| 1 |
104(d)(1) |
Research in Established or Commonly Accepted Education Settings that Involves Normal Educational Practices |
N/A |
- Not Likely to Adversely Impact Students’ Opportunity to Learn or Assessment of Educators Providing Instruction
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| 2 |
104(d)(2) |
Research only includes interactions involving Educational Tests, Surveys, Interviews, and Public Observation if at least ONE of the following criteria is met: |
N/A |
- Data Collection Only;
- May include visual or auditory recording;
- May NOT include Intervention
- Only includes interactions
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| |
(i) Recorded information cannot readily identify the subject (directly or indirectly/linked) |
N/A |
- Surveys & Interviews: No Children;
- Educational Tests or Observation of Public Behavior: Can only include children when investigators do not participate in activities being administered/observed
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| |
(ii) Any disclosure of responses outside of the research would NOT reasonably place the subject at risk (criminal, civil liability, financial, employability, educational advancement, reputation) |
N/A |
- Surveys & Interviews: No Children;
- Educational Tests or Observation of Public Behavior: Can only include children when investigators do not participate in activities being administered/observed
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| |
(ii) Information is recorded with identifiers or code linked to identifiers & IRB conducts a Limited Review |
Privacy and Confidentiality Review |
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| 3 |
104(d)(3)(i) |
Research involving Benign Behavioral Interventions (BBI) through verbal, written responses, (including data entry or audiovisual recording) from adult subject who prospectively agrees and ONE of following met: |
N/A |
- NO Children;
- May not include Medical Interventions;
- Subject prospectively agrees;
- BBI must be:
- Brief in Duration
- Painless/Harmless
- Not Physically Invasive
- Not Likely to Have a Significant Adverse Lasting Impact on Subjects
- Unlikely that Subjects Will Find Interventions Offensive or Embarrassing
- No deception unless participant is informed in the prospective agreement that he/she will be unaware of or misled regarding the true nature or purpose of the research
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| |
(A) Recorded information cannot readily identify the subject (directly or indirectly/linked) |
N/A |
| |
(B) Any disclosure of responses outside of the research would NOT reasonably place subject at risk (criminal, civil liability, financial, employability, educational advancement, reputation) |
N/A |
| |
(C) Information is recorded with identifiers & IRB conducts a Limited Review |
Privacy and Confidentiality Review |
| 4 |
104(d)(4) |
Secondary Research for Which Consent is Not Required: Use of Identifiable Information or Identifiable Biospecimen that have been or will be collected for some other ‘primary’ or ‘initial’ activity, if ONE of the following criteria is met: |
N/A |
- No Primary Collection from subjects for the research;
- Allows Both Retrospective and Prospective Secondary Use
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| |
(i) Biospecimens or Information is Publicly Available |
N/A |
- Must be publicly available (e.g., commercially available specimen or open access data). May also qualify as not human research (NHR).
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| |
(ii) Information recorded so the subject cannot readily be identified (directly or indirectly/linked); Investigator does not contact subjects and will not re-identify the subjects |
N/A |
- PI does not contact;
- Will not re-identify
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| |
(iii) Collection and Analysis involving Investigators Use of Identifiable Health Information when use is regulated by HIPAA “health care operations,” or “research,” or “public health activities and purposes.” |
N/A |
- HIPAA regulations still apply;
- HIPAA protections include authorization or waiver of authorization;
- Does not include biospecimens (only PHI);
- Only covers “investigator’s use”; does not indicate that sharing PHI is permitted under this exemption.
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(iv) Research information collected by or on behalf of the federal government using government-generated or collected information obtained for non-research activities |
N/A |
- If research generates identifiable private information, it is subject to specified federal privacy laws (see iii for list)
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| 5 |
104(d)(5) |
Research and demonstration projects supported by a Federal Agency/Dept. AND Designed to study…improve… public benefit or service programs. |
N/A |
- Must be posted on a Federal Website
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| 6 |
104(d)(6) |
Taste and Food Quality – no change |
N/A |
- Wholesome food without additives;
ingredient level and use found to be safe (see ii)
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| *The University of Kentucky does not review research protocols for exemption under the following regulatory categories: |
| 7* |
104(d)(7) |
Storage or Maintenance of Identifiable Private Information or Identifiable Biospecimens for Secondary Research For Which Broad Consent Is Required |
If there is a change made for research purposes in the way material is stored or maintained, a privacy and confidentiality review |
- All requirements for Broad Consent Met;
- Broad consent is obtained
- Documented or documentation waived
- MUST TRACK REFUSALS as the IRB may not waive consent for use of identifiable material for any individual who refuses
|
| 8* |
104(d)(8) |
Secondary research involving the use of Identifiable Private Information or Identifiable Biospecimens for Which Broad Consent was Required |
- Privacy and confidentiality review &
- Research is within the scope of the broad consent &
- PI does not plan to return research results
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- Privacy and Confidentiality protections are adequate;
- Broad consent was obtained;
- Documented or documentation waived
- No plan to return research results;
- MUST TRACK REFUSALS as the IRB may not waive consent for use of identifiable material for any individual who refuses
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