Regulatory compliance updates
While the university is in the process of a phased reopening, all URCO staff will be working remotely. We are still accepting new protocols, and all committees are meeting to review and approve new protocol submissions. If there are any questions, please email email@example.com.
February 2, 2021: Last Week for PDF IRB Applications
February 5, 2021 will be the last day that word and pdf versions of IRB applications will be accepted. After that date, all new protocol applications will need to be done through IRBManager. More information on IRBManager can be found here.
December 22, 2020: Coming Soon: New System for Submitting IRB Applications
Beginning January 11th, our office will be updating the application and submission process for research involving human subjects (IRB). More information will be provided in K-State Today and Research Weekly in early January 2021.
November 19, 2020: 6th Edition of BMBL Released
The newest edition of the BMBL has now been released. A free copy can be downloaded here.
November 9, 2020: New SOP on the engaging with any person or organization on the Department of Commerce Entity List
Information regarding this new SOP can be found here.
September 24, 2020: NEW: Export Control Changes Related to Cuba
The Department of Treasury Office of Foreign Assets Control is eliminating the general authorization related to attendance at, or organization of, professional meetings or conferences in Cuba. These activities may be authorized via specific license on a case-by-case basis. Other changes include a ban on lodging in hotels or properties controlled by the Cuban government, government officials and the Communist Party, or their close relatives. The rules went into effect on September 24, 2020. Please contact firstname.lastname@example.org with any questions.
September 21, 2020: Enhancing the Security and Integrity of America's Research Enterprise
The White House Office of Science and Technology Policy has released a new PPT presentation titled "Enhancing the Security and Integrity of America's Research Enterprise." Click here to view.
February 25, 2020: New USDA Regulations Regarding COVID-19
December 23, 2019: Shipping Internationally and Export Controls
Recent reports in the news indicate that the FBI and other federal law enforcement agencies have increased their surveillance efforts to identify transport of research materials and verify that those exports comply with federal laws. There are reports where researchers have attempted to export research materials abroad, without making required customs’ declaration. The increased scrutiny is part of a nation-wide enforcement action to control the transport of biological materials that may present a threat to the U.S. national security, or reduce the theft of intellectual property developed in the U.S., much of it with federal funds.
There are several federal regulations that deal with proper identification, classification, and description of goods, packaging certifications, permits, and custom declarations. Transporting certain materials may require import/export permits or other documentation from federal agencies, including U.S. Customs and Border Protection (CBP), the FDA, USDA, Fish and Wildlife, and the CDC. We would like to remind all K-State researchers to comply with all applicable federal requirements. Please contact URCO at email@example.com with any questions.
November 13, 2019: Travel to Embargoed Countries - Export Controls Compliance Program
The U.S. government maintains comprehensive sanctions and embargoes against a number of countries. The programs are administered by the Office of Foreign Assets Control (OFAC), Department of Treasury, and generally prohibit importation and exportation of goods and services to and/or from an embargoed country. Travel related activities that are allowable for other destinations might require an export license or other authorization if the travel is to an embargoed destination. For example, while travel to Iran is not prohibited and does not require a license, attending a conference or conducting research in Iran requires a license. Travel to Cuba on the other hand is prohibited, unless authorized by a specific or a general license. The rules are different for each embargoed destination. Please contact URCO at firstname.lastname@example.org, phone 785-532-3224 for guidance prior to travel as soon as you become aware of your impending travel. URCO will assist with applying for the license when necessary. Licenses can take several weeks before they are granted, so it is important that the traveler contacts URCO as early as possible.
September 27, 2019: Resource Guide for International Travel
September 16, 2019: Letter to the United States Research Community
September 5,2019: Science and Security Regulatory Updates
Review the updated summary of regulatory reminders in regards to additional research security measures. (pdf)
August 21, 2019: The European Union's General Data Protection Regulation (EUGDPR)
The European Union’s (EU) General Data Protection Regulation (GDPR) is a Data Protection Directive that is designed to harmonize data privacy laws across Europe, to protect and empower all EU citizens’ data, outlining several rights of the individual for explicit consent on how personal data can be used, processed, transmitted, as well as how any such data must be protected. The GDPR applies to organizations located within the EU, and it also applies to organizations located outside of the EU if they offer goods or services to, collect data from, or monitor the behavior of individuals in the EU, regardless of the organization’s location. It is intended to affect organizations worldwide, including universities. The GDPR went into effect for businesses outside the EU that process data on EU citizens on May 25, 2018.
We have developed documents to assist investigators with the collection of information with the collection of personal data from individuals located in the EU. Details can be found on the “EUGDPR Privacy and Consent” webpage, which can be accessed from the URCO main webpage.
July 16, 2019: Azure Availability for research involving controlled unclassified information or export-controlled material
Researchers whose studies involve working with CUI or CUI export-controlled items that fall under ITAR or EAR should be aware that K-State’s officially approved electronic storage and communication method for such items is now Microsoft Azure. If you have questions about this or need to request access to Azure, email CUI@k-state.edu.
If an outside entity with whom you are working tries to use ANY other route to send such materials — e.g. unsecured email, unsecured website or cloud domain— do not open them and immediately report such attempt to CUI@k-state.edu.
July 11, 2019: NSF Disclosure Requirements
July 10, 2019: NIH Disclosure Requirements
The NIH published a notice reminding the extramural community about the need to report foreign activities through documentation of other support, foreign components, and financial conflict of interest to prevent scientific, budgetary, or commitment overlap. Read the NIH memo.
June 7, 2019: Department of Energy Foreign Government Talent Recruitment Programs
Jan., 21, 2019: Revisions to Human Subject Regulations
The revised Common Rule took effect January 21, 2019. A revised application, consent form, and additional informational documents are now available.