Event Start

2016
May 19-20

Maine
USA

200 Plus
Participants

40
Presenters

Key Note Speaker: Ivan Oransky

8:30 AM Friday

Dr. Ivan Oransky

Retraction Watch

Ivan Oransky and Adam Marcus founded Retraction Watch in 2010. Unbeknownst to them, retractions had grown ten-fold in the previous decade. Oransky will discuss the reasons for that increase, whether fraud is on the rise, the growth of post-publication peer review, and other trends he and Marcus have seen as they've built a site that is now viewed by 150,000 people per month, and funded by philanthropies including the MacArthur Foundation.



Evaluation: Keynote Address Evaluation

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Session Schedule

12:30 PM Thursday

Presenter:Joel C. Relihan & Panel: Griff Griffin, L. Eric James, JD MS, and Dr. Shara Kabak, HHS/OASH


Location: Hawthorne Room
Description: The Research Integrity Officer (RIO) Roundtable is an association of New England Research Integrity Officers (RIOs), primarily from smaller institutions, who meet for education and mutual support, sharing resources and expertise, to ensure their readiness in the event of an allegation of Research Misconduct on any member’s campus. At this session, the topic is sequestration: What local/regional sources of technical support can we identify and cultivate, both for the physical demands of sequestration and for the interpretive demands of data analysis, given that most members would not have adequate in-house resources?
Evaluation: Session I - RIO Roundtable Evaluation
Handout(s): Agenda, Kabak Presentation, KGH Presentation
12:30 PM Thursday

Regulatory Compliance

Presenters: Anthony DeCrappeo & Panel: Elizabeth Haney, Joseph Tomaras, Cara Martin-Tetreault

Anthony (Tony) P. DeCrappeo is currently President of the Council on Governmental Relations (COGR), having assumed that position on September 1, 2005. Prior to being appointed President, he was Vice President for Business Operations and Director, Cost Studies and Policy at COGR, providing staff support to the COGR Board and Committees with particular attention to research costing, financial and audit issues. In addition DeCrappeo worked with special COGR Working Groups on the impacts on research from new policies and regulations on Export Controls, Biosecurity, and Select Agents. When first engaged with COGR in 1995, he staffed the Research Compliance and Administration Committee, dealing with pre-and post-award policies and regulatory issues including Animal Welfare, Human Subjects in Research, and Conflicts of Interest.

Prior to working for COGR, DeCrappeo was Director of the Office of Grants and Contracts at New Mexico State University, from 1992-1995. From 1981 to 1992, he worked for the Pennsylvania State University, first as Senior Auditor in the Internal Audit Department, then as Associate Director in the Office of Sponsored Programs, before leaving for New Mexico State.

In addition to his university career, DeCrappeo was in the federal service. From 1974 to 1980 he worked for the General Accounting Office in Washington DC, where he spent most of his time on Congressionally-directed reviews of the regulatory effectiveness of various federal agencies with respect to the oil and natural gas industries during the energy crisis in the mid-1970’s. For two of those years DeCrappeo was on detail to the House Oversight and Investigations Subcommittee to provide technical support for the Subcommittee’s investigation of price fixing by the major oil companies.

Elizabeth Haney is an Associate Director in the Office of Grants and Sponsored Programs at Middlebury College in Middlebury, Vermont and a Certified Research Administrator (CRA). She began her research administration career at the Wyss Institute for Biologically Inspired Engineering at Harvard University in 2011, and her background includes biology research, scientific writing and editing, and lab administration. Liz graduated from Florida State University with a Bachelor of Science in Biology, from Brown University with a Master of Science in Biology, and from Emmanuel College with a Master of Science in Management. She is actively involved with NCURA Region I—she was selected for the Executive Shadow program in 2014, she has served on Program Committees for the Region I spring meeting and on the advisory board for Region I, and she will begin her term as Secretary in 2017.

Cara Martin-Tetreault is currently serving as the Director of Sponsored Research Programs at Bowdoin College. In this role, she coordinates a wide range of pre-award and post-award services including implementing policy, facilitating proposal development, maintaining an environment of research integrity, and providing trainings for PIs.

Joseph Tomaras has worked in a variety of research administration roles, at public and private institutions ranging from community colleges to graduate schools of engineering, for a total of 12 years, of which the last three have been at Bates College. Among his responsibilities at Bates, he is the convener of the Research Compliance Working Group. He has a B.A. in philosophy from the State University of New York at Binghamton.


