human research protection program research university 2018 · resident. he completed a clinical...

Human Research Protection ProgramResearch University 2018

Proudly Hosts: Research University 2018

“Shifting the Research Environment: New Trends, New Rules”

Sponsored by:

“RU2018” will focus around the various significant regulatory changes and implementations, and delve into new research trends.

Taking into account your suggestions from prior events, RU2018 will be broken up into a two, half-day event. The days are not duplicates plan to attend both days! Different presentations, speakers and breakout workshops will be offered.

Please plan to take part in the network breakfast activities hosted by the CTSC’s Education Specialists, Rebecca Monette and Regis Lacher, from 8am-8:20am on both days. The CTSC will also be hosting an information table. Take advantage of this great resource.

For questions: [email protected] (505)272-1688/272-6765

AGENDA

AGENDA Day 1, Tuesday, July 17, 20187:30am-8:00am Registration and Badge Pick-up

8:00am-8:20amRegis Lacher and Rebecca Monette

Networking Breakfast Activities

Presentation

New Domenici 3740

8:20am-8:25amJames MacFarlane, CIP

Welcome Greeting

Presentation

New Domenici 3740

8:25am-8:35amVanessa Will, PhD, CIP

PRIM&R Presentation

Presentation

New Domenici 3740

8:35am-9:10amTom Byrd, MD

Keynote Address: “TBD”

Presentation

New Domenici 374010 minute break

9:20am-10:05amSanjeev Arora, MD

“Democratizing Knowledge to Reduce Disparities: Opportunities for Research and Collaboration”

Presentation

New Domenici 3740

10:10am-10:55amHengameh Raissy, PharmD

“A Review of Pharmaceutical Sponsored Clinical Trials Flow Process”

Presentation

New Domenici 3740Breakout Workshops

11:05am-12pm Linda Petree, CIP

“NIH Policies Updates”

Breakout Workshop

Domenici 301011:05am-12pm Vanessa Will, PhD, CIP, Marguerite Valencia-Reed

“Single IRB Part Deux: Hand-on with Click IRB”

Breakout Workshop

Med II Classroom

11:05am-12pmSarah Targownik, CIP, MSW

“Insider’s Guide to UNM Research Resources”

Breakout Workshop

Domenici 3740

AGENDA Day 2, Wednesday, July 18, 20187:30am-8:00am Registration and Badge Pick-up

8:00am-8:20amRegis Lacher and Rebecca Monette

Networking Breakfast Activities

Presentation

Domenici 3740

8:20am-8:25amJames MacFarlane, CIP

Welcome

Presentation

Domenici 3740

8:25am-9:15amScott Tonigan, PhD

“Navigating in a Sea of Uncertainty and Change”

Presentation

Domenici 3740

7:30am-8:00am Registration and Badge Pick-up

10 minute break

9:20am-10:05amSuzanne Heske, R.Ph, MS

“A Robust Quality Management System and Adherence to GCP’s = Clinical Trial Success”

Presentation

Domenici 3740

10:10am-10:55amAriadna Vázquez, Aida Andujo

“The Intersection of Research: Data Security, Data Use Agreements and HIPAA”

Presentation

Domenici 3740Breakout Workshops

11:05am-12pm HRPO Staff

“What’s the Holdup”? A Hands-on Approach to Complete Submissions

Breakout Workshop

Med II Classroom11:05am-12pm James MacFarlane, CIP

“Research with Devices and Part 11 Adherence”

Breakout Workshop

Domenici 3010

11:05am-12pmVanessa Will, PhD, CIP

“Risky Business: Assessing and Minimizing Risk for Research Participants”

Breakout Workshop

Domenici 3740

LOCATION AND REGISTRATION

Location: UNM Domenici North Wing Room 3740 (New Building 3rd Floor). Visit our website for mapped directions https://hsc.unm.edu/research/hrpo/

Time: 7:30AM – 12:00PM

Registration: Please register at Eventbrite: https://researchuniversity2018.eventbrite.com

Breakout session space is limited! Reserve your seat quickly.

Parking: Public parking is available for a fee west of the complex in the "M" parking lot along the row of trees in the center of the lot.

