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, February 28, 2016

WS9: Designing and Implementing Comprehensive Research Education and Training Programs
Sunday, February 28, 2016 - 1:30pm to 5:00pm

Content level: Intermediate

In this highly interactive half-day workshop, best practices for developing effective research administration education and training programs for faculty, professional staff members, postdoctoral scholars and students will be presented. Key topics and materials for inclusion in pre-award, post-award, clinical research and responsible conduct of research (RCR) curriculum will be described. The process of planning and structuring classes and presentations will be explained including guidance, tips and strategies for effective communication to a variety of adult learning styles. Information for integrating different content formats into effective online training modules and web resources will be illustrated. Discussion will include examples of "what works" and "what does not work" with demonstrations of successful assessment, certification and course tracking systems. Attendees will participate in small group and "hands-on" activities to further enhance the workshop learning experience and to provide practical subject matter and skill sets which can be directly implemented at their institutions.

Learning objectives:

  1. Better understand how to prepare effective training materials, content development, implementation strategies and instructional technologies for enhancing research education and training programs.
  2. Implement practical tips and techniques for managing, tracking, assessing and documenting RCR training and certification programs for a variety of research constituencies.

Prerequisites: None

Speaker(s):

Tony Onofrietti, CRSS, Director, Research Education, The University of Utah

Monday, February 29, 2016

M105: Ethics and Compliance in Research: Aren't They the Same Thing?
Monday, February 29, 2016 - 9:30am to 10:45am

Content level: Basic

Decision making in research is often based solely on federal regulations that primarily focus on the institution, the compliance committees and the research team. However, the ethics of research is far broader and is impacted by everyone who is involved in assuring the varied fields of compliance. This presentation addresses a model for ethical decision making; how individuals responsible for budgets and awards, recruitment and informed consent, to working in an adjacent office or laboratory can impact the ethical conduct of research activities. Learning topics will address a model for making ethical decisions, why it takes a village and not an individual to conduct ethical research, rights of whistleblowers and why research is no longer institutional but international.

Learning objectives:

  1. Have a model for making ethical decisions. 
  2. Better understand how unethical research impacts far more than the Principal Investigator (PI) or the institution.

Prerequisites: None

Speaker(s):

Norma Epley, MS, CIP Director, Research Integrity & Compliance, East Carolina University

M106: Case Studies in Research Ethics: A Historical Perspective
Monday, February 29, 2016 - 9:30am to 10:45am

Content level: Intermediate

The proper conduct and reporting of research is of paramount importance to our institutions. Noncompliance can result in severe penalties to the organization, the individual(s) and their reputations. The modern definition of research misconduct however, in the context of responsible conduct of research training, reflects an evolution of hundreds of years of social and ethical issues that have arisen in the practice of scientific research. What may have been acceptable practice a century ago may be considered unacceptable practice by today’s standards. An examination of the global history of biology, chemistry, physics and medicine provides some insightful examples of both responsibly and irresponsibly conducted research by many famous scientists. 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.

Learning objectives:

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

Prerequisites: None

Speaker(s):

Tony Onofrietti, CRSS, Director, Research Education, The University of Utah

M205: Keeping Up With Clinical Trials.gov: A Systematic Approach in Maintaining Compliance
Monday, February 29, 2016 - 11:00am to 12:15pm

Content level: Intermediate

Are your clinical trials falling behind in reporting results at ClinicalTrials.gov? If so, there are ways to train and educate your research staff on maintaining compliance. A summary of the trial should be readily available and the results should be accessible to all in a timely manner. Understanding the efficacy of medical intervention represents ethically what the Belmont Report and Declaration of Helsinki speaks to in regards to keeping the results publicly available. Analysis of the data supports the basic principles of evidence based practice and is the foundation of guiding the public in making rationale decisions about their care. This session will review the rational of study registration and data reporting, and recommend steps on how to evaluate where your investigators stand with keeping up with their results reporting and how to resolve the issues. The new updates and information from the recent National Institutes of Health (NIH) ClinicalTrials.gov Train-the-Trainer Workshop will be shared in this presentation, including the latest tools and checklist to enhance your result reporting.

