Huron Safety - Create and Submit a New Biosafety Submission

Prior to the Study

Studies can be entered by either the Principal Investigator (PI) or the Study Team. However, only the PI can submit the submission.

Navigation

1. Navigate to the Safety Module tab
2. Click Create Safety Submission
3. A pop-up window will appear. Click Create New Study. The SmartForm will open.

Basic Information

1. Title of study: Enter your submission title; this can be copied and pasted directly from your protocol document.
2. Short title: The "Short Title" and the "Title of the Study" should match. The term short title is slightly misleading and is a peculiarity of the Huron system. Please simply re-copy the title of the protocol in this field.
3. Provide an overview of the biosafety aspects of the grant: Enter a brief high-level overview of the research to be performed. This field is primarily looking to identify the central question the research is intended to answer, the primary objectives, and the methods or approach used.

   Example: This research tests the effectiveness of drug X for the treatment of Ebola virus disease. The general approach is to…

   Please do not copy and paste your abstract in this field. The abstract typically contains too much extraneous information not relevant to the biosafety aspects of the submission.

4. Select appropriate safety review: Ohio State only has one type of safety review. This field will default to "Biosafety," which is the appropriate selection.
5. Principal investigator: This will default to the name of the person entering the study. If you are not the PI for this study, click the ellipses […] and a full list of Ohio State investigators will appear. Select the PI from this list. If the PI is not listed, please contact IBCinfo@osu.edu.

Protocol Team Members

1. Identify each additional person involved in the design, conduct, or reporting of the research: Click the +Add button and a slide-in window will appear.

   Add Study Team Member (Slide-in)

   1. Select the protocol team member: The ellipses […] will allow you to access a list of Ohio State affiliated individuals. Select the appropriate team member and click OK.
   2. Role in research: There are only two potential roles available.
      • Administrator: Select for administrative roles not directly responsible for research procedures.
      • Research Personnel: Select for all roles directly involved in research procedures.
   3. Additional roles performed by team member: This is not a required field and would only be used if the selected member is involved with the protocol in a capacity not covered by one of the two research roles above.
   4. Is this team member involved in procedures? Indicate whether the person selected will be involved in the safety procedures.

   Once you have completed all fields for your first team member, you can select OK and Add Another to continue adding the rest of your study team.

2. External team member information: Collaborating individuals must have an active Ohio State ID and complete required training. Use the Ohio State job aid for creating a guest account. This step must be completed for external members before they can be added in Huron. In addition to an Ohio State ID, a CV should also be added for any external members.

Funding Sources

1. Identify each organization supplying funding or in-kind support for the submission. Click the +Add button to add funding sources and the Add Funding Source slide-in window will appear.

   Add Funding Source (Slide-in)

   1. Select the funding organization: Click the ellipses […] to access an extensive list of over 13,000 funding sources. If your funder does not appear on this list, contact IBCinfo@osu.edu.
   2. Sponsor's funding ID: If you have the identification number assigned by your external sponsor for your external award (for example, DAMD17-01-1-0461 or G12AP20082), please enter it here.
   3. Grants office ID: If you have the grant identification number assigned by Ohio State, please enter it here.
   4. Attach files: Please upload a copy of your grant if available. This is used by the committee to complete a grant congruency review.

Once you have completed all fields for your first funding source, you can select OK and Add Another to continue adding additional funding.

Biosafety Summary

1. Select any items involved in the protocol: There are 11 categories in this question. Select all that apply to your submission. For each selection, an additional corresponding field will appear in the left navigator.
   • Tissues, Blood, or Body Fluids: Material collected directly from a human or animal.
   • Primary Cells or Cell Lines: Cells purchased from a vendor or established cell lines acquired from another lab.
   • Genetically Modified Animals: Animals that you are modifying or have purchased already modified.
2. Does the research involve the use of human stem cells? Respond yes or no.

Additional Fields

The following fields will appear in the left navigator if you selected the corresponding boxes in the Biosafety Summary page:

• Agents, Toxins and Microorganisms
• Recombinant & Synthetic Nucleic Acids
• Human Gene Transfer / Human Clinical Trial
• Animals and Genetically Modified Animals
• Plants
• Gene Drives / Gene Drive Modified Organisms

Risk Group and Containment Practices

1. What is the highest risk group level of the biological agents and materials you will use in the proposed research? Use the NIH Guidelines Appendix B to select the highest group of biological agents in your proposed research. A full summary of each of the four risk group elements can be found in Appendix B: Classification of Etiologic Agents on the Basis of Hazard on pages 39–46 of the NIH Guidelines.
2. What are the highest biosafety containment practices required for the research activities covered by this protocol? If you are unsure about the required containment practices for your research activities, please refer to the BMBL or NIH links in each category below.
   • For more information about the first three categories (Biological Research Standards, Biological Research Involving Animals, and Biological Research Involving Arthropods), refer to the Biosafety in Microbiological and Biomedical Laboratories (BMBL).
   • For more information about Physical Containment, Research Involving Animals, Research Involving Plants, or Large-scale Uses of Organisms, refer to the NIH Guidelines.