SPEAKER BIOS


Mr. MacFarlane is the Human Research Protections Program Director for UNM HealthSciences, where he manages all three branches of the department—HRRC Review,Education and Outreach, and QI/QA. He received his undergraduate degree in theHistory of Science and Medicine at Northern Kentucky University. James has abackground in IRB administration and organizational improvement. He is a long timemember of PRIM&R and Mensa International.

“Research with Devices and Part 11 Adherence”HSC Domenici West Wing Room 3010: 11:05am to 12:00am

James MacFarlane, CIP


Dr. Byrd is a Professor of Internal Medicine and has served as the Interim Chief ofInfectious Diseases at UNM. He received his MD from Vanderbilt University andcompleted his residency at the University of Florida where he also served as Chief MedicalResident. He completed a clinical fellowship at UCLA and the research component of histraining in the laboratory of Dr. Marcus Horwitz where he was the recipient of an NIHNational Research Service Award (NRSA).Dr. Byrd is a clinical investigator with a strong commitment to laboratory investigation.His research focuses on mycobacterial pathogenesis, including Mycobacteriumtuberculosis and nontuberculous mycobacteria. He has been the recipient of NIH,American Lung Association and Cystic Fibrosis Foundation funding in the past. He iscurrently the recipient of an NIH R03 award which is examining the host immuneresponse to Mycobacterium abscessus lung infection.

Keynote SpeakerHSC Domenici NW Room 3740: 8:35am to 9:10am

Thomas Byrd, MD


Sanjeev Arora, MD, MACP, FACG is the Director and Founder of Project ECHO. He is aDistinguished Professor of Medicine with tenure in the Department of Internal Medicineat University of New Mexico Health Sciences Center. Project ECHO® (Extension forCommunity Healthcare Outcomes) dramatically improves both capacity and access tospecialty care for rural and underserved populations by linking expert inter-disciplinaryspecialist teams with primary care clinicians through teleECHO™ clinics, in which theexperts mentor primary care clinicians to help them manage their patient cases and sharetheir expertise via mentoring, guidance, feedback and didactic education. This helps ruralclinicians develop knowledge and self-efficacy so they can adopt research findings anddeliver best practice care for complex and chronic health conditions.

“Democratizing Knowledge to Reduce Disparities: Opportunities for Research and Collaboration”

HSC DCNW Room 3740: 9:20am to 10:05am

Sanjeev Arora, MD, MACP, FACG


Dr. Raissy’s research interest is in pediatric asthma pharmacotherapy with an emphasis in the evaluationof new and existing therapies in the treatment of children with asthma as we learn more aboutpersonalized medicine.As the principal investigator of multisite asthma studies and networks supported by NIH/NHLBI,including 1) Childhood Asthma Management Program (CAMP), 2) Childhood Asthma Research andEducation (CARE) and 3) AsthmaNet network at UNM , she has been able to collaborate with the leadingexperts nationally, investigate asthma management from infancy to adulthood to learn about the naturalhistory of asthma, and evaluate existing and new therapies for asthma tailored to individual patients.Currently, she is the Co-director of UNM IDeA State Pediatric Clinical Trial Network (ISPCTN) as part ofEnvironmental influences on Child Health Outcomes (ECHO) program, an NIH initiative tounderstanding the effects of environmental exposures on child health and development.In addition to multisite network trials, she has also been a principal investigator of numerous industry-sponsored Phase I-IV trials evaluating novel asthma and cystic fibrosis therapies in children and adultpatients.

“A Review of Pharmaceutical Sponsored Clinical Trials Approval Process”


Hengameh Raissy, PharmD


Suzanne Heske, R.Ph., MS is the Senior Director of the Quality Risk Management team at Syneos Health,the only fully integrated biopharmaceutical solutions organization which includes a Contract ResearchOrganization (CRO) and Contract Commercial Organization (CCO). Currently she has a three yearResearch Collaboration Agreement with FDA Center for Drug Evaluation and Research / Office ofTranslational Sciences assist with conducting risk assessments and benefit-risk evaluations for highpriority public health initiatives which will support the creation of a systematic and comprehensive riskrepository for future use. She received her undergraduate degree in Biological Chemistry and Pharmacyat Temple University and completed and externship in the Radiological Biology laboratories at MerckSharpe and Dome. After serving as the Chief Radiopharmacist at Thomas Jefferson University Hospitaland an Associate Professor at Philadelphia College of Pharmacy and Science she decided relocate to NewMexico to obtain a graduate degree at UNM. She is a licensed Pharmacist for over 30 years and is BoardCertified as a Radiopharmacist which includes all of the imaging modalities. Her Clinical Researchexperience spans over 25 years across many areas of drug development and clinical operations, includingmultiple therapeutic indications and clinical trial phases. She has held position such as PrincipalInvestigator, Clinical Research Associate (CRA), Associate Director of Operational Quality Management,Clinical QA and Compliance Manager, Feasibility Specialist, and Territory Development Specialist.

