Submitting NHSR Protocols (New WVU+kc IRB Module)

Overview:

A new IRB Protocols module in WVU+kc is being piloted by OHRP. During the early-adoption phase, only Not Human Subject Research (NHSR) protocols can be submitted in the new application. All other protocols should be submitted in the existing WVU+kc IRB module.

If conducting human subject research, a protocol must be submitted in WVU+kc to the WVU Institutional Review Board for review. Researchers will submit the protocol to be automatically routed to the appropriate reviewers (or returned to the researcher when necessary). Notifications by email will inform users when action or additional detail is needed.

training video overview of the submission process is also available.

Getting Started:

Start a new NHSR protocol document by logging into the NEW WVU+kc IRB module using your WVU Login credentials.

  1. On the Kuali dashboard, click Protocols. You will see the Manage Protocols page.
  2. Click the New Protocol button, and choose IRB from the drop-down. The IRB Protocol document will open.

Complete all required information in the following sections:

General Information:

The General Information section will walk you through choosing a principal investigator, and entering the title of the protocol. There are four required fields in this section:

  1. Principal Investigator: Click in the field, and begin typing the PI’s name; you will see suggested matching names. Click on the PI’s name from the list. You may need to include first and last names, search by username or scroll through the options to locate the correct person.
  2. Department/Lead Unit: enter part of the name of the WVU department that will oversee the proposed research. When you begin typing, units that match will appear in the list — click on the unit name to fill the field.
  3. Protocol Long Title: type the full title of the protocol
  4. Protocol Short Title: type a short-hand name for the project

Then click Next in the actions panel on the right side of the page to continue to the Screening Questionnaire.

Screening Questionnaire:

Which of the following best describes your research?

Carefully read over the qualifications and examples of a Not Human Subjects Research project. You can also use the Protocol Type Determination Tool to help you choose the correct protocol type. 

  1. Select the Protocol Activity Type that best describes your research by clicking the radio button next to the appropriate category.
  2. Click Next in the actions panel on the right side of the page. The full protocol document will open.

Note: Navigate to each section of the Protocol document by clicking the Jump to... links on the left side of the page. As you complete each section, a check-mark will appear next to the section links.

Personnel:

The Personnel section is where you will specify details about the PI and the other individuals who will work on this protocol or require access to the WVU+kc protocol document. 

  1. Click the Jump to menu link or scroll to the Personnel section of the protocol document.
  2. Will this study will include non-WVU personnel? Answer Yes or No
    • If Yes, an additional section for non-WVU Personnel will appear at the bottom of this section.

Note: COI Disclosure Status will appear on each protocol personnel record. The status field is populated according to data from the WVU+kc COI module, where researchers are required to report conflicts of interest in research annually. All Principal and Co-Investigators must have an Approved COI Disclosure Status.

Principal Investigator

  1. The Principal Investigator will already be listed in the WVU Personnel chart, with info provided in the General Information section. You must edit the PI’s personnel entry to complete a few remaining fields. Click the pencil icon to edit the PI’s information.
  2. If any fields are missing, enter the correct Email Address, Phone, or Non-Researcher Role.
  3. Review the COI Disclosure Status. If an update is required, follow the ‘here’ link to complete a new COI Disclosure in WVU+kc.
  4. Scroll down to the Delegated Tasks section of the Edit form, and click at least one check box to select tasks the PI will perform on the project.
  5. Review the Training Status area. Any current training certifications recorded in the WVU+kc system will be displayed here.
  6. In the Personnel Attachments chart area, click the Add Info (or Add Line) button to upload any attachments that are relevant for the PI’s personnel details - such as a CV or certification document.
  7. Attach any training or qualifications documentation by dragging & dropping a file into the box, or by clicking the Choose button to pick a file from your computer.
  8. Enter a Name (description) for this attachment.
  9. Click the drop-down in the next field to select the Attachment Type.
  10. Enter any Comments about the attachment, such as a description if Other was the selected Type.
  11. Click the Done button to close the Add Attachment window.
  12. Click the Done button at the bottom of the Edit window to save changes to the PI’s personnel information.

