PLAN FOR INSTRUCTION IN THE RESPONSIBLE CONDUCT OF RESEARCH
UAB has a strong and ongoing commitment to the responsible conduct of research. The campus offers many opportunities for initial and annual training including formal courses through the Center for Ethics and Values in the Sciences, the Graduate School, the Office of Postdoctoral Education (OPE), and through programs and training sponsored on a regular, ongoing basis by the Institutional Review Board (IRB), Conflict of Interest Review Board (CIRB), Institutional Animal Care and Use Committee (IACUC), Occupational Health and Safety (OHS), and the UAB Center for Clinical and Translational Science (CCTS). All entering biomedical sciences students are educated during orientation about requirements to complete human subjects and animal use and care training programs; completion of requisite training is arranged and documented by their specific graduate programs.
All trainees will be are required to participate in, and satisfactorily completePrinciples of Scientific Integrity (GRD 717) (see below) within the first year of training. Additionally yearly refresher RCR activities will be required for trainees that include additional ethics courses and/or utilizing Institutional resources such as the new training videos developed by the UAB Center for Ethics and Values in Sciences ((http://www.uab.edu/images/gradsil/rcr/index.html). These include “Teaching Research Integrity in Analysis and Reporting”, “Image Manipulation”, “In the Lab: Mentors and Students Behind the Scenes”, “Ethical issues in Underpowered Clinical Trials”, and “The Lab: Avoiding Research Misconduct” (Descriptions follow; Section 5A3). UAB has also recently developed a new scholarly integrity workshop “Ethics for Authors”, which is organized around interactive and facilitator-led discussions and exercises (www.uab.edu/ethicsforauthors/).
In addition, all mentors are advised and encouraged to include and document discussions regarding RCR during their one-on-one interactions with their students during mentor/student meetings, lab meetings, and during discussions of authorship on papers, how to handle various types of data, etc. As an example, when manuscripts are written, authorship and peer review are discussed. These recommendations will be disseminated to all training faculty by email on an annual basis at the time trainee applications are solicited.
Finally, we note that UAB is one of eight institutions recently awarded funding by the Council of Graduate Schools and the Office of Research Integrity to develop strategies to integrate RCR educational materials into the graduate curriculum, for use by faculty and graduate students in discussion of scholarly integrity. UAB’s national and international leadership in the area of ethics training was reflected by presentations at the 2010 Project for Scholarly Integrity Capstone Conference and the 2012 ORI conference “Quest for Research Excellence” and were highlighted in the book, “ Research and Scholarly Integrity in Graduate Education: A Comprehensive Approach,” published in 2012 by the Council of Graduate Schools.
A1. Coursework – Year 1 REQUIRED of all Trainees
Principles of Scientific Integrity (GRD 717; 3 credit hours)
Format: The Principles of Scientific Ethics course (GRD 717) includes a blended approach of on-line training and in-person discussion on topics related to the responsible conduct of research (RCR) . Specifically, the on-line training component includes completion of all RCR-related CITI Program modules; participants are required to successfully complete each of these modules, achieving a score of 80% or better. Once completed, participants then attend an in-person discussion session that consists of an all-day (8 hours) Saturday workshop facilitated by training program directors, preceptors, and administrators. Three Saturday sessions are offered so that participants and facilitators have the opportunity to select a date that best fits their schedules. These sessions debate case-studies in a team-based learning format as well as allow for additional RCR-related activities, such as panel discussions with faculty and administrators regarding ‘real-world’ RCR examples and role-playing RCR scenarios.
Subject Matter: Topics covered in GRD 717 include the nature, extent, and causes of fraud in science; UAB policies on fraud; ideals of good science; the responsibilities of authorship and peer review; potential problems raised by the commercialization of research; scientists as public policy advisors; and ethical issues involved in animal experimentation and in clinical trials. Among the areas previously discussed are:
• Ethical Decision Making
• UAB Policies on Research Misconduct
• Protection of Human Subjects in Research
• Welfare of Laboratory Animals
• Best Practices for Data Management
• Identifying and Managing Conflicts of Interest
• Ethical Authorship and Avoiding Plagiarism
• Best Practices in Collaborative Research
• Mentor and Trainee Responsibilities
• Expectations of the Peer Review Process
Duration of Instruction: This course is offered in the Fall, Spring, and Summer semester of each year meeting weekly over the course of the semester.
