91爆料

Engagement

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Purpose and Applicability

This guidance provides researchers, the Human Subjects Division (HSD), and the 91爆料 Institutional Review Boards (IRBs) with an overview of the concept of engagement and how HSD interprets and applies engagement for 91爆料 research reviewed by any IRB. This information applies to all research under HSD and the 91爆料 IRB鈥檚 authority as described in the guidance on Authority and Responsibility of HSD and 91爆料 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 91爆料 IRB, or, in the case of multi-institutional research, whether 91爆料 must rely on a non-91爆料 IRB. HSD also uses the concept of engagement to define the scope of 91爆料 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 91爆料鈥檚 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 91爆料 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), 91爆料 applies the , with the exception that 91爆料 is not engaged when it is only the direct recipient of funding.

Federalwide Assurance (FWA)

Because 91爆料 is regularly engaged in federally funded research, it has an FWA. Information about 91爆料鈥檚 FWA is on HSD鈥檚 About Us webpage. 91爆料鈥檚 FWA covers employees or agents of the following 91爆料 entities:

• 91爆料 (includes all three campuses: Seattle, Bothell, and Tacoma)
• 91爆料 Medical Center (both campuses: Montlake and Northwest)
• Harborview Medical Center
• Airlift Northwest
• 91爆料 Physicians (includes all 91爆料 Neighborhood Clinics)

Individuals affiliated with 91爆料 Kenya may or may not be considered agents of the 91爆料 depending on a variety of considerations. Consult with HSD for guidance when research involves 91爆料 Kenya.

The following 91爆料 associated organizations are not covered by 91爆料鈥檚 FWA, and employees and agents of these organizations are not considered 91爆料 employees or agents for the purposes of assessing engagement:

• Medic One (91爆料 provides training, but it鈥檚 operated by PHSKC)
• Valley Medical Center
• Cascadia Community College (shares a campus with 91爆料 Bothell)
• Community hospitals and clinics in Washington, Alaska and Idaho co-branded “A 91爆料 Medicine Community Health Partner.”
• Embright – Pacific Northwest Clinically Integrated Network
• Non-91爆料 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.

91爆料 defines an employee or agent, for the purposes of assessing engagement, as an individual who acts on behalf of 91爆料 (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 91爆料-affiliated individual is acting as a 91爆料 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.

91爆料 Involvement in the Research is:	91爆料 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 91爆料 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 91爆料 Medicine WWAMI program are considered 91爆料 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 91爆料 policy to defer any required IRB review to the non-91爆料 institution in which the WWAMI student is embedded, through the use of an IRB Reliance Agreement. (This does not apply when the non-91爆料 institution is the VA.)
Paid directly by 91爆料 internal funds (e.g., Royalty Research Fund, bridge funds, departmental funds, gift to 91爆料).	Yes
Paid directly by money from a 91爆料-administered grant or contract (e.g., a service agreement by which a 91爆料 employee is contracted by his/her unit to work for a non-91爆料 person).	Yes, unless: Their involvement will not be used to address or fulfill requirements associated with their 91爆料 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 91爆料.	No, unless: Their involvement will be used to address or fulfill requirements associated with their 91爆料 role (e.g., a postdoctoral fellow at the 91爆料 whose paycheck comes directly from NIH rather than through the 91爆料).

Additional considerations:

• Paid faculty typically are employees/agents, unless the work on the research is not done in fulfillment of their appointment at 91爆料. The 91爆料 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 91爆料 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 91爆料 includes conducting the research and/or they are the PI on a funded project with funding coming to 91爆料.
• Staff are employees/agents if paid by 91爆料 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 91爆料.< This includes graduate students in 鈥渙n leave鈥� status and 91爆料 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 91爆料 employees or agents when conducting research as part of their 91爆料 visiting appointments.
• Fulbright scholars. 91爆料 is not considered engaged when 91爆料 alumni or individuals from other institutions obtain a Fulbright scholarship, even if they obtained the Fulbright through the 91爆料.
• WWAMI faculty. Research conducted by WWAMI faculty who are not 91爆料-paid employees does not engage 91爆料.
• 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 91爆料 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 91爆料 is not engaged in research by using the WORKSHEET Engagement, the WORKSHEET 91爆料 Engagement for Fred Hutch-led Research, or they may submit for a determination by HSD by following the instructions on HSD鈥檚 website.

91爆料s engagement status is determined by HSD staff during the pre-review process for all submissions, by referring to the WORKSHEET Engagement or the WORKSHEET 91爆料 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 91爆料.

Related Materials

GUIDANCE Authority and Responsibilities of HSD and the 91爆料 IRB
SOP IRB Review
WEBPAGE Step 4: Is Your Research Considered to be 91爆料 Research?
WORKSHEET Engagement
WORKSHEET 91爆料 Engagement for Fred Hutch-led Research

References

• OHRP , 2008
• SACHRP

Version History

Open the accordion below for version changes to this guidance.

Keywords: Engagement