21)How are volunteers selected?
Volunteers are selected based upon the results of the screening procedures and lab tests, among the leading causes of rejection are lab results that show
abnormalities in the blood or urine. Besides testing your blood for HIV and hepatitis, most clinics check if your blood has enough red cells (cells created by iron) and
haemoglobin (the protein in red cells that contains iron) , and a normal number of white cells (cells that protect against infection and illness). If your blood is low in
either red cells or haemoglobin, then this means you have an iron deficiency, and you might be anaemic. This is usually resulting from a loss of blood. Naturally, many
women become anaemic during their period. You can build up your iron stores by taking iron supplements whenever necessary, or by eating a lot of iron-rich foods. If your
blood is low in white cells, then your immune system is weak, and you have a greater risk of contracting infections such as cold and flu. Also, exposure to viruses and
bacteria may lead to an increase in your number of white cells which is necessary to fight an infection. Therefore, if too many white cells are present in your blood,
this may indicate you already have an infection. You can limit exposure to germs by washing your hands regularly, and you can keep up your resistance by getting adequate
rest and by avoiding too much strenuous exercise. If you do get sick, drink plenty of water to flush out your system, which can help speed your recovery. Urine samples
are routinely tested for drugs of abuse, alcohol, and common medications. They may also be tested for the presence of blood, sugar, and protein, any of which may be
considered an indication of possible infection or disease. To improve the chances of all the test results being normal, you will want to eat a healthy balanced diet,
avoid excessive drinking, and avoid using drugs or medications if at all possible.
22) What happens if I make the study?
You will be given a time to arrive at the clinic, usually on the day or evening before the study starts. You may be asked to phone a day or two prior to
confirm that you are still interested and intend to show up. You will be told to abstain from drugs, most or all medications, alcohol, smoking, and possibly caffeine,
multi-vitamins, and herbal remedies, as well as strenuous exercise. You may also be asked to fast (not eat) for 4-12 hours before coming in, though this is not common.
You are expected to show up at or before your check-in time and you disregard this at your peril. Arriving late without phoning ahead is never a good idea if the clinic
has a surplus of volunteers. Upon arrival, you will usually need to repeat at least some of what was done on the screening day, i.e. blood and urine samples may be
collected, as well as height, weight and vital signs, ECG, and a physical examination by the study doctor. You may also have your breath tested for the presence of alcohol
and nicotine. At some clinics, you may be required by the staff to allow a search of your personal belongings. The reason for "bag checks" is to ensure that
volunteers have not brought into the clinic anything that is prohibited. The search may be a thorough one, or just a quick once-over. Prohibited items include most or all
of the following, depending upon the clinic: - Drugs and medications of any kind - Food and drink - Sweets/candy and chewing gum - Cameras (for privacy reasons) -
Cellphones (they can interfere with medical equipment)
23) What happens during a typical study?
Obviously it depends on the type of study as to what is involved, but a typical "in-house" study will probably run something like this: Within
8 to 24 hours after check-in, the "study day" begins. If it is a drug trial, this is the time you will be "dosed" (given the study drug). This will
usually happen in the morning of the day following check-in, and usually after you have fasted for at least eight hours, though some studies feed you breakfast just before
you are dosed. The drug could be administered in any one of several ways. The most common is to use an oral medication, either in pill form (tablet or capsule), or by
drinking a liquid or powder solution. Other study drugs might be inhaled, injected, rubbed onto the skin, or absorbed from a patch applied to the skin. On many studies, a
placebo (a dummy drug with no active ingredients) is given randomly to some subjects during each phase of the study. After dosing is completed, back-up subjects are sent
home. The hours following dosing are likely to include most or all of the following: - Blood samples - Blood will be taken at regular intervals, most frequently in the
2-4 hours after dosing. Blood is drawn from the arm using either a needle and syringe, or an intravenous cannula (a small plastic tube that is usually inserted into a
forearm vein). The more blood samples required, the more likely you will have a cannula. - Fasting - You will usually be required to fast for between 2 to 6 hours after a
dosing, so they can be sure that food is not affecting the absorption of the drug. - Position or activity restriction - Some studies may require you remain upright
(sitting or standing) for 2 to 4 hours after dosing, and some require you remain in bed for this period of time. - Vital signs - Blood pressure, pulse, and temperature will
be taken at regular intervals. - ECG - Many studies will involve multiple ECG recordings.
24) What is it like to stay in a clinical unit?
The experience you have while staying in a clinical unit can range from very pleasant to extremely comfortable. Most clinics have spacious, well-equipped
facilities that provide volunteers with numerous forms of entertainment. On all studies involving overnight stays (in-house studies), the following can be expected: - Your
meals will be provided (though the quality and quantity will depend on the clinic, and you may be on a restricted diet for most of the study). - You\'ll be given a bed.
