Office of Research & Innovation Newsletter · Spring 2023
In this issue:
Introduction from Cassandra J. Myers, Associate Vice Provost of Research Compliance & Regulatory Affairs
General
Core Facilities
Innovation
Research Compliance
Research Development
Sponsored Programs
Did You Know?
Meetings/Opportunities
Introduction from Cassandra J. Myers, Associate Vice Provost of Research Compliance & Regulatory Affairs
Dear Colleagues,
Over the last several years we have seen unprecedented changes in the regulatory landscape and research landscape is no exception. The obligations and responsibilities are comprehensive and consist of a complex and dispersed framework. Historically we have seen individual funding agencies (e.g., NIH, NSF, CDC) and individual regulatory agencies (e.g., OHRP, FDA, USDA) propose rule changes, revise requirements, and create new policies in silos or independent from other agencies. These changes may have been inconsistent with other requirements or rules, and often only applicable to projects conducted or funded by the funding agency or limited to certain types of research.
Frequently these agency specific changes were met with frustration by the research community, institutions, and central administration offices as these requirements and rules were often not clearly articulated or failed to supply adequate guidance due to lack of resources, understanding of operational impact, and limitations placed on the agencies and their staff. In the last several years we have seen a shift in our federal agencies' responses to rule making, and they have begun to look at regulatory compliance holistically and provide prompt guidance, transparency, value-add propositions, and seek broader input and partnerships.
One driver for this shift was most certainly COVID-19 and the need to expand on regulatory text and guidance that had been in place, in some instances since the 1970’s when the FDA (Food and Drug Administration), OHRP (Office for Human Research Protection), USDA (United States Depart of Agriculture), PHS Animal Welfare Policy, among others introduced much of the basis for the current regulatory framework. For example, prior to COVID-19 being declared a national health emergency in February of 2020, the FDA had issued approximately 30 Emergency Use Authorizations (EUA’s) for earlier declarations of emergency, including H1N1, MERS, Ebola and Zika from its 2004 conception to 2020. Once HHS declared COVID-19 a public health emergency within three years, over 400 EUAs were given by the FDA, of which many have received amendments and subsequent concurrence. This increase in responses from federal agencies was also demonstrated in guidance documents, question and answer sessions, and increased transparency in what were often described as previously opaque enigmatic processes.
The FDA was not alone in developing guidance or providing notices of new policy; in October of 2020, the NIH released NOT-OD-21-013-NIH Policy for Data Sharing and Management. This release was to expand NIH’s “long championed commitment to data sharing and further reinforced NIH’s dedication to research participants and the research community”. NIH noted that their policy “must be flexible to evolve with science and technology and the need for researchers to generate, store, share, and combine data has never been greater”. The rollout by NIH of the Policy for Data Sharing and Management was unprecedented in its clarity, resources, and guidance given to the public, prior to the effective date, and hopefully is a standard for future changes across different regulatory and funding agencies, which allowed institutions and the research community to be prepared.
Following this acknowledgement for flexibility and consideration for the research community's needs comes National Security Presidential Memorandum-33 (NSPM-33). Among the regulatory changes being proposed in NSPM-33 is continuation of the holistic theme represented by establishment of an extensive institutional research security program and is not a study-by-study requirement. These newly established programs would ensure a certain level of institutional compliance. The final guidance for NSPM-33 has not yet been released, however institutions across the country have begun to explore, design, define and determine resources for this pending requirement and Drexel is no exception.
Drexel University’s strategic plan and CLARITY project aligns with the recent agencies' shift to provide operational guidance, improve transparency, and as noted in NSPM-33, strengthen and standardize processes. This will contribute to a culture of effective compliance and support Drexel University’s R-1 status. A culture of effective compliance does not mean that as an institution we are unable to accept risks, implement barriers to the conduct of research, decline collaboration with external parties, or fail to explore unique funding opportunities, but instead enhance the structure, guidance and framework to do so.
To support this work, amongst many activities, the Office of Research & Innovation has developed a “Guideline and Standard Operating Procedures” workgroup and processes to identify topics, obtain feedback, and provide useful guidance and operational tools to ensure that conduct of Drexel University’s research continues to promote delivery of impactful solutions that address the problems of tomorrow. Most recently these processes, as requested by Drexel departments and researchers, concluded with the Research Blood Draw Procedures, and the development of standardized procedure templates, workgroup structure and efficient timelines.
