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4507 Developing and implementing a Principal Investigator (PI) primer to improve the conduct of human research at the University of Minnesota
- Jessica Wright, Jennifer Maas, Megan Hoffman
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- Journal:
- Journal of Clinical and Translational Science / Volume 4 / Issue s1 / June 2020
- Published online by Cambridge University Press:
- 29 July 2020, p. 59
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OBJECTIVES/GOALS:
1. Assess the institutional and individual training needs and gaps in the conduct of human research for PIs at the University of Minnesota.
2. Define the training program’s learning objectives.
3. Develop and implement an in-person training session that addresses the gaps.
METHODS/STUDY POPULATION:
Establish a planning committee
Identify required and optional training that is already available for PIs, then determine gaps
Understand research training needs based on conversations with departmental and human research protection program leaders.
Develop learning objectives and curriculum based on Federal and Local regulations, guidelines, and policies.
Establish a feedback loop regarding research compliance with the HRPP, to assess trends and ensure continuous improvement.
Evaluate the training program’s participants using confidence and satisfaction measures.
RESULTS/ANTICIPATED RESULTS: Developed and piloted a 90-minute in-person training program entitled “PI Primer” with the goals of:
Increasing awareness and knowledge of the role and responsibilities of the Principal Investigator (PIs) according to the International Harmonization for Good Clinical Practice (ICH-GCP), Federal Regulations (FDA, DHHS, ect.), and University of Minnesota Policies.
Identifying root causes for receiving an FDA 483 (inspection findings).
Addressing and preventing common inspection findings (CAPA).
Describe individual and institutional conflict of interest (COI), and identify the key steps necessary to manage COIs.
DISCUSSION/SIGNIFICANCE OF IMPACT: OHRP’s guidance on the “Responsibilities of Investigators” states that it is the Institution’s responsibility to provide human research training on a wide variety of topics to ensure the ethical conduct of research and protection of participants. PI Primer provides an in-person forum for investigators to build upon required responsible conduct of research and good clinical practice training to be able to apply the role and responsibilities of a PI to their own research. PI Primer also establishes a network of PIs in order to enhance connectivity and shared learning.
4116 Comprehensive training and support for Research Professionals at the University of Minnesota
- Jennifer Maas, Megan Hoffman, Jessica Wright
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- Journal:
- Journal of Clinical and Translational Science / Volume 4 / Issue s1 / June 2020
- Published online by Cambridge University Press:
- 29 July 2020, p. 58
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OBJECTIVES/GOALS: Coordinating research studies is multifaceted and requires a foundational level of research knowledge, skills and abilities in order to contribute to high-quality, ethical research projects that adhere to local and federal regulations as well as Good Clinical Practice. Oftentimes, coordinators who are new to research or new to an institution have trouble navigating the research landscape. Departments within the University of Minnesota have limited resources to devote to developing robust training programs above and beyond protocol or department-specific training. Therefore, UMN’s CTSI created a comprehensive training and support program for research professionals at the University of Minnesota. METHODS/STUDY POPULATION: CTSI employs several strategies to provide a comprehensive training program for the University of Minnesota Research Workforce. The offerings are based on the The Joint Task Force for Clinical Trial Competency (JTF). In addition to training programs, valuable resources, materials, and connections are provided to trainees.
An Onboarding process for new coordinators that includes a welcome email upon hire that provides resources as well an opportunity to meet face-to-face to get their questions answered about where to start with research training.
Foundations for Research professionals, two week (20 hour) training program, provides a foundational level of knowledge to new coordinators via in-person and online training modules.
Informed Consent 1 & 2 provides in-person training on the informed consent including the process, documentation, and ethical issues around consenting vulnerable populations.
Over 40 on-line research training modules that coordinators can take at anytime.
An active list serv that connects >600 research professionals with training updates and opportunities.
Bi-weekly seminar series that provides a forum to share current regulations, best practices, resources, and guidelines pertaining to clinical research at the University.
An online training “Roadmap” tool that customizes individual research training plans, and includes an inventory of training available.
