Vulnerable Populations: Indicate whether this project involves any of the following populations? Children (Children are defined by local law as anyone under the age of 18.) [If so, please complete Supplemental Form “J”] Prisoners [If so, Do not qualify for Exempt] Pregnant women/Neonates/Fetuses [May qualify for exemption under certain circumstances: 45 CFR 46.101(b) (1) through (6)] Note: If you indicated the inclusion of any of the above populations: In the space below please describe additional safeguards for protection from coercion or undue influence to participate. You must also complete the relevant supplemental forms. For research involving prisoners, exemption of an informed consent is DISALLOWED: Description of the vulnerable population to be included in your research: Under which of the following categories are you seeking exemption? Please check whichever is applicable: 45 CFR 46.101(i) Is the Human Subjects Research Eligible for Exemption? 45 CFR 46.401(b) CATEGORY 1 For Educational Settings: §46.101(b)1 For Educational Tests, Surveys, Interviews, Public Behavior CATEGORY 2 Observation: §46.101(b)2 For Educational Tests, Surveys, Interviews, Public Behavior CATEGORY 3 Observation of public officials: §46.101(b)3 CATEGORY 4 For Existing Data, Documents and Specimens: §46.101(b)4 For Public Benefit or Service Programs (Federal): CATEGORY 5 http://www.hhs.gov/ohrp/policy/checklists/decisioncharts.html#c6 §46.101(b)5 For Taste and Food Quality and Consumer Acceptance Studies: CATEGORY 6 §46.101(b)6
Vulnerable Populations: Indicate whether this project involves any of the following populations? Children (Children are defined by local law as anyone under the age of 18.) [If so, please complete Supplemental Form “J”] Prisoners [If so, Do not qualify for Exempt] Pregnant women/Neonates/Fetuses [May qualify for exemption under certain circumstances: 45 CFR 46.101(b) (1) through (6)] Note: If you indicated the inclusion of any of the above populations: In the space below please describe additional safeguards for protection from coercion or undue influence to participate. You must also complete the relevant supplemental forms. For research involving prisoners, exemption of an informed consent is DISALLOWED: Description of the vulnerable population to be included in your research: Under which of the following categories are you seeking exemption? Please check whichever is applicable: 45 CFR 46.101(i) 45 CFR 46.401(b) Is the Human Subjects Research Eligible for Exemption? CATEGORY 1 §46.101(b)1 For Educational Settings: CATEGORY 2 §46.101(b)2 For Educational Tests, Surveys, Interviews, Public Behavior Observation: CATEGORY 3 §46.101(b)3 For Educational Tests, Surveys, Interviews, Public Behavior Observation of public officials: CATEGORY 4 §46.101(b)4 For Existing Data, Documents and Specimens: CATEGORY 5 §46.101(b)5 For Public Benefit or Service Programs (Federal): http://www.hhs.gov/ohrp/policy/checklists/decisioncharts.html#c6 CATEGORY 6 §46.101(b)6 For Taste and Food Quality and Consumer Acceptance Studies: