To: Dean De Rosa

From: Colin Parrish, Chair

Date: June 18 2023

Subject: IBC Annual Report

Executive Summary

The IBC reviews and approves research activities at Cornell University involving the use of r/sNA and biohazardous materials in research. The IBC manages 312 research labs comprising 2282 research personnel with containment practices ranging from BSL1 to BSL3. The IBC continues to see increased activities in higher risk BSL3/ABSL3, increased studies in the interactions between plants and plant pests, and increased projects involving the use of CRISPR Cas9 in diverse organisms. IBC member recruitment continues to be a challenge in finding qualified PIs to join the committee in the areas of research the committee covers.

In addition, discussions and recommendations at the Federal level, that would expand the definition of Dual Use Research of Concern (DURC) and Potential Pandemic Pathogen Care and Oversight (P3CO), will lead to an increase in the number of qualifying agents in Cornell’s research portfolio and add further requirements to the review and approval of work with these agents. Overall, the number of requests to the IBC for review are stabilizing after a long period of increased requests but there has been an increase in the number of requests to review more complicated and higher safety level research.

1. Charge to the IBC

Cornell University’s Institutional Biosafety Committee (IBC) is responsible for reviewing University research activities that are conducted by faculty, staff, students, or visiting scientists at, or under the auspices of, Cornell University’s Ithaca campuses (Ithaca, Geneva), and that involve the use of recombinant or synthetically derived nucleic acid molecules (r/sNA) or other biohazardous materials (regulated human, animal and plant pathogens, and biological toxins). The review process is initiated by submission of a Memorandum of Understanding and Agreement (MUA) to the IBC. The purpose of these reviews is to ensure that all activities involving r/sNA or other biohazardous materials, and the facilities used to conduct such work, comply with all applicable external regulations and University policies. The IBC’s objective is also to ensure that such activities meet standards of good biological safety practice emphasizing protection of personnel, the public, and the environment. The IBC assists researchers in meeting their responsibilities, imposes requirements, and reviews and approves policies, procedures, programs, and facilities pursuant to the safe use of r/sNA or other biological materials. For a copy of the Charge to the IBC, please see:  https://researchservices.cornell.edu/sites/default/files/2020-05/IBC_Charge.pdf

2. Committee Membership

The committee is currently Chaired by Professor Colin Parrish. Appendix A provides the membership list as of June 30, 2024. Finding new members who are knowledgeable in the different areas of the IBC’s oversight is a continuing challenge, and we often lack members from some large departments that send us many applications to review. Over the course of the year, the following membership changes occurred:

• Jeffrey Pleiss Associate Professor, Molecular Biology and Genetics, has stepped off the committee after his term was completed.
• Xiaohong Wang, Professor Courtesy, Plant Pathology and Plant Microbe Biology, has stepped off the committee after her term was completed.

3. Active Projects

The IBC reviews and approves the following categories of projects (detailed explanations of these classifications are provided in Appendix B):

1. Projects with r/sNA Use:
   • Exempt from the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines)NIH Guidelines (Section F)
   • Non- Exempt, subject to NIH Guidelines (classified as Section D or Section E)
2. Projects with Biohazardous Materials
   • Infectious/pathogenic agents classified in the following categories: Risk Group 2, 3, and 4 bacterial, fungal, parasitic, viral, rickettsial or chlamydial agents as defined by the National Institutes of Health (NIH) or,
   • Other agents that have the potential for causing disease in healthy individuals, animals, or plants, or
   • Toxins of biological origin, which include metabolites of living organisms and materials, rendered toxic by the metabolic activities of microorganisms (living or dead).
3. Active Projects Registered with the IBC:

As of June 30, 2024, there were 312 active MUAs: 303 MUAs at BSL1 or BSL2 and 9 MUAs at BSL3.

4. Initiatives Supported by the IBC

• Increase in complexity and urgency of reviews. The continued increase in submissions in response to expanded use of recombinant nucleic acid technologies has shifted to more complex and often more urgent requests for review. With the post-COVID increase in infectious disease investigation, Cornell researchers often take a lead in responding to outbreaks in real time – the most recent example being the high pathogenicity avian influenza viruses (HPAI) in cows, where Cornell researchers have taken important leading roles in the responses. This means that new host animals, infectious agents and processes that need to be evaluated both diligently and responsively are added to our portfolio, so incoming samples can be evaluated for treatment, modes of transmission, risk, and potential vaccine development. Since the beginning of the COVID pandemic, we have developed processes that help us respond quickly, but all PIs benefit as it includes IBC’s larger goal of actively helping PIs with their MUAs, providing thorough review, and working actively with IACUC and Environment, Health and Safety’s Biosafety and Biosecurity (EHS Biosafety) to get in front of PIs’ needs – more effectively maintaining full compliance with funders and regulatory-stake holders.