RESULTS/ANTICIPATED RESULTS:
218 research professionals participated in our Foundations blended training program with 191 completing (88% completion rate) the entire training. A comprehensive assessment based on national competencies is completed by all participants at Baseline and Post training. Baseline scores average at 75% and Post scores average at 82% (7% increase). Satisfaction is measured and participants are overall satisfied with the training, 4 out of 5 on a Likert Scale.
353 research professionals have participated in our Informed Consent Session 1 & 2 in-person training. Satisfaction is measured and participants are overall satisfied with the training, 4.5 out of 5 on a Likert Scale.
Over 190 research professionals have utilized our research on-line training modules.
Training participants have been from 27 different departments across the University.
The Clinical Research Professional Development Seminar Series has offered over 87 seminars with 4907 total attendees. These seminars are offered in-person and live stream.
DISCUSSION/SIGNIFICANCE OF IMPACT: Establishing a comprehensive training program at the University has streamlined the training that research professionals receive across departments. It also ensures that all coordinators have access to research training, a network of other research professionals, resources, and continuing education opportunities.
Product reformulation and nutritional improvements after new competitive food standards in schools
- Jaquelyn L Jahn, Juliana FW Cohen, Mary T Gorski-Findling, Jessica A Hoffman, Lindsay Rosenfeld, Ruth Chaffee, Lauren Smith, Eric B Rimm
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- Journal:
- Public Health Nutrition / Volume 21 / Issue 5 / April 2018
- Published online by Cambridge University Press:
- 21 December 2017, pp. 1011-1018
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Objective
In 2012, Massachusetts enacted school competitive food and beverage standards similar to national Smart Snacks. These standards aim to improve the nutritional quality of competitive snacks. It was previously demonstrated that a majority of foods and beverages were compliant with the standards, but it was unknown whether food manufacturers reformulated products in response to the standards. The present study assessed whether products were reformulated after standards were implemented; the availability of reformulated products outside schools; and whether compliance with the standards improved the nutrient composition of competitive snacks.
DesignAn observational cohort study documenting all competitive snacks sold before (2012) and after (2013 and 2014) the standards were implemented.
SettingThe sample included thirty-six school districts with both a middle and high school.
ResultsAfter 2012, energy, saturated fat, Na and sugar decreased and fibre increased among all competitive foods. By 2013, 8 % of foods were reformulated, as were an additional 9 % by 2014. Nearly 15 % of reformulated foods were look-alike products that could not be purchased at supermarkets. Energy and Na in beverages decreased after 2012, in part facilitated by smaller package sizes.
ConclusionsMassachusetts’ law was effective in improving the nutritional content of snacks and product reformulation helped schools adhere to the law. This suggests fully implementing Smart Snacks standards may similarly improve the foods available in schools nationally. However, only some healthier reformulated foods were available outside schools.
How do we actually put smarter snacks in schools? NOURISH (Nutrition Opportunities to Understand Reforms Involving Student Health) conversations with food-service directors
- Lindsay E Rosenfeld, Juliana FW Cohen, Mary T Gorski, Andrés J Lessing, Lauren Smith, Eric B Rimm, Jessica A Hoffman
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- Journal:
- Public Health Nutrition / Volume 20 / Issue 3 / February 2017
- Published online by Cambridge University Press:
- 30 August 2016, pp. 556-564
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Objective
In autumn 2012, Massachusetts schools implemented comprehensive competitive food and beverage standards similar to the US Department of Agriculture’s Smart Snacks in School standards. We explored major themes raised by food-service directors (FSD) regarding their school-district-wide implementation of the standards.
DesignFor this qualitative study, part of a larger mixed-methods study, compliance was measured via direct observation of foods and beverages during school site visits in spring 2013 and 2014, calculated to ascertain the percentage of compliant products available to students. Semi-structured interviews with school FSD conducted in each year were analysed for major implementation themes; those raised by more than two-thirds of participating school districts were explored in relationship to compliance.
SettingMassachusetts school districts (2013: n 26; 2014: n 21).
SubjectsData collected from FSD.
ResultsSeven major themes were raised by more than two-thirds of participating school districts (range 69–100 %): taking measures for successful transition; communicating with vendors/manufacturers; using tools to identify compliant foods and beverages; receiving support from leadership; grappling with issues not covered by the law; anticipating changes in sales of competitive foods and beverages; and anticipating changes in sales of school meals. Each theme was mentioned by the majority of more-compliant school districts (65–81 %), with themes being raised more frequently after the second year of implementation (range increase 4–14 %).
