The consent form contains a lot of information for you to evaluate and understand. Here is an actual consent form used for a clinical trial. This form is clearly written and intelligible, but most forms will be difficult to understand. This example will give you an idea of the structure of the informed consent form.
Research Subject Information and Consent Form
Title of Study:
An 8-Week, Double-Blind, Placebo-Controlled Trial
of Pregabalin (300 mg/day) for Relief of Pain in Patients
With Painful Diabetic Peripheral Neuropathy
(Protocol 1008-13 1)
Protocol No.:
1008-131-114, WIRB 991249
Sponsor:
Parke-Davis Pharmaceutical Research
Ann Arbor, MI 48105
Investigator:
James Smith, M.D.
(800) 555-1234 (24-hour number)
Sites:
2030 Monroe Avenue
Rochester, NY 14618
This consent form may contain words that you do not understand. Please ask the study doctor or the study staff to explain any words or information that you do not clearly understand. You may take home an unsigned copy of this consent form to think about or discuss with family or friends before making your decision.
This section of the consent form provides the title of the study, which is often too technical for most volunteers to understand. The term “placebo-controlled” means that some patients will receive the drug being studied and other patients will receive a placebo, and the findings of the two groups will be compared. “Double-blind” means that neither the research subjects nor the researchers will know which patients will be receiving the active study drug and which patients will be receiving the placebo.
This section also tells you the number assigned to the clinical trial. The first number, 1008-131-114 is the number assigned by the company sponsoring the study. The second number, WIRB 991249, is the number assigned by the institutional review board that reviewed the safety and ethical aspects of the protocol and the consent documents.
A reminder that you should ask questions is not always included in a consent form, but your right to do so always applies.
Nature and Purpose of this Study
You have been invited to participate in a medical research study. The purpose of this study is to compare the pain relieving effects and safety of pregabalin (300 mg/day) compared to placebo (inactive substance) in subjects with painful diabetic neuropathy.
Pregabalin is an experimental (investigational) drug that is being developed as a pain-relieving drug for patients with diabetic neuropathy. An investigational drug is one which has not been approved by the U.S. Food and Drug Administration (FDA).
You will be one of approximately 140 subjects participating in this study. Sixteen (16) of those subjects will come from this site.
This section describes, in simple terms, the purpose of the study and the number of research subjects who will be enrolled in the study.
Duration of Study
Participation in this study will involve taking study medicine for an eight-week period. During this time you will be required to complete regular office visits so that your medical condition may be monitored. There will be three phases to the study: the baseline phase (lasting one week before taking study medicine), the eight-week double-blind phase (during which you are taking study medicine), and the one-week follow-up phase (lasting one week after you stop taking study medication). If necessary, however, the study may be stopped or you may be withdrawn at any time.
This paragraph tells you how long each phase of the study will last. It also states that the study may be stopped or that you may be withdrawn. This would happen if the drug is found to cause unacceptable side effects.
Description of the Study
A. Baseline Phase
In order to qualify for this study, you must be at least 18 years old and you must have had a history of pain associated with diabetic neuropathy for one to five years. You cannot be pregnant or nursing a baby. If you meet these qualifications, you will be scheduled for a screening visit.
During the screening visit you will undergo a medical history, a physical examination, have your vital signs taken (pulse rate, respiration rate and blood pressure), have blood drawn, and provide urine samples, both for laboratory testing. You will also have an electrocardiogram (ECG – a tracing of the electrical activity of your heart), a visual function test (a test to check your eyes), and a neurological exam (a test of your nervous system function). For females of childbearing potential, a serum pregnancy test will be performed (and must be negative) during your screening visit. You will also have a chest x-ray taken unless you have had one done in the past two years. You will be asked to complete a pain questionnaire. If you are found to qualify and want to participate in the study, you will begin the seven-day baseline phase.
During the baseline phase you will be given a pain and sleep diary. You will be given instructions on how to complete the diary. This diary must be completed daily in order to receive study medicine.
During the baseline phase you will be required to stop most of the pain relieving medicines and possibly other medicines that you may currently be taking. The study doctor will carefully go over with you the medicines you can and cannot take.
