Biological Registration and Renewals

Quick Start Guide for PIs

Last updated: February 4, 2019

lumen.northwestern.edu

Table of Contents

Complete a Biological Registration….…..………...………………..…..………………………………………………………… 1

When to Complete a Biological Registration……………..……………………………………………………………….. 1

Biological Registration Wizard……..……………………………………………………………………………………………… 1

Delegate the Registration to a Lab Member…...………………………………………………………………………….. 2

Add Research Projects…………..…...………………...…………………………………………………………………………… 3

Complete the Biological Research Project Form…..…………………………………………………………………….. 4

Add Biological Materials Surveys……...……………………………………………….………….….……………………….. 6

Recombinant or Synthetic Nucleic Acid Molecules Survey………………….………………………………….. 7

Enter Biological Materials Data…………………………………………………………………………………………………... 8

Add Biological Forms………………………………………………………………………………………………………………….. 10

Review Registration Summary……………………………………………………………………………………………………. 13

Certify and Submit Registration………………………………………………………………………………………………….. 14

Registration Submission Confirmation………………………………………………………………………………………... 15

Address Requested Changes……………………………………………………………………………………………………….. 16

Registration Approval…………………………………………………………………………………………………………………. 17

Amendments……………………………………………………………………………………………………………………………... 18

Complete a Biological Registration

When to Complete a Registration

You will be asked to complete a Biological Registration if you:

1. Have a lab that is newly approved for use of biological materials (recombinant and non-recombinant)

2. Have a biological materials lab with a registration that has expired

Upon login you will see a prompt alerting you to this requirement. Select “Biological Registration Wizard” to

begin completing the Registration. Select “Skip Setup” to complete the Registration at a later time.

1

1. Choose to delegate the task of completing the Registration to a trusted member of your laboratory

(such as a Safety Designate), or

2. Select “Continue” to fill out the Registration yourself.

The Biological Registration Wizard page gives you basic information about what to expect when you

complete the Registration. On this page you may:

Biological Registration Wizard

2

Delegate the Registration to a Lab Member

If you choose to delegate this task to a trusted member of your lab, you will see this page. You may:

1. Select one of the members of your lab from the dropdown, or

2. Add a new member to your lab if you do not see them available

Once you are finished, select “Delegate” to complete the process. A message will be sent to your chosen

delegate to notify them of this assignment.

3

Add Research Projects

Select “Add a Project” to enter specific details of your lab’s biological research. This section collects

information about your lab’s research with human source materials, microbial agents and recombinant

or synthetic nucleic acid molecules.

Complete this step for each distinct project in your lab before moving on in the Registration process.

Only include information about the current research projects in your lab. If your research changes in the

future, you must submit an amendment to update your research projects.

4

Complete the Biological Research Project Form

Enter basic information about the project. Throughout the Registration, all fields with an asterisk (*) are

required.

Enter information about the project’s biological materials. Some selections in this section will trigger

additional surveys to provide more accurate classification of experiments.

5

Complete the Biological Research Project Form continued

Indicate spaces where project work will be conducted and materials will be stored.

Identify all individuals involved the in the project, including your lab members, other individuals who are

part of the University community (lookup tool searches University directory) and any external collaborators.

When you have entered all information on the Project Form, click “Submit”.

6

Add Biological Materials Surveys

Next, you will be required to complete surveys specific to biological materials you checked in the Project

Form(s). Some selections in these surveys will trigger additional surveys to provide more detail about

your research. For example, checking “Inject human cells into laboratory animals (mice, rats, etc.)” will

trigger the Animal Source Materials Survey later in the Registration process.

Click “Next” or select each individual tab to complete the survey. If a survey does not apply to your lab,

click Opt Out.

For each survey completed, click Save on the final screen.

If you attempt to save a survey without providing all the required fields, you will be prompted to complete

the necessary information.

