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BioRAFT Information

The University of Maryland has purchased the BioRAFT platform in order to centrally manage safety inspections, training, and Institutional Biosafety Committee protocol submissions. This platform streamlines compliance by allowing both ESSR and laboratories to manage research safety through a single portal.

All University of Maryland laboratories are required to register in BioRAFT. Registrations in BioRAFT are tied to the principal investigator. Hazards and personnel present in all spaces controlled by a principal investigator will be aggregated into a “Lab Profile”.

Automated BioRAFT emails will have a @bioraft.com domain name. Emails sent by ESSR personnel through the system appear as jdoe@umd via bioraft.com. ESSR wants to assure you that these emails are legitimate. It is NOT a phishing email.  If you notice that you are not seeing BioRAFT emails, it may be going to your Spam Folder. Please go into your email filter settings and add a new filter. Enter the following information in a new filter: 

  1. In the "From" field, type the email address or domain (@umd.edu | @bioraft.com
  2. In the “To” field enter your email address (username @umd.edu).
  3. Select the box "Do not include chats"
  4. Select Create Filter and check the box that indicates "Never send it to spam"
  5. Select Create Filter again to complete the filter

Set-Up and Laboratory Management

Laboratories must update their information annually, or when research or personnel change.  

  1. Login to umd.bioraft.com with UMD CAS login credentials.
  2. Complete the General Laboratory Setup Wizard by clicking the link that pops up when you login. Click “Continue to Laboratory Setup”.
    • If you want to delegate the rest of the setup, click “Delegate Now” and follow the instructions.
    • Note, PIs will still have to certify the information that the delegate fills out.
  3. Enter laboratory contact information.
  4. Enter Lab Category and Research Focus. The Lab Category summarizes the types of activities performed in the space (e.g., research lab, shared facility, teaching lab). The Research Focus is a description of the overall research goals of the lab group.
  5. Complete lab hazard assessment. This is a checklist where you will select the hazards that affect all of your lab personnel and spaces (this list is not room specific). If you have no hazards in your laboratory check the “No Hazards” box at the bottom of the page. When you are done, click “Submit”.
  6. Enter all laboratory members. Begin typing a researchers name in the “Name” field, it will search the directory and bring up their name (note, this can take over 30 seconds). Select their name and click “Lookup/Add”. After you are finished adding everyone, click “Done Adding Members”.
  7. Configure lab member job activities. This will present your list of laboratory personnel and a number of tabs that have job activities that describe tasks that may apply to a researcher (e.g., works with biological materials). Select all job activities that apply to each lab member. Click “Submit” when all tabs have been investigated.
  8. Complete laboratory setup. Click “Continue”.

Biological Research Registration

UMD laboratories working with biological research that involves infectious and/or recombinant material must register using the BioRAFT with the Institutional Biosafety Committee (IBC) for review and oversight per federal and institutional requirements. Laboratories working with biological materials that are neither infectious or recombinant are expected to register their work in BioRAFT for “acknowledgement” by the Biosafety Office. Use of BioRAFT is required.

To register or revise research for IBC review, all relevant information pertaining to biological material must be entered into the BioRAFT "Bio Summary" under the "Bio" tab. The purpose of the "Bio Summary" section is to communicate biohazardous aspects of research to the IBC, in order to properly review and approve biological work within a lab.

The BioRAFT registration process is designed to collect specific information about a PI’s research, thereby streamlining the process of IBC review. The PI is required to complete this survey in BioRAFT, which identifies biohazards involved in their research (including, but not limited to: animals, cells, recombinant DNA, human source materials, pathogens, etc.). Any changes or updates can be made through the “Edit” function in BioRAFT.

When the information gathering process is complete, BioRAFT will prompt a "Certify" message, confirming that information in the "Bio Summary" (registration) is correct. To certify, the PI will initial several compliance statements before registration submission. Please Note: Information is only be sent to Biosafety for pre-review after certification and submission by the PI.

The Biosafety Office then reviews BioRAFT Bio Summary (registration) for completeness.  Staff may contact the PI to discuss any questions or concerns related to the protocol, and to ensure the protocol is ready for IBC review. Please ensure information provided in BioRAFT is as accurate and descriptive as possible, so that the IBC can conduct a thorough and timely review. Incomplete or inaccurate information in the Bio Summary may delay the approval process.  Common reasons for delay include the failure to list the genes of interest, not describing the recombinant work completely, and not describing the process for containing and managing waste.

