Agreement Pages

All Principal Investigators (PIs) and Faculty Sponsors must read and agree to the conditions corresponding to their roles before IRB approval can be granted.

Electronic Submission (Preferred):

Please digitally sign directly on the application/form after reading the correct agreement page. Before approval is granted by the IRB, you are required to submit a signature to the IRB Office.

Paper Submission (of the agreement page only):

The IRB Office will accept a physically signed agreement page in lieu of a digitally signed application/form if you are unable to sign the application/form digitally. Please print and sign the correct agreement page in blue or black ink then submit to the IRB Office by fax, mail, or as an email attachment.

If you need to print any of the agreement pages, please click on the links in the table below.

 Principal Investigator’s Agreement

(For Initial, Continuing Review, and Amendment Applications)

As Principal Investigator, I understand that I have the fundamental responsibility to conduct this study in accordance with ALL Montclair State University’s IRB policies and federal, state, and local laws that relate to research involving human participants.

I agree:

1. That submitted information in this application is accurate and complete
2. To conduct this study in accordance with ALL Montclair State University’s IRB policies, guidelines, and approvals and federal, state, and local laws that relate to research involving human participants
3. To promptly supply the IRB with requested information
4. To promptly implement any requested changes by the IRB during the review process
5. Not to implement any changes until AFTER IRB WRITTEN APPROVAL is granted for the requested Amendment(s)
6. Not to continue the study until IRB WRITTEN APPROVAL for Continuing Review is granted
7. That when applicable, protocol information approved by MSU’s IRB for this study will be consistently represented in ALL funding applications and processes
8. Not to implement any changes until AFTER IRB WRITTEN APPROVAL is granted for the requested Amendment(s) or Continuing Review. Changes must be requested by submitting an Amendment Application and continuation must be requested by submitting a Continuing Review Application; both applications are found on MSU’s IRB website
9. That during emergencies, only necessary study changes will be made to ensure the participants’ well-being without getting prior IRB approval
10. To maintain the Human Participants Protection Tutorial requirements (CITI) in accordance with the MSU IRB guidelines
11. To ensure that all research staff, who will have contact with human participants and/or their data, maintain the Human Participants Protection Tutorial requirements (CITI) in accordance with the MSU IRB guidelines
12. That all research staff will be qualified to conduct the research
13. To immediately report any problems involving risks to participants (e.g., complaints, injuries, adverse events) to the IRB, sponsors, Data Safety and Monitoring Boards, and other agencies
14. That if research must continue in my absence (during vacations, sabbaticals, etc.), I will arrange for another PI to carry out my responsibilities
15. To submit a Continuing Review form for the activity described in this protocol if it has not been completed by the date of approval expiration. This form is available on the MSU’s IRB website  
16. That if the Continuing Review form is not returned on time, the study becomes inactive, and I will ensure that ALL research activities will cease on the study’s expiration date  
17. To submit a Project Completion form at the end of the project. This form is available on the MSU’s IRB website.
18. To comply promptly with IRB requests to completely suspend, withdraw, or terminate this study’s research activities
19. That if the Project Completion form is not returned by the expiration date AND Continuing Review approval has not been granted, the study becomes inactive, and I will ensure that ALL research activities will cease on the study’s expiration date

Faculty Sponsor’s Agreement

(For Initial, Continuing Review, and Amendment Applications)

As faculty sponsor, I understand that I have the fundamental responsibility to oversee this study in accordance with ALL Montclair State University’s IRB policies and federal, state, and local laws that relate to research involving human participants.

I agree:

1. That submitted information in this application is accurate and complete
2. To ensure that the student PIs conduct this study in accordance with ALL Montclair State University’s IRB policies, guidelines, and approvals and federal, state, and local laws that relate to research involving human participants
3. To meet regularly with the student PI to monitor the study
4. To ensure that the student PI promptly supplies the IRB with requested information
5. To ensure that the student PI promptly implements any requested changes by the IRB during the review process
6. To ensure that the student PI does not continue the study until IRB WRITTEN APPROVAL for Continuing Review is granted
7. To ensure that the student PI does not implement any changes until AFTER IRB WRITTEN APPROVAL is granted for the requested Amendment(s) or Continuing Review. Changes must be requested by submitting an Amendment Application and continuation must be requested by submitting a Continuing Review Application; both applications are found on MSU’s IRB website
8. That when applicable, protocol information approved by MSU’s IRB for this study will be consistently represented in ALL funding applications and processes
9. To ensure that during emergencies, the student PI only makes necessary study changes that will ensure the participants’ well-being without getting prior IRB approval
10. To ensure that the student PI maintains the Human Participants Protection Tutorial requirements (CITI) in accordance with MSU IRB guidelines
11. To ensure that all the student PI’s research staff, which will have contact with human participants and/or their data, maintain the Human Participants Protection Tutorial requirements (CITI), in accordance with the MSU IRB guidelines
12. To ensure that all the student PI’s research staff will be qualified to conduct the research
13. To ensure that the student PI immediately reports any problems involving risks to participants (e.g., complaints, injuries, adverse events) to the IRB, sponsors, Data Safety and Monitoring Boards, and other agencies
14. That if research must continue in the student PI’s absence (during vacations, sabbaticals, etc.), the student PI will arrange for another PI to carry out his/her responsibilities
15. That if I (the Faculty Sponsor) am not available to advise the student PI’s research (during vacations, sabbaticals, etc.), I will arrange for another Faculty Sponsor to carry out my responsibilities
16. To ensure that the student PI submits a Continuing Review Application for the activity described in this protocol if it has not been completed by the date of approval expiration. This application is available on the MSU’s IRB website. 
17. That if the Continuing Review form is not returned on time, the study becomes inactive, and I will ensure that ALL of the student PI’s research activities will cease on the study’s expiration date
18. To ensure that the student PI submits a Project Completion form at the end of the project. This form is available on the MSU’s IRB website.
19. To ensure that the student PI complies promptly with IRB requests to completely suspend, withdraw, or terminate this study’s research activities
20. That if the Project Completion form is not returned by the expiration date AND Continuing Review approval has not been granted, the study becomes inactive, and I will ensure that ALL of the student PI’s research activities will cease on the study’s expiration date