The Clinical Perspective - Biomedical Informatics in Translational Research - page 28

behooves the principal investigator and study coordinator to become familiar with
the requirements of their IRB. Attention to detail in this phase of research will prove
beneficial as the study is conducted.
After the IRB has granted initial approval of a research protocol, a yearly, con-
tinuing review will be required. The IRB will provide the format for what is called a
Continuing Review application. This is likely to include a progress report of the
number of enrollees during the past year, as well as the duration of the study,
changes in such things as survey instruments, consent forms, or any changes to the
protocol's activities that require approval from an IRB. If any significant events
requiring regulatory reporting have occurred, the original report to the IRB of the
event is included in the progress report.
2.8.2 Implementing the Research Protocol
Once the protocol, consent form, questionnaire/survey instrument(s), and HIPAA
authorization have been approved by the IRB, and the biomedical informatics sys-
tems and repositories are functioning to receive data and specimens, a planned
implementation of the research protocol can take place. Clinical staff responsible for
specimen acquisition need training in exactly how specimens will be obtained, trans-
ported within the clinic, stored temporarily, and shipped to the repository. Team
planning and “dry runs” for every aspect of the acquisition process, but with no
actual specimen, should be considered. This will help ensure that the first batch of
biological specimens sent to the repository location will not be compromised due to
unforeseen problems. Similar “dry runs” should be done with subject enrollment
and clinical data management.
All staff responsible for obtaining informed consent, administering survey
instruments to subjects, and conducting quality oversight on the biomedical infor-
mation collected will need to be thoroughly knowledgeable about the protocol and
proficient in their respective specialties. Completion of a live or online course in the
protection of human subjects is recommended for all staff directly involved in the
research and is required by many IRBs. Courses may be offered through professional
organizations such as the Society of Clinical Research Associates [16]. The Office
for Human Research Protections and the National Cancer Institute offer free
web-based resources for human subjects training [17, 18]. Information about inter-
national codes and ethics for human subject protections is also covered by these
sources. The Collaborative IRB Training Initiative (CITI), out of the University of
Miami, provides a comprehensive selection of educational modules for biomedical
and social and behavioral researchers. Continuing education modules are also
offered as a refresher to ensure that the research staff remains competent in the area
of Human Subject Protection [19]. Staff responsible for consenting subjects to the
protocol, as well as completing the questionnaire/survey instrument, should be
encouraged to keep track of any issues or problems experienced with the consent
form or the survey instrument. Staff meetings are a good forum to discuss “best
practices” in administration of the instrument and consenting of subjects. Also dis-
cuss any questions frequently asked by subjects to help determine which questions
on the survey may need special attention and clarification. This will augment reli-
ability and standardization of both the administration of the survey instrument and