33rd Edition - January 12, 2023

We’re all glad for the return of the opportunity to travel internationally once again! The resumption of international travel for personal or professional reasons means IU faculty, staff, and students should again take a minute to consider whether export control regulations might impact their plans. Depending on the travel destination, the hardware, software, and/or technical data that is taken and any collaborators you will encounter, you should consider consulting with the IU Export Control Office.

Export control requirements for international trips are determined by:

1. Where you are going:
   
   The Office of Foreign Assets Control (OFAC) is part of the U.S. Treasury Department and manages the government sanctions and embargoes program.
   
   Currently, CUBA, IRAN, NORTH KOREA, SUDAN, and SYRIA are on the list of embargoed countries, which prohibits ALL transactions (including imports and exports) without a license authorization or an exception.
   
   Other countries are subject to targeted sanctions and restrictions as well. Fortunately, normal travel does not usually constitute a problem. However, the technology/information exported during your trip, the persons/organizations met, and the type of activity performed can trigger export control issues, depending on the destination. Also note that some countries have their own additional import and export controls regulations which may affect how you can use items while overseas, and which could restrict your ability to bring them back. You should be aware of all applicable regulations and how they could apply to you.
   
   
2. What you are taking:
   
   When traveling outside the U.S., even to countries beyond the above list of embargoed countries, everything you take with you is subject to the U.S. export controls regulations. This includes tangible items (laptops, cell phones, equipment, samples, paper documents etc.) and intangible products (trainings, know-how, files, data etc.). In order to determine whether an export authorization is required prior to traveling, you should think about what you’re bringing and whether it is listed on one of the US government’s lists for export control items and technology. The IU Export Control Office can review the items with you and determine if there may be any restrictions that need to be considered.
   
   Certain exceptions allow you to take your personal laptop to any countries except Cuba, Iran, Syria, and North Korea. Note, however, that if your laptop contains controlled software/data, a license will be required. This exception applies only to personal items and, thus, does not apply to items owned by IU (e.g., laptop bought with university funding).
   
   Other temporary export/reexport of institution-owned items can be allowed if the equipment is being returned to the United States within one year. The items must remain under the effective control of the exporter/re-exporter. Please contact us to help verify that what you bring is within the scope of applicable federal law!
   
   
3. Who is working with you:
   
   Specially Designated Nationals (SDNs) and Blocked Persons are entities or individuals owned or controlled by, or acting for or on behalf of, the governments of target countries. SDNs may also be associated with international narcotics trafficking or terrorism. United States persons may be prohibited from conducting certain activities with the listed individuals and entities without prior OFAC authorization.
   
   Therefore, it is recommended to know in advance with whom you will be communicating and collaborating, and a Restricted Parties Screening (RPS) can be performed on those persons and entities. Certain foreign universities have been added to these various US government lists. Please contact the IU Export Office and allow us to help you screen potential partners.

Questions should be directed to IU's Export Control Office

Contact IU's Export Control Office at export@iu.edu. You may also schedule an in-person meeting at a campus location convenient for you.

The HRPP has made updates to guidance and Policies effective January 1, 2023. A summary of updated information is provided below.

• The IU IRB has adopted additional expedited categories that may be applied to minimal risk research that is not federally-funded, FDA-regulated, and/or subject to VA regulations. These new categories appear below the federal expedited categories in section 2.5, Expedited Research Categories in the HRPP Policy on IRB Review Process. When submitting to the IRB, researchers are not required to determine if their research fits into the new categories; whether the new categories apply to the research will be determined by HRPP staff and the IRB during review and noted in the Approval Letter when applicable.
  
  
• New studies, regardless of risk level, that require review by the convened biomedical IRB and have not undergone a peer-review process must be submitted to the Clinical and Translational Science Institute (CTSI) Scientific Review Committee (SRC) for scientific review prior to submission to the IRB. In addition, research that qualifies for review under the new flexible expedited categories 400(b) and/or 700(b) that has not undergone peer review must be submitted to the CTSI SRC for scientific review. More information may be found in section 3.5, Scientific Review in the HRPP Policy on IRB Review Process or guidance on Additional Review by Non-IRB Committees.

Please contact the HRPP with any questions regarding these changes at irb@iu.edu.

Are you seeing a red "Error while saving..." message at the bottom of the browser window when uploading an attachment, editing a section, or submitting an item in Kuali Protocols?

