11) Are clinical studies safe?
Our paramount concern is the safety and the rights of our volunteers. All trials attended by volunteers through BioTrax are approved and reviewed by
independent ethics committees, which must adhere to good clinical practice codes. All drugs must be rigorously tested, firstly in pre-clinical trials befor given to
healthy volunteers and then in healty volunteers before they can be given to patients. A trial will not commence without EC (ethics committee) approval. The physicians
are bound by the Declaration of Helsinki ( Scotland 2000 ) guidelines for conducting biomedical research. In all, BioTrax will not trade with any association/
organisations that do not meet industry ethics/ guidelines or act considerately towards volunteers, other clinics, and for the greater benefit of the industry as a whole.
In the UK only BioTrax also acts as your independent,unbiased comfort zone.You can turn to us for any amount of industry advice at all . If you have a problem, well look
into it . If your unsure about something ie (Patient notes, Informed Consent ) we will look into that too. BioTrax is on your side.
12) Will I be paid for my time and inconvenience?
This varies according to the length and inconvenience of the trials. The reimbursements for 'Healthy' volunteers are usually greater than those for
'Patient' volunteers (i.e. People with medical conditions). Although BioTrax represents Patient volunteers, who are extremely well reimbursed - such as our Asthmatics!
You are reimbursed for inconvenience, and or travel. This is not danger money; this payment is made directly to you by way of cheque, or into your bank account.
13) Can I participate in my spare time?
Absolutely - There are weekend studies, and studies comprising of short visits to the clinics, all of which are as equally rewarding. Some people even
use their holidays as a chance to participate!
14) Will I be eligible?
If you passed our instant online eligibility test, then yes you are eligible for the Biotrax Database. Just about anyone can participate in Consumer
studies, and we also represent and have a surplus of opportunities for Asthmatics, and many other medical conditions. Smokers can often take part in many studies, and we
recruit between the ages of 18 - 85.
15) What are my rights?
When you take part in a study you will receive a full explanation of the medicine, the purpose and the duration of the study, and what you will be
required to do.
- You sign a consent form - As well as the particulars of the study, it will include a declaration on behalf of the sponsor. We are very careful to recommend only the
most credible and considerate of clinics for our volunteers.
- You are free to choose which study you take part in - They vary in duration and payment. Some studies may require you to stay in the unit for up to four weeks:
others may be simple weekend studies or out patient visits, which would suit those in full time employment or education.
- You are completely free to withdraw from any study at anytime, without justification, though you may be asked to sign a self-discharge document depending on the
country or clinic . In the UK we act as your independent representatives, should you have any concerns during a study, we do ask that you contact the volunteer
recruitment officer at BioTrax to help you with your concerns - as it may be something we can help you with. In the USA we do not provide advisory/ help services.
- Information about your participation in studies is kept strictly confidential.
16) What sort of drugs do they test, and why?
It could be anything at all, from an asprin to a vaccine, The BioTrax Trials section will keep you informed where clinics are prepared to tell you of
the medication involved - Most clinics will give you some idea of what the medication is being tested for.
17) Aren't these trials considered risky, or even dangerous?
Not all medical trials contain an element of risk, But where regulatory oversight exists to safeguard the treatment of research subjects, and where
drug companies and testing clinics can be held liable for injuries which may occur, they are very carefull to keep all risks to an absolute minumum. It is true that until
the late 1970s, taking part in such trials contained larger risk because researchers were not obligated to provide accurate information about the drug being administered.
In addition, the subject population consisted mainly of prisoners who took part in trials in order to gain early release, and conscientious objectors in the military who
wanted to avoid combat duty. As such, participation in trials was motivated by coercion, and thus subjects were not necessarily "volunteering" of their own free will. In
the late 1970s and the 1980s, research involving human subjects in most developed nations came under scrutiny. Protective legislation was enacted as a result, and ethical
guidelines were established to ensure the professional conduct of researchers. Subjects began to be recruited from the general population and to be paid for their services.
18) What other studies can I volunteer for, besides drug trials?