Faculty Participation: GRD 717 is led by Lisa Schwiebert, Ph.D, Associate Dean, UAB Graduate School, using a “Team Based Learning” approach. She is assisted by faculty facilitators, including T32 program directors, who maintain active research labs and have graduate faculty status. These facilitators lead discussions with graduate students and postdoctoral fellows in the responsible conduct of research.
Scott Ballinger, PhD Medicine / Pathology
Subhashini Bolisetty, PhD Medicine / Nephrology
|Dan Bullard, PhD Medicine / Genetics|
|Jill Butler, PhD Medicine / Biochemistry|
|David Cannon IACUC|
|Anil Challa, PhD Medicine / Genetics|
|David Chaplin, MD, PhD Medicine / Microbiology|
|Lisa Curtis, PhD Medicine / Nephrology|
|Jennifer Frank, PhD Nursing|
|Cristin Gavin, PhD Medicine / Neurobiology|
Mohammad Hassan, PhD Dentistry / Oral & Maxillofacial Surgery
Akhlaque Haque, PhD Arts & Sciences / Government
Anita Hjelmeland, PhD Medicine / Cell, Developmental, and Integrative Biology
|Margaret Johnson, PhD Arts & Sciences / Chemistry|
Bruce Korf, MD, PhD Medicine / GeneticsMargaret Liu, PhD Biomedical Engineering
|Robin Lorenz, MD, PhD Medicine / Pathology|
Mary MacDougall, PhD Dentistry / CraniofacialManoj Mahapatra, PhD Materials Science & Engineering
|Lori McMahon, PhD Medicine / Cell, Developmental, and Integrative Biology|
Ichiro Nakano, MD Medicine / Neurosurgery
Mark Napierala, PhD Medicine / Biochemistry
Lyse Norian, PhD Heatlh Professions/ Nutrition Sciences
Suzanne Oparil, MD Medicine / Cardiovascular Disease
|Joseph Roberson Compliance|
|Linda Roussel, PhD Nursing|
|David Schneider, PhD Medicine / Biochemistry|
|Harry Schroeder, MD, PhD Medicine / Immunology|
|Lisa Schwiebert, PhD Medicine / Cell, Developmental, and Integrative Biology|
|Raj Soorapan, PhD Medicine / Pathology|
Michael Twa, PhD Optometry / Vision SciencesNabiha Yusuf, PhD Medicine / Dermatology
A2. Alternative Courses for Additional Future Training Years:
Research Writing and Style (GRD 712)
This course is designed for pre and postdoctoral trainees managing personal writing efforts (e.g., journal article for publication or dissertation), in which goals for effective strategies of successful writers are conveyed, with emphasis on ethical standards in publishing scientific literature, peer review, and techniques for efficient editing. Topics include the different types of writing that students and professionals do (such as abstracts, proposals, journal articles, progress reports, and correspondence), publishing, and ethical issues related to writing and publication.
The Power of Ethical Thinking (GRD 718)
This all-day workshop offers proactive strategies for avoiding pitfalls in authorship, co-authorship, and team leadership when disseminating and publishing research. The workshop is designed to raise research writers’ awareness of critical ethical issues that can occur in the processes of deadline writing, shared authorship, peer review, copyright adherence, and faithful data/image representation. Students analyze published case studies for risky writing and publishing practices that lead to integrity breaches (including group, mosaic, and accidental plagiarism) and compromised scholarship. More importantly, they familiarize themselves with best ethical practices to apply to their own writing and publishing careers.
Biomedical Ethics (HA 616)
This course focuses on the examination of various faith traditions, theories, principles and methods that influence reasoning, analysis and argument in contemporary health care ethics. Investigation of notable cases, the application of Modern Moral Theory, and in depth discourse on current issues in health care ethics (including media) is the cornerstone of the course.
A3. Institutional Resources
UAB Center for Ethics and Values in the Sciences
The UAB Center for Ethics and Values in the Sciences is committed to providing academic enrichment in the responsible conduct of research. In conjunction with the CCTS, the Center has developed training modules appropriate for self-directed or small group learning. It has also engineered an online Learning Tool for Research Integrity and Image Processing. This web-based learning tool features video illustrations of responsible conduct and best practices for presenting image data in research publications and grants. It also demonstrates issues in image processing for research publications and image-related issues regarding the detection of manipulated data. Users can learn about the boundary between questionable practices and practices that demonstrate research integrity and can improve their decision-making skills in analysis and reporting.
