Department of Biomedical Informatics - University of Pittsburgh

Instruction in the Responsible Conduct of Research for all Trainees in the Biomedical Informatics Degree Program

The Pittsburgh Biomedical Informatics Training program provides instruction in the responsible conduct of research through the University of Pittsburgh’s “Research Practice Fundamentals” (RPF). Such instruction is a requirement for all staff, faculty, clinicians, and researchers of the University of Pittsburgh. Begun early in 2000, the RPF project has deployed eight modules.

All trainees in the Biomedical Informatics Training Program will be required to certify in Modules 1, 2, and one of the three HIPAA-related modules (Modules 6, 7, and 8), during their initial first months of training.

Module 1 addresses basic issues of research integrity, Module 2 addresses human subjects research, and Module 3 addresses animal research (those of our students who may be doing research on animals must also complete Module 3). The Research Integrity module includes specific chapters on authorship and publication practices, data management, mentoring, conflict of interest, other investigator responsibilities, and research misconduct. The Human Subjects module includes specific chapters on historical background, current regulations, institutional review boards, informed consent, PI responsibilities, and study documentation. The Animal Research module includes specific chapters on generally accepted practices and ethical principles associated with the use of animals in biomedical research, current regulations of the use of animals in research, the structure and function of the Institutional Animal Care and Use Committee (IACUC), issues involved in the choice of appropriate animal models, and services offered by the division of animal resources, and only those trainees in the Biomedical Informatics Training Program who are using animals in their research are required to successfully complete this module. HIPAA regulations also require our trainees to take one of the HIPAA modules, which depends on your education/position/personnel classification. Researchers must take Module 6; Staff must take Module 7; Physicians must take Module 8. (Trainees who practice medicine at UPMC Health System or another local hospital must complete Modules 6 and 8; trainees who are physicians but do not practice medicine in Pittsburgh need only complete Module 6.)

  • Modules Menu Module 1, Research Integrity
  • Module 2, Human Subjects Research
  • Module 3, Use of Laboratory Animals in Research & Education
  • Module 4, Conflict of Interest
  • Module 5, Human Embryonic & Fetal Stem Cell Research
  • Module 6, HIPAA Researchers Privacy Requirements
  • Module 7, HIPAA Staff Privacy Awareness Training
  • Module 8, HIPAA Physicians Privacy Awareness Training by UPMC

The RPF model has instructional, certification, and documentation components. Each module includes didactic content accessible through an easily navigable Web interface. A pool of multiple choice questions were created for each chapter of each module. Individuals certify their mastery of the content of each module by passing a quiz on each chapter, comprised of a sample of questions from the pool, at the 80% level. After each quiz, RPF users can immediately review their results, with the ability to hyperlink to the content that is most relevant to each question. If a user does not pass a test, s/he can retake the test (with new questions drawn from the pool) until a passing score is attained. Individuals who believe they already know the content of an entire module can certify themselves on that module by passing a 30-item test covering the entire module. Those who do not pass the test on the first attempt cannot retake the test and must certify on a chapter-by-chapter basis.

The certification status of each individual is recorded in a database. Certification in each module must be renewed every three years. All persons in the health sciences involved in the conduct of research are required to certify in relevant modules.

All modules are designed to meet the requirements of NIH and other agencies relating to the responsible conduct of research.

To review the Education Modules and to take the online tests, see the Research Practice Fundamentals website.

Highly Recommended Workshops for Additional Research Training Amplifying the resources available to our trainees, we can recommend, although we do not require, the “The Survival Skills and Ethics” Workshops offered each year by Dr. Michael Zigmond and colleagues. These Workshops have received very positive reviews by both faculty and students. They take place one Saturday each month from September through April. At each Workshop, there are 90 minutes of research ethics instruction on topics that include student-faculty interactions; issues of authorship; fabrication, falsification, and plagiarism; being accurate on your feet; ethical grant applications; honest advertising for a position after training; and social responsibility as a professional. These interactive sessions provide further educational opportunities to our trainees. See http://www.survival.pitt.edu