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  • Given that the data in the registry is obtained under a mixture of informed consent, waivers, and business associate agreements, how should these conditions be tracked?
  • Given that the registry contains PRO data, which in some cases patients have consented for research use (and in other cases not), what, if any, are the researcher’s obligations for the use of data without explicit patient consent? How should the entity managing the registry deal with consent and data use?
  • Does the fee affect real or perceived ethical concerns?
  • Would concerns be different if the research obtained IRB approval for use of deidentified data, with some concerns for re-identification? 
  • Do concerns differ if the PROs include instruments intended to measure post-surgical depression?
  • What additional protections must be in place given the availability of the limited data set?

 

Title

Response

Description

A registry contains health data and PROs approved for research purposes, and each record has been approved under different conditions.

Primary actor/participant

Researcher (end-user) using registry

Support actor/participant

Registry-affiliated entities who submit clinical data, patients who submit PRO data

Preconditions

  • Registry has been created with all necessary approvals
  • Approval of research protocols by IRB
  • Payment to cover costs of data extraction has been obtained
  • The registry manages the data submitted by participating data sites, and manages that store relevant information for a given protocol/study.

Post conditions

  • The researcher accesses registry data electronically by the researcher (clinical data, and PROs).
  • Researcher has access to data set and is able to analyze/combine them for a specific research study.
  • Researcher contacts patients and collects additional PRO data.

Alternatives

  • Max is a member of the public interested in analyzing registry data.
  • Max’s study does not involve contacting patients, but analysis of a limited data set with some risk of re-identification.
  • No fees are charged.
  • PROs contain measures of substance misuse/substance use disorders relevant to pain treatment that may have implications beyond screening for depression.
  • PROs include measures of depression as well as functional status.
  • Do other concerns apply if data submission to the registry is mandated by state law?

Considerations

  • Tracking conditions for the registry data that is obtained under a  mixture of informed consent, waivers, and business associate agreements
  • Researcher’s obligation, if any, to obtain explicit patient consent for the data patients may or may not have consented for research use
  • Whether the PROs include instruments intended to measure post-surgical depression

Data Elements Considered

Electronic data from multiple sites and patient reported outcomes,

Purpose of the Data Collection

Improved clinical care and patient outcomes

 

Purpose of Data Use

Analysis under a specific research protocol

Terms of Transfer to the Data Holders

DUA between organizations, informed consent

Terms of Transfer to Researchers

IRB approval and terms of consent or other agreements

 

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