For questions or assistance in completing a BioRAFT biological registration, please contact Biosafety at biosafety@umd.edu.

Basic Steps of Biological Research Registration

  1. Login to the BioRAFT system with your UMD CAS login credentials.
  2. Click on the tab on the left to drop down the menu for your lab.
  3. Select View Lab Profile to see a summary of your lab.
  4. Once in the View Lab Profile, select the "Bio" tab at the top of your profile page to get to your Bio Summary. If you do not see this tab, please contact biosafety@umd.edu.
  5. To enter/edit information, click on "View or Update Biological Usage Summary" found within the Bio Summary box.
  6. Complete/edit all relevant biological surveys.
    • NOTE:  Be sure to completely describe your intended work in the “Description of Experimental and Procedural Details”. This is an open text box, and it is best to use spacing to define sections. Please include the scope, locations, a description of the materials used, an assessment of the risk (virulence of the agents, equipment used, use of research animals, field work, viral vector system, etc.), waste handling, PPE required, and the decontamination/disinfection methods to be used.
  7. Hit "certify" at the bottom of the Bio Usage Summary page to go to Submit page (this is also done for revisions/amendments).
  8. Read statements and initial boxes and then hit "certify and submit".

Post-Submission Steps

  1. ESSR/Biosafety Pre-Review.  The Biosafety Officer (BSO), or designee, will review your protocol and conduct a risk assessment based upon the information submitted.  A biosafety audit of the lab may be conducted as part of the risk assessment.  Any questions/problems/concerns will be directed back to the PI for clarification.  If the protocol requires full IBC review, the protocol will be placed on the agenda for review at the next IBC meeting.  If the work does not require full committee review, the BSO will work to approve or acknowledge the protocol. Also see – “Use of comments function” below.
  2. IBC Review (if required). The IBC will review the research information submitted through BioRAFT and discuss the safety and regulatory aspects of the research project.  Discussion topics include: the nature of experimentation, location of the work, rDNA aspects, training requirements fulfilled by research staff, past laboratory inspection record, etc.  If warranted, researchers may be invited to present their research protocols to the IBC committee.
  3. Decision Letter Sent to PI.  Once the IBC has made a decision regarding the research project reviewed, a decision letter will be sent through the BioRAFT correspondence function to the PI from the BSO, or designee. Retain the decision letter for your records.  Often, the IBC requires modifications to the protocol (additional information, correction of errors) prior to full approval. This is managed through the Biosafety Office. Also see – “Use of comments function” below.
    • NOTE: Protocols are valid for four years to the end of the month from the moth they were approved. (Ex. If approved June 15, 2017, the protocol expires June 30, 2021.) Expiring protocols must be resubmitted and reviewed de novo.
  4. Conduct Research.  Research may commence once an approval letter has been received from the IBC.
  5. Calendar. IBC committee meetings and submission deadlines are available here. All meetings are open to the public.

Use of Comments Function. BioRAFT has a function within the “Bio Summary” page that allows the BSO and the IBC to comment on specific sections of a protocol or the registration. This streamlines the process of review and clarification.  If you are asked to address comments, please go to the bottom of the “Bio Summary” page to view any open comments.  You can respond in the comment (generally for answering a question, such as “Do you plan to express the protein?”), but if the comment requires a change to the protocol, you must click “edit” and make the change. HINT: You can click on the section of the registration in the far left column and the registration will go right to the spot where the issue needs to be addressed. Once you have addressed a comment, click “resolve” so the Biosafety Office knows you have completed this task. Since the comments can be tied to specific sections, you may see a number of notes, or repetitive notes if an action is needed in more than one place. This is meant to assist PI’s in editing the registration, since easily addressed items can be separated from items that may need more discussion. Once the comments are addressed, the PI must certify/submit to indicate the changes were made and they are ready to have the Biosafety Office review.

Changes in Research Scope.  Addition/removal of an agent, new process, addition of animals, etc.) you must submit an amendment.  Simply click on the “edit” button next to the project you wish to modify.  Editing and certifying a biological registration sends the lab into amendment. Remember, the lab must be certified by the PI before the Biosafety office is alerted to the request for amendment.

Amendments to Existing Protocols are submitted using the current amendment form which is then emailed to biosafety@umd.edu.

