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Recruitment Oversight

Ethical Concerns


Ethical Concerns

The researcher and the study team members should consider the following ethical questions when evaluating a recruitment strategy:

  • Respect for privacy: Does the recruitment strategy respect an individual’s reasonable expectations for privacy? Will patients be upset when they learn researchers not involved in their care have read their medical records without permission?
  • Lack of pressure: Is the study introduced in a way that allows subjects ample time to consider, with no undue pressure because of timing of the request, who makes the request, how the request is made, or the offering of excessive inducements? Will patients be put in a situation where they may hesitate to say "no" to their own physician? How will pressure be minimized?
  • Unbiased presentation: Is all information accurate, balanced, and free of misleading emphases that make the study excessively attractive? Is the information as complete as is appropriate for each stage of recruitment?
  • The "Therapeutic Misconception": Patients tend to believe a clinical trial—or anything proposed by health care providers—will benefit them, even if they’re told there is no assured benefit. Does the recruitment strategy work to counteract this misconception?
  • Conflicting concerns:
    • Subjects may prefer that someone involved in their care contact them about research, but they may find it hard to say "no" to a care provider.
    • Clinicians may find their clinical judgment in conflict with a desire to enroll patients in their research.

Principles

  • Use of medical records: Access to medical records and identifiable health information by people not directly involved in a patient’s care should be avoided.
  • Use of Protected Health Information: The amount of identifiable information gathered and the number of people who have access to identifiable information must be minimized.
  • Contact: Prospective research subjects should be contacted by people directly involved in their care, not by unknown researchers.

 

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