Concurrent Sessions

Clinical trials must comply with the Good Clinical Practice guidelines (GCP). Unfortunately, the GCP is not well defined. This session will review the Department of Health and Human Services, Food and Drug Administration, and major international regulations and guidelines that govern clinical research. Participants will learn how the actions of regulatory agencies affect budget development, contract negotiations and the way studies are conducted. Topics will include the ethical origins of the GCP, historic milestones and their regulatory significance, and discussion of best practices to enhance regulatory compliance.

Senior leaders at academic institutions use a variety of internal and external factors and research metrics to develop priorities, manage resources, and evaluate success. Even though these indicators may not be directly attributed to the work of research administrators, the financial resources available to support research administration are directly impacted by these measures. Understanding this research landscape is important for leaders in research administration when driving initiatives and garnering financial support. This interactive session will dive into the key factors and metrics that impact research administration resources.

As research continues to reach across oceans and borders, international collaboration can often resemble a game of Chutes and Ladders. You think you have made significant progress, but as soon as you start to move forward...you end up sliding back. What makes international research uniquely prone to pitfalls and how can you ensure efficient and timely administration? This session will address how a specific case study launched the UVA International Collaboration Workgroup and led colleagues to develop and share best practices for faculty and staff engaging in international research. We will discuss common difficulties in international collaboration, how administrators can identify areas of concern and how to implement specific processes to reduce complications for everyone involved in an international research project. Attendees will leave this session with action items on how to independently assess the efficiency of their current processes, introduce best practice and ultimately improve international administration processes within their institution. 

A career takes its direction from the events that precede the next step. Society of Research Administrators International (SRAI) not only provides education for your current position but is able to assist you with advancement in the field of Research Administration. This session will provide examples from each long-time SRAI panel member on how volunteering for SRAI impacted her career growth and life. The panel, that includes a representative from each U.S. section, will describe the path she took, the various volunteer opportunities for members, and how these enhanced her career, while entertaining questions and discussion from the audience.

Many factors determine financial and logistical feasibility of clinical research studies for your site. This session provides an overview of standard operating process and tools necessary to make this determination, developed from study examples and case studies. Tips on reviewing initial documents such as the site feasibility questionnaires, proposed contract, sponsor budget, protocol with schedule of events and informed consent in the development of accurate internal cost projections and budgets will be reviewed.

This session will compare and describe the general organization of universities with Veterans Affairs (VA) Medical Centers, discuss various differences the structure provides, present what is needed for the VA in order to make working with the VA smoother. This will be an interactive presentation.

This session will provide a comprehensive review of the key issues faced by academic institutions when negotiating clinical trial agreements with pharmaceutical and biotech companies, with specific in-depth focus on the following provisions: publication rights, ownership of intellectual property, confidentiality, indemnification and study subject injury.

As the work of the research administrator has become more global, so has the challenges facing them in the realm of international collaborations. In particular, working with entities in developing nations can present unusual situations that stretch one's problem solving skills in new and creative directions. This session will present real-life situations and problems that were presented to research administrators, coupled with a discussion of practical solutions.

This session provides an opportunity to learn what is new and what is being developed within the National Institute of Health’s (NIH) programs, policies, and budgets. In this comprehensive review, participants will learn about the newest policy updates and how their respective institutions may be impacted. Participants will also have the opportunity to ask questions about new and existing policies and procedures. Topics include recent and upcoming changes to NIH policy, compliance requirements, and much more.

This session will cover new developments related to proposal and award policy at NSF. NSF staff will provide a comprehensive review of NSF’s response to the COVID-19 pandemic, recent policy changes and updates to NSF’s proposal system modernization efforts.

UCSF has rolled out a Principal Investigator (PI)-oriented tool, Award Verification, to replace the effort reporting system. This new tool meets the requirements of the Uniform Guidance for after-the-fact payroll verification. It provides for a one-stop portal for the PI to verify not only payroll charges but all financial charges on not only just federal awards but all of extramural funding (grants, contracts and gifts). It leverages the University's existing financial management tools related to general ledger reconciliation to reduce the administrative burden not only for the PI but for their entire team. The session will help Research Administrators learn about ways to leverage their existing financial tools to reduce administrative burden while still fully complying with the federal regulations.

W. Earl Sasser, Jr, and Frank S. Leonard, in a Harvard Business Review article (March 1980), stated that “Being a first-level supervisor is one of the most difficult, demanding, and challenging jobs in any organization.” You were once among the employees you are now trying to supervise. This session will look at the increased pressure for administrative and clerical efficiency and the two most problematic areas for first-time supervisors: human relations and technical knowledge.

21st century leaders increasingly rely on diverse, multidisciplinary teams to help drive their organization’s success. It is therefore the leader’s role to create an inclusive work environment where all employees feel included, valued, and are treated fairly and respectfully. Studies show that the degree to which an employee is engaged in their job and feels included at work largely depends on their immediate supervisor’s actions and attitudes. This session will provide an overview of inclusive leadership, its enabling traits and competencies and its importance for leading teams. Tools will be discussed that a leader can use to evaluate and strengthen their inclusive leadership competencies and to promote an inclusive work climate. The presenters, from two research-intensive institutions, in the U.S. and Canada, will highlight inclusive leadership practices they have applied in their institutions and some lessons learned. An interactive discussion period will engage participants in applying some of these tools and in sharing experiences from inclusive leadership activities in their own institutions.

Effective engagement with research faculty can be an art form and requires consideration of multiple variables. Three experienced research administrators will discuss lessons learned for engaging faculty from the university and college administration perspectives, including different event formats, topics and participant backgrounds. The presenters will discuss case studies comparing metrics from an evolving series of research-focused events at our institution. Attendees will gain insight into trends of what has (and hasn’t) worked well in engaging faculty from multiple perspectives.

Participants in this session will learn best practices for internal controls and guidance as organizations have transitioned to working remotely during the pandemic. With changes in UG and our workspaces, there has been an increased focus on internal controls, award performance, and CARES Act funds treatment. This session will discuss how to deal with the additional pressure institutions and organizations have been placed under to manage their sponsored awards appropriately.

