Research Ethics & Compliance

PROJECT REGISTRATION

It is the policy of The University of Alabama to have all work involving biological material as well as all work involving recombinant or synthetic DNA reviewed by the Institutional Biosafety Committee (IBC).  Approval must be granted before work begins. To submit a project or protocol for review, please complete a Biological Use Authorization (BUA) Form. If a protocol needs to be closed, please submit an IBC Protocol Closure Form.

TIMELINE

Total turnaround (barring revisions) is approximately 4-6 weeks (barring revisions):

• PI Submits BUA – 1-2 weeks prep time
• BSO reviews application – 1-2 weeks
• BSO/IBC reviews pre-meeting – 1 week
• IBC deliberations – 1 day
• ORC document turnaround – 1-2 weeks

A BUA IS REQUIRED FOR THE FOLLOWING:

1. Projects that utilize Recombinant or Synthetic Nucleic acids.
2. Projects utilizing potentially pathogenic materials/organisms, including those that are considered hazardous to humans, animals, agriculture, and the environment.
3. Projects that will import biological/botanical samples internationally.
4. Projects categorized as Risk Group 1 or 2. (BMBL 6th ed.)
5. Projects that are currently not funded, or are categorized as ‘Start-Up’ funding, especially federally funded projects.

Frequently Asked Questions about the BUA

APPLICATION REVIEW

EACH SUBMISSION

1. Must be received by the 1st of the month to be considered for the next IBC meeting. IBC meetings are scheduled on the first Tuesday of the following month (Please see the schedule).
2. BUA must be complete, including supporting documentation, permits, and SOPs. BUAs may accompany IRB or IACUC protocol submissions.
3. If the submission is complete and deemed fully eligible for IBC review by the BSO, it will be posted to the next meeting’s agenda. Incomplete submissions will be returned to the applicant for revisions.

THE BSO REVIEWS APPLICATIONS FOR THE FOLLOWING:

1. The title of the project must match any corresponding IRB or IACUC protocols.
2. SOPs attached and current.
3. The project abstract is written in plain language. It should be clear, concise, organized, and appropriate for the intended audience. (Community members sit on the IBC)
4. Exposure Control Plan (Bloodborne Pathogens).
5. Permits/MTAs attached

TIMELINE

Preliminary application review will take approximately 1-2 weeks.

RISK ASSESSMENT

Project risk assessment is initially performed by the PI. Following BUA submission, the BSO will perform a full Risk Assessment.

1. Determine Category, Risk Group, and Containment level.
   • Category A: Containment level 1 based on NIH Guidelines; BMBL; and/or established guidelines plus additional project-specific considerations.
   • Category B: Containment levels 1 & 2 include proposals for recombinant or synthetic nucleic acids (r/sNA) covered by NIH Guidelines and/or other biohazards or pathogens requiring BSL-1 or BSL-2.
2. Are additional containment practices needed?
3. Full inspection of Lab space and equipment.
4. Is Occupational health surveillance requested?
5. Evaluate the experience and training of all researchers listed on BUA. (training certificates)

The BSO then utilizes the BSO/IBC review flow chart to determine what the path of review will be.

• Biosafety SOP Template & Guidance

TIMELINE:

• BSO/IBC reviews pre-meeting – 1 week
• IBC deliberations – 1 day
• ORC document turnaround – 1-2 weeks

MONITORING & REPORTING

POST-APPROVAL MONITORING (PI, BSO, EHS, ORC)

1. PI is responsible for submitting an updated inventory and self-audit of the lab annually.
2. Once the rDNA protocol is approved, the lab becomes eligible for random compliance inspections by the BSO and/or EHS.
3. BSO performs and documents random inspections of labs with approved BUAs yearly.

REPORTING IS ONGOING FOR THE LIFE OF THE AUTHORIZATION

1. IBC receives written results of lab inspections at regularly scheduled meetings.
2. PI receives written notification of results of lab inspection and submits response to corrective actions.
3. ORC submits NIH OSP notification if required.
4. ORC submits an annual report to OSP.

When completing forms, examine all biological hazards associated with the proposed work. Consider how the associated risks will be minimized. The IBC will review your forms.

