Procedure for research of records containing Protected Health Information (PHI)

1. This procedure applies to county archival records which would be open to public inspection except for provisions of the federal Health Insurance Portability and Accountability Act (HIPAA).

2. If the research request applies to a single record, in which the research interest is not protected health information, the county records program will respond to the request by supplying a copy of the record from which all PHI has been redacted.

3. If the research request is for records of multiple individuals, all containing PHI, the following actions must be taken:

a. The researcher must submit a research plan that includes all of the waiver criteria included in 45 CFR 164.512(i)(2)(ii)

b. The County Privacy Officer will create a privacy board of members with varying backgrounds and appropriate professional competency to evaluate the research plan. The County Privacy Officer shall serve as the board chair unless the Privacy Officer has a conflict of interest.

c. If the research involves no more than minimal risk to the privacy of the individuals who are the subject of the protected health information for which use is being sought, the board chair will use the expedited review process described in 45 CFR 164.512 (i)(2)(iv)(C) to review the research request and approve or deny the waiver of authorization.

d. If the board chair feels that full board review is necessary, a board meeting must be convened and the waiver must be approved by a majority of the members present.

e. If a waiver is granted, the researcher will sign a research agreement and file it with the County Privacy Officer.

f. The County Privacy Officer and the County Records Program will maintain copies of the research plan, denial/approval of the authorization waiver, and the signed research agreement.

4. The form of the research agreement follows:

Research Agreement

Researcher Name:

Researcher Affiliation:

Researcher Contact (address, phone, email, etc)

Records requested:

Research purpose:

As a condition of having access to the records described above, I will abide by the following conditions:

  1. I will not use the information in the records for any purpose other than for the research purposes stated unless I have Multnomah County’s written authorization to do so.
  2. I will not identify in notes and/or in any other public way any PHI contained in the records described above.
  3. I will ensure that no PHI will be used or disclosed in a form in which the individual to whom it relates can be identified.
  4. Records which are photocopied may be used for purposes of private research and reference only. No further copies may be produced or distributed.
  5. I will not contact any individual to whom PHI relates, directly or indirectly.
  6. If researcher is not a county employee, researcher agrees to accept full responsibility for any breach of personal privacy arising out of an infringement of these conditions including any financial liability against Multnomah County.

Researcher signature: _______________________ date: ________________