This session will assist prospective and current research administrators with getting more ideas and effective methods to gather the information based on the proposal guideline with the appropriate timeline for proposal stage / Pre-award stage. This includes explaining the budget generating based on different agency requirements.

This Service Center session will cover examples of several service center administrative and compliance programs. The session will begin with the importance of creating such a program and associated compliance related issues. The key components of a program will then be identified. General discussions will be based upon the topics of Service Center policies and procedures. Roles and responsibilities will be covered for all related parties. Ownership of the program and decision making authority will be discussed in an effort to cover all key components of a Service Center administrative and compliance program.

Research administrators are a resilient group and many of us have endured natural disasters, a global pandemic, staff resignations and retirements, and other major disruptions that impact our business operations. How can we be better prepared? Join us for this case study discussion comparing a major state university extension program and central services of a mid-sized research university as they’ve developed business continuity and succession plans to help guide decision making, continuity of service, and staffing.

A hospital took over clinical research from a university's medical school. This required building a Sponsored Projects Office from the ground up at an institution that had previously not managed grants. The session will highlight the challenges of building a Sponsored Projects Office at a hospital in a rural environment. The challenges of recruiting at team when there are few applicants, utilizing existing hospital technology that was not intended to manage grants, and building an office while the research portfolio is doubling. Solutions such as: organization structure, staff development, as well as outsourcing will presented in the context of building a new Sponsored Projects Office.

This session will explore the issues raised by an international collaboration between a US institution, a foreign university, and multiple for-profit entities that wanted to commercialize IP arising from the collaboration. The “Bayhl-Dole” Act, covering rights in intellectual property developed with US government support, requires very specific provisions in the licenses and other documents related to commercialization of the IP developed under the grant or other agreement. Additionally, there are limitations on the scope of any license granted related to the place of production and to the organizations that can be involved. This session will delineate just what each university and each company must do to reach agreements that comply with US and other laws.

The declaration of a Public Health Emergency (PHE) in 2020 has led to a new and unique regulatory environment. Federal and state waivers of long-standing regulatory requirements and processes has created more flexibility in health care delivery and research to encourage innovation, information-sharing, and solutions to the pandemic. This presentation will focus on the relaxation of regulatory requirements in the research space and whether the reliance on Emergency Use Authorizations (EUA) and shortened processes will result in less oversight and more streamlined processes by the FDA when the PHE is over. We will provide a high-level overview of pre-COVID processes and contrast those with how therapeutics and vaccines have more quickly been provided to the public, primarily through the EUA process. We will explore the risks and benefits of “normal” vs. “EUA” approvals and opine on whether the FDA policies and processes should shift based on the experience in the PHE de-regulated world. We will also discuss enforcement, if any, in the de-regulated environment and give applicable compliance advice based on enforcement and guidance by the FDA.

Many hospitals must engage in the process of negotiating federal indirect rates, and they face unique challenges in preparing, submitting and negotiating indirect rates under the 45 CFR Part 74, Appendix E, “Principles for Determining Costs Applicable to Research and Development under Grants and Contracts with Hospitals.” As we go through this process, many of us often wonder if we have 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.

The oversight provided by IRBs focuses on compliance with research regulations, but those regulations only dictate process. At the center of ethical review is how members of an IRB answer the questions the regulations ask: does the potential benefit justify the risk of the research? Is it inequitable? Is consent really informed and freely given? IRBs answer these questions one protocol at-a-time, and the system does not formally capture the thinking of the IRB in a way that contributes to shared ethical standards or promotes broader development of scientific and ethical consensus. We propose a new model, the Learning IRB, to address some of these shortcomings, and describe a case study at the University of Southern Maine that tested this new model IRB focused on pandemic research. We will do a deep dive into the ethical principles driving this model and how it could potentially benefit other research institutions. Finally we will address the unique challenges of pilot testing this new model during a pandemic.

Little is known about the process of tracking the activity and days-to-productivity of new research faculty in academic medical centers in the United States. The purpose of this study was to design a quantitative technique for measuring the startup journey and academic productivity of new research faculty at an established research academic medical center. Three measures, (1) engagement, (2) efficiency, and (3) publication, were used to identify the total number of days that it takes for a new research faculty member to move from the discovery phase (value-consumed) into the engagement phase (value-created) after accepting a new position. This session will outline best practices for tracking, reporting and comparing the startup journey and academic productivity of new research faculty in pediatric academic medical centers.

The session will discuss a range of communication methods available (within an office) and the benefits and drawbacks that come with them. It will delve into group dynamics - the social processes that emerge in groups - servant leadership and the vulnerability of trust. 
This presentation will describe a dozen reasons why you should consider shouldering the responsibility for an office newsletter, and provide you with strategies to get it off the ground. It will also touch on why teams not always work and why some newsletters have a surprisingly short lifespan. 
 

Healthcare providers have obligations for health-related data management under state and federal health data privacy law, and often under contract with research sponsors or partners. HIPAA, HITECH, and CMIA mandate that entities establish procedures to ensure confidentiality of health data, and information security measures against unauthorized use and disclosure. This session will review basic components of a Data Management Plan (DMP) for a clinical trial or other research project, and consider the following: What does the FDA recommend be included in a DMP? What data management tasks are commonly included in a clinical trial agreement (CTA)? What are Good Clinical Practice (GCP) guidelines for recording and reporting trials, and the basic reporting requirements for ClinicalTrials.gov? What are fundamental intellectual property and publication considerations for research data management? When might the General Data Protection Regulation (GDPR) be a consideration, and what are its basic recordkeeping tasks for a research office? What is "digital data" for purpose of a clinical trial, and what does FDA Form-4070 require for the federally funded collection of digital data? What preventative measures should healthcare entities consider to protect data systems from ransomware attacks, and their institution from civil claims or enforcement actions?

Budget regulations for Federal grants can be difficult to navigate if new to the profession of Research Administration. The overall goal of this presentation is to introduce the main budget categories allowed for a Federal grant application and how to calculate a budget as it pertains to Modified Total Direct Costs.

