VCOM Institutional Policy and Procedure Manual

VCOM Policy and Procedure

Policy #R004

or employment record). Identifiable private information is private information in which the identity of the subject is or may be readily determined by the investigator or associated with the private information gathered . Protected Health Information (PHI): HIPAA defines protected health information as individually identifiable health condition, health care and health care payment information, including the demographic data that is a potential identifier of the individual, maintained in the records of “covered entities”. PHI does not include individually identifiable health information in personnel records or education records covered by the Family Educational Right and Privacy Act. Public Health Authority: An agency or authority of the Unites States, a state, a territory, a political subdivision of a state or territory, an Indian tribe, or a foreign government, or a person or entity acting under a grant of authority from or contract with such public agency, including the employees or agents of such public agency or its contractors or persons or entities to whom it has granted authority, that is responsible for public health matters as part of its official mandate. Research/Research Activity: Any systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for the purposes of this policy, whether or not they are supported under a program that is considered research for other purposes. For example, some demonstration and service programs may include research activities. For the purpose of this part, the following activities are deemed not to be research: scholarly and journalistic activities including the collection and use of information, that focus directly on the specific 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; collection and analysis of information, biospecimens, or records by or for a criminal justice agency for 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 mission.[45CFR46.102(l)]. Serious Adverse Effect (SAE): An adverse effect which is fatal or life threatening, results in significant or persistent disability, requires or prolongs hospitalization, results in a congenital anomaly/birth defect, or represents other significant hazards or potentially serious harm to research subjects or others. Test Article: Any drug (including a 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 act or under sections 351 and 354-360F of the Public Health Service Act [21CFR50.3(j) and 21CFR56.102(l)]. Unexpected or Unanticipated: Adverse events or other problems in the research, the specificity or severity of which is not consistent with the information already provided to the IRB, including the investigator’s research protocol or consent form. Unanticipated Problems (UP): These may or may not include specific events experienced by individual subjects, but are developments within the research activity that suggest a potential for increased risk to subjects or others.

VCOM Institutional Review Board Policies and Procedures

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