UMass Lowell Compliance News Issue No. 6 • March 2011
• Training Opportunities • New IRB Policy to meet federal timeline for annual reviews
• Institutional Biosafety Committee News …. And more.
UML Compliance News Issue No. 6 • March 2011 Export Compliance 101 Research is defined as an organized and systematic investigation to find answers to questions with the intent of broadly disseminating the results.
OIC Contacts: Elaine Major x3452, Director Dr. Stephen Moses x4134, IRB Administrator Amy Finneral x4698 IACUC Administrator & IRB Assistance Kim Baxter x 4631, IBC Administrator & Export Controls Assistance Committee Chairs: IACUC, Elaine Major IBC, Dr. Susan Woskie IRB, Dr. Joyce White
Inside this issue:
Export Compl.101 (cont.) Foreign Visitors Deemed Exports Updated Guidelines
2
IBC News
3
IACUC Notices
3
Compliance Office Briefs Meet Kim Baxter! IRB Updates (cont.)
4
Website Resources
4
Do you: • Travel internationally? • Work with foreign nationals? • Send items, data, technology, etc. out of the U.S.? • Have projects with publication or personnel restrictions? If you respond ‘yes’ to any of these, you need to understand the basics of export compliance!
What is OIC? OIC is the acronym for the Office of Institutional Compliance.
Compliance Hotline Call the Compliance Hotline at x3100 (978-934-3100) to anonymously report potential research compliance violations. The hotline is only for complaints related to non-compliance with UML policies and procedures governing research activities and the Federal and State regulatory requirements for these activities.
While part of UMass Lowell’s mission is to build and support diverse faculty and student populations and international collaboration, OIC’s goal is to help you understand when these activities are conTraining Opportunities trolled AND to ask you to contact us for help to meet export control compliance OIC frequently provides training to groups regulations. or individuals that is tailored to meet your needs. Topics include IRB Basics, Export International Travel Control Compliance Updates, IACUC UpInternational travel can cause several dates and Health and Safety Training, and types of situations that require export more! compliance review. Licenses are required Call OIC x3452 to schedule for travel to some countries. OIC recommends that you get an annual certification letter for travel with any electronic equipment (i.e. laptop,PDA, smartphone, black- IRB Updates berry, iPhone.). The letter can be preAnnual/Continuing Review sented to customs agents if you are ques- Federal regulations require a minimum of tioned. annual review of human subject protocols. The UML IRB has had to implement a new Travel with Equipment policy to meet the federally required timeIf you travel with any borrowed equiplines for annual reviews. Notifications are ment, please be aware that you cannot guarantee an item’s security outside of the sent out 30 days before the expiration date to U.S. Items may be confiscated and held all researchers to remind them of the deadby U.S. or foreign customs agents. line. The IRB will no longer accept any new applications or process materials from a Incident Report Forms given researcher until all outstanding conSome UML personnel have been stopped tinuing reviews or final reports are submitby customs agents. Please be aware that ted. Special circumstances will be considdocumentation may be requested and/or ered but must be communicated to the IRB equipment may be confiscated. Contact before the deadline for renewal. OIC to report these incidents so we can advise you to prepare for international (Cont. on page 4) activities! (Cont. on page 2)
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Export Compliance 101(cont.) Foreign Visitors and Visiting Scholars To sponsor foreign visitors, a sponsor letter should be submitted to OIC for review and vetting before the letters are issued. In addition, the H-1B Petition form has been revised for visiting scholars and now includes export control language. Sponsors must verify whether or not the person will have access to any export controlled information or work on any restricted projects. If so, you must indicate whether an export license will be required. This form must be submitted to and approved by the International Students and Scholars Office. Deemed Exports Keep in mind that you should focus on using publicly available, published information for general teaching activities. A deemed export is the transfer or dissemination of controlled or sensitive information to a foreign national WITHIN the U.S. Disseminating controlled technology that is not published, or publicly available, or any material that is not ordinarily taught in institutions of higher education to foreign nationals is a deemed export and could result in a violation. Updated Export Control Compliance Guidelines were posted on the website in August 2010. Standard Operating Procedures have also been developed and distributed for the various activities that routinely are involved in export control review. Go to www.uml.edu/ora/institutionalcompliance Contact OIC for help if: ♦ Documents are marked as ‘FOUO’ ♦ Working with personnel from an embargoed country ♦ Shipping/carrying/transmitting anything out of the U.S. ♦ Activities are NOT considered fundamental research, for example, work under service agreements ♦ Research grants or contracts include personnel or publication restrictions ♦ Activities involve development of materials for military application Update for Travel to India! India is now in Country Group A rather than D so travel will no longer need to be vetted through OIC. However, remember if you are taking any equipment, materials, or technology, it is still considered an ‘export’ and you should have the appropriate documentation. There may also be specific entities listed that will require a license.
