Frequently Asked Questions

 

  • Who can participate in a research study?

All research studies have guidelines about who can participate. Using inclusion/exclusion criteria is an important part of medical research that helps to produce reliable results. The factors that allow someone to participate in a research study are called "inclusion criteria". The factors that disallow someone from participating are called "exclusion criteria". These criteria are based on factors like age, gender, the type and stage of a disease, and other medical conditions. Inclusion and exclusion criteria are not used to reject people personally. Instead, the criteria are used to identify appropriate participants and keep them safe. The criteria help ensure that researchers will be able to answer the questions they plan to study.

  • What happens during a research study?

The process depends on the kind of study being conducted. The research study team includes doctors and nurses as well as social workers and other health care professionals. They check the health of the participant at the beginning of the study, give specific instructions for participating in the study, monitor the participant carefully during the study, and stay in touch after the study is completed.

Some research studies involve more tests and doctor visits than someone would normally have for an illness or condition. For all types of studies, the participant works with a research team.

  • What is “informed consent”?

Informed consent is the process of learning the key facts about a research study before deciding whether or not to participate. It is also a continuing process throughout the study to provide information for participants. To help someone decide whether or not to participate, the doctors and nurses involved in the study explain the details of the study. If the participant's native language is not English, translation assistance can be provided. Then the research team provides an informed consent document that includes details about the study, such as its purpose, duration, required procedures, and key contacts. Risks and potential benefits are explained in the informed consent document. The participant then decides whether or not to sign the document. Informed consent is not a contract, and the participant may withdraw from the study at any time.

  • What kind of preparation should a potential participant make for the meeting with the research coordinator or doctor?

Advance planning is recommended:

1. Write down possible questions to ask.

2. Bring a friend or relative for support and to hear the responses to the questions.

3. Bring a tape recorder to record the discussion to replay later.

Every research study in the U.S. must be reviewed and monitored by an Institutional Review Board (IRB) to make sure the risks are as low as possible and are worth any potential benefits. An IRB is an independent committee of physicians, statisticians, community advocates, and others that ensures that a research study is ethical and the rights of study participants are protected. All institutions that conduct or support biomedical research involving people must, by federal regulation, have an IRB oversee the research.

  • What should people consider before participating in a study?

Answers to these questions from a studies health care team may be helpful in making your decision:

-What is the purpose of the study?

-Who is going to be in the study?

-Why do researchers believe the experimental medication 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 study affect my daily life?

-How long will the study last?

-Will hospitalization be required?

-Who will pay for the experimental medication?

-Will I be reimbursed for other expenses?

-What type of long-term follow up care is part of this study?

-Will results of the studies be provided to me?

-Who will be in charge of my care?

  • Does a participant continue to work with a primary health care provider while in a study?

Yes. Most research studies offer short-term participation related to a designated illness or condition, but are not the same as primary health care.

  • What are side effects and adverse reactions?

Side effects are any undesired actions or effects of the experimental drug or treatment. Negative or adverse effects may include headache, nausea, hair loss, skin irritation, or other physical problems.

Experimental treatments must be evaluated for both immediate and long-term side effects.

  • What are the benefits and risks of participating in a research study?

Research studies that are well-designed and well-executed allow participants to:

-Play an active role in their own health care.

-Help others by contributing to medical research.

There are risks to research studies.

-There may be unpleasant, serious or even life-threatening side effects to an experimental treatment.

-The experimental treatment may not be effective for the participant.

-The study may require more time and attention than a non-study treatment, including trips to the research study site, hospital stays or complex treatment requirements.

  •  How is the safety of the participant protected?

The ethical and legal codes that govern medical practice also apply to research studies. In addition, most research is federally regulated with built-in safeguards to protect the participants. The study follows a carefully-controlled protocol, a study plan which details what researchers will do in the study. As a research study progresses, researchers report the results of the study 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.

  • Can a participant leave a research study after it has begun?

Yes. A participant can leave a research study, at any time. When withdrawing from the study, the participant should let the research team know about it, and the reasons for leaving the study.

  • What are research studies?

A research study is created to answer specific health questions. These questions may involve new treatments, new combinations of medicines, or new approaches to preventing and detecting disease.

Carefully conducted research studies are the safest and fastest way to find treatments that work in people, and new ways to improve health.

Research studies are conducted according to a plan called a protocol. The protocol describes what types of patients may enter the study, schedules of tests and procedures, drugs, dosages, and the length of time for the study.

  • Why are research studies done?

Many research studies are done to see if a new drug or device is safe and effective for people to use. Some studies compare existing treatments to determine which is better. For most studies in the United States, researchers, doctors, and other health professionals administer the research studies according to strict rules set by the Food and Drug Administration (FDA).

  • Where can people find out about research studies?

One way to find information about research studies is by searching this Website: www.clinicaltrials.gov. ClinicalTrials.gov is an interactive online database, managed by the National Library of Medicine. It provides information about both federally and privately supported clinical research. ClinicalTrials.gov is updated regularly and offers information on each trial's purpose, who is eligible to participate, locations, and phone numbers to call for more information.

  • Why should I consider participating in a research trial?

For those who are eligible, taking part in research studies offers several benefits:

  • Getting actively involved in their own health care
  • Having access to investigators who are often specialists in the disease area being studied
  • Helping others by contributing to medical research

It is important to test drugs and medical products in the people they are meant to help. It is also important to conduct research in a variety of people because different people may respond differently to treatments.

For each research study, researchers develop eligibility criteria, such as age, gender, previous treatment history, and other medical conditions. Not everyone who applies for a research study will be accepted. Volunteers may be excluded based on the eligibility criteria and/or the number of participants needed by the researchers.

  • Where are research studies conducted?

Research studies can be sponsored by an organization such as a pharmaceutical company, a federal agency such as the Veterans Administration, or an individual, such as a physician or health care provider. The sponsor determines the location(s) of the studies, which are usually conducted at universities, medical centers, clinics, doctor's offices, and/or at hospitals.

Source: National Library of Medicine, “Understanding Clinical Trials”.
Available at: http://www.clinicaltrials.gov/ct/info/resources;jsessionid=B0C362BDFAD571C76D7907979724E470. Accessed July 12, 2010

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