Previously approved protocols (before BioRAFT) were attached as PDFs in a PI’s dashboard in BioRAFT during the transition. They are in the ‘Documents’ section. Please contact biosafety@umd.edu if you have looked and are unable to find an old protocol.

 

Inspections

All ESSR research-related inspections are conducted using the BioRAFT platform. All inspections for a given laboratory are housed on the Laboratory’s Inspection Dashboard. The dashboard is found by selecting the “Lab Inspections” option on the “View” tab on the laboratory’s front page.

 

Inspection Process/Responding

Laboratories receive automatic emails through the BioRAFT system when inspections have been conducted. After your inspection is performed, you will receive an email containing a link to your inspection report in the BioRAFT system. Within 7 days of receiving your inspection report, you will need to login and confirm the receipt of the report. You will receive an automated reminder via BioRAFT if this is not completed.

 

To respond to the inspection report, scroll to the bottom of the report to the box entitled “Correspondence”.  There should be four options to select from:

  • All audit findings have been resolved.
  • Audit findings have been resolved except those noted below in comments.
  • Corrective actions have not yet been put in place.
  • Please have the auditor contact me to discuss this report.

There is an “Additional Comments” box that you can describe the lab’s response to the report. Pictures or other documents can be attached by selecting the “Attach Documents” option. Select the “Choose File”, browse for your file, and select “Upload” to attach it to the response. 

When you have finished responding to the report, click “Submit”.

Within 30 days of receiving your inspection report, all corrective actions must be resolved. You will be asked to confirm that they have been resolved in the “Submit Response” section found at the end of your inspection report. BioRAFT will send you automated reminders at 7 day intervals reminding you of the approaching due date. If corrective actions are not resolved within 45 days, your department chair will be automatically notified via BioRAFT. Your chair will be emailed every 7 days until action has been taken. 

Training

Training can be found both at essr.umd.edu/training and by selecting the “Training” option in the left-hand menu and selecting “Course Directory”. You can see that we have both online and classroom trainings available. You may not be able to register for a training until you have taken the online prerequisites.  

Anyone with BioRAFT login access can view their research-related training records by selecting the “Training” option in the left-hand menu and clicking “My Training”. The default is most recent training, but you can view all

We are in the process of rolling out training requirements that are tied to job activities that have been identified. At this time, when you login to BioRAFT, on your front page you will see a notice indicating that you are overdue for a particular training. You can also see these notices on the Course Directory. Eventually, this will be implemented for all research-related training and automatic emails will be generated to remind you to complete training requirements.

Frequently Asked Questions

Why BioRAFT?

In 2013, a University Systems audit that found that departments had difficulty tracking inspection responses by laboratories and training records of lab personnel. BioRAFT was purchased so that departments could monitor and follow up on compliance issues related to training, inspections, and registration of biological materials. University leadership and ESSR can also monitor compliance and track trending issues over time using this system.

How do I add/remove members of my laboratory?

Information on the BioRAFT system is required to be updated annually. Laboratory member information should be updated when personnel are added or removed from the lab.

On the left hand menu, select your laboratory. In the expanded menu, select “Manage Members”. You can add members as described in the setup section. You can also edit job activity information or remove a member by selecting the “edit” or “remove” button, respectively. To make more extensive changes to job activities you can select “Manage Job Activities” in the “Members” tab and adjust job activities for multiple members at once. 

How do I add temporary users who have no UID to my laboratory?

For workers from other institutions, high school students, or who will otherwise not be entered into the UMD directory, temporary accounts can be arranged so that they can take trainings and be tracked in BioRAFT. Contact support@bioraft.com and provide the following information.

  1. Name of person needing access
  2. Length of time they are expected to be part of the lab (e.g., 1 year, 3 years)
  3. Primary email address for the person needing access

            BioRAFT will provide the login information directly to the person needing access.

I do biological research, but I don't see a Bio tab on my lab's profile. How do I request access to this module? 

Laboratories in BioRAFT must be “Bio-enabled” in order to have access to the tab where they can where describe biological materials and research processes, as well as submit protocols to the UMD IBC. If your lab is not “Bio-enabled”, please contact biosafety@umd.edu. Once a PI is “Bio-enabled”, the ‘Bio’ tab will appear at the top of the lab page and the registration process can begin.