Compliance Office Data (Numbers reported are from Jan 1 to Dec. 31, 2010)
IACUC Protocols
2007
2008
2009
2010
Submitted
19
5
13
17
Current Active
23
IBC Registrations
2007
2008
2009 2010
Submitted
13
3
8
Exempt BSL1 BSL2 BSL3
1
Current Open By Category:
26 36
7 27 1-offsite
IRB Protocols
2007
2008
2009
2010
Total
136
132
127
150
Category: Exempt Expedited Full
34 86 16
34 89 9
36 86 5
52 91 7
Current Open
Export Compliance Information: Three Training Events in 2010 Activities Reviewed and Vetted: 93 Annual Certification Letters 110 International Travel Forms Vetted 62 Foreign Funders/Vendors Screens 11 Sponsor Letters 14 International Shipments 30 Research and Service Agreements
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Issue 6
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March 2011
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Institutional Biosafety Committee News IBCs are required by the Office of Biotechnology Activities at NIH for use of the following types of materials: • Human tissue or body fluids and nonhuman primate materials (blood, blood components, tissues and body fluids,, cultured human cell lines, animal cell lines that may be potentially infectious) • Research that involves any of the above materials with animal and/or human subjects • Tissues treated with pathogenic agents or transfected or otherwise treated with rDNA • Select Agents (regulated by HHS, CDC or USDA) or other biologically derived toxins • Recombinant DNA (rDNA), synthetic DNA or transgenic plants, animals, and microbes • Infectious agents [pathogenic or infectious bacteria, viruses, fungi or parasites or nucleic acids (prions) or agents of unknown pathogenicity to humans, plants , or animals] • Drug restistant bacteria, including those containing plasmids specifying drug resistance • Xenotransplantation • Stem cells Registrations are required for research AND teaching activities at UML. Registrations must be submitted to and approved by the IBC prior to initiation of any project involving use of these materials or agents. Submit registrations to: BiosafetyOfficer@uml.edu or Kimberly_Baxter@uml.edu NEW!!! CITI online training certification is now required for anyone submitting registrations to the IBC and must be renewed every 3 years. Go to www.citiprogram.org to create a user name and password. Affiliate yourself with the University of Massachusetts Lowell and OIC will receive a copy of your certification when completed! Basic IBC Training includes: •Biohazard Risk Assessment •Risk Management-Personal Protective Equipment •Confining Aerosols and Effective Use of BSCs •Risk Management-Laboratory Design •Risk Management-Emergency and Spill Response BBP Training includes: •Labels & Engineering Controls •Emergency Response Procedures •Universal Precautions and Work Practices (Additional modules include Animal Biosafety, Shipping and Transport of Regulated Biological Materials, Select Agents, and NIH rDNA Guidelines.) Laboratory safety training is required annually by UMass Lowell EHS and includes BBP training. Visit the website for more information and application forms at www.uml.edu/ora/institutionalcompliance
IACUC Notices Protocols submitted to the IACUC for pre-review will not be forwarded for full committee review until all of the concerns have been addressed. ALL protocols will be charged per diems as of 1-1-11. Teaching activities are exempted from per diem charges.
ANY research activity with human subjects MUST be reviewed and approved by the IRB before beginning!
Compliance Hotline
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Compliance Office Briefs Many of you may have already been working with Kimberly Baxter, the compliance office assistant. She started working for the Office of Institutional Compliance about a year ago. Kim has both a bachelor’s and master’s degree in biology from Clark University. She is currently a sophomore in the nursing program at UMass Lowell! Previously Kim was employed in the pharmaceutical industry for eight years where she worked in FDA regulated laboratories. For export control or institutional biosafety committee questions, contact Kim at Kimberly_Baxter@uml.edu or x4631.
IRB Updates (Cont. from page 1) : Submit all applications and materials for review to IRB@uml.edu For funded human subject research , the IRB is required to review the full proposal to ensure consistency between the IRB application/protocol and the proposal. Please submit proposal documents with your IRB materials. Research with human embryonic stem cells is considered human subject research and additional federal and state laws apply to the research. UMass Lowell is now registered with the state to conduct such activities. Please be aware that the work must have an ethical review (independent of IRB, IBC and/or IACUC) before these materials are received or used at UMass Lowell. We are interested in identifying researchers who have experience with stem cell work to assist in reviewing such research activities. Please contact Elaine at x3452 if you are interested!
Website Resources UML Institutional Compliance website: www.uml.edu/ora/institutionalcompliance Training Information: www.citiprogram.org/ Modules available now include: • Human Subject • biomedical or sociobehavioral disciplines • Working with the IACUC • Basic Institutional Biosafety Committee • Blood borne pathogens • RCR Certification
Export Control Commerce Department– EAR www.bis.doc.gov/policiesandregulations/ index.htm#ear State Department-ITAR www.fas.org/spp/starwars/offdocs/itar/p121.htm Treasury Department-Sanctions Program http://www.treasury.gov/resourcecenter/sanctions/Programs/Pages/Programs.aspx
Alternative Human Subject Research Training: http://phrp.nihtraining.com/users/login.php Office for Human Research Protections: www.hhs.gov/ohrp/
Comments?
Traveling abroad with your laptop? Be sure to get an annual certification letter from OIC!
If you have any questions or problems related to compliance issues, ideas for improvements, or questions about policies or procedures, please contact Elaine at x3452.
Cover Photo: Permission granted by www.exportimportcompliance.com. All rights reserved.