This session will provide an overview of foreign influence regulatory requirements while exploring how institutional eRA systems can be leveraged to create compliance and efficient reporting workflows.

The applicability of the NIH guidelines to research activities involving animals creates an overlap between the IBC and the IACUC. This session will help provide strategies to minimize redundancies, implement systems and processes to ensure compliance with the NIH Guidelines and minimize administrative burden on Investigators.

Since the passage of the 1980 Bayh-Dole Act, universities have seen significant growth in the number of technologies commercialized and the number of patents issued from intellectual property created out of sponsored research. Research administrators can find themselves negotiating intellectual property terms in new awards or asked to process a non-disclosure agreement or proprietary information agreement. These administrators may not know who to turn to or what to do if a proposal or project has the potential for commercialization. Similarly, researchers may engage with a technology transfer office without simultaneously engaging with sponsored programs, leading to confusion or agreements in conflict with one another. In this session, a sponsored programs specialist and a technology transfer specialist will discuss the overlap between sponsored research and technology transfer and provide guidance for when and how to connect across the research enterprise to best help the researcher.

During this session, we will discuss current enforcement action in research and how to translate this into practical and actionable compliance steps at your institution. Topics that will be covered include foreign influence in research, COVID research activity, anti-kickback activity and late breaking enforcement action in research. We will conduct an overview of these topics individually and then provide compliance tips aimed at mitigating risk in each area. Foreign influence in research has been a particularly hot topic for the past several years, but many institutions continue to struggle with how to properly manage and disclose these relationships. We will provide an overview of key cases, outcomes and the current posture of the government, as this may evolve under a new administration, and practical tips and guidance as to how to communicate, collect and manage relevant disclosures of research relationships with foreign partners. COVID research will likely result in government scrutiny and enforcement due to the massive influx of funding, principal investigators and institutions that may be new to research with minimal research infrastructure, and other consequences of a rapid on-boarding of critical research activity during a pandemic. Analysis of actual or anticipated enforcement activities as well as practical tips to get ahead of research compliance issues in COVID research will be provided such as proactive monitoring, audit activity and communication with sites to ensure corrective action takes place in advance of any government action. Finally, we will cover any other late-breaking and emerging enforcement trends to ensure the session is up to date, informative and practical in its compliance take-aways that can be implemented at any management level of an institution engaging in research. These issues are critical to the proper administration of a research program at any institution, and this program will increase awareness of these issues in various areas of research administration, empowering them to identify and mitigate risk to their institution.

We will explain the National Science Foundation (NSF), National Institute of Health (NIH), and National Aeronautics and Space Administration (NASA) requirements incorporated into the terms of research grants. We will reflect on the intersectionality between the NSF, NIH, and NASA grantee requirements with Title IX of the Education Amendments of 1972 (Title IX) and federal antidiscrimination laws, including Title VI and Title VII of the Civil Rights Act of 1964. Nationwide, the science, technology, engineering, and math (STEM) sector is grappling with a sea change to stop discrimination and harassment. This session will provide an update on the latest studies and stories about diversity, discrimination and harassment in the U.S. STEM workforce. Touchstones in our presentation will include confirmation of the key differences in the policies and open discussion on their implementation. We will discuss how requirements in research grants related to discrimination can be incorporated in different ways into your compliance training, in order to consider specific scenarios relevant to your researchers. We will share examples of case-based training scenarios offerings, such as the top ten scenarios in which researchers might face administrative action. We will reflect on the differences between University action versus action by federal agency, and the challenge in rendering a decision as to whether the matter stem from “concerns about safety and/or work environments (e.g., due to concerns about harassment, bullying, retaliation, or hostile working conditions).”

Periodically universities need to take a critical look at their seed grant program to make the recipients more accountable and to determine the return on investment on the internal investment. This session will highlight steps that can be taken to determine what is and isn't working with the program; the rebranding steps to rollout the program; and the future steps to record metrics and determine the return on investment.

We will discuss current Financial Reporting Standards for Asset Management and Financial Reporting purposes. College/Universities and Medical Centers are facing many challenges with their Pre and Post COVID 19 asset management and financial reporting requirements. We will have an interactive dialog to review and discuss these matters for a go forward basis.

This session will provide an overview of the fundamental concepts of subrecipient monitoring compliance. What do the regulations require and how do you prepare for an audit? We will explore subrecipient monitoring roles and responsibilities across the institution, key processes to have in place during the life of the subaward, and how to identify appropriate subrecipient monitoring actions. We will also explore the responsibilities of the pass through entity (prime recipient) to ensure the subrecipient complies with the terms and conditions of the award.

The various offices and people that are involved with research at an institution have different roles and responsibilities. This session will use Responsible, Accountable, Consulted, Informed (RACI) method to demonstrate how to define roles and responsibilities between; central administration and departments, grants offices and clinical trials offices, research and the other missions of the institution.

This session will help participants fully understand clinical research from the industry perspective. The major components of the pharmaceutical industry are traditional pharmaceutical companies, stand-alone biotechnology companies, and biopharmaceutical companies that represent a melding of traditional and biotechnology approaches to discovery. In addition, there are medical device companies that, again, are either stand-alone entities or into larger pharmaceutical companies. The session will cover the industries issues with timelines, quality and cost. The presenter will provide an overview of the clinical trial protocol development process and clinical study conduct. Pharmaceutical drivers for study site selection will be highlighted. Site-based contracts, including budgets, publication rights, intellectual property, and subcontracting issues will also be discussed. 

Researchers increasingly are expected to demonstrate the social relevance and impact of their research, and many universities have put services in place, such as community partnership development or science communications, to support this engagement. These activities, commonly referred to as knowledge mobilization (KMb), have been impacted by the COVID pandemic, as areas of research became more focussed on the pandemic and the means of communications shifted to virtual formats. This session is an international case study from two research-intensive universities, in the U.S. and Canada, which describes the support services provided by their institutions; how they were impacted during COVID; lessons learned; and how they plan to carry forward these experiences post-pandemic for strengthened community engagement. An interactive discussion period will engage participants on the implications of these examples for their organizations and will stimulate dialogue on their own organizational lessons that can help shape the post-pandemic future for researcher interactions with broader stakeholder communities.

