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.

Sunday, April 2, 2017

WS7: Clinical Trial Budgeting Boot Camp
Sunday, April 2, 2017 - 9:00am to 12:30pm

Content level: Intermediate

Budgetary issues are at the heart of successful clinical trial conduct. Inadequate budgeting results in hardships at the site level that compromise recruitment and overall trial success. In addition, under budgeting can be seen as a sign of lack of expertise and can undermine credibility in the conduct of research. This session will discuss budget development in a frank and straightforward manner using example clinical trial protocols to demonstrate items, both listed and omitted, that need to be included in calculating a representative cost budget. The participants will interactively discuss issues within the protocol and what impact they will have on the final budget. Generic clinical trial protocols will be examined over the course of the workshop.

Learning objectives:

  1. Define clinical trial budgetary requirements.
  2. Provide time, cost, and procedural breakdown utilizing protocol as a template.

Prerequisites: None

Speaker(s):

Pavel Kruchek, MBA, Director, Business Operations, Clinical Trials Office and Vanessa Bryant, Sr. Budget Analyst, Clinical Trials Office, University of Utah

Monday, April 3, 2017

M105: Building Responsible Conduct of Research Training Programs at Predominantly Undergraduate Institutions (PUIs)
Monday, April 3, 2017 - 9:30am to 10:45am

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 (PUIs) 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.

Certificate: IRAM-R, Category: III. Regulatory Compliance

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: None

Speaker(s):

Tony Onofrietti, M.S., CRSS, Director, Research Education, The University of Utah and Dominic Esposito, CRA, Director of Sponsored Programs and Research, Baruch College

M205: Indigenous Research Ethics
Monday, April 3, 2017 - 11:00am to 12:15pm

Content level: Intermediate

Indigenous Research Ethics is a (k)new area of academic study arising from the recognition of shifting demographics and awareness articulated by native world scholars. It is at the forefront of expanding mainstream research methodologies because of its linkages with Indigenous epistemology and holistic thinking shaped within authentic processes connected to the care of land and people. The panel will provide an introduction to Indigenous hermeneutics and its role in the design, purpose and function of research for, about, and within Indigenous communities and beyond. Hermeneutics is the theory and methodology of text interpretation, especially the interpretation of biblical texts, wisdom literature, and philosophical texts (Wikipedia). In modern academia it deconstructs the idea: “Whose knowledge is privileged?” In research it asks: “Whose worldview is privileged?” 

Learning objectives:

  1. By the end of this panel presentation, participants will be able to recognize abusive research and identify three essential concepts to ensure respectful research with and for Indigenous People.
  2. By the end of this panel presentation, participants will be able to identify six common values across Indigenous communities and strategies for ensuring those values direct the research process.

Prerequisites: None

Speaker(s):

Terrrilani Chong, MA, Research Administrator, University of Hawaii at Hilo; Shawn Kanaiaupuni, PhD, Director of Policy Analysis & System Evaluation (PASE), Kamehameha Schools; Aulii Silva, Native Hawaiian Student Support Coordinator, Leeward Community College; Kamuela Werner, Research Associate, Department of Native Hawaiian Health; Joan Jensen, MA, Graduate Assistant, University of Hawaii at Manoa; Maile Taualii, PhD, Assistant Professor, University of Hawaii and Manulani Aluli Meyer , PhD, Indigenous Scholar-Practitioner, University of Hawaii at West Oahu

M305: Overview Discussion on the Top 5 Gnarly Issues in Research Compliance
Monday, April 3, 2017 - 2:15pm to 3:30pm

Content level: Intermediate

Misconduct and quality assurance (repeat offenders?); single Institutional Review Board (IRB) and the Notice of Proposed Rulemaking (NPRM) (bio repository issues); National Institute of Standards and Technology (NIST) standards and export controls; lessons from the initial Uniform Guidance (UG) audits; controversies in chimera - stem cells and Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR) technology ethical dilemmas.

Each one of those could be it's own session. The goal here would be a very quick summary of biggest concerns with Q and A format. Primarily for those with an already working knowledge of the regulations so we can get to the real issues and resolutions or solutions being used by our peers. 

Learning objectives:

  1. Discuss regulatory change and ethical considerations in a broad range of compliance areas.
  2. Learn how other institutions are adapting to and responding to these transitions.

Prerequisites: None

Speaker(s):

Craig  Allison, MPH, JD, Director of Research Compliance and Integrity and Cindy Kiel, Executive Associate Vice Chancellor, Research, University of California Davis

M405: International Case Studies in Research Misconduct
Monday, April 3, 2017 - 3:45pm to 5:00pm

Content level: Intermediate

Research integrity is of paramount importance to our institutions and noncompliance with modern 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.

