I am happy to welcome our Guest Blogger, Mark Hochhauser, Ph.D., here writing about patient informed consent – a subject he is a national expert on.
Before Mark begins, I have included an excerpt of consent language taken from a genetic testing patient form:
“In many cases, a genetic test directly detects an abnormality. Molecular testing may detect a change in the DNA (mutation). Cytogenetic testing may identify whether there is extra, missing or rearranged genetic material. Biochemical methods are sometimes used to look at abnormalities in the protein products that are produced by the genes. Most tests are highly sensitive and specific. However, sensitivity and specificity are test dependent.” (Mayo Clinic)
Written by Mark Hochhauser, PhD
Informed consent is an essential part of medical treatment and clinical research. Ethical guidelines in the Declaration of Helsinki, Nuremburg Code, and US Code of Federal Regulations all emphasize that information given to patients and subjects should be written in “understandable language.”
For decades the Food and Drug Administration and National Cancer Institute have recommended that consent forms be written at a 6th-8th grade reading level. Unfortunately, that hasn’t happened. If anything, consent forms are getting longer and more complicated, instead of shorter and more understandable.
What seems to happening is that in their zeal to “comply” with regulations, drug and device companies and health care facilities are writing consent forms that will meet all regulatory requirements—except they will be incomprehensible to the average patient.
Researchers in health literacy and plain language have been trying to improve the quality of written information that’s given to patients and research subjects, but with very limited success. So…
1) Given your own health experiences, how would you describe the quality of the informed consent conversation and paper documents you’ve experienced?
2) What do you think hospitals, clinics, dental offices, etc. can do to better achieve “informed consent” with their patients?
3) Both medical care and research deal with sick patients across the lifespan. What do you think could be done to better communicate with patients aged 18-100+? Think about how your parents or grandparents deal with the written information they’re given.
4) Living in a multi-cultural society, what can be done to better communicate with patients and subjects with different language, culture, and communication backgrounds?
5) Some health care providers and researchers aggressively market their treatment and research services in ways that may conflict with true “informed” consent, sometimes by over-emphasizing the benefits and under-estimating the risks. Can you suggest some strategies for helping patients and subjects make more informed decisions?
More about Dr. Hochhauser
Mark Hochhauser is a readability consultant in Golden Valley, MN. His 1973 PhD is in Experimental Psychology from the University of Pittsburgh. He’s researched the readability of consent forms, HIPAA notices and patient’s bill of rights, and has 125 presentations and 215 publications. For 21 years Mark’s been an IRB member at North Memorial Medical Center in Robbinsdale, MN. He’s consulted with 21 law firms and has testified as an expert witness on the readability, legibility and comprehension of consumer agreements.