IRB #______
DATE ______
Lesley University IRB*
Exempt Research Categories
*The IRB makes all determinations of Exempt Status using the criteria below. Applicants must submit an application in order for determination to be made.
Evaluation Sheet for the Determination of Exempt Status
46.101 (b) (1) Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods. [Subjects may be adults or children.]
46.101 (b) (2) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:
(i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and
(ii) 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.
NOTE: (b) (2) activities are allowed unless (i) and (ii) are both true. If (i) is not true, then (ii) cannot occur. If (i) is true, then (ii) must also be true for the exemption to be lost. [Note added restrictions, if are children involved.]
There is a further restriction in the regulations on 46.101 (b) (2) in Subpart D: Children
§46.401 (b) The exemption at §46.101(b)(2) regarding educational tests is also applicable to this subpart. However, the exemption at §46.101(b)(2) for research involving survey or interview procedures or observations of public behavior does not apply to research covered by this subpart, except for research involving observation of public behavior when the investigator(s) do not participate in the activities being observed.
Subpart D concerns research involving children as subjects; it allows exemption 46.101 (b) (1); and, 46.101 (b) (2) with regard to educational tests. But, it disallows an exemption when surveys and interviews involve children. Such studies would require review. And, it disallows observations of children’s public behavior, unless the observer does not participate with the children. The key is that the researcher cannot qualify for an exemption if he or she interacts with children through surveys, interviews or participant observation. If the research requires such activities, the research will require IRB approval.
There is an exemption for research involving either adults or children if the project involves only existing data.
§46.101 (b) (4) Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
Research is exempt.Research is not exempt.