Request to Conduct Research at a Family Medicine Clinic Site

Policy Overview/Summary:

The Department of Family Medicine (DFM) values innovation and discovery, and welcomes the opportunity to support the Research mission of OHSU by allowing access to our clinic sites when appropriate. Due to the volume of research activity in our clinic sites, we have adopted a process that allows us to manage research participation requests expediently while continuing to be an effective collaborator. This policy provides information about both our decision-making criteria and the review process.


Definitions:

Core Clinic Site – ambulatory care sites managed by the DFM; current locations include Beaverton, Gabriel Park, Richmond, Scappoose, and South Waterfront


Shared Clinic Site – ambulatory care sites co-managed by the DFM in partnership with another OHSU Department (e.g. Internal Medicine and Pediatrics); current locations include Beaverton and Orenco Station


DFM Faculty/Staff – any employee with a primary job assignment through the DFM


FM Collaborator – DFM Faculty/Staff who serves as the primary point of contact for a study in our clinic(s)


Research Participation – any study activity that requires the DFM Clinic Faculty/Staff to engage with researchers, either internal or external to our department


Review Committee: The Review Committee is comprised of representatives from DFM Core and Shared Clinic Site(s) - Medical Director and Practice Manager (or an assigned delegate), Education and Research mission areas (when applicable)


Types of Requests: Research participation in our clinic sites requires varying degrees of impact on clinical workflow. The three categories listed are based on the typical types of requests received, and not intended to be a comprehensive list.


Low Impact – Includes activities that require minimal support from clinic Faculty/Staff, such as posting recruitment flyers on designated information boards


Medium Impact – Includes activities that require moderate support from clinic Faculty/Staff, such as on-site information session or handing out a survey to patients at check-in


High Impact – Includes activities that require intense support from clinic Faculty/Staff, such as engaging in direct patient contact through written communication or providing study information during visit


Criteria for Decision:

The following criteria is considered when deciding whether to allow access to DFM clinic sites for study activities

  • Alignment with DFM Patient Care mission
  • Support of DFM Collaborator(s)
  • Scholarly opportunity for DFM Faculty
  • Impact on DFM Clinic Faulty/Staff workflow


Review and Notification:

Upon receipt of complete application packet, we will route to the appropriate reviewers. The target timeline for notification of decision is two weeks.


MyChart:

Our standard practice is not to use MyChart for study participant recruitment. Our preference is to preserve this application for healthcare-related communication only. Requests to contact patients are reviewed on a case-by-case basis. If approved, then we would work together with the study team on a communication plan for contacting patients via telephone, email, or other options.

This person will be the primary point of contact for this request.

Please type information with format Last Name, First Name

Updates and notifications will be sent to the email address provided

Do not complete if same as Requestor

Please enter the Study PI's name using format Last Name, First Name

Investigator Type

Please select the type of investigator conducting this study

Please enter the department or division or unit's full name (no abbreviations or acronyms)

Please enter FM Collaborator's name using format Last Name, First Name

If a FM collaborator is not yet identified, then enter "TBD"

Select all that apply

Please select date that you anticipate starting study activities in FM clinic site(s)

If unknown, then leave blank

Please select date that you anticipate concluding study activities in FM clinic site(s)

If unknown, then leave blank

If study IRB is not complete, then enter "TBD"

Please give us a brief description of your research project and specify how it will impact clinic operations.

  • Objective
  • Participant eligibility
  • Study activities
  • Tasks the clinics/clinic staff are asked to complete

Attach any documents that are relevant to this request

Some examples include:

  • IRB approved protocol
  • Study flyers
  • Informed consent with information sheet
  • IRB approved communication to study participants (either patients or other groups like providers)
  • Sample Practice Agreement or MOU
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