Certificate: IRAM-R, Category: III. Regulatory Compliance

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: None

Speaker(s):

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

Tuesday, April 4, 2017

T102: What’s Up with the Common Rule and Single Institutional Review Board (IRB) Regulation Changes and What do Research Administrators Need to Know?
Tuesday, April 4, 2017 - 9:15am to 10:30am

Content level: Basic

The Common Rule is a basic floor of protections that has covered federally-funded research since 1991 with very few revisions. After over five years of proposed rule-making and public comment periods, the “final rule” was signed into law on January 18, 2017. Change in the revised common rule impact the scope of the law, exemption categories, Institutional Review Board (IRB) operations, and informed consent.  These new rules can have implications at all levels of research: organization leadership, grants and contracts, investigators, and department research administrators.  Research administrators and institutional leadership will receive valuable information during this session regarding the requirement of Single IRB review, IRB reliance agreements, the definition of research and scope requirements of their institutions.  Those that work directly with human research participants will also learn more about the impacts of the consent process.  Because of uncertainty during the transition of presidential administration, there has been confusion about new laws and regulations.  This will be discussed and clarified so that institutions and their research teams are prepared to be compliant, regardless of the status of the regulation.

Certificate: NIH-R, Category: III. Compliance

Learning objectives:

  1. Identify the changes to the common rule that will be in effect as of 1/19/18 – 1/20/20.
  2. Describe new requirements of informed consent outlined by the final rule.

Prerequisites: None

Speaker(s):

Russ Price, Federal Compliance Manager, Utah State University, Office Of Compliance Assistance

T104: There’s a Policy for That – or There Should Be? Issues with Standard Operating Procedures (SOPs)
Tuesday, April 4, 2017 - 9:15am to 10:30am

Content level: Basic

This session will present a case study in what can happen when Standard Operating Procedures (SOPs) are not followed.  Further presentation and discussion will address the advantages and disadvantages of SOPs.  We will also offer an alternative approach using best practices and discuss when one has an advantage over the other.  Audience participation is encouraged.

Learning objectives:

  1. Determine when SOPs are necessary and when they can get in the way.
  2. Understand the difference between SOP and best practices.

Prerequisites: None

Speaker(s):

Gayle Walters, MS, Associate Director, School of Medicine, Johns Hopkins University

T105: Public Access Policy: Accelerating the Delivery of Tomorrow's Advancements
Tuesday, April 4, 2017 - 9:15am to 10:30am

Content level: Basic

This workshop provides an overview of how grant-funded publications are managed to ensure an accurate and up-to-date list of publications (bibliography) that meets National Institutes of Health (NIH) requirements for grant applications, progress reports, and public access. It also provides and overview of setting up My National Center for Biotechnology Information (NCBI), My Bibliography, adding new publications, linking My NCBI account to an Electronic Research Administration (eRA) Commons account and grants. This will be a hands on workshop. Please bring your laptop or electronic device to connect directly with My NCBI.

Learning objectives:

  1. Understand what is My NCBI. Accessing, registering, creating, linking and managing publications.
  2. Understanding the four methods and what submission method to use.

Prerequisites: None

Speaker(s):

Timothy Schailey,  MS, Director, Research Administration, Thomas Jefferson University; Erin Bailey, Chief Financial Officer, CTSI and Erin O’Byrne, Research Administrator, University of Buffalo

T302: Collaborative Research and the Role of the Scientist in Society
Tuesday, April 4, 2017 - 1:45pm to 3:00pm

Content level: Intermediate

A variety of collaborative relationships in research amongst academia, industry, government and society result in different roles for the researcher. Whether viewed as a "discoverer of new knowledge”, an “independent authority”, or a “deliverer of tangible goods”, researchers often face conflicting agendas while striving to ensure scientific objectivity and ethical decision-making in their work. Research Administrators can become more effective and productive in their work and interactions with researchers by better understanding these differing roles and dynamics. This presentation will discuss some of these conflicting agendas, the different roles of researchers, how the practice of science is affected, and how the training of new researchers and staff members are impacted.  NOTE:  Use of an electronic audience response system will further engage participants and foster discussion of this interesting topic.

Learning objectives:

  1. Attendees will gain a better understanding of a variety of ethical issues encountered by researchers from collaborative relationships between academia, industry, government and society.
  2. Attendees will be better able to identify and respond to the tensions, challenges and expectations researchers face in different collaborative relationships in science.