5. Initiatives Managed or Supported by ORIA for the IBC

• New software system for IBC application management. ORIA and RAIS leadership and the IBC staff are currently working with Novelution to develop a new system to replace the current eMUA system.  The IBC software system will be integrated into the Research Administration Support System (RASS) streamlining processes for faculty members. By consolidating various modules, including IRB, COI, and OSP, RASS enables a better user experience and facilitates data connections related to PI research activities. Additionally, there will be significant enhancements to the IBC committee reviewer experience and administration capabilities. Work is currently underway to develop a new IBC form, migrate existing data, and prepare for launching the new system in the Fall of 2024.  Previously, Cornell had been working with Cayuse to develop a new system but in December of 2023, we came to the conclusion that the company would not be able to deliver a functional product, so a decision was made to switch vendors in favor of Novelution.
• Response to new proposed research regulations. In the Fall of 2023, Cornell University was approached by the Council of Government relations (COGR) to assist with developing a response to new proposed updates to the NIH Guidelines for r/sNA and the United States Government Policy on Dual Use Research of Concern (DURC) and research involving enhanced Potential Pandemic Pathogen Care and Oversight (P₃CO). The IBC staff worked with the IBC committee to develop comments which were shared with COGR resulting in a responses issued from COGR to the NIH Guidelines for r/sNA and DURC/P3CO respectively.
• Updates to the NIH Guidelines for r/sNA (2024). In April of 2024, new NIH Guidelines for r/sNA were published by the NIH Office of Science Policy. These guidelines went into effect immediately. Additions to the guidelines include new requirements for the review and approval of research involving the use of Gene Drive technology in living organisms (plants, animals, and certain single cell eukaryotes). The IBC staff has worked to notify the committee of the changes, update guidance documents, websites, and other tasks to bring the IBC up to the date with the newly issued guidelines. Currently, Cornell does not support any work with Gene Drive modified organisms, however we would be able to support research projects under BL2 containment conditions within current facilities. The IBC would need to identify and either appoint, as a member of the committee, or consult with an expert in environmental ecosystems for the Ithaca and Geneva area.
• Updates to the US Government’s policy on DURC/PEPP. In May of 2024, the Office of Science, Technology, and Policy released an updated policy covering research activities that fall within the definition of Dual Use Research of Concern (DURC) and Pathogens with Enhanced Pandemic Potential (PEPP). This policy establishes a framework for how funding agencies, institutions, and PIs are to award funding, review, and regulate research that fall within DURC and PEPP. The policy charges funding agencies to modify their grant applications to identify work subject to the DURC/PEPP policy and after merit review, require institutions and PIs to review of these applications and complete a risk to benefit analysis, a risk assessment, and provide a communications plan (identify restrictions in information that can be published). These three documents will then be delivered to the funding agency for approval before funding for the project will be awarded. In order to accomplish this, multiple Cornell affected parties (Office of Sponsored Programs, Environment, Health and Safety, Office of Research Integrity and Assurance, the Institutional Biosafety Committee, and several others) will need to put into place a committee to review this work (referred to as an Institutional Review Entity [IRE]) and meet several other requirements as detailed in the DURC/PEPP policy and the DURC/ PEPP implementation guide. Funding agencies have until May of 2025 to update and develop policies to comply with this new policy. Cornell University has several current research projects that will be subject to these new regulations. The various interested parties affected by this policy are currently meeting to determine what resources will be needed for Cornell research to comply with this policy and will be developing new procedures within the next calendar year to respond effectively and efficiently. Because of the technical knowledge about molecular biology and pathogen biology we believe that review would likely be highly complementary to the IBC committee, but requiring additional reviews and procedures.

6. Initiatives managed or supported by EHS Biosafety for the IBC

The EHS Biosafety team provided BSL-2 training to 431 individuals and blood-borne pathogen training to 648. In collaboration with the IBC team, the EHS Biosafety team also completed onboarding 14 new researchers and their labs. Onboarding the lab includes meeting with the PI before arrival, laboratory design, protocol consultation, and the startup lab safety assessment. In the same period, we decommissioned 10 laboratories, primarily due to faculty retirements.

During the past year, the biosafety team performed 185 general laboratory safety assessments. These assessments are an opportunity for biosafety specialists and research labs to engage, allowing both parties to stay informed about science and safety. Chemical safety, particularly the labeling of chemicals and chemical waste, remains a challenge in laboratories. We continue to work with laboratories to ensure the proper use of personal protective equipment.