Exposure Assessment and Protective Equipment

1. Describe consequences of exposure or release of agents used to humans (including lab personnel), animals, and plants: Write a brief description of the consequences of exposure. This may include impacts to laboratory workers, pharmacy staff, vivarium workers, general faculty and staff, people in surrounding areas, laboratory animals, wild or feral animals, plants, crops, and the livestock and poultry industry. Include both occupational and environmental outcomes.
2. Indicate the personal protective equipment that will be used: Select all PPE that will be used in the proposed research.
3. If other, specify: This optional field captures any PPE not included in the previous question.
4. If performing field research, please describe the field research being performed as well as any risk mitigation measures being taken. If you will be performing field research, complete this field and be sure to attach a Field Research Safety Plan in the Supporting Documents section.

Dual Use Research of Concern

Certain types of research conducted for legitimate purposes can be utilized for both benevolent and harmful purposes. Such research is called "dual use research."

The United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern articulates the practices and procedures required to ensure that dual use research of concern is identified at the institutional level and risk mitigation measures are implemented as necessary.

1. Describe materials subject to DURC review: Work with materials that fall under the definition of "dual use research" must be assessed by the PI and institution to determine appropriate risk mitigation measures. Dual use research of concern is a subset of dual use research defined as: "life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies that could be directly misapplied to pose a significant threat with broad potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, materiel, or national security." Use this entry field to describe the materials in your proposed research that are subject to this type of review.
2. Dual use experiment categories used in this research: Review the 14 categories listed in this section and select all that apply. If none apply, select "None of the above."
3. Explain why you believe this protocol is or is not dual use research of concern: Provide a brief explanation.
4. Has a risk-benefit assessment been completed? Answer yes or no.
5. Has a risk mitigation plan been completed? Answer yes or no.
6. Supporting documents: Upload any supporting documents, including any risk assessments already performed.

Waste Management

1. Describe the process for decontaminating biological waste: Provide a brief description of the decontamination process for your proposed research.
2. Autoclave location: Use the ellipsis […] to access a full list of potential rooms housing the autoclave. Use the wildcard [% symbol] at the beginning of the building name for additional search help.
3. Describe the plans for decontamination in the event of a biological accident, including decontamination of surfaces: Provide a brief description.
4. Describe routine surface decontamination and biohazard spill clean-up: Provide a brief description.
5. Describe the process for treating, collecting, and disposing of liquid and solid biological waste: Provide a brief description.

Human Stem Cells

1. Check all human materials involved in the project: Select all categories that apply to your proposed research.
2. Will the proposed research use or involve: Select all categories that apply to your proposed research.
3. List the origin of each stem cell line and the NIH code. If applicable, enter the origin of each stem cell line and the NIH code.

Department Approval

Ohio State requires departmental endorsement of all regulated research submissions.

1. Once a new submission is ready for review, check the box labeled "I certify that this submission is ready to be routed for departmental approval." By checking this box and clicking Save, your submission will be routed to your departmental approver.
2. You cannot proceed further until you have signed approval. The approval process happens outside the Huron system — you can save and exit for now.
3. The departmental approver will receive a notification email letting them know that a summary of the protocol is ready for review in DocuSign. The PI will also receive a verification email confirming the protocol has been routed for departmental review. Check with your department for their approval process and timelines; your approver may request additional information before endorsing.
4. Once the departmental approver signs the protocol, the PI will receive a confirmation email from DocuSign. The PI can then download a PDF copy of the signed approval from DocuSign.
5. Once the PI has downloaded the departmental approval, they are ready to submit. Log back into Huron, navigate to your dashboard, find your Biosafety submission, and click Edit Protocol.
6. Once inside the SmartForm, navigate to the Departmental Approval tab.
7. Click the +Add button to access a document submission window.
   1. Use the Submit a Document pop-up to find and upload the Departmental Approval from your device.
   2. Confirm your approval has uploaded correctly and click Continue.

Finalize and Submit

1. After clicking Continue on the Departmental Approval page, the final SmartForm page will appear. Before finishing, check your study for errors using the Validate button at the top of the left navigator.
2. After correcting any errors, click the Finish button and exit the SmartForm.
3. After exiting the SmartForm, you will be back in the study workspace. The study is complete but has not yet been submitted. The workflow map will show the study is still in pre-submission.
4. Study staff can enter a study, but only the PI can submit. The PI will click Submit.
5. After clicking Submit, an agreement page will appear. After reading this page, the PI or PI Proxy can click OK.
6. The study is now submitted. Congratulations! The state will change to Pre-Review on the study workspace, indicating it is now In-Review.

Article ID: 130
Created: March 10, 2026
Last Updated: March 16, 2026

Online URL: https://ohiostateresearch.knowledgebase.co/article/huron-safety-create-and-submit-a-new-biosafety-submission-130.html