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Strategic Plan for Office of Research Compliance & Integrity

Context For Planning

The Office of Research Compliance and Integrity (ORCI) works directly with GVSU researchers to create a culture of active, engaged, and ethical research by providing research compliance guidance and oversight. The ORCI supports GVSU researchers through protocol review, training and educational activities, regulatory compliance oversight, and post approval compliance review in the following areas: 

 • Human Subjects Research 
 • Export Controls 
 • Conflict of Interest in Research 
 • Animals in Research & Education 
 • Responsible Conduct of Research 
 • Research Safety (including laboratory, radiation, biosafety, and laser safety) 

While the ORCI serves all GVSU researchers (faculty, staff, and students), it is noted that the majority of our direct customer service interactions occur primarily with faculty members, due to the services provided by our office and the general nature of the research process. Faculty members serve as the principal investigators of the protocols reviewed by our office, and they are primarily responsible for mentoring and training their student researchers. The ORCI provides supplemental training and education to student researchers as needed (such as when the research involves human participants or animals) or upon request.

The ORCI was created in 2016, replacing the existing Research Protections Program (RPP). The RPP had limited staff (occasional part-time staff and graduate assistants) whose role consisted of helping to process research protocols and provide very limited compliance oversight; staffing levels did not permit the additional activities currently performed by the ORCI. The current staffing level of ORCI (two full-time AP positions) was established in late September 2016; therefore, nearly all of the strategic objectives for the ORCI were initiated in 2017.

Mission

Creating a culture of active, engaged, and ethical research.

Vision

The Office of Research Compliance and Integrity will be recognized for its strong commitment to the safe and ethical conduct of research, and will provide the tools and education necessary for Grand Valley State University researchers to conduct their research activities in accordance with all applicable Federal, State, Local, and University policy and regulatory requirements.

Value Statement

We believe all research should be conducted in a safe and ethical manner. 


We value a research community that is diverse, inclusive, and collaborative among faculty, staff, students, and the broader community. Research integrity is an essential component to enhance scholarly excellence through sharing knowledge, learning, and discourse.

We believe all research participants should be aware of their rights as a research participant, and participants should feel confident that Grand Valley State University is doing everything it can to ensure these rights are protected and that all Federal, State, Local, and University policies and procedures are being properly followed.

Strategic Priorities, outcomes, and key objectives

Strategic Priority Area 1: Actively engage learners at all levels.

Strategic Priority Area 2: Further develop exceptional personnel.

Outcome D: Grand Valley supports innovative teaching, learning, integrative scholarly and creative activity, and the use of new technologies.

Objective 2.D.1

Increase the number of GVSU researchers successfully completing core research compliance training programs by at least 5% year-to-year, from 2017-2021, in each of the following compliance areas: Responsible Conduct of Research (RCR), human subjects research, animal care and use, lab safety, and export controls.

Baseline

In May 2016 GVSU initiated use of Epigeum as its online research compliance training provider, resulting in additional offerings to researchers in all areas of research compliance identified in this objective. GVSU has additional Blackboard courses available to researchers for animal care and use training and laboratory safety, offers several in-person lab safety training courses annually, and offers an in-person Responsible Conduct of Research (RCR) workshop every two years. Typically 300-400 researchers complete lab safety training every year, and 40-60 complete animal care and use training. The last RCR workshop was held in February 2016 and attended by 52 researchers. Baseline data for this objective will be collected in FY17 to incorporate the use of Epigeum.

Progress

2019 Status
Substantial Progress
The number of individuals completing training in each area for FY19 was as follows: Responsible Conduct for Research (RCR) – 2068 (includes Epigeum and CITI) [0.01% decrease from FY18] Animal Research – 119 (includes Epigeum and Blackboard courses) [25.3% increase from FY18] Human Subjects – 1551 (includes Epigeum and CITI) [63.4% increase from FY18] Export Controls – 139 [183.7% increase from FY18] Lab Safety – 452 (includes Epigeum, Blackboard, and in-person courses) [9.1% decrease from FY18]

2018 Status
Substantive Progress
The number of individuals completing training in each area for FY18 was as follows: Responsible Conduct for Research (RCR) – 2099 (includes Epigeum and in-person course) [25.4% increase from FY17] Animal Research – 95 (includes Epigeum and Blackboard courses) [12.0% decrease from FY17] Human Subjects – 949 [90.6% increase from FY17] Export Controls – 49 [63.2% decrease from FY17] Lab Safety – 497 (includes Epigeum, Blackboard, and in-person courses) [14.5% increase from FY17]

Objective 2.D.2

Increase educational outreach to faculty, staff, and students by at least 5% year-to-year, 2017-2021, through research compliance classroom presentations and outreach activities that further support and reinforce GVSU’s core research compliance training programs.