ConclusionsFSD in more-compliant districts were more likely to talk about themes than those in less-compliant districts. Identified themes suggest best-practice recommendations likely useful for school districts implementing the final Smart Snacks in School standards, effective July 2016.
Contributors
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- By Brittany L. Anderson-Montoya, Heather R. Bailey, Carryl L. Baldwin, Daphne Bavelier, Jameson D. Beach, Jeffrey S. Bedwell, Kevin B. Bennett, Richard A. Block, Deborah A. Boehm-Davis, Corey J. Bohil, David B. Boles, Avinoam Borowsky, Jessica Bramlett, Allison A. Brennan, J. Christopher Brill, Matthew S. Cain, Meredith Carroll, Roberto Champney, Kait Clark, Nancy J. Cooke, Lori M. Curtindale, Clare Davies, Patricia R. DeLucia, Andrew E. Deptula, Michael B. Dillard, Colin D. Drury, Christopher Edman, James T. Enns, Sara Irina Fabrikant, Victor S. Finomore, Arthur D. Fisk, John M. Flach, Matthew E. Funke, Andre Garcia, Adam Gazzaley, Douglas J. Gillan, Rebecca A. Grier, Simen Hagen, Kelly Hale, Diane F. Halpern, Peter A. Hancock, Deborah L. Harm, Mary Hegarty, Laurie M. Heller, Nicole D. Helton, William S. Helton, Robert R. Hoffman, Jerred Holt, Xiaogang Hu, Richard J. Jagacinski, Keith S. Jones, Astrid M. L. Kappers, Simon Kemp, Robert C. Kennedy, Robert S. Kennedy, Alan Kingstone, Ioana Koglbauer, Norman E. Lane, Robert D. Latzman, Cynthia Laurie-Rose, Patricia Lee, Richard Lowe, Valerie Lugo, Poornima Madhavan, Leonard S. Mark, Gerald Matthews, Jyoti Mishra, Stephen R. Mitroff, Tracy L. Mitzner, Alexander M. Morison, Taylor Murphy, Takamichi Nakamoto, John G. Neuhoff, Karl M. Newell, Tal Oron-Gilad, Raja Parasuraman, Tiffany A. Pempek, Robert W. Proctor, Katie A. Ragsdale, Anil K. Raj, Millard F. Reschke, Evan F. Risko, Matthew Rizzo, Wendy A. Rogers, Jesse Q. Sargent, Mark W. Scerbo, Natasha B. Schwartz, F. Jacob Seagull, Cory-Ann Smarr, L. James Smart, Kay Stanney, James Staszewski, Clayton L. Stephenson, Mary E. Stuart, Breanna E. Studenka, Joel Suss, Leedjia Svec, James L. Szalma, James Tanaka, James Thompson, Wouter M. Bergmann Tiest, Lauren A. Vassiliades, Michael A. Vidulich, Paul Ward, Joel S. Warm, David A. Washburn, Christopher D. Wickens, Scott J. Wood, David D. Woods, Motonori Yamaguchi, Lin Ye, Jeffrey M. Zacks
- Edited by Robert R. Hoffman, Peter A. Hancock, University of Central Florida, Mark W. Scerbo, Old Dominion University, Virginia, Raja Parasuraman, George Mason University, Virginia, James L. Szalma, University of Central Florida
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- Book:
- The Cambridge Handbook of Applied Perception Research
- Published online:
- 05 July 2015
- Print publication:
- 26 January 2015, pp xi-xiv
