The Clinical Perspective - Biomedical Informatics in Translational Research - page 16

Microsoft Word offers functions for calculating readability scores for a docu-
ment. These can be optionally displayed when using the Spelling and Grammar
tools. A student's or children's dictionary can also be a useful tool. It is important
that the consent form be written in the language that the research subjects use; there-
fore, more than one language version of the consent form may be necessary.
Be sure to include all of the required elements as outlined in the CFR in your
informed consent document. These are likely to be reviewed carefully by the IRB.
An excerpt from the informed consent document used by the Clinical Breast
Care Project (CBCP) is shown below. CBCP is a biomedical research collaboration
between Walter Reed Army Medical Center in Washington, D.C., and Windber
Research Institute in Windber, Pennsylvania. The CBCP seeks to decrease morbidity
and mortality from breast cancer and breast disease by providing patients with
state-of-the-art clinical care, including advances in risk reduction. The CBCP is also
committed to a translational research goal of rapidly translating research findings
into clinical practice. The CBCP has a state-of-the-art biospecimen repository to
which research subjects contribute blood and tissue samples. Multiple question-
naires containing clinical data are collected on each patient and biospecimens are,
thus, extensively annotated. Researchers use the repository to conduct proteomic
and genomic research. Clinical data are analyzed in response to proteomic and
genomic analysis and findings. Biomedical informatics scientists develop informa-
tics structures and expand the informatics environment on which the research relies
for rapid translation into the clinical environment. Given the challenges of ade-
quately describing research with many goals in easy-to-understand language, the
section of the informed consent document used by the CBCP that describes the study
is two pages long. The following is an excerpt from that section:
The tissue and blood samples will undergo the primary research studies as described
in the next paragraphs.
This breast tissue can be used for many types of laboratory research looking at
cell changes during breast cancer development, identification of risk factors that
lead to breast cancer, learning why and how breast cancer spreads to lymph nodes,
and breast tissue biology. Some of this type of research on tissue is genetic research.
These research studies may include examination of the gene markers of the breast
cells or lymph nodes, as well as other parts of the breast cells.
The primary research uses of the blood and tissue samples are to study the
genetic makeup, protein changes, and to look for other research markers that may
be associated with breast disease. This information will be analyzed and stored in a
computer database using your assigned code number.
Any remaining blood and tissue samples left over after these studies are done
will remain frozen indefinitely until needed for approved research projects. There
may be future uses of the remaining frozen samples of your blood that are not
known to us at this time. If other research is to be conducted using these samples,
this research also will only be conducted after the samples have been stripped of all
identifiers. It is not possible at this time to predict all the potential future research
uses of the samples. You will be given the opportunity at the end of this consent form