天美影院

Engagement

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Purpose and Applicability

This guidance provides researchers, the Human Subjects Division (HSD), and the 天美影院Institutional Review Boards (IRBs) with an overview of the concept of engagement and how HSD interprets and applies engagement for 天美影院research reviewed by any IRB. This information applies to all research under HSD and the 天美影院IRB鈥檚 authority as described in the guidance on Authority and Responsibility of HSD and 天美影院IRB.

Context

A research project involving human subjects may be conducted by multiple institutions and individuals. Depending on the nature of their involvement, they may or may not have to comply with federal regulations about human subjects research.

Federally Funded Research

The federal Common Rule uses the term 鈥渆ngagement鈥� to define the circumstances under which an institution must comply with the rule. This compliance includes:

• holding an OHRP-approved Federalwide Assurance (FWA), and
• certifying to the funding agency supporting the research that the research has been reviewed and approved by an IRB, and
• if the research engages multiple institutions, relying upon approval by a single IRB for the portion of the research that is conducted in the United States.

The Office for Human Research Protections (OHRP) provides a , along with illustrative examples. In general, an institution becomes engaged in human subjects research when its employees or agents:

1. Intervene or interact with living individuals for research purposes; or
2. Obtain individually identifiable private information for research purposes; or
3. Obtain consent from subjects, or
4. When an institution is a direct recipient of federal funding (prime awardee) for a human subjects research project, even if it conducts no work with human subjects itself.

Other federal agencies (including those who are Common Rule signatories) may have different definitions of engagement for research they support, however these have not been published.

FDA Regulated Research

The FDA does not have a comparable concept that applies to institutions, and instead relies on the responsibilities of sponsors and investigators as outlined in materials such as the Form FDA 1572.

Other Research

Non-federal funding agencies do not typically use the term engagement or any other comparable concepts.

Policy

HSD uses the concept of engagement to determine whether a non-exempt activity must be reviewed by the 天美影院IRB, or, in the case of multi-institutional research, whether 天美影院must rely on a non-天美影院IRB. HSD also uses the concept of engagement to define the scope of 天美影院IRB review when it is not the only engaged institution and it is not relying on a single IRB. This is described in the SOP IRB Review and in other guidance materials.

Definitions

Engagement

The specific criteria HSD uses to determine UW鈥檚 engagement are outlined in the WORKSHEET Engagement.

HSD uses the following definitions of engagement:

• Research funded or supported by a federal agency that has signed onto the Common Rule: Unless otherwise instructed by the federal funding agency for a specific research project, the 天美影院applies the to all research, regardless of the source of the research funding.
• All other research: Unless otherwise instructed by the funding agency for a specific research project (excluding industry funders), 天美影院applies the , with the exception that 天美影院is not engaged when it is only the direct recipient of funding.

Federalwide Assurance (FWA)

Because 天美影院is regularly engaged in federally funded research, it has an FWA. Information about UW鈥檚 FWA is on HSD鈥檚 About Us webpage. UW鈥檚 FWA covers employees or agents of the following 天美影院entities:

• 天美影院 (includes all three campuses: Seattle, Bothell, and Tacoma)
• 天美影院Medical Center (both campuses: Montlake and Northwest)
• Harborview Medical Center
• Airlift Northwest
• 天美影院Physicians (includes all 天美影院Neighborhood Clinics)

Individuals affiliated with 天美影院Kenya may or may not be considered agents of the 天美影院depending on a variety of considerations. Consult with HSD for guidance when research involves 天美影院Kenya.

The following 天美影院associated organizations are not covered by UW鈥檚 FWA, and employees and agents of these organizations are not considered 天美影院employees or agents for the purposes of assessing engagement:

• Medic One (天美影院provides training, but it鈥檚 operated by PHSKC)
• Valley Medical Center
• Cascadia Community College (shares a campus with 天美影院Bothell)
• Community hospitals and clinics in Washington, Alaska and Idaho co-branded “A 天美影院Medicine Community Health Partner.”
• Embright – Pacific Northwest Clinically Integrated Network
• Non-天美影院clinics within the ITHS Primary Care Research Network (WPRN)
• Pacific Northwest National Laboratory

Employee or Agent

The concept of employee or agent is critical to the determination of engagement. It can include faculty members, staff, students, contractors, and volunteers, among others, regardless of whether the individual is being paid.

天美影院defines an employee or agent, for the purposes of assessing engagement, as an individual who acts on behalf of 天美影院(or the components of its FWA), or exercises institutional authority or responsibility; or performs institutionally designated activities.

