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Informed Consent Appendix:

Total Waiver or Alteration

PROTOCOL TITLE:

IRB REFERENCE #/ACCT #:      

Principal Investigator:

|Instructions: Complete this form if you want to waive or alter the informed consent requirement for the entire study. |

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|Please contact the HRPP Office (860-972-2893 or irb@ ) if you have questions about this form. |

Total Waiver or Alteration

1) Do you want to request to totally waive OR alter the informed consent requirement for the Entire Study?

Yes - Request to totally waive the informed consent requirement

Yes - Request to alter the informed consent process

No - I will be obtaining written informed consent OR requesting other types of

consent and/or waivers

❖ Note: The most common type of study that the IRB would allow a complete waiver of informed consent would be a “Retrospective Chart Review”

Totally waiving or altering the consent form is NOT applicable for FDA-regulated research except for planned emergency research or research involving human specimens that are not individually identifiable for FDA-regulated in vitro diagnostic device investigations as per FDA guidance (OMB Control No. 0910-0582).

Answer the following questions related to waiving/altering informed consent

2) The research involves no more than minimal risk to the participants because:

     

3) The waiver or alteration will not adversely affect the rights and welfare of participants because:

     

4) The research could not practicably be carried out without the waiver or alteration because: (Indicate why it is not feasible to get consent and why the research could not be done if consent were required.)

     

Informed Consent Alteration - Special

5) If you want to alter some or all of the elements of informed consent or use a consent procedure that varies significantly from the usual consent process, explain which elements will be altered and why.

     

6) If necessary, load the alternate consent form or tools at the end of the form.

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