The USDA and CDC visited us for several permit inspections. The biosafety team met with researchers in advance of announced inspections to prepare lab staff. None of the routine inspections resulted in any reported findings. Additionally, 2023 was the renewal year for Cornell University’s Select Agents’ Program registration with the Federal government. All the offices and teams that support this research collaborated to host our combined Federal Select Agent Program inspectors, completing the inspection successfully.

In the coming year, we will continue to work closely with our researchers to enhance our safety culture at Cornell. We will transition to a more modern, nimble laboratory safety assessment tool, EHS Assistant, and look forward to implementing the new learning management system in Workday Learning.

7. MUA (Project) review and activities

During the reporting year June 1, 2023 – June 30, 2024, the IBC held 11 duly convened meetings to review new MUAs, amendments to approved MUAs, and applications for renewal of approved MUAs.

• Review of Exempt Projects: The Chair of the IBC, another designee, or the Biosafety Officer reviews and confirms the classification of projects that are exempt from the NIH Guidelines, and approves the submission. If there are questions raised, additional review is carried out by those participants. Those are reported to the IBC at a subsequent meeting, but do not need ongoing oversight.
• Review of Non-Exempt MUAs and MUAs with Biohazards: These projects are assigned for review to a subcommittee of at least three members, one of whom prepares a summary of the project. The projects are then discussed by the full committee at a convened meeting, which issues the formal approval. Approvals are granted for a period of three years, although continued approvals are contingent upon the successful completion of annual reviews and amendments.
• Review of Biosafety Level 3 (BSL3) Applications:  BSL3 Applications are reviewed by the BSL3 Review Committee (BRC), which is composed of the Biosafety Officer and Biosafety team members, CVM Director of Biocontainment Operations, Occupational Medicine Physician, and at least two IBC members. The BRC makes recommendations to the Principal Investigator (PI) for improving the application and outlines the required training and other requirements before the project can be approved. Based on these findings, appropriate classroom and facility on-site training is delivered. An Occupational Medicine evaluation is conducted, and a corresponding exposure control plan is put into place. The IBC reviews all the recommendations and actions undertaken to address those recommendations and determines if the project can be approved for BSL3 work. Three review pathways exist that evaluate proposed work based on risk. All new BSL3 applications are reviewed by the BRC and discussed and approved at an IBC committee meeting. To add flexibility, two additional review pathways were added, including a process which permits the BRC to review and approve amendments with minor changes to BSL3 work, and a Biosafety Officer (BSO) review pathway to review and approve administrative changes to BSL3 work. A detailed policy and procedure was developed to define the process and characterize what kinds of research can qualify for each review pathway.
• Agents or Toxins Falling under Select Agent Regulations: Some agents or toxins fall under the oversight of the Federal Select Agent or Toxin control programs. In these cases the IBC reviews those in the usual away to ensure that those meet the criteria for the appropriate level of containment (or for toxins that amounts in use fall below the levels at which Federal oversight is required). The Biosafety Officer, who is the university’s Select Agent Program Responsible Official assists investigators in obtaining approval from the Federal Select Agent programs, and the IBC coordinates to ensure that all approvals are in place before the experiments are initiated.
• Annual Questionnaires and MUA amendments:  Review is by the Chair of the IBC, designated committee member, or Biosafety Officer, and the IBC administrators. Amendments with only personnel changes are approved administratively. Amendments that add a new scope of research or work requiring a more thorough review are reviewed at a regularly scheduled full committee meeting.

A total of 435 MUAs or continuation requests (amendments and annual questionnaires) were reviewed during the 2021-22 cycle. A breakdown of projects submitted for review during the same periods in 2020-2021 and 2021-2022 is on the following page:

8. Adverse Events

Two adverse events  occurred in the reporting period involving the use of r/sNA materials. The events were reported to the NIH Office of Science Policy in accordance with the NIH Guidelines for r/sNA. All reports were accepted by the NIH with no further information requested. Further details about the incidents can be found below.

 Adverse Events Reported to the NIH-Office of Science Policy (OSP):

1. On May 20, 2024, a postdoctoral researcher was bit by a transgenic mouse in a laboratory procedure space. Samples were being taken by the researcher to genotype recombinant mice The researcher described scuffing the mouse, but they did not have a firm grasp and the mouse managed to wiggle free and bite the researcher, breaking the glove and the researcher’s skin on their left index finger. Shortly afterwards, the researcher’s finger began to swell. The researcher stated that they do have documented allergies to mice. The researcher treated themselves for the bite, re-gloved, and continued with genotyping. They later treated themselves for the allergic reaction and declined further medical treatment. The incident was reported the same day.

