Compliance 411 is published by the Office of Compliance & Risk Assurance of The University of Alabama at Birmingham. Feedback from the UAB community is welcome. Please email compliance@uab.edu to subscribe. Objectives of Compliance 411 are

To raise awareness To communicate important developments To foster transparency

www.uab.edu/compliance l www.uab.edu/policies 701 20th St. S., AB 1120G l Birmingham, AL 35294

(205) 996-6540

August 2020

Crenshaw Begins Service as OC&RA Leader, 1

UAB Leadership Commits to Health and Safety, 1

Everybody Counts Every Day: A Call to ACT, 1

Compliance Challenge, 3

Compliance Challenge Winners, 3

Policy Updates, 4

FCOI Refresher Training Required, 4

Export Compliance in Research, 5

Code of Conduct Standard: Respect, 5

Announcing IRB ePortfolio, 6

Guide to Other Support Pages Preparation, 6

Thinking of Starting a Business Outside of UAB?, 6

Transfer of Tangible Research Materials, 6

Contents

411

Everybody Counts Every Day: A Call to ACT At UAB, even in the most challenging of times, we continue to affirm our shared values of diversity, respect, in-clusiveness, accountabil-ity, collaboration, and integrity. The students, faculty, and staff who enrich our diverse campus demon-strate these values in our community, state, and nation. The senseless murders of George Floyd, Breonna Tay-lor, Ahmaud Arbery, and so many others have forced many of us to reflect on the history of racial injustices in our nation. These acts insist that we find ways to be more intentionally and actively engaged in promoting social justice for historically marginalized communities including Black people and all indigenous people of color in the U.S. and abroad. Continued on page 2

UAB has started its phased, gradual re-entry to campus, and leadership wants to be clear that COVID-19 safety pre-cautions are required and will be enforced. The Re-entry Expectations & Guidelines are spelled out clearly and posted online at uab.edu/reentry as are Personal Safety Practices. All students, faculty, and staff are expected to comply fully with policies, protocols, and guidelines outlined by the uni-versity and specialized guidance from their particular de-partments/units/schools. Employees should review them now — before they are notified to return to campus — and clarify any areas of ambiguity with their supervisor. “We are committed to preserving the health of the communities in which we live and work, and the safety precautions we have adopted to respond to the COVID-19 pandemic apply to everyone equally,” said President Ray Watts. “These safety guidelines are based on the input of infectious disease and public health experts and are con- sistent with CDC guidance. By observing them, we are con-

Continued on page 2

UAB Leadership Commits to Campus-wide Health & Safety

Katie Crenshaw, J.D., Begins Service as Chief Risk and Compliance Officer for University

Crenshaw, who served as associate university risk and compliance officer since 2010, began in her new role as Chief Risk & Compliance Officer in the Office of Compliance & Risk Assurance (OC&RA) on May 15. In this capacity, she will lead assessment, prioritization, mitigation, and monitoring of risks in conjunction with the President’s Risk Cabinet, college/school Executive Risk Oversight committees, and other stakeholders while providing assurance to leadership that the elements of an effective compliance program are maintained. Crenshaw also will coordinate university efforts with UAB Medicine Compliance and the University of Alabama System Office direc-tor of Risk and Compliance. Crenshaw’s position has functional accountability to President Ray Watts. “Ensuring full compliance with all regulatory guidelines and UAB policies and procedures is al-ways critical to the functioning of our university,” Watts says. “It is especially important in these unprecedented times.” Continued on page 2

“At UAB, we should strive to build and maintain a culture and climate based on mutual respect and caring.” Paulette Dilworth, PhD, Vice President for Diversity, Equity and Inclusion

Health and Safety, continued from page 1 fident we can continue to teach, research, support Ala-bama’s social and economic needs, and deliver the pa-tient care upon which we all depend.” A culture of safety requires vigilance, monitoring, effective structures for reporting concerns, and correc-tive action for non-compliance. Each UAB employee and student has a role to play. If you observe health and safety rules not being en-forced appropriately or fairly, discuss your concerns with your supervisor. If non-compliance persists, contact Hu-man Resources, or report it anonymously through the UAB Ethics Hotline. Persistent failure or willful disregard for health and safety guidelines by any employee or stu-dent will result in consequences outlined in UAB’s disci-pline policies for staff, faculty, and students. “There will be penalties for non-compliance with safe-ty requirements like mask wearing and social distancing,” said Vice President for Research Chris Brown. “In the re-search setting, non-compliance could result in a lab being shut down. This would be extremely disruptive and is not something we want to do, but we will aggressively enforce requirements that will help keep our employees and stu-dents safe and our institution open for the greater good.” Anyone who reports non-compliance is protected against retaliation, and any concerns of retaliation should be reported to Human Resources or the Office of Compli-ance and Risk Assurance. We also ask that — to protect the UAB family and broader community — you practice safety guidelines when you are off campus. Faculty and staff should continue to read eReporter, and UAB Medicine employees also to read ONE. Employ- ees or others who want to keep up with student commu-nications, sign up to receive Greenmail, and visit the stu-dent sections of uab.edu/coronavirus and uab.edu/reentry.