“A Robust Quality Management System and Adherence to GCP’s = Clinical Trial Success”


Suzanne Heske, R.Ph, MS


Dr. Tonigan has been continuously supported by the National Institute of Health for 29years. His research focuses on how, and under what circumstances, substance abusersbenefit from behavioral and pharmacotherapy treatment and mutual help participation.Dr. Tonigan has chaired the NIH Clinical and Treatment Health Services review panel(AA-3), the NIH Loan Repayment Program, the University of New Mexico main campusinstitutional review board, and numerous boards of addiction journals. Dr. Tonigan hasover 200 addiction focused publications, many of which have investigated vulnerablepopulations in New Mexico. During his career Dr. Tonigan has served as co-director ofCASAA in Albuquerque NM, and he has participated in many of the largest randomizedclinical trials sponsored by the NIAAA: Project MATCH, COMBINE, and REPP. Dr.Tonigan was trained in statistics and measurement and he has co-authored many of theassessment tools widely used by NIH addiction researchers.

“Navigating in a Sea of Uncertainty and Change”HSC DCNW Room 3740: 8:25am to 9:15am

J. Scott Tonigan, Ph.D.


Linda Petree, BA, CIP is the Director of the UNM Human Research Protections Programfor main and branch campuses. She has been working in human research protections forover 15 years. She is a site visitor for the Association of Accreditation of Human ResearchProtections Programs (AAHRPP) and in 2016 she co-founded the national SBERNetwork, a collaborative of IRB professionals that focus on the unique issues andchallenges of ethical oversight of Social Behavioral Educational Research, which is hostedby the Public Responsibility in Medicine and Research (PRIM&R). She has served onseveral PRIM&R conference planning committees and presented at national andinternational conferences. Linda also conducted NIH-funded research at the MindResearch Network focused on the ethics of returning incidental findings (IF) inneuroimaging research and has co-authored several publications on IF.

“NIH Policies Updates”HSC Domenici North Room 3010: 11:05am to 12:00pm

Linda Petree, CIP


Ariadna Vazquez, JD, is the UNM Health Sciences Center’s privacy officer. In this role,she oversees HIPAA compliance, federal and state reporting, employee training andincident management, among other duties. Before becoming the HSC’s privacy officer,she served as an associate university counsel for the Office of University Counsel-HSC,where her responsibilities included handling contracting for physician services andmanaged care, compliance and research matters, telehealth and telemedicine and theUNM Health insurance plan. Prior to joining UNM, Ari spent many years working incorporate law and at the Department of the Treasury in Washington, D.C. She is agraduate of the Columbia Law School in New York.



Ariadna Vazquez, JD


Aida Andujo completed her undergraduate degree at CalPoly, Pomona, a Master’s fromNorthridge, and is a Certified Research Administrator. She has over 10 years of researchadministration experience coming from Cedars-Sinai Medical Center, Los Angeles, in2013. Aida has worked in the Sponsored Projects Office/PreAward as a SponsoredProjects Specialist, Sr. Sponsored Projects Officer and now as a Manager for one, of thetwo, PreAward Teams. She is responsible for HSC Sponsored Projects Reporting, theAncillary Agreement Lead, and is a contributor to the HSC Lobo Quality ImprovementProcess. She takes pride in assisting the HSC Community with various projects.



Aida Andujo, MPA, CRA


Rebecca has been in research at the University of New Mexico Health Sciences for overeight years. She has managed departments in the areas of regulatory knowledge andsupport, continuing medical education, translational workforce development, andprogram evaluation.

