Informed consent is based on communication, requiring language to convey meanings and ensure understandings. The purpose of this study was to investigate the use of language in informed consent documents used in the genetics research funded by Canadian Institutes of Health Research and Genome Canada. Consent documents were requested from the principal investigators in a recent round of funding. A qualitative content analysis was performed, supported by NVivo7™. Potential barriers to informed consent were identified, including language that was vague and variable, words with both technical and common meanings, novel phrases without clear meaning, a lack of definitions, and common concepts that assume new definitions in genetics research. However, we noted that difficulties in comprehension were often obscured because the words used were generally simple and familiar. We conclude that language gaps between researcher and potential research participants may unintentionally impair comprehension and ultimately impair informed consent in genomics research.
AlbrechtTLFranksMMRuckdeschelJC (2005) Communication and informed consent. Current Opinion in Oncology17: 336–339.
2.
AppelbaumP (2002) Clarifying the ethics of clinical research: A path toward avoiding the therapeutic misconception. American Journal of Bioethics2(2): 22–25.
3.
BayertzK (1998) What’s special about molecular genetic diagnostics?Journal of Medicine and Philosophy23(3): 247–254.
4.
BeardsleyEJeffordMMileshkinL (2007) Longer consent forms for clinical trials compromise patient understanding: So why are they lengthening?Journal of Clinical Oncology25(9): E13–E14.
5.
BeauchampTChildressJ (2001) Principles of Biomedical Ethics. Oxford: Oxford University Press.
6.
BedellSEGraboysTBBedellELownB (2004) Words that harm, words that heal. Archives of Internal Medicine164: 1365–1367.
7.
BhuttaZA (2004) Beyond informed consent. Bulletin of the World Health Organization82(10): 771–777.
8.
BjornERosselPHolmS (1999) Can the written information to research subjects be improved?: An empirical study. Journal of Medical Ethics25(3): 263–267.
9.
BubelaTMCaulfieldT (2004) Do the print media “hype” genetic research? A comparison of newspaper stories and peer-reviewed research papers. Canadian Medical Association Journal170(9): 1399–1407.
10.
BurgessM (2007) Proposing modesty for informed consent. Social Science & Medicine65: 2284–2295.
11.
Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada and Social Sciences and Humanities Research Council of Canada (2010) Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans.
12.
CatanzaroM (1988) Using qualitative analytical techniques. In: WoodsNFCatanzaroM (eds) Nursing Research: Theory and Practice. Thousand Oaks, CA: SAGE, pp. 437–456.
13.
ChappleACampionPMayC (1997) Clinical terminology: Anxiety and confusion amongst families undergoing genetic counseling. Patient Education and Counseling32: 81–91.
14.
ConditCMArcherPSefcovicE (2002) The changing meanings of “mutation:” A contextualized study of public discourse. Human Mutation19: 69–75.
15.
ConditCMDubriwnyTLynchJParrottR (2004) Lay people’s understanding of and preference against the word “mutation”. American Journal of Medical Genetics: Part A130: 245–250.
16.
CorriganO (2003) Empty ethics: The problem with informed consent. Sociology of Health & Illness25(3): 768–792.
17.
CoxGBurgerJLipVMauUWuBHorsthemkeB (2002) Intracytoplasmic sperm injection may increase the risk of imprinting defects. American Journal of Human Genetics71(1): 162–164.
18.
Department of Health and Human Services (HHS) (2009) Policy for Protection of Human Research Subjects (45 CFR 46). Washington, DC: HHS.
19.
ErbyLHRoterDLarsonSChoJ (2008) The rapid estimate of adult literacy in genetics (REAL-G): A means to assess literacy deficits in the context of genetics. American Journal of Medical Genetics: Part A146(2): 174–181.
20.
FarrellMDeusterLDonovanJChristopherS (2008) Pediatric residents’ use of jargon during counseling about newborn genetic screening results. Pediatrics122(2): 243–249.
21.
Ghulam AT (2006) Patients’ satisfaction with the preoperative informed consent: A multi-centre questionnaire survey in Switzerland. Mayo Clinic Proceedings81(3): 307–312.
22.
GraneheimUHLundmanB (2004) Qualitative content analysis in nursing research: Concepts, procedures, and measures to achieve trustworthiness. Nurse Education Today24: 105–112.
23.
GreenJBDuncanRBarmesGOberklaidF (2003) Putting the “informed” into “consent”: A matter of plain language. Journal of Paediatrics and Child Health39(9): 700–703.
24.
HochhauserM (2000) The informed consent form: Document development and evaluation. Drug Information Journal34(4): 1309–1317.
25.
HodgsonJHughesELambertC (2005) “SLANG”: Sensitive language and the new genetics: An exploratory study. Journal of Genetic Counseling14(6): 415–421.
26.