The Biosafety Officer responded to the report to gather preliminary information and ensure the postdoctoral researcher had contact information for local medical providers. No further treatment was sought, and the researcher recovered.

The procedure used by the lab to produce the transgenic mice uses CRISPR/Cas9, with Cas9 mRNA and guide RNA injected into the mouse testes to insert HA-MYC into the Mus81 allele. A bite from a mouse transformed in this manner, with this insert, poses a very minor health risk to the human.

The research is described in the relevant IBC and IACUC protocols. The researcher is listed appropriately in both protocols. A review of training records found that the researcher is trained for ABSL-2 mouse handling and has been trained by a more senior member in the lab for the procedure. The researcher was wearing the prescribed PPE for this procedure – gloves and a lab coat.

This particular researcher is experienced in handling mice, and the technique is not new to them or the lab. The incident was reviewed between the Biosafety Officer and the researcher. The root cause was determined to be that the mouse managed to maneuver itself free of the researcher’s grasp. The solution is for the researcher to potentially move more deliberately and if they sense they are losing grasp, reposition the animal.

The NIH accepted the report and recommended that we remind all research staff that they should consult with or be evaluated by a medical care provider as soon as possible after an exposure incident in case treatment is warranted.

2. On August 10, 2023, during a routine monthly assessment, a biosafety cabinet in a BSL-3 facility was found to have a non-functional blower. An email was circulated to all users on August 10 with a description of the issue with the biosafety cabinet, seeking information about anyone who may have worked in the cabinet the day before. One postdoctoral researcher (Postdoc A) identified that they could not recall whether the blower was functional when working in the cabinet on August 9.

CVM Biocontainment Operations staff identified that the last date the cabinet blower was known to be working was July 27, 2023. With the PI’s assistance, additional tracing continued to ensure all BSC users were identified who had used the cabinet between July 27 and August 10. Two additional postdoctoral researchers (Postdoc B, Postdoc C) were identified as unsure that the cabinet blower was functional when they were working in the cabinet.

Postdoc A and Postdoc B both had worked with a non-replication competent HIV strain, NL4-3 envFS eGFP Δvpu/env. Postdoc C had worked with a recombinant Mycobacterium tuberculosis Erdman strain carrying a fluorescent marker.

All researchers wore standard personal protective equipment for work with these agents in this BSL-3. Personnel conducting work with these agents wear facility-specific scrubs, socks, wrap-around impervious gowns, two pairs of gloves, an N-95 respirator, and safety glasses. While there were no overt exposure events, the postdocs were given advice about the risks and advised to seek medical counseling, particularly if they were concerned. All Tuberculosis researchers in this facility are enrolled in a medical surveillance program that provides tuberculosis testing biannually. Though there is annual counseling on the risks for HIV, there is no medical surveillance for HIV.

The cabinet is a Type II A2 biosafety cabinet with a thimble connection. Smoke testing conducted on the morning of August 11th revealed that the cabinet was drawing air even with the blower turned off, through the thimble connection. The containment efficiency may have been compromised compared to when the cabinet blower is operational, but this mitigates some exposure concerns. The cabinet is relatively new, having been installed in July. Cornell has reached out to the cabinet servicer and certifier, who promptly investigated the issue and identified a loose wire, which was installed by the manufacturer and caused the blower failure. We also contacted the manufacturer to express our concerns regarding this apparent malfunction in a recently purchased and installed cabinet.

The NIH reviewed the report and had no further questions.

9. Appendix A: Current Committee Membership

Voting Members

Colin Parrish Ph.D. (Chair) – Professor, James A Baker Institute for Animal Health, Microbiology & Immunology

Georg Jander Ph.D. – Adjunct Professor, Plant Biology Section

Christy Michaels MS – Biology Teacher, Community Member, Non-affiliated

Cathy Moseley Moore MS – Enrichment Teacher, Community Member, Non-affiliated

Bryan Swingle Ph.D. – Asst. Professor, Plant Pathology & Plant-Microbe Biology Section

Luis Schang Ph.D. – Professor, James A Baker Institute for Animal Health, Microbiology & Immunology

Ping Wang Ph.D. – Professor, Entomology

Laura Goodman Ph.D. – Asst. Research Professor, Department of Public & Ecosystem Health

