Unanticipated Problem (UP): A UP includes any incident, experience, or outcome that meet all of the following criteria:
- unanticipated or unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are described in the protocol-related documents, such as the IRB-approved research protocol and informed consent document; and (b) the characteristics of the subject population being studied;
- related, probably related or possibly related to participation in the research (possibly related means there is a reasonable possibility that the incident, experience, or outcome may have been caused by the procedures involved in the research); and
- suggests that the research places participants or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.
Assent: Although parents and guardians must consent for their child to join a study, children should have a part in making a decision to join a study, if they are capable of doing so. When a child is asked to have a part in the decision, this is called "assent".
Centers for Disease Control and Prevention (CDC): A health surveillance system in the Department of Health and Human Services, which investigates, diagnosis and tries to control or prevent diseases, especially those that are new and unusual diseases.
Cognitively impaired: Having either a psychiatric disorder (e.g., psychosis, neurosis, personality or behavior disorders, or dementia), or a developmental disorder (e.g., mental retardation) that affects cognitive or emotional functions to the extent that capacity for judgment and reasoning is significantly diminished. Others, including persons under the influence of or dependent on drugs or alcohol, those suffering from degenerative diseases affecting the brain, terminally ill patients and persons with severely disabling physical handicaps, may also be compromised in their ability to make decisions in their best interests.
Cohort: A group of subjects initially identified as having one or more characteristics in common who are followed over time. In social science research, this term may refer to any group of persons who are born at about the same time and share common historical or cultural experiences.
Compensation: Payment or medical care provided to subjects injured in research; does not refer to payment for participation in research.
Data Safety Monitoring Board (DSMB): The Data Safety Monitoring Board (DSMB) is often an independent group of experts that advises sponsors and study investigator. Their primary responsibility is to periodically review and evaluate study data for participant safety, study conduct and progress and when appropriate efficacy. They also make recommendations to the sponsor of study investigators concerning continuation, modifications, or termination of the research study.
Food and Drug Administration (FDA): The FDA is the U.S. government agency that approves all drugs for marketing before they are made available to the public. The agency is responsible for enforcing laws on the manufacturing, testing and use of drugs and medical devices.
Health Insurance Portability and Accountability Act (HIPAA) Authorization Form: Is a form that explains how your personal, protected health information will be used and disclosed in the study. Your protected information is information about you that could be used to identify you, such as your name, address, telephone number, date of birth, medical record number etc. It may come from you or be gathered from your medical record.
Institutional Review Board (IRB): The IRB is a special committee that reviews human research to check that the rules and regulations are followed.
Minimal Risk Study: A minimal risk study is a study where the level of harm or discomfort anticipated is not greater than those ordinarily encountered in daily life activities or during the performance of a routine physical or psychological examination or test. For example, the risk of drawing a small amount of blood from a healthy individual for research purposes is no greater than the risk of drawing blood for a routine examination.
National Institutes of Health (NIH): An agency in the Department of Health and Human Services whose mission is to employ science in the pursuit of knowledge to improve human health. It is the principal biomedical research agency of the federal government.
Protocol: The formal design or plan of an experiment or research study, specifically, the plan submitted to the IRB for review and to an agency for research support. The protocol includes a description of the research design or methodology to be employed, the eligibility requirements for prospective subjects and controls, the treatment regimen(s) and the proposed methods of analysis that will be performed on the collected data.
Risk: The probability that harm or injury, whether (physical, psychological, social or economic) will occur as a result of participation in a research study. Both the probability and magnitude of possible harm may vary from minimal to significant.
Therapy: Treatment intended to alleviate a disease or disorder.
The Department of Health and Human Services (DHHS): The United States federal government's department that administers all federal programs dealing with health and welfare, for human services.
Voluntary: Acting or done of one's own free will without valuable consideration or legal obligation. Used in the research context to refer to a subject's decision to participate (or to continue to participate) in a research study.
Resources for More Information
Food and Drug Administration
Department of Health and Human Services, Office for Human Research Protections (OHRP)
National Clinical Trials Listing (to search for studies going in Chicago, IL)
National Cancer Institute Information About Cancer