Baseline

This is a new initiative. Baseline data will be collected in 2017.

Progress

2019 Status
Substantial Progress
ORCI staff offered 27 outreach events in 2019. This included research compliance presentations in 13 undergraduate/graduate courses, three orientation events, two classroom research administration courses, several faculty events, and several departmental faculty/staff meetings. In total, 158 individuals attended: 53 faculty members, 20 staff members, and 85 students.

2018 Status
Substantive Progress
ORCI staff offered 14 outreach events in 2018. This included research compliance presentations in five undergraduate courses, two orientation events, several faculty events, and drop-in help sessions. In total, 158 individuals attended: 53 faculty members, 20 staff members, and 85 students.

Objective 2.D.3

Identify research compliance areas requiring additional service initiatives and educational outreach by developing and implementing a tracking tool to document and analyze inquires received by the ORCI.

Baseline

None. This is a new initiative.

Progress

2019 Status
Substantial Progress
The tracking tool was developed and implemented on August 27, 2018. For FY19 (8/27/18-6/30/19), 551 individuals contacted our office with research compliance questions. The breakdown of individuals contacting us was as follows: 67.3% faculty, 16.7% students, 11.3% staff, and 4.7% non-GVSU/not identified. The breakdown of inquires by compliance topic area was as follows: 79.1% human subjects research, 10.9% animal research, 5.3% responsible conduct of research, 1.3% export control, 2.2% conflict of interest, and 1.3% for other items.

2018 Status
Substantive Progress
The tracking tool was developed and implemented on August 27, 2018. To date, 197 individuals have contacted our office with research compliance questions since the tool was introduced. The breakdown of inquires by compliance topic area are as follows: 73.6% human subjects research, 11.7% animal research, 9.6% responsible conduct of research, 2.0% export control, 1.0% conflict of interest, and 2.0% for other items.

Objective 2.D.4

Develop and implement post-approval compliance review programs for IRB and IACUC protocols to monitor the implementation of approved protocols, identify areas of potential improvement by researchers, and gather information for continuous improvement of ORCI processes and educational opportunities. Upon program implementation, conduct at least 16 IRB and 4 IACUC post-approval compliance reviews per year.

Baseline

This is a new initiative.

Progress

2019 Status
Substantial Progress
The IRB post-approval compliance review (PACR) program was developed in 2018, and operated at full capacity in FY19. 16 reviews were conducted in FY19. The IACUC PACR program was developed in 2019, and is currently in the initial testing phase. One IACUC PACR was conducted in FY19.

2018 Status
Substantive Progress
The IRB post-approval compliance review (PACR) program was developed in 2018, and 11 reviews were conducted. The program is now operating at full capacity.

Outcome E: Grand Valley strategically allocates its fiscal, human, and other institutional resources.

Objective 2.E.1

Each ORCI staff member will attend at least two professional educational opportunities (conferences, webinars, etc.) per year in research compliance areas supported by the ORCI.

Baseline

None. ORCI staff were hired in late 2016 and did not attend any professional educational events.

Progress

2019 Status
Substantive Progress
The Research Compliance Specialist attended an IRB conference. The Director attended an IRB workshop, an IACUC conference, and an export control conference. Both staff members attended six webinars, covering various research compliance topics.

2018 Status
Substantive Progress
The Research Compliance Specialist attended two IRB conferences and an export control conference. The Director attended 1 IRB conference, 1 export control conference, and 1 IACUC conference. Both staff members attended three webinars (two covering export controls, one covering General Data Protection Regulations).

