The CTRI is developing numerous ways of helping the public understand more about clinical trials and research. The information provided below helps to explain both what clinical research is and what informed consent means.
About Clinical Research
Medical science has progressed from depending upon the 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, 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 in people?" and "Does it work?". To answer these questions, specific conditions and treatments are studied in a research study or clinical trial to understand the nature of a disease or the effectiveness of a drug or medical device. Examples of results from clinical trials and research include the following:
Many parties are necessary to 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 PRINCIPAL 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. At UCSD, the IRB is also called the HUMAN RESEARCH PROTECTION PROGRAM (HRPP).
The most important person of all in every clinical trial is the volunteer participant often called the RESEARCH SUBJECT. Without these volunteers no clinical research can be done!
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
- Do you know who the PI is? / who the sponsor is?
- Do you expect any personal benefits from this trial?
- Will you be paid? How much?
- What tests and procedures will be performed on you? What are the risks?
- How often must you come to/ how long must you stay in the clinic?
- What medications, foods or activities must you avoid? / What must you take?
- What alternative treatments are available to you outside of this trial?
Be certain that
- The language in the informed consent document clear to you
- You have adequate opportunity to ask questions
- 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 these 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
- You keep all your legal rights even if you sign the consent