Research Ethics & Compliance (RE)

Applies to attendees involved or interested in issues such as: human research; animal research; peer review; mentor/trainee responsibility and development; publications; collaborative research ethics; scientific misconduct; standards for the responsible conduct of research; and research ethics education programs, curricula, requirements, and approaches.

Monday, May 8, 2017

M105: International Case Studies in Research Misconduct
Monday, May 8, 2017 - 9:30am to 10:45am

Content level: Intermediate

Research integrity is of paramount importance to our institutions and noncompliance with modern Responsible Conduct of Research (RCR) standards can result in severe penalties to the organization, the individual(s), and their reputations. But the modern definition of research misconduct is relatively new, having evolved from hundreds of years of social and ethical issues that have arisen in the practice of scientific research. A review of new and historic cases involving accusations of research misconduct in biology, chemistry, physics and medicine provide some insightful examples of both responsibly and irresponsibly conducted science. What may have been acceptable practice a century ago may be considered unacceptable practice by today’s standards. In this highly interactive session, participants will become familiar with an international case history of research misconduct and will engage in discussion of how these prominent cases have shaped contemporary perspectives on the responsible conduct of research. NOTE: This is a highly interactive session using a wireless audience response system to engage participants, evaluate feedback and formulate group consensus on a variety of ethical issues and questions.

Learning objectives:

  1. Describe a variety of international cases involving ethical issues in research and apply modern RCR standards to better assess and work through those issues.
  2. Discuss the relevant rules and regulations of modern RCR standards and the ethical principles and cases that justify current institutional compliance policies.

Prerequisites: A basic working knowledge and fundamental understanding of responsible conduct of research.

Speaker(s):

Tony Onofrietti, M.S., CRSS, Director, Research Education, The University of Utah

M205: Connecting the Dots of Conflict of Interest (COI) Management and Institutional Review Board (IRB) Administration in Clinical Research
Monday, May 8, 2017 - 11:00am to 12:15pm

Content level: Intermediate

While Conflict of Interest (COI) Management and Institutional Review Board (IRB) Administration may seem to be two different research administration functions, they intersect often within complex COI management plans before, during and after the review of human subject research protocols by the IRB. It is critical that the individuals and organizations with COIs and to the human subjects that participate in research that these research administration functions are closely aligned. This session will highlight the components of managing COIs related to clinical research and how the IRB utilizes this information to ensure quality reviews of protocols. The presenters will address specific concerns and evaluation strategies in managing COIs from both the COI office and the IRB perspectives. The session participants will share their experiences, via anonymous polling and open discussion, related to the management of COIs and their experiences in or with their IRBs.

Learning objectives:

  1. Identify key overlapping risk factors relative to conflicts of interests and human subjects research.
  2. Analyze organizational approaches to conflict of interest management and IRB administration as two key research administration functions.

Prerequisites: None

Speaker(s):

Adrienne Dumke, MBA, Research Integrity Specialist, University of Louisville and Philip A. Cola, Ph.D., Vice President for Research and Technology Management, University Hospitals Case Medical Center

M305: Research Clinical Trial Compliance
Monday, May 8, 2017 - 2:15pm to 3:30pm

Content level: Advanced

This session will explore clinical trial compliance from a good business, financial and clinical practice. We will distinguish what the risks are associated with clinical trials and how to implement process improvement.

Certificate: CTRA 201-R

Learning objectives:

  1. Identify good business, financial and clinical practice goals.
  2. Implementation opportunities for process improvement.

Prerequisites: None

Speaker(s):

Kelly Willenberg, DBA, MBA, BSN, CHRC, CCRP, CHC, Manager, Kelly Willenberg, LLC

M405: Food and Drug Administration (FDA) Oversight Introduction for Social, Behavioral and Educational Research (SBER) Institutional Review Boards (IRBs)
Monday, May 8, 2017 - 3:45pm to 5:00pm

Content level: Basic

Institutional Review Boards (IRBs) who are primarily Social/Behavioral/Educational research focused sometimes find themselves reviewing research involving drugs, dietary supplements, devices, food, and apps that may require Food and Drug Administration (FDA) oversight. This presentation provide basic guidance for determining when FDA oversight may be applicable.