As we continue these processes within the Office of Research & Innovation, we will be working over the coming months on several different areas of focus, including the publication of PI Guidelines and Responsibilities, Research Security Guidelines, and Research Education requirements, among others, as requested by the Drexel University research community.
Questions? Email Cassandra Myers, Associate Vice Provost of Research Compliance & Regulatory Affairs at cjm523@drexel.edu.
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General
Welcoming New ORI Team Members
Drexel’s R-1 Carnegie Classification as a “Very High Research Activity” institution was first attained in 2018 and reaffirmed in 2022, with the University improving on the majority of classification metrics. Since 2014 our externally sponsored research expenditures have increased by more than 40 percent, and in the last fiscal year alone, our research community achieved the highest levels of sponsored research expenditures to date, representing a 9 percent increase over the prior year. Sustaining this activity requires a robust research support team and the Office of Research & Innovation is thrilled to introduce new team members who will help to support our continued growth. Many of these new colleagues are filling roles that have been vacant for some time, while a few roles have been strategically added to support growth and the new strategic plan. Please join in welcoming our new colleagues to the following teams:
Drexel Applied Innovation team:
Ravi joined the Intellectual Property & Agreements team within Drexel Applied Innovation in August 2022 and is reporting to Senior Associate Vice Provost for IP & Agreements Robert McGrath. He is working with Drexel innovators to identify new inventions, review them for commercial and intellectual property potential, market technologies, and negotiate licenses with commercial partners.
In October 2022, Tanvi became a member of the Intellectual Property & Agreements team in Drexel Applied Innovation, reporting to Senior Associate Vice Provost for IP & Agreements Robert McGrath. Tanvi’s efforts will focus on the commercialization of new inventions developed by Drexel innovators, securing intellectual property protection, communicating to potential partners, and negotiating licensing agreements.
Lillie joined Drexel Applied Innovation in January 2023 to collaborate with department heads, faculty, and personnel across the University as we strengthen our partnerships and engagements, support to the entrepreneurial community, and develop our capital initiatives.
Research Compliance & Regulatory Affairs team:
Having joined Drexel in October 2022, Cassie leads the Research Compliance and Regulatory Affairs team and oversees human research protections, animal welfare, research integrity, export controls, research security, and research conflicts of interests.
Lacee joined ORI in September 2022 and oversees the Drexel’s Research Compliance team, which manages export control, research conflicts of interest, research security, and research integrity.
John joined Drexel in September 2022 to lead the Human Research Protection Program (HRPP). This team provides guidance on the responsible conduct of human research to Drexel's IRB members, faculty, and their research assistants. HRP guidance documents and forms are critical to ensuring compliance with local, and federal regulations.
Liz joined Drexel in August 2022 to oversee the Animal Welfare team, which supports the Institutional Animal Care and Use Committee (IACUC). She oversees the research community’s IACUC protocol submission and review process, and provides training and post-approval monitoring.
Laura joined the IRB Team in September 2022, bringing nine years of compliance experience in Institutional Review Board at the University of Missouri, as well as years of experience working in accounting. Laura provides compliance expertise to assist and support investigators and the IRB.
Heidi joined the IRB Team in February 2023, bringing 10 years of compliance experience in Institutional Review Board at the University of Missouri. Heidi provides compliance expertise to assist and support investigators and the IRB.
Sherri joined the Human Research Protections team in August 2022, bringing over seven years of business-to-business management and service delivery experience for high-profile national and international accounts. Sherri provides administrative assistance for preparing and review applications, supporting data management and reporting functions.
Research Development team:
Sarah joined the Research Development team in October 2022 as Graphic Designer. She brings more than 8 years of educational media product and materials development including websites, videos, graphics, poster events, press briefs and writing copy that utilize visual literacy and hierarchy tools. Most recently, Sarah served as project manager for Drexel’s participation in the AAAS 2023 Annual meeting.
Charlie joined the Research Development team in October 2022. He is a former Senior Standards Management Analyst who conducted research, data analysis, and stakeholder interviews to inform minimum standards for B Corp Certification. Charlie has experience as a Research Assistant and Teaching Assistant in Spreadsheet Modeling for Management and Economics.