Prerequisites: None

Speaker(s):

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

T305: Indirect Cost Rates – A Non-profit Perspective
Tuesday, April 4, 2017 - 1:45pm to 3:00pm

Content level: Basic

Almost every research institution must engage in the process of negotiating federal indirect rates. Non-profits face unique challenges in preparing, submitting and negotiating indirect rates. As we go through this process, many of us often wonder if we’ve done everything we can do within the constraints of federal regulations in order to maximize our institution’s negotiated indirect rate and resulting indirect cost recovery. In this session, we will discuss strategies that may be employed to maximize indirect cost recovery, both in the preparation of your indirect rate proposal as well as during the subsequent rate negotiation and budgeting of indirect costs on grants and contracts. Participants will be encouraged to share their experiences concerning the indirect rate process. We will also discuss the impact that the new Uniform Guidance will have on preparing and negotiating indirect rates and what participants are doing to prepare for these changes.

Certificate: IRAM-R, Category: IV. Financial Management and Compliance

Certificate: FM-R

Learning objectives:

  1. Identify what an indirect cost rate is, its importance and the various types of costs recovered through the indirect rate.
  2. Explore different types of rates and how they impact recovery and understand the process for preparing, submitting and negotiating the rate under the Uniform Guidance.

Prerequisites: None

Speaker(s):

Alex Weekes, CPA, PARTNER, ML WEEKES & COMPANY, PC

LC11: Hot Topics Related to Your Human Research Protections Program (HRPP) and the Institutional Review Board (IRB)
Tuesday, April 4, 2017 - 3:15pm to 4:30pm

Content level: Intermediate

A Human Research Protections Program (HRPP) , which includes the Institutional Review Board (IRB), is the mechanism by which an institution protects subjects participating in human research. There are many issues related to human subjects research  that a Research Administrator must be aware of to effectively and efficiently interact with departmental faculty in their role as a Principal Investigator or sub-investigator. This Learning Café will focus on Hot Topics related to IRBs  HRPPs and the role of the Research Administrators in IRB reliance agreements, compliance activities (routine and for-cause audits; investigator self assessments), AAHRPP accreditation, and IRB and HRPP processes (pre/post award).

 

Learning objectives:

  1. Attendees will be able to discuss a wide range of IRB issues (pre and post award) relevant to departmental faculty conducting human subjects research.
  2. Attendees will understand their department's role in the institution's HRPP.

Prerequisites: None

Speaker(s):

Julie Doherty, MSN, RN, CIP, Director, Regulatory Compliance, Office of Academic Affairs, Human Research Protections Office, University of Maryland Baltimore

T405: Thriving in Departmental Cultures: Strategies from the Trenches
Tuesday, April 4, 2017 - 3:15pm to 4:30pm

Content level: Basic

Although departmental work is fundamentally the same anywhere, anyone who has worked in multiple departments can tell you that each and every location can be very different - even within the same institution. From differences in internal policies, to training infrastructures, to unique tools and systems, the Research Administrator needs to embrace the culture of his or her individual department in order to help it thrive, but can also influence that culture and make it work with his or her own. This discussion session will encourage people to share their own tips and tricks for departmental work in addition to discussing various tools (databases, shadow systems, etc.) that the presenters have developed and used in multiple departments.

Certificate: IRAM-E

Learning objectives:

  1. Compare strategies for supporting research in departmental roles.
  2. Identify and analyze shortfalls in current practices, while discussing options and avenues for improvement; analyze various technological solutions to common problems and department-specific tools/systems used; share tips and tricks learned.

Prerequisites: None

Speaker(s):

Heidi Kendig, M Ed (Higher Ed Administration), Senior Financial Administrator, MIT and Kate Mollen,  Associate, Higher Education Consulting, Huron Consulting Group

Wednesday, April 5, 2017

W105: VA Research: Why You Should be in Business with Us
Wednesday, April 5, 2017 - 9:00am to 10:15am

Content level: Basic

Partnering with the VA research is a unique opportunity.  This session will outline the value the VA can provide to your research programs.

Learning objectives:

  1. How to work with the VA.
  2. The proven innovations from VA research.

Prerequisites: None

Speaker(s):

Edward Black, Executive Director, Denver Research Institute (DRI) and Rebecca Rosales, MBA, Executive Director, Northern California Institute for Research and Education, Inc.

W206: That National Institutes of Health (NIH) Grant is in Trouble: Houston We Have a Problem
Wednesday, April 5, 2017 - 10:30am to 11:45am

Content level: Intermediate

Can you identify the telltale signs of a grant with problems? What do you do when you see them? With examples from National Institutes of Health (NIH) grants, multiple case studies will be used to illustrate warning signs with research grants in trouble and to suggest solutions to correct (or at least mitigate) problems at early as possible.

Certificate: NIH-R, Category: II. Post-award

Learning objectives:

  1. Recognize indicators of problems with a research grant.
  2. Describe possible solutions to specific problems identified with research grants.

Prerequisites: None

Speaker(s):

Theresa Jarosik, Supervisory Grants Management Officer, National Institute of Mental Health (NIMH)