1) Q: What is a Non Invasive Medical Research?
A: Non Invasive Medical Research means there are no invasive proceedures involved . That means no drugs to be internalised or needles canulas etc . A typical non invasive research study would include cogntive tests for motor function or psychology pen and paper tests.
2) Q: What is a Phase 1 Medical Trial?
A: This is where medications are being tested for the first time in people after many years of pre-clinical research . This reaserch is usually performed on animals and also very stringent laboritiory tests to insure the maximum saftey of healthy research particpants . There are no health benifits to participating in healthy volunteer medical trials and consequently the reason for your payment for time and inconveiences incured . There is always the knowledge and greater purpose that in some way you have aided towards reducing the suffering of less fortunate people . The risks involved with Phase 1 Medical Trials can be likened to crossing the street . You could get hit by a bus although its unlikely , but there are things you can do to prepare yourself for medical trials to further insure your ultimate saftey .
3) Q: What is a Phase 2 Clinical Trial?
A: This is where a small number of patient volunteers are enrolled onto studies after it has been established that the medications are tollerable in humans and can now be passed onto patient volunteers to see if any likely benifts are apparent for the patient population concerned . This usually involves a very small number of patients .
4) Q: What is a Phase 3 Drug Trial ?
A: This is where a very large number of patients are used to acertain improvments in lifesyle in a broader selection of people . Usually trials that make it to Phase 3 Testing will be approved by the authorities for the marketing of the new drug .
5) Q: What is a Phase 4 Medical Trial?
A: These can be condusted through general practitioners or professional testing centers . The drugs are already approved by the authorites but make be looking at different applications or whether or not tha drug is better administered in powder form as opposed to tablet form . Generally speaking Phase 4 Trials are the safest of any medical testing as so much more is known about the medications.
6) Q: What sort of drugs do they test on healthy people, and why?
A: Every drug, in any form, whether prescription or over-the-counter, has to be approved by a government regulatory agency before it can be made available. In order for a drug to be approved, it must be deemed both safe and effective. The drug is first tested in laboratory animals (eg. rats, guinea pigs) to determine if it is safe enough to be tested in humans.
If safety is determined to an acceptable degree, then trials with humans are conducted using very low dosages of the drug. This is necessary to obtain specific information about the drug, for instance, the rate at which it is absorbed, metabolised, and passed out of the body, how it affects blood pressure, heart rate, etc. and what dosage can be given to subjects before they begin to experience minor side effects such as headache, sleepiness, or dizziness. Many such trials do not involve “experimental” drugs. Instead, they test medications which are identical to or very similar to those already approved and available on the market. This is necessary to learn how a marketed drug compares to a newly developed generic equivalent, to learn how two marketed drugs interact when taken together, or to investigate new formulations of a marketed drug in an effort to improve it.
The first phase of human testing usually involves healthy people who act as control subjects. This is necessary to learn how a drug reacts in a healthy person as compared to a sick person for whom the drug is intended. Healthy volunteers are paid for their time as an incentive for them to participate, since there is no expectation that they will benefit from taking the drug.
7) Q: Aren’t these trials considered risky or even dangerous?
A: 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 minimum .
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
8) Q: What other studies can I volunteer for besides drug trials?
A: 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, newpapers, 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, behavior 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.
Sperm donation – It is possible for healthy men, aged 18-45, to earn a steady extra income by donating sperm for insemination purposes, but this generally does not pay well outside North America, and always involves a great deal of hassle in getting accepted. Also the program usually requires that you commit to donate regularly for at least 4-6 months (1-3 times every week) and then return for a final blood test 6 months after your last donation (often most of your money will be withheld until this time). They also won’t pay you for a sample you give them if the sperm count is insufficient.
However, it is occasionally possible to find a sperm bank (also called a cryobank or fertility centre) that needs sperm samples for cryogenic (freezing) experiments. For this, the only requirement may be the ability to produce sperm into a cup. If you find such a place (some are listed in the clinic directory), it could be some of the easiest money you’ll ever make, and you could walk out of the clinic with a cheque for say, $50 in your hand. Usually this will occur only on a one-off basis, though they might need you again in a few weeks or months. Unfortunately this might only be possible in the US, and even there only at a very few cryobanks.
9) Q: How much will I be paid, and when will I get my money?