HolmesJ (2001) An Introduction to Sociolinguistics. Toronto, ON, Canada: Pearson Education Ltd.
27.
HsiehHFShannonS (2005) Three approaches to qualitative content analysis. Qualitative Health Research15(9): 1277–1288.
28.
IssaAM (2002) Ethical perspectives on pharmacogenomic profiling in the drug development process. Nature Reviews: Drug Discoveries1: 300–308.
29.
JeffordMMooreR (2008) Improvement of informed consent and the quality of consent documents. Lancet Oncology9: 485–493.
30.
LanderESSchorkN (1994) Genetic dissection of complex traits. Science266(5181): 2037–2048.
LippmanA (1991) Prenatal genetic testing and screening: Constructing needs and reinforcing inequities. American Journal of Law & Medicine17(1–2): 15–50.
33.
LissPAspevallOKarlssonDForsumU (2004) Interpreting definitions: The problem of interpreting definitions of medical concepts. Medicine, Health Care and Philosophy7: 137–141.
MillerFAAlvaradoK (2005) Incorporating documents in qualitative nursing research. Journal of Nursing Scholarship37(4): 348–353.
38.
MillerFBegbieMGiacominiMAhernCHarveyE (2006) Redefining disease? The nosologic implications of molecular genetic knowledge. Perspectives in Biology and Medicine49(1): 99–114.
39.
MurgatroydRJCooperR (1991) Readability of informed consent forms. American Journal of Hospital Pharmacy48(12): 2651–2652.
40.
MykitiukRNiskerJ (2010) The social determinant of “health” of embryos. In: NiskerJBaylisFKarpinIMcLeodCMykitiukR (eds) The “Healthy” Embryo: Social, Biomedical, Legal, and Philosophical Perspectives. Boston, MA: Cambridge University Press, pp. 116–135.
41.
PassargeE (2007) Color Atlas of Genetics. New York, Stuttgart: Thieme Publishers.
42.
PetersenA (2001) Biofantasies: Genetics and medicine in the print news media. Social Science & Medicine52: 1255–1268.
43.
PothierD (2005) Many patients may not understand consent forms. British Medical Journal330: 1151.
44.
RothsteinMABillingsP (1992) But is he genetically diseased?Hastings Center Report22(4): S18–S21.
45.
SankarP (2004) Communication and miscommunication in informed consent to research. Medical Anthropology Quarterly18(4): 429–446.
46.
SpeedE (2006) Patients, consumers, and survivors: A case study of mental health service user discourse. Social Science & Medicine62: 28–38.
47.
StablefordSMettgerW (2007) Plain language: A strategic response to the health literacy challenge. Journal of Public Health Policy28: 71–93.
48.
SteadMEadieDGordonDAngusK (2005) “Hello, hello: It’s English I speak!”: A qualitative exploration of patients’ understanding of the science of clinical trials. Journal of Medical Ethics31(11): 664–669.
49.
StraussACorbinJ (1998) Basics of Qualitative Research: Techniques and Procedures for Developing Grounded Theory, 2nd edn.London: SAGE.
50.
StrijbosJMartensRPrinsFJochemsW (2006) Content analysis: What are they talking about?Computers & Education46: 29–48.
51.
SutherlandHLockwoodGTritchlerDSemFBrooksLTillJ (1991) Communicating probabilistic information to cancer patients: Is there “noise” on the line?Social Science & Medicine32(6): 725–731.
52.
ten HaveH (2003) Genetic advances require comprehensive bioethical debate. Croatian Medical Journal44(5): 533–537.
VanstoneMKinsellaEANiskerJ (2012) Information-sharing to promote informed choice in prenatal screening in the spirit of the SOGC clinical practice guideline: A proposal for an alternative model. Journal of Obstetrics and Gynaecology Canada34(3): 269–275.
55.
WaggonerWCMayoD (1995) Who understands? A survey of 25 words or phrases commonly used in proposed clinical research consent forms. IRB: Ethics and Human Research17(1): 6–9.
56.
WaggonerWCShermanB (1997) Who understands? A survey of 27 words, phrases, or symbols used in proposed clinical research forms. IRB: Ethics and Human Research18(3): 8–10.
WertzDC (2002) Genetic discrimination: An overblown fear?Nature Reviews: Genetics3(7): 496.
59.
WertzDCKnoppersBM (2002) Serious genetic disorders: Can or should they be defined?American Journal of Medical Genetics108: 29–35.
60.
WhiteT (2001) “Get out of my lab, Lois!”: In search of the media gene. In: HindmarshRLawrenceG (eds) Altered Genes II: The Future?Melbourne, VIC, Australia: Scribe Publications, pp. 69–81.
World Health Organization (WHO) (2011) Standards and Operational Guidance for Ethics Review of Health Related Research with Human Participants. Geneva: WHO.
