Research FAQs
1) What is a clinical trial?
2) What are the different types of clinical trials?
3) What is an informed consent?
4) What is an Institutional Review Board, or IRB, and what does it have to do with research?
5) How is the safety and privacy of the patient/research participant protected?
6) What are the potential benefits and risks of participating in a clinical trial?
7) What are my rights as a research subject?
8) What is the difference between medical or clinical care and research participation?
9) What is randomization?
10) What is a placebo?
11) What is a control group?
12) What does the term blind or blinded mean in a research trial?
13) What should I know or consider before enrolling myself or a family member in a clinical trial?
14) References and Links
A clinical trial (also known as clinical research) is a research study involving humans to answer specific health questions. Clinical trials conducted at the Brooks Center or within the Brooks Rehabilitation sites focus on rehabilitation research. These studies, which are carefully conducted, are the safest and most effective way to find treatments that work in people and ways to improve health.
2) What are the different types of clinical trials?
- Treatment trials test experimental treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.
- Prevention trials look for better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include medicines, vitamins, vaccines, minerals, or lifestyle changes.
- Diagnostic trials are conducted to find better tests or procedures for diagnosing a particular disease or condition.
- Screening trials test the best way to detect certain diseases or health conditions.
- Quality of Life trials (or Supportive Care trials) explore ways to improve comfort and the quality of life for individuals with a chronic illness.
3) What is an informed consent?
Informed consent is the process of learning all the major facts about a clinical trial before deciding whether or not you want to participate. The informed consent should tell you exactly what will happen during the trial, your commitments and any potential risks or benefits. It is also an ongoing process to educate and provide information to participants throughout the study.
4) What is an Institutional Review Board, or IRB, and what does it have to do with research?
Before most research studies can start, they must be approved by a committee, usually called an institutional review board, or IRB. IRBs are made up of scientists, doctors, non-scientists and community members. The IRB reviews the research to make sure it is well designed, that the risks are as low as possible and that these risks are reasonable when compared to the possible benefits of the research. The IRB also reviews the consent form for the research to make sure that it is accurate. If it approves the research, the IRB continues to review the ongoing research after it starts. It is important to understand that IRB approval does not mean that a research project is safe or that it is right for you. When an IRB approves research, it means that the members of the IRB believe that the research is acceptable to present to people like you for your consideration. However, you need to carefully look at the details of the research and decide whether it is right for you.
5) How is the safety and privacy of the patient/research participant protected?
The ethical and legal codes that govern medical and clinical practice also apply to clinical research trials. Clinical research with human subjects is federally regulated with built-in safeguards to protect the participants. The trial follows a carefully controlled protocol with a previously approved study plan that explains everything the researchers do. The investigators are required to report to their IRBs on the progress of their study as well as any adverse events that may occur while participating in a trial. Patient privacy is governed by the federal laws as related to the Health Information Insurance and Portability Act, or HIPAA. The investigators must explain to the participants how their protected health information will be used and stored during the informed consent.
6) What are the potential benefits and risks of participating in a clinical trial?
Benefits Clinical trials that are well-designed and well-executed offer the opportunity for eligible participants to:
- Play an active role in their health care.
- Gain access to new research treatments before they are widely available.
- Obtain extra treatments or greater frequency than would normally be allowed by a
Medical insurance company. - Obtain expert medical care at leading health care facilities during the trial.
- Help others by contributing to medical research that may lead to better treatment outcomes.
Risks There are also potential risks to clinical trials:
- There may be unpleasant, serious or even life-threatening side effects to experimental treatment depending on the nature of the treatment. These should be stated prior to enrollment.
- The experimental treatment may not be effective for the participant.
- The experimental drug or treatment may not be available after the study is completed.
- The protocol may require more time and attention than would a non-protocol treatment, including trips to the study site, more treatments, hospital stays or complex dosage requirements.
7) What are my rights as a research subject?
You have many rights as a research subject including, but not limited to:
- You have the right to decide not to participate in the research, and there will be no penalty or loss of benefits.
- If you decide to participate, you have the right to quit at any time. Again, there will be no penalty or loss of benefits.
- You have the right to be informed about the research study, without any coercion, undue influence, or pressure. Your main source of information about the research study is usually the consent form.
- You have the right to ask questions about the research study.
- You have the right to get a copy of the consent form.
- You do not waive any of your legal rights by joining a research study or signing a consent form.
Deciding to be in a research study is an important decision and requires that you understand what your expectations are. You should talk about your expectations with the study staff before you agree to be in a research study.
8) What is the difference between medical or clinical care and research participation?
The strict requirement to follow a protocol is what makes a research study different from the medical or clinical care patients receive from their personal doctor or therapist. In standard medical or clinical care a patient may be started on one course of treatment and then switched to another treatment when it is determined that the patient is not improving or is experiencing side effects. These decisions are made on the basis of what might be best for the patient.
On the other hand, when a person participates in a research study as a subject, the investigator must follow the study protocol and provide only the clinical care that is specified in the protocol. Consequently, the tests, medications and treatments given to the subject may be different than those the doctor or therapist would give to his or her regular patients. There are several things commonly done in research studies that are not done in regular medical care, such as randomization, blinding, and use of placebo (see the description of these terms below).
In many research studies subjects are assigned to different groups. The subjects in the different groups may receive different doses or drugs, different devices or treatment procedures. Many times the assignment to a group is made randomly (like flipping a coin). This means that neither the subject nor the investigator chooses which group the subject is placed in. Randomly assigning subjects to groups helps ensure that the results from the study are more accurate.
A placebo is an inactive pill, liquid or powder that has no treatment value. In a clinical trial an experimental treatment is often compared with a placebo to assess the experimental treatments effectiveness.
A control is the standard by which the experimental observations are evaluated. In a clinical trial, a control group is usually given some standard treatment or a placebo and the other group receives the experimental treatment the one the researchers are interested in investigating. At the end of the trial, the effects or outcomes of the control subjects are compared to the experimental subjects.
12) What does the term blind or blinded mean in a research trial?
A randomized trial is blind if the participant is not told which part of the trial he/she is on. A clinical trial is blind if participants are unaware whether they are in the experimental or control part of the study. This type of study is also called masked.
A double blinded study is designed so that neither the participating individuals nor the study staff knows which participants are receiving the experimental drug or treatment and which are receiving a placebo (or another therapy). Double-blind trials are thought to produce objective results, since the expectations of the doctor and the participant about the experimental drug do not affect the outcome; also called double-masked study.
A single blinded study is one in which one party, either the investigator or participant, is unaware of what medication the participant is taking; also called single-masked study.
13) What should I know or consider before enrolling myself or a family member in a clinical trial?
- What is the trials purpose and how is it carried out?
- Is there a placebo and why?
- Is there a control group and how does it differ from the experimental group?
- What are the benefits and risks?
- Are there other treatment choices available?
- What tests and procedures are involved?
- Are there required visits to the doctor/clinic?
- Is there required travel to participate in a study?
- Is hospitalization required?
- How long will the trial last?
- What are the daily/weekly time commitments?
- How long will I be followed after the trial?
- Can I participate in any other trials during this same period?
- If a drug is given, will it be available after the trial is done?
- Will my doctor and I know the results?
- What are our costs?
- Will our costs be reimbursed?
- Will we be paid for participating?
- What are the study personnels qualifications?
14) References and Links:
National Institutes of Health Clinical Trials Online Guide
Western Institutional Review Board
Partnership for Human Research Protection, Inc.
Good Clinical Practice in FDA-Regulated Clinical Trials