HSD applies the principles outlined in the table below to determine whether a UW-affiliated individual is acting as a 天美影院employee or agent. Note: information in the table is about non-VA related appointments. For VA related appointments, review HSD鈥檚 webpage on research involving the VA.

天美影院Involvement in the Research is:	天美影院Employee or Agent?
Unpaid – they receive no salary for the research activities (i.e., they are working “on their own time”).	No, unless: Their involvement will be used to address or fulfill requirements associated with their 天美影院role (e.g., a student who will use research results for a thesis; activities that meet the definition of research and are being used to fulfill a class requirement; or to obtain class credit).Note: Students in the 天美影院Medicine WWAMI program are considered 天美影院employees/agents when they perform research in order to fulfill a WWAMI-related requirement, regardless of whether they are paid for the activity and regardless of which institution pays them. However, it is 天美影院policy to defer any required IRB review to the non-天美影院institution in which the WWAMI student is embedded, through the use of an IRB Reliance Agreement. (This does not apply when the non-天美影院institution is the VA.)
Paid directly by 天美影院internal funds (e.g., Royalty Research Fund, bridge funds, departmental funds, gift to UW).	Yes
Paid directly by money from a UW-administered grant or contract (e.g., a service agreement by which a 天美影院employee is contracted by his/her unit to work for a non-天美影院person).	Yes, unless: Their involvement will not be used to address or fulfill requirements associated with their 天美影院role (e.g., a student who will use research results for a thesis; fulfillment of a class requirement; or to obtain class credit).
Paid by money from another organization, with the money not going through the UW.	No, unless: Their involvement will be used to address or fulfill requirements associated with their 天美影院role (e.g., a postdoctoral fellow at the 天美影院whose paycheck comes directly from NIH rather than through the UW).

Additional considerations:

• Paid faculty typically are employees/agents, unless the work on the research is not done in fulfillment of their appointment at UW. The 天美影院Academic HR website has a list of all types of faculty appointments, including information that helps assess whether individuals in each type of appointment are 天美影院employees or agents when they conduct research.
• Unpaid faculty (e.g. affiliates and emeritus) typically are not employees/agents unless the formal scope of work for 天美影院includes conducting the research and/or they are the PI on a funded project with funding coming to UW.
• Staff are employees/agents if paid by 天美影院for the research.
• Students are employees/agents if they are currently matriculated and the work is done in fulfillment of the requirements of their course of study at UW.< This includes graduate students in 鈥渙n leave鈥� status and 天美影院students conducting research at other locations (e.g. WWAMI students).
• Unpaid volunteers are employees/agents as long as the work is within the written scope of work authorized by the department.
• Visiting faculty members, postdoctoral fellows, and graduate students are generally considered to be 天美影院employees or agents when conducting research as part of their 天美影院visiting appointments.
• Fulbright scholars. 天美影院is not considered engaged when 天美影院alumni or individuals from other institutions obtain a Fulbright scholarship, even if they obtained the Fulbright through the UW.
• WWAMI faculty. Research conducted by WWAMI faculty who are not UW-paid employees does not engage UW.
• Sabbatical and other on leave statuses. The purpose of sabbatical is to increase the scholarship and professional development of the faculty and thereby enhance their capacity for service to the University. As such, as long as the work is done in fulfilment of their 天美影院appointment, individuals on sabbatical are considered engaged. Individuals on sabbatical may obtain other, temporary appointments with other organizations which may also engage those organizations.

Procedure

Determination of Engagement

Researchers may self-determine that 天美影院is not engaged in research by using the WORKSHEET Engagement, the WORKSHEET 天美影院Engagement for Fred Hutch-led Research, or they may submit for a determination by HSD by following the instructions on HSD鈥檚 website.

UWs engagement status is determined by HSD staff during the pre-review process for all submissions, by referring to the WORKSHEET Engagement or the WORKSHEET 天美影院Engagement for Fred Hutch-led Research.

HSD does not have the authority to formally determine whether other institutions and unaffiliated investigators are engaged in research, however, to facilitate compliance, it may make informal recommendations for projects involving UW.

Related Materials

GUIDANCE Authority and Responsibilities of HSD and the 天美影院IRB
SOP IRB Review
WEBPAGE Step 4: Is Your Research Considered to be 天美影院Research?
WORKSHEET Engagement
WORKSHEET 天美影院Engagement for Fred Hutch-led Research

References

• OHRP , 2008
• SACHRP

Version History

Open the accordion below for version changes to this guidance.

Keywords: Engagement