Location: Rines A
Description: Part I of this session, presented by Tony DeCrappeo, COGR President, will cover current issues in research policy and regulation that are in play by OMB, OSTP, and any of the federal funding agencies, or that external groups- Congress, the National Academies, or the Government Accountability Office - have taken an interest in. 
In Part II, the panel will discuss their experiences with and advice for supporting an engaged faculty by providing assistance at all stages: grant-seeking, proposal development, and grant administration.
Evaluation: Session 2 Evaluation
Handout(s): Overview, Tetreault Handout, Tomaras Handout, Haney Handout
Presenter: Ada Sue Selwitz, MA

Ada Sue Selwitz, MA has been responsible for assisting the University of Kentucky in developing institutional policies and educational program pertaining to a variety of compliance issues such as protection of human subjects, scientific misconduct, humane care and use of animals, Health Insurance Portability and Accountability Act (HIPAA), and data sharing and retention. She has worked at the University of Kentucky in a variety of roles including Director of Sponsored Program Development, Director of the Office of Research Integrity, Adjunct Associate Professor in the Department of Behavioral Sciences in the College of Medicine, Co-Director of Regulatory Support and Research Ethics of the National Institutes of Health (NIH) funded Center for Clinical and Translational Sciences, and Executive Integrity/Compliance Advisor. Ms. Selwitz has co-authored publications and given over 150 national/state presentations. Ms. Selwitz has been involved in extramurally funded research projects funded by the National Institutes of Health (NIH), the Scientist Center on Animal Welfare, and the National Science Foundation. She has been the recipient of several national awards such as Society of Research Administrators Excellence Award, Applied Research Ethics National Association Distinguished Service Award, ARENA Appreciation Award, and National Council of University Administrators Outstanding Achievement in Research Administration Award. Ms. Selwitz served on the Department of Health and Human Services Secretary’s Advisory Committee on Human Research Protection, the NIH Regulatory Burden Committee, Public Responsibility in Medicine and Research (PRIM&R) Board of Directors, the CITI Executive Advisory Committee, 45 CFR 46 Secretary’s Advisory Committee on Human Research Protections (SACHRP) Subpart A Subcommittee, and chaired the NIH Regulatory Burden Human Research Protection Subcommittee.


Location: Eastland Ballroom
Description: The Department of Health and Human Services has issued proposed changes in the 45 CFR 46 Subpart A which would dramatically change regulatory requirements for IRB Review of Human Research and the administration of IRB operations. This session will provide an overview of the proposed revisions including a description of the requirements for new categories of review mechanisms and Single IRB Review of collaborative projects. The session would also discuss the impact the changes could have on Institutions, IRBs, and researchers.
Evaluation: Session A-1 Evaluation
Handout(s): A-1 Handout Selwitz
Presenters: Dave Canarie & Thomas Record

Dave Canarie, VP and Managing Counsel, UNUM Group Law Dept.; Adjunct faculty member, USM School of Business: Dave Canarie is Vice President and Managing Counsel in the Unum Law Department where he leads a practice team focusing on Investments, Corporate Real Estate, Reinsurance and Procurement matters. A frequent speaker at CLE programs, Dave is a graduate of the Boston University School of Law and former Chair of the Maine State Bar Association Continuing Legal Education Committee. He is an adjunct faculty member in the USM School of Business and teaches courses on business law.

Thomas Record, is Senior Staff Attorney at the Maine Bureau of Insurance. Tom has been employed by the Bureau since 1978. He is a graduate of Oxford Hills High School, the University of Maine and the University of Maine School of Law.


Location: Rines A
Description: This presentation provides an overview of the state and federal regulatory process and takes an in-depth look at two regulatory agencies: the Maine Bureau of Insurance and the Federal Trade Commission. In doing so it emphasizes the real world operation of agencies and the way in which individuals and businesses interact with them.
Evaluation: Session B-1 Evaluation
Handout(s): D Canarie Handout, T Record Handout
Presenters: Sarah Marie Huban & Stephanie deRijke, RN, MSN

Sarah Marie Huban is the Manager of the Human Protections Program and Research Regulatory Affairs at Children’s Healthcare of Atlanta. Huban has over 10 years expereince in research, including working in the IRB offices at Emory University and Ohio State University. Prior to her current work in research compliance, Huban worked on the “other side of research” at RTI, International in the Education Surveys Division. She currently serves as an IRB member on the Emory University IRB and is an active volunteer with Public Responsibility in Medicine and Research (PRIM&R). Huban received her BS from Ohio University and her MA in Communication and Journalism from Ohio State University. She holds a Certified IRB Professional (CIP) certification and is Certified in Healthcare Research Compliance (CHRC).

Stephanie deRijke, RN, MSN Stephanie has 10 years of clinical research experience, and is currently serving as the director of an internal, clinical trial quality assurance and improvement program at Emory University. In this role, her responsibilities include managing not‐for‐cause and forcause audits and providing on‐site, individual, large group and electronic GCP training to numerous clinical research professionals at all stages of career. Prior to her current role, she developed and managed a new quality assurance program at the Emory Institutional Review Board. In 2010, Stephanie became a site visitor for the Association for the Accreditation of Human Research Protections Programs and obtained a Certified IRB Professional certificate. Before moving to the administrative side of research, Stephanie spent two years working as a nurse practitioner co‐investigator at the NIH Clinical Center in Bethesda, MD. She obtained both a BSN and MSN from the Nell Hodgson Woodruff School of Nursing at Emory University and began her nursing career in Labor and Delivery at Emory University Hospital Midtown.


