Frequently Asked Questions About Research
Below are frequently asked questions (FAQs) from the community. Click the down arrow on each question for more information.
Research is a process to establish or confirm facts, solve new or existing problems, or discover new knowledge. This process can involve human volunteers, animals, health record data, community data, and so much more.
Clinical studies involve research using human volunteers (also called participants). The purpose of clinical studies is to develop new and better ways to treat patients. There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies.
- Clinical trials are conducted to collect data regarding the safety and efficacy of new drugs and devices and usually occur after extensive testing in the laboratory. Drugs and devices must submit to three phases of clinical trial testing before being considered for approval by the Food and Drug Administration (FDA) and available to consumers. These phases test the safety of drugs, how the drugs are absorbed and cleared from the body, how much drug is needed to be therapeutic, and the subsequent side effects. Typically, the clinical trial has two groups: one group that receives the study drug or device, and another group that receives a placebo (not the real drug) or the usual treatment. The participants and the research team are usually “blinded,” which means that they do not know which group the participant is in — though this information can be revealed if necessary. Approved drugs and devices may submit for a fourth phase to review the long-term effectiveness and impact on a patient’s life and to compare it to similar drugs on the market.
- Observational studies collect information to assess how participants or groups do with standard therapies, such as drugs, devices, activities, or diets prescribed as part of their routine medical care.
Other types of research include health services, behavioral, survey, specimen, pharmacokinetics (how drugs are absorbed and cleared from the body), and pharmacodynamics (how much drug is needed to be therapeutic and the subsequent side effects). For more information about clinical studies and the phases or stages of testing that new drugs or devices must go through to obtain approval by the FDA, go to CenterWatch.com or ClinicalTrials.gov.
Clinical studies address a wide range of health problems, such as cancer, HIV/AIDS, neurologic diseases, heart diseases, kidney diseases, high blood pressure, trauma, psychiatric problems, chronic dental pain, oral health’s impact on overall health, medication-related problems in patients at home, and so much more. By taking part in clinical trials and other types of research, participants not only play a more active role in their own health care, but they also can access experimental treatments and help others by contributing to medical research. Your participation is always voluntary.
Most research is funded by taxpayer dollars through government grants, such as the National Institutes of Health (cancer, diabetes, kidney disease, etc.), private companies, and nonprofit foundation grants, such as the National Kidney Foundation and the Bill & Melinda Gates Foundation.
All research conducted on the University of Maryland, Baltimore (UMB) campus involving human subjects must be reviewed, approved, and monitored by the UMB Institutional Review Board (IRB). The IRB is a panel of scientists and nonscientists (including members of the community) whose role is to protect the rights, privacy, and welfare of the research participant and to ensure that the research meets the required standards, regulations, and policies established by the FDA and the U.S. Department of Health & Human Services Office for Human Research Protections.
Research is conducted across the entire University of Maryland, Baltimore (UMB) campus, including the School of Medicine, School of Pharmacy, School of Nursing, School of Social Work, School of Dentistry, as well as the School of Law. UMB collaborates with the University of Maryland Medical System and the Baltimore VA Medical Center to solve complex health and community problems. The School of Medicine also has active research and development programs in vaccines, complementary medicine, and in medical devices and technology. If the campus does not currently offer a study you are interested in, consider searching some of the national research study databases. You also might consider adding your name to a research registry if you would like to be contacted should a particular type of research become available. See below for information about registries.
- All UMB research studies actively enrolling participants are registered at ClinicalTrials.gov
- Some UMB research studies are performed and listed at the General Clinical Research Center (GCRC) website.
UMB Clinical Research Highlights
- Cancer studies through the University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center
- Complementary and alternative medicine, environmental sustainability, nutrition studies through the Center for Integrative Medicine — current studies and studies now enrolling
- Human virology research studies through the Institute of Human Virology
- Psychiatric research through the Maryland Psychiatric Research Center
- Vaccine research through the Center for Vaccine Development — current studies
Healthy volunteers are people who have no known significant health problems. Their participation helps develop information about a new drug, device, or intervention and define what normal limits are. Healthy volunteers must be similar in every way to the population that the treatment is intended for (in terms of age and gender), but cannot have the illness. Read more about what it means to be a healthy volunteer in clinical research.
Registries help link volunteers to specific studies by collecting information about the specific disease or condition a volunteer is interested in along with their medical history, age, gender, contact information, etc. Since this information is personal, you will want to know who is sponsoring the registry and how your information is used and protected.
- About registries and a list of national registries
- Research Match
- The U.S. Food and Drug Administration (FDA) Office of Women’s Health is partnering with the NIH Office of Research on Women’s Health on an initiative to promote the participation of diverse women in clinical trials. To learn more about these activities, go to www.fda.gov/womeninclinicaltrials
- UMB community volunteers registration through Research Harbor
- Center for Information and Study on Clinical Research Participation (CISCRP)
- National Institutes of Health (NIH)
- Participant resources at UMB GCRC
- UMB Institutional Review Board
- Food & Drug Administration (FDA)
- U.S. Department of Health and Human Services Office for Human Research Protections