1. Please only complete those sections that are pertinent to your research project.
2. Please make sure that all personnel has proper training. (only list those who will actively participate in the study).
3. If there is an IACUC or IRB associated with the BUA, please make sure that the title of the study matches those protocols.
4. Be sure to attach the following to your BUA under the ‘Hazard Control’ section. (If you require more than 3 files to be attached, consider combining multiple pdfs into one continuous file and then upload as one file).
   1. SOPs; Shipping and Transport SOPs
   2. Exposure Control Plans for your lab
   3. Emergency protocols and infection control policies for your lab
   4. Vector maps
   5. Materials certifications
   6. Material Transfer Agreements
   7. Permits (domestic or international)
   8. Equipment decontamination SOPs from the manufacturer
5. Note: Formstack will allow you to save the document as you go (partial submission), however, before you SUBMIT, you will need to re-attach files; re-check the Appendix A box at the end of the form, and sign the form again. It is recommended that you do these just before you are ready to submit.
6. Successful submission will be accompanied by an Email confirmation to the BSO and the PI. Note: if you would like a pdf copy of the completed BUA, please email that request to biosafety@ua.edu.

Amendments to submitted or approved BUAs can be made by email to the BSO and must be accompanied by the assigned BUA # (ex. 20-123-IBC) in addition to detailed changes requested.

A list of all forms related to Biosafety can be found on ORED’s Forms page.

TIMELINE

The committee recommends planning 1-2 weeks for preparing a BUA submission.

Waste Triage Flowchart

It is the responsibility of the Principal Investigator (PI) to ensure that all responsibilities within the guidelines are met.

• Biological Safety Manual
• Biosafety in Microbiological and Biomedical Laboratories, 6th edition
• BMBL BSL-1 Standard Microbiological Practices
• Companion Guide to U.S. Government Policies for Oversight of DURC
• Dual Use Research of Concern (DURC)
• Funding agency regulations (NIH; NSF; DOD, etc.)
• National Institute of Health (NIH) Guidelines – Features incident reporting, FAQs, and reporting template.
• NIH Guidelines – Frequently Asked Questions
• Section IV-B-& Roles and Responsibilities of the Principal Investigator
• UA Office of Environmental Health & Safety (EHS)

Please note that CITI biosafety coursework and that which is assigned by EHS through Skillsoft are separate assignments.

You will need to initiate the CITI coursework aided by the instructions below.

BIOSAFETY EDUCATION THROUGH THE CITI PROGRAM

UA faculty, staff, and students

• Go to CITI Program website.
• “Log in through my organization”
• UA uses Single Sign On (SSO), which requires a myBama username and password.
• Click “View Courses” next to UA
• At the bottom of the page, under “Learner Tools for Univ. of Alabama,” select “Add a Course.”
• Complete the Training Decision Questionnaire. Answer Question #2 with “not at this time,” then under Question 6, select Training for Investigators, Staff, and Students Handling Biohazards.

Non-UA faculty, staff, and students

• Go to CITI Program website.
• Register using a preferred email and password.
• Select UA as the Organization Affiliation.
• Log in and select “UA institutional courses”
• At the bottom of the page, under “Learner Tools for Univ. of Alabama,” select “Add a Course.”
• Complete the Training Decision Questionnaire. Answer Question #2 with “not at this time,” then under Question 6, select Training for Investigators, Staff, and Students Handling Biohazards.

REQUIRED PRIMARY COURSEWORK

Training for Investigators, Staff, and Students Handling Biohazards. (ID: 44244)

Select the following additional courses that are not covered in the primary training but may be necessary for your research:

1. Dual Use Research of Concern (DURC) (ID: 104813)
2. Shipping and Transport of Regulated Biological Materials (ID: 44247)
3. Select Agents, Biosecurity and Bioterrorism (ID: 44270)
4. Animal Biosafety (ID: 44246)

Note: Coursework can be accessed from future institutions that are affiliated with CITI.

For more information on the required training, contact the Biological Safety Officer, at (205) 348-5941.

The University of Alabama adheres to the NIH Guidelines for Research Involving Recombinant and Synthetic Nucleic Acid Molecules and follows the recommendations of the NIH Office of Science Policy (OSP). Inspections by the BSO must be performed to ensure that laboratory standards are rigorously followed (Section IV-B-3-c-(1) NIH Guidelines).