Confidentiality Agreements are often the first step in establishing a relationship with a pharmaceutical or biotech company for a research project. The company wants to ensure that any confidential or proprietary information that it discloses to an academic institution is kept confidential. It is critical that academic institutions understand the intent of the confidentiality agreement and negotiate terms that are clear, not overly broad and reasonable. This session will introduce basic information about negotiating confidentiality agreements, including what terms are appropriate and why, as well as instruction on how to effectively negotiate revisions in an efficient and professional manner.

Everyone is talking but is anyone listening? This may be a question research administrators may ask themselves from time to time and in the heat of the moment. That is because research, and by extension research administration, is a team sport, with many moving parts, adapting and changing given the context and circumstance. A successful research enterprise depends on the "team" working together. Principal investigators (PIs), researchers, research administrators, staff and even students are therefore crucial to the success of the research enterprise. Developing and sustaining good, positive, working relationships between PIs, research administrators, and anyone in the grant cycle is imperative and can make a world of difference in running a high functioning research office, department, school, or institution. But how do you foster and build these relationships? What are some strategies for effective communication and team building? How can you work together to build productive and positive environments? This session will discuss some strategies to use in your practice.

Protecting intellectual property rights (IP) is a critical component to the success of a research enterprise. In order for a sponsored projects or technology transfer office to protect the institution's IP, research administrators should understand how key intellectual property rights work. In this session, we will examine: 1) how patent, copyright, and trade secret ownership works in the United States if there is no agreement in place to allocate these rights, and 2) ways parties can use contracts to determine intellectual property ownership. Does the party that developed the IP own it? What happens if the other party is paying? What if IP developed by one party is an improvement to IP owned by the other party? What if the parties develop IP jointly during the course of the research? We will answer these questions and provide the basic framework for negotiating IP rights in sponsored research.

Many grant agencies now require a short preliminary paper before a full proposal can be submitted, especially for large, complex or collaborative projects. These documents serve multiple purposes in funding agencies, including agency decisions about whether a full proposal can be developed and submitted, but often without specific instructions on how to prepare them. The speaker will offer effective strategies to increase chances of funding success with well-developed short papers that meet agency needs. Grant agencies also have begun to require logic models or quad charts as graphic additions to proposal narratives. This session will provide definitions of these types of papers, their multiple purposes, and which funding agencies require them. Agency-specific formats will be illustrated and a template will be provided for use with agencies that do not offer specific instructions. This session will be useful for research administrators working with a variety of U.S. federal funding agencies and faculty disciplines.

This session will review opportunities to align conflict of interest (COI) and conflict of commitment (COC) disclosure, review, and management processes, paying particular attention to recent federal guidelines around disclosure of COC and foreign entity involvement. The session will also review how systems can be used by research administration stakeholders to mitigate foreign influence risk.

This session will provide an overview of key research information security compliance areas and best practices for organizations to address these requirements and have a cross-institutional dialogue. Facilitators have deep experience in both research administration/compliance and information security and will describe the current threat landscape and trajectory of regulations and compliance concerns (think cyber incidents, foreign influence, and remote work considerations!) for 'non-technies.' This session will also provide tangible, helpful strategies for how to initiate self-assessments and have a cross-functional dialogue within organizations to encourage a culture of compliance and security.

Public trust and credibility are essential to a university’s ability to address fundamental scientific questions and pressing societal challenges. Likewise, researcher trust in the project review process is essential to a university’s ability to maximize the scientific potential of its students, faculty, and staff. Over the past two years, the division of Scholarly Integrity and Research Compliance (SIRC) has improved its relationship with the research community by enhancing review processes and emphasizing thoughtful RCR education. SIRC’s approach to organizational change can serve as a model for creating a culture of responsible and objective research.

Research Administration is about relationships and soft skills just as much as it is about knowing the right policy or procedure. Being able to listen, find a yes in the no, and connect with who you are speaking with are valuable skills in any office. In this session we will talk about the lessons to be learned from improv and how improv can reduce stress. We will also play a few improv games.

It is easy to become lost and burdened with regulations which were originally designed to protect us from repeating research abuses of the past. We can easily forget that history and why the system of research protections in place today exists in the form that it does. In this session we will take a tour through the history of research, the foundations of the Belmont Report, and explore the ethical underpinning of our research ethics review systems. We will also explore contemporary research ethics issues. For those new to research, a good history lesson goes a long way to a greater understanding of why the research oversight process exists and how it came to be structured the way it is.

This session will provide an overview of federal guidelines for protection of Controlled Unclassified Information (CUI). It will specifically focus on the evolution of the Department of Defense guidelines, from inception through the present day and discuss compliance issues about how institutions of higher education can achieve the level of Cybersecurity Maturity Model Certification (CMMC) required for work on research projects containing CUI.

This session will provide an overview on how an institution can prepare for am upcoming base year. Key data sets required for the proposal will be discussed in detail and items that can be reviewed prior to the base year to maximize research recovery. Space survey preparation will also be discussed and a case study on how Mississippi State University successfully conducted a space survey remotely.

A major factor in preparing successful grant applications is understanding how the agency review process works and tailoring the application to ensure a positive review. Research administrators can play a crucial role in proposal success by understanding similarities and differences in the review process at major U.S. federal and non-federal grant agencies. This session will present information about the review process at NSF, NIH, DOD including DARPA and ONR, DOE, Education, NASA NEH, and the Robert Wood Johnson and Susan G. Komen foundations. Participants will learn the stages of the review process, scoring and rating systems, how reviewers are selected, what reviewers look for in successful proposals, the benefits of becoming a reviewer, and why it is important for research administrators to understand and communicate the diverse agency review systems.

