Office of Institutional Compliance (OIC) Newsletter Issue No. 8 • August 2013 OIC Staff News Contact OIC as soon as possible for questions about industry collaborations to understand compliance requirements! OIC can begin evaluations early to help avoid delays.
OIC Contacts: Elaine Major x43452, Director Amy Finneral x44698, Animal Research Compliance Man‐ ager Thomas Porro x43207, Export Control Compliance Manager Emily Sousa x44134, IRB Administrator Commi ee Chairs: COI, Dr. Julie Chen IACUC, Dr. Peter Gaines IBC, Dr. Susan Woskie IRB, Dr. Doreen Arcus
Inside this issue: IRB Updates Interna onal Travel Guide‐
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lines Ac vi es Requiring OIC
Review IACUC News COI Informa on Biosafety Training Remind‐
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ers Export Compliance Re‐
minders Website Resources
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Thomas Porro, the Export Control Compli‐ ance Manager, has been busy reaching out to faculty who are involved in ac vi es that require export compliance reviews. He brings 20 years of experience in federal law enforcement and regulatory compliance, including 9 years with the U.S. Department of Commerce. Tom provides faculty and de‐ partmental customized training, reviews interna onal travel, ensures interna onal shipments are prepared following regulatory requirements, assists with award and con‐ tract reviews, helps faculty develop Technol‐ ogy Control Plans, and more! He is always available for export control compliance ques ons at Thomas_Porro@uml.edu or x43207.
Export Reform Updates!!! Substan al progress has been made to date in the U.S. Export Control Reform Ini a ve, which is in‐ tended to streamline the en re U.S. export control system. Some changes could benefit research uni‐ versi es while others could impose addi onal con‐ trols. On a posi ve note, there will likely be more license excep ons available that would enable non‐ U.S. persons to work on controlled projects without requiring the current lengthy approval pro‐ cess. There are other changes that could further complicate the export control evalua ons of some campus ac vi es and result in restric ons to ac vi‐ es that are currently not controlled. OIC will be monitoring and communica ng the changes in the U.S. export control regula ons to the affected UMass Lowell community as they are ul mately enacted.
Export Compliance Training As a reminder, annual training on export controls is required for all faculty in high‐risk disciplines, primarily Sciences and Engineering. Training op ons include the online CITI program module for export compliance at www.ci progam.org or in‐person training with Tom Porro. For CITI, log in and create or enter your user name and password, then affiliate yourself with UMass Lowell and select the export control modules.
Emily Sousa is the Ins tu onal Review Board (IRB) Administrator as well as provides IBC Administra on. Emily is a UMass Lowell alumna with a Bachelor’s degree in Criminal Jus ce, Forensic Criminology Cer ficate, and Master’s degree in Criminal Jus ce. Emily can help guide you through the IRB process and provides pre‐reviews for all IRB applica‐ In‐person training can be tailored to individual ons so materials are be er prepared when research disciplines and be provided any me for they are sent to the commi ee reviewers. individuals or groups upon request. Please contact Faculty with IRB applica ons will likely re‐ Thomas_Porro@uml.edu to schedule a training or to ask ques ons. Anyone who requires a TCP is also ceive comments/concerns regarding IRB required to complete project specific briefings at the applica ons soon a er submission to make me the TCP is implemented. the applica on materials easier to review! Make sure materials and ques ons are sent to IRB@uml.edu or contact Emily at x44134. International Travel and Physical Exports ALL Interna onal Travel is now reviewed and Amy Finneral is the Animal Research Compli‐ ve ed by OIC to make the process easier for ance Manager and can assist you with any travelers. Approvals are then sent directly to ques ons about animal research or protocol Accounts Payable for processing. OIC also pro‐ review. Contact Amy_Finneral@uml.edu or vides an Annual Cer fica on Le er for travel x44698. with electronic equipment—you simply verify that you are not taking any export controlled Elaine Major is now assis ng the Vice Prov‐ informa on out of the U.S. The le er is valid for ost for Research with Outside Ac vi es and one year. Conflict of Interest repor ng. Look for more Remember, ALL physical exports (including mail) announcements on what and how to dis‐ going out of the U.S. need to be evaluated to close various ac vi es! make sure materials sent (or hand carried) and where you are sending/taking them will not cause an export viola on.
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Institutional Review Board Updates New! IRB Inves gator Guidelines provide an‐ swers you need in an easy‐to‐read, organized guide that includes training requirements, explains which forms you need for what, how to handle various types of data, and more! IRB Policies and Procedures have also been recently updated!
International Travel Recommendations
Remember, you MUST submit a signed Travel Authoriza‐ on form at least 10 business days before travel. All trav‐ el must be ve ed by OIC and signed by your Dept. Chair and Dean. OIC can vet the travel at any point in the pro‐ cess. Our goal is to prevent a problem of visi ng with listed en es. Reimbursement may not be approved without the appropriate signatures and ve ng BEFORE you travel!