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- By Lenard A. Adler, Pinky Agarwal, Rehan Ahmed, Jagga Rao Alluri, Fawaz Al-Mufti, Samuel Alperin, Michael Amoashiy, Michael Andary, David J. Anschel, Padmaja Aradhya, Vandana Aspen, Esther Baldinger, Jee Bang, George D. Baquis, John J. Barry, Jason J. S. Barton, Julius Bazan, Amanda R. Bedford, Marlene Behrmann, Lourdes Bello-Espinosa, Ajay Berdia, Alan R. Berger, Mark Beyer, Don C. Bienfang, Kevin M. Biglan, Thomas M. Boes, Paul W. Brazis, Jonathan L. Brisman, Jeffrey A. Brown, Scott E. Brown, Ryan R. Byrne, Rina Caprarella, Casey A. Chamberlain, Wan-Tsu W. Chang, Grace M. Charles, Jasvinder Chawla, David Clark, Todd J. Cohen, Joe Colombo, Howard Crystal, Vladimir Dadashev, Sarita B. Dave, Jean Robert Desrouleaux, Richard L. Doty, Robert Duarte, Jeffrey S. Durmer, Christyn M. Edmundson, Eric R. Eggenberger, Steven Ender, Noam Epstein, Alberto J. Espay, Alan B. Ettinger, Niloofar (Nelly) Faghani, Amtul Farheen, Edward Firouztale, Rod Foroozan, Anne L. Foundas, David Elliot Friedman, Deborah I. Friedman, Steven J. Frucht, Oded Gerber, Tal Gilboa, Martin Gizzi, Teneille G. Gofton, Louis J. Goodrich, Malcolm H. Gottesman, Varda Gross-Tsur, Deepak Grover, David A. Gudis, John J. Halperin, Maxim D. Hammer, Andrew R. Harrison, L. Anne Hayman, Galen V. Henderson, Steven Herskovitz, Caitlin Hoffman, Laryssa A. Huryn, Andres M. Kanner, Gary P. Kaplan, Bashar Katirji, Kenneth R. Kaufman, Annie Killoran, Nina Kirz, Gad E. Klein, Danielle G. Koby, Christopher P. Kogut, W. Curt LaFrance, Patrick J.M. Lavin, Susan W. Law, James L. Levenson, Richard B. Lipton, Glenn Lopate, Daniel J. Luciano, Reema Maindiratta, Robert M. Mallery, Georgios Manousakis, Alan Mazurek, Luis J. Mejico, Dragana Micic, Ali Mokhtarzadeh, Walter J. Molofsky, Heather E. Moss, Mark L. Moster, Manpreet Multani, Siddhartha Nadkarni, George C. Newman, Rolla Nuoman, Paul A. Nyquist, Gaia Donata Oggioni, Odi Oguh, Denis Ostrovskiy, Kristina Y. Pao, Juwen Park, Anastas F. Pass, Victoria S. Pelak, Jeffrey Peterson, John Pile-Spellman, Misha L. Pless, Gregory M. Pontone, Aparna M. Prabhu, Michael T. Pulley, Philip Ragone, Prajwal Rajappa, Venkat Ramani, Sindhu Ramchandren, Ritesh A. Ramdhani, Ramses Ribot, Heidi D. Riney, Diana Rojas-Soto, Michael Ronthal, Daniel M. Rosenbaum, David B. Rosenfield, Durga Roy, Michael J. Ruckenstein, Max C. Rudansky, Eva Sahay, Friedhelm Sandbrink, Jade S. Schiffman, Angela Scicutella, Maroun T. Semaan, Robert C. Sergott, Aashit K. Shah, David M. Shaw, Amit M. Shelat, Claire A. Sheldon, Anant M. Shenoy, Yelizaveta Sher, Jessica A. Shields, Tanya Simuni, Rajpaul Singh, Eric E. Smouha, David Solomon, Mehri Songhorian, Steven A. Sparr, Egilius L. H. Spierings, Eve G. Spratt, Beth Stein, S.H. Subramony, Rosa Ana Tang, Cara Tannenbaum, Hakan Tekeli, Amanda J. Thompson, Michael J. Thorpy, Matthew J. Thurtell, Pedro J. Torrico, Ira M. Turner, Scott Uretsky, Ruth H. Walker, Deborah M. Weisbrot, Michael A. Williams, Jacques Winter, Randall J. Wright, Jay Elliot Yasen, Shicong Ye, G. Bryan Young, Huiying Yu, Ryan J. Zehnder
- Edited by Alan B. Ettinger, Albert Einstein College of Medicine, New York, Deborah M. Weisbrot, State University of New York, Stony Brook
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- Book:
- Neurologic Differential Diagnosis
- Published online:
- 05 June 2014
- Print publication:
- 17 April 2014, pp xi-xx
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