The responsibilities of a clinical research volunteer
First and foremost, research subjects are volunteering to participate in a clinical research study. Nobody is forcing anyone to do a study. Certainly the clinics make it enticing with the prospects of earning a small or large stipend for completing a study, but it is still your decision to screen and check-in to a study.
The primary concern of the clinic is to get valid and accurate study results from the volunteers. Every procedure is timed for a reason. The drug company and the FDA must know that every subject was given the study medication, all blood collections and study procedures were collected at the same time intervals. If some subjects are late, then the results are useless because the time intervals are different. It is your responsibility to keep an eye on your upcoming procedures and to be early. Times listed on your clipboard or itinerary is the time the procedure must be done, not when you should show up. You should always show up 3 to 5 minutes before the scheduled procedure. Many studies have additional restrictions and rules. These are usually put in place due to the class of drug you are taking and because of known potential side-effects. The clinic is also concerned about your safety and will enforce these restrictions. Bottom line, the clinic is paid by the sponsor to carry out the study in a predetermined way and the clinic staff will follow the protocol to the T. If you don’t wish to continue the study, you are free to leave at any time.
Every clinic has rules of conduct that are to be followed by all research subjects. Why do clinics have rules? Because without rules and protocols, the study would be chaos. Sometimes even with rules, the studies can be chaotic because some volunteers choose not to follow some or all of the rules. It’s pretty simple. And more clinics are taking a more serious stance on infractions. If you break the law while driving your car, you get fined. If you commit a serious enough offense, you get arrested. It is the same in a research study. Most clinics will fine you if you are late to a procedure. They may fine you more if you are constantly late. They may fine you more for more serious infractions like vandalism. If you commit a major infraction like fighting, theft or serious vandalism then you may be removed from the study with the loss of part or most of your earned study stipend and not allowed to do future studies which in the real world would amount to life in prison without parole.
Some volunteers believe that if they don’t get caught, their not causing any harm. Well, I’ve got news for you! When you participate in a research study, you are confined to a relatively small space with many other volunteers from various backgrounds, ethnicities, religious beliefs, ages and so on. What seems appropriate to you and your background may be offensive to someone else. Simple manners here. It seems silly to even have to write an article about this but if I didn’t see this happen all day long in the studies I do, then I wouldn’t be writing this! Treat others as you would like to be treated. Respect others people belongings including the clinic’s property. Don’t borrow stuff unless you ask the rightful owner. Throw away your trash into a trash receptacle. Flush the toilet. Throw your towels in the laundry hamper. Turn your lights out at bed time. These are all simple manners you should have learned in preschool but many of the volunteers must’ve missed that day.
Long story short, every clinic has an informed consent form and a rules agreement. When you sign those forms, you are agreeing to follow the rules and outlines of the study, Failure to do so is a breach of contract so don’t be surprised if you get fined or thrown out of a study for not following the rules. There are many people out there who would love the chance to volunteer for a study and get paid, so if you don’t like doing studies, don’t complain all day and make it miserable for others around you. Go do something else. Go back to work at Taco Casa. If you choose to participate in a study, take it seriously because the lives of millions are at stake. People need medications to treat their aliments and the longer a potential drug is tied up in clinical trials, the more people suffer. Look beyond the money and see what clinical research is all about.