Location: Longfellow
Description:  This session will provide attendees with an overview of various types of events that occur in research which may require reporting to IRBs. We will discuss a streamlined process for IRB investigation and review of reportable events and discuss of two different options for full board review of reportable events. The session will include case examples of reportable events.
Evaluation: Session C-1 Evaluation
Handout(s): Huban & deRiijke Handout,
Presenter: Bruce Thompson

Bruce Thompson completed his undergraduate studies and Masters degrees (MA Psychology and MA Art History) at the University of St. Andrews, Scotland, and his doctoral studies in social and cognitive development at the University of Edinburgh, Scotland. Since returning to the United States he has held post‐doctoral fellowships and faculty appointments at Boston University, Gettysburg College and Harvard University. Currently, Dr. Thompson is a full‐time faculty member in the department of Psychology at the University of Southern Maine, and serves as Chair of the USM IRB. Dr. Thompson’s primary research focus is on early childhood social‐cognitive development, particularly processes related to emergent metacognition and associated language abilities. A key interest is in the effects of poverty on these aspects of development and their long‐term impact on educational outcomes.


Location: Hawthorne
Description: Appropriately recruiting and conducting research with children goes far beyond regulatory compliance. Inadvertently inducing stress, anxiety or confusion are ethical concerns and are threats to validity. This presentation addresses features of cognitive development that shape how children at different ages respond to requests and testing within research contexts.
Evaluation: Session D-1 Evaluation
Handout(s): B Thompson Handout
Presenters: Ted Myatt, Sc.D, Sabune Winkler, J.D, Kathryn Holthaus

Ted Myatt, Sc.D. leads the URI Office of Research Integrity, which has oversight in all research compliance areas including the Human Research Protection Program, Animal Research Protection Program, Institutional Biosafety Committee (IBC), export controls, and research misconduct. Prior to joining URI, Ted served as the Director of the Partners Healthcare IBC, which served as the IBC for Massachusetts General Hospital, Brigham and Women's Hospital, and McLean Hospital. He received a Bachelor’s of Science in microbiology at the University of Illinois, a Master’s of Environmental Management at Duke University, and a Doctorate of Science at the Harvard School of Public Health.

Sabune Winkler, J.D. is the director of regulatory affairs operations within Harvard Catalyst | The Clinical and Translational Science Center at Harvard Medical School (HMS). Ms. Winkler is responsible for reducing legal, regulatory, and administrative and policy barriers in biomedical and clinical research through identifying opportunities for improvement as well as establishing and making transparent adoptable best practices. In her current position, Ms. Winkler successfully drafted and delivered major contracts such as reliance agreements among the HMS affiliated IRBs, IACUCs, and IBCs, all unprecedented in scope. She is currently an Administrative Fellow of the Harvard University Office of the Assistant to the President, Institutional Diversity and Equity 2015-2016 and she was a fellow in the Division of Medical Ethics at HMS 2013-2014. Ms. Winkler graduated from Northeastern University School of Law with a JD and earned a BA in Asian studies from Bates College.

Kathryn Holthaus focus is on maintaining compliance and safety in animal and human subjects research programs through proactive initiatives, such as education and training for researchers and creation of institutional policy and guidance to close gaps in existing processes. Kathryn obtained her MS in ‘Animals and Public Policy’ at Tufts University Cummings School of Veterinary Medicine in 2008, her MA in ‘Developmental Psychology and Education’ and her BS in Biology, both from Boston College. She was Co-director of the Undergraduate Teaching Laboratories at Boston College where she designed curriculum for and oversaw laboratories in molecular biology, genetics, and general biology. In the past, she has also utilized both zebrafish and murine models in cancer and matrix biology research programs at Beth Israel Deaconess Medical Center.Ted Myatt, Sc.D. leads the URI Office of Research Integrity, which has oversight in all research compliance areas including the Human Research Protection Program, Animal Research Protection Program, Institutional Biosafety Committee (IBC), export controls, and research misconduct. Prior to joining URI, Ted served as the Director of the Partners Healthcare IBC, which served as the IBC for Massachusetts General Hospital, Brigham and Women's Hospital, and McLean Hospital. He received a Bachelor’s of Science in microbiology at the University of Illinois, a Master’s of Environmental Management at Duke University, and a Doctorate of Science at the Harvard School of Public Health.


