RECOMMENDED TERMS FOR USE IN CONSENT FORMS
To facilitate understanding of consent forms by the subject, it is recommended that the language used is at a reading level of an 12 year old (eighth grade reading level). The following lay terms, definitions and suggestions are recommended to help investigators in this process.
TermLay Definition
affectivelyemotionally
agitationupset
amelioratemake smaller or less, reduce
analgesiapain relief
anaphylactic shocka severe and sometimes dangerous reaction which may cause problems breathing, fainting, itching and skin rash
aspirationremoval by using a sucking machine
barrier methoddiaphragm and condom (with spermicide), cervical cap, or sponge
biomicroscopyexamination, looking at
clinical statusstate of health, how you are doing and feeling
clonalitygrown from a single cell
completeddone
consequencesresult or effects
conventional therapystandard treatment
culturetake a sample of blood, tissue to see if bacteria or viruses can be found in it
dehydrationloss of fluids
dilationexpansion or stretching
discomfortpain, uncomfortable
disseminatedwidely-spread, all through
double-blindneither subject nor physician can know what is being given
efficacyproducing a positive result
electrocardiogramheart test
erythrocytered blood cell
gastrointestinalstomach and intestines
granulocytewhite blood cell
hematocritnumber of red blood cells
HLA-matchedtissue matched, similar to
hormonal therapytreatment with hormones
human trialspatient studies
hypertensionhigh blood pressure
hypotensionlow blood pressure
incidencenumber of new illnesses
increased dosehigher dose
infectious occurrencesinfection
intravenousby vein
investigatordoctor/researcher
lactatingnursing
marrow suppressiondecreased growth of bone marrow
morbiditysickness/illness
mortalitydeath
murineobtained from mice; from mice, mouse
neural cresttissue of brain and nerves
obviateto prevent
occult blood testtesting a stool sample for trace amounts of blood
pancytopenialow number of blood cells
past historyhistory
placeboinert substance, inactive medication, dummy pill
post-after
probabilitychance
productiongrowth
psychological disturbancementally disturbing or distressing
psychosismajor mental problem
rarelyin rare cases
relative toafter
renalkidney
respiratory failurelung failure
significantly shortenmay shorten
subcutaneousunder the skin
subsequentanother, next
tachycardiarapid heart beat
taperreduce, decrease
therapytreatment
thrombosisget or have a blood clot
topicalproduct applied to skin
toxicityharm, problem, poisoning
transientshort-term, brief
trialstudy
tubingtube
uremiakidney failure
vasodilationwidening of the blood vessels
vehicle preparationplacebo cream (inactive preparation)
venipunctureby vein
viaby
visual motor, fine motor,coordination
and spatial skills
waivegive up
washout periodexplain detail[1] based on study design
Requests for terms to be followed by definitions in parentheses:
allergic reaction (such as itching and swelling)
allogeneic (provide definition)
autologous (provide definition)
biological engineering components (provide definition)
cardiac events (provide definition)
cataract (a whitening of the lens)
chemotherapy (treatment of diseases with chemicals)
erythropoietin (a protein that helps the growth of red blood cells)
FDA (Food and Drug Administration)
glaucoma (increased pressure in the eye)
IgE, IgG, IgM (provide definition)
immunoglobulin (antibodies)
immunologic (provide definition)
lymphocytes (white blood cells that take part in resistance to disease)
minor transplantation (provide definition)
molecular probe (provide definition)
monoclonal antibody (very specific, purified antibody)
placebo (a substance, such as a sugar tablet, containing no medication)
radiotherapy (treatment with radiation)
randomly assigned/randomization process (similar to the toss of a coin)
serum sickness (allergic reaction to the injection of a foreign "serum" - blood component)
skin punch biopsy (provide definition)
suction biopsies (provide definition)
syngeneic (provide definition)
Zidovudine (AZT)
General Requests
-Rather than abbreviating such words as teaspoon and tablespoon, please spell them out. Rather than using ml. or cc. as a volume representative, give a volume equivalent in teaspoons or tablespoons.
-Define terms such as "CIG" and "GVHD" the first time used before referencing the abbreviation throughout the text.
-Do not use symbols such as ">"; use "greater than."
-Describe study design procedures such as "double blind," "randomized," and "placebo/controlled" when the concept(s) is/are first introduced.
-Use page numbers on protocol, consent and any other documents.
-Keep sentences simple - divide into two when necessary.
Glossary of Terms/Informed ConsentPage 1
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(Rev. 12/1205)
[1]Waggoner, William and Mayo, Diane M.: TITLE IRB 1995; 17(1):6-9