Regulatory Management: PI/Lab Team - IBC Application Overview

Overview

This document provides an overview of the IBC Application and the functionality within it.

The IBC Application has six high-level sections:

• Overview
• Lab Personnel and Space
• Types of Work (i.e. recombinant DNA/SNA, non-recombinant infectious agents/biological toxins, human- or animal-derived substances, federally regulated Select Agents/Toxins)
• Risk Mitigation
• Dual Use of Concern
• Finish Application

All questions that display are required. Depending on the response to questions, related sections and questions may display (see E below). These sub-sections and sub-questions provide the IBC, OSEH, and associated compliance offices (e.g. IACUC) with the detail about the research and biosafety precautions needed to protect the PI, lab personnel, campus, and the community.

Important Information

• For an overview of the conditional content sections, see IBC Application Smartform Path.
• IBC Applications have a naming convention of Last Name, First Name – IBC Application (IBCA000001234).
• Your previous IBC Registration (i.e. “legacy” registration) has a naming convention of IBC Registration for First Name Last Name (IBC000001234). Legacy registrations are available for viewing.

Contents

• Navigation Tools
• Question Formats
• Table Views
• Error Notifications
• Finish the IBC Application

Navigation

Role: Study Team Member > Home Workspace > Create New Biosafety / IBC Application

Navigation Tools

Navigation tools display at the bottom and left-hand side of each application page.

1. Click Continue to save your answers and go to the next section in the application.
2. Click a section in the Forms Menu to go to that section. This navigation tool is most often used to return to a previously completed section of the application to make changes; or when amending an approved application.
3. Click Save to save your data entry in the application and remain on the same page.
4. Click Exit to close the IBC Application and go back to the Application Workspace.
   Note When closing an incomplete application, always click Save prior to clicking Exit to save your work for a later date.

Question Formats

Many of the questions in the IBC Application are Yes/No answers, but you will also see text entry fields. "Yes" answers may trigger more detail sections and sets of questions. The conditional functionality allows you to answer only those questions that are relevant to the type of work you will do with biohazards.

Example: Types of Potentially Hazardous Biological Materials Page

5. Depending on the response to questions, additional sections may be required. For example, if you select Yes to Recombinant DNA as a type of work, then sub-sections 1-3 (e.g. 1. NIH Guidelines for Research Involving rDNA/SNA Molecules) and related question-sets (e.g. 1.1 NIH Guidelines Exempt) will display. Clicking Continue takes you to the first sub-section.
   Note The Forms Menu list updates to display the additional required sections (see the highlighted section in the screenshot above).

Example: Question Set

Questions with an Add button allow you to enter multiple sets of answers (as applicable).

6. Click Add to open the initial question-set.
7. After completing all answers in the initial question-set, click (as applicable):
   • OK – if you have only one answer-set, or after entering the final answer-set.
   • OK and Add Another – to enter an additional set of answers.

delete You must click OK to save answers and close the question-set. Then, click Continue to go to the next section of the application.

Table Views

There are two types of table views in the IBC Application:

• Question-set summaries (editable)
• Conditional section summaries (viewable)

See the examples below.

Example: Question-Set Summary

8. A row-complete indicator (green checkmark) displays for a set of answered questions.
9. A warning symbol delete (yellow exclamation point) displays if one or more questions have not been answered or are incomplete within an answer-set.
10. Click delete Update to edit an answer-set.
11. Click delete Delete to remove an answer-set.

Example: Conditional Section Summary

12. A summary page may display at the end of a section for you to review answers and check for completeness. To update an answer, use the Forms Menu to return to a previous page.

Error Notification

In addition to the warning symbol delete that may display in a question-set summary table (see I above), the IBC Application also displays error information in the following ways:

Page Level Error Validation

13. A few application pages contain page-level validation that requires you to answer a question before you can continue to the next page. In these cases, an error message displays near the top of the page.

Change Previous Answer Warning Message

14. A warning pop-up displays if you change a previously saved answer to a question (e.g. from Yes to No) that will cause conditional sections and questions located elsewhere in the application to be deleted.
15. Click OK to change your answer and delete previously entered information.
16. Click Cancel if you do not want to delete previous answers. You will then need to change your answer back or Exit without saving changes.

Validate

Click file Validate to check the application for errors or incomplete answers. Error/Warning messages display within the forms menu.

17. Use a Forms Menu link to go directly to the page, section, or question-set to correct the error. Remember to Save your changes.

Finish the IBC Application

18. Always click Error Check prior to finishing the application to validate that data entry is complete. Error Check displays the same results table as file Validate (see Q above), but in a separate window.
19. Click Finish to indicate all data entry is complete and return to the IBC Application Workspace.
    Note Clicking Finish does not submit the IBC application. Only the PI can submit the Application for review. For more information, see Submit an IBC Application.