7

Recombinant or Synthetic Nucleic Acid Molecules Survey

This survey documents your work with recombinant or synthetic nucleic acid molecules and directs you to

applicable sections of the NIH Guidelines. Experiments exempt from NIH Guidelines are also documented

here.

A number of questions in this section expand to require additional information in response to a “yes” answer.

Links in blue will take you to applicable sections of the NIH Guidelines.

8

Enter Biological Materials Data

Next, you will be required to provide additional information related to the Biological Surveys you completed.

Depending on your Biological Surveys, this may include data on cell lines, tissues, microbial agents or nucleic

acid reagents. In the example below:

1. Enter information about the cell line.

2. Click “Submit”.

3. Click “Add Cell Line” to add additional lines, if applicable.

4. When finished adding your cell lines, click “Next Step”.

9

Enter Biological Materials Data continued

For microbial agents, select from the drop-down list and complete additional fields as needed.

1. You may enter multiple strains in the “Strain” field; however, there is a character limit. Alternately,

you may type “Various” in the “Strain” field and enter all the strains in the “Notes” section.

Click “Submit” when finished.

10

Add Biological Forms

If applicable, you will need to complete registration forms for pathogens or viruses used in your research.

Click on “Add Pathogen Registration” or “Add Viral Vector Form” as needed to complete these registrations.

Enter Biological Materials Data continued

You will see a confirmation of your added microbial agent.

11

A separate form should be completed for each pathogen or viral vector. Use the tabs at the top of the form to

progress through the registration.

Add Biological Forms continued

If you are unable to finish a Biological Form, you can return to where you left off by following these steps:

1. Click the Bio tab.

2. Click Biological Summary.

3. Under Additional Forms, click Add a Viral Vector Form/Add a Pathogen Registration Form.

4. Select “Use Autosaved Version” in the pop-up window.

12

When completing the Personnel section (Step 6 in Viral Vector Form, Step 5 in Pathogen Form), check the box

next to any individual who will work with the viral vector/pathogen, then enter the user’s experience and

qualifications.

Add Biological Forms continued

After completing all steps in the Viral Vector/Pathogen form, click Submit.

You will see a confirmation of your added viral vector/pathogen.

Review Registration Summary

13

The final step is to review the information entered in the Biological Registration. You will review all the

information you have added about your lab’s research project(s), use of biological materials and work

spaces and personnel. Each section provides links to edit or remove information you have entered.

Each section provides links to edit or remove information you have entered.

When you have completed your review, click “Certify” at the bottom of the page.

Certify and Submit your Registration

14

Read and initial each item on the Biological Summary page, then click “Certify and Submit”.

Registration Submission Confirmation

15

You will receive a confirmation message that your Registration has been submitted.

You will also receive a message in your Compliance E-Mail Inbox that your Registration Status is “Awaiting

EHS Review”. The Biological Safety Officer will receive notice that your Registration has been submitted.

Address Requested Changes

16

If changes or additional information are required prior to approval of your Biological Registration, you will

receive an email in the Compliance Mailbox.

Click the link in the email.

Click “View Open Notes” to see what needs to be addressed.

Navigate to the section indicated in the Notes, click Edit and make the requested changes. When you have

finished making changes, you will need to Certify, then Certify and Submit again (see pages 13-14 of this

guide).

Registration Approval

17

The Biological Safety Officer will review your Registration and will approve it or indicate that it requires

review by the Institutional Biosafety Committee. You will receive notification of Registration status changes

through the Compliance Mailbox.

Amendments

18

Once your Registration has been approved, you will see the approval on your Compliance Dashboard.

Registration Approval continued

If you want to make changes to your Biological Registration after it has been approved, select “View or

Update Biological Usage Summary” under the Bio tab to edit.

19

Add a project:

Amendments continued

When you are finished with your amendments, you will need to recertify your Registration. Click “Biological

Summary, scroll all the way to the bottom and click Submit Amendment. The status of your Registration will

change to “Amendment Awaiting Review” until it is approved by Biological Safety Officer/Institutional

Biosafety Committee as needed.

Update a project: