BioRAFT Biological Registration Guide

v.20191029

To be able to submit a bio-registration, your lab must be “bio-enabled” within BioRAFT. If you have not yet been “bio -enabled”, then please email biosafety@northeastern.edu. Include a brief

description of your planned research activity and a request to be enabled for bio-registration within BioRAFT.

1. Biological Registration Prompt Once your lab has been “bio-enabled” in BioRAFT, then PI and delegates will be prompted to fill out the registration wizard upon login to BioRAFT. Begin by clicking “Biological Registration Wizard”

2. Biological Registration Wizard You will be prompted with instructions. Click “Continue”.

3. Adding Projects After selecting “Continue”, the PI will be led into the “Enter Laboratory’s Research Projects” page. For each distinct biological project associated with your lab’s work, you will need to generate a separate “project” in BioRAFT. Click “Add a Project” to enter a new Project to your Biological Registration. Be sure to add all projects before moving on to the next step of the registration wizard.

A. Completing the form

At the moment the name of the funding sources for only this project is required not grants

b

Project title should resemble the work intended to be done. If your project is related to any grants the same title should be used.

B. Brief Summary of Project Per the NIH Guidelines, two of the members who sit on the Institutional Biosafety Committee (IBC) are community representatives. In order for these members to understand the proposed research, use lay terms to provide a brief description of the overall objectives and goals of this research. Briefly explain how the agents will be used. Do not use field-specific terms and phrases.

C. Project Biological Materials and Details The next step is to select the appropriate category of materials that will be used for this specific research project. These selections will trigger additional surveys to be completed for more accurate classification of experiments.

All written sections can be expanded by clicking and dragging this corner.

D. Additional Activities/ Dual-Use of Research of Concern Please note that if you plan on shipping any biological materials then you must complete a training requirement to do so. If you were not triggered to do this training, then please have your lab’s designated shipper contact the Office of EHS for the training. Specific forms must be submitted for each shipment.

E. Description of Experimental and Procedural Details You must provide a concise description of this project’s procedures involving biohazardous agents, including all research involving recombinant and synthetic DNA/RNA that you will be performing. You must:

• Provide sufficient information about the techniques that will be in use while handling biohazardous materials. This information must be clear.

• Provide a description of the genes used (including function). • Indicate the culture volumes, maximum concentrations and other agent specific

information. • Identify at what stage the agent is inactivated. • Provide a risk assessment for the materials and procedures (e.g. risk group of agents,

hazards of procedures, etc.) • Outline the controls that are in place to protect against exposure (e.g. personal

protective equipment, etc.)

F. Description of Experimental and Procedural Details (Continued) Structure Template Please try to use subtitles to separate each section of your project. Each section should include the names of the materials that will be used. If you have multiple cell lines that will be used you may be able to generalize by saying, “All human cell lines will be used for…”. It is important to note that fact, where true, in the “purpose” field of each project. When it comes to the use of microbes it is preferred that you list them individually, instead of saying “All bacteria or all viruses.” Strain specific information does not have to be detailed here, but should be clearly listed under “materials”.

Example:

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Complet this if you are required to transport biohazardous materials

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If your work involves the introduction of any biological/biohazardous materials (that are involved in or are products of this project) into animals, then please include this work in a separate subtitle. You also need to submit an Animal Hazard Addendum (AHA). Make sure that the information on the form matches your registration. This will expedite the approval process. AHA is a form used between the NU IACUC office and the EHS Biosafety team to ensure that all procedures are approved.

Provide a risk assessment for the materials and procedures (e.g. risk group of agents, hazards of procedures, BSL for handling, etc.).Outline the controls that are in place to protect against exposure (e.g. personal protective equipment, BSC, safety cups, etc.) *Safety cups must be used when centrifuging RG2 materials and all human materials. Other options are:

• Using airtight rotor that can be removed from the centrifuge without removing the lid. Samples can be spun, whole rotor can be removed and only opened inside the BSC

• Bring centrifuge inside BSC. • Parafilm centrifuge tube, spin, user must wait 10 minutes before opening the centrifuge to allow aerosols to settle.

This section should always be the second to last section of the experimental details, even after amendments, and must be updated as necessary.

Decontamination/ Waste Management All work areas and equipment (bench tops, biosafety cabinets, all benchtop equipment, and incubators) will be decontaminated with the following liquid chemical disinfectant: (insert name of disinfectant, concentration and contact time).

• The disinfectant will be applied liberally. • Surfaces must be treated for a 10-minute contact time • All solutions will be labeled by their contents and date of preparation.

Waste Management – ISEC ONLY.

• All solid waste with the exception of true sharps will be collected inside of a burn box that will be lined with two red biohazardous bags

• Absolutely no disposal of hazardous liquids in burn box. Small volumes of non-hazardous liquids inside sealed plastic tubes is allowed. Nothing larger than 50ml centrifuge tubes.

• Cardboard lid should be on burn box when not in use. • True sharps (needles, broken glass/plastic, blades, Pasteur pipettes etc.) will be placed in a hard-walled sharps container.

• When container reaches 2/3 full. It will be closed and placed inside the burn box. • If preferred serological pipets and micropipette tips can be disposed of in either a pipet keeper. • Bio-bins should only be used by labs producing small amounts of biological waste.

All waste gathering and packaging of burn boxes MUST be done in the lab. NOT in the lab coat room or bio-waste collection site.

• Once burn box is full (no more than 40lbs), both red bags must be gathered and twisted into one gooseneck tie. • Box must be taped down and labeled with PIs name (without blocking the generator label or any other markings). • Generator label must be placed on the box. • Box must be brought down to room 129.

Liquid Waste - Chemical Decontamination All liquid waste will be collected in trap container connected to a vacuum system or in containers that can be closed (ex. Bottles with screw caps).

• For a 10% bleach solution (minimum), 1 part bleach will be added to 9 parts of biohazardous liquid. Mixture will stand for a minimum of 30 minutes at the site of generation (e.g. inside the biosafety cabinet, etc.) before sink for disposal.

• Liquid waste that is not fully decontaminated must never be left in the sink, particularly if the sink is used for handwashing or if it has an eyewash station.

*If you have limited space and do not work with RG2 materials then you can use a glass bottle with a screw cap as a central waste collection site. Bottle must be closed until disposal. **USE OF AUTOCLAVE FOR LIQUID/SOLID WASTE DECONTAMINATION IS NOT ALLOWED IN ISEC. AUTOCLAVES ARE NOT SPORE TESTED ** Solid Waste – Materials that require BSL 2+ containment Waste be collected separately and treated/packaged immediately after generation. All consumables (serological, micropipette tips, culture plates, etc.) must be bleached and drained before disposal into burn box. Liquid waste must be bleached immediately and promptly disposed. ______________________________________________________________________

Should follow the risk assessment. . If the amendment requires new practices then please be sure to update this section.

All labs in ISEC must have this procedure added at the end of the registration with all blanks filled.

Waste Management – ALL OTHER LOCATIONS All waste containers used will be labeled with PI’s name.

• True sharps (needles, broken glass, blades, etc.) will be placed in a hard-walled sharps container. • Serological pipettes and micropipette tips will be disposed of in either a pipet keeper or Bio-bin.

*Once containers reach 2/3 full, they will be closed, taped, checked for labeling and will be dropped off at the closest sharps collection location, ________. Liquid Waste - Chemical Decontamination All liquid waste will be collected in trap container connected to a vacuum system or in containers that can be closed (ex. Bottles with screw caps).

• For a 10% bleach solution (minimum), 1 part bleach will be added to 9 parts of biohazardous liquid. Mixture will stand for a minimum of 30 minutes at the site of generation (e.g. inside the biosafety cabinet, etc.) before sink for disposal.

• Liquid waste that is not fully decontaminated must never be left in the sink, particularly if the sink is used for handwashing or if it has an eyewash station.

*If you have limited space and do not work with RG2 materials then you can use a glass bottle with a screw cap as a central waste collection site. Bottle must be closed until disposal. Autoclave - Only monthly spore tested and annually calibrated autoclaves can be used to disinfect waste. All personnel who use an autoclave must complete the online and classroom autoclave training. Liquid Waste - Autoclave This is not an option for any liquids containing any hazardous chemicals.

• All liquid waste to be autoclaved must be collected in either Pyrex glass containers or autoclavable plastic containers. • Once the container reaches no more than 50-75% of its volume, the cap will be place on top of container’s mouth and

taped down with autoclave tape (Do NOT screw the cap on). • It will then be immediately placed in an autoclavable secondary container and transported in a lipped cart to _____ for

autoclaving. Solid Waste

• All solid NON-SHARP biohazardous materials (gloves, plates, paper towels, etc.) will be placed in a red biohazardous bin, labeled with a biohazardous sticker, and lined with CLEAR AUTOCLAVABLE bags

• When approximately 2/3 full, the bag will be removed and taped partially closed with autoclave tape. • There must be enough space for steam to enter the bag and decontaminate all the waste. The bag will also be

labeled with PI’s name and date. • The bags will then be placed inside a clean red transport barrel and taken to the autoclave room, _______. • Once at the autoclave facility, lab coat, eye protection and a new pair of gloves will be put on. • The bags will be removed from the barrel and placed inside a secondary autoclavable container (MUST be labeled with

the PI’s name and lab location). • Disposable gloves will be removed and placed directly in opened bag to be autoclaved, • Hot gloves will be put on to place the secondary container containing the waste bags inside the machine to be autoclaved

at 121°C. Length of cycle depends of the weight of the bag, can be anywhere between 30 to 60 minutes. • When the cycle has finished and the bags are cool, they will be placed inside a black bag along with a completed

Autoclave Waste Treatment label placed outside the black bag. Solid Waste – Materials that require BSL 2+ containment Waste be collected separately and treated/packaged immediately after generation. All consumables (serological, micropipette tips, culture plates, etc.) must be bleached and drained before disposal into burn box. Liquid waste must be bleached immediately and promptly disposed.

All labs NOT in ISEC must have this procedure at the end of the registration, with all blanks filled in.

G. Authorization and Permits In the Authorization and Permits section, include the relevant protocol numbers and identifying information. Please add the protocol/permit numbers if any apply to the project. If the proposed biological registration does not include IACUC/IRB/USDA/CDC authorization or permits, please fill the indicated section with “N/A” for “not applicable”.

If at any point in the future you make amendments to the IACUC, IRB, USDA, or CDC protocols, then you must include that amended information in the “Additional Information” sub-section.

Contact Nan Regina (NU Intuitional Review Board) if your work involves the use of any biological materials that were obtained from human subjects. Your work might need their approval. Nan Regina: (n.regina@northeastern.edu)

Please list the appropriate IACUC protocols that apply to THIS project. If you haven’t submitted an animal hazard addendum, yet, then please do so.

If you have a USDA permit that applies to this work, please include it here. The transport of biohazardous materials across state lines might require a USDA permit. Please confirm if this applies to you.

H. Rooms and Spaces* This section will list all rooms/spaces associated with your lab in BioRAFT. If there are any missing rooms or spaces associated with biological project’s work or storage, please fill out this request form. This form can also be used to request the removal of spaces that are no longer associated with your lab.

*If you will be using another’s PIs space to do biological work involved in this project, please submit a request to add the space to your lab using the form linked above. In addition, an e-mail/letter must be sent to biosafety@northeastern.edu by the PI responsible for the shared space to confirm that they agree to the use of their space by another group. This email/letter will be uploaded into the BioRAFT profile of both labs.

I. Project Team Members The Project form will automatically include all lab members in BioRAFT. Please select those that will be participating as part of this project. It is important that the lab members list is ALWAYS up to date. Please eliminate lab members who have left the lab, and assure that the list is updated. You can always save your progress and update the lab member list separately. You can “Edit” the project to update the members that will be participating on the project.

If there are collaborators within the institution, but not in the lab, list them here.

List all external collaborators involved in this project here

4. Biological Material Surveys Once you have entered all the lab’s project, you will be prompted to complete biological surveys. These surveys are generated based on the materials that were selected in all of your projects. Below is an example of the types of general information you will need to complete. There are also other surveys that you may be prompted to complete based on your research materials. When filling out these surveys, it is important that you take into consideration that these surveys are meant to capture ALL the information on how this type of materials is used in the laboratory, not just in the a specific project. ** The surveys will be appear automatically AFTER you have completed your first registration submission. After approval, and as you are submitting amendments, you will see a notification under “biological summary” that a new biological survey needs to be completed. When submitting amendments it is essential that you review the material surveys and update all relevant information to reflects any changes indicated in the amendments (if any) **

A. “Describe” Tab in Material Surveys Several of the biological surveys include a tab that will prompt the PI to describe the proposed research as it relates to the indicated material. To complete this section properly, provide a brief description about how you plan to use the indicated materials. As a reminder, the material surveys are meant to capture ALL of the work in the laboratory and not just the work associated with a single project. Accordingly, when filling out the material survey forms, you must include and describe all materials and their usage.

