Thoughts from a Lab Rat

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.