These 11 Human Subject Regulations Decision Charts was developed as a series of graphic aids for entities who decide if an activity is research involving human subjects that must be reviewed by an IRB under the requirements of the US Department of Health and Human Services (HHS) regulations at 45CFR part 46. The full text of applicable regulatory provisions should be considered in making final decisions. These job aids do not address requirements that may be imposed by specific organizations, such as the Food and Drug Administration, National Institutes of Health, other sponsors, or state or local governments.
Using these 11 Human Subject Regulations Decision Charts, you will learn how to follow the thought process for decisions on the following:
- Whether an activity is research that must be reviewed by an IRB
- Whether the review may be performed by expedited procedures
- Whether informed consent or its documentation may be waived
List of Charts in These Human Subject Regulations Decision Charts
- Chart 1: Is an Activity Research Involving Human Subjects?
- Chart 2: Is a Human Subject Research Eligible for Exemption?
- Chart 3: Does Exemption 45 CFR 46.101(b)(1) for Educational Settings Apply?
- Chart 4: Does exemption 45 CFR 46.101(b)(2) / (b)(3) for Tests, Surveys, Interviews, Public Behavior Observation Apply?
- Chart 5: Does Exemption 45 CFR 46.101(b)(4) for Existing Data, Documents, and Specimens Apply?
- Chart 6: Does Exemption 45 CFR 46.101(b)(5) for Public Benefit or Service Programs Apply?
- Chart 7: Does Exemption 45 CFR 46.101(b)(6) for Food Taste and Acceptance Studies Apply?
- Chart 8: Can You Conduct Expedited IRB Review?
- Chart 9: Can You Conduct an Expedited Continuing IRB Review?
- Chart 10: Can You Wave/Alter the Informed Consent under 45 CFR 46.116(d)?
- Chart 11:Can You Wave the Informed Consent Documentation Under 45 CFR117(c)?
Who Can Benefit From These Human Subject Regulations Decision Charts
- The contents are intended to assist IRBs, institutions, and investigators in their decision-making process and do not supersede the regulations applicable per the relevant regulatory body.
- ID: 1319
- SKU: JA-0001-RC
- Type: Job Aid
- Format: Downloadable PDF File
- Date of Last Update: Feb 15, 2017
- Price: $30.00
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