Celia is the newest member of the Research Development. She brings experience as a grant writing and project consultant for a nationwide grants firm. Celia is a Certified Fundraising Executive (CFRE). Her past roles include Assistant Director of Development and Major Gifts, and Director of Development, both in the non-profit social and educational services sectors.
Jennifer joined the Research Development team in January 2023. As an accomplished senior administrator and operations director in secondary education, she brings experience in planning and managing complex in person, virtual and hybrid events, and programs for multiple stakeholders. Prior this role, Jennifer was a secondary school English teacher.
Sponsored Programs team:
Sarah joined ORI in June 2022 to provide strategic and operational oversight of our Grants and Contracts teams. Working closely with ORI colleagues and academic/administrative stakeholders, she supports the research community in their efforts to secure, manage, and execute extramurally funded sponsored programs.
Sue joined the Office of Sponsored Programs’ Grants team in October 2022, bringing over 10 years of research administration experience in both higher education and hospital settings.
Preet joined ORI in April 2022 and provides departmental support for pre and post-award research activities as part of the RBSS unit.
Ekin joined the Sponsored Programs team in March 2023 and provides support for the administration and processing of contracts and agreements for sponsored research projects across the University. Ekin drafts, reviews, and negotiates various types of contracts, cooperative agreements, sponsored research agreements and sub-recipient agreements with private, industry, and federal partners on behalf of the University.
Finance and Administration team
Jeannine joined ORI in January 2023, bringing over 15 years of financial experience. Jeannine provides administrative aid to business and financial operations in support of the activities and functions of the Office of Research.
Facilities & Administration Cost Recovery: Explained
Did you know that, in contrast to tuition, Drexel’s F&A cost recovery is not revenue but a repayment of costs already sustained?
Every sponsored project/program has both Direct and Indirect costs. The federal government has established what costs may be charged as direct costs and what costs are considered included in indirect costs.
Direct costs are those costs that can be identified specifically with a particular sponsored project, instruction, other sponsored activity or other institutional activity relatively easily with a high degree of accuracy.
The terms “Facilities & Administrative Costs," "F&A costs" "Indirect Costs," “IDCs” and "overhead" are often used interchangeably. The F&A (Facilities & Administrative) rate agreement is set by the U.S. Department of Health & Human Services. F&A cost recovery is a reimbursement of expenditures to cover some portion of the Indirect (F&A) costs incurred as a function of completing a research award.
A comprehensive definition of Direct and Indirect (F&A) costs be found at the U.S. Government Publishing Office website, Uniform Administrative Requirements, Cost Principles and Audit Requirements for Federal Awards issued by the Office of Management and Budget (Uniform Guidance).
Questions? Email researchdevelopment@drexel.edu.
Drexel's new Community-Engaged Research Working Group
Under President Fry’s leadership, Drexel has become one of the most civically engaged universities in the nation. Over the past 10 years, our educational and research activities that engage communities have expanded and have helped to differentiate Drexel and the impact of our educational and research missions. As with many urban universities, Drexel has a long and complicated history with the adjacent community, rooted in past and current experiences of displacement, high research burden, and low perceived benefit of research to the community. This results in mistrust and trauma in the community, including perceptions that Drexel does not invest its vast resources in building the capacity of the community to assess and address its own health, economic, safety, employment, housing, and other needs. To maximize the positive impacts and minimize the negative impacts of research activities in communities, it is imperative for the University to establish a strong foundation of policies, procedures, and trainings.
To this end, we have established a new Community-Engaged Research Working Group that will make recommendations for new research-related policies and protocols to the Provost’s office. The working group is led by Dr. Amy Carroll-Scott (associate professor and chair, Department of Community Health & Prevention, Dornsife School of Public Health) and has representation from all academic units, the Faculty Senate, and the Anti-Racism Task Force. This working group will report recommendations and an implementation plan to the Office of the Provost, specifically the Office of Research & Innovation, the Vice Provost of Diversity, Equity and Inclusion, and University and Community Partnerships. If you would like to become involved, please contact Dr. Carroll-Scott at ac3343@drexel.edu.
Drexel Students, Research Community Made Their Mark on 2023 AAAS Annual Meeting
Drexel University sponsored the American Association for the Advancement of Science’s annual meeting for the first time, and students took home 44 percent of the poster competition awards.
