facilities that collect, store, and distribute human data for research purposes. Data management activities involve three components: (i) the collectors of data; (ii) the data storage and management center; and (iii) the recipient investigators. Data management centers may be combined with a human repository.
when mortality is one of the experimental endpoints in animal research.
giving subjects previously undisclosed information about the research project following completion of their participation in the research.
intentionally misleading or withholding information about the nature of the experiment.
an international ethical code containing basic principles, which are similar to the Nuremberg Code, but represent an expansion of what constitutes acceptable research and the ethical responsibilities of investigators.
are one type of violation and include any condition of animal care or treatment that is not in compliance with the Animal Welfare Act (or its regulations and standards); or established by assurance, regulation, policy / procedure with other applicable entities.
animal use areas that are the responsibility of the Department or Institute Chair. This is a location outside of the DLAR managed vivarium that does not meet the minimum criteria for an animal housing area and the animals will held in the area for less than 12 hours and not overnight; must comply with IACUC Policy.
an experienced member designated by the Chair to review business items on behalf of the committee.
are one type of violation and include any variance in the research practices from originally IACUC approved proposal that adversely affect animal welfare.
a departure from the approved study protocol without prior IRB approval that: 1) is generally noted or recognized after it occurs, OR if identified before it occurs cannot be prevented by the investigator (not an intentional deviation); and 2) has no potential substantive effect on the risks to research participants, AND 3) has no substantive effect on the scientific integrity of the research plan or the value of the data, and did not result from willful or knowing misconduct on the part of the investigator(s).
an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is: 1) recognized in the USPÐNF, OR 2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, OR 3) intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.
Department of Health and Human Services is responsible for Improving the health and well-being of America. The National Institutes of Health (NIH), Center for Disease Control (CDC), Health Resources and Services Administration (HRSA) and the Substance Abuse and Mental Health Services Administration are examples of DHHS agencies.
an identified individual who initially declines participation in research.See also: Subject Statuses
is a product taken by mouth that contains a "dietary ingredient" intended to supplement the diet. The "dietary ingredients" in these products may include: vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandular, and metabolites. Dietary supplements can also be extracts or concentrates, and may be found in many forms such as tablets, capsules, softgels, gelcaps, liquids, or powders.
behaviors that would indicate an individual does not want to participate.
A\animal use or housing areas that are the responsibility of the Department of Laboratory Animal Resources (DLAR). In these areas, DLAR 1) approves the species to be housed in the area, no matter whether the University has assigned the space to DLAR or a non- DLAR department, 2) charges per diem or technical fee for vertebrate species, 3) is financially responsible for minor maintenance and repairs, 4) is responsible for daily oversight of the animals when the area is actively in use (note that DLAR may delegate aspects of husbandry- including documentation of daily observation), 5) controls access to the area, and 6) approves any renovations, new construction, major HVAC changes, etc. to any part of the area prior to the start of the project. DLAR management must approve the use of a room prior to occupancy.
1) a substance recognized by an official pharmacopoeia or formulary; AND
2) a substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease; AND
3) a substance (other than food) intended to affect the structure or any function of the body; AND
4) a substance intended for use as a component of a medicine but not a Device or a component, part or accessory of a device.
Note: biological products are included within this definition and are generally covered by the same laws and regulations, but differences exist regarding their manufacturing processes (chemical process versus biological process).
that the product is useful in diagnosing, mitigating, treating or curing a specific disease or class of diseases.See also: Drug