Healthy Volunteer FAQs

1. What are the advantages of participating in a clinical study?

All clinical study participants receive quality medical care. You also help with the development of safer and better medications for future generations.

2. How do you find out about clinical studies?

Information on clinical studies can be found by contacting us via phone, fax or email. There is also a full listing of available studies found in the available studies section. 

3. How do medications get approved?

Each country has a regulatory authority.  In the U.S., The Food and Drug Administration (FDA) is charged with ensuring the safety and effectiveness of all prescription medications marketed in the United States. In Europe, it is the European Medicines Regulatory Agency (EMEA).  Before the regulatory authority gives the medication manufacturer approval for marketing a given medication, it considers two primary points: whether the clinical studies provide substantial evidence that the medication is effective and whether the medication is safe under the conditions outlined in labeling. Ultimately, the consideration is whether the benefits of the medication outweigh its risks. For life-threatening diseases, there are mechanisms to accelerate the approval process so the treatment can be available to patients sooner. 

4. What questions should I ask before I agree to participate in a clinical study?

You have the right to ask any number of questions of the clinical study doctors and sponsors prior to volunteering. Some questions may include:

  • Has this medication been tested on humans before? If so, to what extent?
  • What is the purpose of the medication?
  • What are the perceived risks?
  • Which company developed the medication?
  • How often will I be given the medication?
  • Will there be any invasive procedures carried out?
  • What is the samples type and how often will samples be taken?
  • How long does the trial last? 

5. What does informed consent mean? 

Informed consent refers to the process by which volunteer patients discover the details of their clinical study. Participants must be provided all facts about a trial prior to giving consent to participate, including treatment details and possible risks and benefits. The informed consent form must be signed by volunteers prior to participation. The informed consent process continues throughout the clinical study.

6. How are clinical study participants protected?

Clinical study protocols are developed to ensure that participants are not put at undue risk. These protocols are carefully reviewed by a committee of experts and lay persons, sometimes called an ethics board or Independent Review Board (IRB), before testing can start. As a volunteer, you have the right to refuse treatment at any point in the clinical study and to leave at any time and for any reason. 

7. Where are clinical studies conducted? 

Quintiles Healthy Volunteer studies are conducted from our facilities in Overland Park, Kansas; London, England; or Uppsala, Sweden.  Clinical studies are typically held within a Phase I unit - the facility in which the study is conducted. For Phase I, volunteers stay within the unit throughout the trial and generally are not allowed to leave the premises due to safety reasons. 

8. What happens in a clinical study?

At its most basic level, a clinical study tests the effects of a potential new treatment on participants. Some participants do not actually receive the test treatment, but instead receive a placebo or standard treatment as part of the "control" group. Your progress is followed closely by doctors. 

9. Why should I consider getting involved in a clinical study? 

There are many individual and personal reasons for participation. Medications on trial today could go on to become the licensed medications of the future, and benefit you or family members. Some participants also enjoy the social interaction with fellow volunteers and staff that they experience while participating in clinical studies. 

10. Will I be paid for taking part in a clinical study?

Yes, you will be compensated for the time you spend with us. Compensation varies by study and depends on time and type of study. We offer in-house and out-patient studies, each varying in length. 

11. How safe are clinical studies? 

All trials contain some form of risk. We have been successfully conducting trials for more than 25 years and have an excellent safety record. Our most experienced experts review the trials and compounds to help enhance participants' safety. 

12. What procedures are involved in clinical study participation?

Typically we require blood and urine samples for analysis, but this may differ from trial to trial. You should be provided with this information during the informed consent process.  

13. Can women participate in clinical studies?

Volunteer populations vary by study. We offer male only, female only, and mixed population studies. Contact our recruitment line to check if any such studies are currently available. You may also register to be informed of any studies you are likely to be suitable for. 

14. How long do clinical studies last? 

Phase I studies can last anywhere from a few days to several weeks. We also conduct out-patient studies where periodic visits are required; these studies usually take place over the course of a month or more. 

15. Will I be tested for nicotine, alcohol and recreational drug use?

Yes, these tests will be conducted at screening, check-in and randomly throughout the course of a study. All results will be treated as confidential. 

16. Will I be tested for HIV?  

Yes. Results will be treated as confidential. In some cases, local government (Kansas) must be informed of positive results. 

17. What do I need to do in order to be considered for a clinical study?

Contact our recruiting department by email or phone.  There is an application process you will go through in order to be considered a qualified participant. 

18. What happens at a clinical study screening?

You are provided with information about the study and a doctor will give you a complete physical. Blood and urine samples will be taken and tested for recreational drug and tobacco use. If your health status matches the criteria for the study, you will be given the option to participate.