Other WVU Personnel

  1. Add all WVU personnel who will be working on the protocol to the chart by clicking the Add Line button above the personnel chart. Insert a new line and complete relevant details for each person.
    • If no other personnel will be added at this time, continue to the Primary Study Contact.
  2. On the Add screen, click in the Person field and begin typing the person’s name (or username). Click on the person’s name from the list of suggested WVU personnel.
  3. In the Home Unit field, enter part of the name of the WVU department that this person works in. When you begin typing, units that match will appear in the list — click on the unit name to fill the field.
  4. If the Email Address field is blank, enter this person’s email address.
  5. If the Phone field is blank, enter this person’s phone number.
  6. Enter this person’s Researcher Role and/or Non-Researcher Role. The red warning on these fields will disappear when at least one field has been filled.
    • Click the Add button to choose this person’s role from the list for either field.
  7. Review the COI Disclosure Status for this personnel member. 
  8. What Permissions should this user have to access the WVU+kc Protocol document? Check a box to grant them Full Access or Read Only permissions.
  9. In the Delegated Tasks section of the Edit form, click at least one check box to select tasks this person will perform on the project.
  10. Review the Training Status for this personnel member.
  11. In the Personnel Attachments chart area, click the Add Info (or Add Line) button to upload any attachments that are relevant for the personnel details.
    • Attach Personnel Documentation - attach any documents by dragging & dropping a file into the box, or by clicking the Choose button to pick a file from your computer.
  12. Finally, after all information and attachments are complete, click Done at the bottom of the Add/Edit Person screen to save all person details for this individual.
  13. Repeat the above steps for each WVU personnel member on this protocol.

Primary Contact and PI Details

  1. Designate which personnel member listed above will be the Primary Study Contact for this research project. Choose from the drop-down list.
  2. State the current position of the PI: enter the principal investigator’s position title.
  3. State the research history and years of experience of the PI: enter a thorough description of the PI’s experience with this kind of research.

Non-WVU Personnel

  1. In the Non-WVU Affiliated Personnel chart, click the Add Info (or Add Line) button to add personnel profile information for each protocol team member who is external to WVU.
  2. On the Add screen, complete the required fields for the non-WVU team member’s name and contact information:
    • First and Last Name
    • Phone
    • Email
    • Address
  3. Click Add to choose this person’s Researcher Role from the drop-down selector.
  4. Click to select the boxes for all Delegated Tasks that the non-WVU staff will perform. At least one task must be selected.
  5. In the Personnel Attachments chart area, click the Add Info (or Add Line) button to upload any attachments that are relevant for the personnel details.
    • Attach Personnel Documentation - attach any documents by dragging & dropping a file into the box, or by clicking the Choose button to pick a file from your computer.
  6. Click Done at the bottom of the Add screen to save all person details for this individual.

Degree or Program Requirements

Is this project being done to fulfill any kind of degree, program, or rotation requirements? Answer Yes or No.

Funding Source:

In the Funding Source section of the protocol document, add details about all funding for the project.

  1. Click Funding Source in the Jump to... menu to move to that section (or scroll down the page).
  2. Click the Add Info button in the Funding Source lines chart (or click Add Line above) to begin entering funding data.
  3. On the Add screen, click the drop-down selector to Select the type of funding. Additional details may be required, depending on type.
    • If funded by government, industry, private, non-profit, or higher-ed, please also provide the OSP Number and Sponsor Name and Billing Contact information.
  4. Click Done to complete the Funding Sources line.
  5. Continue adding lines (+Add Line) for each source of funding that will pay for this project.

Design:

Scroll down or click on the Design section of the protocol document. Here, you will describe the design of the project and answer additional questions specific to your type of protocol.

  1. Lay Summary - click in the text box to enter (or paste in) a description of the purpose and general aims of the research project. The lay summary must be written at an 8th grade reading level, and written for those without experience in the field of study. 
    • Use the readability calculator link to check the reading level of your summary.
  2. Click one radio button to Select the NHSR Activity Type that best describes this project.
    • If Case Studies type is selected, see a reminder to obtain authorization from participants.
  3. Type in the field to answer How are you obtaining the data or specimens? used in this project.
  4. Is the information being used de-identified, anonymous, or public data? Click Yes or No.
  5. How will you explain the project activity to the participants? Check all boxes that apply.
  6. How will you obtain permission from participants, and ensure voluntary participation with the option to quit the study for the participants? Check all boxes that apply. 
    • If Other is selected, please describe the method.
  7. Where will the activity take place? Again, check all that apply. 
    • If a commercial or educational facility will be used, please explain how permission for use of the facility will be obtained and provide a letter of permission in the Attachment section.
  8. Will social media be used? Select Yes or No. If Yes, please list all social media platforms that will be used.

Note: Protocol applications submitted without an adequate lay summary will be returned for revision, which may lengthen the time for approval. Review the SOP guide: G-05 Writing a Lay Summary.