A research unit presents a unique set of challenges by the nature of being self-reliant on funding. As a department research administrator, one must be prepared to be a “jack of all trades”. While each research unit has its unique set of challenges and requirements, one thing is constant – the need for prioritization to maximize your ability to work with researchers to fulfill their requirements. This presentation will talk about the pre- and post- award responsibilities of a unit. We will also look at projecting research expenditures, how to manage funding lapses for researchers, basics of Human Resources for research managers, immigration and intellectual property issues. The great thing about being a department administrator is no two days are the same!

This session will use Breakout Group discussions (6-8 members) regarding 3 specific areas (particularly impacted by COVID-19 in 2020): operational conduct of clinical research and specific IT innovations implemented to support remote/hybrid trial models; CTMS implementation status and areas of value, challenges and ROI on this journey; and participant enrollment best practices with particular effort toward increasing enrollment of underrepresented participants and adaptation to COVID-related challenges. The Breakout Groups will talk amongst themselves for 15-20 minutes, then "report out" to the audience the main lessons learned and best practices the Breakout Group believes should be shared to the broad audience as "take home" considerations or key Best Practices. The goal is to interact and discuss with colleagues what worked well and what challenges remain as each institution seeks to keep pace with technology and the rapid changes occurring in clinical research delivery. 

This case study will review a multi-departmental effort undertaken to integrate multiple disparate systems to create a streamlined method for the identification of research conflicts of interest. Specifically, the integration involved three separate software systems, and multiple modules within one of the three systems. By integrating the information from multiple systems, research funding and activities are consolidated and viewable for each researcher at one location, while a summary of financial disclosures (including outside activities) for that same researcher is concurrently compiled, allowing for a quick and real-time comparison. Such comparisons not only allow COI Office staff to readily identify research conflicts of interest, but provide research administrators with the ability to recognize needed disclosures in grant applications and escalate any concerning financial interests or relationships. The integration covers all research; in vitro, animal and human studies.

The Common Rule establishes the requirement to work in the single IRB world for multi-site research. Sites and researchers are still hesitant to fully release oversight due to issues of trust and day-to-day protocol management. Building trust between IRBs and researchers is a crucial aspect towards achieving harmonious and compliant oversight. This session will explore the barriers around successful single IRB oversight, and establish best practices for ensuring compliant processes that meet the regulatory requirements.

The Department of Defense (DoD) funds almost half of all federally sponsored basic science research at US academic institutions, but new principal investigators (PIs) can be intimidated. This concurrent session will help research administrators feel confident about coaching PIs to engage with DoD program officers and find potential research opportunities. We will discuss how DoD mission agencies review proposals and how that should affect the way in which proposals are developed for success with DoD. Finally, we'll discuss some common compliance issues that research administrators should be familiar with and how they affect proposal development.

Learn how CHLA successfully transferred clinical trial post award functions from its Post Award team to its Clinical Trials Office and how it learned to better manage residual funds to ensure adherence to applicable accounting practices.

As institutions of higher education seek to broaden their base of potential sponsors of funded research, more and more IHEs are engaging with industry partners. Academia and industry often have diverging interests. However, partnerships between academia and industry can have powerful impacts, both on science and the sponsored funding bottom line. The ability to bridge the industry-academia divide is a valuable trait of a successful research administrator. Lauren Wilson and Collin Rich lead the industry contracting efforts of The University of Alabama’s Office for Research and Economic Development. In this presentation, we will discuss challenges in industry contracting and share best practices and lessons learned.

Almost every research institution must engage in the process of negotiating federal indirect rates. Non-profits face unique challenges under the Uniform Guidance in preparing, submitting and negotiating indirect rates. As we go through this process, many of us often wonder if we have 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.

Is your institution ready for an audit in 2021? Did you institution receive COVID19 related funding? The COVID19 pandemic left institutions scrambling as researchers cancelled travel plans and leaders made tough decisions to close campuses and labs across the country. Because of the fast pace decisions that had to be made during a time that there was little to no guidance released nationwide for tracking these decisions, institutions are having to look back and document processes, re-review expenditures and funding received in order to prepare for Audits proactively and effectively in 2021. This session will describe in detail how COVID19 flexibilities are currently being audited and discuss real case scenarios on how your institution can best prepare.

SBIR and STTR projects can provide valuable research and financial opportunities to small businesses and the universities with whom they collaborate, but they also present a unique set of challenges. From Conflicts of Interest, IP and Data Rights to invoicing and payment; these projects, which are designed to promote research, have a very real potential to hinder it. This session will highlight the important Program requirements often overlooked by the Small Businesses and shed light on the challenges of partnering with Research Institutions. We will discuss the proposal process, the contract terms, flow down clauses, and various risk mitigation methods available.

The NSF-CREST Center for Cellular and Biomolecular Machines at the University of California, Merced [a Minority and Hispanic-Serving Institution (MSI, HSI)] is an interdisciplinary federally-funded scientific Center. The Center requires a range of approaches to address NSF annual and CREST-specific reporting, oversight of grant funds, integration of both campus and NSF policies, strategic planning and implementation of plans, programmatic oversight, interactions with affiliates, communications, and Center representation. In this session, we will focus on strategies for successful implementation and execution of the Center’s research, education, outreach, broadening participation, and administrative efforts.

Research misconduct (Fabrication, Falsification and Plagiarism) is never good. But it becomes exponentially bad when it takes place within the context of or overlaps with non-compliance in human subjects research or research with animals. The aim of this session is to explore the processes for and unique challenges of HRPPs or IACUCs collaboration with Research Integrity/Misconduct Offices to identify, manage and resolve research misconduct allegations involving human or animal subjects research.

This session will explore diversity and challenge participants to reflect on their own experiences within the workplace and SRAI. Members of the SRAI Diversity, Equity and Inclusion task force will lead this interactive session.

This intermediate level session will explore the use of OTA awards by the federal agencies who have gained legislative approval to use this R&D procurement mechanism. OTA have been used since they were invented to meet the needs of NASA in 1958. Overtime more and more federal agencies have petitioned for, and received, the ability to use this procurement method. In 2016 the NIH most recently gained the authority to solicit for and award OTA. Today research institutions are seeing the increasing use of this mechanism which it by the nature of its intended usage, differs from other types of research and development funding. This session will explore this funding mechanism providing some helpful tips on: 1) how to apply; and 2)how to manage them.

