Event Start

May 19-20


200 Plus


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.

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Session Schedule

12:30 PM Thursday

Presenter:Joel C. Relihan & Panel
Location: Hawthorne Room
12:30 PM Thursday

Regulatory Compliance

Presenters: Anthony DeCrappeo & Panel
Location: Rines A
Presenter: Ada Sue Selwitz, MA
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.
Presenters: Dave Canarie & Thomas Record
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.
Presenters: Sarah Marie Huban & Stephanie deRijke, RN, MSN
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.
Presenter: Bruce Thompson
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.
Presenters: Ted Myatt, Sc.D, Sabune Winkler, J.D, Kathryn Holthaus
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.
Presenter: Elizabeth Bankert
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.
Presenter: Stuart "Tuck" O'Brien
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.
Presenter: Dr. Jennifer Karlin
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.
Presenters: Alyssa Speier MS, CIP, Matt Stafford BA, CIP, Sara Harnish, JD, Dr. Kirby Johnson
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.
Presenter: Alan Dittrich
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.
Presenter: Judith Navratil, MA, CIP
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.
Presenter: Rita Heimes, CIPP/US
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.
Presenter: Erica W. Tauriello, BA, CIP
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.
Presenter: Fariba Houman, Ph.D., CIP
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.
Presenter: Sajal Ghosh
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.
Presenter: Lliam Harrison
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.
Presenters: Jody McColman & Nathan Dore
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.
Presenters: Katie Speanburg & Teresa Doksum, PhD, MPH
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.
Presenter: Wayne Maines, CSHM
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.
Presenters: Cheryl Savini & Kimberly Irvine
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.

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