Participant Information
Benefits of Being a Research Volunteer
Without research, medicine would never move forward, and without volunteers, research would not be possible. There are many reasons why people volunteer for studies. Some possible benefits of participating in a study include:
- Study medication (possibly placebo) that may help the volunteer with a condition
- Study-related medical exams at no cost
- Reimbursement for time and travel expenses in many studies
- Contributing to the development of new therapies while learning about other possible treatment options
Volunteer Eligibility
Studies are rigorously controlled to ensure they fit a specific set of guidelines. These guidelines exist to minimize or eliminate the effect of other variables so that test results better reflect the effectiveness of a specific treatment. While many people may be interested in volunteering for a study, not everyone is a good candidate for a given clinical trial. Volunteer eligibility depends on several factors, which may include:
- A specific symptom or set of symptoms
- A health history that fits the required profile
- Other criteria such as someone who is not ill, but is interested in preventive care
Medical Research Studies Are Completed in Phases
Medical research studies are usually classified into several different phases. Generally speaking, each phase has a specific focus, such as animal or human testing. Each member of a study is carefully monitored through all of the clinical phases with an overall goal of finding out what is and is not an effective form of treatment. Clinical phases may include:
In phase 1 studies, a new treatment or medication is tested on a small group of volunteers – usually numbering from 20-80 participants. Previous studies will have already been completed using animals to ensure safety of the study participants. Animal study results have also been submitted to a government regulating agency. The study must be shown to be safe based on the animal testing in order to gain approval for phase 1 clinical trials.
The primary goal of phase 1 clinical studies is to establish safe dosing guidelines. Researchers want to ensure that the medication or treatment is safe for humans, as well determine how, when, and how much of a medication or treatment should be administered. If this phase is deemed successful, it moves to phase 2.
In phase 2, the pool of volunteers is enlarged, allowing more people to participate. This often means that a placebo will be given to a certain number of participants. The reasoning behind this is to directly measure if any improvements are due to the medication or therapy that is being tested.
As with all phases, all symptoms and side effects are carefully monitored and recorded. Volunteer safety is continually tracked as well. If the results show that the medication or therapy is both safe and effective, it moves to phase 3.
Phase 3 of clinical trials involves a much larger group of participants. Members of the study are often assigned to other groups by random selection. In one group, for example, a thousand participants may be given the new treatment or medication, while another group of participants will be given what is known as a placebo. The placebo looks like the medication or treatment, but is inert, or inactive, such as a sugar pill that is packaged to look exactly like the medication being studied.
The group receiving the placebo is known as the “control” group. The results of the control group are then compared to the results of those who received the medication being studied. These results enable researchers to collect more data about side effects and effectiveness. It can also show researchers if the treatment is improving the quality and/or length of life for participants with the specific disorder or condition the treatment is meant to address. Once completed, this information is compiled and sent to a government agency, such as the FDA, for approval for phase 4 studies.
In phase 4 studies, the medication or treatment has been approved as a new drug. Phase 4 studies are often done in order to determine how effective the treatment is on different groups of people. It may, for instance, be tested to see if it is as effective for males as it is for females.
It might also be used to see if a different dose or form of administration offers better outcomes. For instance, if the dose is offered three times a day rather than two, or if a topical gel is more effective than an injection or a pill.
IRB
In addition to careful monitoring, clinical trials must be approved by an Institutional Review Board, or IRB, which consists of respected professionals in fields such as education, law, medicine, or religion. IRBs exist to protect the rights and safety of volunteers in a clinical trial.
HIPAA Compliance
Other regulations, such as those established by HIPAA (Health Insurance Portability and Accountability Act), set specific standards for the protection and privacy of patients. These rules cover all forms of medical records — digital, video, paper, or orally communicated.
