a protocol will be entered. All required sections will display based on the Type of protocol selected on the Protocol page. The questions are broken into categories listed in different sections of the page. Once all questions in a section have been answered and the page has been saved, the header for that section will change color from red (Incomplete) to green (Complete), to indicate that it is complete.

Click the Save button at the bottom of the page to save your answers to each questionnaire section. After saving your answers, you can exit WVU+kc and come back to finish the questionnaire at a later time. You can modify responses as desired until the protocol is submitted for review.

Notes & Attachments

Throughout the course of completing each section of the Questionnaire page, you may see instructions indicating the need to attach additional documents, such as a HIPPA Waiver of Research form or an IRB Authorization Agreement. Attachments related to protocols can be uploaded on the Notes & Attachments page.  

To attach a document:

1. Click the Upload protocol attachments button in the Add Protocol Attachment section on the Notes & Attachments page. A file upload box will appear.

2. Select files to upload by one of two methods:

   • Drag-and-drop a file into the dashed-line box, from any folder or desktop location on your computer

   • Click the Upload a file button to select the file from its location on your computer

3. Each selected file will appear in a list below the dashed-line box. Click Finished to upload the files and attach them to your protocol.

The documents that you uploaded will now be displayed in the Attached Items section. For each attached document, you must indicate the Type, Status, and include a Description. Click the Show button for each document in the Attached Items section.

To add descriptors for each attachment:

1. Click the Show button next to a document listed in the Attached Items section.

2. In the Attachment Type field, click the drop-down button to choose the type.

3. Review the Status field and select the correct status for this document. This field defaults to Complete. If this field is Incomplete for any document the protocol will not be able to be submitted.

The Notes section allows you to add any notes as a reminder to yourself or protocol staff, or to correspond with departmental administrators or the OHRP. However, notes are not required. You can add, edit or delete notes in this section until the protocol is submitted. After the protocol is submitted, it will become read-only and cannot be edited or deleted unless an amendment/renewal is created from this protocol document.

To add a Note to the Notes & Attachments page:

1. Click Show in the Notes section of the page.

2. In the Add row, enter a Note Topic to identify the type or purpose of the note.

3. Enter the content of the note in the Note Text field (click the pencil icon to open an editing window, if desired).

4. Click the Add button in the same row to insert the note as a new row in this section.  

   • A date/time stamp with the name of the author will appear when the note is saved.

5. After the page has been saved, click the Edit button to make changes, or the Delete button to remove the note.

Submit the Protocol

Navigate to the Protocol Actions page in order to submit a protocol whether it is a new protocol, or to submit a renewal/amendment to an existing protocol. Actions available to you will display in the Request an Action section depending on the status of your protocol. Before you submit the protocol, you can use the Data Validation tool to check that all required information has been included: click the show button on the Data Validation section to view any validation errors, and click the Fix button to resolve each one before proceeding to submit the completed protocol. If you receive a validation error for COI Disclosure status, you will have to ask any undisclosed or out of date personnel to complete their disclosures via the Kuali Conflict of Interest form.

To submit your protocol:

1. Click Show in the Submit for Review sub-section to see the fields.

2. Click the drop-down to select the Submission Type for this protocol document.

3. Select a Type Qualifier if needed.

4. Click the Submit button to send this protocol for PI approval (if needed) and OHRP review.

Once your protocol has been submitted, the status will change to Routing Protocol to indicate your protocol has entered workflow to receive all needed approvals from the PI (if needed), biosafety, and radiation safety, as applicable.

Check the Status of the Protocol

After submitting a protocol, there may be several approvals that need to take place before the protocol reaches the OHRP. 

To check the status of a protocol: navigate to the Protocol Actions page and open the Route Logsection. 

• The Pending Action Requests section will display the next action that is needed, such as PI or biosafety approval.

• Once the protocol has reached the OHRP, the Pending Action Requests section will display multiple people who can approve the protocol (members of the appropriate review board for this type of protocol). 

• The Actions Taken section will show you the date and time that an approver took action on your protocol.

Revise and Resubmit a Protocol

If your protocol has been returned for revisions:

1. Open the Correspondence section of the Protocol Summary page to see the list of letters that have been generated for your protocol. 

2. Click the view button to open the most recent correspondence for Specific Minor Revisions or Substantive Revisions Requested. You will be able to either save or print the PDF letter that list all of the items that need to be addressed on your protocol. 

3. Edit your protocol as needed, and then navigate to the Notes & Attachments page. 

4. Click show to view the Notes section, then enter a Note Topic that corresponds with the bullet points on the revision letter and provide an explanation of the changes made in the Note Textsection. 

5. Navigate to the Protocol Actions page, and click Show in the Submit for Review sub-section.

6. Click the Submission Type drop-down to select the Response to Previous IRB Notificationsubmission type.

7. Click the Submit button located in the Submit for Review section.