Research Integrity and Assurance

New and Departing Investigators

New and departing investigators

Whether you are just starting at ASU or you are departing, attending to all of the details can be overwhelming. To help you navigate the process, we have provided a list of compliance items that you may need to address. Please contact us for assistance as you move through your transition.

Approvals from prior institutions don’t “follow you” to ASU. You must obtain approvals for each compliance area below prior to beginning work at ASU.  It may be helpful to have copies of any prior protocol approvals or training documents before you leave your current institution in the event you need to refer to them.

For those departing ASU, it is highly recommended that you take copies of your ASU protocols, approvals, and training documents for future reference. Record retention requirements can vary and documents are only kept by ASU as required by regulations.

Human subjects
New Investigator

_____      Familiarize yourself with the ASU Institutional Review Board (IRB) protocol submission process and forms. If you are engaged in human subjects research (even if only analyzing data), the ASU IRB will need to review, approve, and have a record of all the research you will be conducting at ASU.

_____     Take or update your CITI training for IRB if not taken within the last four years. If you took IRB training with your prior institution within the last four years, the ASU IRB may accept the training with proper documentation of completion.

_____     We recommend you attend an IRB Basics session to familiarize yourself with the IRB. We are also available for one-on-one consultations either in-person or by telephone.

Departing Investigator

_____     Submit a modification to transfer active protocols to a new ASU PI, if work will continue at ASU after your departure. The new PI must assume full responsibility for the protocol and its associated personnel.

_____     If work will not continue after your departure, close the protocol following the closure process.

_____     For industry-sponsored research, confirm that all outstanding invoices have been paid.

_____     If work will continue at another institution, apply for IRB approval at the new institution. Failure to secure IRB approval at the new institution may result in a non-compliance.

Animals
New Investigator

_____     Familiarize yourself with the ASU Institutional Animal Care and Use Program (IACUC) protocol submission process and forms.

_____     Each individual working with live vertebrate animals must take IACUC Level I Basic and Level II (species-specific) training. This training will need to be repeated every four (4) years.

_____     To perform procedures independently (i.e. without supervision), the person must have a Level III training form submitted and accepted by the IACUC documenting their training and competency.

 _____     Each individual with frequent and substantial contact with vertebrate animals must complete and submit the Occupational Health Surveillance Initial Questionnaire to ASU Health Services.
 

_____     Schedule a consultation with the attending veterinarian to discuss any animal housing or care needs. The ASU veterinarians also provide protocol development consultations and hands-on training free of charge.

_____     If you are transferring animals from another institution, the transfer must be scheduled with the attending veterinarian in advance. Animals may not be transferred to ASU without an approved protocol in place.

_____     The IACUC reviews all protocols at a monthly convened meeting. The schedule of meetings and their corresponding submission deadlines can be found on the protocol submission page of this website. The principal investigator, or a representative knowledgeable about the animal work, is required to attend the meeting to help facilitate the review process. We find this helps questions get addressed during the meeting and shortens the time it takes to receive approval.

_____     If animals will be utilized outside of the central vivaria spaces, the space will need to be inspected prior to animal use.

_____     The IACUC has a list of commonly used animal procedures in the animal procedural and other guidelines page. You can reference the Standard Institutional Guidelines (SIGs) listed in your protocol instead of writing the entire procedure out. Any changes to the standard procedures will need to be defined in the protocol.

_____     If DEA controlled substances are used for the research, consult with the attending veterinarian to determine if the principal investigator will need to obtain a DEA license.

Departing Investigator

_____     If the work will continue at ASU, transfer your active protocol to a new PI by submitting a Request for Changes form. The new PI must assume responsibility for the protocol to include the research, associated personnel, and the animals.

_____     If the work will continue at another institution, you will need to contact the Attending Veterinarian to arrange the transfer of animals. An approved protocol must be in place at the new institution for the animals to be transferred. Once the animals have been transferred, close the protocol by submitting a Final Review Form.

_____     Close the protocol by submitting a Final Review form. The Final Review form cannot be submitted until any remaining live animals under the protocol have been dispositioned by:

  • Completing the project prior to leaving ASU OR
  • Transferring the animals to another PI or DACT by submitting a Transfer of Animals Request form OR
  • Euthanizing by the methods in the approved protocol

_____     Transfer or disposal of DEA controlled substances. For disposal of DEA controlled substances, contact DACT for assistance.

Biosafety
New Investigator

_____     Familiarize yourself with the ASU Institutional Biosafety Committee (IBC) disclosure submission process and forms. Once submitted, the IBC Coordinator will let you know the review process that will be used for your disclosure. If the disclosure requires review at a convened IBC meeting, you will be provided with meeting details. The principal investigator, or a representative knowledgeable about the work being performed, is required to attend the meeting to help facilitate the review process. We find this helps questions get addressed during the meeting and shortens the time it takes to receive approval.

_____     Complete Biosafety training if you will be working with materials at BSL 2 or higher or if you will be working with materials that are BSL 1 but not exempt from the NIH Guidelines.

_____     If you are transferring materials from another institution:

  • Contact industryagreements@asu.edu to determine if a Materials Transfer Agreement (MTA) is required.
  • IBC permission is required to transfer materials to ASU prior to having an approved IBC disclosure. To request permission, contact the IBC.

_____     The IBC requires an inspection of all spaces where biohazards will be used and stored prior to approval of the biosafety disclosure. To schedule an inspection, contact biosafety@asu.edu. Inspections should take place when equipment to be used in the laboratory is in place and functional.

_____     Confirm with ORIA staff or EH&S Biosafety whether permits (e.g., USDA, CDC) are required for transfer of the material. Permits are the responsibility of the PI but ORIA and EH&S staff are available to assist whenever possible.

Departing Investigator

_____     If work will continue at ASU, submit a Modification Form to transfer the disclosure to a new ASU PI. The new PI must assume responsibility for all materials, research, and associated personnel on the disclosure.

_____     If biohazards are being transferred to your new institution:

  • Follow the new institutions procedures to gain approval to receive the biohazards
  • Contact EH&S for assistance with proper containment and shipping procedures
  • Contact ORIA or EH&S for assistance if any permits are required (e.g., USDA, CDC).
  • Follow these instructions for initiating Materials Transfer Agreements and Permits

_____    Follow EH&S guidelines to dispose of remaining biohazards or chemicals used in the research.

  • Notify the IBC of the disposition of biohazards.
  • Schedule a laboratory close-out inspection with EH&S Biosafety and your department’s safety officers.
  • Once all biohazardous material has been disposed of, email IBC@asu.edu to close your biosafety disclosure.
Conflicts of interest
New Investigator

_____     Researchers must disclose any potential conflicts of interest using the ERA system. Information on what to disclose can be found on the financial conflicts of interest page and specific directions on how to disclosure those interests in the ERA can be found on the disclosure process page.

Note that State of Arizona procurement regulations have a $0 threshold for reporting substantial interests.

_____     If you are transferring from another institution and currently have a management plan in place for a financial conflict of interest on an award, contact ORIA for a consultation.

_____     If you are transferring an award from PHS or a sponsor who requires compliance with PHS regulations, you will need to complete Conflicts of Interest training.  This training is required once every four (4) years.

Departing Investigator

_____     Complete any outstanding COI certifications in ERA.

_____     If awards currently under a management plan are being transferred to your new institution, contact ORIA.

Export controls and security
New Investigator

_____     For projects that require export controls or security clearances, contact ORIA for a consultation.

Departing Investigator

_____     Contact ORIA for projects that are subject to a Technology Control Plan (TCP) or have security requirements.