This section describes the basic criteria you must meet in order to qualify for the study. Remember, wanting to participate in a study is no guarantee that you will. The study is a scientific experiment. The tests performed at the screening visit are used to collect “baseline” information – that is, information about your physical condition before you start taking the study drug or placebo. For example, your blood pressure will be taken before you start taking the drug so that researchers can determine if your blood pressure increases or decreases while you are taking the study drug. Some of these tests are used to determine eligibility, as well. For example, a pregnancy test is performed. If a woman is found to be pregnant, she would be excluded from the study because the study drug’s effects on the fetus are unknown and could be harmful.
The last two paragraphs in this section let you know what will be required of you if you meet the inclusion/exclusion criteria and decide to participate in the study. In this case, you would be required to maintain a diary to record any pain and sleep disturbance. It also informs you of what medications you need to stop taking. In this case, you will probably have to stop taking other pain relieving medications (and possibly other medications, too) during the study.
B. 8-Week Double-Blind Phase
After you have completed the seven-day baseline phase and if it has been determined that you meet all of the entry requirements, you will return to the office (for Visit #2) in order to begin study medicine. At this time your pain and sleep diary will be reviewed and you will be asked to rate your pain and sleeplessness as well as answer some questionnaires and surveys. The study doctor will also examine your current symptoms of painful diabetic neuropathy. You will then be randomly assigned (like the flip of a coin) to one of two treatment groups:
- Group #1 pregabalin 300 mg/day; or
- Group #2 placebo.
You have an equal chance of being assigned to either treatment group.
You will remain in the same treatment group throughout the remainder of the study. Neither you nor the study doctor or study nurse will know the treatment group to which you were assigned; however, this information is available to the study doctor if needed in an emergency. All study medication will be in the form of pills and you will need to take it three times a day. You will begin taking the study medication the day after Visit #2. As long as you remain in the study you will continue to fill out your pain and sleep diary every day.
Throughout the eight-week double-blind phase, you will be required to attend four more office visits according to the following schedule:
- Visit #3 one week after Visit #2;
- Visit #4 three weeks after Visit #2;
- Visit #5 five weeks after Visit #2;
- Visit #6 eight weeks after Visit #2.
During your third, fourth and fifth visits your daily pain and sleep diaries will be collected, you will be given new diaries, and you will be asked to complete a questionnaire. Additionally, you will be asked about other medicines you are taking, and you will receive additional study medicine. Also, during your fourth and fifth visits your vital signs will be taken and some blood and urine samples will be taken to check how your body is responding to the study medicine. The serum pregnancy test will be repeated at Visit #4 (if you are of childbearing ability).
You may also need to attend an extra visit at some point during the eight weeks of the study. During this visit you will be asked about other medications you are taking. Blood and urine samples will be taken to check how your body is responding to the study medicine, and you will be asked about any discomfort and pain you have experienced.
In this section, the consent form describes what will happen in the second part of the study, the eight-week double-blind phase. Especially important here is that the participants in this study will be divided randomly into two groups: one will receive the study medication and the other group will receive a placebo. The consent form calls both groups “treatment groups,” but remember that one group will be receiving the placebo or an inactive substance. Some patients will improve on placebo due to what is called a “placebo” or “halo” effect. Some people respond well to any new medication, even inactive substances. For this reason, the study drug must be tested against placebo to determine if the study drug is more effective. If the study drug is not found to be more effective, then it is not considered effective. Because the study is double blinded, neither the participants themselves nor the researchers know which participants are receiving the study medication and which participants are receiving the placebo. The consent form notes, however, that in an emergency (if you develop an allergic reaction, for example) the study doctor can find out whether you are taking the study medication or the placebo.
When a blinded, placebo-controlled study has ended, the study sponsor will usually tell investigators who did and didn’t receive the study drug. At that time your investigator can tell you. Keep in mind, however, that a single study protocol is used in many clinical trials over several years. If you were among the first groups testing the drug, you may have to wait years for placebo information to be “unblinded.”