Learning objectives:

  1. Understand why registration of study and reporting results of a clinical study matter. 
  2. Learn how to summarize and formulate a report for clinical trials by utilizing the latest checklists provided by NIH.

 

Prerequisites: None

Speaker(s):

Cheryl Forst, RN, BSN, CCRP, Director and Niem-Tzu "Rebecca" Chen, Human Subjects Protection Analyst, Rutgers, The State University of New Jersey 

M305: To Institutional Review Board (IRB) or Not to Institutional Review Board (IRB): That is the Question
Monday, February 29, 2016 - 2:15pm to 3:30pm

Content level: Basic

This session will provide research administrators with an overview of the following: when does an institution need an IRB and what regulations apply, what needs to be submitted to the IRB and what regulations and policies apply and overview of the criteria for review of human subjects research.

Learning objectives:

  1. Identify which research related activities should be submitted to the IRB. 
  2. Identify human subjects research.

 

Prerequisites: None

Speaker(s):

Donna Hoagland, CIP, CCRC, CHRC, Director, Institutional Review Board and Paula Bistak, DMH, CIP, CHRC, Rutgers, The State University of New Jersey

M405: Trends in Research Integrity Investigations
Monday, February 29, 2016 - 3:45pm to 5:00pm

Content level: Basic

The National Science Foundation (NSF) Office of Inspector General (OIG) is responsible for conducting investigations into allegations of research misconduct and fraud associated with NSF proposals and awards. This talk will outline the basic missions of the OIG and present the details of recent cases our office has investigated. Case studies will include violations of research misconduct regulations, violations of human subject's regulations, peer review violations and fraud. We will also provide an update on our review of university responsible conduct of research (RCR) programs.

Learning objectives:

  1. Understand the mission of the Inspector General. 
  2. Understand trends OIG is seeing in violations of rules, regulations and law.

 

Prerequisites: None

Speaker(s):

Aliza Sacknovitz, PhD, Investigative Scientist,Office of Inspector General, National Science Foundation

Tuesday, March 1, 2016

T105: Detecting Compliance and Ethics Issues in a Complex Research Environment
Tuesday, March 1, 2016 - 9:00am to 10:15am

Content level: Basic

Ensuring compliance and ethics in the current research climate is becoming increasingly complex as we enter into global collaborations, as the rules continue to change and as around the clock media brings constant attention to research ethics. How do we detect compliance and ethics issues in daily communications with principal investigators (PIs), administrators and collaborators? This is the focus of this workshop. The session aims to introduce 2-3 short case studies through which the audience (in small groups or as a whole - depending on size) can learn to detect the different types of compliance and ethics issues that may arise in a single case.

Learning objectives:

  1. Detect various compliance and ethics issues in specific scenarios. 
  2. Analyze individual cases such that they are able to recognize the inter-dependencies among different compliance and ethics areas.

Prerequisites: None

Speaker(s):

Farida Lada, MBA, University Director for Research Compliance, The City University of New York

T205: Landmark Research Integrity Cases
Tuesday, March 1, 2016 - 10:30am to 11:45am

Content level: Basic

This session will review some of the landmark misconduct cases and how they have shaped the response to research misconduct allegations. This will include a review of the court cases, the significant cases prosecuted by the Office of Research Integrity (ORI) and the cases in which criminal charges were involved. The sessions will also include a summary of the sanctions imposed by the institutions and the government agencies on the respondents in these cases. 

Learning objectives:

  1. Analyze the consequences of misconduct findings for both individual respondents and institutions. 
  2. Evaluate the ways in which landmark misconduct cases have influenced the government's response to subsequent cases.

 

Prerequisites: None

Speaker(s):

Bridget Noonan, JD, Associate, Parrish Law Offices

T305: The Intersection of Grants Management and Compliance
Tuesday, March 1, 2016 - 1:45pm to 3:00pm

Content level: Intermediate

Why do grants managers need to understand compliance policies and procedures? Why do compliance personnel need to understand grant submission and award acceptance policies and procedures? Often, the research compliance committees and the Sponsored Program Office work in silos and neither may truly appreciate the processes, deadlines and responsibilities of the other. In order to ensure timely communication with sponsors, compliant grant applications and progress reports and audit-ready grants management records, it is best when all sides are in sync and can ensure grant congruency.