Learn More
Check out the opportunities to participate in the 2024 AAAS Annual Meeting.
Proposals are now being accepted for Scientific Sessions, Workshops, and Lightning Talks.
Share your work and submit a proposal by May 4, 2023.
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Core Facilities
Materials Characterization Core – NSF Instrument Awards
In July 2022, we took delivery of a new state-of-the-art scanning electron microscope (SEM) that is now installed in the Materials Characterization Core (MCC). The $850K SEM was acquired 
through a successful NSF Major Research Instrument proposal led by Prof. Christopher Li (MSE) along with co-investigators Lin Han (Biomed), Craig Johnson (ORI/MCC), Vibha Kalra (CBE) and Marina Potapova (BEES/ANS). Unique features of the SEM will enable in situ experiments where samples are imaged while also being heated, cooled, deformed, or electrically biased. The instrument will advance research in many disciplines across the University ranging from materials development for next-generation batteries to the study of rare samples from the historic collections of the Academy of Natural Sciences. The new instrument is being brought online presently under the leadership of Dr. Kate Vanderburgh (MCC).
In February, the MCC received a new high-solution 3D X-ray tomography microscope (also known as the nanoCT). This instrument, also acquired through an NSF Major Research Instrument, is the result of a $1.7M proposal led by Prof. Antonios Kontsos (MEM) 
along with co-investigators Antonios Zavaliangos (MSE), Kara Spiller (Biomed), Jocelyn Sessa (BEES/ANS), and Craig Johnson (ORI/MCC). The nanoCT works like a CAT scan machine used for medical imaging in that it takes X-ray images of a sample from many different angles and combines those images into a 3D image of the internal structure of the sample. However, the nanoCT has orders of magnitude higher resolution than a typical CAT scan device and is used to look at nanoscale features in smaller volumes (and non-living materials). Like the SEM, the nanoCT will support a broad spectrum of research relying on accurate 3D characterization novel additive manufactured materials critical for aerospace, automotive, defense and medical applications, cell structures and tissues used in immune system, tissue repair and bioengineering research, pharmaceutical materials, materials for energy applications including novel batteries and energy storage devices, and natural materials and organisms used in climate and earth sciences research. The instrument will be one of only a small number of similarly powerful systems across the country and raise the profile of Drexel and the MCC as a regional resource for advanced instrumentation. The NanoCT will also be managed by Dr. Kate Vanderburgh and will become available for more general use in the coming months.
Visit the MCC Website
Questions? Email Craig Johnson, Operations Director, Research Core Facilities Office of Research & Innovation and Director of Operations, TEM & FIBSEM Manager, Materials Characterization Core (MCC) at clj46@drexel.edu.
Changes in the Cell Imaging Center
Catherine von Reyn, Assistant Professor in Drexel’s School of Biomed Biomedical Engineering, Science and Health Systems has graciously accepted the invitation to Chair the Cell Imaging Center (CIC) Faculty Advisory Committee, which was convened last year to provide shared governance and strategic guidance for the CIC. Catherine’s group uses optical microscopy along with a range of other techniques to understand how neural circuits function and to develop genetic strategies for re-engineering circuits in neurodegenerative and neurophysiological disorders. We are excited to work with Catherine and the Advisory Committee to continue to grow our shared optical microscopy capabilities at Drexel.
Catherine succeeds Elias Spiliotis, Professor of Biology and Faculty Director of the Cell Imaging Center, who has accepted a position at the University of Virginia. In 2009, Elias started the CIC with instruments from his own start up package and since then he has provided guidance and leadership for the facility. In addition to this administrative support, Elias has led multiple grants to acquire new instrumentation in the CIC including the recently commissioned Leica Stellaris 5 Confocal Microscope funded through contributions from Elias, Kari Lenhart and the ORI. We are grateful to Elias for contributions and service to the CIC through the years and wish him the best in his new endeavors.
Harini Sreenivassapa, CIC Director of Core Operations, will continue to provide training and expertise on CIC instruments and day-to-day management of the core.
Questions? Email Craig Johnson, Operations Director, Research Core Facilities Office of Research & Innovation and Director of Operations, TEM & FIBSEM Manager, Materials Characterization Core (MCC) at clj46@drexel.edu.
