Volunteer FAQ
What To Expect FAQ
Bill of Rights for Research Participants
If you are asked to consent to be a subject in a research study, or if you are asked to consent for someone else, you have the right to:
- Learn the nature and purpose of the experiment (also called study or clinical trial).
- Receive an explanation of the procedures and any drug or device to be used.
- Receive a description of any discomforts and risks that you could experience from the study.
- Learn about any benefits you might expect from the study.
- Learn about the risks and benefits of any other available procedures, drugs or devices that might be helpful to you.
- Learn what medical treatment will be made available to you if you should be injured because of the study.
- Ask any questions about the study or the procedures involved.
- Quit the study at any time. Your decision will not be used as an excuse to hold back necessary medical treatment.
- Receive a copy of the signed and dated consent form.
- Decide to consent or not to consent to a study without feeling force, obligation, or coercion.
Volunteer FAQ
Who can be a volunteer?
PPD recruits clinical trial volunteers for a wide range of early development clinical studies. If you are generally healthy and age 18 or older, you may qualify to participate in a study.
You are not eligible for most clinical studies if:
- You use tobacco products, illegal drugs or drink alcohol heavily
- You are trying to become pregnant, are pregnant, have recently given birth or are breast-feeding
How long do trials last?
Each study is different, but you can see most of these details on our clinical trial opportunities. Some studies might require you to stay in our clinic for a weekend or two. In some you may stay continuously for several weeks. Some will require follow-up outpatient visits or phone calls for a period of time and some studies combine all of these elements.
What are the risks?
We refer each study protocol to an Institutional Review Board (IRB) composed of members of the public, including medical professionals, who are independent of the clinic. The IRB evaluates each study protocol to determine if it complies with international regulatory guidelines to ensure volunteer safety and well-being.
The IRB is there to protect your rights, safety and well-being. The board reviews and approves all aspects of each study, including the type and dose of medicine that will be given to you, all the measurements that will be conducted throughout the study and the payment you will receive.
The doses of medicine that volunteers are given are very carefully controlled. Sometimes there might be side effects. All known side effects will be explained to you before you decide whether or not to take part in the study for which you qualify. Most side effects are mild in nature, but the study team, doctor, and informed consent documents will cover everything we know about the specific study and drug you are interested in.
For your own safety, it is essential that you: 1. Always tell us about all prescription and nonprescription medicines and dietary supplements that you are taking, 2. Fully disclose all medical history and answer medical history questions truthfully, and 3. Do not participate in more than one research study at a time.
Are there any rules when I am at the clinic?
Yes, you will be provided a list of house rules for the safety and comfort of all volunteers. These include rules on smoking, alcohol and caffeine use, as well as behavior. In addition, there may be rules that relate to a specific study. For example, you might be required to eat all the food provided or to refrain from physical exercise.
What do I need to bring with me when I am in a study?
You will receive lots of additional details when you come in to screen, but almost everything you need during your stay will be provided by our clinic. We will have scrub bottoms and T-shirts available to you, but you must bring your own undergarments and you may be more comfortable bringing your own clothes to supplement what is provided.
We also ask that you bring your own toiletries, but we do have some supplies to share if you forget something or one of your products isn’t allowed for some reason.
It is also highly recommended to bring entertainment items. We have game rooms, TVs and computers available for use, but most volunteers prefer to bring their own computers, handheld game systems, books or art supplies.
No outside food products, nicotine products or weapons are allowed. More details on what is and is not allowed will be provided at screening.
Are volunteers allowed to bring cell phones with them when they are participating in a study?
Cell phones are allowed; however, if the phone has a camera, it must be covered with tamper-proof tape provided by PPD. No cameras of any type are allowed in the clinic. Cell phones must be turned off during study procedures.
Is there a medically qualified person in case of an emergency?
Yes. The health and well-being of every volunteer is our number one priority. Qualified medical staff are always nearby in the building, and the study doctor is on call at all times.
Trial Process FAQ
Do I have to be sick or have a corresponding underlying condition to test the medicines?
No, most of our trials are looking for healthy volunteers. In these types of studies, we are not testing to see if the medicine works or not. These trials evaluate how investigational products are absorbed and processed in the body while evaluating safety and tolerability.
Some later phase studies do require diagnosed patients and may offer improved outcomes on some illnesses or diseases. If you have a condition that excludes you from our healthy volunteer studies, visit our study listing page to see if we have anything available for you.
Do I have to have a test for HIV?
An HIV test is required for some studies. You will be informed in the screening process as to whether or not you will need to be tested for HIV.
What happens if I don’t want to continue at any point during the study?
Clinical trial participants are willing volunteers and are allowed to stop participating at any time. Our medical staff will guide you on the safety of withdrawing from a study if you have already been dosed with an investigational product, but ultimately, it is up to you to make that decision at any time.
How do I sign up for a study?
You can sign up by calling +1-877-773-3707. A phone recruiter will ask you general questions about your present health and medical history and will schedule an in-person screening appointment if you qualify for the study you have selected.
What happens if you find something wrong with me at the screening visit?
At the screening visit, we may do tests that are not normally conducted in a routine medical checkup. For example, tests might include a heart trace (electrocardiogram) or blood tests that measure the health of your liver. If we suspect something is not quite right, we will do a repeat test to check the results. If we do detect a potential health concern, you will be referred to your primary care doctor with a copy of your lab results by our staff.
General FAQ
Can I do more than one study?
You cannot participate in more than one study at a time, and there is a minimum waiting period between studies. This waiting period is known as the “wash-out” period and can last from a few weeks to several months, depending on the medicine that was tested. Also, if you are a blood donor, you will need to meet a minimum “wash-out” for blood donation, which will vary from study to study.