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Leadership from all areas of campus have joined to-gether to firmly condemn racism, incivility, and all forms of discrimination. UAB’s commitment to fostering a uni-versity where all community members feel a sense of belonging and relationship is spearheaded by the Office of the Vice President for Diversity, Equity and Inclusion (OVPDEI), which encourages anyone who seeks to under-stand what it means to be anti-racist, to ACT – Advocate awareness, Commit to education, and Take action.

Vice President for DEI Paulette Dilworth, PhD, states, “In order to create an inclusive and academically vibrant UAB community, we must work together to better un-derstand and value both our individual differences and common ground. The UAB shared values are aspirational and each one embodies this commitment and reflects the ideals we seek to foster and sustain every day.” There are many opportunities to get involved. We encourage all of our students, faculty, and staff to learn more about and seek the resources and programming offered by UAB’s Student Multicultural and Diversity Pro-grams and OVPDEI. Here are steps you can take: Understand and share UAB’s Strategic Diversity Plan; Become familiar with UAB’s resources and policies; Reflect on your own agency and privilege; Sign up for diversity education courses; Explore the knowledge repository of books, articles,

and media; Engage in uncomfortable conversation; and Get involved with local and national organizations. OVPDEI provides a listing of anti-racist resources that are a start toward learning about and understanding rac-ism in the U.S. To view them, visit www.uab.edu/dei. Additionally, if you need them, seek out the free services UAB offers through the Student Counseling Service and the Employee Assistance Counseling Center. UAB’s commitment to respect, diversity, equity, and inclusion and to compliance with anti-discrimination laws is outlined in these policies: UAB Enterprise Code of Conduct Equal Opportunity and Discriminatory Harassment Policy Student Conduct Code Title IX Sexual Violence and Sexual Misconduct Policy Violence Prevention and Response Policy Cont. on p. 3

Everybody Counts, continued from page 1

August 2020

“I look forward to working with leadership, faculty, staff, and students to ensure the university pursues its mission in ways consistent with its core values of integri-ty, respect, collaboration, and accountability,” Crenshaw said. “In critical times like these, Compliance & Risk As-surance can serve as a key strategic partner to academic and administrative units across campus. Having been part of the Compliance and Risk Assurance team for the past several years, I know the team’s breadth and depth of knowledge and dedication to helping the university address risks associated with its research, education, and business activities and fulfilling its ethical and compliance responsibilities. I am excited to build on this strong foun-dation and lead the program to grow even more effective.”

Crenshaw, continued from page 1

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Read the hypothetical scenario below. Click on an answer A-E to enter a drawing for one of two $10.00 Amazon gift certificates to be held after Sept. 15. Only those with addresses end-ing in uab.edu or uabmc.edu qualify.

Jeannette and Alex are UAB research assis-tants who worked together for several months before the COVID-19 pandemic. Their lab sus-pended operations until it was determined that measures could be taken to ensure the safety of research personnel. A few weeks after their work resumed on campus, they discussed the fact that both had been consistently practicing frequent hand-washing, masking, and social distancing for several months, and that neither one of them had symptoms typical of COVID-19. They agreed that when they were the onlytwo present in the lab, it would be easier andmore comfortable to close the lab door andtake off their masks.

Jeannette’s and Alex’s failure to adhere to UAB’s face covering requirement is inappropri-ate under these circumstances because: A. Under UAB’s re-entry plan, face coverings

may only be removed when at a work-station or in a private office that is in an enclosed space where no other personnel are present.

B. In the required UAB re-entry training course, employees and students agree to take all required health and safety precau-tions.

C. In order to obtain approval to return to research, principal investigators are re-quired to describe in a written plan how health and safety requirements will be met while operating their labs, and all re-search personnel are held accountable to follow the plan.

D. It is possible to transmit COVID-19 to oth-ers and be asymptomatic, so employees and students demonstrate the UAB Enter-prise Code of Conduct standard of behav-ior for respect by wearing a mask properly.

E. All of the above.

Compliance CHALLENGE

In support of anyone reporting non-compliance with these policies, including discrimination based on race, national origin, age, medical history, gender, faith, gender identity and expres-sion as well as sexual orientation, is leadership’s renewed com-mitment to stand behind the Duty to Report and Non-retaliation Policy, which states that retaliation against any individual who reports wrongful conduct in good faith is pro-hibited. You are encouraged to report any such non-compliance to your supervisor or departmental administrator. If you are uncomfortable bringing a report to those individuals, you may contact the Office of Compliance & Risk Assurance or report anonymously to UAB’s Ethics Hotline at 1-866-362-9476 or by filing an online report.