This session will define and explore leading practices related to the institutional internal deadline for proposal submission in advance of the sponsor deadline. This session will take a detailed look at the timeline leading up the sponsor's Due Date, discuss strategies to evaluate the level of proposal review depending on timeline and share institutional strategies for managing risk, employee stress and investigator communications to remove the pressure inherent in this deadline driven process.

Federal contracting agencies are seeing an increase in proposals from research universities. There can be a learning gap when jumping between 2 CFR 200 and the Federal Acquisition Regulations (FAR) as research administrators navigate federal contracts instead of federal grants. In this presentation, a university research administrator and a Federal employee will provide a crosswalk of key issues between grants and contracts. The co-presenters will demystify the contracting process, provide some insight into the negotiation of FAR clauses, and discuss the most effective communication strategies when collaborating with Federal contractors.

Everyone needs to diversify their research funding. This workshop will concentrate specifically on finding appropriate foundations for funding. We’ll discuss differences in terminology, foundations’ different approach to indirect costs, and maintaining good relationships. Foundation staff that hold the proverbial purse strings will be on hand to discuss their practices, give tips, and offer actionable suggestions to make your proposal successful, while at the same time, help the foundations fulfill their mission. Whether your institution is rich or poor, in healthcare or agriculture, this session will help you be better prepared to seek and secure foundation funding.

Institutions of higher education (IHE) have a fairly universal mission: to teach, serve the public, and conduct research through open exchange of information. This mission contrasts with several US Federal laws and regulations that require some of the information generated by US-based PIs and their labs to be safeguarded from unauthorized persons because it is defined as some type of classified or otherwise control-required information. Some IHEs will not deviate from the Fundamental Research Exclusion (FRE) arena, which may exclude them from some research funding. Other IHEs may partition parts of projects in order to protect and foster their core mission to the fullest extent possible, while also abiding by requirements that are in place for controlled and advanced components of the project. In these partitioned projects, robust technology control plans (TCP) are critical to compliant interactions within and outside of the lab. In this session, the presenters will go over the compliance aspects that should be addressed when partitioning fundamental and controlled research components, including physical space, cloud computing and storage, HR, general counsel, research team training and other research compliance issues. This session will use a mix of presentation, case study and discussion to engage with participants and emphasize important considerations.

Increasingly, universities, academic medical centers, and other organizations are interested in applying data-driven decision-making across the research enterprise. Many will encounter a number of challenges given the realities of the current environment. These can include reductions in tuition and state subsidies for higher ed institutions and tightening clinical margins for AMCs as well as increasing operational costs and challenges related to COVID-19. This session aims to address some of the concerns, approaches, and methods to consider when attempting to more successfully monitor and measure the financial performance of the research enterprise. Generally, this analysis covers the aforementioned issues with respect to: • Tracking expenses, space allocations, and space usage • Developing and tracking financial performance metrics and targets.

Central versus Departmental research in academic and non-academic systems vary by organizational characteristics, yet there is a long list of research resources necessary for optimal research conduct. Departmental research operations are fundamental service lines supporting investigator led, and sponsored research. This session is not about “pre-award” and “post-award” resources. This session is about identifying key resources to centralize and how best to optimally organize the research unit.

Federally funded research is often conducted within the University by faculty and staff. However, a significant portion of the required work may need to be provided outside the University by a third party through a subcontract or subaward. Proposing and managing a subaward is a shared responsibility. The goals of the relationship and nature of the parties should drive the structure, from the initial decision to establish a contractor or subrecipient relationship to the specific legal terms that are emphasized in the agreement establishing the legal relationship. We will discuss key decision-points and key considerations in making those decisions, as well as high-risk compliance areas. In doing so, we will address the pros and cons of standard documents such as the Federal Demonstration Partnership (“FDP”) subaward templates. Further, we will touch upon allocation of IRB responsibilities, fundamental intellectual property considerations, and conflict of interest management.

This session will identify and describe the benefits and important differences in securing and using philanthropic gifts to support research. Hear from an experienced fundraiser, and research administrator, how to secure millions in gifts to support important research. We will review simple steps to foster an environment of gift-supported research at your institution; large or small. Learn how to cultivate new and existing donors and how to partner philanthropic funding opportunities with research priorities. We will discuss engaging your faculty, physicians and other staff in philanthropy. Guidelines for distinguishing between gifts and grants will also be shared. Unless your research program is blessed with a fully-funded endowment producing perpetual income sufficient to sustain and grow your research or you’re 100% confident you will be fully funded by the government, then you need to attend this session. This practical session will provide tips to use right away and in the long-term.

For centuries, universities have been seen by communities around the world as “ivory towers”. Probably with reason! An ivory tower, by definition is “an environment of intellectual pursuit disconnected from the practical concerns of everyday life”! In the last decade or two, universities began to establish and/or strengthen their productive relationships with the communities in which they reside. As Universities assert their roles as “stewards of place,” and break out of their ivory towers, cities, counties, and states see the impact of universities in their communities documented through University Economic Impact Reports. And, critically, through the Public Impact Research and services that grow out of university laboratories, research centers, and classrooms, universities continue to drive economic development and community development efforts. This session will explore the some of the ways in which universities do support their communities and the mutual benefits that are derived from the relationship.

This session will review effective management of a data breach under available Federal Trade Commission (FTC), National Institute of Health (NIH), and Cybersecurity & Infrastructure Security Agency (CISA) guidance, as well as sample state regulation. For example, HIPAA and related federal or state law may require healthcare covered entities and their business associates to provide notifications of breach of protected health information (PHI) to the affected individuals, the HHS Secretary, covered entity, State OAG and, in some cases, the media. The Family Educational Rights and Privacy Act (FERPA), governing student educational records, does not contain specific breach notification requirements, but requires recordation of incidences of data disclosures. What resources are also available from the National Institute of Standards and Technology, FBI, DOJ, and Homeland Security, to help private and public entities mitigate ransomware risk? What have we learned about recent cyber and ransomware attacks targeting the healthcare and other sectors from recent data security advisories from the U.S. Department of Health and Human Services, and Cybersecurity & Infrastructure Security Agency (CISA) ? What other types of data breach may occur outside the headlines, and how can these be mitigated?