B. Recombinant or Synthetic Nucleic Acid Molecules Survey When relevant, this survey will ask general questions regarding the overall use of Recombinant or Synthetic Nucleic Acid Molecules in the laboratory. When a topic is selected, that topic will expand, showing more relevant subsections of the NIH-Guidelines. This information will display the applicable NIH-Guideline to that specific question to the Labs Registration. Answering “Yes” to the question below will show further questions with the related topics, the answer of “No” will not expand the sub-questions.

C. Additional information in the rDNA Survey The selection of the applicable links (i.e., “NIH Guideline Section-III-A-1”) will bring you to the website of applicable NIH Guidelines. Hovering over the (?) icon will display help text for the applicable topics.

D. Exempt Experiments If you indicate that you perform Exempt Experiments, the survey will trigger additional information to capture details about this research.

7. Material Data Entry After all Material Surveys are completed, the PI will be prompted to provide additional information about the materials they work with. For instance, if the PI indicates the project involves work with Human Sourced Materials, a Material Data Entry will be triggered for Human Cell Lines and Human Tissues. As you can see the materials used are not linked to specific projects. This is why it is important to reference the materials that will be used

After adding a NEW cell line, click “Submit” at the bottom of the form. Once all cell lines have been added, click “Next Step” in the bottom right corner.

Primary cells should also be listed here.

If you indicate viral packaging, make sure this is properly described in the experimental details of the respective project.

8. Enter Microbial Agents From this window, the PI will be able to enter the Bacteria, Fungi/Yeasts, Viruses, and Parasites they plan to use in their research.

A. Selecting Microbial Agents By Selecting “Add Bacteria,” “Add Virus,” etc. the PI will be prompted to choose from a dropdown menu. This dropdown menu is generated by BioRAFT. Be sure to include all relevant sub-species and strain information. To finish adding a microbe, select “Submit” at the bottom of the form. If this list does not include the microbe you intend to add, please complete this form to request for the microbe to be added to BioRAFT. When filling out the microbe request form, It is extremely important to categorize the type of pathogen (i.e. HP, AP, IP, PP).

A. Selecting Microbial Agents (continued)** It is not necessary to list all microbes that may be available in the lab. Instead, please just list all that are being used as part of your projects. If you notice any incorrect information on the preloaded microbes on BioRAFT. Please send an email to biosafety@northesastern.com. **Please note that if you are loading aby microbes that are RG2 or higher, you must complete a pathogen registration form, this is not automatically triggered so please keep this in mind while complete the form. Not all microbes have the associated RGs on BioRAFT but these will be checked during the pre-review of the registration.

Risk groups classification: RG1 - Not associated with disease in healthy adult humans RG2 - Associated with human disease which is rarely serious and for which preventive or therapeutic interventions are often available RG3 - Associated with serious or lethal human disease for which preventive or therapeutic interventions may be available (high individual risk but low community risk) RG4 - Likely to cause serious or lethal human disease for which preventive or therapeutic interventions are not usually available (high community risk)

9. Nucleic Acid Reagents If the PI indicated work with recombinant DNA or transgenic animals, they will now be prompted to add the relevant plasmids and transgenic animals to their BioRAFT inventory. Be sure to fill out the form completely -- indicating the plasmid/viral vectors name and the genes/inserts in use. Under additional information, include additional information regarding the gene of interest, including if the goal is to express this gene or to knock it down. It is important that all plasmids/vectors used be listed. This helps us identify whether these has been approved when confirming MTAs.

10. Pathogen and Viral Vector Forms A Pathogen Registration or a Viral Vector Form will provide additional safety information for risk assessments, as needed for the agents you are using. These are NOT prompted automatically. Please be sure to complete a pathogen registration if you are using microbes that are considered RG2 or higher and same goes for the viral vector form. Biosafety will check that these are completed during review, if these are not completed it may delay approval.

A. Filling out a Pathogen Registration Form This form can be filled out by using the tabs at the top of the form to navigate between the required information. If you are using multiple pathogens of the same risk group and type, you can group them into a single pathogen form, as in the example below for the indicated Risk Group 2 bacteria. Although you will be using the same form, it is important to include information for all microbes listed on the form.

