HRPP Policy - Emergency use

About This Policy

Effective date:
07/19/2018
Last updated:
01/21/2019
Policy Contact:

IU Human Subjects Office
(317) 274-8289
irb@iu.edu

IU HRPP Policies

Related Policy Documents

View Informed Consent Policy

View Reportable Events Policy

IU HRPP Guidance

Related Guidance Documents

View HRPP Guidance

IU HRPP Documents

Related IRB Questionnaires

  • Emergency Use

View KC Crosswalk

Related Forms and Templates

Browse IU HRPP Forms

7.0 - Definitions

clinical investigation (FDA) (see also research) For research subject to FDA regulations, any experiment that involves a test article and one or more human subjects, and that either must meet the requirements for prior submission to the FDA under §505(i), §507(d), or §520(g) of the Food, Drug & Cosmetic Act, or need not meet the requirements for prior submission to the FDA under these sections of the act, but the results of which are intended to be later submitted to, or held for inspection by, the FDA as part of an application for a research or marketing permit. The term does not include experiments that must meet the provisions of part 58 regarding nonclinical laboratory studies (21 CFR 50.3(c)).

device (medical device) As regulated by the FDA, an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is: 1) recognized in the National Formulary, or the United States Pharmacopeia, or any supplement to them; 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 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 its primary intended purposes. See FDA Guidance for Industry and FDA Staff on Classification of Products as Drugs or Devices and Additional Product Classification Issues.

drug As regulated by the FDA, A) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and B) rticles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and D) articles intended for use as a component of any articles specified in clause (A), (B), or (C). See FDA Guidance for Industry and FDA Staff on Classification of Products as Drugs or Devices and Additional Product Classification Issues.

informed consent An ongoing process by which a subject (or his/her legal representative) voluntarily confirms his or her willingness to participate in a particular research project in accordance with the IU HRPP Policy on Informed Consent.

investigational biologic, drug, device, or test article A drug or device that is the object of a clinical investigation.

IRB-approved protocol Refers to all IRB-approved study information, including the human subject application, formal protocol document, consents, etc.

legally authorized representative (LAR) An individual or judicial or other body authorized under applicable law to consent on behalf of a prospective participant to the participant's participation in the procedure(s) involved in the research. For definition of LAR in Indiana, see the IU HRPP Policy on Adult Individuals Lacking Consent Capacity.

life threatening Diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted, and diseases or conditions with potentially fatal outcomes, where the endpoint of the clinical trial analysis is survival. Also includes severely debilitating, meaning diseases or conditions that cause major irreversible morbidity (e.g., blindness, loss of arm, leg, hand, or foot).

noncompliance (see also continuing noncompliance, minor noncompliance, observed or apparent noncompliance, serious noncompliance) Any action or activity associated with the conduct or oversight of research involving human subjects that fails to comply with federal or state regulations, requirements of VHA Handbook 1200.05, or institutional policies governing human subjects research or the requirements or determinations of the IRB.

sponsor An individual, company, institution, or organization that takes responsibility for the initiation, management, and/or financing of research.

test article Any drug for human use, biological product for human use, medical device for human use, human food additive, color additive, electronic product, or any other article subject to regulation under the Food, Drug, and Cosmetic Act or under §351 or §§354-360F of the Public Health Service Act.

written/in writing Writing on a tangible medium (e.g. paper) or in an electronic format.

Back to top