In addition to adherence to NIH Guidelines, your BSO will evaluate SOPs, general safety measures, compliance with OSHA standards, training records, biomaterials inventory, biosecurity, and containment practices.

Inspections are not limited to those labs working with recombinant/synthetic DNA. BSL-2 labs must be inspected annually, and the BSO must inspect all NEW labs (see lab registration section) prior to the start of work. Annual completion of the Lab Biosafety Self-Audit Form in addition to the Biological Material Inventory Form is required. Please submit completed forms to biosafety@ua.edu.

• Lab Biosafety Self-Audit Form
• Biological Material Inventory Form

If you wish to order a chemical/material for use on the UA campus, you should first check the list of Regulated Chemicals.

If you are purchasing a chemical located on the regulated chemical list be prepared to declare this in the BuyBama purchasing interface. You will receive a request from EHS to provide a standard operating procedure (SOP) detailing how this chemical/material will be utilized in your research. The Biosafety SOP and the EHS SOP are different documents and not interchangeable.

The office of Environmental Health & Safety (EHS) provides proper disposal of both biologically hazardous and regulated medical wastes through a contracted disposal service.

• Waste Disposal Request

Information about the disposal of biological materials can be found on the EHS websites:

• Formaldehyde Program
• Medical Waste Manual
• Autoclave Safety Policy

Additional information on infection control including sterilization guidance

• CDC Infection Control Guidelines and Guidance Library

LAB REGISTRATION

‘Research’ or ‘Teaching’ lab space is considered a “NEW” space if:

• A new PI or instructor, not previously responsible for research or teaching at UA, is assigned to a lab space
• An existing research program is assigned new lab space, either as a result of moving to a new location or through expansion of the program.

In order to register a new lab, please complete the Lab Registration Form or contact the Lab Safety Manager at (205) 348-5905 if you have questions or concerns.

DECOMMISSIONING

Thorough decommissioning MUST be performed by the exiting Lab’s PI, or the research group before any new laboratory personnel can move into that same space. Decommissioning pertaining to biological, chemical, and radiation hazards must be verified by both Biological Safety and EHS. For decommissioning guidelines contact Juliette Commodore-Botoklo in EHS.

• Decommissioning Hazard Tag
• Decommissioning Hazard Tag Guide
• Decommissioning Safe and Compliant Room Tag

The Potentially Infectious Material/Bloodborne Pathogens Program affects a variety of areas on campus. Employees and students may perform tasks that involve much more than simply working with human blood.

An employee or student is covered by this policy if they work with or are potentially exposed to any of the following materials:

• Human blood, human blood components, and products made from human blood.
• Human bodily fluids, including semen, vaginal secretions, cerebrospinal fluid, synovial fluid, plural fluid, pericardial fluid, peritoneal fluid, amniotic fluid, saliva in dental procedures, and any body fluid visibly contaminated with blood.
• Any unfixed tissue or organ (other than intact skin) from a human living or dead.
• Cell, tissue, or organ cultures from humans or animals unless certified free of bloodborne pathogens.
• Blood, organs, or other tissues from animals unless certified free of bloodborne pathogens.
• Culture medium unless certified free of bloodborne pathogens.

• Bloodborne Pathogens-EHS
• Bloodborne Pathogens Program
• Example SOP: With thanks to Dr. Jonathan Wingo (Kinesiology) and the Exercise Physiology Lab
• OSHA Bloodborne Pathogens Standard
• Potentially Infectious Material/Bloodborne Pathogens Program Manual

PERSONAL PROTECTIVE EQUIPMENT (PPE)

CDC Donning/Doffing PPE Videos (YouTube)

• Demonstration of Donning (Putting On) Personal Protective Equipment (PPE)
• Demonstration of Doffing (Taking Off) Personal Protective Equipment (PPE)

Respiratory Protection Manual

SAFETY SIGNAGE

• Signage request form through EHS (all research laboratories)
• Laboratories that are designated as BSL2 will need the following: BSL-2 Signage
  • Please contact BSO for suggestions and guidance on the content.
  • Additionally, if you are unable to print in color, we can provide printouts for your lab.
  • Orange BSL2 Signage must be placed on the outer side of the door to the lab. Interconnected labs must post this signage on both entrance doors. 

