Institutional Review Board Request for Waiver or Alteration of Consent Approval

Principal Investigator (PI) Name:________________________________ Date Approved:___________, _________

IRB Name:________________________________________________________________________________________

Protocol Title and Number: _______________________________________________________________________

Use this form if the procedure for this research will alter or will not include all of the required elements of consent [45CFR46.116(d)]. Please indicate the reason(s) for this waiver request:

[__] To ascertain and/or recruit potential subjects while recording identifiable private information, such as protected health information, prior to obtaining the subject’s consent.

[__] The research in its entirety involves no greater then minimal risk.

[__] The Waiver of Informed Consent will not adversely affect the rights/welfare of the subjects.

[__] It is not practical to conduct the research without the waiver/alteration.

[__] Whenever appropriate, the subjects will be provided with additional pertinent information after their participation.

[__] To conduct the research project.

Please respond to each item in the allotted space below using protocol-specific language to provide justification.

1. Provide a brief explanation of why the research activity to be permitted by this waiver involves no more than minimal risk to the subjects.

2. Demonstrate that the research involves no more than minimal risk to the privacy of subjects by describing the plan to protect the identifiers from improper use and disclosure; and indicate where the identifiable private information will be stored and who will have access and a plan to destroy identifiers unless there is a health, law or research justification for retaining identifiers.

3. Explain why the research could not be practicably carried out without this waiver or alteration.

4. Explain why this waiver or alteration will not adversely affect the rights and welfare of the subjects.

5. If this research relates to research involving deception, explain how subjects will be provided with additional pertinent information after study participation and what information will be provided.

6. Explain how there are adequate written assurances in place that the protected health Information(PHI) will not be reused or disclosed to any other person or entity, except as required by law for authorized over sight of the research project, or other research for which the use or disclosure of protected health information would be permitted by this subject.

Principal Investigator’s Assurance:
I assure the DCH IRB that the information that I provided in this application is accurate and complete.

Signature of PI and Date:_________________________________________________________________________

Comments:_______________________________________________________________________________________

_________________________________________________________________________________________________

_________________________________________________________________________________________________
*The Primary Investigator is to provide a protocol specific summary with this Waiver of Consent.

How to Reach Us

The Driscoll Children's Hospital Institutional Review Board is available to provide information and guidance to participants in clinical research studies and their families regarding their rights as Human Research Subjects. The Institutional Review Board is available to advise and inform investigators who are submitting clinical research protocols and monitor approved research activities in its jurisdiction.

Jucel Nazareno, BSN, R.N., IRB Monitor
(361) 694-4619
Fax: 361-694-5466

Institutional Review Board
Driscoll Children's Hospital
3533 South Alameda St.
Corpus Christi, TX 78411
(361) 694-5000

Institutional Review Board Request for Waiver or Alteration of Consent Approval

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