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Exempt Review

These guidelines will be used by the committee to determine whether your research falls under the exempt review category. Your research must not exceed minimal risk, must involve only the table categories below, and must pass the screening questions following this table:

 
Category
Explanation
1.  Research that is
  • conducted in established or commonly accepted educational settings, and
  • involves normal educational practices.
 

Generally applies to the study of teaching methods, strategies, and curricula in the process of education. If individuals may be identified directly or indirectly, file for Expedited Review.

FERPA and PPRA also regulate research in school settings and limit information that may be gathered from schools and minors without subject or parental consent.   

2.   Anonymous data that is gathered by using
  1. educational tests -
    • cognitive,
    • diagnostic,
    • aptitude, or
    • achievement, or
  2. surveys w/o sensitive information, or
  3. interviews w/o sensitive information, or
  4. observation of public behavior

If data is identifiable, release of the data cannot harm the subject.

If subjects are under age 18, only subsection (a) above is Exempt.  Subsection (b – d) require Expedited Review.

A subject is considered to be identifiable, and thus not anonymous, if any information contained in the data file can be linked back to him or her, either directly or indirectly. In those studies in which individuals may be identified either directly or indirectly, file for Expedited Review.

Subsection (a) uses accepted educational tests, such as standardized tests, or the kinds of tests that might be given to students to evaluate them.

(b) and (c) exempt surveys and interviews do not include sensitive information (e.g. illegal activities, sexual orientation, sexual behavior, undesirable work behavior, mental illness, or other information that may be painful or very embarrassing to reveal, such as death of a family member, memories of physical abuse, sexual abuse, etc.). File for expedited or full review if sensitive information is involved in the study.

For tests, surveys, and interviews, subjects should be informed that their participation is voluntary. Because participation is voluntary and response is anonymous, subjects give "implicit consent" when they participate.

Harm the subject means that any disclosure of the subject’s response(s) outside the research could reasonably place the subjects at risk of criminal or civil liability or could be damaging to the subjects' financial standing, employability, or reputation.

3.  Testing, survey, interview or observation of public or elected officials.

Research in which the subjects are public elected or appointed officials.

 
4.  The collection or study of existing
  • data,
  • documents,
  • records,
  • pathological specimens, or
  • diagnostic specimens,
if
  • these sources are publicly available, or
  • the information is recorded in such a manner that subjects cannot be identified
    • directly or
    • through identifiers linked to the subjects.

“Existing" refers to information that is available before the research begins.  The data in this category must have been previously collected.

Written consent is required in those studies in which individuals may be identified either directly or indirectly, and the data are not publicly available. File for Expedited Review.

5.  Research or demonstration projects
  • that are conducted by or subject to the approval of DHHS or Federal Agency heads, and
  • which are designed to study or evaluate public benefit or service programs. (e.g. Medicare, Public Assistance).
 

6.  Taste and food quality evaluation and consumer acceptance studies.

No potentially harmful additives may be in the foods tested.

45 CFR 46 subpart A - see paragraph (b).

Exemption Screening Questions

If your research involves ONLY one or more of the activities listed above and NO OTHER, please proceed to the Exemption Screening Questions below.

A. For research involving special populations,
  1. Does your research involve adults who cannot give legal consent (ex., mentally retarded or some chronic mentally ill)?
  2. Does your research involve pregnant women, fetuses, or prisoners?
  3. Does your research use surveys or interview procedures with children (Note: Do not confuse category 2(a) with surveys and interviews. Answer yes only if your methods involve more than educational testing)?
  4. Does your research method involve the observation of children in settings where the investigator(s) will participate in the activities being observed?

B. For research using survey procedures, interview procedures, observational procedures and questionnaires (Note: exemption is not allowed in surveys or interviews with children)

  1. Is there potential harm to subjects if the information is revealed or disclosed?
  2. Will data include sensitive information (e.g. illegal activities, sexual orientation, sexual behavior, undesirable work behavior, mental health, or other information that may be painful or very embarrassing to reveal, such as death of a family member, memories of physical abuse)?

C. For research using pre-existing or archived data, documents, records, or specimens

  1. Will any additional data, documents, records or specimens be collected from subjects after the submission of this application?
  2. Is the investigator recording the pre-existing data in such a manner that subjects can be identified, directly or indirectly?

If, during your reading of the above questions, you answer NO to all questions under A through C, your research may fall under the research exemption category.  Whether your research is classified as exempt, expedited, or full review, there is one IRB application form.