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If your project involves one or more ingested substance or dietary supplement, please include the forms below with your IRB application. If you are unsure whether your project includes an ingested substance or dietary supplement, see the information provided below.
Note that projects using ingested substances or dietary supplements should adapt the informed consent template below in place of their consent document.
Ingested Substances and Dietary Supplements Form
Informed Consent with Ingested Substances Template 
Studies involving the ingestion of substances that are not subject to FDA oversight are still covered by Office of Human Research Protections (OHRP) regulations, and therefore must be reviewed by the Institutional Review Board (IRB) at Northwest Missouri State University.
Ingested substance is defined in FDA’s food additive regulations to include foods, food components, and dietary supplements.
When ingested substances are involved in a study, the PI is responsible for providing the Institutional Review Board with appropriate information concerning the substance. Please review the definitions below to ascertain if the ingested substance you propose is a food, food component, or dietary supplement.
The term “food” is defined as an “article used for food or drink, including chewing gum, beverages and articles used for components of any such article” [FD&C Act, section 201(f)]. Therefore, a “substance” may be a food (e.g., an orange) that can be eaten on its own as well as used as an ingredient in other foods, or it may be a food that is used only as a component of other foods (e.g., flour).
The term “dietary supplement” is defined as an article (item) that contains a “dietary ingredient” and is intended to supplement the diet [FD&A Act, section 201(ff)]. The “dietary ingredients” in these products may include: (1) vitamins, (2) minerals, (3) herbs or other botanicals, (4) amino acids, (5) substances found in the diet (such as enzymes and edible organ tissues and glandulars), and (6) concentrates, metabolites, constituents, extracts, or combinations of the substances identified in (1)-(5). Dietary supplements may be found in many forms such as tablets, capsules, softgels, gelcaps, liquids, or powders. Dietary supplements are regulated as foods, rather than drugs, for purposes of the FD&C Act and their labeling must identify them as a dietary supplement.
If the proposed substance does not fit in to either of these categories, it is likely you are proposing use of a drug or biologic (e.g. a therapeutic serum). These substances are subject to additional FDA regulations and require approval from the FDA (see http://www.fda.gov/ for additional information). Please contact the Northwest IRB if your proposed substance is neither a food, food component, nor dietary supplement.
If you propose the use of any ingestible substance, the Ingested Substances and Dietary Supplements Form must be completed and submitted, along with your IRB application, through email to IRBNWMS@253000xa.com. If you propose to use more than one ingestible substance, you must submit a form for each (e.g., if your project involves coffee, vinegar, and a vitamin D supplement, you would need to submit three Ingested Substance and Dietary Supplements forms).
You must receive IRB approval for use of all ingestible substances in a project prior to collecting new research data or accessing existing data.