Objective 2.E.2

Each ORCI staff member will demonstrate proficiency in human subjects research compliance and animal care and use compliance by earning both the Certified IRB Professional (CIP) and Certified Professional in IACUC Administration (CPIA) professional certifications, respectively.

Baseline

None.

Progress

2019 Status
Substantive Progress
Research Compliance Specialist has held CIP certification since 2012. Director earned the CIP certification in 2019. Both staff members plan to take the CPIA exam in 2020 or later, once having obtained the necessary number of work hours to sit for the exam.

2018 Status
Minimal Progress
New staff member hired in 2018 has held CIP certification since 2012. The other staff member is planning to take the CIP exam in 2019, having now obtained the necessary number of work hours to sit for the exam. Both staff members plan to take the CPIA exam in 2020 or later, once having obtained the necessary number of work hours to sit for the exam.

Strategic Priority Area 3: Ensure the alignment of institutional structures and functions.

Outcome E: Grand Valley strategically allocates its fiscal, human, and other institutional resources.

Objective 3.E.1

Improve average turn-around times of IRB research determinations and IRB exempt protocols by at least 50%, and IACUC Designated Member Review protocols by at least 35%, from 2016 levels.

Baseline

2016 average turnaround times – IRB Determinations: 8.40 business days (n=58) IRB Exempt Protocols: 13.54 business days (n=122) IACUC DMR protocols: 28.25 business days (n=12)

Progress

2019 Status
Substantial Progress
Average turn-around times for 2019 submissions were as follows: IRB research determinations, 1.89 business days (n=119; 75% decrease over 2018; 77.5% improvement over 2016); IRB exempt protocols, 6.74 business days (n=140; 443% decrease over 2017; 50.2% improvement over 2016); IACUC DMR protocols, 18.89 business days (n=19, 1.5% decrease from 2018; 33.1% improvement over 2016). (Note: The 2018 exempt protocol numbers were erroneously reported based on time of initial response, rather than time of final approval. Hence the large year-to-year increase in turn-around-time.)

2018 Status
Substantial Progress
Average turn-around times for 2018 submissions were as follows: IRB research determinations, 1.08 business days (n=154; 71.3% improvement over 2017; 87.1% improvement over 2016); IRB exempt protocols, 1.24 business days (n=141; 81.8% improvement over 2017; 90.8% improvement over 2016); IACUC DMR protocols, 18.60 business days (n=20, 6.4% improvement over 2017; 34.1% improvement over 2016).

Objective 3.E.2

Develop policy and procedures committees for human subjects research and animal research and review/update all policies and procedures to ensure compliance with federal, state, and local regulations.

Baseline

None.

Progress

2019 Status
Substantial Progress
The Institutional Review Board Policies and Procedures Committee (IRBPPC) met 6 times during the year and approved updates on 12 policies. The Institutional Animal Care and Use Policy and Procedure Subcommittee (IACUPPS) met 8 times and produced a completely revised and updated version of the GVSU IACUC Policy and Procedures Handbook.

2018 Status
Substantive Progress
The Human Research Review Policy and Procedure Committee (HRRPPC) met 7 times during the year and approved updates on 39 policies. The Institutional Animal Care and Use Policy and Procedure Subcommittee (IACUPPS) was established in 2018 and met 4 times. The committee is working to reorganize and update the current version of the IACUC Policy and Procedures Handbook.

Objective 3.E.3

Identify potential areas of improvement in export control oversight at GVSU and implement initiatives towards development of a robust university-wide Export Control Program in order to minimize export control-related risks to GVSU researchers and the university as a whole.

Baseline

This is a new initiative.

Progress

2019 Status
Substantive Progress
The Export Control Advisory Committee (ECAC) met two times and reassessed Export Control Program initiatives. No new initiatives were identified. Four initiatives were completed in 2019, resulting in 59% of the original program goals being completed to date.

2018 Status
Substantive Progress
The ECAC met two times and reassessed Export Control Program initiatives. One originally identified initiative was removed; no new initiatives identified. Nine initiatives were completed in previous years, and an additional 4 initiatives were completed in 2018, resulting in 48% of the original program goals being completed to date.

Strategic Priority Area 4: Enhance the institution's image and reputation.

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