Version
1.6
Date Updated
Friday, December 2, 2016
Descripton

Approved by:  Human Protections Administrator, Director of OPRS, and Executive IRB Chair
AAHRPP REF#:  128
AAHRPP Elements:  II.2.A., II.2.B.


POLICY


  1. Research in which activities involving human subjects are limited to one or more of
    the categories at 45 CFR 46.101(b) may qualify for exemption
    from 45 CFR 46.
  2. PIs do not have the authority under federal guidance and UIC policy to
    independently determine that research involving human subjects is exempt. PIs
    must submit the research to OPRS for review of a claim of exemption and receive
    written documentation of the determination from OPRS before initiating the research.
    1. The following individuals may review and approve claims of exemption: IRB Chair,
      IRB members designated by the Chair, OPRS Director, Associate Directors, Assistant Directors, and Coordinators designated by the IRB Chair.  
  3. When a proposal has received a written determination that it is exempt, continuing
    IRB review is not required. The proposal receives a 3 year expiration date, after
    which the investigator will need to re-submit or close the study. To implement this
    policy and procedure, the appropriate UIC OPRS staff will use the RiSC action
    “Admin Closure” to close exempt protocols that have been active for more than 3
    years per the previous policy and procedure and require re-submission when
    applicable. The action “Admin Closure” will also be used for exempt protocols that
    have expired but in which the investigator does not close the study. 
  4. General considerations in making a determination of a claim for exemption.
    1. The research involves no more than minimal risk to participants.
    2. The research can not involve prisoners as participants. (45 CFR 46.101(i)).
    3. Exemption categories 1-5 do not pertain to FDA-regulated research. (21 CFR
      56.104).
    4. Exemption categories 1-6 apply to research involving pregnant women,
      fetuses and neonates (45 CFR 46.201(b)).
    5. Exemption categories 1 and 3-6 apply to research involving children.
      Research activities in category 2 are exempt for children only when limited to
      educational tests or observation of public behavior when the investigators do
      not participate in the activities being observed. (45 CFR 46.401(b)).
  5. Categories of research activites as identified as exempt by UIC:
    1. Category 1. Research conducted in established or commonly accepted
      educational settings, involving normal educational practices, such as
      1. Research on regular and special education instructional strategies, or
      2. Research on the effectiveness of or the comparison among
        instructional techniques, curricula, or classroom management
        methods. [45 CFR 46.101(b)(1)]
    2. Category 2. Research involving the use of educational tests (cognitive,
      diagnostic, aptitude, achievement), survey procedures, interview procedures
      or observation of public behavior, unless:
      1. Information obtained is recorded in such a manner that human subjects
        can be identified, directly or through identifiers linked to the subjects;
        AND
      2. Any disclosure of the human subjects' responses outside the research
        could reasonably place the subjects at risk of criminal or civil liability or
        be damaging to the subjects' financial standing, employability, or
        reputation. [45 CFR 46.101(b)(2)]
      3. If the research in this category involves children as participants, the
        activities can not include (45 CFR 46.401(b)):
        1. Survey procedures;
        2. Interview procedures;
        3. Observation of public behavior where the investigators
          participate in the activities being observed.
      4. Additional guidance.
        1. This category requires that information is recorded in a manner
          that:
          1. Participants can not be identified, directly or through their
            responses, demographics, or codes linked to identifiers,
            or
          2. If participants can be identified, directly or through their
            responses, demographics, or codes linked to identifiers,
            any disclosure of the participants’ responses outside the
            research could not reasonably place them at risk of
            criminal or civil liability or be damaging to their financial
            standing, employability, insurability or reputation.
    3. Category 3. Research involving the use of educational tests (cognitive,
      diagnostic, aptitude, achievement), survey procedures, interview procedures,
      or observation of public behavior that is not exempt under category 2 above,
      if:
      1. The human subjects are elected or appointed public officials or
        candidates for public office; or
      2. Federal statute(s) require(s) without exception that the confidentiality of
        the personally identifiable information will be maintained throughout the
        research and thereafter. [45 CFR 46.101(b)(3)]
    4. Category 4. Research involving the collection or study of existing data,
      documents, records, pathological specimens, or diagnostic specimens,
      provided:
      1. These sources are publicly available, or
      2. The information is recorded by the investigator in such a manner that
        subjects cannot be identified, directly or through identifiers linked to the
        subjects. [45 CFR 46.101(b)(4)]
      3. Additional guidance:
