Duke University Health System Institutional Review Board (DUHS IRB)

Request for Waiver or Alteration of Consent and HIPAA Authorization

Principal Investigator: , MD
Protocol Title:
IRB #: PRO000XXXX
  1. Use of Form: Use this form to request DUHS IRB review if the research activity indicated belowrequires a consent and authorization process that will alter, or will not include, all of the elements of consent and HIPAA authorization as required by federal regulations 45CFR46.116(d) and45CFR164.512(i)(2), respectively, or will waive the requirements under 45CFR46.116 to obtain informed consent.

This waiver request applies to the following research activityor activities:

[ ] Scheduling of research activities in MaestroCare prior to obtaining written consent for the research. (If you check this box, please complete all sections below.)

[ ]Ascertainment(identification, selection) and/or recruitment of potential subjects whilerecordingidentifiableprivateinformation, such as protected health information (PHI),prior toobtaining the subject’s consent. (If you check this box, please complete sections B and C below.)

[X]Conduct of the research project without obtaining verbal or written consent and authorization. (If you check this box, please complete sections B and C below.)

(Note: If you checked only the second box above, answer the questions below as they pertain solely to PHI collected prior toconsent. For example, the answer to #5b should only address a plan for the destruction of PHI collected prior toconsent and for those potential subjects who do not enroll.)

  1. Provide the following information:
  1. List the elements of informed consent and/or HIPAA authorization for which waiver or alteration is requested. Provide the rationale for each.

No subjects will be recruited for this retrospective chart review. However, they will be identified for this study by diagnosis and procedure codes. All elements of informed consent are being asked to be waived for this study.
  1. List the specific protected health information (PHI) to be collected and its source(s). (Note: PHI = health information + identifiers)

No subjects will be recruited for this retrospective chart review. However, they will be identified for this study by diagnosis and procedure codes. We will record ______diagnosis and procedure codes, and relevant ophthalmic findings for statistical analysis. PHI will be recorded solely for the purposes of this study, and will be destroyed at the conclusion of the data analysis.
No social security numbers, names, addresses or other personal information will be recorded. ______will be recorded.Data collection will be between the dates of xx/xx/20xx and xx/xx/20xx. Only data in existence as of xx/xx/20xx will be collected.
  1. Criteria for Waiver:The DUHS IRB may waive the requirement for informed consent and authorization if all of the following criteria are met (#s1-6). Please respond to each item in the space below using protocol-specific language to provide justification.
  1. The research involves no more than minimal risk to subjects.

This retrospective study represents no more than minimal risk to subjects andwill not adversely affect their rights and welfare. Due to the impracticality of contacting those individuals no longer in follow-up at the Duke Eye Center/satellites we are requesting waiver of consent and HIPAA authorization. No patients will be contacted as part of this study. All patient identifiers will be removed once the data from the patient medical records is collected.
  1. The waiver or alteration will not adversely affect the rights and welfare of the subjects. Include a description of any measures to be taken to ensure that the rights and welfare of subjects will be protected.

This retrospective study represents no more than minimal risk to subjects andwill not adversely affect their rights and welfare. Due to the impracticality of contacting those individuals no longer in follow-up at the Duke Eye Center/satelliteswe are requesting waiver of consent and HIPAA authorization. No patients will be contacted as part of this chart review. All data collected for this study will be restricted solely to individuals listed on the Duke e-IRB key personnel list.
  1. Whenever appropriate, the subjects will be provided with additional pertinent information.

Due to the retrospective nature of this study, we do not expect our data analysis to yield additional pertinent information. Should relevant information be discovered the investigator will work with the patient’s clinical faculty to notify them of the new information.
  1. If this research activity relates to research involving deception, explain how subjects will be provided with additional pertinent information after study participation and what information will be provided. Otherwise indicate “not applicable”.

Not applicable
  1. The use or disclosure of protected health information involves no more thanminimal riskto the privacy of individuals, based on, at least, the presence of the following elements (a.and b.)

Demonstrate that the use or disclosure of PHI involves no more than minimal risk to the privacy of subjects by describing the plans requested below:

  1. An adequate plan to protect the identifiers from improper use and disclosure.

Describe the plan (how protection will be accomplished)and indicate where the PHI will be stored and who will have access.

Data will be stored on password-protected computer with the data stored behind the Duke firewall. Subjects will be de-identified via the use of a separate document correlating subjects’ Duke medical record numbers with a study ID assigned for the sole purpose of this study. At the end of data collection, that key will be destroyed. Access will be limited to individuals listed on the Duke e-IRB key personnel list. Files will not be shared with non-study personnel.
  1. An adequate plan to destroy the identifiers at the earliest opportunityconsistent withconduct of the research, unless there is a health or research justification for retainingthe identifiers or such retention is otherwise required by law.

Describe the plan(how and when identifiers will be destroyed and by whom). If there is a health or research justification for retaining the identifiers or such retentionis otherwise required by law, provide the reason to retain identifiers.

At the end of data collection, the key to patient identifiers will be destroyed/deleted by a study team member assigned by the PI who is listed on the Duke e-IRB.
  1. Adequate written assurances that the protected health information will not be reused or disclosed to any other person or entity except (i) as required by law,(ii) for authorized oversight of the research study, or (iii) for other research for which the use or disclosure of PHI would be permitted by the HIPAA Privacy Rule. By electronically signing this submission in eIRB, the PI provides this written assurance.
  1. The research could not practicably be conducted without the waiver or alteration.

Explain why informed consent/authorization can not be obtained from subjects.

Patient identifiers are needed to identify eligible patients for this study. This retrospective study represents no more than minimal risk to subjects andwill not adversely affect their rights and welfare. Due to the impracticality of contacting individuals no longer in follow-up at the Duke Eye Center/satellites we are requesting waiver of consent and HIPAA authorization.
  1. The research could not practicably be conducted without access to and use of the protected health information specified in B.2 above.

Patients will be identified for this study by diagnosis and procedure codes, and relevant data collected by accessing ______in the ______database. There are no direct risks or benefits to patients recruited to this study. There will be no study interventions and no contact with the subjects.Patients’ identities will not be identifiable in publications resulting from this investigation.
  1. Waiver of Documentation of Consent and HIPAA Authorization for Scheduling in

MaestroCare

  1. The scheduling of research activities in MaestroCare prior to obtaining written consent for the study presents no more than minimal risk of harm to subjects.

[ ] True[ ] False

  1. The pre-scheduling involves no procedures for which written consent is normally required outside of the research context.

[ ] True[ ] False

  1. An IRB-approved phone script will be used to obtain verbal consent from subjects for scheduling the research activities prior to obtaining written consent for the study.

[ ] True[ ] False

Principal Investigator’s Assurance:

With my electronic signature on this submission to the DUHS IRB, I assure the IRB that the information that I provided in this waiver application is accurate and complete; that the PHI that I request is the minimum amount of identifiable private information necessary for my research project; and that the PHI will not be reused or disclosed to any other person or entity, except (a) as required by law, (b) for authorized oversight of the research study, or (c) for other research for which the use or disclosure of protected health information would be permitted by the HIPAA Privacy Rule.

1

Version 09/03/2013