Methodology” (Required only for federally funded/supported studies, through 6/19/18) Consent Form(s); Check if includes: Present Comments: HIPAA Authorization Language N/A Concerns: Parental Permission Form(s) Pending/missing Requirements: Assent (Children ages Recommendations: 13-17) Assent Form (s). Present Comments: Generally required if you N/A Concerns: are planning to enroll participants age Pending/missing Requirements: Recommendations: Information Sheet (if applicable). Present Comments: Required N/A Concerns: when requesting a waiver of documentation Pending/missing Requirements: of informed consent, when IIHI or PHI is Recommendations: NOT involved. Information Sheet, including authorization Present Comments: to access, use, or disclose IIHI or PHI (if N/A Concerns: applicable). Pending/missing Requirements: Required when requesting a Recommendations: waiver of documentation of informed consent, when IIHI or PHI is involved. Can be used for exempt research that involves IIHI/PHI. Short Form(s). Present Comments: May be used for certain N/A Concerns: studies when enrolling non-English Pending/missing Requirements: speaking participants or those with Limited Recommendations: English Proficiency (LEP). Indicate Arabic; Simplified Chinese; languages: Traditional Chinese; English; Haitian Creole; Spanish For more information, page 15-18 of IRB guidance: HIPAA Waiver(s). Present and criteria are Comments: Indicate Type: met to waiver Concerns: Full; Partial; Alteration N/A Requirements: Form is incomplete or Recommendations: missing information Criteria is not met to waiver Pending/missing Waiver of Informed Consent (Process). Present and criteria are Comments: met to grant waiver Concerns: Required when waiving entire consent Not present, but criteria Requirements: process (e.g., for retrospective data reviews, are met (document in Recommendations: for situations when one research participant IRBNet) provides private information about another, N/A such as future contact when participant is Form is incomplete or not available) missing information Criteria is not met to grant waiver Pending/missing Waiver of Required Element(s) of Informed Present and criteria are Comments: Consent. met to grant waiver Concerns: Required when waiving entire Requirements: consent process (e.g., for not disclosing Recommendations: purpose in deception research)
Methodology” (Required only for federally funded/supported studies, through 6/19/18) Consent Form(s); Check if includes: HIPAA Authorization Language Parental Permission Form(s) Assent (Children ages 13-17) Present N/A Pending/missing Comments: Concerns: Requirements: Recommendations: Assent Form (s). Generally required if you are planning to enroll participants age Present N/A Pending/missing Comments: Concerns: Requirements: Recommendations: Information Sheet (if applicable). Required when requesting a waiver of documentation of informed consent, when IIHI or PHI is NOT involved. Present N/A Pending/missing Comments: Concerns: Requirements: Recommendations: Information Sheet, including authorization to access, use, or disclose IIHI or PHI (if applicable). Required when requesting a waiver of documentation of informed consent, when IIHI or PHI is involved. Can be used for exempt research that involves IIHI/PHI. Present N/A Pending/missing Comments: Concerns: Requirements: Recommendations: Short Form(s). May be used for certain studies when enrolling non-English speaking participants or those with Limited English Proficiency (LEP). Indicate languages: Arabic; Simplified Chinese; Traditional Chinese; English; Haitian Creole; Spanish For more information, page 15-18 of IRB guidance: Present N/A Pending/missing Comments: Concerns: Requirements: Recommendations: HIPAA Waiver(s). Indicate Type: Full; Partial; Alteration Present and criteria are met to waiver N/A Form is incomplete or missing information Criteria is not met to waiver Pending/missing Comments: Concerns: Requirements: Recommendations: Waiver of Informed Consent (Process). Required when waiving entire consent process (e.g., for retrospective data reviews, for situations when one research participant provides private information about another, such as future contact when participant is not available) Present and criteria are met to grant waiver Not present, but criteria are met (document in IRBNet) N/A Form is incomplete or missing information Criteria is not met to grant waiver Pending/missing Comments: Concerns: Requirements: Recommendations: Waiver of Required Element(s) of Informed Consent. Required when waiving entire consent process (e.g., for not disclosing purpose in deception research) Present and criteria are met to grant waiver Comments: Concerns: Requirements: Recommendations: