RESPONSIBLE AND ETHICAL
CONDUCT OF RESEARCH

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Even though scientific research itself is hundreds, perhaps even thousands, of years old, the area of responsible conduct of research (RCR) is relatively new. The discussions around RCR emphasize the nuanced and multidisciplinary social and ethical issues that arise when conducting scientific research. This asynchronous (completely online) class will increase researchers’, scholars’, and research administrators’ awareness about the need for responsible conduct of research (RCR).  The class will highlight strategies to promote research integrity so that the unacceptable research practices as well as research misconduct are prevented.  The RCR class meets the requirements NIH- and NSF-funded research (adapted from the Milken School)

At the conclusion of this class, you should be able to:

• Characterize elements of responsible conduct of research (RCR)
• Describe areas of research misconduct
• Differentiate activities that promote responsible conduct of research (RCR) in your discipline
• Identify federal and university resources that deal with research misconduct

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The responsible conduct of research (RCR) is a relatively new discipline. It is focused on the multifaceted social and ethical issues that arise in the practice of scientific research. But scientific research itself is hundreds, perhaps even thousands, of years old. Reflecting on this history of biology, chemistry, physics and medicine provides insightful examples of both responsibly conducted research, and irresponsibly conducted research, by some of the most famous scientists in history.

Participants will examine a number of notable cases from the history of science and will consider how prominent scientists and their research would fare in the modern age of RCR.

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The process of informed consent will be considered from the research participant's perspective. What is Good Clinical Practice (GCP) when addressing participant questions and concerns? How can the informed consent process be improved for the participant? What do your participants truly understand, consent to, and wish they knew more about? How does Health Literacy impact the informed consent process in clinical research? What is therapeutic misconception and how can it be avoided?

These questions and other "hot topics" will be the focus of discussion in this open forum presentation.

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Research mentors play crucial roles in the development of emerging scholars. Elements of Effective Mentoring/Developing a Mentoring Philosophy is the first class in the Research Mentoring Certificate and provides a foundation for the remainder of the certificate classes.

Participants are introduced to the research-based characteristics of high-quality mentoring and are encouraged to reflect on how their own experiences as a mentor and as a mentee influence their own mentoring practice. Crucially, this class problematizes harmful mentoring attitudes and practices and exposes participants to issues that disproportionally impact marginalized mentees.

At the conclusion of this class, you should be able to:

• Identify research-based characteristics of high-quality mentoring.
• Explain how your prior experiences with mentorship influence their approaches to working with research mentees.
• Recognize considerations/implications of mentorship for diverse mentees.

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Participants will develop an in-depth understanding of the regulatory criteria for IRB approval of research. Join a discussion on the ethical basis for each criterion and the complicating factors that influence how the IRB weighs each of the core ethical principles: Respect for Persons, Beneficence, and Justice. 

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Unanticipated problems in research involving risk to human subjects or others must be reported to the Institutional Review Board (IRB). An "Unanticipated Problem" includes some types of adverse events, protocol deviations, non-compliance, and other incidents that place individuals at risk of harm.

This presentation will include advanced case studies involving IRB reporting policies for unanticipated problems. The criteria for reporting an unanticipated problem, including various definitions and guidance contributing to the interpretation of the criteria, will be discussed.

Participants will learn how to apply the criteria for an unanticipated problem in different scenarios and will better understand how to provide complete and accurate information in the IRB Report Form for complex unanticipated problems.

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This is a REd Asynchronous (online/self-paced) Class.

In this class we will introduce the University's Conflict of Interest policies (Individual and Institutional), explain financial disclosure requirements, and describe the COI review processes.

• Interpret the University's COI policies and appreciate their importance
• Discuss who must file a financial disclosure, what must be disclosed, and how often the disclosure should be updated
• Summarize the University's COI review processes and identify who to contact with questions

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Research is frequently undertaken by researchers working together from different academic departments, multiple institutions, private industry and with the government. Many ethical challenges often arise largely due to the number of people, organizations and resources involved. Scientists and researchers may be at different stages of their careers and have different motivations for conducting research. It often becomes difficult to review the work of collaborators on interdisciplinary and multi-institutional research conducted or located in different regions of the world.

Further, there is a longstanding tension between the role of the scientist as "discoverer of how things work" and the expectations of many in society that scientists should "deliver tangible goods." In addition, governments often encourage scientists to advance specific national agendas, even though scientists are largely viewed by citizens as "independent authorities" able to present findings that transcend national political purposes.

This presentation will discuss some of the challenges inherent in collaborative research, the different roles of scientists and researchers, and the ethical, environmental and societal impacts of scientific research.

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This is a REd Asynchronous (online/self-paced) Class.

The University of Utah is committed to the advancement of research and discovery on a global level, while managing the risk of potential undue foreign influence. The Office of Foreign Influence works to educate, identify, and implement reporting requirements and best practices to prevent and combat undue foreign influence. 

At the conclusion of this class, you should be able to:

• Identify actions most at risk for undue foreign influence and demonstrate actions to mitigate these risks.
• Recognize foreign relationships which need to be disclosed to the University and execute the steps for making these disclosures.

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Publication in science and academia serves several purposes. In addition to advancing the field by making new knowledge permanently and widely available to the scientific and lay communities, publication plays an integral role in an individual's career development. In this workshop, strategies for researchers and other academicians to publish their papers in well-regarded journals in their field will be presented. Several questions will be addressed including:

• What criteria do editors and reviewers use in evaluating papers for publication?
• What can an author do to enhance the likelihood that their manuscript will be reviewed and accepted?
• What can an author do when their manuscript is rejected or unfairly evaluated?
• What is considered ethical and unethical behavior when it comes to issues of authorship, peer review, data presentation, citation and discussion of the literature?
• What are the rights and responsibilities of authors, editors, reviewers and readers?

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Participants should have a basic knowledge of informed consent requirements prior to attending this class.

Different models for obtaining and documenting informed consent based on the required elements and risk level of the research will be presented. The difference in required elements of consent for minimal risk and greater than minimal risk studies will be explained. How to improve the informed consent process and required documents through clarification and simplification will be discussed.

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Participants will understand the basic process and framework used to conceptualize, develop, manage, and administer a successful laboratory in a university setting.

Topics for discussion include how to apply for an academic position (including idealization of a start-up package); determination and prioritization of hiring/staffing with lab technicians, graduate students, and postdoctoral scholars; and mentoring of lab personnel. Additional issues such as time management (setting priorities and how/when to say "no" while remaining a good citizen and colleague), identifying collegial mentors to enhance your personal career, and project management will be presented.

In preparation for the class, participants are strongly encouraged to read the Howard Hughes Medical Institute (HHMI) publication entitled "Making the Right Moves: A Practical Guide to Scientific Management for PostDocs and New Faculty, Second Edition", specifically Chapter 1: Obtaining and Negotiating a Faculty Position; Chapter 2: Understanding University Structure & Planning for Tenure; Chapter 3: Laboratory Leadership in Science; and Chapter 4: Staffing Your Laboratory. The book is available for no cost at http://www.hhmi.org/resources/labmanagement/.

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Information and materials to prepare investigators and research personnel to initiate, manage and oversee a drug or device trial at the University will be presented. The Food and Drug Administration (FDA) Investigational New Drug (IND) and Investigational Device Exemption (IDE) requirements will be described. Topics such as additional investigator responsibilities, the IRB submission and approval process including pre-approval audit, and methods of continued study oversight will be discussed.

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What does it mean to manage and share research data? What are best practices for developing data management plans and increasing access to the results? How are human subject and qualitative research data managed in the social & behavioral sciences and humanities? This informative presentation will explain the motivations behind federal mandates and University policies regarding open data sharing.

Participants will learn practical data management skills including file naming, version control, creating data management plans, and crafting subject-specific metadata in the Data Documentation Initiative (DDI) format. Data archiving options for institutional repositories will be discussed and University data planning, analysis, and archiving services available throughout the research data lifecycle will be described.

At the conclusion of this class, you should be able to:

• Summarize the motivations behind federal mandates and University policies regarding open data sharing 
• Describe practical data management skills including file naming, version control, creating data management plans, and crafting subject-specific metadata in the Data Documentation Initiative (DDI) format 
• Identify data archiving options for institutional repositories
• Describe University data planning, analysis, and archiving services available throughout the research data lifecycle

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This presentation will examine the process of developing non-dilutive funding opportunities for commercialization and partnerships between industry and research institutions. Small Business Innovation in Research (SBIR) / Small Business Technology Transfer (STTR) grant programs, participating agencies, company eligibility and requirements, and recent legislative updates will be discussed.

An overview of SBIR/STTR application procedures including required registrations will be provided. Relevant University policies will be explained, additional federal and state grants which support commercialization efforts will be reviewed (NSF GOALI, GOED, USTAR, etc.), and University Technology Venture and Commercialization (TVC) resources and services will be described.