ADDITIONAL SAFETY SIGNAGE & STICKERS FOR USE IN RESEARCH LABS:

• Download Signs and Stickers (zip file)

Shipping & Receiving Biologicals

When planning to ship/receive biological hazards or specimens, please be aware that there is guidance available through many departments at the University including, Office for Research Compliance, Office for Innovation & Commercialization, and EHS.

1. SHIPPING
   • Biological specimens, human/animal blood or tissue, serum, antibodies, DNA/RNA, etc., are considered hazardous materials and are subject to regulations set forth by numerous federal and international organizations. See: SHIPPING HAZARDOUS MATERIALS below for details.
2. MATERIAL TRANSFER AGREEMENTS (MTA)
   • Many research materials come from our colleagues at other research facilities, the distribution of research results many times includes sharing materials. In these cases, it is best to double-check if you need to complete an MTA to adhere to legal protections afforded by the university. Intellectual property rights can be jeopardized if materials are used without a proper MTA.
     1. MTA Request Form
     2. The sections on incoming/outgoing materials list requirements that must be met.
     3. Materials to be sent outside of the U.S. may be subject to export control laws and regulations.
3. Export License Research Compliance Export Control
4. Import Permit Research Compliance Import Control

Information about ordering biological materials, chemicals, or other items can be found at EHS Ordering/Shipping Information. Shipping biological materials of any type are subject to DOT and/or IATA regulations.

Shipping Hazardous Materials

Contact EHS at (205) 348-5905 for guidance and assistance.

The University of Alabama is responsible for complying with the Department of Transportation (DOT) and/or the International Air Transport Association (IATA) regulations as they apply to all areas of our campus. If you intend on shipping potentially hazardous material, including chemicals, biological materials, or dry ice; please follow the EHS guidelines.

Depending upon the mode of transport and destination, hazardous material shipments are regulated by 49 Code of Federal Regulation parts 171-180 and/or International Air Transport Association (IATA). These items must be properly classified, documented, packaged, and handled. Federal law also requires that anyone who is involved in or responsible for preparing or transporting hazardous material, including those who prepare the paperwork for the shipment, MUST have DOT and/or IATA training and certification. Penalties for non-compliance with these rules are significant and could result in fines up to $500,000 and jail sentences up to 5 years.

EHS personnel have the appropriate DOT training to ensure the proper shipment of all hazardous materials.

A hazardous material/dangerous good is any article or substance, which poses an unreasonable risk to health, safety, or personal property when transported.

Examples of these materials include, but are not limited to: (Items in bold are specific to work with biologicals)

• Laboratory chemicals, cryogenic materials, dry ice, and samples containing flammable, toxic, explosive, radioactive, oxidizer, and/or corrosive materials;
• Paints, stains, thinners, refrigerants, aerosols, medicines, pesticides, disinfectants, fuels (diesel, gasoline, ethanol, etc.); or
• Biological specimens, human blood or tissue, animal tissues, serums, antibodies, etc.,
• Equipment containing hazardous materials, such as mercury, compressed gases, batteries (wet, lithium, and dry batteries containing sodium, potassium hydroxide), etc.
• Equipment containing a radiation source or potentially capable of producing a radiation field

Currently, EHS does not ship any Chemicals Of Interest (COI) off-campus and/or to third parties. This includes original shipments, returns, samples, and/or specimens. Additionally, the university’s Campus Mail department cannot ship hazardous materials.

If you must ship hazardous materials, please complete a Request for Shipment of Hazardous Materials.

• Individuals should plan to submit this request at least 3 days in advance to allow sufficient time to obtain supplies that may be needed for the proper packaging and shipping of your material. International shipments can take longer to process.
• Once the proper packing material and authorizations have been obtained, the EHS staff will prepare your material for shipment; including packaging, labeling, and appropriate documentation for the shipment.
• You will receive email updates and tracking information once the shipment is processed.

NOTE: If you are shipping a hazardous material that is a commercially available product, it is often more cost-effective to purchase the material at the location to which you wish to ship. For example, if you are planning field research, requiring the use of hazardous chemicals, you may find it easier and less expensive to have a vendor ship the chemicals directly to your destination.