The double-blind phase of the study ends on your sixth visit. At this time you will no longer take study medication unless you choose to continue with the pregabalin open label study (a study without a placebo where both you and the study doctor know which study medicine you are taking). If you choose to be in the open label study, you will need to sign a new consent form.
This paragraph tells you that after this phase of the study, you will be able to receive the study medication by participating in another study in which no placebo is used. All participants will receive the study medication. This type of trial is called an “open label” study, meaning that it is not blinded. Both the researchers and participants know that all of the study participants are taking the study medication.
During your sixth visit you will have a physical exam, a neurological exam, an ECG, a visual exam, blood and urine samples will be collected, a serum pregnancy test will be given, and you will be asked about other medicines you are taking. Your daily pain and sleep diaries will be collected and you will be asked to fill out the same surveys and questionnaires you completed during Visit #2. Also, you will be asked to give your overall opinion of any change in your symptoms during the entire study.
During the sixth visit, the investigator will examine study participants. They will have tests performed and will be asked to complete questionnaires and surveys. This information is gathered to help researchers assess how the study medication has affected participants.
At any time, if you wish to take additional non-study pain medication, you must inform the study doctor (or study nurse). At this time you will discontinue the study and begin taking the alternative medication.
Because this study is designed to test the effectiveness of a pain medication, the researchers don’t want you to take any other pain medications during the study. If you did, researchers wouldn’t be able to distinguish the effects of the study medication from the effects of the other pain medication you are taking.
C. Follow-up Phase
If you do not continue into the open-label study, you will be asked to complete a seventh, follow-up visit one week after your sixth visit. At this time additional blood and urine samples will be taken and you will be asked about other medicines you are taking. The study doctor or study nurse will review any medical conditions that may have begun during the study.
Risks, Inconveniences and Discomforts
The side effects seen with pregabalin include headaches, dizziness, lightheadedness, sleepiness, euphoria (an unrealistic feeling of well-being), nausea, impaired concentration, drowsiness, blurred vision, tingling sensations and impaired coordination. In addition, this study drug can cause tremors, clumsiness, confusion and seizures. Mild elevations in some liver function tests have been observed. These have returned to normal levels after stopping medication. Your study doctor will discuss these with you.
This section discloses the risks and problems that can sometimes arise after taking the investigational medication Pregabalin. The first paragraph describes the side effects that other people have experienced after taking the study medication. If you were to participate in the study, you would want to ask the investigator detailed questions about known side effects and how they may affect your life – your ability to work, to function, to sleep and to eat, for example.
A two-year study of pregabalin in mice has shown an increased number of a type of tumor called hemangiosarcoma. This type of tumor tends to occur in mice spontaneously. It is unknown if this indicates an increased risk for cancer in humans.
This paragraph informs you of a finding from earlier animal studies of the drug: Some mice developed a type of tumor called hemangiosarcoma. You may want to ask the investigator to explain what hemangiosarcoma is. You may also want to ask how big a dose the mice received and how much time elapsed before hemangiosarcoma developed. Then ask how that compares to the dose that you will receive.
Because of potential interactions between medications, you should not start taking a new medication or change the dose of an existing medication without first discussing the new medication or medication dose change with the study doctor or a member of his study staff. Medication interactions can have serious, even fatal, consequences.
Drug interactions pose an important risk in clinical trials. If your doctor were to prescribe an already approved medication, information would exist on how that drug interacts with other commonly prescribed drugs. But because the investigational drug in a clinical trial is new and has been taken by few people, little may be known about its interactions with other drugs. If you are in a clinical trial, never begin taking another medication without first discussing it with the study doctor.
There may be side effects which are unknown at this time. Serious allergic reactions that can be life-threatening may occur. You should exercise special caution when driving or using machinery since the study medications may cause drowsiness, lack of coordination or slowed reaction time. Obtaining blood can cause pain, bruising or redness where the skin is punctured. Fainting sometimes occurs and infection rarely occurs.
This paragraph tells you that the study entails risks beyond the risks of the investigational drug. Sometimes tests that are done as part of a clinical trial have risks. It’s possible, for example, that you could develop an infection in your arm where blood was drawn. This is a small risk, and one that you always face when you get your blood drawn whether or not you are participating in a trial, but the researchers are acting ethically by informing you about it.
