Compliance News Issue 7

Office of Institutional Compliance (OIC) Newsletter Issue No. 7 • November 2011

Contact OIC for questions about industry partnerships and compliance requirements!

OIC can begin evaluations early to help avoid delays.

OIC Contacts: Elaine Major x3452, Director Dr. Stephen Moses x4134, IRB Administrator Amy Finneral x4698 Animal Research Compliance Manager Kim Baxter x 4631, IBC Administrator, IRB and Export Controls Assistance

Red Flags and How to Evaluate Them

New Website Address:

The best approach to avoid disclosing controlled information and an export violation is to be inquisitive and ask lots of questions! Confirm that the person contacting you is really who they say they are and are representing the organization they say they represent.

Compliance Hotline

The following may be considered ‘Red Flags’:

Call the Compliance Hotline at x3100 (978-934-3100) to anonymously report suspicious contacts or suspected research compliance violations. The hotline is only for complaints related to noncompliance with policies and procedures governing research activities.

Person unknown to you is requesting information about controlled materials or activities.

New!!! Export Compliance Online Training

Email may be considered suspicious when from a yahoo, gmail or hotmail account instead of professional email address. Verify the person’s identity by checking the website for their professional affiliation. Send an email to the professional email address to verify the person contacting you. Be careful about what information you provide in any event.

The CITI website now includes online training! Export Compliance training is required annually for all personnel in high-risk disciplines as outlined in the UMass Lowell compliance program requirements. Face-to-face training can also be scheduled at any time by calling x3452.

No website is found or the one found shows the business is not related to information requested.

Committee Chairs: IACUC, Elaine Major IBC, Dr. Susan Woskie IRB, Dr. Joyce White

www.uml.edu/Research/OIC/

Business address is in a home.

IRB Updates  

Person identifies themselves as a ‘broker’ or ‘consulting company’.

Inside this issue: 2 Partnering w Industry Activities requiring review Foreign Travel Awareness

IACUC News Conflict of Interest IBC News

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Export Compliance Reminders Website Resources

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Finances are provided up front and/or financial incentives are offered.

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Person wants arrangements completed quickly.

Person refuses to identify the end user or  an inappropriate end user noted such as a bank or overseas freight forwarder Conflicting information on documents.

Customer listing is CLOSE to one noted on a denied person list.

Person requesting the information does not understand its purpose or use.

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New forms are now available online and the old forms will no longer be accepted.

Note that the IRB has changed from using the term ’subject’ to ’participant’ for persons recruited to participate in research activities.

Allow extra time if your protocol involves international research as an outside reviewer may need to be found who is familiar with the country to help evaluate any risks to human participants.

To avoid confusion for research participants, the IRB recommends using your professional credentials after your name.

For example, use Jane Doe, Ph.D. rather than Dr. Jane Doe. The IRB has been extremely busy this semester so review time has slightly increased. Please be patient but contact us if you have something that is urgent!

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Partnering with Industry UMass Lowell encourages partnerships with industry for a variety of reasons including to promote cooperative study opportunities for students, develop and expand research partnerships, test materials, commercialize new ideas and inventions, and educate the workforce.

In addition to working with Commercial Ventures and Intellectual Property (CVIP), researchers may also need to address compliance-related issues with industry partners prior to formal engagement. Because activities supported by Purchase Orders or Research Service Agreements generally do not meet the Fundamental Research Exclusion (requires the results will be published or broadly disseminated), export compliance review is required for each activity. The Researcher should complete a Research Service Agreements Form to describe the activities, list the materials the company is providing, identify whether any controlled materials would be involved, and cite any standard testing methods that would be used. OIC is available to help you and/or the company representative with this evaluation. To avoid delays, contact us as early as possible in the process to complete the export compliance evaluation.

Foreign Travel Awareness Be aware that you are a potential target: Because of the knowledge you possess, understand that Foreign Intelligence Services have approaches designed to acquire information that will benefit their country’s economic interests.

Usually these approaches are unobtrusive and non-threatening, but they can be very detrimental to U.S. security, the economy and to the originating academic institution, due to the loss of proprietary information.

