DSRB Revisions to Exemption Categories

Exemption Category 1

(Category S1 in ECOS* IRB Application Form)

Normal Educational Practices and Settings

Research conducted in established or commonly accepted educational settings, that specifically involves normal educational practices, that are not likely to adversely impact students’ opportunity to learn required educational content or the assessment of educators who provide instruction.

Examples of such research are:

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.

The condition that the research should not be likely to adversely impact students’ opportunity to learn required educational content or the assessment of educators who provide instructions has been added explicitly.

Exemption Category 2

(Category S2 in ECOS* IRB Application Form)

Educational Tests, Surveys, Interviews, or Observations

Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behaviour (including visual or auditory recording) if at least one of the following criteria is met:

1. The information obtained is recorded by the investigator in such a manner that the identity of human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects; or

2. Any disclosure of the human subjects’ responses outside of the research would not reasonably place subjects at risk of psychological harm or criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation; or

3. The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and the IRB conducts a limited IRB review to determine adequate provisions to protect the privacy of the subjects and to maintain the confidentiality of data are in place.

If research includes children, only observation of public behaviour and educational tests without investigators’ intervention is permitted. Education tests, surveys, and interviews with investigators involvement as well as conditions meeting point (iii) above may not be applied to children.

Identifiable information can be recorded by the investigator if DSRB determines that adequate provisions to protect the privacy of the subjects and to maintain the confidentiality of data are in place.

Exemption Category 3

(Category S3 in ECOS* IRB Application Form)

Benign Behavioural Interventions

Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection and at least one of the following criteria is met:

1. The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects; or

2. Any disclosure of the human subjects’ responses outside the research would not reasonably place the subjects at risk of psychological harm or criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation; or

3. The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and the IRB conducts a limited IRB review to determine adequate provisions to protect the privacy of the subjects and to maintain the confidentiality of data are in place. 

• A. For the purpose of this provision, benign behavioural interventions are brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing. Provided all such criteria are met, examples of such benign behavioral interventions would include having the subjects play an online game, having them solve puzzles under various noise conditions, or having them decide how to allocate a nominal amount of received cash between themselves and someone else. 

• B. If the research involves deceiving the subjects regarding the nature or purposes of the research, this exemption is not applicable unless the subject authorises the deception through a prospective agreement to participate in research in circumstances in which the subject is informed that he or she will be unaware of or misled regarding the nature or purposes of the research.

This is a new category. The previous category “Identifiable Subjects in Special Circumstances” has been removed.

Exemption Category 4

(Category S4 in ECOS* IRB Application Form)

Secondary Research for which Consent is Not Required

Secondary research uses of identifiable private information or identifiable biospecimens, if at least one of the following criteria is met:

1. The identifiable private information or identifiable biospecimens are publicly available; or

2. Information, which may include information about biospecimens, is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, and the investigator will neither contact the subjects nor re-identify the subjects.

It is no longer a requirement for data or biospecimens to be existing. Data or biospecimens may be collected prospectively, provided the information is either publicly available, or is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, and the investigator will neither contact nor re-identify the subjects.

Exemption Category 5

Public Benefit or Service Programs

This category has been removed as it is not applicable to the local context.

Exemption Category 6

(Category S5 in ECOS* IRB Application Form)

Taste and Food Evaluation and Acceptance Studies

Taste and food quality evaluation and consumer acceptance studies,

1. if wholesome foods without additives are consumed; or

2. if 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

No revisions were made to this category.