Navigating Research Compliance

Congratulations #

Your proposal has just been accepted by the AIC. Your team and the AIC are busy preparing for your visit and ironing out all the experimental details. During this time, please take a few moments to consider and address our regulatory and compliance requirements.

Cautionary Tales #

Consider the following scenarios:

• Bob is coming to the AIC from a destination outside the US. He’s shipped his samples; and as he is boarding his flight, he receives a call from his carrier of choice stating that his package is stuck in US Customs. His package does not have the required paperwork and will be held until it is received. His samples are temperature sensitive and must get to the AIC before the dry ice runs out.
• Jane has noticed that her cells do not grow well when she uses a different lot of fetal calf serum (FBS) in her media; however, she didn’t mention this to the AIC staff during the initial planning. She is coming to the AIC from a destination outside the US and is scheduled to begin her visit in two weeks. As she is preparing her package, she alerts the AIC that she will be bringing her own FBS. Unfortunately, this FBS originated in Brazil; and its import will require a permit from the US government. There is not enough time to acquire this permit before her scheduled visit.
• When Gerry proposed his experiments, he planned to use transient transfection to express GFP-LifeAct. His colleagues have seen better expression and imaging results using adenoviral vectors to express GFP-LifeAct. He decides to send some adenoviral vectors when he ships his samples a week before he arrives; however, the Janelia Institutional Biosafety Committee (IBC) has not reviewed this technique and may not be able to review and approve the work prior to the start of his visit.
• Cornelia requires cells to be harvested from mice directly before imaging. On her AIC application, she indicated that she will need mice. She arrives at the AIC expecting the mice to be ready; however, there are no mice for her to use. What went wrong?

Bob, Jane, Gerry, and Cornelia all missed a key piece of the puzzle in preparing for their AIC visits. Bob and Jane didn’t ensure that they were meeting the requirements set forth for importation of samples into the US. Gerry and Cornelia did not engage with the appropriate compliance committees at Janelia. Bob, Jane, Gerry, and Cornelia watched other fellow AIC visitors, whose experiments began as scheduled, collect huge amounts of data. Bob, Jane, Gerry, and Cornelia now must wait for the next Call for Proposal to finish the experiments they had planned.

To ensure that you don’t end up like Bob, Jane, Gerry, or Cornelia, the AIC staff, Cell Culture Lab staff and Janelia’s Environmental Health and Safety/Compliance (EH&S/C) team will work closely with you in preparation for your visit. Below is some helpful information explaining the issues associated with two areas for which we interface often with our visitors:

• imports into the US
• and registration with the Janelia Institutional Biosafety Committee (IBC) and the Janelia Institutional Animal Care and Use Committee (IACUC).

Please note that there may be other areas of compliance or regulations which are specific to your particular project. These can include issues such as interstate transit, US state specific regulations, export regulations, and US select agent and toxin regulations. AIC staff, Cell Culture Lab staff and EH&S/C will work with you to ensure compliance with these regulations as well.

Imports into the United States #

Multiple US agencies regulate the import of materials into the US including US Customs and Border Protection, the United States Department of Agriculture, the Centers for Disease Control and Prevention, and the Food and Drug Administration. Each of these agencies has a different mission and need to know what is being imported to the US to protect agriculture, public health, and the food and drug supply in the US. Therefore, each agency may require specific paperwork to accompany your shipment. The paperwork required will depend on the types of materials which you are shipping. If this paperwork is missing when the package is inspected at US customs, it may be held until the appropriate paperwork is received. In certain circumstances, packages may also be returned or even destroyed. Once a package is held by customs, it may take a few days to get the package released. Unfortunately, this is what happened to Bob.

Some materials may require an import permit (e.g., pathogenic microorganisms, certain primary cell lines, animal models, FBS from specific countries). Due to a higher level of review required for these materials, it can take 90 days or longer to receive the permit from the United States Government after submission. Therefore, advance planning is critical.

Institutional Biosafety Committee (IBC) #

Janelia’s IBC plays a critical role in the evaluation and management of risks associated with biohazardous material by reviewing certain types of experiments and advising EH&S/C on issues related to the science and practice of biological safety. All AIC proposals are reviewed for items which require registration with the IBC. Examples of materials which require registration include pathogenic organisms, transgenic plants, toxin genes, and genes derived from pathogenic organisms. The AIC and EH&S/C will work with visitors in advance to draft registrations and to ensure that all work with biohazardous materials is done safely at Janelia.

Institutional Animal Care and Use Committee (IACUC) #

Janelia’s IACUC reviews all work involving vertebrate animals and certain higher level invertebrates (e.g., squid, crabs, sea urchins). The work is reviewed to ensure the welfare of the animals involved in the experiments as well as the health and safety of the personnel working with the animals. All AIC proposals involving animals require a protocol to be approved by the IACUC.

Projects involving animals should also be coordinated with our Vivarium staff to ensure that the vivarium can support the work being proposed during the scheduled visit. The vivarium will need to ensure that there is space for the animals, that there is the appropriate housing and enrichment for animals, and that they can breed or acquire the requested animals in the appropriate time frame. No animals can be ordered until a protocol is approved by the IACUC. Visitors will also need to attend an orientation session in order to access the vivarium.

Dos and Don’ts #

✅ Do start planning early.

✅ Do send us a list of all materials which you intend on using at Janelia. Indicate which ones you will be shipping to us.

✅ Do alert AIC staff, Cell Culture Lab staff and Janelia EH&S/C immediately if you are considering changing the materials you need to complete your experiment.

✅ Do respond quickly to communications from Janelia. Please respond to all questions and provide all requested information. Please also follow all instructions provided by Janelia staff.

✅ Do follow all dangerous goods regulations (e.g., IATA, US Department of Transportation).

✅ Do ensure that your packages will arrive when our dock is staffed (e.g., Monday – Friday, 9:00 AM to 5:00 PM).

✅ Do let us know whenever you are shipping something and send us the tracking number.

✅ Do coordinate shipments with your host institution shipping office.

❌ Don’t include additional materials in your shipment which are not covered by the shipping paperwork.

❌ Don’t hand carry samples.

We look forward to seeing you soon; and we wish you and your samples a seamless journey here. Please contact your AIC host, Cell Culture Lab Coordinator (Satya Khuon: khuons@janelia.hhmi.org), or Janelia EH&S/C (safety@janelia.hhmi.org) with any questions or concerns regarding your visit.

Last modified Jul 16, 2020