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Informed Consent Process & Documentation Checklist

Instructions: For those studies in which the USF IRB has required documentation of the informed consent process, review each consent form and answer the following questions to ensure your consent process was performed and documented in accordance with HRPP Policy. Documentation typically present to verify and meet each checklist item is indicated in italics whenever possible. Best practices for addressing specific checklist items are indicated by a star ([pic]).

|Informed Consent Process & Documentation: |

|( Informed consent was obtained from each participant before study interventions began |

|Example: All signatory dates on the informed consent form are before the date research activities began. |

|For studies in which the informed consent process occurs on the same date as the research intervention, document the time informed consent was obtained and the time the|

|research intervention began as a Note to File or directly on the ICF. |

|( Informed consent forms (ICFs) are without strike-throughs or modifications |

|Example: The participant did not strike out text indicating disagreement with one or more aspects of the research procedures or waive their rights as described in the |

|ICF. The study staff did not hand-write a portion of the ICF to reflect a change in procedure for this participant. |

|( Participants were consented with a valid, USF IRB-approved version of the ICF |

|Example: All signatory dates on the ICF fall within the approval period stated on the USF IRB Approval Stamp printed on the ICF. |

|If you find that an invalid ICF was used to consent a participant, be sure to report this to the USF IRB and let it know whether the difference between the ICF used and|

|the ICF that should have been used affects the risks to the participant and, if so, whether you plan to re-consent the participant. |

|( All participants have an original, signed and dated ICF on file (i.e., not a photocopy) |

|( All ICFs were signed and dated by the participant or the participants’ legal representative |

|( All ICFs were signed and dated by the witness to the informed consent process |

|Note: Not all informed consent processes require a witness. The IRB-requirement for a witness to the informed consent process is evidenced by a USF IRB |

|approval-stamped ICF with the following lines for a witness: signature, printed name, and date. |

|( All ICFs were signed and dated by the person obtaining informed consent |

|( All persons obtaining informed consent were approved by the IRB to obtain informed consent |

|If you find that the person obtaining informed consent was not authorized by the USF IRB to perform this task, this is considered a deviation from the IRB-approved |

|informed consent process and must be reported to the IRB with your plan to correct this going forward (e.g. request the USF IRB to add them as Key Personnel on your |

|study, add them to your Key Personnel Log, provide their human subjects research education certificates to the IRB to show they are indeed qualified, etc.). |

|( The date the participant, witness, and person authorized to obtain informed consent signed the ICF was the same date |

|( Each participant received a copy of the signed and dated ICF |

|This is typically evidenced as a Note-to-File, Progress Note in your participant records; listed on your Case Report Form; or logged on the Participant Screening & |

|Enrollment Log. |

|( All ICFs have a valid phone number in case the participant had any questions, concerns or complaints about the study |

|( All ICFs have a valid phone number for the USF IRB |

|( All ICFs have a valid phone number for reporting adverse events/unanticipated problems involving risks to participants or others or requesting study information |

|( All pages of the ICF are present in the file for each enrolled participant (i.e., all pages were present for each participant consented) |

|( All other IC documents (e.g. assent, parental permission, HIPAA Authorizations) were appropriately signed, dated, and completed |

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