Allen College Institutional Review Board

Principal Investigator[1]:
Title of Project:

APPLICATION FOR USE OF PROTECTED HEALTH INFORMATION

SECTION I:CATEGORY OF PROTECTED HEALTH INFORMATION

Please indicate below how the protected health information (PHI) will be obtained.

Review of a patient’s medical record with authorization through informed consent by the subject and cooperation of the healthcare facility.

Review of a patient’s medical record with a waiver of authorization from the IRB. If a “waiver of authorization” is being requested, please answer all questions below in Section II.

Review of a patient’s medical records preparatory to research with authorization through cooperation of the healthcare facility.

Research on decedent’s information with authorization through cooperation of the healthcare facility.

De-identified health information with authorization through cooperation of the healthcare facility.

Limited data set agreement with authorization through cooperation of the healthcare facility.

SECTION II:REQUEST FOR WAIVER OF AUTHORIZATION[i]

1.Describe the protected health information that you plan to use or analyze in this study, including the beginning and end date of the records.

2.Please explain why this study involves no more than minimal risk to the privacy of the participants. Minimal risk is defined as the probabilityof the anticipated risk to the privacy of the participants in the proposed research is not greater than that encountered ordinarily in daily life or during the performance of routine physical, dental or psychological examinations or tests.

3.Please describe your plan to protect the identifiers from improper use and disclosure.

4.Please describe your plan to destroy the identifiers at the earliest opportunity consistent with the conduct of the research. If there is justification for retaining the identifiers or if law requires retention, please explain this as well.

5.Please explain why this research could not practicably be conducted without access to and use of the protected health information.

6.Please explain why this research could not practicably be conducted without the waiver or alteration.

YesNoDo you agree to notreuse or disclose the information to any other person or entity (beyond the named research team) except as required by law, for authorized oversight of the research project, or unless subsequent IRB approval is obtained for such reuse or disclosure?

Signature of the PIDate

By checking this box, the PI waives his/her signature on this form.

Signature of the student advisor, if applicableDate

By checking this box, the student advisor waives his/her signature on this form.

FOR IRB USE ONLY:

Initial action by the Institutional Review Board (IRB):

Waiver approved. Date:

Pending further review. Date:

Waiver denied.Date:

Follow-up action by the IRB:

IRB Approval Signature

By checking this box, the IRB reviewer waives his/her signature on this form.

[1] If there are additional investigators, please attach a page with all names listed.

[i] Criteria for Waiver of any or all required elements of informed consent:

  1. Research involves no more than minimal risk to the subjects.
  2. Waiver or alteration will not adversely affect the rights and welfare of the subjects.
  3. Research could not practicably be carried out without the waiver or alteration.
  4. Whenever appropriate, subjects will be provided with additional pertinent information after participation.

Note that time consuming, expensive, or inconvenient are not reasons to request or be granted waiver for informed consent.