Patient Recruitment at AHS

 

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When AHS staff apply privacy principles in their daily work, we instills 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, Operational Approval must be obtained in order to recruit patients or AHS staff 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 an AHS operational areas:

• If the research team has accessed any type of personal health information to identify potential participants (pre-screening), an AHS intermediary (such as a member of the care team or an AHS operational staff not assigned as a member of the research team) is required to be the first point of contact for that patient. The role of the intermediary is to ensure the patient knows (through written, verbal or graphic materials):

1. They may be approached by a research team member

2. They will receive the best available care whether or not they participate

3. They can talk to their care team about their experience or if they have questions
   
    

• If the research team has NOT accessed personal health information for pre-screening purposes, the research team may directly approach patients must be performed in the study-specific 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.

Guidance for research team members approaching patients in AHS operational areas:

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

A.      Approaching patients for study-specific consent to participate:

1. At admission, a clinical 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. Participant chooses whether or not to sign the enrollment consent form.

B.       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.) may follow the recruitment process (bullet A) above then ask the patient if they would sign a study-specific consent form (ie. 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. The research team member with appropriate access and training can then access the relevant EMRs and paper charts (as approved per study) for pre-screening activities to confirm potential participant eligibility.

3. A member of the research team may approach the potential participant to solicit their interest in participating in the study and perform the consenting process for enrollment.

4. Participant chooses whether or not to sign the enrollment consent form.

If the REB has waived the consent requirement

1. The approved research team member 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 member of the research team 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 enrollment consent form.

General AHS 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 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 care-giver 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 (ie. 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.

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 Health System Access hub, The Alberta Clinical Research Roadmap or AHS Research to find out more.