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Innovation
Drexel Joining NSF's Innovation Network Regional Hub Led by Princeton
Drexel University has been tapped to join the National Science Foundation’s I-Corps, a network of universities focused on nurturing researchers as they translate their innovative work for commercial viability. As a partner institution of the I-Corps Hub Northeast Region led by Princeton University, Drexel will share its deep expertise in experiential learning and entrepreneurial training with faculty, staff, and students throughout the region.
As a member of the I-Corps, Drexel will receive $600,000 over four years to provide experiential training focused on entrepreneurship to participating teams, including faculty, staff, and graduate students working in science and engineering fields.
Learn more
Current or prior NSF funding is not required to participate in I-Corps.
Drexel faculty, staff and graduate students can learn more about the program at https://icorpsnortheasthub.org/.
Questions? Contact Caroline Schauer, Interim Associate Vice Provost for Faculty Advancement at cls52@drexel.edu or Shintaro Kaido, Vice Provost for Innovation & Executive Director, Drexel Applied Innovation at sk3434@drexel.edu.
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Research Compliance
Research Security - Community Input Requested
NSPM-33 (National Security Presidential Memorandum 33) provides for a National Security Strategy for U.S. Government supported research and development. The Office of Science and Technology Policy (OSTP) invites comment from any interested stakeholders. In particular, OSTP is interested in input from research organizations that will be subject to the Research Security Program requirement, researchers within those organizations, professional organizations representing those organizations, and organizations representing diverse interests across the U.S. research ecosystem.
If you are a researcher or stakeholder interested in participating, the ORI Research Compliance team is sharing a short questionnaire to collect feedback from the research community and prepare comments for Drexel University. The survey will be open through Monday, May 8th.
Questions? Email Lacee Harris, Executive Director of Research Compliance at lh976@drexel.edu.
USDA Inspection Results in a Clean Report
On April 6, 2023, the Drexel University Animal Facilities received an unannounced inspection by the US Department of Agriculture as required by the Animal Welfare Act. The veterinary inspector visited rooms where animals are housed, research laboratories, support rooms, and reviewed IACUC records. The inspection resulted in a clean report with no violations to the Act. The inspector verbally congratulated the team for a great program. Thanks to the researchers and their staff, the IACUC, and the ULAR team for maintaining a program which provides excellent care for the animals vital to Drexel's research program.
Questions? Email Rick Huneke, Executive Director, University Laboratory Animal Resources at rbh25@drexel.edu.
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Research Development
Searching for Project and Programmatic Funding?
Access and explore our funding search tools:
For access and the best user experience, sign in with your Drexel credentials and use Drexel VPN when not on campus.
Questions? Email researchdevelopment@drexel.edu.
ARPA-H Meeting
On April 12, the Office of Research & Innovation hosted the leadership team from the Advanced Research Projects Agency for Health (ARPA-H). A group of Drexel researchers and ORI leadership met with the visitors to gain insights, understand ARPA-H’s vision and mission, and discuss how we might work together to bring about transformational change in ARPA-H’s four areas of focus:
- Health Science Futures
- Scalable Solutions
- Proactive Health
- Resilient Systems
The mission of this new federal agency is to accelerate better health outcomes for everyone. In the words of President Biden, “ARPA-H will pursue ideas that break the mold on how we normally support fundamental research and commercial products in this country.”
In the coming weeks and months, the Office of Research and Innovation will endeavor to maximize our engagement with this bold federal investment in transformational change to improve the health of the nation. Find more information about ARPA-H here. Current opportunities include opportunities for researchers to serve as Program Managers and for researchers to respond to the Open Broad Agency Announcement (BAA).
Questions? Email researchdevelopment@drexel.edu.
Call for Proposals in Select Areas of Excellence & Opportunity
Pilot Areas Included:
Advanced Materials & Manufacturing
Computing, AI & Cyber Security Frontiers
Register for Convening Event by May 4, 2023
Proposals Due June 9, 2023
The Office of Research & Innovation will provide resources to support innovative and strategic collaborations in two of Drexel’s Areas of Excellence & Opportunity (AEOs): Advanced Materials & Manufacturing and Computing, AI & Cyber Security Frontiers. These resources will enable two to three teams of faculty and students to spend a year engaged in interdisciplinary research that aligns with the AEOs. All faculty and staff whose research interests align with these areas are encouraged to attend the convening event on May 9 to share their project ideas, learn about other projects and potential network with potential collaborators.
