255are required by most publications, and most IRBs will not produce such a determi-
nation after the fact. The vast majority of quality outcomes studies are performed as
retrospective chart reviews of already recorded medical records, although they can
be designed to be prospective. Quality outcomes are not only conducted in hospital
and academic institutions, but they are also necessary for private practices since the
passing of the Affordable Care Act since reimbursement is now also associated with
high-quality services [ 14 ].
Prospective Randomized
Prospective randomized studies are more complex endeavors that require extensive
literature review, detailed protocol development, and, depending on the risk to
patients, a potential full IRB review. They also require a greater time commitment
during the hours of business to allow for not only screening but also to be able to
meet with patients to conduct the consenting process. For residents/students, pro-
spective randomized trials are more feasible if there is an extended frame of time
dedicated to research. Multicenter randomized clinical trials (RCTs) fall into this
category. Although residents and students have limited exposure as to their involve-
ment in RCTs because of their ever-changing schedules and rotations, they can
witness and obtain experience to such studies if they are conducted in any depart-
ments through which they rotate or train in. All RCTs also have an added complex-
ity involving confidentiality clauses requiring stringent lists of the associated
research personnel allowed access to the study with great regulatory effort needed
to add and remove personnel, thus limiting rotating residents and students in the
possibilities of fully participating in them.
Population Studies
Population studies are the current “hot” topic in research. These studies are used to
measure the impact of an intervention in a particular population (i.e., minorities,
women, rural vs. urban). They help to define if disparities exist between different
populations and if interventions need to be adjusted in order to bridge these dispari-
ties. The National Institutes for Health (NIH) and office of disease prevention has
identified six population studies [ 15 ] and has over 50 funding opportunities pertain-
ing to a search on disparities alone [ 16 , 17 ]. Population studies do require IRB
involvement, but they, depending on the study design, can fall into exempt, expe-
dite, and full board review categories.
Regulations and Research Training
In order to conduct any research, certifications, orientations, and other trainings are
required. They are based on federal, state, local, and often institutional policies put
in place to protect both researchers and their subjects whether human or animal.
Residents and students must make sure to familiarize themselves with all of these
prior to conducting any research.
15 Optimizing Research in Surgical Residents and Medical Students