1. Do I have to be ill
or in pain to test the medicines?
No, we are not testing to see if the medicine works or
not. These studies are to find out how the medicine acts in the bodies of
healthy volunteers -- how the compound is absorbed, distributed, metabolized
and excreted.
2. 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,
and our doctor will counsel you about AIDS, HIV and issues relating to the
test. You will be told the result in a confidential manner.
3.How long do studies last?
It varies. Some studies involve visits that last only a few hours and
are called outpatient studies; other studies require overnight stays and are
called residential studies. The longest residential studies may last about
three weeks. Post-study follow-up visits for blood samples are sometimes necessary.
4. Can I do more than one study?
Yes, many of our volunteers qualify for different studies and work with
us a number of times. However, 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 varies between one
and four months, depending on the medicine that was tested. Also, if you are
a blood donor, you must not have donated blood for three months prior to applying
for a study.
5. 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 and PPD. 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 of 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 may 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. These side effects are generally mild and could possibly include
headaches and sickness. For your own safety, it is essential that you always
tell us about all prescription and nonprescription medicines and dietary
supplements that you are taking.
6. What happens if I don't want to continue
at any point during the study?
You can withdraw from a study at any stage.
7. Are there any rules when I am at the clinic?
Yes, we provide you 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, an individual sponsor may have rules
that relate to a specific study. For example, you may be required to eat all
the food provided or to refrain from physical exercise.
8. What do I need to bring with me when I
am on a study?
You need to bring all toiletries, towels and sufficient clothes for the duration
of your stay. Also, you will need to bring enough change for your use of the
phone. Do not bring in any food, drink or cigarettes if it is a non-smoking
study.
9. Is there a telephone?
Yes, there are pay phones for volunteers to use.
10. Are volunteers allowed to bring cell phones with
them when they are participating in a study?
Cell phones that are not camera cell phones are allowed, but no cameras
of any type are allowed in the clinic. Cell phones must be turned off during
study procedures.
11. Is there a medically qualified
person in case of an emergency?
Yes. The health and well-being of every volunteer are our priority. There
is always qualified medical staff available during the day and a doctor on-call
at all times.
12. What happens if you find something wrong with me
at the screening visit?
At the screening visit, we may do tests that you may not normally have
had done in a routine medical checkup. For example, tests may include a heart
trace (electrocardiogram), or blood tests which 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, our doctor
will inform you so that you can take the appropriate action.
13. I am on Social Security benefits. Will they be taken
away?
You are advised to declare payments made to you when you complete a study.
The PPD Clinic is required by law to provide information to the IRS about
payments to volunteers enrolled in studies.
