Sharing Qualitative Data

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Qualitative data, including those from interviews, focus groups, or even questionnaires with free text fields, raise unique challenges in assessing whether Protected Heath Information (PHI) has been included. Often, participants’ responses to open-ended questions include PHI even if the questions do not specifically ask about health information.

HIPAA requires that, in all cases, covered entities use and disclose the “minimum necessary” PHI to accomplish a given purpose. That means reasonable efforts must be made to remove individual identifiers from a research data set before it is analyzed or shared with collaborators, to the extent practicable without diminishing the data set’s value in answering the research question. For qualitative data sets, that can be easier said than done.

Usually, the best way to ensure compliance with HIPAA is to obtain participants’ authorization to share their data. Depending on the study, this doesn’t necessarily need to be signed authorization. The consent and authorization forms, scripts, or information sheets can include language explaining that although researchers’ best efforts will be made to remove participants’ identifiable information, information volunteered by a participant in an open-ended response or discussion may be shared with collaborators.

If complete de-identification is preferred or required, any data set that contains free text or open-ended responses to questions must be reviewed carefully to ensure that it is de-identified per HIPAA’s definition. For smaller data sets, the study team should read through all such fields and redact any individual identifiers, keeping in mind whether a set of personal characteristics, taken together, could identify the individual even in the absence of the 18 HIPAA identifiers. Then the study team must submit the full data set, including all free-text items, to the research compliance manager with a De-Identified Data Approval Form for verification.

For large qualitative data sets, it may not be feasible to conduct this review. In such cases, researchers must proceed as if the data set contains at least some PHI. If participant authorization was not obtained, the IRB must approve a waiver of HIPAA authorization before the data set can be shared.

Sharing PHI under any circumstance also requires a DUA, DTA, or other acceptable agreement, as well as a Data Transfer Request.


NIH Data Repositories

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Currently, 69 sub-departments of the NIH have individual repositories for sharing information and specimens. Not all of these are relevant to research conducted at CHR; however, it has come to the attention of the Research Subjects Protection Office (RSPO) and Research Compliance (RC) that some NIH departments are requiring submission of data specifically to one of these repositories as a condition of funding.

RSPO and RC are working in collaboration with CHR IT to iron out some of the finer details of how we will implement cooperation with this mandatory data-sharing requirement. If you are the recipient of an NIH award and are being notified that you must share data from your project with an NIH repository, the following information will help you move forward with this step:

  • RSPO and RC confirm that Sponsored Projects Administration (SPA) may sign the data-sharing agreement that is likely being required by your NIH funder.
  • RSPO has drafted template language for your consent document that may be used to notify participants of your contribution to the repository. Contact us if you would like a copy.

In the coming months, RSPO plans to share additional guidance with the CHR community about these data-repository requirements and how the Center will comply with them. Please contact us directly in the meantime for additional assistance and information if your award requires you to participate in this repository program. 


Policy Updates

NWRC.HRPP.101, Identifying Potential Research Participants

This is a new policy to document the IRB’s position that viewing individually identifiable, private information for the limited purpose of identifying potential research participants prior to obtaining informed consent does not meet the regulatory definition of human subjects research. As such, the IRB does not grant a waiver of informed consent for these activities, but reviews the proposed procedures as part of the IRB submission to ensure respect for potential participants’ privacy.

IRB Tips and New Information


CITI Refresher Training in Conflicts of Interest and Human Subjects Protection

Be on the lookout for an email from the CITI Program if you completed conflicts of interest training in 2013 or human subjects protection training in 2014. CITI sends a reminder 90 days before current training expires and automatically adds required refresher courses to user course lists. Users can check current training and previously completed coursework by logging into CITI.

Keeping Primary Contact and Study Team Information Current

Annual continuing review is a good time to check that a study’s primary contact and study team information is up to date. The primary contact is the person assigned to receive all communications from the IRB on behalf of the study team. Use the Assign Primary Contact activity to update the primary contact. Submit a combined modification and continuing review to add or remove study team members.

Research Staff Encouraged to Observe IRB Meetings

The Research Subjects Protections Office (RSPO) staff is inviting research staff to attend IRB meetings. Attending meetings will lead to a better understanding of what the IRB and RSPO do and how we do it. We are only able to accommodate two guests a month. The meetings are the third Wednesday of each month at noon and usually last an hour or two. We provide lunch and send out the agenda the Thursday prior to the meeting. Please contact to get on the list.

Research Compliance Staff Updates

On May 5, the Research Compliance team said farewell to Sandy Heintz, our IRB manager, who retired after 32 years with KPNW.

We are excited to announce that Kaija Maggard, previously an IRB coordinator in the department, has been selected as the new IRB manager. Congratulations, Kaija! Kaija’s first task as manager will be to hire a new IRB coordinator to fill the position she has vacated.

Additionally, Melinda Allie, IRB coordinator/trainer, will be transitioning later this year to full-time quality improvement work, building upon the existing Quality Improvement–Monitoring program to further our compliance partnerships with the research community.

Finally, it is with mixed emotions that we learned David Matthews, IRB Coordinator, will retire August 18 after 8 years with the department. We will miss him very much but are happy for him!

IRB Humor

Taken from an actual consent form: “Up to 4 (4) extra teaspoons of blood will be collected . . .”