This could be in a private room (don\'t count on it), a room you share with 1-3 other subjects, a ward with beds for up to 24 subjects, or a dormitory-style arrangement
with bunk beds. - Entertainment - This at minimum will consist of a common room or lounge area with a television (often including cable, sky or movie channels), and usually
a VCR, with a selection of movie videos either rented or stocked. - Reading material - Most clinics provide daily newspapers and have a selection of books and magazines on
hand, though it is always a good idea to bring your own reading material. - Many clinic facilities include a pool table, video games, and board games. During the course of
the study, whenever you\'re not involved in study procedures you can take advantage of the above, or simply lie in bed and relax or sleep, though there may be times when
this is not allowed. - Toiletries - A few clinics will provide subjects with shampoo, toothpaste, etc. but most will not. You will be told if you need to bring your own. -
Clothing - A very few clinics will issue hospital scrubs or uniforms to their subjects, but most require you bring enough clothes to last the study. Some clinics have a
washer and dryer on the unit, which you may have to pay to use. - Phones - Nearly every clinic will have at least one phone for volunteers to use, but you will need to
bring coins or a phone card.
25) What Happens when the study is completed?
On the day of discharge, or the final return visit usually 2-7 days after, you will have a repeat of all the screening and check-in procedures (see
previous section), including a post-study physical examination by the doctor. These are done to see if any changes have occurred since the beginning of the study. There
may be an additional visit required if any results are abnormal, in order to repeat the tests.
26) How much will I be paid, and when will I get my money?
The pay for any study is usually determined by the amount of time you spend in the study facility. You are paid for your time and inconvenience, NOT
according to the "risk" the study involves. The rate of pay depends on the clinic, and will usually be in the range of US $100-200/UK £70-150 per 24 hours
spent in the facility. Visits of less than a few hours during the day will of course pay much less than this. If you become a study "extra" you can probably
expect to be paid between $25-100/£20-120, though a very few clinics pay nothing to extras. If you are forced to drop out for personal or medical reasons, clinics
will usually pay you a pro rated amount, based on the portion of the study that you completed. Some clinics will even pay you in full if you are withdrawn for medical
reasons related to your participation in the study. Be aware, however, that a very few clinics won\'t pay you at all unless you complete the entire study. Many that do
will include a bonus in the pay structure to encourage you to complete the study. They also withhold part of your payment if you fail to return for follow-ups, repeat
tests, etc., if they are required. How you are paid and when depends entirely upon the individual clinic. Larger clinical units will normally pay you immediately on the
final day of discharge or the last follow-up visit. Some clinics are not set up for this and you may have to return within one or two weeks to pick up your cheque, or it
might be mailed to you (within one to two weeks usually). Nearly all pay by cheque, and most will have an arrangement with a local bank which allows you to cash it there.
Sometimes, however, you may have to deposit the cheque into an account, for instance, if it is not drawn on a local bank. Note that experiments in psychology and cognitive
neuroscience departments, which can last from several minutes to a few hours per session, usually pay in cash immediately upon completion of the experiment. It is
practically unheard of for a clinic to deduct tax from the study payment, though they generally report your earnings to the government at the end of the tax year.This
will almost invariably be the same for most consumer or usability studies. Many clinics in out-of-the-way locations may reimburse volunteers for their travelling expenses
during the study, either based on the distance travelled, or on presentation of receipts.
27) Why should I subscribe to Biotrax?
BioTrax acts as your added comfort zone, and can help you with your understanding of patient notes, possible side effects, if any, and we can help you
with your understanding of informed consent. BioTrax is the world\'s most informative information service for Healthy/Patient Volunteers/ Panellists. By subscribing to
BioTrax you can receive the world\'s most comprehensive directory, which will give you information that would normally take you years of research to develop yourselves.
This means you will not only have a greater freedom of choice, but you will be able to instantaneously find placements in Medical research and Consumer research studies.
BioTrax members are always given first priority on placements with all establishments we recruit for. This means if there is an excess of volunteers, you will come first.
There are many advantages to our services as can be seen on the rest of our website.
28) Are other information services better?
Just about all other information services throughout the world will charge you for information, whether you are eligible to participate or not. Often
they are directories/lists that are not up to date, and comprise of very few clinics. The Biotrax directory is by far the most credible, informative and comprehensive
document available in the world today.
29) What is BioTrax Quality Assurance?
This is where the clinic has passed a series of practical and written assessments over a period of time, and have been found to be living up to the day
to day Ethics/Guidelines of our industry.
30) Will I be guaranteed satisfaction?
It has always been the aim of Biotrax to satisfy everyone of its members. You are given a lifetime membership, so there should be plenty of opportunities
to enjoy the benefits of the world\'s most comprehensive service for research volunteers. So the answer is yes |