Understanding Clinical Research
What is Clinical Research?
Medical science has progressed from accidental discoveries which advanced learning in the past to thoroughly planned and carefully conducted research. At the same time, medical treatment has progressed from the simple relief of symptoms to the understanding of disease mechanisms, and in some cases, to the actual cure of diseases.
Clinical research, performed in a patient-oriented clinic or hospital setting, is vital to modern medical progress. Although laboratory and animal research are important, clinical research is needed to answer the questions "Is it safe for people?" and "Does it work?” To answer these questions, specific conditions and treatments are studied in a clinical "research study" (also known as a "clinical trial") to understand the nature of a disease or the effectiveness of a drug or medical device.
Who is involved in Clinical Research?
Many types of people are necessary for the success of clinical research.
- The Sponsor of the clinical trial provides the primary source of funding and may also have a role in its design and conduct. Often, the sponsor is a federal agency such as the National Institutes of Health (NIH) or a pharmaceutical company.
- A key person in the research study is the Principle Investigator, commonly called the "PI." The PI conducts the clinical research, and may have designed it or may have been chosen to conduct it by a sponsor.
- At each research institution is a group of persons known as the Institutional Review Board (IRB). The IRB consists of doctors, scientists, and non-medical persons from the community, who must review and approve all clinical research done at that institution. No clinical research can be started without IRB approval.
- The most important person of all in every clinical trial are the volunteer participant often called the Research Subject. Without these volunteers no clinical research can be done!
Who can participate in Clinical Research?
All clinical trials have guidelines that explain who can participate. The guidelines are based on factors such as age, medical history, illness, and current medication. These factors are used to identify appropriate people to participate, and keep them safe.
Clinical trials also often need people who are free from disease or illness to serve as "healthy controls." Healthy controls are people who are compared to the research participants that are experiencing the disease or illness being studied. Learn more about ways to volunteer for a research study.
What is Informed Consent?
Informed consent is the process of agreeing to participate in a study after being informed about it. The document or consent form that you read and sign must be approved by the IRB, and there should be a dated stamp on the document certifying that it is approved.
Be sure that you have answers to the following questions before giving consent:
- Who is the Principal Investigator? / Who is the sponsor?
- Are there any personal benefits from this trial?
- What tests and procedures will be performed as part of this study?
- What are the risks?
- Is there compensation for participating in this clinical trial? How much?
- What medications, foods, or activities must you avoid? / What must you take?
- What alternative treatments are available outside of this clinical trial?
Also, be certain that:
- The language in the informed consent document is clear to you;
- You have adequate opportunity to ask questions; and
- You are given a copy of the informed consent document to keep, and a copy of the Research Subject's Bill of Rights.
The consent documents of every study should make the following points clear:
- You can leave the trial at any time you wish;
- You will be able to get medical care even if you leave the clinical trial;
- The PI can discontinue you from the trial at any time; and
- You keep all your legal rights even if you sign the consent.