There are a wide variety of research studies and clinical programs that need normal/healthy volunteers, although drug trials are generally the most
profitable studies that you can volunteer for on a regular basis. Other studies are either more difficult to find, or they involve less of a time commitment, which means
they won't pay as much. In terms of time commitment most studies can be divided into two categories: "In-house" studies, in which subjects stay at least one overnight,
and "Out-patient" studies, consisting of one or more brief visits to the clinic, which usually last a few hours or less. While it would be impossible to list every
conceivable type of study you might encounter, here are some worth noting: ° Sleep deprivation and sleep research ° Time isolation - involves spending a period of
days or weeks in a comfortable but solitary and windowless room with no time cues permitted (such as TV, radio, newspapers, clock, etc.). ° Virus challenge - cold
and flu experiments ° Bed rest studies - remain constantly lying in bed for weeks or months to simulate the effects of prolonged space travel. ° Tube studies - a
narrow plastic tube is inserted through your nose and down the length of your throat until it reaches your stomach, where it is used to measure acidity levels. °
Vaccine studies ° Cognitive studies - involve tasks which test memory, concentration, reaction time etc., often using a computer. ° Brain wave (EEG) studies -
monitoring of brain waves using electrodes attached to your head. ° Psychology studies - these test personality, perception, behaviour etc. and may involve completing
questionnaires, performing computer tasks, or simulating social situations. ° Sensory studies - testing taste, smell, etc. ° Brain imaging studies (PET scan,
magnetic resonance imaging) - these involve a scanner taking pictures of your brain. ° Visual studies ° Respiratory studies ° Consumer product testing -
sample new products (food, cosmetics, etc.) and evaluate them. ° Bone marrow extraction - a sample of bone marrow is removed from your lower back. This is done under
local anaesthetic, but may result in minor bruising. ° Skin biopsy studies - A small sample of skin is removed from your arm or leg under local anaesthetic (also a
risk of bruising). ° Spinal Tap - A procedure which involves draining fluid from the base of your spine, done under local anaesthetic. It can sometimes result in a
severe headache lasting for a couple of days. ° Dermatology studies - test topical medications on skin. ° Research into the effects of alcohol, caffeine or
nicotine. ° Diet and nutrition studies ° Exercise studies ° Sexual response studies ° Blood and plasma donation ° Egg donation - in the US it is
possible for women in their 20s and early 30s to earn large amounts of money (up to $5000 and possibly more) by becoming egg donors. The process, however, can sometimes
be lengthy and involves a great deal of hassle. Besides being healthy and having the ability to conceive, egg donors must be non-smoking, drug-free, emotionally stable,
and have no family history of any genetic disorder. Some fertility clinics disqualify those on any form of government assistance and some may require the donor to have
medical insurance, though this may be paid for, in whole or in part, by the recipient couple or the clinic itself. A few clinics require that donors have conceived
children previously to prove their fertility, though most do not. If you do manage to meet all the criteria you can move onto the actual screening process, which is
similar to that of medical trials, with the addition that egg donors must undergo extensive psychological evaluation, including personality tests, and interviews. There
will of course be a thorough review of your medical history, family background, personal details, and social habits, followed by a physical examination, informed consent,
and an explanation of the lifestyle restrictions, possible risks, and time demands of being a donor. In most cases (80%) donors are anonymous and information about them
is kept confidential. If you are accepted as a donor after all of this, you then will need to wait until the clinic matches you to a recipient, which could take a few
weeks or up to 2-3 months. After you are matched with the recipient, your menstrual cycles must be synchronised. Following this, you are given fertility drugs,
administered orally or by injection, which induce the ovaries to produce multiple eggs. This happens over a period of 7-14 days. After this you are given hormonal
injections to initiate the maturation of your eggs. When your eggs are matured, they are then extracted by a minor surgical procedure, which is performed in a hospital
under sedation. The risks include a slim chance of temporary complications, physical and emotional stress due to hormonal manipulation, and potential physical discomfort.
The entire process of egg stimulation and retrieval takes about 3 weeks to a month, and you are paid when the cycle is completed. You can donate up to 3 times total
(even 3 in one year). A number of fertility clinics are included in the directory.