Networking Breakfast ActivitiesHSC DCNW Room 3740: 8:00am to 8:20am

Rebecca Monette, BA


Regis Lacher is Education Specialist at the Clinical & Translational Science Center, wherehe develops and facilitates a variety of training programs for UNM’s translationalworkforce. Regis has a B.A. in Professional Writing from UNM and is a certificatedprofessional trainer.

Networking Breakfast ActivitiesHSC DCNW Room 3740: 8:00am to 8:20am

Regis Lacher


Vanessa Will holds a PhD in Linguistic Anthropology from the University of Michigan.She conducted multiple years of ethnographic field research on the Isle of Lewis inScotland, working with both children and senior populations.After a nomadic life moving between Germany, the US, Scotland and New Zealand,Vanessa joined the HRPO in 2014, first as an Analyst and then as a Senior Analyst. Sherecently returned to the HRPO after a stint as Clinical Research Manager in theDepartment of Obstetrics and Gynecology. Vanessa particularly enjoys helpingresearchers to design their projects with human research regulations in mind, and to‘bridge the gap’ between the biomedical focus of the regulations and the aims andmethodologies of social-behavioral research. She holds the CIP® certification fromPRIM&R, and is also a certified Child Passenger Safety Technician.

Day 1: PRIM&R Presentation HSC DCNW Room 3740: 8:25am to 8:35am

&“Single IRB Part Deux: Hands-on with Click IRB”

Med II Classroom: 11:05am to 12:00pm

Day 2: “Risky Business: Assessing and Minimizing Risk for Research Participants”HSC DCNW Room 3740: 11:05am to 12:00pm

Vanessa Will, PhD, CIP, CPST


Marguerite Valencia-Reed holds a Bachelor’s of Business Administration from theUniversity of New Mexico. She has been with UNM Health Sciences Center since 2013and is currently an Analyst/Programmer 2 and the system administrator for Click IRBand the Conflicts of Interest (COI) portion of Click ERA.

“Single IRB Part Deux: Hand-on with Click IRB”MEDII Classroom: 11:05am to 12:00pm

Marguerite Valencia-Reed


Sarah Targownik earned a BS in psychology from Georgetown University and a Master’sin Social Work from the University of Kansas. She practiced as a medical and psychiatricsocial worker in inpatient hospital settings for 15 years, specializing in working withpatients with Alzheimer’s disease and their families. She began her career in research in2004, at Quintiles, a clinical research organization (CRO). While working for the CRO shewas involved in many tasks that contribute to supporting large sponsored new drug anddevice trials: from site identification, study start-up, monitoring, through creation andarchival of the trial master files. Her last two years with Quintiles were spent working as aQA auditor for the Quintiles Phase One Clinical Trials Unit. She moved from Kansas Cityto Albuquerque June 2015 to be the “IRB-On-the-Go” for the Human ResearchProtections Office at the University of New Mexico Health Sciences Center.

“Insider’s Guide to UNM Research Resources”HSC DCNW Room 3740: 11:05am to 12:00pm

Sarah Targownik, MSW, CIP


From left top row: Hadya Khawaja, Marguerite Valencia-Reed, Ernestine Frank, JamesMacFarlane, Vanessa Will, Erik Neal, and Becky Brito

From left bottom row: Christina Gallegos, Rochelle Garcia, Alina Peña, and SarahTargownik

HRPO STAFF

SPONSORS AND DONORS

We are also grateful to our HSC donors whoprovided event support and our attendees with swag!

A sincere thank you to our sponsor, PRIM&Rwho provided funding and support!

Requesting Speakers

We are always in need of speakers who are experts in their fields and able to relate that expertise to the

research community.

If you are interested in presenting at future events, please submit an outline of your proposal or

completed presentation and it will be reviewed. You may submit your proposal and materials and direct all

questions and comments to Alina Peña at [email protected]

mailto:[email protected]

THANK YOU!From the

HRPO Staff

From left top row: Hadya Khawaja, Marguerite Valencia-Reed, Ernestine Frank, James MacFarlane, Vanessa Will, Erik Neal, Becky Brito

From left bottom row: Christina Gallegos, Rochelle Garcia, Alina Peña, Sarah Targownik

human research protection program research university 2018 · resident. he completed a clinical...

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