Research Ethics and Compliance

Time: 9:00am to 12:30pm

Content level: Basic

Research administrators (RAs) have a crucial role in the responsible conduct of research. RAs need to be able to recognize potential problems, consider the appropriate actions to take, then resolve the conflict according to institutional and sponsor policies. Using real-life examples, we will explore each area of potential conflict and discuss how to effectively address problems.

Learning objectives:

1. Identify potential ethical issues.
2. Evaluate possible resolutions for lapses in the responsible conduct of research.

Prerequisites: None

Speaker(s):

Jane Dumsha, PhD, Chief Research Operations Officer, Philadelphia College of Osteopathic Medicine

Time: 9:30am to 10:45am

Content level: Basic

The experiences of 1st time users of electronic protocol submission and review system and what we have learned. Guidance and/or recommendations for walking through protocol review and approval with our current policies and processes.

Learning objectives:

1. Experience best practice recommendations for using an electronic protocol review system.
2. Learn how institutions can adapt electronic review to current policies and procedures.

Prerequisites: None

Speaker(s):

Andrew Glenn, Compliance Specialist; Chanell Rome, eRA Business Analyst; Timothy Sparklin, MSW, Research Compliance Officer, University of Maryland, Baltimore County

Time: 11:00am to 12:15pm

Content level: Intermediate

It is scientifically and ethically imperative for researchers to understand it is a key commitment to report the results of clinical trials to research participants, so the advanced knowledge can be utilized collectively to make informed medical decisions. This session will discuss the most recent federal mandates, pertinent requirements of clinical trials disclosure and good practice. The presenters will share the approach that Rutgers, The State University of New Jersey, took to establish a robust, effective program for clinical trials registration and results reporting. Rutgers’ Human Subjects Protection Program (HSPP) has adopted a proactive plan to identify key issues and facilitate investigator to stay compliant within ClinicalTrials.gov records through the HSPP’s guidance, including a website and ongoing, customized trainings.

Learning objectives:

1. Describe why clinical trials disclosure matters and List resources and tools to assist investigators and organizations in maintaining compliance for clinical trials disclosure.
2. Identify key elements to establish a system in your organization to facilitate and monitor clinical trials registration and results reporting.

Prerequisites: None

Speaker(s):

Cheryl Forst, RN, BSN, CCRP, Director, Human Subjects Protection Senior Analysts Rutgers, The State University of New Jersey; Rebecca Niem-Tzu Chen, MS, MEd, CCRP, Human Subjects Protection Senior Analyst, Rutgers, The State University of New Jersey

Time: 11:00am to 12:15pm

Content level: Intermediate

The revised Common Rule, released by the U.S. Department of Health and Human Services (DHHS), is the first major change to that set of regulations in more than 25 years. Human research protection professionals will be subject to following the revised Common Rule provisions starting on its effective and compliance date, January 21, 2019. This session will review the major changes and highlight specific changes with examples of implementation approaches and considerations. This session will also provide an overview of considerations for working with both sets of regulations (pre-2018 and 2018) and transitioning studies.

Learning objectives:

1. List the major changes in the revised Common Rule and implementation examples.
2. Identify best practices when working within both sets of rules.

Prerequisites: None

Speaker(s):

Philip Cola, PhD, Associate Professor Design & Innovation Organizational Behavior Associate Director, Academic Affairs Doctor of Management Programs Weatherhead School of Management, Case Western Reserve University; Madeleine Williams, MA, Senior Consultant, Huron Consulting Group Browse Ruwix, the portal dedicated to puzzle programs and tutorials .

Time: 9:15am to 10:30am

Content level: Basic

We will discuss how our institution used its enterprise reporting system, Banner, to track compliance training. By using Banner, the Research Compliance team now documents student and faculty compliance training records, which facilitates reporting of this information across teams in an efficient manner.

Learning objectives:

1. Learn how Banner may help individuals with compliance tracking.
2. Streamline access to compliance information.

Prerequisites: None

Speaker(s):

Josh Hignight, Manager, Research Compliance; Domenica Pappas, CRA, Director, Office of Sponsored Research and Programs, Illinois Institute of Technology

Time: 10:45am to 12:00pm

Content level: Advanced

Research teams are passionate about all of their studies, yet research organizations are responsible for conducting only high-quality research and doing so with limited resources. This presentation will discuss the use of a review and selection process, known as Research Administrative Preauthorization (RAP), used at Aurora Health Care (AHC) to screen studies for merit, compliance, resource needs, and other variables important to a research organization. All research proposals at AHC must be vetted through RAP, thereby allowing the institution to maximize the amount and quality of research conducted by the institution, while also providing oversight by research leadership, guidance from research support teams, and feedback from other researchers. This presentation will provide an overview of the preauthorization process and its purpose, support required for effective administration, lessons learned, and system-wide implementation processes.

Learning objectives:

1. Determine whether research preauthorization would be useful to their organization.
2. Develop a research preauthorization process that is quick and effective.

Prerequisites: None

Speaker(s):

Nina Garlie, PhD, Director of Patient-Centered Research for Neuroscience and Emerging Areas, Aurora Health Care Content composed with the instant Online HTML editor . Please purchase a HTMLg license to remove the promotional messages from the edited documents.

Time: 3:15pm to 4:30pm

Content level: Intermediate

PHS policy allows for a subawardee or collaborator to rely upon the prime awardees Financial Conflict of Interest policy and oversight. As evidenced by the Federal Demonstration Partnership’s Risk Assessment Questionnaire, that comes with above average risk to the prime. Are you uncomfortable with increased risk for conflicts of interest associated with your subrecipients or research collaborators? This session will explore the considerations for accepting oversight compliance for subawardees, improved ways to monitor and mitigate those risks.

Learning objectives:

1. Recognize the responsibility and risks inherent in assuming responsibility for subawardees’ financial conflict of interest oversight.
2. Identify solutions for mitigating those risks.

Prerequisites: None

Speaker(s):

Susan Sedwick, PhD, CRA, Senior Consulting Associate, Attain LLC

Time: 9:15am to 10:30am

Content level: Intermediate

This session will lend guidance on how to define allowable, allocable and reasonable costs while adhering to sponsor guidelines, federal regulations and institutional policies. Participants should come ready to discuss, their decision metrics for making the case for allowability. The facilitator and participants will highlight and discuss their own unique situations they’ve encountered in determining allowableness of costs, and discuss the current audit environment and findings as it relates to Uniform Guidance Subpart E: Cost Principles.

Learning objectives:

1. Describe the four steps that govern direct cost.
2. Provide overview on how to allocate expenditures to sponsored projects appropriately.

Prerequisites: None

Speaker(s):

Tolise Dailey, CRA, Training Manager, Johns Hopkins University; Debra Murray, University of Maryland