Recommendations: Take only what is pertinent Take computers and all other electronic devices as carry-on Don’t use telephones, computers and fax equipment at foreign hotels or business centers for anything you don’t want known Don’t divulge your affiliation or academic status unnecessarily in public Beware of sexual overtures Be suspicious of quick friendships Beware of situations where alcohol is offered in abundance Too much personal information can be used against you Don’t leave documents or electronic devices in hotel rooms or safes Protect your Passport

Activities Requiring Compliance Review

Be prepared to expedite the replacement of lost or stolen information

InsƟtuƟonal Animal Care and Use CommiƩee (IACUC) – all research with animals InsƟtuƟonal 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, and measurements of physiological responses InsƟtuƟonal Biosafety CommiƩee (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– 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) as these ac vi es are not typically published and do not meet the Fundamental Research Exclusion

Issue 7

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November 2011

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Institutional Animal Care and Use Committee News There have been many changes recently in regards to animal research oversight at UMass Lowell. The highlights include:  Amy Finneral is the full time Animal Research Compliance Manager!

She still serves as the IACUC Administrator and is now located in Olsen 618 and can still be reached at ext. 4698.  Dr. Scott Perkins is our new consulting veterinarian and is available to assist with research activities and protocol development. Please be aware that excessive veterinarian consulting time may require that you will be charged if the time exceeds the monthly contract covered by OIC. Annual IACUC and Occupational Health Training is required for all faculty, staff, and students who are involved with animal research. The meeting is scheduled for 2P.M. on Thursday, December 1, 2011 in 503 Olsen. Refreshments will be provided! If you cannot attend, contact Elaine or Amy for a briefing and copy of the presentation.

New forms have been developed for protocol submissions and are available from the website or by contacting Amy_Finneral@uml.edu.

No cell phones are allowed to be used in the facility to meet the photography policy. Photography must be noted in the protocol and specifically approved by the IACUC. Please step outside the facility to accept phone calls.

Budgeting for new proposals? Please include an approximate 10% increase in per diem expenses for future animal research activities.

COI Information Under the Federal financial disclosure regulations, a conflict of interest (COI) exists when it can be reasonably determined that an investigator's personal financial concerns could directly and significantly influence the design, conduct, or reporting of government funded research activities.

Conflict of interest Policies apply to several types of activities at UMass Lowell and are posted online. COI disclosures apply to federally funded research, proposed intellectual property transactions and company start-ups involving the office of Commercial Ventures and Intellectual Property, human subject research, nepotism, and disclosure of outside activities. State of Massachusetts Employees are required to complete online training and disclose any conflicts.

Institutional Biosafety Committee News The IBC now has online training available through the www.citiprogram.org website or you can access training information from www.uml.edu/Research/OIC. Affiliate yourself with the University of Massachusetts Lowell, create your own username and password, and OIC will be sent a copy of your training certification!

Basic IBC Training –valid for 3 years BBP Training– valid for 1 year EHS Laboratory Safety Training –valid for 1 year New registration forms are online. Stay tuned- The IBC Policies and Procedures are in the process of being revised!

Compliance Hotline

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Export Compliance Reminders: Any Shipments outside of the U.S. requires review by OIC to determine if a license is required Personnel issuing a sponsor letter for international visitors or scholars 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. ISSO forwards the information to OIC as necessary Updated Export Control Compliance Guidelines are on the website!

International Travel– remember to submit your travel forms early and get an Annual Certification Letter if you are travelling with any electronic equipment!

Core Facilities and Services (non-research)-typically involve conducting testing services or providing evaluations with no intent to publish. Export exclusions therefore do not apply and these projects should be evaluated for export control compliance. Contact OIC for assistance!

Personal Consulting and Outside Activities may also require export compliance review and it is your responsibility to ensure compliance with all federal regulations.

Website Resources NEW!!! UMass Lowell OIC website address: www.uml.edu/Research/OIC/ Online Training: www.citiprogram.org/ Now Includes Modules for:  Human Subjects (IRB required)  Working with the IACUC (IACUC required)  Basic Institutional Biosafety Committee  Blood borne pathogens  Export Controls Compliance Training  Responsible Conduct in Research (optional)  Effort Reporting

Updated Export Compliance Websites: Export Administration Regulations (EAR): Commerce and Foreign Trade 15 CFR Pts. 730-774 U.S. Munitions List State Department (ITAR) Foreign Assets Control Regulations (OFAC), 31 CFR, Parts 500-599, Embargoes, Sanctions, Executive Orders Sanctions Program and Country Information Country Group Information (scroll to the bottom for the various group designations). Remember that a country listed in two groups is reviewed as the most restricted. If a country is listed under both group B and D, it is considered as Group D for export control review purposes.

BIS Commerce Control List

To report a suspicious contact: Contact OIC immediately at x3452! Check www.Snopes.com to verify scams

Comments or Questions?

Contact Compliance@uml.edu