Everybody Counts, continued from page 2

Congratulations Compliance Challenge Winners! Winners from the December 2019 and April 2020 Compliance Challenge are Claire Auriemma, Lisa Hethcox, Ra-chel Taylor, and Julie Spencer. By par-ticipating, they won a drawing for Ama-zon gift certificates worth $10.00 each. To participate in this issue’s Challenge and enter a drawing for one of two $10.00 Amazon gift certificates, see the Compliance Challenge on page 3. This issue’s Challenge topic is masking as a safety measure against COVID-19. Claire tells us she reads Compliance 411 and participates in the Challenge because “I’m always in competition with myself to be better than before. Many people in my department come to me for answers on policy and proce-dural questions, so I try to stay on top of the latest information. In nearly eve-ry newsletter, I find something that helps me do my job better.” Rachel says that she reads Compli-ance 411 “to stay informed on COVID-19 policies and procedures.” Thanks to our winners for modeling healthy behaviors by showing off their face coverings!

Claire Auriemma, Program Coordinator II, School of Health Professions, Dept. of Nutrition Sciences & husband Matthew Auriem-ma, Informatics Analyst III, School of Medicine Infor-matics Institute.

Lisa Hethcox, Researcher IV, Dept. of Ophthalmolo-gy, School of Medicine.

Rachel Taylor, Adminis-trative Supervisor, Finan-cial Accounting, Financial Affairs & Administration.

August 2020

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P O L I C Y U P D A T E S

Formerly titled Event Scheduling Priorities for UAB Fa-cilities, the revised Freedom of Expression and Use of UAB Facilities Policy took effect on July 1, bringing UAB into compliance with Alabama House Bill 498. While reinforc-ing UAB’s commitment to free speech and assembly for faculty, staff, students, and registered student organiza-tions, Freedom of Expression and Use of UAB Facilities also promotes efficient, responsible, and safe use of uni-versity facilities in support of its mission. Procedures sup-porting the revised policy are currently in development . Replacing the 2016 version of the policy, UAB’s Student Conduct Code has been revised to be more concise and dynamic to better serve UAB students. The Code was re-vised significantly to: Create a more dynamic document with relevant links Remove redundant language; Update philosophy and purpose to include University

vision, mission, and shared values, The Blazer Way, and Student Conduct & Outreach’s mission;

Clarify roles and responsibilities of University adminis-trators to promote students’ understanding of contact points and authority lines;

Clarify parties’ rights to ensure they are appropriate for process timeline and to align with federal and state law;

Clarify compelling factors that may be considered in determining sanctions;

Provide language to more clearly describe impact of sanctions;

Incorporate opportunity for students to request expul-sion rescission after five years; and

Create opportunity for Administrative Resolution of first-time violation of Residence Life policies.

UAB’s Title IX Sexual Violence and Sexual Misconduct Policy and its supporting procedures are under revision based on new U.S. Department of Education regulations and emerging case law. On May 6, 2020, the U.S. Depart-ment of Education issued new regulations under Title IX of the Educational Amendments of 1972 changing how institutions of higher education are required to respond to complaints of sex discrimination, sexual harassment, and sexual violence. To satisfy these new requirements, a UAB Title IX working group has developed a draft policy revision that is currently under review by The University of Alabama System Office per Board Rule 108. The antici-pated effective date of the new Title IX policy and its ac-companying procedures is August 14, 2020, the date the new regulations are to take effect. In the time since the UAB Enterprise Conflict of Interest and Conflict of Commitment Policy was last updated in August 2012, there have been significant shifts in expecta-tions for public transparency, research regulatory require-ments, and approaches peer institutions are taking to identify and manage conflicts of interest and commit-ment. To address those shifts, as well as requests from internal stakeholders for greater clarity in requirements and processes, a drafting committee comprising repre-sentatives from academic and administrative offices across the University and UAB Health System has devel-oped a draft revision that will be presented to the Presi-dent’s Risk Cabinet for approval in the near future. For general information on the University-wide policy Development Process, please view this pdf. You may also contact policies@uab.edu.

Did you know that all UAB investigators are required to complete a Financial Conflict of Interest (FCOI) refresher course every four years and also upon revision of the UAB Enterprise Conflict of Interest and Conflict of Commit-ment Policy? While this policy is currently under revision (see above), many UAB investigators are also due for their FCOI Refresher Course in 2020. New training is available that addresses the four-year retraining and the new conflict of interest policy requirements. If you receive a re-training request and are unsure if this applies to you, please contact OCIRB at cirb@uab.edu.