Learning objectives:

  1. Identify potential areas when FDA regulations may apply to a research protocol.
  2. Understand the IRB's and IRB Office's roles when FDA regulations may apply.

Prerequisites: None

Speaker(s):

Robin Tyndall, Director, Office of Research Protections, Appalachian State University

Tuesday, May 9, 2017

R1: Working with the Institutional Review Board (IRB) on Review of Contracts, Data Use Agreements (DUAs) and Material Transfer Agreements (MTAs)
Tuesday, May 9, 2017 - 8:30am to 9:00am

Content level: Basic

Discussion about how the Office of Sponsored Programs and Institutional Review Board (IRB) at Children's have worked together to build a more robust review of Contracts, Data Use Agreements and Material Transfer Agreements by identifying areas of concern for each department. Provide examples of issues we have encountered and averted. Open the conversation to learn how other attendees work with various departments for a more thorough review of contracts.

Learning objectives:

  1. Identify areas where the IRB can provide assistance in review Contracts, DUAs and MTAs.
  2. Identify potential issues that OSP might be able to identify for the IRB.

Prerequisites: None

Speaker(s):

Sarah Marie Huban, MA, CIP, CHRC, Manager, HPP and Research Regulatory Affairs and Shanta Laurie, Manager, Office of Sponsored Programs, Children's Healthcare of Atlanta

T105: Financial Conflicts of Interest in Research
Tuesday, May 9, 2017 - 9:15am to 10:30am

Content level: Basic

I propose to deliver an interactive presentation focusing on financial conflicts of interest in research. I propose to take a particular look at conflicts of interest that may arise as a result of outside consulting activities by research principal investigators. The importance of compliance with National Institute of Health and National Science Foundation financial conflict of interest rules will be stressed.

Learning objectives:

  1. Understand and comply with financial conflict of interest rules put in place by federal research sponsors.
  2. Understand the importance of avoiding financial conflicts of interest arising from outside consulting activities of research principal investigators.

Prerequisites: None

Speaker(s):

John Cates, JD, Chief University Counsel, University of Alabama System

T205: Defining and Streamlining Review of Reportable Events: A Practical Approach
Tuesday, May 9, 2017 - 10:45am to 12:00pm

Content level: Basic

This session will provide attendees with an overview of various types of events that occur in research which may require reporting to Institutional Review Boards (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.

Learning objectives:

  1. Define different types of reportable events: AEs, SAEs, UPs, NC, SNC, CNC.
  2. Identify strategies for streamlining review of reportable events.

Prerequisites: None

Speaker(s):

Sarah Marie Huban, MA, CIP, CHRC, Manager, HPP and Research Regulatory Affairs and Emily Smotherman, Manager of Research Compliance, Children's Healthcare of Atlanta

T304: Data and Privacy
Tuesday, May 9, 2017 - 1:45pm to 3:00pm

Content level: Basic

We all live in a world of digital data, generating an information trail as we e-mail and study, conduct research, use health care, shop with loyalty cards, and make wireless calls. In response, individuals and watchdog groups are raising alarms about the Orwellian implications and government agencies are increasing regulation and instituting severe punishment for privacy infractions. In Europe and the United States, elaborate bodies of law as well as a structure of non-legislative rules and regulations  have formed around privacy issues. Computer technology, and increasingly biotechnology (e.g., genetic information gathering) is getting ever more powerful and sophisticated and the issues of digital privacy and disclosure of personal information is rapidly coming to the fore.

Learning objectives:

  1. Identify the privacy issues that arise in the research enterprise and the steps governments taking to regulate and control research activities use of personal information and development of technology that can invade privacy and that can protect individuals from identification or location?
  2. Examine the laws and regulations that most affect the compilation and use of personal, private, and confidential information in research and resulting from research, treatment and education.