Take only what is per nent—any controlled or sensi ve informa on should be removed from all electronic devic‐ es before travel to comply with export regula ons and to protect the data.
Take all electronic devices as carry‐on. Store under the seat in front of you –not in the overhead bin!
Use of telephones, computers and fax equipment at for‐ eign hotels or business centers o en means foreign gov‐ ernments will know what you say or send.
Be wary of people you don’t know asking a lot of ques‐ ons about where you work or what you do.
Be suspicious of quick friendships.
Beware of situa ons where alcohol is offered in abun‐ dance: your personal informa on can be used against you.
Hotel rooms are o en not safe in foreign countries: nev‐ er leave informa on or electronics unprotected.
Protect your Passport! Be prepared to expedite the re‐ placement of lost or stolen informa on. Visit the U.S. State Department’s Smart Traveler Program for travel advisories (h ps://step.state.gov)
Highlights:
Outside researchers or ins tu ons are no longer allowed to use UMass Lowell student, staff, or faculty popula ons for survey research to avoid survey fa gue, unless UMass Lowell faculty are engaged in the research. Student Psychology Pool may only be used for research ac vi es by full me Psychology faculty. New informa on on interna onal research and how to begin is included in the new policy document. Changes in regards to use of Office of Ins tu onal Research data: even if you can access it for teaching, you need IRB approval to use it for research! NSF has a new policy that now requires incen ve payments may only be made by cash. A new module, Health Informa on Privacy and Security, has been added for students in Health Sciences who will be working with clinical affiliates for training or internships and will have access to protected pa ent informa on. Anyone is welcome to take it as an elec ve! OIC will soon begin random audits of approved IRB protocols!
IRB Commi ee Members: Chair, Doreen Arcus, Psychology Vice‐Chair, Jill Lohmeier, Graduate School of Educa on Joyce White, Physical Therapy Maria Brune e, Work Environment Robin Toof, Center for Community Research and Engagement Margaret Knight, Nursing Karen Melillo, Nursing‐Alternate Linda Williams, Criminal Jus ce
Activities Requiring Compliance Review
Stay tuned for the NEW OIC Gold Star Recognition Program!
Ins tu onal Animal Care and Use Commi ee (IACUC) – all research with animals Ins tu onal Review Board (IRB) – research ac vi es that involve human subjects such as surveys, interviews, focus groups, collec on of any human body fluids or ssues, preexis ng data, and measurements of physiological responses Ins tu onal Biosafety Commi ee (IBC) – use of biohazardous substances for research and teaching. Examples of substances that must be registered include viruses, rDNA, infec ous agents, human ssue or bodily fluids, select agents, stem cells Export Control Compliance Program – common ac vi es that require review include Interna onal travel Shipments out of the U.S. Research that has personnel or publica on restric ons designated in the award Service Agreements (work coming in on P.O.s). These ac vi es do not meet the Fundamental Research Exclusion A license may be required to conduct the ac vity or complete the export from Commerce or State Department!
Issue 8
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August 2013
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Institutional Animal Care and Use Committee News IACUC Commi ee Members: Chair, Peter Gaines, Biology Vice Chair, Thomas Wilson, Clinical Lab/Nutri onal Sciences Susan Woskie, Work Environment Mahdi Garelnabi, Clinical Lab/Nutri onal Sciences Chur (Karen) Masors, Biology Glenn MacDonald, EHS Elaine Major, OIC Rev. Jonathan Mackenzie, Community Member Sco Perkins, Consul ng Veterinarian A commi ee has been established to help create a vision statement for animal research needs and to assist with informa on gathering required to support planning requirements for facility renova on. The EHS Occupa onal Health and Safety Program has been expanded to require ANYONE entering the facility or handling live animals complete a baseline health assessment. Several new Policies and addi onal Guidelines have been implemented! They include: Mul ple Survival Surgery Cage Density for Mice and Rats Transporta on of Animals Physical Restraint and Immobiliza on Use of Animals for Teaching‐jus fica on is required that no alterna ve methods are available Protocol pre‐review process ‐ALL pre‐review concerns must be addressed before going to commi ee review Other IACUC Informa on The Emergency Response Plan is in the process of being updated to meet new USDA regula ons. OIC will be coordina ng and encouraging animal researchers to meet to discuss be er ways to op mize resources, space, and equipment needs.