Financial Conflict of Interest Refresher Training Required

August 2020

Title IX Sexual Violence and Sexual Misconduct Policy

Student Conduct Code

Freedom of Expression and Use of UAB Facilities Policy

UAB Enterprise Conflict of Interest and Conflict of Commitment Policy

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Code of Conduct Corner Standard of Conduct:

Treat Individuals with Respect

The UAB Enterprise Code of Conduct is a shared statement of commitment to uphold the ethical, pro-fessional, and legal standards used as the basis for daily and long-term decisions and actions. Adherence to its spirit, as well as its specific provisions, is critical to UAB’s continued success. Now more than ever, the UAB community is collectively accountable for up-holding these standards of behavior, possibly none more than the standard to treat individuals with respect.

UAB is an institution dedicated to tolerance, diver-sity, and respect for differences. Central to that com-mitment is the principle of treating each UAB commu-nity member and those we serve with respect. UAB community members are expected to:

Be respectful, fair, and civil;

Value diversity of opinion and contributions of others;

Avoid all forms of harassment, illegal discrimina-tion, threats, or violence;

Provide equal opportunity for access to programs, facilities, and employment; and

Promote conflict resolution.

August 2020

Export Compliance in Research

With President Watts’ appointment of Vice President for Research Chris Brown, PhD, to the role of Empowered Official, operational responsibility for Export Control has shifted from the Office of Compliance & Risk Assurance to the Office of Research. The Empowered Official is charged with administering all research endeavors in

IRB ePortfolio Announcement

The Office of the IRB, in collaboration with the Research Technology & Communication office, is developing electron-ic submission forms (eForms) to replace many of the ex-isting Word and PDF forms. A set of electronic smart forms called the IRB e-Portfolio will replace the current Human Subjects Protocol and 12 other submission documents. The e-Portfolio has been in development and has undergone beta testing,  which began in spring of this year. A campus-wide launch is scheduled for August 28, 2020. This user-friendly application process has been stream-lined to present users with only questions relevant to their research.  The new IRB e-Portfolio utilizes branching log-ic with specific questions to better ascertain the regulatory information necessary to make IRB determinations. For more information, contact irb@uab.edu.

UAB has been proactively working to provide its research community with important information and tools as federal funding agencies increase scrutiny of documentation sub-mitted in support of sponsored projects. Federal sponsors are especially focused on Other Support pages. As an addi-tional resource, the Guide to UAB Information Sources for Preparing and Reviewing Other Support Pages was devel-oped. The guide sets out available reports and tools provid-ing information in various UAB databases that are relevant for preparing and reviewing Other Support pages to help ensure accuracy and consistency. It is now available at the UAB Transparency in Research site.

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August 2020

Guide to Preparing Vital Other Support Pages Now Available

Thinking of Starting a Business Outside of UAB? If you, your spouse, or dependent owns a business

that wishes to do business with UAB, special instructions apply. It is critical to consult with University Contracts & Vendor Compliance or the Office of Compliance & Risk Assurance before providing any goods or services in or-der to avoid potential criminal implications of the Ala-bama Ethics Law.

Transfers of Tangible Research Materials When receiving or sending tangible research, the transfer must be reviewed and approved at the institu-tional central administrative level in advance of the trans-fer. Such transfers can be made under a variety of agree-ment types or without an agreement based on the cir-cumstances of the transfer. When the transfer is not cov-ered by some other type of agreement, a submission for the transfer request must be made to UAB’s Material Transfer Office (MTO) through IRAP. Please see these step-by-step instructions. The transfer document is a legal agreement with terms and conditions for the use of the shared research materials/tools. The investigator and those in his/her la-boratory who will use the materials/tools are responsible for adhering to those terms and conditions. All users should review the transfer document from time to time to remain familiar with any restrictions. If a signed agreement is sent by the provider to the investigator rather than to the MTO, the document should be forwarded to the MTO by the investigator. If the materials being requested are provided prior to finali-zation of transfer documents, notify the MTO so that the record can be updated to reflect the correct status. Sending Research Materials The MTO will create the appropriate transfer docu-ment based on the information provided in the submis-sion package. If additional information or clarification is required the MTO will contact you directly. The UAB in-vestigator who is providing the material is responsible for packaging and arranging shipment of the material. Receiving Research Materials You should request that the material provider send to you the transfer document, preferably in an editable Word format, or a written statement from the provider’s legal or material transfer office that no agreement is re-quired. When UAB receives materials without a written agreement, we consider the transfer to have been made under the terms and conditions of the Uniform Biological Material Transfer Agreement (UBMTA). A typical material transfer agreement will ask you to provide your contact information, description of research use, a description of the material, quantity, etc. Fill in this information on the agreement, and upload the partially completed docu-ment as part of the MTO submission package in IRAP. The MTO will complete the rest of the form, such as the names and contact information of the UAB authorized signatory.