30th Edition - March 31, 2022

Think Research Misconduct Allegations Can’t Happen to you? Think again!

Research misconduct allegations at IU continue to rise, and have a huge impact on the affected researchers, their colleagues, and their research. Falsification, fabrication, and plagiarism can happen in any discipline, on any campus, and often looks very different from the research misconduct cases in the headlines. The Vice President for Research, IU School of Medicine, and the Office of Research Compliance invite you to join us for this live webinar series.

In this ongoing webinar series, IU Research Integrity Office (RIO) staff join faculty members who adjudicate research misconduct cases to discuss the causes and consequences of research misconduct and share lessons learned from real cases right here at IU. Learn what falsification, fabrication, and plagiarism look like in real life, how research misconduct allegations can affect you and your research, and approaches for preventing research misconduct, and research misconduct allegations, in your own labs and research teams.

Join us for the 3rd session in our series: The Culture of Research Misconduct

April 18, 2022, 11:30am – 1:00pm

The environment and culture of a lab or research team is a significant predictor of research practices, both good and bad. RIO staff will share examples of how negative environments have led to allegations of research misconduct, and faculty colleagues will discuss approaches for ensuring a culture that discourages research misconduct.

Presenters:

• Shelley Bizila, MS, Director & Research Integrity Officer, Research Integrity Office, IU Office of Research Compliance

• Ted Cummins, PhD, Department Chair and Professor, Department of Biology, IUPUI School of Science

• Linda Smith, PhD, Distinguished Professor and Chancellor’s Professor, Department of Psychological and Brain Sciences, IU Bloomington College of Arts + Sciences

With an introduction by:

John Baumann, Associate Vice President for Research, IU Office of Research Compliance

Register and learn more about the series, including future sessions.

In 2021, the IU IBCs and IACUCs that are supported by ORC completed evaluation and started planning for the implementation of an electronic system for protocol submission, review, and approvals.  We are planning for Kuali Protocols to go live later this year for protocol submissions to the Bloomington and Indianapolis IBCs, followed by the IACUCs.  Kuali Protocols is the base platform currently used by the Human Research Protection Program for human subjects research.  Implementing the Kuali Protocols system for IBC and IACUC will allow investigators to complete online versions of the forms that are currently filled out individually in Microsoft Word and submitted via e-mail. The Office of Research Compliance is carefully planning the implementation to minimize disruption to research while benefitting from the opportunities that come from the use of an electronic system.  Look for more information and training opportunities over the coming months as we progress toward implementation.  Contact Eric Swank at edswank@iu.edu with questions about the system implementation.

The IU IRB has long had policy requirements addressing consent processes for individuals who do not speak English. While some of the requirements have also been applied to individuals who speak but do not read English, no specific policies have existed addressing accessibility for individuals who are unable to read the English consent form.

To address this gap and to promote inclusion in research, the IU HRPP Policies have been updated to include specific requirements to be met when a research participant speaks English but is unable to read the informed consent statement. The updated policy language mirrors the requirements for non-English speakers. The updates include a requirement to provide an accessible version of the informed consent to the participant, for example, an electronic consent that is compatible with a screen reader or a Braille consent, unless an exception is met. The updated policy language can be found in the IU HRPP Policy on Informed Consent. Contact the HRPP at irb@iu.edu with any questions regarding this policy revision.

In an effort to ensure information in Kuali Protocols remains up to date and to assist the IU HRPP with workload management, a new process has been implemented regarding withdrawal of pending (not yet approved) IRB submissions.  New study submissions that have been pending and inactive for more than six months since initial IRB review will be permanently withdrawn from the system.  This will impact new studies that have been reviewed by the convened IRB and provisionally approved or tabled, or for expedited studies, an IRB member has reviewed the study and requested revisions to be completed.  If a substantive response to the IRB’s requests has not been received within six months, the new study will be permanently withdrawn from further IRB review, i.e., submission will be marked as Abandoned in Kuali Protocols.  After permanent withdrawal, a new study submission will be required.  If you have any questions or to request an exception to this process, contact the HRPP at irb@iu.edu.

Before and after the Russian attack on Ukraine, the US Government has implemented sanctions that target individuals and certain commercial activity in Russia.  In addition, many businesses have voluntarily withdrawn from markets in the Russian Federation.   If you have questions about how these sanctions might impact your research, travel, or other university activities, please contact the Export Control Office at export@iu.edu.

Below is a summary of some of what has been adopted that could impact university business. These restrictions are changing almost daily and may affect collaborations, agreements, and research projects at IU.

On February 22, 2022, Executive Order 14024 imposed a virtually complete economic embargo on the Donetsk and Luhansk regions of Ukraine, meaning that no U.S. company or individual may conduct business with those regions.

Since then, the US Government has imposed severe economic sanctions and export controls on Russia, Belarus, and on entities that support the actions of the Russian government. The restrictions consist of significant financial sanctions on Russian financial institutions and individuals and heightened export controls that impose stringent license requirements and policies. This includes blocking sanctions on most Russian banks, the removal of certain banks from the SWIFT system, and asset freezes on individuals.

Economic Sanctions: Many businesses, banks and individuals have been designated restricted parties by the US Government. Collaborations, business transactions and other activities with these restricted parties may be prohibited or may require an export license. Contact the Export Control Office (export@iu.edu) for assistance with the identification of restricted parties if you have questions about a current or future collaboration or transaction.

Export Controls: The export control sanctions are intended to limit Russia’s ability to import advanced technologies in the defense, aviation, and maritime sectors. Items that did not previously require a license to export now require authorization. Items and technologies subject to the Export Administration Regulations (EAR) are affected, including but not limited to computers, semiconductors, telecommunications, and encryption security.

Affected items include those in Categories 3-9 on the Commerce Control List (CCL), such as:

• General purpose electronic equipment (ECCN 3A992)
• Specific processing equipment (ECCN 3A999)
• Telecommunications equipment (ECCN 5A991)

Exports of nearly all U.S. items, except food and medicine, are now restricted for military end-uses and end-users (MEUs) in Russia. Contact the Export Control Office (export@iu.edu) before shipping or transferring any items or technology to Russia, Belarus, or a Russian entity.

Travel Advisory: As of March 5, 2022, the State Department has advised all U.S. citizens to depart from Russia immediately.

The Export Control Office is continuing to closely monitor new economic sanctions and export controls. Contact export@iu.edu for guidance if you have or anticipate having activities or transactions involving individuals, researchers, colleagues, businesses, or universities in Russia, including:

• Collaboration on research or other projects
• Shipments
• Financial transactions
• Exchanges of technology