Thoughts from a Lab Rat

Every clinic is like a restaurant. Some people adore Mc Donald’s while some people avoid it like the plague. I don’t think there is one restaurant in the world that everyone would equally like.

There are many different clinic environments. Some clinics have that industrial look and feel, like cruising down a Miami industrial area with the theme music from Miami Vice blaring. White buildings with lots of steel and black smoke glass. The interiors with bright colors and minimal furnishings. Yeah, you know the look. Other clinics tend to have a more homely feel with couches, recliners, pictures and flowers everywhere.

I find that the smaller clinics tend to be more laid back as there are fewer subjects. The larger clinics must run with more of an iron fist in order to maintain order and keep all of the subjects in line. It’s not that clinics are trying to be mean to the volunteers.

With any job, there must be rules to be followed in order to ensure that the objectives are being met. In the case of clinical research, each clinic can set their rules to what they believe will get the best results for the study. Certainly we are all adults and can take care of ourselves but anytime you put a bunch of strangers in close quarters, there’s bound to be compatibility issues with each other. The clinic’s main role is to conduct the study and get valid results.

So not everyone is going to like every rule. But again, and I can’t seem to stress this enough, everyone is there voluntarily. You may leave the study at any time, though you will get paid less. It is up to each volunteer to be responsible for him or herself.

So long story short, there are clinics I personally like and some that I’m not fond of. But all clinics are working towards the same goals; conducting clinical research studies in the safest and efficient manner to get new drugs to the market or at the very least, discover what compounds work and do not.

I have been alerted that various clinics have been cracking down on their confidentiality policies. The biggest concern is making confidential information public. The information on the informed consent is confidential information. You are allowed to share the information with family and friends in order to decide if you want to participate in the research study but any other use of the information is strictly prohibited. While the information contained in the informed consent form seems unimportant, it is considered industry information as these studies are being conducted for FDA approval.

While we (lab rats) are very much involved with the clinical research process, we are merely here to collect data. We are not here to draw conclusions about whether a drug is good or marketable. How could we? We are healthy, we rarely have the condition that these drugs are being developed to treat. The only reason why I say rarely is there are some people who are on the borderline of qualifying for most studies and thus are eligible to participate in some patient studies. Let the clinic and the sponsors gather their data and draw their conclusions based on fact and not hearsay.

People who participate in research studies need to be careful with the information they share. Certainly, there is a difference between saying “I did an HIV study and I got a rash” and “I did XYZ drug made by XYZ pharmaceuticals and man it gave me a rash.” Bottom line is that you should not be sharing your adverse effects with anyone other than the study staff and principle investigator. As I said, its okay after the study to say you did a study and got a rash but any information beyond that is confidential.

Now some of these points may seem hypocritical as I provide lots of information about clinics. The majority of this information is provided on their websites while many clinics have voluntarily provided the information. I am careful to only include information that is relevant as well as useful for volunteers to plan their studies. Certainly the fact that one clinic provides color coded shirts is not going to be the deciding factor of whether a drug passes the trial. And of course any clinic may contact this site to have inappropriate information corrected or removed.

The reason why most clinic ban camera phones and webcams is not so much to protect the way the clinic operates but to protect the people participating in the studies. Everyone is entitled to privacy while participating in a research study. This includes their health records and the fact that they are even there. Clinics will not disclose whether someone is participating in a trial if someone called. So by banning cameras, this further protects the volunteers from people finding out that they are in a study. Not everyone wants people to know and that is their right under the Health Insurance Portability and Accountability Act (HIPAA). While not all clinics make you sign a HIPAA form, you still have the right to privacy. So, while not having a cell phone may be a bummer during a study, you are helping to ensure the privacy of yourself and others.

In order to help affirm this site’s dedication to promoting ethical and responsible volunteering, a new policy has been implemented for the message board.

Posting of confidential information such as informed consent forms, information from informed consent forms, side-effects you have experienced with a drug name mentioned, or the full names of clinic staff including principle investigators is prohibited. Posts with such information will be edited or removed.

So, you just finished up a study. So now what? Well, many clinics recommend that you take an iron supplement to help replenish your red blood cells and hemoglobin. While your body does need the extra iron, you will be better off eating foods that are naturally high in iron. Natural iron absorbs quicker and more complete than supplements. Foods that are high in iron include red meat, oysters, mussels, clams, shrimp, beans and green leafy vegetables. If you feel you must take a supplement, take an iron-complex supplement rather than iron by itself. The iron-complex comes with additional elements like vitamin C which aid in the absorption of the iron.

Once you complete a study, you should not have unprotected sex for a period of at least 90 days or as outlined in the informed consent. The effects of an experimental study drug are unknown and can be harmful to child conceived while taking the drug. If you have sex during this time, you need to use a double-barrier method of birth control.

All clinics in the US require a minimum 30 day washout period between studies. During this time, you must not participate in another clinical research study. Some drugs will have longer washouts in order to be sure that the drug is completely out of your system and your body allowed enough time return to normal. At most clinics, you can screen for another study during the washout period as long as the study checks in after the required washout period. I recommend waiting at least 2 to 3 weeks after the completion of the previous study before screening for another. Certain clinics, sponsors or study specific guidelines will determine when the washout period begins. Sometimes it is the last dosing date, sometimes the last participation date (check out or out patient visit).

Study Payments

Every clinic has their own policies on how and when they pay your stipends. Every clinic usually outlines their payment information in the informed consent and or house rules. Generally, short studies (less than a week) will be made in one lump payment in the mail. Longer studies (over a week and or multiple stays) may have two or more payments. Again, there is no set standard and each clinic can pay you however and whenever they like. Most clinics will specifically say 7 to 14 business days once the study is complete but most times you will get it sooner.

It is important to note that most clinics operate on a completion payment system. That means that in order to get the full advertised amount, you must complete all parts of the study. This includes all in-patient and out-patient visits. Failure to complete all parts will result in forfeiture of the completion bonus as most clinics call it. Many clinics also fine you if you are late to your procedures or fail to follow all the clinic rules. If you are fined, this can delay your payment.

So it’s best to make sure you follow all the rules, be on time to all of the procedures (that is what they are paying you for after all) and complete all parts of the study.