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Research Registration Form Checklist
Please use the following as a tool to help you complete your research registration form. There are 4 sections that must be completed for all work: Title and Abstract, Personnel, Other Hazards and Risk Assessment. The three remaining sections (Pathogens, Recombinant DNA, and Biosafety Cabinets) may be required depending on the work.
Please take your time and fill out sections accurately and completely to avoid any delays in the process. All incomplete forms and any forms replete with grammar and spelling errors will be returned to you to be revised. Thanks in advance for your help in practicing safe science!
Title & Abstract
The abstract portion of the form includes both the scientific abstract and the lay abstract.
- Scientific Abstract: An overview of what your research will entail, including a brief explanation of any procedures to be used. This abstract should be scientific in nature and detail. The audience of this abstract understands technical lingo and can relate scientific visions to practical applications. Goals of your research should also be mentioned.
- Lay Abstract: An overview of your research written in a language suitable for the public. This should be phrased in a way as to satisfy the “non-scientific” person. The lay abstract should include all procedures and goals mentioned in the scientific abstract, aimed toward the average individual. Explain the aims of your work and why it is important.
Personnel
This includes the full name and employee ID number of each individual involved in your research.
Pathogens
This section allows you to list all pathogens to be used. Some of the information required in this section includes risk group, storage location, and animal usage information (if applicable).
Recombinant DNA
The information required in this section is collected to help both you as the investigator and the Institutional Biosafety Committee, classify your work according to the NIH Recombinant DNA Guidelines . The information is also used to assess the risks of the work being conducted so that appropriate precautions are taken to protect the researcher and the community at large.
Other Hazards
Indicate whether use of human materials, select agents, heavy metals, hazardous or toxic chemicals, or lasers are to be used in your work.
Risk Assessment
The risk assessment is the most crucial part of the research registration form. This section provides the Biosafety team with the necessary information to conduct a full biological safety assessment of the work to be done. Some hints in completing this form:
A) If you have answered “Yes” to the question regarding work with human materials previously in the form, there are two questions that are absolutely necessary within the Risk Assessment. These questions are:
- Have all staff with potential exposure been offered vaccines where licensed vaccines are available and the benefits outweigh the risks?
- Have all personnel been apprised of potential hazards and medical conditions that should prevent working in this environment?
All staff that have the potential exposure to human materials are at risk of exposure to bloodborne pathogens, including Hepatitis B. The Occupational Safety and Health Administration require that all staff with this potential exposure be offered the Hepatitis B vaccine. Staff who decline the Hepatits B vaccine must sign a declination form to be sent to Student Employee Health. Staff should also be apprised of the hazards of working with human materials.
B) For the risk assessment table, please use the more info links under each topic for an explanation of what is expected in those areas. Additional information for the risk assessment can be obtained by visiting:
C) Based on your risk assessment, you should be able to determine what biosafety level is required for your work. Again, the more information link will help you in this process.
D) The final four sections must contain specific details. This will serve as your biosafety SOP for this project. When listing procedures for minimizing the potential for exposure to personnel and the environment, be sure to include all safety practices as well as the personal protective equipment and engineering controls (i.e. biosafety cabinets, containment centrifuges, microisolators, etc.) to be used. Decontamination procedures must include the full and proper name of the decontaminant as well as the concentration and contact time (lay terms such as bleach or the name, Clorox, are not permitted). Lastly, emergency procedures should define immediate actions as well as any follow-up procedures.
Biological Safety Cabinets
Biological Safety Cabinet information is to be completed here. This shows that the researcher is taking the appropriate steps to ensure a level of containment appropriate for the work to be done. If you are uncertain of whether a Biological Safety Cabinet should be used, the Biosafety team can help to assess the risks of your work and determine what type of containment is needed.
Any questions, comments, or concerns can be addressed to the Biosafety Office;
Melissa Morland or Katherine Norelli at 410-706-7055.
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