By Julie Carrico, MBA, CCRC
I’ve been thinking about that amusing anecdote on social media about a typical day in a dog’s life, where for every event the dog proclaims, “My favorite thing!” For example:
- 8:00 a.m. – Dog food! My favorite thing!
- 9:30 a.m. – A car ride! My favorite thing! And so on, until the day’s final entry:
- 11 p.m. – Sleeping on the bed! My favorite thing!
This blog is about Informed Consent, which is – you guessed it – my favorite thing!
One of the first things potential clinical study participants encounter is a document called the Informed Consent. The following is the official definition of Informed Consent, according to the guideline from the International Conference on Harmonisation, a worldwide advising body for drug research:
A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject’s decision to participate. Informed consent is documented by means of a written, signed, and dated informed consent form.
The importance of careful patient review of the Informed Consent document cannot be overstated. These documents are written in patient-friendly terms so the language is simple and relatively free of medical jargon. The documents spell out exactly what will happen in the clinical study so there should never be any surprises. Our site does not allow patients to sign the initial Informed Consent without having a sit-down meeting to discuss it. If patients are so inclined, we encourage them to share the Informed Consent document with family or trusted friends prior to our sit-down discussion.
And now for my favorite thing! I love it when patients bring their copy of the Informed Consent to our sit-down meeting and it is a bit battered, has notes scribbled in the margins and maybe a post-it note or two sticking out. Why is this my favorite thing? Because it tells me the patient has thoroughly read the Informed Consent, and I know we will have a meaningful discussion about the study, its risks and benefits, and patient responsibilities. In other words, the patient will make an informed decision about whether or not to participate. My favorite thing!
The Clinical Research Center is currently seeking volunteer patients in studies for Alzheimer’s disease, Type 2 diabetes, and those with very high triglyceride levels. Who knows? Being involved in a research study might turn out to be your favorite thing!
If you are interested in learning more about clinical trials, contact the Clinical Research Center at 541-766-2163, or send an email to research@corvallisclinic.com or fill out our Research Study Information Requestform. And, don’t forget to follow us on Facebook at https://www.facebook.com/corvallisclinicresearch.
– Julie Carrico is Associate Coordinator of The Corvallis Clinic Clinical Research Center
