Professor Knighten Writing 39C Robert Wong

What is informed consent? What is defined Informed consent is a legal procedure to ensure that a patient, client, and research participants are aware of all the potential risks and costs involved in a treatment or procedure. The elements of informed consent include informing the client of the nature of the treatment, possible alternative treatments, and the potential risks and benefits of the treatment. What it should mean The same definition written above, but with an emphasis on making sure the patient comprehends the relevant information to make an informed decision.

What is the problem and why? Patient comprehension is key towards informed consent. Problems that arose from a lack of comprehension: Moore v Regents of the University of California (1990)- Cell ownership Havasupai Tribe of the Havasupai Reservation v. Arizona Board of Regents and Therese Ann Markow  (2004)- Use of cells for a different study Target Ranges of Oxygen Saturation in Extremely Preterm Infants (2010)- Study on mortality of extremely early birth infants. Trying to prevent something that has not have much information to them.--needed better explanation It is the responsibility of the patients to read and decide what is best for them, but is it correct to let them sift through a vast sea of information? Misunderstanding, mostly due to assumptions of what the result will be like, usually lead to conflicts. Like Moore vs Regents of the University of California. Moore had signed the consent form saying he would allow use of his organs after removal, however he was not informed of the potential gains that his doctor have exploited from him afterwards. Personal influence from Dr. Golde interfered with his ability to make an informed consent. Target- 2005-2009

How does it affect you? Researchers from Arizona State University enters into a research partnership in 1989 called the Diabetes Project with Havasupai tribe members. ( health edu, collecting and testing blood samples) Consent was obtain for the research on “studying the causes of mental/behavioral disorders” for type 2 diabetes. Informed consent was NOT obtained on what the study actually… studied. The problem is that the research is being conducted on a different path than it promise, contradicting their tradition. Herein the cause can be solved by comprehension. English is the 2nd language to them, so things were simplified. It does not mean it has to be Question to note: Is it necessary, for instance, to ask someone who has donated DNA for research on heart disease if that DNA can be used for Alzheimer’s or addiction research? Years later, the samples were used to study things like schizophrenia, alcoholism, and inbreeeding.

My solution Attributes used: Study done by University of Michigan in 2012-2013 Use of a revised informed consent form with easier to understand Attributes used: Readable Formatting Graphic Verbal disclosure Message length Done by researchers in University of Michigan Formatting= putting relevant information like risk, benefits, purpose, conditions, compensation, and rights closely together

The results? Most of the participants have a college grade or higher education. Use of all five attributes shows higher comprehension rate.

Another approach Electronically assisting consent forms Conducted by the Midwestern University of Philadelphia in 2008 Study involved use of a web module that uses a test format to test for comprehension Patients were given a test a day before the exam and right before a procedure to test for comprehension. Questions, written down during the quiz section, were answered by their physicians the next day. Overall, comprehension is improved dramatically. (10% on this graph is statistically significant. ~33->37/40) Done by Midwestern university of Philadelphia 2008-2009 Quiz would have a selected writing portion in which questions were of a qualitative variety. This allows for patients to have a prepared set of question they could ask later on that couldn’t be answered then.

But atlas people still have problem. Even though study result shows positive improvement to comprehension, other factors can bias these solution: Health Literacy- Understanding of how health works. Actual patient-doctor interaction- Not small talks. People- No matter what there will always be some sort of misunderstanding, slight if not confused. Still, many people will not understand due to them simply not following through.

Bibliography http://genetics.ncai.org/case-study/havasupai-Tribe.cfm http://jme.bmj.com/content/37/4/194.long (A novel method to enhance informed consent) http://archpedi.jamanetwork.com/article.aspx?articleid=1686980 (Informing the uninformed) http://archpedi.jamanetwork.com/article.aspx?articleid=1686981 (Can we keep it simple?)