A: 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 prorated 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.
Many clinics in out-of-the-way locations may reimburse volunteers for their traveling expenses during the study, either based on the distance traveled, or on presentation of receipts.
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.
10) Q: Who can volunteer for studies?
A: Not everyone is considered suitable to take part in research studies. Eligibility is usually determined by the study sponsor (the company or institute that pays for the study). However, some exclusions apply to a majority of studies.
1) As the term implies, “Healthy volunteers” must be healthy, both physically and psychologically. This means not having any diseases, medical conditions, or psychiatric disorders.
2) Volunteers are expected to be drug-free. This means not taking any recreational drugs or prescribed medications, either currently or recently. Common, over-the-counter medications and oral contraceptives are sometimes tolerated on certain studies.
3) Volunteers are usually required to be within the normal weight range for their height and body frame.
4) The majority of clinics will not accept smokers, or anyone who admits to smoking in the last 6 months. However, smokers may be tolerated if the clinic is located in a community where it is difficult to find non-smoking volunteers. Also, some clinics have studies that specifically require smokers.
5) Most studies will have an age range. The optimum age is between 18-35, and the possibility of being excluded increases with each 5 years after age 35. Some clinics allow volunteers even up to age 75.
6) Gender will be an exclusion from certain studies, as a study may require that volunteers be only male, or only female. Traditionally, women of child-bearing age have often been excluded from many studies involving drugs, out of concern that they might become pregnant during the course of the study. In recent years, however, more clinics are accepting female volunteers. Some studies even require that female volunteers account for at least 50% or more of the study group. This is because researchers know they cannot get complete information about a drug if they only test it on a male population.
Still, women of child-bearing potential who wish to volunteer for a drug trial will need to attest that they are practising a reliable form of birth control (sometimes double-barrier methods are required), and that they will continue to do so throughout the study. Of course, a pregnancy test will be included as part of the trial screening.
7) Volunteers must not be allergic to the type of drug being tested, or have food allergies that would conflict with the study diet.
8) Exclusion could also result from admission to one of the following:
– Alcohol consumption of more than 21 units per week for men, and 14 units for women.
– Caffeine consumption of more than 6 units per day.
– Current or recent illness (including a cold).
– Past addictions or a pattern of substance abuse.
– Past surgeries.
– Being asthmatic.
– Having any other serious allergies.
– Following an extreme fitness regimen.
– Being a vegetarian.
– Having a family history of a disease considered to be hereditary.
11) Q: How do I volunteer?
A: 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. BioTax provides the most comprehesive directory service on the internet 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.
12) Q: What is involved in screening for a study?
A: 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. F
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.
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13) Q: How are volunteers selected?
A: Volunteers are selected based upon the results of the screening procedures and lab tests (see FAQ #6), which are used to determine if they are healthy enough to take part in a study. 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. (See “Rebuild your blood” on the Tips Page for further information.)
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. (Also, see “Avoid getting sick” on Tips Page for further information.)
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.
14) Q: What happens if I make the study?
A: 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. If you don’t do this as required, you might be dropped from the study. 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:
– Weapons (or anything that could be used as a weapon)
– 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)
15) Q: How long does a typical study last?
A: Studies may range from a one-time visit lasting less than an hour, to a continuous stay in a clinical facility lasting several months. Generally, though, a “typical” study involving some type of medication will consist of multiple “phases” (periods during which the study takes place). The number of phases is usually between one and four, and they usually last between one and seven days (including overnights) during which you stay in the clinic facility. Each phase is followed by a “wash-out” period of three to ten days before the next phase begins. During the “wash-out” period you are usually (but not always) released from the facility. Some studies may consist entirely of out-patient visits (brief visits to the clinic during the day) and some will have out-patient visits during the wash-out periods.
16) Q: What happens during a typical study?
A: 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.
17) Q: What is it like to stay in a clinical unit?
A: The experience you have while staying in a clinical unit can range from very pleasant and comfortable to incredibly boring and uncomfortable. Some clinics have spacious, well-equipped facilities that provide volunteers with numerous forms of entertainment, while others are basic, spartan, and crowded, with few amenities. Of course, most clinical units fall somewhere in the middle. 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.
18) Q: What happens when the study is completed?
A: 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.