Request for Continuing IRB Approval

Part 1 – Administrative Information

1. Protocol information
   Protocol#Title
2. Contact information
   • 2.1 Principal Investigator (PI)
   • 2.2 Name
     Email address
     College/Division
     Department/Unit
     Status   o Undergraduate Student       o Graduate Student   o  Faculty           o Staff
   • 2.3 Please list current members of the research team:

Name	Email addresses	College and Department	Name of organization	State and Country

3. Funding information
   • 3.1 Indicate if your project is funded by an external sponsor, including a gift or a sponsored award.
     • Federal Funding Agency
     • Federal Flow   through funds
     • Student projects funded fully or in part by Federal funds received by a Faculty Advisor
     • Non-Federal sponsor that requires compliance with Federal IRS regulations
     • Other Funding source
     • My research is not funded by any outside funding agency (this option should be available only if none of the above are selected)
       Name of the external funding agency:

Part 2 – Study Overview

1. Please provide a summary of the study purpose and the general research questions/objectives.
2. Progress report since the last approval (please explain the progress of the study since the initial IRB approval or last approval, excluding amendment approvals)
3. Please select all of the types of research activities that were conducted on this protocol since last IRB approval (excluding amendment approvals)
   • Active collection of data (not human biological materials or physiological data
   • Use of physiological or biomedical devices, or drugs, biologics, or chemical agents
   • Use of existing data (not human biological materials)
   • Use of existing human biological materials
4. Please summarize the research activities since last IRB approval (excluding amendment approvals):

5. Since the last IRB approval (excluding amendment approvals), were there any participant withdrawals from the study or complaints about the research activities? o  Yes  o  No
   If Yes Explain:

6. Since the last IRB approval (excluding amendment approvals), were there any unexpected problems or adverse events involving risks to participants? o  Yes   o No
   If Yes Explain:

7. Since the last IRB approval (excluding amendment approvals), were there any changes to your study (including with recruitment, informed consent, study design and/or research procedures, research personnel, study location, etc.)? o Yes   o No
   If Yes Explain:

8. Research activities planned for the next year or more
   8.1 Do you plan to recruit new participants?                   o Yes   o No
   If Yes Explain:
   8.2   Do you plan to collect new or additional data from current research participants?  o Yes   o No
   If Yes Explain:

Part 3- Proposed Changes to Study Design

1. Please select ALL the categories of amendment(s) you are requesting.
   • Change in Study Title
   • Change in Principal Investigator
   • Addition of/change in research personnel
   • Addition of/change in funding source
   • Change to research/study design, methods or procedures (e.g., observations, interventions, collection of biological samples or biometric information, participant tasks, etc.)
   • Addition of/change to study population
   • Addition of/change to recruitment or compensation procedure(s)
   • Addition of/change to survey(s), questionnaire(s}, or other research instruments  -please attach the revised instruments
   • Addition of/change to the identifiers collected in the study, or any others that would impact the privacy and confidentiality of the study participants
   • Addition of/change to informed consent/assent document(s) and/or procedures -please attach all related documents
   • Other changes
   • 1.1 You selected the following categories of amendments. For each of the following, please describe the change you are proposing.
     Change in Principal Investigator
     New Principal Investigator (PI):
     Email address:
     College/Division:
     Department/Unit:
     Status      o Undergraduate Student         o Graduate Student   o Faculty   o Staff
   • 1.2 Please state the reasons you are making amendments to the study.
   • 1.3 Are any of these changes the result of something that occurred during human participant interaction or an unexpected event?            o Yes   o No
     If Yes Please Explain:
     1.4     How will the proposed changes have an impact on the risks or benefits to research participants?
     1.5     Do these changes involve information that might relate to a subject’s willingness to continue to take part in the research?                o Yes   o No
     If Yes Please Explain:

Include a clean copy of the consent forms, debriefing scripts, recruitment scripts or any other study materials that you plan to use for this project, in the coming year. You have now completed this form. Please review it to ensure that it is filled out completely and accurately. Please save this form and proceed to the signature page. If you have any questions or need assistance, please contact the IRB staff.

Contact
irb@umsv.edu

 Signature

This page is to be signed by the principal investigator. If the principal investigator is an undergraduate or graduate student, the faculty supervisor must also sign in the lower box.

Principal Investigator
I certify that the information I provide in this application is correct and complete. I also pledge that I will not change any of the procedures, forms, or protocols used in this study without first seeking review and approval from the Institutional Review Board for Human Participants.

o Attestation of Principal Investigator

 

_____________________________________                                   ______________________

Name /Signature of Principal Investigator                                                             Date

 

_____________________________________                                   ____________________

Faculty Supervisor                                                                                                        Date