The Basics of Clinical Research for Participants

What is research?

Research is a process to discover new knowledge or test what we predict might be true (a hypothesis).1

Clinical research is the study of health and illness in people.2 It looks at new ways to prevent, detect, treat, or understand disease.3 It may test new drugs or combination of drugs; new surgical procedures or devices; or new ways to use existing treatments.3 You can learn about basics of clinical research on the NIH’s website. If you are interested in learning about the different types of clinical research, please visit the FDA’s website.

Who participates in research?

Anyone can participate in research. You may be a healthy volunteer or an individual with specific health conditions. Additionally, individuals with and without health insurance are able to volunteer. For all studies, an individual must meet certain eligibility criteria.

Why should I volunteer?

  • To help others by allowing science to move forward3
  • To possibly receive the newest treatment3
  • To have the additional care and attention from the clinical trial staff3
  • To learn more about your health or specific health condition3

How do I know the research I’m participating in is safe?

In most cases, new therapies or procedures are first tested in the laboratory or in animal studies. All studies must be approved by an Institutional Review Board, which protects the rights and welfare of human research subjects. Additionally, government agencies ensure all research is conducted with patient safety in mind. These agencies include the Office of Human Research Protections and the Food and Drug Administration.

How does clinical research differ from my usual medical care?

Medical care is specifically based on you. Your doctor will develop a plan of care specifically to you and your medical history. The goal of care is to help you directly.2
In clinical research, you and the researcher must follow a set plan, called a protocol. Additionally, you may or may not benefit directly from being in a clinical research study.

Where can I find a research study that’s right for me?

If you are interested in a study in our Clinical Trials Unit, please consider enrolling in our registry. Additionally, research studies are advertised on several websites, including the BU StudyFinder website, ResearchMatch.org, and ClinicalTrials.gov.

References

  1. The Office of Research Integrity. Module 1: Introduction: What is research? https://ori.hhs.gov/content/module-1-introduction-what-research. Accessed July 27, 2017.
  2. University of Virginia School of Medicine. What is clinical research? Clinical Research Web site. https://research.med.virginia.edu/clinicalresearch/participate-in-a-trial/what-is-medical-research/. Updated 2017. Accessed July 27, 2017.
  3. National Institutes of Health. NIH clinical research trials and you. https://www.nih.gov/health-information/nih-clinical-research-trials-you/basics. Updated 2017. Accessed July 27, 2017.
  4. American Cancer Society. How are clinical trial participants protected? https://www.cancer.org/treatment/treatments-and-side-effects/clinical-trials/what-you-need-to-know/protection-for-study-participants.html. Updated 2016. Accessed July 27, 2017.

Prepared by Mary-Catherine Stockman, RD, LDN