Many institution struggles with award closeouts in their financial system/ERP. A backlog in award closeouts could expose an institution to potential financial and compliance risk. What are best practices that can help an institution manage their closeout process? How can an institution make their closeout process more efficient and timely? The intent of this session is to talk through best practices for managing the closeout process, starting well before the award is expected to end. We'll talk through 1) the timeline for the entire closeout process, including how soon the effort should commence, 2) roles and responsibilities for the closeout process and 3) key components of a checklist that could help the process.

To adapt that cliché from the world of acting (there are no small roles, only small actors), there are no easy conflicts in research, but there are some “really, especially not easy” conflicts of interest and commitment. The aim of this session is to explore those “really, especially not easy” conflicts of interest and commitment which research administration and compliance offices are increasingly confronting; including but not limited to: Conflicted Person outside of Definition, Start-ups, Foreign Influence, and Management Plan related Issues.

When budgets are tight and you have to fight for everything you need, from additional staff to more space, to large investments in systems, you can create an unforgettable presentation that leaves your leaders no choice but to say "Yes!" Build an opening statement that will grab their attention, keep it with short anecdotes, and build the strength of your request with ideas to extract and use data you already have. You will gain presentation strategies that lead to a request fulfilled.

This session is interactive and provides several "real-life" case studies that illustrate warning signs of research grants in trouble and suggests solutions for correcting, mitigating, and even avoiding problems, as early as possible. the session provides opinions, drawing on knowledge and experience of the audience to further flesh out the situations and possible solutions. All of the case studies are real situations that NIH Grants Management Staff have experienced and resolved, and this unique perspective also lets the audience know they are not alone when it comes to troublesome situations and who can help.

Research administration, being a dynamic field aims to provide services to principal investigators (PIs) in conducting research projects while also adhering to the regulatory requirements. It has been observed that at times PIs form unrealistic expectations or come up with certain demands for their research projects which are practically not doable. However, they cannot be blamed entirely, as it is the research administrator’s responsibility to maintain the right balance between what a PI expects and what can be done in a legit manner, ensuring compliance with all the applicable national and international regulations. This session aims to apprise its audience with the real life challenges that are being faced by research administrators in terms of trying to balance off the PI expectations and what is doable. Accompanying this the audience will be educated on how the research administrator worked out a solution by catering to ‘what they want’ without compromising on the regulations.

Diversity in research means that people of different ages, different social and ethnic groups, and different genders participate in the research enterprise. Research has shown that organizations that build an inclusive culture, with individuals from different cultures and backgrounds, have higher market share, better brand visibility, and an increased ability to serve diverse populations. U.S. workforce is more ethnically diverse than ever before. According to a Pew Research Center report on demographic trends, the U.S. will not have a racial or ethnic majority by 2055. While having a diverse workforce is good business, leading a diverse team presents unique challenges for research administrators. This chat acknowledges implicit bias and the crucial conversations that result from self awareness. Case studies are offered to help facilitate becoming comfortable with “the uncomfortable.”

Research administrators often find their career through varying paths and backgrounds, but once identified as a passion and long-term interest, how does one plan for a career in research administration? The field has several different specialties and avenues one can explore as a career, so before a research administrator can make a career plan, they need to investigate the diverse positions within the field. After a research administrator determines their immediate path and the next step they would like to achieve, it is important to develop a career plan to help guide them in their desired direction. Incorporating professional development into a career plan can be paramount when preparing for the next step. Platforms such as SRAI, provide fantastic options for professional growth and continuing education. This session will outline different career paths within research administration and help prepare research administrators on how to build a career plan incorporating professional growth opportunities. It will also provide a stimulating activity amongst the participants to explore each other’s careers, experiences, and past professional development. This session offers something for everyone, so individuals from any stage of their career are invited to join!

There are many moving parts organizations need to consider during the early stages of a potential research misconduct investigation. One of the most critical elements supporting productive stakeholder and deciding official discussions around potential research misconduct is effective acquisition and analysis of research data. Research data forensics, including research data sequestration, is a team effort and often requires research administrators to build effective collaborations with colleagues between different departments and administrative teams (such as Information Technology) and model the scientific practice and data management proficiency we value and reinforce within our research communities. Navigating the necessary transparency of research data assessments critical to investigations within an environment that requires continued confidentiality is an additional responsibility layered within these efforts. This complex process is further stretched to incorporate the breadth and scope of the research enterprise at our varying institutions; research integrity teams must be ready to support the evaluation of scientific and research data in all forms and from all disciplines represented within their organizations. During this session, we will explore these “forensics pillars” of research misconduct investigations including data sequestration, forensic research data analysis and case management techniques and technology.

This session will discuss recent developments in the regulatory framework for export control management as it pertains to research institutions, specifically focusing on highlights from the 2020 Government Accountability Office report on how State and Commerce can address university-specific compliance issues and the uptick in research projects being deemed as controlled by Departments of Defense, Energy, and others. This session will also highlight how institutions can leverage compliance technology solutions and modules to assess, manage, and report on export control transactions and risks, specifically as they relate to research administration.

The 21st century research community has become global, with increased international collaboration and changing demographics of the U.S. population. As fewer US students pursue graduate degrees in science and technology, research administrators increasingly are working with faculty and graduate students from around the world. At the same time, international collaborations are becoming more common, especially for large, collaborative projects. Consequently, awareness of cultural differences is crucial for research administrators to function effectively. Diverse cultural characteristics and communication patterns need to be considered in hiring and managing staff, forming research teams, developing proposals, and managing funded projects. Drawing from research, literature, and case studies, this workshop will help participants to understand the changing demographics of the U.S. research community, learn characteristics, cultural traits and communication patterns of diverse populations, recognize barriers to effective intercultural communication in research development and administration, and apply current strategies and best practices to developing effective research and administrative teams. Participants will explore case study scenarios, learn and use tools that assess knowledge of other cultures, share their own experiences, and learn strategies, solutions and best practices for enhancing intercultural communication.