Location: Winslow Homer
Description:In this session, the speakers will provide an overview of when agreements are needed for research that extends beyond the borders of your institution. Specifically, Institutional Review Board (IRB) Authorization and Reliance Agreements (IAA), Memoranda of Understanding (MOU) between Institutional Animal Care and Use Committees (IACUC), Institutional Biosafety Committee (IBC) agreements, and other agreements will be discussed.
Evaluation: Session E-1 Evaluation
No Handouts for this Session
Presenter: Elizabeth Bankert

Elizabeth Bankert is the Director of the IRB at Dartmouth College and Dartmouth Hitchcock Medical Center. She is a Past President of the Applied Research Ethics National Association (ARENA) and a member of the faculty for Public Responsibility in Medicine & Research (PRIM&R). In December of 2007, Liz received the ARENA Legacy Award. This award recognizes individuals who have made an outstanding contribution to the goals of PRIM&R by promoting the ethical conduct of human subject research through mentoring, teaching, and leadership. Liz served on the Secretary of Health & Human Services Advisory Committee for Human Research Protections (SACHRP) from October 2007 through October 2010. She is the co‐editor of the book entitled: IRB: Management and Function first published in October 2002 now in its second edition and The IRB Member Handbook now in its third edition. Most recently Liz has been a member of the team initiating a program aimed at improving the informed consent process using the “teach back” method: VoICE: Valid Informed Consent Education Program.


Location: Eastland Ballroom
Description: Ensuring individuals are able to make an informed decision when deciding whether or not to enroll in a research study is a cornerstone of conducting ethical research. How do we ensure that the consent is valid, and that the signature on the document represents a truly informed study participant? A team at Dartmouth have developed an education program developed as a resource for research team members involved in the consent process. ACRP on VoICE recently published an article in its journal of Clinical Research. This one hour presentation describes the development and content of the VoICE education program..
Evaluation: Session A-2 Evaluation
Handout(s): VoICE Handout
Presenter: Stuart "Tuck" O'Brien

Stuart "Tuck" O'Brien, City Planning Director, City of Portland, Department of Planning and Urban Development: Fifteen years’ experience with the various elements of infrastructure development from planning and project management to finance, legal and public engagement across a variety of sectors from energy and real estate to transportation. Legal practice focuses on transactional and administrative law with additional expertise emphasizing project development and delivery in both the public and private sector. Licensed to practice law in Maine and Massachusetts.


Location: Rines A
Description:This presentation will provide a survey of innovation, evolution and disruption in the field of land use regulation. Focusing on recent experiences in Portland, Maine, this session will look at the successes and failures of traditional zoning concepts in addressing land use challenges in the 21st Century..
Evaluation: Session B-2 Evaluation
Handout(s): O'Brien Handout
Presenter: Dr. Jennifer Karlin

Dr. Jennifer Karlin received her undergraduate degree from Washington University in St. Louis and her Ph.D. in industrial and operations engineering from the University of Michigan, specializing in engineering management. As far as her committee could determine, she was the first person in the Industrial and Operational Engineering department to successfully defend a solely qualitative methodology dissertation. While a graduate student at the University of Michigan, she taught a senior elective and worked for the Center for Research on Learning and Teaching. Dr. Karlin is now a professor of industrial engineering at the South Dakota School of Mines and Technology and holds the Pietz Professorship for entrepreneurship and economic development. She teaches courses in engineering management, quality, strategy, and operational excellence in both the industrial engineering and engineering management undergraduate graduate programs. Her research studies colleges and universities as organizations and how adjustments in organizational infrastructure can create positive change. She served a five term as the Coordinator of Faculty Development for the university.

Location: Longfellow
Description: If the researchers are the actors on the stage, research integrity and compliance offices are among the vital back stage crew without whom there would be no performance. Yet, sometimes faculty still say the darnedest things, often without realizing it. In this session, a professor who is both a researcher and a faculty developer shares commonly held faculty beliefs, assumptions, and reward systems that cloud faculty understanding of the ‘back stage’ activities when things are going well and may confuse the process when something goes poorly. Participants will learn new ways to translate research integrity and compliance requirements into terms more likely to be understood and valued by the faculty.
Evaluation: Session C-2 Evaluation
Handout(s):All the World's a Stage, Influencer Model, Left Hand Column Technique
Presenters: Alyssa Speier MS, CIP, Matt Stafford BA, CIP, Sara Harnish, JD, Dr. Kirby Johnson

Alyssa Speier, Assistant Director for Regulatory Affairs & Research Compliance, serves as the primary point of contact for Harvard T.H. Chan School of Public Health faculty on developing Memorandums of Understanding (MOUs) between the School and other collaborating institutions. She also works with the School's Associate Dean for Regulatory Affairs & Research Compliance to develop and implement policies and procedures related to the detection, investigation, and prevention of research misconduct and provides faculty/post‐doc training and education on such policies and procedures. Alyssa also continues in her role as a member of the Harvard Longwood Medical Area Schools' Quality Improvement Program (QIP) providing investigators and their study staff consultation and guidance on regulatory requirements and institutional policies and developing and presenting focused educational material. Alyssa joined OHRA in 2005 and worked as IRB analyst conducting protocol reviews. Prior to that, she worked at the Harvard Business School coordinating the computer lab for experimental research. Alyssa earned the Certification of IRB Professionals (CIP) designation in 2007. She received her BA in Psychology from the University of Virginia and her MS in Health Communication from Tufts University School of Medicine.

