New YorkMedicalCollege

REQUEST FOR WAIVER OF HIPAA AUTHORIZATION

INSTRUCTIONS: An investigator requesting a waiver of authorization to use or disclose Private Health Information of study subjects must provide the information requested below on an attached page. Complete and sign this form and submit the request to the Office of Research Administration with the College Forms and a protocol.

Project Title: ______

  1. Provide a detailed list of the Private Health Information (PHI) to be collected.
  1. Provide a list of the source(s) of the PHI.
  1. Describe the plan to protect identifiers from improper use and disclosure. Indicate where PHI will be stored and who will have access. List any and all of the entities that might have access to the study’s PHI including but not limited to the NYMC Office of Research Administration, the IRB, sponsors, FDA, data safety monitoring boards, as appropriate.
  1. Describe the plan to destroy the identifiers collected during the study at the earliest opportunity consistent with the conduct of research. Provide specific benchmark or time when identifiers will be destroyed. Please describe the procedure used to destroy all the data collected during the study (electronically, paper, audio/video, photography, other).
    OR If there is a health or research justification for retaining the identifier or if such retention is otherwise required by law, please explain.
  1. Explain why the research could not practicably be conducted without the waiver.
  1. Explain why the research could not practicably be conducted without access to and use of the PHI.
  1. The HIPAA regulation requires reasonable efforts to limit protected health information to the minimum necessary to accomplish the intended purpose of the use, disclosure, or request. Explain why PHI obtained for this study is the minimum information needed to meet the research objectives.

Assurance

The information listed in the waiver application is accurate and all research staff will comply with the HIPAA regulations and the waiver criteria. I assure that the information I obtain as part of this research (including protected health information) will not be reused or disclosed to any other person or entity other than those listed on this form, except as required by law. If at any time I want to reuse this information for other purposes or disclose the information to another individual or entity I will seek approval from the New York Medical College IRB.

Principal Investigator Signature: ______Date: ______

Typed Name: ______

ORA 4/9/03