Proposals are often prepared and submitted very close to the deadline. They are then filed away until the award is made even though there is a high probability that the budgets contain errors. This puts post-award administrators in the unenviable position of discovering these mistakes after the project start date which can lead to delays and unhappy Principal Investigators (PIs). This interactive session will examine the pre- to post-award progression and introduce attendees to a post-submission, pre-award review process.

This is a session on how you can monitor transactions using an efficient, risk-based approach. Participants will hear from audit experts on how monitoring expenses on a routine basis can reduce the risk of audit findings. The session will provide an overview of high-risk transaction areas and introduce ideas of how one might use a risk based approach to inquire about a subset of the transactions. The instructors will review how one might approach monitoring COVID funding, travel and entertainment expenses, participant support costs, among others! 

This session will look at Yale University’s approach to regionalizing research administration services for academic and non-academic departments and will focus on the activities we considered. We will look at how to identify the need for and effective design and implementation of a shared services model. Our objective was to create a unit that raises the level of service to Faculty/Principal Investigators while increasing compliance and mitigating risk. During this session we will discuss the challenges and successes during the transition and the approach we took with staffing the organization. We will also look at opportunities that were availed as we transitioned to remote working.

Research administration continues to undergo significant change as we look to better serve our researcher and leadership stakeholders. Research organizations have focused on streamlining processes, implementing information technology solutions, enhancing reporting, and redefining their operating models. But have we done enough? And what comes next? In this session, the speakers will outline their vision of research administration for the next 20 years, discussing where organizations and people may want to invest as they continually pivot to meet the needs of a growling complex international research model.

COVID-19 brought many changes to the field of research administration, some of which were implemented on a truncated timeline, or no timeline at all. This class seeks to engage in discussion on some of the permanent changes to the field of research administration as a result of the pandemic including permanent remote workers and how to effectively collaborate between the department and the SPO, implementing systems changes in a telework-friendly environment, and engaging all participants in institutional training across campus and remotely. The speakers will share challenges, opportunities, and solutions they have encountered during and because of the pandemic and will give insight from both the central office and departmental perspectives. One speaker works in the central office full time and the other speaker is a permanent remote departmental administrator who lives in a different time zone. Using examples from the speakers' experience as a starting point, we hope to engage the audience in creative solutions to the dynamic workforce.

How has our approach to leadership changed as a consequence of COVID-19? Are we more aware of the need for responsible, aware and compassionate leadership? Are we better able to generate a diverse and equitable environment and culture? How do we generate proximity when we work remotely? Did dealing with the pandemic mean our strategy was put on hold, or has it galvanised a revision of it? Are we now more adaptive and agile leaders? The COVID-19 pandemic has created leadership and management challenges for everyone. Practices have quickly been changed, but how many will be retained? Will our new insights into working requirements affect the way we think about the research environment and the cultures and behaviours required? How will we help our organisations, disciplines and the RMA profession to work responsibly and with enhanced integrity? This panel of experienced research managers from across the world will explore these issues with the audience, seeking to identify good practices that should be continued, concerns that have emerged or been reinforced, and thoughts about future developments.

The session will review the requirements for subrecipient monitoring under OMB Uniform Guidance 2 CFR 200. Topics under this session include: subaward vs. contractor determination, institutions policies on UG, risk assessment, risk mitigation, subrecipient monitoring, and more. The session will also briefly discuss FFATA reporting. This session will be interactive and encourages participants to share ideas from their respective institution.

Annual progress reports are a term and condition of all NIH grant awards (including multi-year funded awards) and the Research Performance Progress Report (RPPR) is used by grantees to submit these reports to NIH. Failure to submit complete, accurate and timely reports for a grant routinely results in delayed awards and may result in closer monitoring by the NIH. This session will examine what is required for RPPR submission; detail financial and administrative elements of the RPPR that require special attention by the research administrator, including the requirements for updated other support and biosketch; and describe some of the more common pitfalls of RPPR submission.

Developing new contract negotiators can be a complicated, challenging, but exciting process. This session will provide insights into how to develop an effective training program that incorporates self-paced learning and mentoring by senior contract negotiators using SRAI programming. A multi-faceted approach is needed to convey the body of knowledge of the basics of contract administration, and specifically, the contract terms and conditions relevant to research. Research administration leaders will provide insights into contracting principles, consideration of institutional policies, and the regulatory framework relevant to research contracting. This structured approach avoids the hazard of leaving those new to the field feeling as if they are drinking from a fire hose. SRAI educational platforms combined with negotiator reference materials will be demonstrated to help institutions develop a nuanced program that teaches the basics for analyzing risk in contract terms and viewing the deal from the other side. This session is appropriate for managers tasked with developing these programs as well as individuals who are hoping to expand their experience into the contracting role of research administration.

The Federal Government first issued the regulations at 2 CFR 200 - Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards - in December 2013. These regulations were updated and became effective on November 12, 2020. While many of the changes were corrections, there were a few that raised concerns for Research Administrators. This session will review the changes and their potential impacts.

Have you ever had a conversation with an individual from a different generation, and at the end of the conversation, you thought to yourself, I am not sure if we were talking about the same thing? Each generation has different preferences when it comes to communicating. Understanding what is being said and who is saying it is essential, as well as the unique communication style of each generation. And how this dynamic will build trust, respect, and most importantly, an engaging and productive workplace team.

We have participated in institutions, schools, and hobbies that emphasize winning or being the top achiever. The way many organizations are structured, recognition, compensation, and promotions work against teamwork values. A work culture where employees are compensated and celebrated for their performance and contributions can't encourage teamwork. Instead, it fosters a sense of competition. This session will focus on building a culture of teamwork through collaboration and mutual respect for otherness.