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Common Rule Exemption Categories
Revised Human Subjects Regulations (Common Rule) Wednesday, June 20th 2018
The regulations that human subjects researchers must adhere to (referred to as the Common Rule Regulations) were established in 1991. In 2011, federal agencies began the long-awaited process to revise these regulations and, on January 18, 2017, the final revisions to the Common Rule (Final Rule) were posted in the federal register. The effective and implementation dates have recently changed. As posted in the federal register on June 18, 2018, the revised final Common Rule is both effective and to be implemented on January 21, 2019 with the option of implementing 3 burden-reducing provisions before January 21, 2019. Learn more about the regulations.
Effective January 21, 2019
- Subpart B: Studies Involving Pregnant Women, Fetuses & Neonates are Eligible for Exempt Under All 8 Categories
- Subpart C: Exemptions Do Not Apply to Research Involving Prisoners Except “for Research Aimed at Involving a Broader Subject Population that Only Incidentally Includes Prisoners”
- Subpart B: Children are allowed in categories 1,4,5,6,7, & 8; Limitations & Exclusion of Children in Category 2 & 3
Updated to include restrictions
| Exemption Category Description | Limited IRB Review | Conditions/Allowances/Limitation |
|---|---|---|
| Research in Established or Commonly Accepted Education Settings that Involves Normal Educational Practices | N/A | What’s New in January 2019? Research not likely to adversely impact a student’s opportunity to learn or the assessment of educators who provide instruction If the research is in an unusual education setting, or includes an unusual education practice, the exempt category does NOT apply. |
Exemption Expanded
| Exemption Category Description | Limited IRB Review | Conditions/Allowances/Limitation |
|---|---|---|
| Research only includes Educational Tests, Surveys, Interviews, Public Observation if at least ONE of the following criteria met: | N/A | Data Collection Only; May include visual or auditory recording; May NOT include Intervention |
| i. Recorded information cannot readily identify the subject (directly or indirectly/linked); OR | 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 Observed |
| ii. Any disclosure of responses outside of the research would NOT reasonably place subject at risk (criminal, civil liability, financial, employability, educational advancement, reputation); OR | 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 Observed |
| iii. Information is recorded with identifiers & IRB conducts Limited Review | Privacy and Confidentiality Review | NO Children |
Old exemption 3 has been removed; this is a new exemption
| Exemption Category Description | Limited IRB Review | Conditions/Allowances/Limitation |
|---|---|---|
| Old exemption 3 has been removed; this is a new exemption. 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; |
| i. Recorded information cannot readily identify the subject (directly or indirectly/linked): OR | N/A | (ii) BBI must be:
(iii) No deception unless participant prospectively agrees |
| ii. Any disclosure of responses outside of the research would NOT reasonably place subject at risk (criminal, civil liability, financial, employability, educational advancement, reputation); OR | N/A | |
| iii. Information is recorded with identifiers & IRB conducts Limited Review | Privacy and Confidentiality Review |
This exemption has been revised and expanded
| Exemption Category Description | Limited IRB Review | Conditions/Allowances/Limitation |
|---|---|---|
| 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 following criteria met: | N/A | What’s new in 2019? No Primary Collection from subjects for the research; Allows Both Retrospective and Prospective Secondary Use |
| i. Biospecimens or Information is Publically Available; OR | N/A | Must be publicly available |
| ii. Information recorded so subject cannot readily be identified (directly or indirectly/linked); Investigator does not contact subjects and will not re-identify the subjects; OR | N/A | |
| 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”; OR | N/A | HIPAA still applies; HIPAA protections include authorization or waiver of authorization; |
| iv. Research information collected by or on behalf of 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 iv for list) |
This exemption has been revised and expanded
| Exemption Category Description | Limited IRB Review | Conditions/Allowances/Limitation |
|---|---|---|
| Research and demonstration projects supported by a Federal Agency/Dept. AND Designed to study, public benefit or service programs. | N/A | Must be posted on a Federal Web Site |
This exemption has been revised and expanded
| Exemption Category Description | Limited IRB Review | Conditions/Allowances/Limitation |
|---|---|---|
| Research and demonstration projects supported by a Federal Agency/Dept. AND Designed to study, public benefit or service programs. | N/A | The food must be wholesome with no additives, or The consumed food ingredients must meet federal agency safety standards for amount and type. Ingestion of alcohol or dietary supplements will not be considered exempt under this category. Studies including alcohol that are limited to sensory tests (such as smell or taste followed by expectoration prior to swallowing) will be considered for this exemption category depending on the specifics of the target population, the precautions taken to minimize risk, and the nature of the other study activities |
CSU will not be using the following categories
New exemption (optional) CSU has not adopted this exemption
| Exemption Category Description | Limited IRB Review | Conditions/Allowances/Limitation |
|---|---|---|
| Taste and Food Quality | Broad consent is obtained Documented or documentation waived If there is a change made for research purposes in the way material stored or maintained, Privacy and confidentiality review | All requirements for Broad Consent Met; MUST TRACK REFUSALS –as the IRB may not waive consent for use of identifiable material for any individual who refuses |
New exemption
| Exemption Category Description | Limited IRB Review | Conditions/Allowances/Limitation |
|---|---|---|
| Secondary research involving 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 | Privacy and Confidentiality protections 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 |