Data Protection Certificate:

An approved data protection plan and certificate are required for submission of an IRB protocol.

  1. Attach the Data Protection Certificate received after completing the WVU Research Data Protection application form. Drag & drop a file into the box, or click the Browse button to pick a file from your computer.
  2. Does your Data Protection Certificate say that a Data Use Agreement is also needed? Answer Yes or No
    • If Yes, please attach the Data Use Agreement below. Drag & drop or Browse for a file.

HIPAA Requirements:

Scroll down or click on the HIPAA Requirements section, where you will answer questions about protected health information in this project.

  1. Does the research project involve collection of, or access to Protected Health Information? Answer Yes or No. This information will be indicated on your Data Protection Certificate. 
  2. If the project will involve PHI, are you requesting a HIPAA waiver? 
    • If Yes, please attach the HIPAA waiver below. Drag & drop or Choose a file.
  3. Will the data be de-identified? Answer Yes or No.
    • If Yes, review the de-identified data description and complete the additional fields:
      1. Please indicate the source of the de-identified data - click in the field to type a name/description for the data source.
      2. Please list the information requested in the data set - click in the field to enter the types of identifying information collected in the original data set.
      3. Investigator Certification - click the check-box to certify that the project’s data will not include identifying information and cannot be used to ID any individual.
  4. Are you collecting information on decedents as your target population? Answer Yes or No.
    • If Yes, you must complete the HIPAA Decedent Agreement fields below. If No, continue to the Attachments section.
  5. Click the Add Info (or Add Line) button to insert a line in the Everyone with Access to PHI chart.
  6. In the Personnel field on the newly created line, click the drop-down arrows to pick a personnel member on this protocol.
  7. Repeat steps 5 and 6 to add all individuals who will have access to any protected health information.
  8. Which HIPAA identifiers will be reviewed for decedents? Check the boxes for all that apply. If Other, please describe below.
  9. Read and confirm each of the statements in the Investigator Agreement list by checking all of the boxes.

Attachments:

Depending on your Project Type, different additional documents may be required to be submitted with your IRB protocol. Review the list of applicable document attachments.

  1. Click the Add Info (or Add Line) button to insert a line in the Protocol Attachments chart.
  2. Attachment - attach additional documentation by dragging & dropping a file into the box, or by clicking the Choose button to pick a file from your computer.
  3. Click in the Name field, and type the name/title of the document being attached.
  4. In the Attachment Type field, click the drop-down to choose the type of file being attached.
  5. Optionally, enter the Version Date for this file, or any Comments about the attachment.
  6. Below the Protocol Attachments chart, answer whether you need to record any general protocol notes. Answer Yes or No
    • If Yes, click Add Info (or Add Line) to create an entry in the Notes chart. 
    • Enter a Note Topic, Note (content), and click the calendar to select a Date.

End of Protocol Form:

Instructions for submitting the protocol will appear in this section. Once all sections of the protocol document are marked complete (check-mark) in the menu, principal investigators can submit the protocol for approvals and IRB review. Non-PI protocol creators can send a notification to the PI that the document is ready for submission.

Note: The Administrative Details sections at the bottom of the protocol form are for IRB administrative use only. This area is read-only for researchers.

Submit the Protocol:

When all details are included and each section displays a check-mark in the Jump to... menu, you are ready to submit the protocol for review. Only the principal investigator can submit the protocol.

  1. In the actions menu in the right-hand column of the protocol page, click the Submit (or Notify PI to Submit) button to send this protocol for review. 
    • If choosing Notify PI to Submit, the principal investigator will receive an email notification to complete the submission. The protocol remains editable until actually submitted.
    • Click the Back button to return to the Protocols application page.

Note: After submission, the Status of the protocol will show Submitted for Review, and the actions menu will display the option to Withdraw (rather than Submit) the protocol. The document can not be edited unless sent back for revisions.

Validation Tool:

If your protocol contains any errors, the Validation Tool will produce a warning message at the top of the document indicating how many errors were found. Green check marks will also be
removed from the Jump to... menu for any section that does not pass the validation check.

  • Fields that need attention can be identified easily by looking for red error icons.
  • Correct the errors by clicking in each field or list item to edit or add the missing information until all the warning messages disappear. Then, click Submit again to send your protocol.

Details

Article ID: 133264
Created
Wed 7/14/21 1:54 PM
Modified
Tue 9/14/21 4:38 PM

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