Definitions of Common Terms

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  • Anonymity: no identifying information is recorded, therefore, making it impossible to trace the data back to the original source.
    • *Assent: a child's affirmative agreement to participate in research. Mere failure to object, absent affirmative agreement, should not be construed as assent.
    • Confidentiality: the investigator guarantees that the identifying information will not be shared with unauthorized individuals. Please note that this guarantee is only as good as the integrity and care of the authorized individuals.
  • Continuing Review: a periodic review of all research protocols that are subject to oversight by the IRB. The time period for periodic review depends on the risk(s) associated with each protocol and is determined by the reviewer or full board at the time of review. The PI will be advised of the beginning and end dates in the approval letter. This time period will be no longer than 12 months.
    • Types of review: at the initial review of an application for permission to use human participants in research the IRB determines the type of review needed for approval of the application. The categories are based on specific guidelines listed in the DHHS guidelines 45 CFR 46. These types are exempt, expedited, and full board review.

      • Exempt Review: research in this category is exempt from federal regulations at 45 CFR 46. Research that falls under this type of review is not subject to a formal informed consent process or to continuing review by the IRB.  However, determinations of exemption must be made by a qualified member of the IRB. There are six categories that can be used in exempt review as specified in 45 CFR 46.

      • Expedited Review: research in this category involves no more than minimal risk and involves research in at least one of 7 categories specified in 45 CFR 46 (Note: there are two additional categories in the expedited review process that can be used but only at the time of continuing review).

      • Full Board Review: research in this category does not meet the qualifications for review in either the exempt or expedited processes and must be reviewed by members of the Full Board at a regularly scheduled meeting.

    • *Human Participant: a living individual about whom an investigator (whether professional
      or student) conducting research obtains 1) data through intervention or interaction with the individual or 2) identifiable private information.
    • Informed Consent: a process by which a competent individual can make a reasoned decision based on necessary information. The information must be adequately understood, and the individual can make his/her decision without experiencing coercion, undue pressure, inducement, or intimidation.
    • *Institutional Review Board (IRB): a committee that performs ethical review of proposed research.
    • *IRB Approval: the determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and federal requirements.
    • *Minimal Risk: the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

 

  • *Research: a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.

* Source: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html Accessed 7/8/11