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are not limited to animal care and use, biosafety and biosecurity, conflicts of interest,
good clinical practice (GCP), good laboratory practice, information privacy and
security, responsible conduct of research, and human subject research. The human
subject research course is the base requirement needed to able to conduct the major-
ity of clinical research outlined in this chapter. All of these courses are conducted
online at http://www.citiprogram.org and include modules consisting of reading followed
by quizzes that require a minimum of 80% passing to achieve certification.
There are several other training opportunities available to help learn about the
theoretical concepts on conducting research. Some institutions hold annual clinical
research training seminars that they provide instruction and insight for young inves-
tigators or new (to the institution) investigators [ 21 ]. The NIH office of extramural
research offers an online course on protecting human research participants at https://
phrp.nihtraining.com as well as providing training courses for their own investiga-
tors. The FDA collaborates with the NIH on the training offered online. For students
and residents with a burning desire to earn a more formal research education, there
are opportunities for the completion of a certificate in clinical research (usually
1 year programs) or masters in research [ 22 , 23 ].
Even with all of the required training and optional graduate level research train-
ing available, as with any discipline and especially medicine, learning and reading
are not the same as actually conducting it.

Executing Research

For every complex problem there is a simple answer, and it is wrong. H.L. Mencken

Collecting the information may be the easiest part of any research project. The
most difficult aspects are coming up with the question, designing the study, analyz-
ing the data appropriately, and having enough time to do it in. The ultimate goal is
to produce a timely, quality finished product that is publishable or presentable with-
out violating any rules.

The Logistics

After research training is completed and a question has been identified, the actual
process to set up the study has to begin. After a thorough literature review is con-
ducted to verify that the question posed is novel, a protocol must be written. Case
reports aside, a protocol (templates available with most IRBs) should include objec-
tives, background, study design, methods, data analysis, inclusion and exclusion,
identified research team (if necessary), and a clear outline of data points to be col-
lected. A carefully crafted research protocol in the beginning produces approxi-
mately three quarters of the manuscript required at completion. Care must be taken
to review the study methodology so as to not to fall into some common mistakes that

15 Optimizing Research in Surgical Residents and Medical Students