IRB Continuing Review/Amendment/Adverse Events Form

IRB Continuing Review/Amendment/Adverse Events Form

Please be aware that if you do not complete this submission form in a single sitting your responses will not be saved.
Name*

First NameLast Name
E-mail*
example@example.com
Title of Approved Study*
One Word Title for the Approved Study*
Date study was approved:*

MonthDayYear
Date
Your association with Knox College*

StudentFacultyStaff
Advisor Name*

First NameLast Name
Advisor E-mail*
example@example.com
Before you submitted this form, did your adviser review ALL the submitted materials and answers, AND approve them?*

YesNo
You cannot proceed further until your adviser has approved your submisson.
To date, how many Knox College participants have been enrolled in your study? If needed (e.g., for qualitative research projects with dynamic groups), provide your best estimate.*
To date, how many participants from outside of Knox College have been enrolled in your study? If needed (e.g., for qualitative research projects with dynamic groups), provide your best estimate.*
Are you reporting adverse events?*

YesNo
Describe adverse events and your response.*
Are you submitting a continuing review?*

YesNo
End date of study (estimate):*

MonthDayYear
Date
Would you like to amend your study?*

YesNo
Would you like to change your sample?*

YesNo
Please describe intended changes to your sample.*
Would you like to add personnel?*

YesNo
List personnel you would like to add:*
Would you like to remove personnel?*

YesNo
List personnel you would like to removed:*
Would you like to change your study procedure? (e.g., new protocols or instruments, new surveys topics / questions, new interview questions / topics, new sites of observation, etc.)*

YesNo
Please describe intended changes to your study procedure.*
Would you like to change your consent form?*

YesNo
Please Upload Modified Participant Consent Form*

Upload a File

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Would you like to change your consent procedure?*

YesNo
Will you be obtaining consent from your subjects before they participate?*

Yes, I will use a consent formYes, but I will not use a consent formNo
Explain why you believe it is ethical for you to collect data from the subjects without first obtaining their consent.*
Explain why you believe it is ethical for you to collect data from the subjects without using a consent form. Describe the procedures that you will use to obtain consent and to inform subjects about the project and their rights as subjects.*
Will any participants in your study be under 18 years of age or have limited capacity to consent (due to low IQ, dementia, etc.)?*

YesNo
Describe the procedures you will use to obtain consent from a guardian of these participants and assent from the participants themselves.*
Please Upload Guardian Consent Form (if required)

Upload a File

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Do any of the amendments alter the risk or benefits that participants might experience?*

YesNo
Please describe changes to the risks or benefits that participants might experience.*
Will previously enrolled participants be informed about changes?*

YesNo
Provide any new or edited materials that the participant will experience as part of this research project. These might include survey instruments, interview protocols, auditory or visual stimuli, or any other thing that the subject will see, hear, or sense in some way. If you are not revising any of your documents, please include the original informed consent document / script, so we may ensure that it still adequately applies to your amended protocols.
Upload Materials

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Upload Materials

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Uplooad Materials

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Upload Materials

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Upload Materials

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Upload Materials

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IRB Continuing Review/Amendment/Adverse Events Form

You cannot proceed further until your adviser has approved your submisson.