Research participation can be an exciting and meaningful experience. Research participants play a role in framing the future of medicine and other therapies. The medicines and medical devices we benefit from today are available because of research studies. Let’s look at some of the questions frequently asked by those who are considering participating in research studies.
What is a research study? A research study is systematic method of investigation, used to answer questions and to provide additional information on a topic. There are various types of research studies. The focus of this article is on clinical research studies.
What is a clinical research study? A clinical research study is an investigation that is done using human study participants and is designed to test medicines, devices or treatment methods that are used to prevent or manage medical conditions. Clinical research studies provide information on whether a treatment option is safe and effective for use in humans. Clinical research studies are also known as clinical trials, clinical investigations, and clinical studies.
What is a human subject? A human subject is someone who has volunteered to participate in a research study. Human subjects are also known as research participants, study participants, subjects and test subjects.
What is an experimental drug? An experimental drug is a medicine that has not yet received approval (from the Food & Drug Administration), to be used in the management of a particular disease or condition. Experimental drugs are also known as investigational drugs or investigational agents.
Who can participate in a research study? Several factors are used to determine who is eligible to participate in a research study. These factors are based on the purpose of the study and the associated risks, and are therefore different for each study. Some studies may require that participants be of a certain gender, others may require that participants be of a certain age range and others may recruit only participants who suffer from a particular disease.
Is participating in a research study voluntary? Yes! Participating in a research study is completely voluntary. Individuals choose whether or not they want to participate in a study. Research subjects can choose to withdraw from a study at any time, with no penalty.
What are the benefits of participating in a research study? Sometimes there is no direct personal benefit gained from participating in a study. However, participation in a study may help to provide useful information which can provide a benefit to society. This could be information about a disease, a new drug or there may be other new information learned. Some people feel a sense of satisfaction from contributing to science and to society in this way. There are some cases when individuals may benefit directly from participating in a study. For example, a participant suffering from a disease, may get access to an experimental medication that helps to improve the symptoms of the disease.
Are there risks to participating in a research study? There may be certain risks associated with participating in a study. The types of risks will depend on the type of study. The risks will be greater for some studies than for others. Members of a research team have an obligation to discuss known or anticipated risks with potential participants before they start the study.
Will it cost me money to participate in a study? Study participants do not pay to take part in a study. There may be expenses related to travel, but usually participants are compensated for travel. Travel compensation may be in the form of payment or reimbursement for travel, the direct provision of transportation or the provision of bus or train tickets.
Who is a Principal Investigator? The Principal Investigator (PI) is the person who is responsible for managing all aspects of the study. The PI is the leader of the research team.
What is an Informed Consent? An informed consent is the process detailing the facts of a study to potential study participants, before they start the study, so that they can be fully informed before they decide to agree to participate in the study. In this process, a member of the research team shares information about the purpose of the study, the potential risks and benefits, the tests and procedures that are conducted as a part of the study, the contact information of the Principal Investigator and other relevant study information. During the Informed Consent process, potential study participants are also told about their rights.
What are inclusion criteria? The inclusion criteria are a list of the characteristics that potential participants must have to qualify to participate in a study. For example, if one of the inclusion criteria of a particular study states that participants must be 60 years old or older, then a 30 year old would not qualify to participate in that study.
What are exclusion criteria? The exclusion criteria are a list of factors that would deem a potential participant ineligible for a study. For example, if one of the exclusion criteria of a study is “individuals diagnosed with Type II diabetes,” then potential participants who have been diagnosed with Type II diabetes would not qualify to participate in the study.
What is an IRB? An Institutional Review Board (IRB) is a committee that provides oversight of research studies. An IRB is made up of scientists and non-scientists and protects the rights and welfare of research participants. Research studies must be approved by an IRB before the study can begin. While the study is ongoing, the research team must periodically submit information about the study to the IRB and must get approval from the IRB before making certain changes in the study.
What is a placebo? A placebo is a substance or treatment method that has no effect on the disease or condition that is being treated. In the case of a medications, a “placebo drug” does not contain the actual medicinal agent that being investigated. Instead, it contains substances such as sugar, starch or other inactive substances. A placebo drug is designed to look, taste, smell and feel like the drug with the active medicine. The use of placebos helps to prevent bias in reporting the effects of the treatment. Placebos are not used in all studies.
If you are participating in a clinical research study, it is a good idea to share that information with your doctor, pharmacist and others who help to manage your health.