Frequently Asked Questions about Research
1 - What is a clinical trial?
A clinical trial (also clinical research) is a research study done using in human volunteers to answer specific health questions. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people and ways to improve health. Clinical trials called interventional trials determine whether experimental treatments or new ways of using known therapies are safe and effective under controlled environments. Clinical trials called observational trials address health issues in large groups of people or populations in natural settings.
2 - What are the benefits and risks of participating in a clinical trial?
Benefits - Clinical trials that are well-designed and well-executed are the best approach for eligible participants to:
- Play an active role in their health care.
- Gain access to new research treatments or products before they are widely available.
- Obtain expert medical care during the trial.
- Help others by contributing to vision research.
Risks - There may be risks to clinical trials:
- There may be unpleasant, serious or even life-threatening side effects to certain kinds of experimental treatment.
- The experimental treatment may not be effective for you.
- The protocol may require more of your time and attention than would a non-protocol treatment, including trips to the Clinical Vision Research Center, more treatments, or complex treatment requirements.
3 - What happens during a clinical trial?
The clinical trial process depends on the kind of trial being conducted. The clinical trial team can include optometrists and nurses as well as social workers, students and other health care professionals. They check your health at the beginning of the trial, give specific instructions for participating in the trial, monitor the participant carefully during the trial, and, depending on the study, may stay in touch after the trial is completed.
Some clinical trials involve more tests and clinic visits than you would normally have for an illness or condition. For all types of trials, participants work with a research team. Clinical trial participation is most successful when the protocol is carefully followed and there is frequent contact with the research staff.
4 - What does informed consent mean?
Informed consent refers to the process by which volunteers discover the details of their clinical study. Participants must be given all the facts about a trial before giving consent to participate, including treatment details and possible risks and benefits. The informed consent form must be signed by volunteers prior to participation. The informed consent process continues throughout the clinical study.
5 - How is the safety of the participant protected?
The ethical and legal codes that govern healthcare practice also apply to clinical trials. In addition, most clinical research is federally regulated with built in safeguards to protect the participants. The trial follows a carefully controlled protocol, a study plan which details what researchers will do in the study. As a clinical trial progresses, researchers report the results of the trial at scientific meetings, to medical journals, and to various government agencies. Individual participants' names will remain secret and will not be mentioned in these reports.
6 - Why should I consider getting involved in a clinical study?
There are many individual and personal reasons to participate in research studies. Treatments and medications on trial today could go on to become the treatments and licensed medications of the future, and benefit you or family members. Some participants also enjoy the social interaction with fellow volunteers and staff that they experience while participating in clinical studies.
7 - Will I receive free care or be paid for taking part in a clinical study?
Some studies provide free products, care or reimbursement for time. This depends on the nature of the study. You will be told about any potential benefits or reimbursement for the study during the consent process.
8 - How long do clinical studies last?
Clinical studies vary in length depending on what vision problems or treatments we’re researching. Some studies involve only one visit. Some studies involve participants coming in for visits for several years. Study staff will explain the length of participant involvement before asking you if you want to volunteer.
9 - What should people consider before participating in a trial?
People should know as much as possible about the clinical trial and feel comfortable asking the members of the health care team questions about it, the care expected while in a trial, and the costs and benefits of the trial. The following questions might help you to discuss the study with the health care team. Some of the answers to these questions are found in the informed consent document each research participant must read and sign when volunteering.
- What is the purpose of the study?
- Who is going to be in the study?
- Why do researchers believe the experimental product or treatment being tested may be effective? Has it been tested before?
- What kinds of tests and experimental treatments are involved?
- How do the possible risks, side effects, and benefits in the study compare with my current treatment?
- How might this trial affect my daily life?
- How long will the trial last?
- Who will pay for the experimental treatment?
- Will I be reimbursed for other expenses?
- Is long-term follow up care part of this study?
- How will I know that the experimental treatment is working?
- Will results of the trials be provided to me?
- Who will be in charge of my care?
For more information about clinical trials, you can visit www.clinicaltrials.gov.
10 - How do I find out more?
11 - Where can I sign up?