An initiative of Drexel’s 2030 Strategic Plan led by the Office of the Provost, Drexel’s Areas of Excellence and Opportunity represent high-impact areas in which the University can leverage current strengths while generating new opportunities for transdisciplinary education, scholarship and external partnership.
Goals of this Funding Initiative
- Identify 2-3 scholarly areas within the two AEOs mentioned above where Drexel can take a leadership position nationally and internationally.
- Stimulate the formation of new, effective, innovative and diverse multidisciplinary research teams that engage students.
- Facilitate the submission of large, multidisciplinary proposals to governmental agencies, private industry, foundations/nonprofits, and/or philanthropic sponsors.
- Align with the imperatives of the University’s Strategic Plan: Drexel 2030 Designing the Future and the Areas of Excellence & Opportunity initiative.
- Cultivate inclusive excellence and equity at Drexel.
Read the full announcement
Questions? Email fundingportal@drexel.edu.
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Sponsored Programs
Changes to Award Set-up Process
In an effort to apply best practices in research administration, there will be a few changes to award set-ups moving forward. Once the Office of Sponsored Programs receives a notice of award, a member of the team will be reviewing the financial conflict of interest (FCOI) forms submitted at the proposal stage. OSP will confirm with the PI and department if any FCOIs have changed. A new FCOI form may be requested. In addition, any necessary FCOI 2 and/or export control reviews will be conducted prior to any fund number creation. This includes advanced fund accounts as well. This change will assist Drexel to maintain compliance with federal and sponsor regulations.
Questions? Email Sarah Saxton, Executive Director, Sponsored Programs at sms559@drexel.edu.
Paying Research Study Participants? Try QuickPay!
J.P. Morgan Corporate Quick Pay is an electronic payment platform that pays research study participants by using their email address or mobile phone number. Secure electronic payments are sent by J.P. Morgan to research study participants. Any Drexel PI can request access to utilize Corporate Quick Pay to pay their research study participants. (Participants need to have a bank account and be a U.S. Citizen.)
JP Morgan Quick Pay steps for PI and Department [PDF]
JP Morgan Chase Corp Quick Pay SOP [DOC]
Questions about using Quick Pay? Email Jennifer Reed-Hack, Assistant Director of Finance at jr375@drexel.edu.
Revising the NIH/AHRQ/NIOSH Post-Submission Material Policy
For applications submitted for the May 25, 2023 receipt date and beyond, NIH, AHRQ, and NIOSH will accept a one-page update with preliminary data as post-submission material for Type 1 R01, R21, or R03 applications, including resubmissions, if the notice of funding opportunity (NOFO) used for submission allows preliminary data in the application.
The deadline for submitting all post-submission materials, including preliminary data, will be 30 days before the study section meeting, unless specified otherwise in the NOFO.
Refer to NOT-OD-19-083 for a list of acceptable post-submissions materials and instructions on submission.
For additional information, please see NOT-OD-23-106.
Questions? Email Sarah Saxton, Executive Director, Sponsored Programs at sms559@drexel.edu.
University Sponsored Programs Council Forming
In Summer 2023 the University Sponsored Programs Council (USPC) will be launching. In an effort to improve research administration across the institution, the USPC will be charged with reviewing sponsored programs policies, procedures, and guidelines as well as develop better ways in engaging the research community. This Council is part of ORI's Clarity Project initiative to provide better communication, transparent processes, and develop training on campus. More information will be forthcoming.
Questions? Email Sarah Saxton, Executive Director, Sponsored Programs at sms559@drexel.edu.
New Resource Available: Navigating the NIH
The Center for Scientific Review (CSR) has created a helpful guide to clearly share the steps for NIH grant application submissions.
The resource includes the following useful information for investigators and institutions:
- Early Stage Investigator (ESI) materials
- Tips for Scientists
- NIH Submission Policies
- Support and contact information
- Additional resources for Organization Administrated Offices and scientists
View the infographic on the NIH website
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Did You Know?
Did You Know?: Human Subjects Study Closures
When should an investigator report a study closure to the IRB?
