This seminar is designed to meet the basic educational requirements in scientific integrity and the responsible conduct of research as per "NOT-OD-10-019" (Update on the Requirement for Instruction in the Responsible Conduct of Research), November 24, 2009, released by the National Institutes of Health (NIH).
This is a required course for all The Saban Research Institute investigators, post-doctoral fellows, graduate students, It is also a requirement for all clinical fellows. The core of the seminar is the 9 hours of directed discussion among the attendees and faculty facilitators around case vignettes.
Content areas include:
- Conflict of interest: personal, professional, and financial;
- Policies regarding human subjects, live vertebrate animal subjects in research, and safe laboratory practices;
- Mentor/mentee responsibilities and relationships;
- Collaborative research including collaborations with industry;
- Peer review;
- Data acquisition and laboratory tools; management, sharing and ownership;
- Research misconduct and policies for handling misconduct;
- Responsible authorship and publication;
- The scientist as a responsible member of society, contemporary ethical issues in biomedical research, and the environmental and societal impacts of scientific research.
Course Objectives
At the conclusion of the course, participants will:
- Recognize situations of potential abrogation of research integrity.
- Know the initial steps for restoring responsible conduct of research.
- Engage in responsible mentor-mentee relationships.
Certificate of Completion
Attendance and completion of assigned tasks will result in the award of a certificate of completion which stipulates that the individual has met all the federal requirements for such education.
CME Credits
For the clinician scientists attending the course, CME credits may be awarded based on the number of contact hours (1.5 hours per session completed).
Expectations
- Each participant is expected to do the required pre-readings which will be distributed by e-mail one week prior to each session and formulate responses to the readings. The required readings should not take more than 1 hour.
- Active verbal participation in each session is considered an important demonstration of acquisition of and appropriate application of the content of the course. Therefore, participants who do not participate in the discussion during each session may not be awarded attendance credit.
- Attendance at all six sessions is required for certification in this course. It is strongly recommended that all six sessions be completed during one course. However, given the many competing time demands on participants, the course sessions can be completed over 2 or more course repetitions.
- Completion of written evaluations for both individual sessions and the course overall. The faculty for this course have based revisions and to this course on evaluation commentary from past attendees.
Textbooks and Other Readings:
- Pre-readings will be assigned 1 week prior to each course session. These readings will be distributed by e-mail to each registered attendee.
- Recommended textbooks:
- Macrina F: Scientific Integrity: textbook and cases in responsible conduct of research, 3rd Edition. American Society for Microbiology Press, Washington DC. 2005.
- Shamoo AE & DB Resnik: Responsible Conduct of Research, 2nd. Edition. Oxford U Press, New York. 2009.
- National Academy of Sciences, National Academy of Engineering, and Institute of Medicine: On Being a Scientist—a Guide to Responsible Conduct in Research, 3rd Edition. National Academies Press. 2009. [Also available online.]
- Supplementary readings for each session:
- Assignments will be distributed prior to each session.
- Supplementary reference lists will be provided at each session.
Course attendees with disabilities are encouraged to participate. If there are special needs, particularly with respect to participation in the interactive discussions, these should be brought to the attention of the course coordinators (Dr. Lew and Ms. T. Tierney) so that accommodations can be arranged.
Course Calendar
Date
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Topic & Objectives
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Materials & Assignments
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Mar. 1
Saban 3rd Floor Conference Room #302
8 - 9:30 a.m.
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Session 1: Introduction to Responsible Conduct of Research
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Vignettes:
- Mentorship
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Mar. 8
Saban 4th Floor Conference Room #402
8 - 9:30 a.m.
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Session 2: Research Fraud; Responsible Authorship
Additional Resources on Responsible Authorship
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Vignettes:
- Responsible Authorship
- Authorship and Industry
- Falsification of Data
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Mar. 15
Saban 4th Floor Conference Room #402
8 - 9:30 a.m.
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Session 3: Human Subjects Research
Participants will be able to:
- Identify the basic ethical principles which underlie human research and protect the right rights and welfare of human research subjects;
- Apply ethical principles to case scenarios which illustrate difficulties in protecting human research subjects;
- Understand how independent review of human research can help to protect the rights and welfare of human research subjects.
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Materials:
Human Subjects Research Handout
Session Materials:
Responsible Conduct of Research Syllabus
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Mar. 22
Saban 4th Floor Conference Room #402
8 - 9:30 a.m.
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Session 4: Animal Subjects Research
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Mar. 29
Saban 4th Floor Conference Room #402
8 - 9:30 a.m.
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Session 5: Pragmatics of Responsible Research
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Apr. 5
Saban 4th Floor
Conference Room
#402
8 - 9:30 a.m.
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Session 6: Conflicts of Interests in Research
Participants will:
- Recognize situations of potential confict of interest in research.
- List at least 2 approaches for management of conflict of interest.
- List at least 2 types of conflict of interest
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Materials:
Conflict of Interest Pre-Reading
Session Materials:
Conflicts of Interest Dark Side Syllabus
Vignettes:
- Conflict of Interest
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Course Resources - General Resources
Course Resources - Resources on Responsible Authorship
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