Your pain may not improve or may worsen while participating in the study. The study drug must be taken only by the person for whom it has been prescribed, and it must be kept out of the reach of children and persons of limited capacity to read or understand.
If you are a woman of childbearing potential: If you are or become pregnant, the treatment involved in this study may involve unknown risks to you or the fetus. Therefore, you must be using an effective method of birth control before, during and immediately after the study. Acceptable methods of birth control include being post-menopausal or surgically sterile; using oral contraceptive implants or injections; ITUD; diaphragm or cervical cap with spermicide; abstinence; condoms with contraceptive foam/gel/cream; or male sterilization. If you suspect that you have become pregnant you must notify the study doctor immediately.
Because the study drug is new, the risks to a fetus are unknown. The researchers will want to be sure that women enrolled in the study are not pregnant and will not become pregnant during the study.
You will be notified of significant new findings that may affect your willingness to continue in this study.
During the course of the study, if the investigational drug is found to cause side effects that had not been anticipated, this new information must be conveyed to you. In light of this new information, you may want to reconsider your decision to participate in the study.
Safeguards
For your own safety, you must tell the study doctor all your past and present diseases, allergies you are aware of; and all drugs and medications you are presently using.
Benefits
Your participation in this study may decrease the pain you feel from diabetic peripheral neuropathy. However, you may not receive direct benefit from your participation in this study and no direct medical benefits are guaranteed. Your participation in this study may provide knowledge that may be of benefit to you or to others.
Costs
There will be no cost to you for the study doctor’s time, procedures, and supplies related to this study. The study medication will be provided to you without charge.
This paragraph describes the benefits that you may gain by participating in the study. It is careful to point out that you may not benefit at all. Typically you should not have to pay for any costs associated with your participation in a clinical trial.
Alternative Treatments
You do not have to participate in this study to receive pain medication. Instead, you may choose to receive standard treatment as prescribed by your doctor.
If you are considering participating in a clinical trial because the medication you are taking for your condition isn’t helping you, there may be other drugs available that have been tested and approved by the Food and Drug Administration. Participating in a clinical trial usually isn’t the only option available to you. Researchers should be able to tell you more information about these alternative treatments.
Confidentiality
Information from this study will be gathered and submitted to Parke-Davis Pharmaceuticals (sponsor) and to the U.S. Food and Drug Administration (FDA). It may be submitted to governmental agencies in other countries where the study drug may be considered for approval. Medical records which identify you and the consent form signed by you, will be inspected and/or copied by the sponsor and an agent for the sponsor, and may be inspected and/or copied by the FDA, the Department of Health and Human Services (DHHS) agencies, governmental agencies in other countries; the University of Rochester; and the Western Institutional Review Boards (WIRB).
Because of the need to release information to these parties, absolute confidentiality cannot be guaranteed. The results of this research study may be presented at meetings or in publications; however, you will not be identified by name in any publication or presentation.
This section informs study participants about who will have access to the information collected as part of the clinical trial. Absolute confidentiality cannot be guaranteed. But research information, as a rule, is very tightly secured and will be even more so once sweeping federal privacy regulations go into effect February 26, 2003. Results of investigational treatments will go into your medical record and they will be as well protected as any other part of your medical history. Clinical trials are generally designed to protect study participants from loss of privacy and breach of confidentiality. This includes the removal of names and other identifying information about illnesses and behaviors, limiting access to the data, and hiding the personal identities of study participants when research results are presented at meetings and in medical publications. Investigators can get a Certificate of Confidentiality that provides protection even against a court subpoena for data from any FDA-regulated research. The provision was initially designed to shield the identities of study participants who use illegal drugs or commit crimes. Today, it is considered equally important in preventing the leakage of genetic information about study participants that could threaten their employment, health insurance or social standing.