This usually occurs when an attachment does not upload successfully, or an edit is not saved successfully. When this happens, either wait a few seconds then remove and re-upload the attachment, or exit out of the submission in Kuali Protocols and re-open it to ensure all edits saved successfully. A black "Save complete" message will appear at the bottom of the browser window if an action is successful.

Kuali recently introduced a new feature called “Download All”.

This button appears in the attachment section in the submission form and allows you to download all documents attached with one click. We hope this new feature improves your Kuali Protocols experience!

Some Kuali notifications for IRB protocols, IBC protocols, and/or COIC disclosures are ending up in individual’s Junk Email folder in Outlook. These notifications include important updates regarding our protocol(s) and/or COIC disclosure. To ensure that these notifications do not end up in the Junk Email folder please follow the steps below to add no-reply=kuali.co@mx3.kuali.co to your safe sender list.

1. Log into mail.iu.edu
2. At the top right, click the Settings (gear) icon, and then at the bottom of the "Settings" window, click View all Outlook settings.
3. If it isn't already selected, click Mail and then Junk email. From here you can view, add, and remove addresses and domains as "Blocked" or "Safe".

For more instructions please visit the Knowledge Base article about junk email settings at IU: https://kb.iu.edu/d/auel

Responsible Conduct of Research spring workshops are open to all IU research community. Consists of two, 2-hour workshops offered per semester. Designed to satisfy the NIH requirements on responsible conduct of research.

The Office of Research Compliance, in collaboration with Vice Provost for Research Office, Office of Vice Provost for Graduate Education, and participating NIH Principal Investigators are pleased to continue offering the Responsible Conduct of Research (RCR) Series. If supported by National Institutes of Health (NIH) F, K, T, or Dissertation Awards, NIH requires that all eligible researchers complete an in-person (virtual given the pandemic) interactive program of RCR education of at least 8 hours.

Led by faculty researchers, key administrators and representatives of Office of Research Compliance, including faculty members of compliance committees. Join us this spring for the following live virtual sessions:

February 23, 2022, 4pm-6pm: Data Management, Research Mentoring & Collaborative Research

March 30, 2022, 4pm-6pm: Peer Review, Authorship, & Publication

Register through IU Canvas. Contact rhopson@iu.edu with any questions.

The Office of Research Compliance shares research-related news and updates from IU research partners. Please see the latest research updates from Eskenazi Health below.

The Eskenazi Health webpage for Researchers has been in the works for quite some time, and it is finally here. We are so excited about this webpage and there could not be a more perfect time to launch it than the start of a new year!

The webpage welcomes visitors with an introduction to Research at Eskenazi Health and provides focused content on how to conduct research at our organization.

We would like to invite you to visit our new webpage.

The webpage can also be accessed by visiting www.eskenazihealth.edu and clicking on “Researchers” at the top of the main page.

Research Stations at Eskenazi Health

With a goal of accommodating research teams and fostering research within our organization, Eskenazi Health is excited to announce our new Research Stations.

The new Research Stations are located on the Eskenazi Health main campus in the waiting rooms of OCC3, OCC4, OCC5, and OCC6. The beautiful, frosted glass enclosures are wheelchair accessible and have sliding glass doors to provide for privacy. Each Station is equipped with a table, two chairs, an electrical connection, and wireless access. These Stations will provide research teams a space to meet with research participants to conduct non-clinical research activities.

Ideally the Research Stations CAN be used for:

• Informed consent discussions
• Research interviews, surveys, or education with participants or caregivers (both Eskenazi Health patients and non-patients)
• Recruitment activities such as study explanations

Research Stations CANNOT be used for:

• Clinical care such as billable appointments
• Specimen collection (e.g., blood, urine, swabs) or procedures
• Researcher office space

All Research Station appointments MUST be scheduled in Epic by the research team. Scheduling education is available via the Manage Research Study Patients Tip Sheet that contains screen shots and instructions for Research Station scheduling, or through personal Webex training with our Epic Research Trainer. To receive a Tip Sheet or more information related to Research Station scheduling please contact researchtraining@eskenazihealth.edu.

For additional Information related to either the Eskenazi Health Webpage for Researchers or the New Research Stations, please contact Patti Noblet at patricia.noblet@eskenazihealth.edu.