Key Terms and Definitions
Association for the Accreditation of Human Research Protection Programs (AAHRPP)
An independent, non-profit accrediting body that ensures human research protection programs (HRPP) meet rigorous standards for quality and protection, in order to promote excellent, ethically sound research. Through partnerships with research organizations, researchers, sponsors and the public, AAHRPP encourages effective, efficient and innovative systems of protection for human research participants.
Collection of biospecimens (blood, DNA, tissue, biopsy specimens, etc.) with corresponding patient data such as genetic profile, medical history and lifestyle information.
A study in which the participant does not know if they are in the treatment or control group. In double-blinded research, neither the participant nor the researcher knows whether the participant is in the treatment or control group.
Center for Disease Control and Prevention (CDC)
CDC conducts critical science and provides health information that protects our nation against expensive and dangerous health threats and responds when these arise.
Clinical Research Coordinator / Nurse (CRC / CRN)
A specially trained coordinator or nurse works with a Principal Investigator (PI) to support, facilitate and coordinate clinical trials.
Clinical trials are designed to learn if new treatments are safe and effective. These trials might be evaluating new drugs, new devices or procedures, or new ways to use existing treatments.
A registry and result database of publicly and privately supported clinical studies of human participants conducted around the world. This is a useful tool to find access to research studies that are enrolling volunteers, and a place to find results for completed studies.
Conflict of Interest (COI)
A situation in which financial or personal interest may compromise or appear to compromise one's professional judgement.
The group of participants that receives standard treatment or a placebo. The control group may also be made up of healthy volunteers. Researchers compare results from the control group with results from the experimental group to find and learn from any differences.
The factors or reasons that prevent a person from participating in a clinical study.
Food and Drug Administration (FDA)
A federal agency of the United States Department of Health and Human Services that is responsible for protecting the public health by ensuring the safety, efficacy and security of human and veterinary drugs, biological products and medical devices.
Good Clinical Practice (GCP)
Regulations and requirements that must be adhered to while conducting a clinical study. These regulations apply to manufacturers, sponsors, clinical investigators, institutional review boards, etc.
Human Research Protection Program (HRPP)
A committee responsible for reviewing research involving human subjects. It is also referred to as an Institutional Review Board or IRB.
The factors or reasons that allow a person to participate in a research study.
Investigational New Drug (IND)
Investigational New Drug, an application submitted to the FDA for safety review prior to any clinic trial activities beginning.
Industry Sponsored Research
Research in which an industry sponsor (e.g. device or drug company) designs a research protocol.
Informed Consent Form (ICF)
Informed consent is the process of providing potential participants with the key facts about a clinical trial before they decide whether to participate. The research team provides a document called an informed consent form (ICF) that includes details about the study, such as its purpose, duration, required procedures, potential risks and benefits, and who to contact for further information. The participant then decides whether to sign the ICF.
Investigational Device Exemption (IDE)
Allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data.
Investigator Initiated Research
Research which is designed by the investigator who is planning to carry out the research.
IRB (Institutional Review Board)
An IRB is an independent committee that consists of physicians, statisticians and members of the community who ensure that clinical trials are ethical and that the rights of participants are protected. Most clinical trials in the United States are approved and monitored by an Institutional Review Board (IRB) in order to ensure that the risks are minimal and are worth any potential benefits. (see also HRPP)
National Institutes of Health (NIH)
Part of the U.S. Department of Health and Human Services (HHS), NIH is the primary Federal agency for conducting and supporting medical research. NIH scientists investigate ways to prevent disease as well as the causes, treatments and even cures for common and rare diseases. Composed of 27 institutes and centers, NIH provides leadership and financial support to researchers in every state and throughout the world.
A pill, liquid or powder that does not contain active ingredients and is made to be physically indistinguishable (that is, it looks and tastes identical) from the actual drug being studied. In clinical trials, experimental drugs are often compared with placebos to evaluate the treatment’s effectiveness.
The individual who is primarily responsible for ensuring that a study is conducted according to the investigational plan and applicable regulations; for protecting the rights, safety and welfare of subjects under the investigator's care; and for the control of drugs under investigation.
Clinical research is conducted according to a plan known as a protocol. The protocol is carefully designed to safeguard the participants’ health and answer specific research questions. A protocol describes the following: who is eligible to participate in the trial; details about tests, procedures, medications and dosages; and the length of the study and what information will be gathered.
A study design in which researchers evenly and randomly assign study participants into a group receiving the experimental treatment being studied, and others into a group receiving standard or no treatment. Participants are assigned to a group based on chance, not choice. Participants have the same chance to be placed in any of the test groups.
A study designed to observe subjects with certain shared characteristics. Ongoing data is collected over time for analysis and reporting.
A study designed to look at existing information, often using medical records.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.