Patient Recruitment

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Privacy Principles Related to Approach/Screening Activities in AHS Operational Areas

When recruiting AHS patients to a Research Ethics Board (REB)-approved clinical health research study:

  • AHS will work to provide restricted access to the least amount of identifiable health information under REB-approved conditions to enable research-related activities if a waiver of consent was granted for the study.
  • Contingent upon the operational approval conditions, members of the research team (whether an employee of AHS or not) may approach a potential participant directly if no health information had been accessed prior to the initial contact.  A poster or brochure in these operational areas may be used provide awareness to patients who may be approached.
  • Members of the research team (as an AHS employee or not, who is not acting in the role of a primary caregiver or member of the assigned care team) may not initiate contact with a potential participant when they have previously accessed health information for that patient (i.e. as a part of the pre-screening process).  For the comfort of potential participants in AHS operational areas, an AHS employee or care provider should be the first point of contact with that patient to obtain permission for researchers to approach.

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Best Practices for Patient Recruitment

​When AHS staff apply privacy principles in their daily work, we instill confidence in each other and in our patients that their personal and health information is protected.  Whether personal or personal health information is being requested, an operational approval must be obtained in order to recruit patients as study subjects in AHS clinical areas.

Guidance for AHS staff (not a research team member) working in operational areas where research is happening

We support these approaches to recruit potential subjects in AHS operational areas:

  1. If the research team has accessed any type of personal health information to identify potential participants (pre-screening), an AHS intermediary (i.e. care team member or AHS operational staff that is not a research team member) is required to be the first point of contact for that patient. The role of the AHS intermediary is to ensure the patient knows (through written, verbal or graphic materials):
  • They may be approached by a research team member
  • They will receive the best available care whether or not they participate
  • They can talk to their care team about their experience or if they have questions
  1. If the research team has NOT accessed personal health information for pre-screening purposes, the research team may directly approach patients for recruitment as specified in the operational approval. It is recommended that the patients be approached in a respectful, professional manner that is appropriately sensitive to the patients comfort, safety and security. The operational area should always be informed about when research team members intend to approach patients and has the right to impose conditions on the approach.

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Guidance for Research Team Members Approaching Patients in AHS Operational Areas

The process below may be used to develop the participant recruitment strategy and is suggested as best practice for approaching patients in AHS operational areas.

Approaching Patients for Study-specific Consent to Participate

  1. At admission, an AHS staff member who is not part of the research team could be the first point of contact with the potential participant to promote the comfort and trust between the patients, caregiver and researchers. They may provide a brochure, direct attention to a poster or state something similar to the following upon check-in "This is a research hospital and you may be approached about research. You don't have to agree and it won't impact your care".  A strong trust relationship forms a strong foundation for research enrollment.
  2. A member of the research team may approach the potential participant to solicit their interest in participating in the study and perform the enrollment process and gathering of consent.
  3. The patient chooses whether or not to sign the study-specific consent form.

Pre-screening of Patients for Eligibility to Develop a Pool of Potentially Eligible Candidates

If the REB has NOT waived the consent requirement:

  1. A member of the research team (i.e. clinical research coordinator, research assistant, etc.) must follow the conditions of the operational approval established to approach a patient to obtain a study-specific consent form (i.e. Consent to Screen form) prior to accessing the patient's medical record. This consent form must clearly identify the study to which they are being pre-screened for and provides explicit consent for the researcher to access the patient's health record.
  2. A research team member with appropriate access and training can then access the relevant electronic medical records (EMRs) and paper charts (as approved per study) for pre-screening activities to confirm potential participant eligibility.
  3. A research team member may approach the potential participant to solicit their interest in participating in the study and perform the consenting process for enrollment.
  4. The patient chooses whether or not to sign the study-specific consent form.

If the REB has waived the consent requirement:

  1. A member of the research team may review the relevant EMRs and paper charts (as approved per study) for the purposes of pre-screening patients to confirm potential participants for eligibility.
  2. A member of the patient's care team must then approach the identified patient to request patient's permission for researchers to approach the patient.
  3. A research team member may then approach the agreeable potential participant to solicit their interest in participating in the study and perform the consenting process for study enrollment.
  4. Participant chooses whether or not to sign the study-specific consent form.

Many resources exist to help researchers and AHS staff understand best practice and requirements in the set-up and conduct of research studies including in AHS operational areas. Visit the Alberta Clinical Research Roadmap to find out more.

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