The new privacy regulations contained in the Health Insurance Portability and Accountability Act (HIPAA) will substantially limit access to archived medical records, which researchers insist they need for the design of safe and sensible clinical trials. Protected health information is also to be “de-identified” by removing key information like your name and social security number. Waivers for unauthorized access are to be granted only if a strict set of criteria is met, including disclosure of information that involves no more than “minimal risk” to you and research that would be impractical to conduct without access to that information. Chances are, clinical investigators will need to obtain not only your consent to participate in a trial (as is currently the case), but also your permission to use and disclose personal health information in your past and future medical records.
Questions
If you have any questions concerning your participation in this study, or if at any time you feel you have experienced a research-related injury or a reaction to the study medication, contact:
Dr. James Smith at (800) 555-1234 (24-hour number).
If you have questions about your rights as a research subject, you may contact:
Western Institutional Review Board (WIRB)
Telephone: (800) 562-4789.
Do not sign this consent form unless you have had a chance to ask questions and have received satisfactory answers to all of your questions. Do not sign this consent form if you do not wish to participate in this study.
There should always be two people for you to contact in order to discuss your questions and concerns. The first contact is the principal investigator. The second contact is a representative from the institutional review board (IRB) or a patient advocate that is responsible for ensuring the safety and ethical treatment of volunteers in the study. This section also reminds you again not to sign the consent form until you have had your questions answered.
Consent
I have read and I understand the information in this consent form. All my questions regarding the study and my participation in it have been answered to my satisfaction. I have been informed of the risks involved and my rights as a research subject.
I voluntarily agree to participate in this study. I understand that I will receive a signed and dated copy of this consent form. I authorize the release of my medical records to Parke-Davis, Kendle, the FDA, DHHS agencies, governmental agencies in other countries, the University of Rochester, and WIRB.
By signing this consent form, I have not waived any of the legal rights which I otherwise would have as a subject in a research study.
Subject’s Name (Printed):
Subject’s Signature:
Date
The above-named subject has been fully informed of the study.
Signature of Person Conducting
Date
Informed Consent Discussion
Investigator’s Signature (if different from above)
Date
At the conclusion of the consent form, you provide your consent in writing. And the study staff involved in this process also sign. This completes the contract that you have now entered into with the investigator and the research center.
Unlike study volunteers, investigators have usually gone through the informed consent process countless times before. Research staff may zip through explanations and give you too little time to think of questions that you might want to ask. They may also explain things in a way you don’t understand. There is absolutely nothing wrong with asking a researcher to slow down and repeat something. It is also not out of line to ask them to explain something in another way, using everyday words. If English is not your first language, you need to speak up. Research centers can, and should, produce documents in your first language upon request.
It is the principal investigator’s responsibility to make sure that you completely understand everything that you’ve read in the consent form. It is also the investigator’s responsibility to give you enough time to think of any questions that you may still have. This is not necessarily going to happen in a single visit. When given time to think over your decision, you may raise important concerns that no one else ever thought to bring up.
Questions to Ask Before Participating in Clinical Research
Following is a comprehensive list of questions for you to consider asking. More than anything else, this checklist of questions may assist you in beginning your conversation with research center staff. You may want to invite along a friend or relative for support – and to help you recall answers to your questions. You may even want to record answers to these questions so you can replay them at a later date.
About the Clinical Trial
- What is the main purpose of the study?
- Why is this study important to me?
- What are the chances that this drug will work?
- Is the drug already being used in other countries?
- How long will the clinical trial last?
- What kinds of risks are involved?
- What are the eligibility requirements?
- What kinds of medical problems would prevent me from
participating in the study?
- What kind of screening do I have to go through to qualify
as a study subject?
- Where is the study being conducted?
- Who else is participating in the study?
- How much of my time will this take?
- Does the study involve a placebo or a treatment already
on the market?
- What are my chances of getting a placebo?
- Have other studies already been done on this drug?
- What has been learned about this drug so far and where
have those results been published?
- How many adverse events have been associated with this
drug to date?
- What kind of side effects have other people (or animals)
experienced?
- (If pregnant) What kinds of effects might this drug have
on my unborn child?
- Who will be watching out for my safety?
- What other kinds of treatments are available to treat
my condition?
- What can you tell me about the drug company sponsoring
this study?
