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Title

Response

Description

Participant that is or may become decisionally impaired is consented into a longitudinal study. The participant’s capacity to consent changes over the course of the study.

Primary actor/participant

Research team, participant, LAR or proxy

Support actor/participant

Information systems  

Preconditions

  • At the time of initial record release approval, all parties obtain all legally required authorizations for health data linkage and transfer.
  • Data requests use unique identifiers to protect the identity of patients so they cannot be re-identified.
  • The data exchange will be funded by a research agency.
  • Capacity to consent will be determined by someone qualified to assess decisional capacity.
  • Participants will be asked to demonstrate that they understand the purpose of the study, procedures, potential risks and benefits, alternatives to participation, and can indicate a choice to participate in the research.
  • Participant capacity to consent will be re-evaluated as necessary.
  • If the participant lacks the capacity to consent, the consent of a Legally Authorized Representative will be sought.
  • If the participant lacks the capacity to consent, the participant’s assent will be sought.

Postconditions

  • Data will be made available to researchers for uses in a manner that is compliant with legal concerns and ethical concerns of the research team.

Alternative

  • A patient that has the capacity to consent becomes decisionally impaired, and their LAR is unaware they are enrolled in a research study.

Data Elements Considered

Not specified

Purpose of the Data Collection

Research

Purpose of Data Use

Analysis under a specific IRB approved research protocol

Terms of Transfer to the Data Holders

Direct consent from participants to researcher

Terms of Transfer to Researchers

IRB approval

 

Anchor
decisionallyimpaired
decisionallyimpaired

 


[i] The participant may be designated a legally authorized representative (LAR). A LAR is a court-appointed guardian that can provide proxy consent for prospective participant to participate to a study.

Prospective participants may have also that designated a health care proxy appointed by a power of attorney. The research team will need to identify this individual and contact the participant’s health care proxy in the event the participants becomes subsequently incapacitated for some reason (e.g. patients with dementia). This person can provide proxy consent for the participant to enroll or remain enrolled in the research study.

If the prospective participant is decisionally impaired and does not have the capacity or competence to consent, but also has not designated LAR or health care proxy, the team may need to reach out to the following individuals, in the order listed below, to obtain consent:

  • Spouse;
  • Natural or adoptive parent;
  • Adult child;
  • Adult sibling;
  • Any other available adult relative related through blood or marriage known and documented to have made decisions for the subject in prior health care settings.

The protocol may also have different requirements for consenting decisionally impaired persons when delivering an interventional treatment versus releasing healthcare records. The IRB will need to assess the level of risk in the protocol to participants to determine whether it is appropriate to enroll participants with certain decisional impairments.