B. Filling out a Viral Vector Form If your work involves working with a viral vector, you must fill out the viral vector form. As with the pathogen form, be sure to fill out and complete each tab at the top of the page.

11. Registration Completion Once the Biological Forms are completed, you will be prompted to review all the content that has been provided. At the top of the page we can see the Usage Summary for the materials selected in the project, the lab focus that was provided during the General Set up Wizard, and the links to the relevant NIH Guidelines (completed in the Recombinant and Synthetic DNA Survey, section 7) with external links to the applicable guidelines. This is your bio-registration, you will be asked to scroll through and review the

data. If you need to make any changes to the registration before submission, you will be able to do it directly here by clicking “edit”, “add”, “remove” buttons in each section.

A. Review and Certify Once the document is ready for submission, refer to either 11c if you are the laboratory delegate or 11d if you are the laboratory PI. B. Delegate Submission If you are the laboratory delegate, when you scroll down to the bottom of the Biological Summary click “Notify PI.”

This will generate an email to the PI to notify them of the submission. In this email there will be a link that takes them directly to the Biological Summary, where they will be able to review the submission/changes.

Please note that the biosafety team cannot do anything with the registration until it is “certified” by the PI.

Although they will be receiving the email above, please make sure to confirm with them.

If your PI has not certified the registration, the status will show up as “Awaiting Submission”.

C. PI Submission If you are the laboratory PI, scroll down to the bottom of the Biological Summary and click “Certify.”

D. Post-Submission The PI will be prompted to initial each statement to indicate that they will comply with institutional policies before submitting the registration for review by the Biological Safety Officers.

E. Confirmation screen After certification, a message is displayed to confirm submission.

12. Awaiting Review After submission, the Biological Registration status should now be “Awaiting EHS Review”. This screen is available in the “Biological Snapshot” page. We have quick access to detailed information about the Biological Registration by selecting the links for the appropriate category at the top of the page.

13. EHS (Biosafety) Review If the Biosafety team determines that the registration requires revisions or clarifications, then an email from BioRAFT will be sent to the PI with comments. This email will include a link directly to the Biological Summary, which can also be accessed through the lab’s BioRAFT page (under the Bio Tab). Below is an example of what the comments may look like. It will identify the section/project where the revision needs to be made. You can make all necessary changes by editing the specific section identified under the comment.

Area that needs revision

Once you have taken care of the requested change. Please click “Resolve.”

Comment Date added

A. Resolving each comment After you click “resolve” you will be asked to document HOW the issue was resolved. This must be completed.

B. Re-submit After the changes have been made you must resubmit the registration. This can be done directly through the Biological Summary by scrolling down and clicking “Notify PI” or “Certify.”

14. Environmental Health and Safety / Bio Safety Officer Approval Process The Biological Safety Officer will get a notice to review the submitted Biological Registration. Once the Biological Safety Officer has reviewed the documentation, it may be submitted for IBC review or administrative approved based on the work that is described on the registration. The PI will be notified re: the biological registration status change via the Compliance Mailbox. Their status will also be reflected in the Compliance Summary by a green check mark next to the Biological category. Registration Status

• Not Started – Lab has been “Bio-Enabled” but bio-registration has not been started. • Started – Bio-registration has been started by either a delegate or PI but not submitted.

• Awaiting Submission – Bio-registration is waiting for PI certification and has not been submitted to EHS biosafety.

• Awaiting EHS Review – Bio-registration has been submitted to EHS biosafety by PI and isawaiting review.

• Awaiting IBC Review – Bio-registration has been submitted to the IBC for review by EHS biosafety.

• Approved with conditions – The IBC has reviewed the bio-registration/amendment and some clarifications/revisions must submitted before full approval will be granted.

• Approved - The IBC has reviewed the bio-registration/amendment and it has been fully approved.

• Denied - The IBC has reviewed the bio-registration/amendment and voted to have it revised and resubmitted for the following meeting due to the substantive changes that must be made.

• Awaiting Amendment – An amendment has been submitted for PI review, but the PI has not submitted the amendment to EHS biosafety.

• Amendment Awaiting Review – Amendment is waiting for PI submission to EHS biosafety. • Admin Approved – Bio-registration/Amendment submitted has been administratively

approved by the biosafety team (Not IBC).

*END* Please contact biosafety@northeastern.edu with any additional questions.

Registration Status