        1. Publicly available means that the general public can obtain the
          data/biological specimens. Sources are not considered publicly
          available if access to the data/specimens is limited to
          researchers.
        2. All material that will be used to conduct the research must exist
          at the time the research is proposed; no on-going or prospective
          collection of material is allowed.
        3. Under this exemption, an investigator may review identifiable
          records, but must record information in the research record in a
          non-identifiable manner. Moreover, the data must be
          permanently and completely de-linked at the time of extraction
          (that is, the investigator will not have any further access to the
          identifiable records).
        4. Exemption from IRB review does not represent an
          exemption from HIPAA requirements for authorization or waiver
          of authorization when the research involves the use or access of
          PHI.
        5. Research involving the retrospective analysis of medical records
          qualifies for exemption category 4 when the information
          extracted from the chart and recorded in the research record
          does not contain any identifiers, including most of the 18 HIPAA
          elements (dates of service and geographic codes less specific
          than street address are allowable), codes derived from any of
          the HIPAA elements or codes linked to identifiers. The
          investigator must also receive a waiver of HIPAA authorization
          from the IRB, as looking at medical records is considered
          accessing PHI regardless of whether or not identifiers are being
          recorded.
      4. Research involving the retrospective analysis of medical records does not qualify for a claim of exemption if prospective rather than retrospective data is collected, any of the 18 HIPAA elements, except dates of service and geographic codes less specific than street address, combinations of the elements are entered into the research records, or data contained in the research records are linkable in any way to the identity of the subjects.
    5. Category 5. Research and demonstration projects which are conducted by or
      subject to the approval of federal department or agency heads, and which are
      designed to study, evaluate, or otherwise examine:
      1. Public benefit or service programs;
      2. Procedures for obtaining benefits or services under those programs;
      3. Possible changes in or alternatives to those programs or procedures;
        or
      4. Possible changes in methods or levels of payment for benefits or
        services under those programs. [45 CFR 46.101(b)(5)]
      5. Federal guidance specifies that the following criteria must be satisfied
        to apply this exemption:
        1. The program under study must deliver a public benefit (e.g.,
          financial or medical benefits as provided under the Social
          Security Act) or service (e.g., social, supportive, or nutritional
          services as provided under the Older Americans Act);
        2. The research or demonstration project must be conducted
          pursuant to specific federal statutory authority;
        3. There must be no statutory requirement that the project be
          reviewed by the IRB; and
        4. The projects must not involve significant physical invasions or
          intrusions upon the privacy of participants.
        5. Authorization or concurrence of the Federal funding agency for
          the exemption determination is needed. 
    6. Category 6. Taste and food quality evaluation and consumer acceptance
      studies, if:
      1. Wholesome foods without additives are consumed; or
      2. A food is consumed that contains a food ingredient at or below the
        level and for a use found to be safe, or agricultural, chemical, or
        environmental contaminant at or below the level found to be safe, by
        the FDA or approved by the Environmental Protection Agency or the
        Food Safety and Inspection Service of the U.S. Department of
        Agriculture. [45 CFR 46.101(b)(6), 21 CFR 56.104(d)]
  6. Although exempt research is not subject to the federal regulations at 45 CFR 46, the UIC policy requires all research involving human subjects, including exempt research, to be performed responsibly and in accordance with the ethical guidelines of the Belmont Report. Researchers performing exempt research are expected to institute appropriate protections, including obtaining informed consent as appropriate and implementing measures to protect privacy and confidentiality.
  7. Previously claims of exemption were assigned to a registered UIC IRB.  As such, every claim of exemption was reported to the IRB on meeting agendas and meeting minutes.  As claim of exemptions are exempt from the federal regulations at 45 CFR 46, they do not need to be reported to an IRB.  Therefore the OPRS submission process has changed in that research submitted to OPRS for review of a claim of exemption are no longer assigned to any of the UIC registered IRBs.  The submissions are logged into the RiSC database under “IRB 7”.  This is for administrative purposes only.  Please note that the submissions are not associated with University of Illinois at Chicago IRB #7 – Chicago Area Institutional Review Board (CHAIRb) (IRB00009693).
  8. The Assistant Director, Education, oversees the review process of the proposals submitted for a claim of exemption.