Clinical study Participation
- Who can participate in a clinical study?
- What happens during a clinical study?
- What is informed consent?
- What kind of preparation should a potential participant make for the meeting with the research coordinator or doctor?
- Does a participant continue to work with a primary health care provider while in a study?
- What are side effects and adverse reactions?
- What are the benefits and risks of participating in a clinical study?
- How is the safety of the participant protected?
- Can a participant leave a clinical study after it has begun?
Who can participate in a clinical study?
All clinical studies have guidelines about who can participate. Using inclusion/exclusion criteria is an important principle of medical research that helps to produce reliable results. The factors that allow someone to participate in a clinical study are called "inclusion criteria" and those that disallow someone from participating are called "exclusion criteria". These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. Before joining a clinical study, a participant must qualify for the study. Some research studies seek participants with illnesses or conditions to be studied in the clinical study, while others need healthy participants. It is important to note that 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 clinical study?
The clinical study process depends on the kind of study being conducted (See What are the different types of clinical studies?) The clinical 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 clinical studies involve more tests and doctor visits than the participant would normally have for an illness or condition. For all types of studies, the participant works with a research team. Clinical study participation is most successful when the protocol is carefully followed and there is frequent contact with the research staff.
Informed consent is the process of learning the key facts about a clinical 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?
- Plan ahead and write down possible questions to ask.
- Ask a friend or relative to come along for support and to hear the responses to the questions.
Does a participant continue to work with a primary health care provider while in a study?
Yes. Most clinical studies provide short-term treatments related to a designated illness or condition, but do not provide extended or complete primary health care. In addition, by having the health care provider work with the research team, the participant can ensure that other medications or treatments will not conflict with the protocol.
What are side effects and adverse reactions?
Side effects are any undesired actions or effects of 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 clinical study?
Benefits
Clinical studies that are well-designed and well-executed are the best treatment approach for eligible participants to:
- Play an active role in their own health care.
- Gain access to new research treatments before they are widely available.
- Obtain expert medical care at leading health care facilities during the study.
- Help others by contributing to medical research.
Risks
There are risks to clinical studies.
- There may be unpleasant, serious or even life-threatening side-effects to treatment.
- The treatment may not be effective for the participant.
- The protocol may require more of their time and attention than would a non-protocol treatment, including trips to the study site, more treatments, hospital stays or complex dosage requirements.
How is the safety of the participant protected?
The ethical and legal codes that govern medical practice also apply to clinical studies. In addition, most clinical 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 clinical 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 (See Confidentiality Regarding study Participants).
Every clinical study in the U.S. must be approved 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 clinical 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 that initially approves and periodically reviews the research.
Can a participant leave a clinical study after it has begun?
Yes. A participant can leave a clinical 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.