Study closures should be reported to the IRB via a final report in COEUS when the human subjects research, including research that has received an exempt determination, is permanently closed to enrollment, all subjects have completed all protocol related interventions and interactions, and the collection and analysis of private identifiable information is complete.
Reporting that a study has been completed is best practice for several reasons:
- Permits the institution and Drexel University’s HRPP to maintain accurate metrics, appropriately respond to monitoring or audit inquiries or accounting requests relevant to its human subject research portfolio,
- Provides a start date on the record retention timeline required by the FDA, OHRP, HIPAA, and Drexel University’s records retention policy (OGC-4 Records Retention Policy) and records retention schedule [PDF],
- Allows the institution to properly manage and transfer IRB oversight to another IRB when necessary.
The Office for Human Research Protection (OHRP) and the Food and Drug Administration (FDA) require IRBs to function under written procedures. These procedures include keeping the IRB informed of study completion and close out to ensure record retention in compliance with 45 CFR 46.115(b) and/or 21 CFR 56.115(b). Additionally, per the FDA [21 CFR 56.108(a)(3)] procedures require ensuring "prompt reporting to the IRB of changes in a research activity." The completion of the study is a change in activity and should be reported to the IRB and the information provided may be used in the evaluation and approval of related studies.
If Drexel investigators are relying on an external IRB, that IRB is responsible for indicating when the site’s IRB approval status has changed. The reliance agreement will typically require the reviewing IRB to inform our site/investigator when changes in the status of our site approval occur, and closing the study with the IRB is a change that is reported. When correspondence from the reviewing IRB has been received indicating the Drexel site has been closed and no longer carries approval by the reviewing IRB, the closure should be submitted via COEUS so that the project’s record may be closed with the Drexel IRB.
The process for submitting a final report is the same as submitting for a continuing review. Reference the COEUS Lite-How to Submit Continuing Reviews (Renewals) [PDF] document for a step-by-step guide with screenshots.
Questions? Email John Roberts, Executive Director, Human Research Protection Program at jtr77@drexel.edu.
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Meetings/Opportunities
33rd Annual St. Chris Research Day
Join in for Research Day at St. Christopher's! The event will begin at 8 a.m. with platform presentations during Grand Rounds followed by a Q&A session.
SCHEDULE OF EVENTS
7 a.m – 2 p.m. Poster viewing
St. Christopher’s, Lower Atrium
8 – 9 a.m. Grand Rounds Presentation
St. Christopher’s, Angelo DiGeorge Auditorium
Noon – 1 p.m. Author Attendance
St. Christopher’s, Lower Atrium
We encourage the PI and mentor to attend this session
All investigators who submit an abstract are invited to display a poster of the research in the Lower Atrium on Research Day.
Poster boards: Available on Thursday, May 18th at 3 p.m.
CALL FOR ABSTRACTS
We encourage faculty, trainees, students, nurses, and staff from Tower Health and Drexel University to submit new or ongoing research including basic science and clinical research, case reports, medical education, and quality improvement.
All projects require documentation of IRB review.
SUBMISSION DEADLINE: SUNDAY, APRIL 30
Abstracts can be submitted through the 2023 St. Chris Research Day website. Researchers will be required to complete a Research Day agreement form at the time of submission.
PLATFORM PRESENTATION
Selections for platform presentations will be decided after the April 30th deadline submission. You will be contacted if you have been selected to present at the 8 – 9 a.m. Platform Presentations at Grand Rounds. Further instructions will be provided the week before the event.
REVIEWERS AND JUDGES NEEDED
Reviewers and judges are needed for all categories. Please contact Hans Kersten, MD at hk39@drexel.edu if you are interested.
Spring 2023 NSF Virtual Grants Conference – Save the Date
Save the Date! Join the National Science Foundation (NSF) for the Spring 2023 NSF Virtual Grants Conference, to be held during the week of June 5 – 8, 2023.
Registration will be free of charge and opens on Wednesday, May 10 at 12 pm EST. In the meantime, check nsfpolicyoutreach.com for the most up-to-date information and view recordings of sessions from previous conferences. The Fall 2022 Virtual Grants Conference recordings can also be found on the NSF YouTube page.
Questions? Email grants_conference@nsf.gov.
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