Versions Compared

Old Version 9

changes.mady.by.user Gagan Jindal

Saved on

compared with

New Version Current

changes.mady.by.user Gagan Jindal

Saved on

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

...

  • Are there special considerations with regard to the risk of re-identification due to the small population size?
    • Specifically, what provisions should be in place in the protocol to prevent such a situation?
  • Are there any other alternative protections to de-identification?
  • What are the implications of the research participation or research findings that might negatively impact/stigmatize the population of interest? How can these risks be mitigated effectively?
  • Are AN/AI excluded from research due to the burdens of research study approval? How can these issues be resolved/eased (e.g., better clarity for researchers on what tribal governments may require)?

 

Title

Response

Description

Max Researcher is conducting research on the American Indian/Alaska Native subpopulations, where risk for re-identification is high due to the small population size.

Primary actor/participant

Covered Entity, Researcher

Support actor/participant

IHS Information System, and Research Information System

Preconditions

  • All parties obtain all legally required authorizations for data transfer (DUA).
  • Both the IHS IRB and Max’s research institution’s IRB must approve the study protocol.
  • The Tribal governments must also approve the research protocol.
  • The IRB approved research protocol specifies terms of data release.
  • Data will be de-identified by IHS before sharing it with Max Researcher.

Postconditions

The Covered Entity continues to transmit the healthcare records to the researcher in a standardized format consistent with policy and protocol.

Alternative

  • The study population is too small and thus additional protections must be put in place to reduce the risk of re-identification. Or, the researcher shows the study will provide adequate benefit, in spite of the reidentification risks.
  • Study participants are willing to consent to the study given benefits of research findings for these populations. 

Considerations

It is ethical to avoid the creation or exacerbation of stigmas among these individuals/populations when publishing study results

Data Elements Considered

Healthcare records, Study Data

Purpose of the Data Collection

Clinical care, administrative purposes, research

Purpose of Data Use

Research

Terms of Transfer to the Data Holders

DUA

Terms of Transfer to Researchers

IRB approval

 

...