Ethics for Authors
The UAB Ethics for Authors website explores ethical issues for students, researchers and faculty writing who want to follow best practices while incorporating prior source work and writing for publication. The site includes FAQs on citing and writing for research, e-tools and activities, several handouts, presentations, and information on citing and referencing as well as research writing. http://www.uab.edu/ethicsforauthors/
Ethical issues in Underpowered Clinical Trials
By George Howard, DrPH, Professor and former Chair, UAB Department of Biostatistics, this presentation reviews the organizational needs of clinical trials from a statistical perspective and the possible implications as they may impact human subject research.
Center for Clinical and Translational Sciences (CCTS)
The Training Academy of the UAB CCTS is helping to produce intellectually innovative and methodologically rigorous clinical and translational researchers. As part of this effort, this component has an ongoing commitment to the development of training tools in the Responsible Conduct of Research. In collaboration with the Center for Ethics and Values in the Sciences, the CCTS aids in promoting the research ethics training and development of research integrity educational materials at UAB.
Additionally, the CCTS provides a six-month certificate program that provides training in clinical and translational research, including approximately 50 hours of didactic instruction as well as interactive experiences. Course content represents the following modules: Clinical Trials, Epidemiology, Biostatistics, Ethics, Clinical Genetics Research, Behavioral Research, Outcomes Research, Dissemination of Results, and Grant Writing and Funding Opportunities. Sessions are presented by experienced clinical and translational researchers or individuals with special expertise in areas such as grants and contracts and regulatory issues. Preceptors include faculty and research staff from across the CCTS Partner Network.
Office of Postdoctoral Education (OPE; Lisa Schwiebert, PhD, Associate Dean)
The OPE, established in 1999 as one of the first Postdoctoral offices in the country, is instrumental in establishing and maintaining competitive terms, benefits and training programs for all postdoctoral fellows at UAB. It works closely with the University's academic administration, the UAB Council on Postdoctoral Education and the UAB Postdoctoral Association to address the needs and concerns of postdoctoral fellows in a timely and professional manner.
Financial Conflict of Interests in Research Training
Training program for UAB investigators who are responsible for the design, conduct, or reporting of research; Investigators are required by federal regulation and UAB Enterprise Policy to complete training on conflicts of interest prior to engaging in research, charging effort to a federally-sponsored program, and every four (4) years thereafter.
UAB Institutional Review Board for Human Use (IRB; Leslie Cooper, CIP, Interim Director); Collaborative IRB Training Initiative (CITI)
The CITI Courses in the Protection of Human Research Subjects generally provides the initial training opportunity for researches seeking to engage in human subjects research. Online training modules include information for biomedical and social-behavioral researchers in a myriad of areas, including defining research with human subjects, basic IRB regulations and review process, informed consent, social and behavioral research, regulations, assessing risk, records-based research, genetic Research, vulnerable subjects, FDA-regulated research., international research, internet research, HIPAA, and conflicts of interest.
Institutional Animal Care and Use Committee Training (IACUC; David G. Cannon, CPIA, Director)
Before a researcher or trainee may work with animals, he/she must complete IACUC training, which encompasses a set of online modules including an introduction to the IACUC, regulations, policies, and procedures, personnel health and safety, and chemical safety training. Additional species specific training courses are available, which may be customized to the research program.
Occupational Health and Safety Training (OHS; Max Richard, Asst. Vice President)
The OHS provides a myriad of training courses tailored to the research program needs. Some of these courses, based on their broad applicability to fundamental laboratory research, have become standard requirements of pre and postdoctoral training at UAB, including: Hazardous Waste Handling and Packing (CS055), Online Initial Radiation Safety Training (RS1001), Basic Biosafety Training (BIO303), Laboratory Safety Workshop (LSW2001) and Chemical Safety Training (CS101). Other specialized courses are also available, which may be customized to the research program.
A4. Other Resources
RCR Resources - General RCR Training
Funded by a grant from the Office of Research Integrity (ORI) for the Department of Health and Human Services, this resource collates a myriad of html, pdf, and video files focusing on issues of mentoring, student conduct, and scientific integrity. The material is provided in complement to the didactic curriculum made available to our trainees. http://ori.hhs.gov/