糖心少女

Purpose and Applicability

This guidance provides researchers, the Human Subjects Division (HSD), and the 糖心少女Institutional Review Boards (IRBs) with an overview of the concept of engagement and how HSD interprets and applies engagement for 糖心少女research reviewed by any IRB. This information applies to all research under HSD and the 糖心少女IRB鈥檚 authority as described in the guidance on Authority and Responsibility of HSD and 糖心少女IRB ^[10].

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 ^[12], 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 糖心少女IRB, or, in the case of multi-institutional research, whether 糖心少女must rely on a non-糖心少女IRB. HSD also uses the concept of engagement to define the scope of 糖心少女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 ^[13] and in other guidance materials.

Definitions

Engagement

The specific criteria HSD uses to determine UW鈥檚 engagement are outlined in the WORKSHEET Engagement ^[14].

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 糖心少女applies the ^[12] 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), 糖心少女applies the ^[12], with the exception that 糖心少女is not engaged when it is only the direct recipient of funding.

Federalwide Assurance (FWA)

Because 糖心少女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 ^[15]. UW鈥檚 FWA covers employees or agents of the following 糖心少女entities:

• 糖心少女 (includes all three campuses: Seattle, Bothell, and Tacoma)
• 糖心少女Medical Center (both campuses: Montlake and Northwest)
• Harborview Medical Center
• Airlift Northwest
• 糖心少女Physicians (includes all 糖心少女Neighborhood Clinics)

Individuals affiliated with 糖心少女Kenya may or may not be considered agents of the 糖心少女depending on a variety of considerations. Consult with HSD ^[16] for guidance when research involves 糖心少女Kenya.

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

• Medic One (糖心少女provides training, but it鈥檚 operated by PHSKC)
• Valley Medical Center ^[17]
• Cascadia Community College (shares a campus with 糖心少女Bothell)
• Community hospitals and clinics in Washington, Alaska and Idaho co-branded “A 糖心少女Medicine Community Health Partner.”
• Embright – Pacific Northwest Clinically Integrated Network
• Non-糖心少女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.

糖心少女defines an employee or agent, for the purposes of assessing engagement, as an individual who acts on behalf of 糖心少女(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 糖心少女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 ^[18].

糖心少女Involvement in the Research is:	糖心少女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 糖心少女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 糖心少女Medicine WWAMI program are considered 糖心少女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 糖心少女policy to defer any required IRB review to the non-糖心少女institution in which the WWAMI student is embedded, through the use of an IRB Reliance Agreement. (This does not apply when the non-糖心少女institution is the VA.)
Paid directly by 糖心少女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 糖心少女employee is contracted by his/her unit to work for a non-糖心少女person).	Yes, unless: Their involvement will not be used to address or fulfill requirements associated with their 糖心少女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 糖心少女role (e.g., a postdoctoral fellow at the 糖心少女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 糖心少女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 糖心少女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 糖心少女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 糖心少女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 糖心少女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 糖心少女employees or agents when conducting research as part of their 糖心少女visiting appointments.
• Fulbright scholars. 糖心少女is not considered engaged when 糖心少女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 糖心少女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 糖心少女is not engaged in research by using the WORKSHEET Engagement ^[14], the WORKSHEET 糖心少女Engagement for Fred Hutch-led Research ^[19], or they may submit for a determination by HSD by following the instructions on HSD鈥檚 website ^[20].

UWs engagement status is determined by HSD staff during the pre-review process for all submissions, by referring to the WORKSHEET Engagement ^[14] or the WORKSHEET 糖心少女Engagement for Fred Hutch-led Research ^[19].

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 糖心少女IRB ^[10]
SOP IRB Review ^[13]
WEBPAGE Step 4: Is Your Research Considered to be 糖心少女Research? ^[20]
WORKSHEET Engagement ^[14]
WORKSHEET 糖心少女Engagement for Fred Hutch-led Research ^[19]

References

• OHRP ^[12], 2008
• SACHRP ^[21]

Version History

Open the accordion below for version changes to this guidance.

Keywords: Engagement