- Who has reviewed and approved this study? How can I
contact them?
- Will I be able to find out the results of the study?
About Your Care
- How will the treatment be given to me?
- What kind of tests will be done? Will they hurt? If so, for
how long?
- How will the tests in the study compare to tests I would have outside the study?
- Will I be able to see my own doctor?
- Will the research staff work with my doctor while I am in the clinical trial?
- Will I be able to take my regular medications during the study?
- If the study drug doesn’t work, will I be able to take anything else for my symptoms?
- Will everything be done on an outpatient basis, or will I have
to be hospitalized?
- What if I miss a dose of the study drug?
- If I have side effects, can they be treated during the study?
- Is it possible my condition will worsen during, or after, the study?
- Will I receive any follow-up care after the study ends? Who will provide it?
- Whom can I call with questions and concerns during the study?
- Who on the research staff will be with me in the event of an emergency?
- If the treatment works for me, can I keep using it after the study ends? For free?
- Who will provide my medical care after the study ends?
About Your Personal Matters
- Can anyone find out if I’m participating in the clinical trial?
- How might this study affect my daily life?
- Who will review my information collected during the trial?
- Can I talk to other volunteers in the trial?
- What support is available in the community for me and
my family?
- What happens if I decide to quit the study?
- Can I be withdrawn from the study for any reason?
About Your Compensation and Costs
- Do I have to pay for any part of the study? If so, will insurance cover these costs?
- Do I have to talk to my health insurance company before enrolling in the study?
- How much will I be paid for my participation?
- Will I be reimbursed for gas, or will transportation be provided?
About the Research Staff
- Why did the investigator decide to get involved in clinical research?
- What is the investigator’s background and training?
- What sort of research training and certification have the investigator and coordinator had?
- How many studies has the investigator done before?
- Was the investigator involved in the design of the study?
- Has the investigator or study coordinator ever participated
in a clinical trial?
- Does this facility have any special credentials or experience
in research?
- Do the investigator and study coordinator have any formal training in research safety and ethics?
- Does the investigator have a financial interest in the drug
being studied?
- Is the investigator or study coordinator paid a bonus for
recruiting me into the trial?
If a study involves a great deal of risk and close patient monitoring, for instance, it will probably be very important to the study volunteer (or their legal guardian) to know how much research training and experience the principal investigator has had. Two-thirds of our country’s 50,000 investigators have limited experience conducting clinical trials. Being a researcher is a tough job, even for otherwise well-schooled medical doctors.
The U.S. Department of Health and Human Services requires that investigators involved in any of the studies it funds (through the NIH, for example) be instructed on how to conduct research responsibly. Although the FDA intends to become more specific about its educational requirements, the onus is currently on pharmaceutical companies to ensure that clinical investigators are sufficiently qualified with experience and training. Investigators have a medical or professional degree, but it is not always enough because many investigators have not received formal training in clinical research. A pathologist accustomed to working all day in a lab, for instance, wouldn’t be well suited for clinical trials with pediatric populations.
Although there are no certification exams for physicians as proof of their competency in conducting clinical trials, there is plenty of accredited coursework being offered by universities, trade associations and training companies. A number of medical schools also offer research training during doctors’ internship and residency years. And at this time, 10 medical colleges and universities now offer doctors a two-year program leading to a Master’s degree of Science in Clinical Research. Some research institutions require that all investigators undergo a fairly rigorous educational program covering the basics of clinical research. The NIH and several universities (Case Western Reserve University and the University of Rochester among them) make investigators take an online test that demonstrates their knowledge of human research protections before they can seek IRB approval of a protocol.
Study coordinators and other support staff have a wide variety of accredited courses to choose from. Study coordinators can be certified. This distinction adds the letters “CCRC” – Certified Clinical Research Coordinator – to their titles. Coordinators tend to be the ones who handle informed consent discussions. In fact, at some universities, informed consent discussions exclude investigators who are also healthcare providers. This is done to lower the chance that potential study volunteers will be influenced to participate in research simply because it’s being done by people they know and respect as healers.
