26th Edition - April 22, 2021

The IU Office of Research Compliance has obtained and maintains three international accreditations:

• Association for the Accreditation of Human Research Protection Programs (AAHRPP -  reaccreditation every 5 years) for the Human Research Protection Program at IU
• American Association for Accreditation of Laboratory Animal Care (AAALAC  - reaccreditation every 3 years) for the IACUC at IU Bloomington
• American Association for Accreditation of Laboratory Animal Care (AAALAC  - reaccreditation every 3 years) for the IACUC at IU School of Medicine and IUPUI.

Sometimes the stars line up in just the wrong, most burdensome manner.  This is such a year – between Spring of 2021 and 2022 all three accreditations will occur requiring extensive preparation by each office and site visits to our campuses.  We just completed a very successful AAHRPP site visit and AAALAC will be here for what we have every reason to expect to be an equally successful site visit in Indianapolis and Bloomington during summer of 2021 and early 2022 respectively.

Special appreciation goes to the staff of the HRPP and IACUCs for their preparation and planning and to the committee members and researchers for their continued collaboration and participation.

Biological research and the shipment of biologicals are subject to the oversight of various agencies and their regulations, including export control laws and, potentially, DOT/ IATA and CDC and APHIS regulations. The costs and consequences of non-compliance can be significant, as was the case with a U.S. university recently fined $54,000 by the Department of Commerce for export control violations related to the shipment of animal pathogens (in this case VSV-G packaging plasmids) overseas. Although the material was not a fully virulent select agent, the items being shipped still contained genetic material from the select agent and were subject to export control restrictions.  For this reason, contact the Export Control Office before shipping biologicals to ensure that your shipment is in compliance with relevant laws.

Two sets of export controls govern biological research and the physical shipments of biologicals: the Export Administration Regulations (EAR), which control dual-use items and technologies and software with commercial and military applications; and the International Traffic in Arms Regulations (ITAR), which control materials, technologies and software specially designed for military applications. Note that the EAR imposes controls over a broader group of items than those controlled by other U.S agencies, including APHIS and the CDC.

The EAR controls “certain viruses, bacteria, fungus and toxins, as well as genetic elements or genetically modified organisms that contain or code for the genes of controlled pathogens, even if that genetic material is not, itself, pathogenic.” It is important to note, too, that export controls apply regardless of quantity or attenuation, including to small quantities or attenuated strains of select agents of toxins that are excluded from lists administered by APHIS or the CDC. Finally, the controls apply to shipments to all countries and for all purposes and “even when the materials at issue are widely available and in use internationally.”

The transport of materials across or outside of the U.S. border may require special handling, export or import licenses, and/or Customs clearance. Contact the Export Control Office at export@iu.edu if you plan to ship any of the following controlled materials, technologies, or software:

EAR Controls

• Materials listed on the Commerce Control List (CCL) under Export Control Numbers (ECCNs) 1C351 and 1C 354, including: Chikungunya virus; Cholera toxin; Ebola virus; Salmonella typhi; and Saxitoxin. As noted above, the CCL is broader than the Select Agents List. (See pages 65-73 at for a current version of the full list of controlled materials.)
• Genetic elements and genetically modified organisms that contain or code for genes of the pathogens and toxins above; therefore, the controls apply not only to “the complete, wild-type organisms” on the CCL, but also to “any GMO that contains, or any genetic element that codes for, genes of the listed organisms or subunits of the listed toxins.” Genetic elements is defined broadly, and includes, without limitation, “chromosomes, genomes, plasmids, transposons, vectors, and inactivated organisms containing recoverable nucleic acid fragments, whether genetically modified or unmodified, or chemically synthesized in whole or in part ,” as described under ECCN 1C353. (See pages 70-71 at for a complete description.)
• Vaccines against the items referred to above, or immunotoxins containing items referred to above.

Other Controls

Other controls apply to material that can be used offensively or that might be used by a recipient in the design, development, production, stockpiling, or use of chemical or biological weapon.  Additionally, export controls will limit shipments to countries (Cuba, Iran, North Korea, and Sudan) or individual entities that are sanctioned by the US government. 

If you have questions:

Contact Export Control Office at export@iu.edu with questions about shipments of biological materials.  Our office can help secure appropriate permissions and serve as a clearing house to connect you with other IU offices that can assist with logistics, packaging, and the other complex requirements that may apply.

On January 19, 2021, the new IRB system, Kuali Protocols was implemented.  Thank you for your patience, understanding, and flexibility during the development and implementation process! 

The latest information on Kuali Protocols, including instructional guides and a training video, can be found on the HRPP website.  Additionally, you can reach out to HRPP staff at irb@iu.edu with any questions regarding use of the new system.

In May, the HRPP plans to implement enhancements to the Kuali Protocols online IRB submission system.  Most of the planned changes are simply minor wording updates to the application forms and will not impact use of the system.  However, a few changes to system functionality are being developed and tested for potential release in May.  These changes include:

• Elimination of Renew/Amend action. Concurrent Renewal and Amendment submissions will still be permitted after the Renew/Amend action is removed.  However, the Renewal and Amendment will need to be created as two separate submissions rather than as a single Renewal with Amendment.
• Automatic addition of the individual who initiates a new study submission to the Permissions tab. This will replace the current functionality which assigns the initiator to the Personnel list.
• The addition of a non-affiliated section of the Personnel List. This will only be available for new studies first submitted after the enhancement.  For new studies, this will eliminate the need for HRPP staff to add non-affiliated personnel to the Person lookup in Kuali Protocols.

Watch your email and announcements in One.IU for additional information regarding the release date and more information regarding the changes as plans for this release are finalized.