Matt Stafford is the Assistant Director for Clinical Research Compliance at Boston Children’s Hospital, and Co‐Chair of the Harvard Catalyst Regulatory Group’s Social Behavioral Educational Research (SBER) Sub‐ Committee. He is a frequent presenter at the annual Public Responsibility in Medicine and Research (PRIM&R) research ethics conferences. At Children’s he manages the day‐to‐day operations of the IRB Office. Before coming to Boston, he managed the IRB Office at the New York Blood Center and also worked at Columbia University’s Morningside (SBER) IRB. He has a degree in South Asian studies from Columbia and is currently a student at Boston University’s School of Public Health. He is a lover of spicy food, an avid distance runner, and he lives in Newton with his wife and two sons.

Sara Harnish, JD from Dana-Farber Cancer Institute, Associate Director for Non-Clinical Research in the DFCI Office for Human Research Studies. The office oversees the protocol review (both scientific committee review and IRB review) of all cancer-related research done by the seven Dana-Farber/Harvard Cancer Center consortium institutions.

Dr. Kirby Johnson oversees research ethics training and manages research misconduct and conflict of interest processes at Tufts University. Dr. Johnson also directs a variety of research support programs, including seed grant funding mechanisms; research facilities and services development; and graduate student and postdoctoral support endeavors, towards enhancing collaborative, interdisciplinary research and training across the University.


Location: Winslow Homer
Description:Through a collection of case studies studies, attendees will identify, examine, and explore IRB strategies to address and mitigate SBER risk based on IRB review criteria such as: study procedures, population, risk/benefit, harm, confidentiality, etc. The cases raise important and difficult ethical issues connected with planning, reviewing, or conducting SBER. During this session, faculty will: Review how research that does not necessarily pose risk of physical harm can pose other harms (e.g., psycho‐social, legal, psychological, data protection) and how this can challenge researchers and IRBs with respect to how they identify and assess risk, Identify and examine the ethical and practical issues surrounding risk to subjects when designing and implementing SBER protocols’, and Explore IRB and researcher strategies to identify, assess, mitigate, and manage SBER risks.
Evaluation: Session D-2 Evaluation
Handout(s): SBER,SBER Risk, Part II
Presenter: Alan Dittrich

Alan Dittrich became President of the Massachusetts Society for Medical Research in September of 2002. Since then, MSMR has increasingly focused on three areas: customized member services; the changing security, legal and communications landscapes for biomedical research with animals; and collaboration with like‐minded organizations around the country. Previously, Alan was Director of Prospect Development at Brown University; Marketing Director for Intertek Testing Services; Editor‐in‐Chief of Compliance Engineering Magazine; and a principal of Cahill‐Dittrich Marketing Communications. Alan Dittrich’s first career was as a teacher. After attending Caltech he graduated from Williams College with a dual major in mathematics and English. He earned the MA and PhD in at Brandeis University. In addition to his work at MSMR, Alan is also the treasurer of States United for Biomedical Research. He represents MSMR on the Board of Trustees of AAALAC International.


Location: Hawthorne
Description: Beagle Freedom Project and No New Animal Labs have taken somewhat different actions and paths to try to achieve their goals, which, broadly speaking, include ending animal research. In this session we'll examine their campaigns tactics as part of understanding the challenges of modern pressure groups..
Evaluation: Session E-2 Evaluation
Note: No handouts for this session
Presenter: Judith Navratil, MA, CIP

Judith Navratil, MA CIP, is the Faculty Research Liaison for the University of Pittsburgh Human Research Protections Office, and an Exempt/Expedited review coordinator for the University of California at San Francisco Committee on Human Research. She earned a Master of Arts degree in Bioethics at the University of Pittsburgh in August, 2015, and is certified as an IRB Professional by the Public Responsibility in Medicine and Research (PRIM&R) Council. Prior to becoming an IRB administrator, she was a research coordinator in the Department of Psychiatry at the University of Pittsburgh for 19 years. She has published several peer reviewed articles on retention and recruitment of research subjects as well as Peer Commentary articles published in the American Journal of Bioethics. In 2014, her paper entitled, The Problem with Informed Consent for Research: the Devil is in the Details was awarded the Best Formal Paper by a Graduate Student Award from the Association for Practical and Professional Ethics.


Location: Eastland Ballroom
Description: While the recent Notice of Proposed Rulemaking calls for changes to improve informed consent, this presentation will demonstrate that until the regulatory requirement to provide information in a manner that the subject can understand is taken more seriously, informed consent will continue to be problematic..
Evaluation: Session A-3 Evaluation
Handout(s): Navratil Handout
Presenter: Rita Heimes, CIPP/US

Rita Heimes, CIPP/US is Research Director at the International Association of Privacy Professionals (IAPP). She is an attorney and academic with many years of experience in the fields of privacy, information security, and intellectual property law. In her role at the IAPP, Rita helps to promote the privacy profession through empirical and qualitative research on privacy functions globally as well as though outreach to academic institutions developing the next generation of privacy and security professionals. Prior to joining the IAPP, Rita was a law professor and academic dean at the University of Maine School of Law, where she directed the Center for Law + Innovation and developed the nation’s first Privacy Pathways program and one of the first intellectual property clinics. Rita remains an active scholar, and still coordinates and teaches in the Information Privacy Summer Institute at Maine Law. Over her law career, Rita has practiced privacy and intellectual property law with firms in Seattle, Boulder, and Portland (Maine). She received her BA in Journalism from the University of Iowa and her JD from Drake University School of Law.


