Research Glossary

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Research Glossary2020-06-30T11:26:33-04:00

The Indiana CTSI aims to make research as accessible and community-friendly as possible, so we’ve compiled a list of key terms and definitions to help define and explain some common phrases you may come across on our website and when working with us. See also: Community Glossary

All IN for Health Volunteer Registry: a database of Indiana residents who have voluntarily signed up to participate in health research studies, including clinical studies, that are of interest and benefit to them.

Biobank: A collection of biological samples (also referred to as biospecimens) such as blood, tissue, urine, saliva, bone marrow and more, and/or data, stored for research purposes. The Indiana Biobank was established in July 2010 to create a “bank” of biospecimens that are linked to participants’ electronic medical information. Participants are recruited throughout the state of Indiana. Data and specimens are made available to academic and commercial researchers. In addition to banked specimens, the Indiana Biobank offers prospective custom collections to obtain biospecimens and data meeting a researcher’s specific needs.

Biological samples: A sample of material, such as urine, blood, tissue, cells, DNA, RNA, or protein, from humans, animals, or plants. Also referred to as biospecimens, biological samples are used in labs for research purposes.

Clinical research: A branch of medical science that determines the safety and effectiveness (efficacy) of medications, devices, diagnostic products and treatment regimens intended for human use. Clinical research “aims to advance medical knowledge by studying people, either through direct interaction or through the collection and analysis of blood, tissues, or other samples.” (National Institutes of Health)

Clinical study: A research study involving human volunteers (also called participants or subjects) that is intended to add to medical knowledge. There are two types of clinical studies: interventional studies (also called clinical trials) and observational studies.

Clinical trial: A clinical trial “involves research participants. It follows a pre-defined plan or protocol to evaluate the effects of a medical or behavioral intervention on health outcomes. By taking part in clinical trials, 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.” (National Institutes of Health)

Confidentiality: The state of keeping or being kept secret or private. (Duke)

Consent form: A document that provides potential research subjects sufficient written information to decide whether to participate in a research study or not, based on an explanation of the proposed research and the nature of the participation that is requested of them. (Duke)

CTSA Program: The Clinical and Translational Science Awards (CTSA) Program is part of the National Institutes of Health’s (NIH) National Center for Advancing Translational Science (NCATS). The Indiana CTSI is been continuously funded since 2008 by multiple multi-million dollar grants through this program, which funds more than 50 member sites throughout the nation.

Effectiveness: The degree to which something is successful in producing a desired result; success. (Duke)

Efficacy: The ability, especially of a medicine or a method of achieving something, to produce the intended result.

Evidence: The effectiveness of an intervention in achieving an outcome that will create lasting changes in the health of the population. (Duke)

Evidence-based: Supported by a large amount of medical research. (Oxford)

Grant: a financial award given to an academic investigator to support his or her research. (The Free Dictionary)

Health research: Research that is done to learn more about human health. (Harvard)

Healthcare provider: Healthcare providers are all types of healthcare professionals who directly administer some type of medical aid to a patient. In general, a healthcare provider is trained in some type of healthcare role such as doctors, nurses, medical assistants and many more.

Healthy research volunteer: Someone with no known significant health problems who participates in research to test a new drug, device, or intervention. (NIH Clinical Center)

Implementation: The process of putting a decision or plan into effect; execution. (Duke)

Informed consent: a process through which a competent human subject, after having received and understood all the research related information can voluntarily provide his or her willingness to participate in a health research or clinical study.

Interventional Studies: are experimental research studies that compare the effectiveness of medical treatments, management strategies, prevention strategies, and other medical or public health interventions. (Boston University School of Public Health)

Investigator: a person who conducts experiments or is involved in scientific studies for health research.

ISDH: Indiana State Department of Health. (ISDH)

KL2 Scholars: KL2 Scholars are exceptional early-career investigators that compete for and are chosen to receive support for their work through the Indiana CTSI.

NCATS: The National Center for Advancing Translational Science (NCATS) is part of the National Institutes of Health (NIH). The Indiana CTSI has been continuously funded since 2008 by multiple multi-million dollar grants through NCATS’ Clinical and Translational Science Awards (CTSA) Program, which funds more than 50 member sites throughout the nation.

Observational studies: A research study in which the results are obtained retrospectively or without a control group. Some examples include case reports, chart reviews, and longitudinal studies of large cohorts followed over time (The Free Dictionary).

Outcomes: The way a thing turns out; the consequences of a health research study or clinical study.

Participatory research: comprises a range of methodological approaches and techniques, all with the objective of handing power from the researcher to research participants, who are often community members or community-based organizations. In participatory research, participants have control over the research agenda, the process and actions. Most importantly, people themselves are the ones who analyze and reflect on the information generated, in order to obtain the findings and conclusions of the research process.  (British Academy and Institute of Development Studies)

Patient population:  The common characteristics of a particular group of patients being studied in health research, such as a specific type of cancer or disease.

PDTs: The Indiana CTSI’s Project Development Teams (PDTs) provide investigators access to experts who can help implement high-quality pilot projects that generate successful external grant submissions. They provide support for researchers and their projects at all stages of the translational research process.

Pediatric research: Research relating to the branch of medicine dealing with children and their diseases. (Oxford) The American Academy of Pediatrics recommends people be under pediatric care up to the age of 21.

Protected health information (PHI): Demographic information, medical history, test and laboratory results, insurance information and other data that a healthcare professional collects to identify an individual and determine appropriate care. (Duke)

Practical clinical studies : Clinical studies for which the hypothesis and study design are developed specifically to answer the questions faced by decision makers. (Duke)

Principal Investigator (PI): The holder of an independent grant administered by a university and the lead researcher for the grant.

Research partnerships: A partnership approach to research that equally involves, for example, community members, organizational representatives, and researchers in all aspects of the research process and in which all partners contribute expertise and share decision making and ownership. (Duke)

Specimen Storage Facility (SSF): The Specimen Storage Facility (SSF) currently maintains four mechanical freezer storage sites, a LN2 freezer storage site, and a nucleic acid extraction laboratory. Both investigator- and SSF-owned freezers are monitored and maintained by SSF staff 24/7 to virtually eliminate specimen loss due to freezer failures. Quality is maintained via our contracted independent QA oversight and guidance. Our facility and procedures are ISBER compliant (International Society for Biological and Environmental Repositories).

Target population: A specific group that a researcher is interested in studying.

TL1 research: Basic science at the molecular and cellular levels.

TL2 research: Animal subjects research.

Translational research: Translational research is “the process of turning observations in the laboratory, clinic and community into interventions that improve the health of individuals and the public—from diagnostics and therapeutics to medical procedures and behavioral changes.” (National Center for Advancing Translational Science)

Withdrawal of consent: A patient’s voluntary termination of informed consent to participate in a health research or clinical study at any point.

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