An unintended, but not necessarily unexpected, result of therapy or other intervention that is unpleasant or dangerous.
Refers to information or data where identifiers (and codes that are linked to identifiers) have been removed, as well as other values that would enable individuals to be identified by inference. Close correlation with values in additional datasets, or unique values, or cells containing few data points, for instance, could support such inferences. A dataset, therefore, must at least have been thoroughly de-identified in order to be anonymized. For all practical purposes, anonymized data cannot be linked to the individual. Examples of anonymized data are public use files made available by the Bureau of the Census.
Association for Health Services Research
Health Services Research is a field of inquiry using quantitative or qualitative methodology to examine the impact of the organization, financing, and management of health care services on the access to, delivery, cost, outcomes, and quality of services.
An agreement or contract between an institution and the Office of Human Research Protections (OHRP), on behalf of the Secretary of Health and Human Services; the assurance stipulates the methods by which the institution will protect the rights and welfare of research subjects in accordance with the regulations.
A statement of basic ethical principles governing research involving human subjects issued by the National Commission for the Protection of Human Subjects in 1978
The official notification to the supporting department or agency, in accordance with the requirements of this policy, that a research project or activity involving human subjects has been reviewed and approved by an IRB
A person who has not attained the legal age for consent to treatments or procedures involved in the research
Any experiment that involves a test article and one or more human subjects
The central federal policy adopted "in common" by 16 federal departments and agencies (and concurred, with some modifications, by the FDA) that support and/or conduct research involving human subjects. The adoption of the federal policy in 1991 implements a recommendation of the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research that all federal departments and agencies "adopt as a common core the regulations governing research with human subjects issued by the Department of Health and Human Services (codified at 45 CFR 46, Subpart A), as periodically amended or revised, while permitting additions by any department or agency that are not inconsistent with these core provisions" (OPRR Guidebook, Chapter 2).
Payment or medical care provided to subjects injured in research; does not refer to payment (remuneration) for participation in research
The manner of treating private information, which has been disclosed by the individual subject of the information to a particular person or persons for a specific purpose, such that further disclosure of the information will not be allowed to occur without authorization
Research that has been approved will undergo review until the completion or termination of the research, including scheduled continual reviews of research that will occur at least annually
Cooperative Research Projects
Those projects normally supported through grants, contracts, or similar arrangements, which involve institutions in addition to the grantee or prime contractor (such as a contractor with the grantee, or a subcontractor with the prime contractor)
Refers to information that is collected for analysis or used to reason or make a decision
Informational privacy especially when the information in question is stored in a database
Refers to information or data where direct identifiers such as name and address have been removed. In common use, the term refers to data where it may still be possible to identify individuals by inference or through codes held by the investigator or a third party. Therefore data that is de-identified may not be anonymized because it may still permit at least probabilistic re-identification when analyzed in conjunction with other datasets.
Department or Agency Head
The head of any federal department or employee of any department or agency to whom authority has been delegated
Therapeutic, diagnostic or prosthetic articles, which do not interact chemically with the body (e.g., pacemakers, intrauterine contraceptive devices, diagnostic test kits, crutches, and artificial joints)
An individual who is considered to have reached maturity by: 1) the appointment by a court of a guardian; 2) upon marriage; or 3) upon attaining majority
The use of a test article on a human subject in a life-threatening situation in which no standard acceptable treatment is available and in which there is not sufficient time to obtain IRB approval
The Common Rule codified in 45 CFR 46.101(b) specifies that research activities may be exempt from the policy if human subjects involvement is limited to one of the listed scenarios, including studies involving the collection or study of existing data when those data either are publicly available or are not personally identifiable. As detailed in the text, however, some IRBs request to see the studies that may be exempt, and open files on them for tracking.
The Common Rule codified in 45 CFR 46.110 specifies that research activities may be eligible for expedited review if the protocol involves only minimal risk or a previously reviewed protocol is receiving modifications that are only minor. Expedited review is carried out by the IRB Chair or by one or more experienced reviewers designated by the chair. Such expedited reviews have the force of full reviews, except that if the protocol is found not acceptable, then it must receive review by the full committee; the chair or designee alone cannot reject a proposal.
Regulations are the rules that departments or agencies issue to provide specific guidance to themselves and others about how they will implement pertinent laws. In this particular report, "regulations" refers to federal regulations on human subjects protection to the Department of Health and Human Services' regulations, since that agency sponsors most of the relevant research and this project, but the report applies similarly to other departments and agencies.
An individual who is authorized under applicable state or local law to consent on behalf of another person (e.g., children) to general medical care
Health Information Privacy
Informational privacy especially when the information in question pertains to the health or medical condition of the individual in question
Individuals about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information
A proposition (or set of propositions) proposed as an explanation for the occurrence of some specified group of phenomena to be tested by research
The right of individuals to control access to, and the use of, information about themselves.
The knowing, legally effective consent of any individual or the individual's legally authorized representative; such consent can be obtained only under circumstances that provide the prospective subject or representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence
Institute of Medicine (IOM)
Health services is a multidisciplinary field of inquiry, both basic and applied, that examines the use, costs, quality, accessibility, delivery, organization, financing, and outcomes of health care services to increase knowledge and understanding of the structure, processes, and effects of health services for individuals and populations.
Any public or private entity or agency (including federal, state, and other agencies)
Institutional Review Board (IRB)
A committee formed to ensure the protection of human subjects in research
Includes communication or interpersonal contact between investigator and subject
Includes both physical procedures by which data are gathered (e.g., venipuncture) and manipulation of the subject or the subject's environment that are performed for research purposes
The determination by the IRB that the research has been reviewed and may be conducted within the constraints set forth by the IRB and by other institutional and federal requirement
Legally Authorized Representative
An individual or judicial or other body authorized under North Dakota law to consent on behalf of a prospective subject to the subject's participation in the procedures involved in the research
That the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests
A child's biological or adoptive parent
The agreement of parent(s) or guardian to the participation of their child or ward in research
Personally Identifiable Health Information
Health or medical data or information that can be linked manifestly or inferentially to an individual
The individual with primary responsibility for the design and conduct of a research project
The formal design or plan of an experiment or research activity
Payment for participation in research
Studies undertaken to contribute to the body of generalizable knowledge
Any drug/biological product/medical device for human use, human food additive, color additive, electronic product, or any other article subject to FDA regulations
Waiver of Informed Consent
The Common Rule codified in 45 CFR 46.116(d) specifies that an IRB can alter or waive the requirement to obtain informed consent if it finds and documents that the research involves no more than minimal risk to the subjects, the waiver or alteration will not adversely affect the rights and welfare of the subjects, the research could not practicably be carried out without the waiver or alteration, and whenever appropriate, the subjects will be provided with additional pertinent information after participation.
Waiver of Review
FDA regulations at 21 CFR 56.105 permit the agency to waive any of its requirements including the requirement of IRB review. Since this report addresses human subject research, not product safety and effectiveness, this provision is unlikely to apply (OPRR 1993, Chapter 2).
The above compilation is taken from http://www.nd.gov/dhs/info/research/definitions.html . Follow this link for more details.