HRPP Policy - IRB Membership

About This Policy

Effective date:
03/29/2018
Last updated:
01/21/2019
Policy Contact:

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

IU HRPP Policies

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IU HRPP Guidance

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IU HRPP Documents

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Related Forms and Templates

  • IRB Member Information Sheet
  • IRB Member Evaluation Form

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Regulatory References

7.0 - Definitions

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.

fetus The product of conception from implantation until delivery.

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

investigator (FDA, see also research personnel, IU-affiliated research personnel, key personnel, non-key personnel, non-affiliated research personnel, principal investigator (PI), student, fellow, resident PI, site-specific PI) In research subject to FDA regulations, an individual who actually conducts a clinical investigation, i.e., under whose immediate direction the test article is administered or dispensed to, or used involving a subject, or, in the event of an investigation conducted by a team of individuals, is the responsible leader of that team.

neonate A newborn child less than four weeks old. A Bold-nonviable neonate-Bold is an expelled or delivered fetus who, although living, cannot sustain life independently, even with medical intervention.

prisoner Any individual involuntarily confined or detained in a penal institution. The term is intended to encompass individuals sentenced to such an institution under a criminal or civil statute; individuals detained in other facilities by virtue of statutes or commitment procedures that provide alternatives to criminal prosecution or incarceration in a penal institution; and individuals detained pending arraignment, trial, or sentencing. Examples of individuals considered prisoners are available in the Link-OHRP Prisoner Research FAQs.-Link

research A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge (Synonymous with clinical investigation 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)).) The following activities are deemed not to be research under this definition: Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information that focus directly on the individuals about whom the information is collected; Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters); Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for the activities authorized by law or court order solely for criminal justice or criminal investigative purposes; Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.

suspension Temporary cessation of some or all activities in a currently approved research study.

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