Volunteering, How Does It Work?

The Protocol

Every research study must have a protocol, or a detailed plan that will explain in detail what will be done in the study, how it will be conducted, and why each part of the study is necessary.

Volunteering for a Clinical Trial

Every day, people from all over the world volunteer to participate in clinical trials to help develop new and improved drugs. If you think you want to join them, we would love to speak with you!

PRA International offers healthy volunteers within driving distance of Lenexa, Kansas, the opportunity to participate in many research programs every year at our clinic. Each trial is different; some require only a few quick visits to our clinic while others require an extended stay with us. We encourage you to review our list of current research trials or contact our Recruiters for information on current trials.

If we do not currently have any trials that fit your personal profile, we will, at your request, place your information in our confidential database. As we receive new trials, we will contact you if you may qualify.

Clinical trial participation is voluntary. You are compensated for your time and travel. The total compensation for each trial varies depending on the time commitment required from the participants. Our Recruiters will explain the trial to you. If you are interested in participating, they will schedule an appointment for you to visit with our medical staff (a screening visit). At the screening visit, the trial will be thoroughly explained to you and a free physical exam will be performed. If you and the medical staff agree that this trial may be right for you, you will be invited to participate.

Protecting your Personal and Health Information

Your personal health information is protected by law. Some of this information called Protected Health Information is also protected by law. By signing this consent form, you give permission for your Protected Health Information to be collected and used inside and outside the United States for research at PRA International.

You will not be identified (by name, street address, social security number, etc.) in any information used outside of the clinic unless required by law. If the study results are published, no information will be included that can identify you. The information that will be collected could be a part of your medical record filed at PRA International. You may ask for your medical records at any time.

Phone Screening

Our recruiters will take your study application over the phone. It takes just a few minutes to go over a questionnaire to see if you qualify to screen for a particular study. Once you qualify, and all your questions have been answered, the recruiter will schedule a screening appointment for you.

Informed Consent

Your participation in any clinical trial is voluntary. Before volunteering to participate, you will receive an informed consent. This is a document that explains the details of the study, including the potential risks and benefits, as well as your rights and responsibilities. One of our medical staff will discuss the study with you and answer your questions so you can make an informed decision about whether or not to participate. Also, you may ask questions throughout the course of the study and may remove yourself from the study at any time.

Medical Screening

At this appointment you will provide identification and your medical history. You will then undergo blood and urine screenings, as well as a physical exam and other necessary procedures performed by our physician and medical staff.

 

 

Screening Results

During the screening you will be instructed to call back into the Recruiting department on a specific day and time to see if you have been selected to participate in the study. If you are selected the recruiter will give you further instructions at that time.

Registration of your Information

All volunteers who have filled out an online application, or have completed a phone questionnaire will be entered in our volunteer database.

If you complete a medical screening, we will add the screening information to your file. Only PRA employees responsible for your health are authorized and have access to your file.

Types of Studies

There are two types of research studies:

• Out-Patient Studies: You come to the clinic for one or more visits, but are not required to stay overnight. Visits will range in time depending on the procedures being performed on that particular day.
• In-House Studies: One or more overnight stays are required.

In-House Studies

Volunteers are given a specific time to arrive at the clinic for check-in. At this time check-in procedures are required, such as lab/urine tests and a physical exam. You will once again have the opportunity to go over the informed consent with a staff member. Test results are returned and the final selection is made by the study physician. Disqualified volunteers are sent home and receive reimbursement for their time.

Relax Time

We have given you a lot of information about the study and the participation in it, but there is more!

• We have live musical entertainment for some in-house studies.
• We have activity rooms in which you may enjoy games and TV.
• Small radios, TV’s, and computers are allowed. Headphones must be used.
• Computers are conveniently located in the activity room with internet access.
• Supervised outside activities are allowed for some in-house studies.

Last Visit

Before the study is completed, a post-screening will take place. We want to ensure that you will leave the clinic as healthy as you entered. Because we always encourage volunteer feedback, we ask that you fill out a participant survey following your stay with us here at PRA. After this, your participation for this study is finished.

Participation in a study is more than financial compensation. Besides financial compensation, the research results in much more, because: Thanks to your contribution to drug research, development doesn't stop. Even if a drug does not go public, you will have helped medical science step forward!