Version
1.4
Date Updated
Monday, May 14, 2012
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) [38 CFR 16.102(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. For research conducted at UIC and other non-VA performance sites, the
      following individuals may review and approve claims of exemption: IRB Chair,
      IRB member designated by the Chair, IRB Assistant Directors, experienced
      IRB Coordinators, and the OPRS Director or Associate Director. Experienced
      coordinators are individuals who have reviewed exemptions for at least 6
      months under the supervision of an IRB Assistant Director and Chair and who
      have been judged by them to be qualified.
    2. For VA Research, the review and approval of claims of exemption is
      performed by the Chair for UIC IRB#4 or an IRB member designated by the
      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 re-submit or close the study. The
    action “Admin Closure” will not be used for any other purpose. Investigators
    conducting exempt protocols at the JBVAMC are required to obtain initial JBVAMC
    R&D approval before initiating the research and must also submit an annual report of
    research activities directly to the JBVAMC R&D committee.
  4. General considerations in making a determination of a claim for exemption.
  5. The research involves no more than minimal risk to participants.
  6. The research can not involve prisoners as participants. (45 CFR 46.101(i)).
  7. Exemption categories 1-5 do not pertain to FDA-regulated research. (21 CFR
    56.104).
  8. Exemption categories 1-6 apply to research involving pregnant women,
    fetuses and neonates (45 CFR 46.201(b)), with the exception that VA
    Research may not involve the fetus as a subject.
  9. 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)).
  10. 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), 38 CFR 16.102(b)(1)]
  11. Category 2. Research involving the use of educational tests (cognitive,
    diagnostic, aptitude, achievement), survey procedures, interview procedures
    or observation of public behavior, unless:
  12. Information obtained is recorded in such a manner that human subjects
    can be identified, directly or through identifiers linked to the subjects;
    AND
  13. 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, loss of
    insurability (this later criteria is for VA Research only; 1200.05) or
    reputation. [45 CFR 46.101(b)(2), 38 CFR 16.102(b)(2)]
  14. 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.
  15. Additional guidance.
  16. 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.
  17. The human subjects are elected or appointed public officials or
    candidates for public office; or
  18. 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), 38 CFR 16.102(b)(3)]
  19. These sources are publicly available, or
  20. 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, 38 CFR 16.102(b)(4)]
  21. 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 also 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.
  22. For VA Research, if exemption category 4 is claimed, the investigator
    may not retain any of the 18 identifiers outlined in the HIPAA Privacy
    Rule, and the investigator may not have access to any code by which
    the information may be linked to individuals. When the investigator will
    review PHI for the research, a waiver of authorization is required.
  23. 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.
  24. Public benefit or service programs;
  25. Procedures for obtaining benefits or services under those programs;
  26. Possible changes in or alternatives to those programs or procedures;
    or
  27. Possible changes in methods or levels of payment for benefits or
    services under those programs. [45 CFR 46.101(b)(5), 38 CFR
    16.102(b)(5)]
  28. 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. For VA Research,
      determination of exempt status for these research and
      demonstration projects must be made by the Under Secretary of
      Health on behalf of the Secretary of Veterans Affairs.
  29. Wholesome foods without additives are consumed; or
  30. 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), 38 CFR 16.102(b)(6)]
  31. 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:
  32. Category 4. Research involving the collection or study of existing data,
    documents, records, pathological specimens, or diagnostic specimens,
    provided:
  33. 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:
  34. Category 6. Taste and food quality evaluation and consumer acceptance
    studies, if:
  35. Categories of research activities identified as exempt by UIC:
  36. Although exempt research is not subject to the federal regulations at 45CFR46 (or
    38CFR16), 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.