Prerequisites: None

Speaker(s):

Michael Slocum, President, Slocum & Boddie, PC, Alexandria, Virginia

T305: Building Responsible Conduct of Research Training Programs at Predominantly Undergraduate Institutions (PUIs)
Tuesday, May 9, 2017 - 1:45pm to 3:00pm

Content level: Intermediate

Responsible Conduct of Research (RCR) training programs are required of institutions receiving funding for certain types of grants from the National Institutes of Health (NIH) and the National Science Foundation (NSF). Predominantly Undergraduate Institutions (PUI) often have unique challenges in contrast to larger higher education research universities in complying with these regulations. What strategies can the research administrator apply to design effective RCR education plans? What policies will enhance the “culture of compliance” at the PUI? In this highly interactive session, different institutional perspectives and best practices for developing, implementing and documenting effective RCR training programs and policies for faculty, staff and students at PUIs will be presented.

Learning objectives:

  1. Attendees will gain an understanding of a variety of proven techniques for delivering effective responsible conduct of research (RCR) training programs and policies at PUIs.
  2. Attendees will learn how to design an effective RCR training plan utilizing different instructional methods to enhance teaching and learning effectiveness.

Prerequisites: A basic working knowledge and fundamental understanding of responsible conduct of research.

Speaker(s):

Tony Onofrietti, M.S., CRSS, Director, Research Education, The University of Utah

T405: Singing from the Same Sheet: Effective Communications between Sponsored Programs and Research Compliance
Tuesday, May 9, 2017 - 3:15pm to 4:30pm

Content level: Basic

Conflict of interest, human subjects, animals, biohazards & radioactive materials, export controls..... How does a research administrator sleep at night while managing multiyear projects?  It takes team work and coordinated efforts with planned followups and reviews, standard operating procedures, and policies that govern next steps when things go wrong.

Learning objectives:

TBD

Prerequisites: None

Speaker(s):

Charna Howson, Director, Sponsored Programs; Amy Roberts, CRA,  Director of Special Funds and Robin Tyndall, Director, Office of Research Protections, Appalachian State University

Wednesday, May 10, 2017

W104: Cybersecurity Compliance for Department of Defense (DoD) Contractors: Making sense of Defense Federal Acquisition Regulation Supplement (DFARS)
Wednesday, May 10, 2017 - 9:00am to 10:15am

Content level: Intermediate

Please join us to discuss compliance focusing on Defense Federal Acquisition Regulation Supplement (DFARS) clause 252.204-7012. Compliance with the 110 controls is due at the end of 2017. We will go over the controls at a high level and highlight the top 5 controls. We will also discuss the history of DFARS compliance and what non-compliance means for the contractor.

Learning objectives:

  1. At a high level, understand the breadth of security requirements that DoD contractors must be compliant with by the end of 2017.
  2. Determine if they need to be concerned with these requirements.

Prerequisites: None

Speaker(s):

Drew Hollander, M.Eng., Senior Cyber Engineer, DESE Research and Adam Maddox, Chief Technology Officer, H2L Solutions

W205: Intellectual Property Laws and Recent Changes as it Pertains to Protecting Innovation from Universities for Economic Development
Wednesday, May 10, 2017 - 10:30am to 11:45am

Content level: Intermediate

As research administers, one of the most difficult issues when it comes to negotiating research contracts with industrial partners is the intellectual property (IP) rights. And increasingly universities and research institutes are looking to protect IP generated so that it can be a basis of a startup. This session will give research administrators a fresh/new perspective on IP and help in the negotiation process.

Learning objectives:

  1. Understand the different kinds of Intellectual Property (IP).
  2. Understand issues facing both the industry when funding research at the universities.

Prerequisites: None

Speaker(s):

Kannan Grant, BSEE, MBA, Director, Office of Technology Commercialization, University of Alabama in Huntsville