Conflict of Interest Information Under the Federal financial disclosure regula ons, a conflict of interest (COI) exists ‘when it can be reasonably determined that an inves gator's personal financial concerns could directly and significantly influence the design, conduct, or repor ng of government funded research ac vi es.’ However, Conflict of interest Policies apply to several other types of ac vi es at UMass Lowell, includ‐ ing but not limited to outside ac vi es, other funded research, proposed intellectual property transac ons and company start‐ ups, human subject research, and nepo sm. State of Massachuse s Employees have addi onal disclosure requirements. OIC will now be assis ng the Vice Provost for Research and ORA to manage detailed conflict disclosures. A new campus Conflicts Commi ee has been established to review and provide management guidance for those employees who do have significant fi‐ nancial conflicts. The OIC website has been updated with the policies, updated forms, commi ee members and other resources. Check out the informa on on the OIC website! We hope to also disseminate informa on at College or Department mee ngs dur‐ ing the Fall 2013 Semester! For immediate assistance, contact Elaine Major at x43452.
Institutional Biosafety Training Reminders Biosafety and bloodborne pathogen training is required and can be completed either by a ending in‐person EHS courses (required for first me learners) or online from www.ci program.org to meet follow‐up training requirements: Basic IBC Training – valid for 3 years BBP Training – valid for 1 year EHS Laboratory Safety Training – valid for 1 year Registra on forms are at www.uml.edu/Research/OIC/ and go to the Biological Safety naviga on bar. Policies and Procedures were recently updated as well! Contact Emily_Sousa@uml.edu for Biosafety Commi ee mee ng informa on or help with a reg‐ istra on form. For ques ons about working with specific materials or to get your laboratory approved for specific ac vi es, con‐ tact Dr. Ruth Medina, Biosafety Specialist at x42778.
Compliance Hotline
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Export Compliance Reminders: Any Shipment (including le ers) outside of the U.S. requires review by OIC to determine if a license is required!!! Anyone issuing a sponsor le er for interna onal visitors or scholars must determine whether the person will re‐ quire access to export controlled informa on or be involved in a restricted projects. If so, an export license will be required and it must be indicated on the form. The Interna onal Students and Scholars Office reviews the form and forwards to OIC for addi onal review. Review the updated Export Control Compliance Guidelines
Iranian Students ‐ New regula ons prompted a new policy regarding advising and registra on process for students with Iranian ci zenship who want to enroll in ‘energy‐related’ coursework. Contact OIC for help! Interna onal Scholars Many people have had ques ons about the export control sec on on the ISSO form required when sponsoring in‐ terna onal visi ng scholars. These ques ons serve two purposes. First, they help the University iden fy persons who may be working on export controlled projects, before they even arrive on campus. Second, and even more important, these ques ons mirror those the ISSO is required to answer on forms submi ed to the U.S. government in the University’s visa applica on package. The affected department is in the best posi on to provide informa on on the exact nature of the work in which the visi ng scholar will be engaged, and, as always, the OIC is available for consulta on and assistance in determining whether this work could possibly trigger export controls.
Website Resources UMass Lowell OIC website address: www.uml.edu/Research/OIC/
State Ethics Commission Information: h p://www.mass.gov/ethics/about‐the‐commission/
Online Training: www.ci program.org/ Includes modules for Human Subjects (IRB required) Working with the IACUC (IACUC required) Basic Ins tu onal Biosafety Commi ee Blood borne pathogens Export Controls Compliance Training Responsible Conduct in Research (op onal) Effort Repor ng Health Privacy Informa on Security (Log in, affiliate yourself with University of Massachu‐ se s Lowell, create your username and password, select your courses/modules to add to your learner groups, complete the training and test, and OIC re‐ ceives a copy of your cer ficate!)
DON’T LET THIS HAPPEN TO YOU CORNER! (Export Violation News) Recently, two individuals convicted of illegally expor ng controlled technical data (in completely separate cases) lost their appeals of the convic ons in court. These cas‐ es are of special interest to the academic community because of the defense claims made by both men (former University of Tennessee professor John Reese Roth, and California engineer Chi Mak). At their trials, and in their appeals, both men asserted that the infor‐ ma on which they were convicted of transferring was already in the public domain and/or the product of fun‐ damental research, and as such was not subject to ex‐ port controls. These cases serve as a strong warning to all members of the research community to be hyper‐ vigilant when engaging in ac vi es possibly subject to export controls, and to have all research designated as fundamental research by the sponsor, in wri ng, when applicable. Also, N.J. defense contractor Steve Liu was recently convicted of export viola ons for taking export‐ controlled technical data stored on his laptop on an overseas trip. Despite Liu’s claims that it was not an inten onal viola on, he was sentenced in March to al‐ most six years in federal prison.
Report suspicious contacts to OIC: Contact OIC at x3452 or email Compliance@uml.edu Check for Scams: Go to www.Snopes.com
Report Suspected Violations Anonymously: Call the Compliance Hotline 978-934-3100