Section Meeting Template

The Spectrum Health Department of Research (SHOR) supports all of the research activity at Spectrum Health, a mid-size non-academic affiliated, not-for-profit health system that includes 14 hospitals in Western Michigan. In November 2018, SHOR launched a process improvement tool titled RiHub - Research Improvement Hub. The RiHub in SHOR was developed with two goals in mind: 1) To promote excellence in research administration by adopting cutting edge tools and smart, lean processes, and; 2) To enhance department culture by promoting team-based all-inclusive problem-solving. This presentation will tell the story of how we came to deciding to launch the RiHub, describe a few of our current projects, and summarize reactions six months in that may help you in your current academic role.

Content level: Intermediate

Learning objectives:

1. Understand how the Kaizen methodology of process improvement can be applied to administrative tasks.
2. Walk away with inspiration to consider using some of the methodology outlined in this initiative.

Prerequisites: None

Speaker(s): Shanta Layton, Director, Pediatric Research, Helen DeVos Children's Hospital/Spectrum Health

This session will share the experiences of first-time users of electronic protocol submission and review systems. We will share guidance and/or recommendations for walking through protocol review and approval using current polices and procedures.

Content level: Basic

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

Every university should have policies in place to manage all funds consistent with federal, state, and local laws, and with the specific terms and conditions of any gift, grant or contracts. This session will discuss the classification of external funding as a gift or sponsored award, including the relationship to Administrative Requirements Cost Principles and Audit Requirements for US Federal Awards. It will also help you answer the following questions: What internal controls exist for Foundations? Does our University have a gift policy? Who has the final word on gift vs sponsored funding?

Content level: Basic

Learning objectives:

1. Participants will critique real life case studies to demonstrate knowledge gained.
2. Participants will gain the ability differentiate between the terms gift and sponsored agreements.

Prerequisites: None

Speaker(s): Denise Clark, Associate Vice President for Research, University of Maryland; Ann Holmes, Assistant Dean, College of Behavioral and Social Sciences, University of Maryland

It is scientifically and ethically imperative for researchers to understand that 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.

Content level: Intermediate

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 A collection of great CSS tools and resources can be found at html-css-js.com: code beautifier, cheat sheet, style generators, useful links and more.

Colleges and universities receiving direct federal awards are typically required to have a federally negotiated facilities and administrative (“F&A”) cost rate in order to receive reimbursement for indirect costs. For most people, however, the process of preparing, submitting, and negotiating the F&A rate proposal under the Uniform Guidance can appear overly technical and painfully detailed. This session is intended for anyone who is new to the F&A process or would simply like to better understand the basic requirements, inputs and objectives that make up this calculation. The discussion will include a high-level perspective regarding how the regulations, financial and other data inputs, and submission and negotiation processes work together and will provide practical insight into the application of the F&A rate to the organization’s awards. Participants are encouraged to share their role in as well as their experience with the indirect rate process at their institution.

Learning objectives:

1. Identify what an F&A rate is, its importance and the various types of costs recovered through the F&A 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, Principal, ML Weekes & Company, PC