Location: Winslow Homer
Description: Privacy has emerged as one of the primary societal concerns in our digital age. This session will review our understanding of the issue, and offer perspective on the trajectory of privacy risk management and regulatory compliance in the future..
Evaluation: Session B-3 Evaluation
Handout(s): Heimes Handout
Presenter: Erica W. Tauriello, BA, CIP

Erica W. Tauriello, BA, CIP directs the Human Research Protection Program at Wentworth‐Douglass Health System (WDHS) in Dover, NH. At WDHS she implemented a committee to create SOPs for clinical research, as well as a clinical research regulatory compliance program. She serves as an IRB member, and is involved in all aspects of research and research compliance. Ms. Tauriello is also a Lean Six Sigma Green Belt Project Manager. Her past experience includes almost 20 years in the pharmaceutical and biotechnology industries in both Clinical Development and Regulatory Compliance. Ms. Tauriello has led workshops at PRIM&R and served as an affinity group leader. She is a member of PRIM&R, the NH IRB Regional Network for Small Research Institutions, a Local Site Advisor to the NCI‐CIRB, a past member of the State of NH Vital Records Privacy Board, and a Special Olympics and local food pantry volunteer.


Location: Longfellow
Description: Whether large or small, institutions conducting clinical trials run the risk of being inspected by health authority inspectors, litigation by study participants, and negative publicity, if trials are not conducted ethically and according to a pre‐determined study protocol. The objective of this presentation is to provide a method, tools and discussions around conducting effective internal clinical trial evaluations to ensure organizational compliance..
Evaluation: Session C-3 Evaluation
Handout(s): Tauriello Presentation, Audit Closure Letter, CIRB QA Generic Review Letter, CIRB QA Review Report, CIRB QA Review Tool, Review Plan, LD-69 Human Research Protection Program
Presenter: Fariba Houman, Ph.D., CIP

Fariba Houman Ph.D., CIP, serves as the Director of the Human Research Protections Program at Massachusetts Eye and Ear. She is responsible for operations oversight, quality assurance, and regulatory compliance of a mid‐size biomedical HRPP. Dr. Houman received a Ph.D. in microbiology and molecular biology from Tufts Sackler School of Graduate Biomedical Sciences. After a postdoctoral fellowship in yeast genetics, she worked as a bench scientist for two Boston‐area antimicrobial drug‐discovery startup companies before switching careers. As Project Manager for an international malaria project, she became interested in human research ethics and has been working in protection of research subjects since 2003.


Location: Hawthorne
Description: In this workshop, we will review some of the special challenges biomedical IRBs are facing in review of early phase trials. We will use case studies to examine subtle design or COI issues that can impact IRB approval criteria; we will discuss educational requirements, and other practical strategies to ensure that scientific and COI issues are properly recognized and addressed during the IRB review process. Finally, we will brainstorm how single IRB review or regional review can influence HRPP effectiveness..
Evaluation: Session D-3 Evaluation
Handout(s): F Houman Handout

Presenter: Sajal Ghosh

Sajal Ghosh has been a member of the Institutional Biosafety Committee at Boston University for over 10 years and an Assistant Professor of Medicine at the Boston University. He has reviewed and presented over 300 IBC protocols as a primary reviewer. Dr. Ghosh received his Ph.D. in Biochemistry from Calcutta University, India and post‐doctoral fellowship in molecular virology at the Comprehensive Cancer Center, University of Alabama at Birmingham, concentrating on HIV research in the BSL‐3 facility. He continued his work on molecular virology and cancer biology at the Cancer Center of Boston University and published 20 papers. His work also includes over ten years of research on Epstein Barr virus (a member of the herpesvirus family). Dr. Ghosh moved on to become full time member of the Research Compliance Office of Boston University. As a Compliance Specialist for the IBC of Boston University, Dr. Ghosh manages IBC protocols for the entire University and provide guidance to the principal investigators regarding federal, state and city regulatory requirements on their research work. Dr. Ghosh also provides orientation to new IBC members about their roles and responsibilities.