19) What is involved in a screening for a study?
First, the clinic will arrange with you a screening appointment, and tell you what to avoid in the days prior to the screening. This will usually
include alcohol, recreational drugs, most or all medications, and any food or beverages containing caffeine, such as tea, coffee, cola, cocoa, and chocolate. They may
also tell you to refrain from strenuous exercise, and not to eat or drink certain things. Some clinics also ask you to fast (not eat) for between 4 and 12 hours before a
screening. When you arrive at the clinic, you usually need to show photo ID, and then you are given forms to fill out concerning your personal details and your medical
history. You will need to sign a consent form for screening, which gives the clinic permission to test your blood for HIV and Hepatitis B & C, and to test your urine
for drugs and alcohol. The results of these tests are confidential unless the clinic tells you otherwise. The most important form you will encounter is the legally
required "informed consent form", which you must read to ensure that you are familiar with what the study involves, and any possible risks it might entail. If the study
involves a drug, it will explain the type of drug, its purpose, its stage of development, and its reported or possible side effects in humans. Most of the common side
effects will be minor, and typically include such things as headache, sleepiness etc., which often can be attributed to other causes. The ICF will also include other
information, such as the name and contact number of the doctor or doctors in charge of the study, and a phone number to call if you feel your rights have been violated,
or your safety compromised. This will refer to a Research Ethics Committee (called an Institutional Review Board ), which consists of persons of medical, legal, and
ethical standing whose responsibility is to approve or reject the human research studies proposed to them from clinics in the local area. These committees do not approve
studies they consider to be dangerous. The form will also explain what happens in the unlikely event that an injury occurs due to participation in a study. British
clinics and their sponsors are required to carry insurance providing compensation to volunteers for any harm or injury they might suffer, and the amount is awarded
according to national guidelines. In the US, you might find it necessary to pursue a claim for additional compensation through legal channels. In any event, medical
treatment will be provided for volunteers who lack health insurance. After you have read the entire form carefully, you will then be asked to sign the form. In doing so,
you are stating that you understand the possible risks involved and agree to take part of your own free will. You are entitled to ask the doctor any questions you may
have about the study, and they are obligated to explain it to you. After you sign the ICF, you will be given your own copy to keep. Following this, you will, in no
particular order, have blood and urine samples collected, vital signs taken (blood pressure, pulse, temperature), height and weight recorded, and be interviewed regarding
your medical history and current state of health. You may also have an ECG (electrocardiogram) which involves leads attached to patches placed on your chest (and
sometimes arms and legs) and connected to a machine which records the electrical activity of your heart. You may also have a chest X-ray for some studies, and possible
hearing, vision, or psychological tests. Following these, you will then undergo a physical exam by a doctor on staff who will determine if you are presently healthy.
After the screening, you may be given a time to phone the clinic to learn if you passed the screening, and whether you have been accepted onto the study. At some point
you will be provided a schedule of the study dates. If any tests appear outside the normal range but are close, you may be asked to return in order to have them repeated.
Some clinics will pay you for screening (around $10-50 /£10-50), or reimburse your expenses in getting there, but this is not very common.
20) How do I volunteer?
The first step is to phone up the clinical centres in your area and ask if they need healthy volunteers for upcoming studies. To find the clinics that
conduct these studies, a good directory is essential, as relatively few studies are advertised. Conveniently, BioTrax has the most comprehensive and informative directory
available today. And our data-base provides contact information for over 500 clinics and consumer study houses in 23 countries, probably the majority in existence
world-wide. When you phone a clinic, you will usually be asked a number of questions in order to determine your eligibility to screen for the study. These questions will
concern your medical history as well as your lifestyle habits, which include your diet, level of physical activity, and what intoxicants, stimulants and other substances
you partake of, and how much. If you answer the questions correctly, you will then be invited to screen for a study. You may be given a choice of studies, and informed as
to the length and dates of each. Most clinics will tell you what the study pays, but some wait until you have completed the screening.