Beginning a Dialogue
When people either blindly or half-heartedly commit to participate in a clinical trial, neither science nor an individual’s health may gain anything. One reason why a high number of volunteers drop out of a study is because many don’t fully understand what they’re consenting to from the outset. That’s why you need to find out all that you can before you give your consent. Informed consent papers and new drug brochures will answer many – but not all – of your important questions.
When it comes to study risks, in particular, you may have to dig for the full story. Families have told stories of needlessly losing a loved one in a clinical trial where earlier deaths and serious adverse events went unreported on informed consent documents because the study’s sponsor didn’t identify the study drug as the culprit. FDA guidelines say that study volunteers should understand the risks they’re taking, but they don’t require a drug’s complete track record be shared. If you want to know details, such as the number of deaths and serious side effects observed in earlier clinical trials even if the study drug was not implicated, you have to make a point to request that information.
Not everyone has the time, interest or even the capability of understanding everything that is uncovered. You may want to bring some of this information to a trusted, impartial family physician or health professional for their medical opinion. Another good option is to consult with the IRB. They decide whether or not a clinical trial gets done. The IRB is also your chief advocate and troubleshooter throughout the course of the trial.
You need to always remember that you are the one volunteering for a clinical trial. The study drug may make you feel better. And your study visits may seem just like any other visit to the doctor’s office, but the main purpose of research is to collect data, not to treat your illness. You should therefore participate in a clinical trial only if you feel that it is in your best interest – not in the interest of your doctor, employer, researchers, college professor or anyone else.
During and After a Trial
Informed consent doesn’t stop the moment a form is signed and witnessed. It’s something you are entitled to during – and even after – the clinical trial has ended. Experienced investigators and study coordinators will repeat, remind and reassure you frequently about what is happening to you. If they don’t (and even if they do), it’s okay to ask questions and expect answers from researchers. It’s their job.
Any time you feel that your questions and concerns have not been sufficiently addressed, you have the option to seek help from the IRB. The pharmaceutical company sponsoring the clinical trial may also have a consumer hotline that participants can call with any unanswered concerns or general questions specifically about the drug. A list of sponsor companies and their contact information is provided in the appendix.
If a clinical trial gets suspended for reasons unrelated to the study drug, volunteers who have a medical need to continue taking the drug may be allowed to do so. If a trial is suspended due to serious adverse events related to the study drug, or production problems on the part of the pharmaceutical company, then you would be required to stop taking the drug and to seek care from your regular doctor. But the principal investigator and study staff would continue to keep an eye on you, at least until the study drug is out of your system.
Your consent means that you can withdraw from a clinical trial. This is your fundamental right as a study participant. If your withdrawal may prove harmful to you, the investigator and study coordinator must tell you so. Investigators and study coordinators should not coerce you to continue to participate in a clinical trial if your decision to withdraw is final. Informed consent regulations forbid investigators who are practicing doctors from denying future care to their patients who have withdrawn from a clinical trial. If you drop out of a clinical trial, you should still be told anything that is later learned about the investigational drug that could affect your health.
Compassionate Use of Experimental Treatments
For most people, access to a study drug ends when the clinical trial does. But there are some notable exceptions. Study volunteers with serious or life-threatening illnesses who have completed a phase III study are sometimes rolled into an “open label” study, allowing them to take an effective investigational drug, for free, until the FDA approves it or for a fixed time period such as six months or a year.
Such compassionate use, as it is often called, is only occasionally extended to patients with debilitating but not necessarily life-shortening medical conditions. And only then if the pharmaceutical company hasn’t abandoned plans to take the drug to market for one reason or another.
Even if a pharmaceutical company is willing to provide compassionate use of a helpful drug, the process doesn’t necessarily happen quickly. The research investigator would need to send in a special FDA form to the company, whose attorneys might mull it over for weeks or even years.
In the meantime, patients can check with the FDA or pharmaceutical companies to learn about where investigational drugs are in the development process. If approval of the desired drug isn’t far off, the best course of action may be to wait it out. There may even be another drug with a similar composition and action under study. Patients can always ask the pharmaceutical company about other promising trials it is conducting, or start a wider search on their own.
Introduction