Learning objectives:

  1. Explore best practices for maintaining quality assurance in grants management with regard to research subjects protections and compliance information. 
  2. Share strategies for communicating more effectively with colleagues in order to achieve grant congruency and accurate records for all appropriate offices.

 

Prerequisites: None

Speaker(s):

Debra Schaller-Demers, MSOM, Director, Research Outreach and Compliance and Erik Schneebeck, JD, Institutional Compliance Manager, Conflicts of Interest, Memorial Sloan Kettering Cancer Center

 

T405: Rethinking Research Compliance: Helping Researchers through Program and Process Improvement
Tuesday, March 1, 2016 - 3:15pm to 4:30pm

Content level: Intermediate

Have your resources been decreasing while demands are increasing? Are existing resources being used in the best way possible? Learn how to evaluate, rethink and re-engineer research compliance programs and in doing so, provide data to executives to justify increasing resources.

Being research-friendly, researcher-friendly and compliant as an institution are not mutually exclusive goals. Taken together they can serve as the starting point of a conversation and develop into a plan toward improvement. This session will share lessons learned from multiple universities toward re-developing our research compliance programs, through the use of a case study. Our ongoing goal is to facilitate compliance through education and client support, particularly in reducing burden to staff and researchers whenever possible.

Learning objectives:

  1. Learn how to develop tools that enable you to identify needs, assess risks and create a plan toward program improvement.
  2. Willingness to read and discuss the application of federal regulations.

Prerequisites: None

Speaker(s):

Bernardica Sculac Stern, Sponsored Projects and Research Manager, The New School

 

Wednesday, March 2, 2016

W105: Research Education – Balancing Knowledge and Compliance
Wednesday, March 2, 2016 - 9:00am to 10:15am

Content level: Basic

Research Administration can be a dizzying world of compliance, ethics and best practices. There are rules our research staffs must follow, rules that should be followed and a host of others that probably fall somewhere in between. Navigating the world of grants management can get confusing for first time investigators, as well as for some seasoned individuals dealing with the ever-changing political and funding landscape. A central Research Education Office helps manage the training needs of a research staff – from investigator to lab staff to office coordinators and grants administrators. Working within a central research administration office, this team of education professionals can help determine what training needs to be offered, help with staff development and keep an academic research community on top of the latest developments in research administration. We will offer examples of classes to offer, practical tips on developing the courses that matter to the research community and advice to help you begin to develop a comprehensive research education program at your campus.

Learning objectives:

  1. Be able to identify the educational needs of their institution. 
  2. Better understand how to implement a centralized research education program.

 

Prerequisites: None

Speaker(s):

Christy Taylor Bray, CRA, Assistant Director of Research Training and Development, Medical Branch, University of Texas

 

W205: Responsible Animal Research: Creating a Culture of Care, Integrity and Responsibility
Wednesday, March 2, 2016 - 10:30am to 11:45am

Content level: Intermediate

Institutions must provide adequate support for the proper care and use of animals in research. For this to occur, it is important that leadership understand the causes and potential risks for noncompliance and the resources and steps that may be needed to prevent their occurrence. Central to this session will be a discussion of what an integrated academic medical center has put in place to address the current challenges in conducting animal research including: effective tools and techniques for training and outreach, challenges and complexities unique to animal research involving non-US trained scientists, the impact of special interest animal groups, the value of working with public relations and media to help educate and inform leadership and the community and the visible role of the Institutional Official as a part of coordinated animal research team.  Presenters will provide tools, processes and techniques that participants can take back to their institutions.  

Learning objectives:

  1. Understand the roles, responsibilities and infrastructure required when engaging in animal research. 
  2. Manage and assess problems and issues related to animal research when they arise.

 

Prerequisites: None

Speaker(s):

Paula Means, MPA, Assistant Dean for Research and Colleen Bennett, Manager, Animal Education and Outreach, Wake Forest University