Location: Rines A
Description: Although the animal model of biological research is considered superior because of their phylogenetic closeness to humans, animal models can cause serious health hazards and even death of researchers. This presentation will provide a thorough understanding of the hazard potential, molecular pathophysiology, risk factor and prevention of the hazard..
Evaluation: Session E-3 Evaluation
Note: No handouts for this session
Presenter: Lliam Harrison

Lliam Harrison has lived in Maine since 2005, migrating east after many years in the American southwest. Originally trained as a medical anthropologist, Lliam developed an interest in bioethics, which led to law school. He graduated from the Sandra Day O'Connor College of Law at Arizona State University, where his studies focused on two areas: law, science & technology and alternative dispute resolution. After graduation, Lliam clerked for a Maricopa County Superior Court judge before entering private practice. Lliam originally practiced in the areas of criminal defense, civil litigation (including insurance bad faith) and professional regulation, including ethics and administrative law. In all of these areas of practice, Lliam drew heavily upon his training as a mediator. A private mediator, Lliam mediates a wide variety of cases and also offers conflict management system consultation, to help address organizational conflict before it begins or at its earliest!


Location: Eastland Ballroom
Description: This presentation invites participants to delve deeper into the question "why regulate"? Viewing regulatory practice from a wider vista provides a richer sense of the underpinnings of regulatory systems. Because it looks at the deeper cognitive and philosophical aspect of regulatory practice, it is not topic or subject matter dependent. Rather, it is applicable across the broad spectrum of regulatory practice.
Evaluation: Session A-4 Evaluation
Handout(s): Harrison Handout
Presenters: Jody McColman & Nathan Dore

Jody McColman is a Staff Attorney with the Maine Public Utilities Commission. Since joining the Maine Commission in 2009, Mr. McColman's practice has been focused on natural gas pipeline safety compliance and enforcement as well as telecommunications regulation. Mr. McColman’s duties at the Maine Commission include serving as Hearing Examiner on cases and disputes brought before the Commission, as well as the development of natural gas safety policy and regulations, and the enforcement of those regulations. Mr. McColman is a summa cum laude graduate of the University of Maine at Farmington (B.A. 2005) and a magna cum laude graduate of the University of Maine School of Law (J.D. 2008). Mr. McColman is admitted to practice in Maine.

Probably the most obvious basis for Nathan Dore’s interest in regulatory compliance is on account of his position with the Maine Public Utilities Commission, where he is a Gas Pipeline Safety Inspector. Prior to his public service work, Nathan was based out of Knoxville, Tennessee, with one of North America’s premier natural gas infrastructure companies, where his primary focus was on regulatory compliance quality. But Nathan also lives at the user end of regulatory enforcement with his family’s small business, Slow Rise Farm, which grows and processes certified organic Maine wild blueberries in Pittston, Maine. Nathan is a 2003 graduate of the University of Maine, where he received a Bachelor of Arts in Theatre while studying with Dr. Sandra Hardy.


Location: Rines A
Description: Regulatory compliance and enforcement, when broken down to its essential elements, is a continuous chain of discretionary decisions on the part of the regulator. We propose to examine this decision chain in the context of natural gas pipeline safety regulation..
Evaluation: Session B-4 Evaluation
Handout(s): Regulatory Discretion Handout
Presenters: Katie Speanburg & Teresa Doksum, PhD, MPH

Katie Speanburg is the IRB Administrator at Abt Associates, as well as a Knowledge Manager. Katie earned an EdM from the Harvard Graduate School of Education in International Education Policy in 2010. She worked at Abt Associates as a researcher in the Social and Economic Division for several years, focusing on Department of Labor and Health and Human Services projects. She then moved over to work for the Abt IRB, focusing on training, communications, ensuring relationships are built and sustained across partners, and keeping the IRB review trains running. Prior to working at Abt, Katie worked at Harvard University for seven years at the Business School and Graduate School of Education.

Teresa Doksum, PhD, MPH, is the Director of Research Ethics and IRB Chair at Abt Associates Inc. She is a health services researcher with more than 30 years of experience conducting social behavioral research and evaluation studies that involve primary data collection (e.g., surveys, interviews, focus groups) as well as analysis of medical records. She is a member of Ab’s Information Risk Management initiative, a cross‐functional team that ensures employees and outside research partners have the tools, training, and resources required to protect sensitive information. Along with information security expert Sean Owen, she has presented on this data security initiative at national conferences. She received her PhD from the Johns Hopkins University Bloomberg School of Public Health and her master’s from the University of California, Berkeley, School of Public Health.


Location: Longfellow
Description: Comprehensive training is a key component of a successful human subjects protection program. Come walk through the life‐cycle of data to determine role‐based training needs for all partners (including non‐ traditional ones) and how to turn data security incidents into an opportunity to educate..
Evaluation: Session C-4 Evaluation
Handout(s): Speanburg & Doksum Handout, Activity Handout
Presenter: Wayne Maines, CSHM

Dr. Maines is the Executive Director of Safety, Health Services, Transportation and Security for the University of Maine System. He also spent 10 years as the Corporate EHS Manager for a global chemical company and 4 years as the Director of The Institute for Safety and Health Training at West Virginia University. Dr. Maines has a BS degree from Cornell University and a master and doctorate from West Virginia University. Wayne has over 800 hours of Industrial/Research EHS, High Angle Rescue, Hazardous Materials, Firefighting, and Confined Space Rescue Training. Wayne has been an SEM & Emergency Management instructor for 25 + years. He has conducted numerous EHS Management, Leadership and Emergency Management training workshops at the state and national level.


