Incoming research fellows paid from our NIH training grants, as part of their research training with us, are required (per NIH policy) to take a formal ethics course, “Responsible Conduct in Research” offered for a week (5 days from 8 AM – 12 PM) in the Molecular Biomedical Research Building (MBRB), over the summer in July. (The on-line mini-course does not suffice for this.) Those who miss the first year must arrange to take it before their second year of research. Those who have already taken this course do not need to do so again, as long as documentation is provided. Research fellows paid from non-NIH sources are expected to fulfill this obligation as well. This course covers issues pertaining to ethics of animal and human subjects; ethics of data acquisition; sharing and ownership of data; mentor and trainee responsibilities; ethics of publication practices; collaboration and peer review; informed consent; research misconduct; and conflict of interest. The incoming research fellow must be made aware of this requirement and can speak in detail about it to the faculty member directing his or her research. Another highly recommended course, “Introduction to Methods in Clinical Research,” focuses on research design. Both courses are offered by our Translational and Clinical Sciences (TraCS) Institute. We pay for the course fee ($50) and for the course booklet. Fellows receive a certificate of completion. Checks should be made payable to the ‘University of North Carolina at Chapel Hill’ and mailed to ‘NC TraCS Accounting, 160 N. Medical Drive, Brinkhous-Bullitt Building, 2nd Floor, CB 7064, Chapel Hill, NC 27599-7064.’ Please note the course title and date in the memo section of the check.

Dr. David Weber of our Division of Infectious Disease teaches these courses. You may contact him about course details by email dweber@unch.unc.edu, pager 347-0639, direct office phone 3-0868, or at hospital occupational health (where he spends a great deal of time) at 6-4480.

Specifically, the Responsible Conduct of Research course is a one-week course organized and taught by Dr. David Weber, MD, MPH, Director of the NC TraCS Institute Regulatory Core. The course covers all NIH-required topics for the first phase of responsible conduct of research training. The course emphasizes the bounds of acceptable conduct including ethical use of animals in research, ethical treatment of human subjects, and conflicts of interest. Through the use of a number of case studies drawn from Scientific Integrity (Francis Macrina, ed. ASM Press, Washington DC, 1995) and Teaching the Responsible Conduct of Research through a Case Study Approach (Association of American Colleges, 1994), the students themselves are very much involved in the teaching process.

Susan Pusek is the Director of Education and Training Programs at our TraCS Institute. You may also contact her about course details by email suspusek@med.unc.edu or at 6-0128.

Because training in “Responsible Conduct in Research” (RCR) is mandated by federal granting programs, and because this course offering through TraCS is limited during the year, our Office of Postdoctoral Affairs offers a course that satisfies the RCR training requirement for the NIH. The primary goal for this course is to address RCR topics such as publication practices and responsible authorship, mentor/trainee responsibilities, research misconduct, and effective communication skills, including management of difficult conversations. The instructor familiarizes postdoctoral trainees with offices on campus where they can get assistance. Upon completing this basic training seminar, postdoctoral scholars have the opportunity to teach the ethics course to graduate students and lead discussion sessions. The course meets for three (3) sessions in the Sonja Haynes Stone Center’s Hitchcock Multipurpose Room 111. You must attend all three sessions to fulfill requirements for the certificate. Breakfast is provided each morning. For course information, please contact the Office of Postdoctoral Affairs at 2-9982.

If your research involves animals, you must visit http://research.unc.edu/iacuc/index.php, the web site for our Institutional Animal and Use Committee (IACUC).

As of March 15, 2005, a new training program for research involving human subjects has been implemented by the Office of Human Research Ethics (OHRE). This training, called CITI (Collaborative IRB Training Initiative), is required of all faculty, staff and students engaged in the planning, conduct, or analysis of research at UNC-Chapel Hill involving the participation of human subjects.

This new training is in the form of a series of modules. You must register for the course, read the required modules, and take the various tests. You must obtain a 75% or better score for each module in order to obtain a certificate. Since this testing takes on average three hours to complete, you can take the modules one at a time and return to them when you have the next opportunity. As this constitutes a major investment of time, you are strongly urged to begin testing if you need to do so. All individuals listed on grants must pass this course to be listed on the IRB submission, and certificates need to be produced prior to initial funding.

The web page is https://research.unc.edu/researchers/policies-procedures/. Individuals certified appear automatically in a database available for you to check your certification. The Research Ethics Training Database is located at http://cfx3.research.unc.edu/training_comp/.

Also, in terms of research, fellows may wish to refer to our Odom Institute for Research in Social Sciences located in 107 Manning Hall, phone 2-3061, fax 2-4777. Research fellows are urged to take the IRB research test, found at http://cme.cancer.gov/c01/. After completing this exam, print out your certificate and email verification that you took and passed the test and notify Dr. Nicholas Shaheen (nshaheen@med.unc.edu) so that he or his assistant can list you in the IRB research database.

It is mandatory that all incoming research fellows paid from our training grant see Elisabeth Rogers, our training grant coordinator, to complete necessary paperwork for appointment or reappointment to the grant. Elisabeth is located in 4160-G Bioinformatics; phone 3-3649, fax 6-7592; email .