Location:Hawthorne
Description: The scope of Environmental Health and Safety (EHS) management continues to grow and meld with other organizational initiatives. This session will introduce you to a few low cost, in-house management tools that might be a good fit for your EHS compliance program and support other regulatory services/accreditation requirements at your institution..
Evaluation: Session D-4 Evaluation
Handout(s): Maines Handout, Maines Policies, Maines2 Handout
Presenters: Cheryl Savini & Kimberly Irvine

As Sr. Vice President, Cheryl Savini has over 25 years’ experience in human research protections, in both the biomedical and social and behavioral fields, serving both the civilian and military arenas. Her experience spans from IRB administration to policy development, and program oversight and monitoring. She has held positions of Acting Research Compliance Officer at the University at Albany for both human research protections and the animal welfare programs; Director, Human Subjects Research Office at the University of Miami; and Quality Assurance Manager for the Human Subjects Research Office for the U.S. Department of the Navy. In addition, Ms. Savini has worked for an independent IRB and medical academic institutions, and has served as an IRB member.

Ms. Savini has been a member of the nationally and internationally acclaimed Collaborative Institutional Training Initiative (CITI) web-based training program since 2002, serving on the social and behavioral developers, editors, and contributors groups. Additionally, Cheryl has been an invited presenter a numerous national and international venues, such as PRIM&R, SRA, and CUNY as well as at human subject conferences in Korea, China, and Singapore. Cheryl is a Certified IRB Professional (CIP) and has been honored with several distinguished awards, including; the University Presidential Award at the University at Albany, the State University of New York Chancellor’s Award for Professional Service; and the Initiatives for Women Award.

Kimberly Irvine is the Executive Vice President and Chief Operating Officer of BRANY. Her responsibilities include coordinating and implementing business processes that enhance BRANY’s efficiency in study start-up, IRB, coverage analysis, clinical trial budgets, and contracts. Before her prior promotion to VP of Operations at BRANY, Kimberly was the Director of the Regulatory Department where her primary responsibilities were in contracts and budgets. Ms. Irvine began her career in Healthcare Administration at the Weill Medical College of Cornell University and subsequently obtained a position as a Business Manager for the Department of Medicine at LIJ. She has 25+ years’ experience in healthcare and research.


Location:Winslow Homer
Description: The research landscape is changing, and while institutions expand their reliance on external IRBs, they are still responsible for the oversight and conduct of research conducted under their auspices. As such, a strong institutional research oversight management program must be implemented. In this session, we will discuss why institutional oversight is required for your research program, and the challenges faced maintaining proper oversight, as well as identify ideas that can help strengthen your institution’s current research oversight infrastructure..
Evaluation: Session E-4 Evaluation
Handout(s): Irvine Handout

Thanking our Sponsors and Vendors

www.primr.org
www.msmr.org
www.nscnne.org
www.verrilldana.com
www.verrilldana.com
www.verrilldana.com
www.verrilldana.com
www.verrilldana.com
learninginnovationcenter.org

Event Logistics

Choose Westin_Conf from the list of networks
Our group's wireless passcode (case-sensitive) is: 5SARA2016
BE SURE TO SIGN-IN TO EACH SESSION AND COMPLETE THE EVALUATION FOR EACH IN ORDER TO RECEIVE PROPER CREDIT FOR ATTENDANCE.

The 2016 MeRTEC Research Integrity and Regulatory Compliance Symposium has been approved for the following continuing and professional education programs:

  • PRIM&R Certified IRB Professional (CIP): Up to 6 CIP
  • PRIM&R Certified Professional IACUC Administrator (CPIA): 140 Minutes
  • Maine Continuing Legal Education (CLEs): Up to 9.3 CLE Credits if you attend both days, including up to 1.16 Ethics Credits (Please provide your Bar Number at session sign-in)
  • Association of Clinical Research Professionals (ACRP) Maintenance Points: Up to 11.25 contact hours of research-related education on applications for Maintenance of ACRP’s CCRC®, CCRA®, or CPI® certification designations.
  • Continuing Education Units (CEUs) – There will be a form available at the Symposium that you will need to complete and submit at the Symposium together with a fee of $20.
For the following organizations, the attendee is responsible for applying for appropriate continuing and professional education credit:

  • National Council of University Research Administrators (NCURA)
  • Society of Clinical Research Associates
  • Maine Board of Social Worker Licensure Continuing Education
  • Maine State Board of Examiners of Psychologists
  • National Association of IRB Managers
  • New Hampshire Continuing Legal Education Units
If you are at the conference, please go the registration table. There will be someone there to help you. Or, find someone with a "Staff" ribbon on their name badge.

After the conference, please e-mail RISymposium@maine.edu for assistance.