Ex-Officio, Voting Members       

Joshua Turse Ph.D. – Biological Safety Officer, Environment, Health and Safety

Paul Jennette MS – Biosafety Engineer, CVM Biosafety Program

Beth Bennett DVM – Clinical Veterinarian, CARE

Ed Koppel MD – Occupational Medicine, Cornell Health Services

Ex-Officio, Alternate Voting Members  

Julie Conyer – Associate Biosafety Officer, Environment, Health and Safety

Bryant Blank DVM – Clinical Veterinarian, CARE

Richard Gaisser – Biosafety Specialist, Environment, Health and Safety

Brendan Chandler MS – Biosafety Specialist, Environment, Health and Safety

Lisa Cope RN – Nurse Practitioner, Occupational Medicine Nurse

Ex-Officio, Non-Voting Members            

Rhoda Maurer MS – Manager, Tower Road Greenhouses, CALS

Krystyn Van Vliet Ph.D. – Vice President for Research and Innovation – Institutional Official

Eve DeRosa Ph.D. – Dean of Faculty

Christine Bellezza DVM – Director of Research Assurance

Administrative Support Staff

Michael Betteken Ph.D. – Senior IBC Administrator

Amy Wells – IBC Administrator

Kelsy Earl – IACUC/IBC Compliance Assistant

10. Appendix B: Classification definitions from the NIH Guidelines

Exempt Experiments

Section III-F.

Recombinant or synthetic nucleic acid molecules described in Section III-F are exempt from the NIH Guidelines but registration with the Institutional Biosafety Committee is still required to ensure that they are correctly classified.

Non-Exempt Experiments

Section III-E. Experiments that Require Institutional Biosafety Committee Notice Simultaneous with Initiation 

Experiments not included in Sections III-A, III-B, III-C, III-D, III-F, and their subsections are considered in Section III-E. All such experiments may be conducted at BL1 containment. For experiments in this category, a registration document shall be dated and signed by the investigator and filed with the local Institutional Biosafety Committee at the time the experiment is initiated. The Institutional Biosafety Committee reviews and approves all such proposals, but the Institutional Biosafety Committee review and approval prior to initiation of the experiment is not required (see Section IV-A, Policy). For example, experiments in which all components derived from non-pathogenic prokaryotes and non-pathogenic lower eukaryotes fall under Section III-E and may be conducted at BL1 containment.

Section III-D. Experiments that Require Institutional Biosafety Committee Approval Before Initiation

Prior to the initiation of an experiment that falls into this category, the Principal Investigator must submit a registration document to the Institutional Biosafety Committee which contains the following information: (i) the source(s) of nucleic acid; (ii) the nature of the inserted nucleic acid sequences; (iii) the host(s) and vector(s) to be used; (iv) if an attempt will be made to obtain expression of a foreign gene, and if so, indicate the protein that will be produced; and (v) the containment conditions that will be implemented as specified in the NIH Guidelines.

For experiments in this category, the registration document shall be dated, signed by the Principal Investigator, and filed with the Institutional Biosafety Committee. The Institutional Biosafety Committee shall review and approve all experiments in this category prior to their initiation. Requests to decrease the level of containment specified for experiments in this category will be considered by NIH.

11. Appendix C: Number of Active MUAs by Unit/Department

12. Appendix D: Research Personnel Registered with the IBC

The IBC provides relevant biosafety information to researchers on the best practices for work with r/sNA, biohazardous materials, and bloodborne pathogens. Below are the total number of registered research personnel with the IBC, which includes PIs, post-docs, lab support staff, and graduate and undergraduate students. The distribution of research personnel working with various materials is also reflected in the table below, along with the percentage of total personnel working with those materials. An example of the type of support provided by the IBC to research personnel includes the coordination of training for work with bloodborne pathogens, which per OSHA regulations, must be renewed annually for all individuals working with those materials.

2022-23, 2021-22, 2020-2021, 2019-2020, 2018-2019, 2017-2018, 2016-2017, 2015-2016, 2014-2015, 2013-2014, 2012-2013, 2011-2012, 2010-2011, 2009-2010, 2007-2008, 2006-2007, 2004-2005

To: Dean De Rosa

From: Andrew Willford, Chair

Date: June 27, 2024

Subject: IRB Annual Report

1. IRB Membership (as of June 1, 2024)

Voting Members

• Andrew Willford (Chair), Professor, Anthropology
• Robin Blair (non-affiliated member, non-scientist)
• Kent Bullis, M.D., Cornell Health Services
• Anthony Burrow, Associate Professor of Psychology and Associate Dean for Outreach and Extension (CHE), Director of the Bronfenbrenner Center for Translational Research
• Bobby Edamala, Chief Information Security Officer (non-scientist)
• Gary Evans, Professor, Human Centered Design & Psychology
• Susan Fussell, Professor, Communications & Information Science
• Kenneth Hill, M.D., Cornell Health Services
• Wendy Ju, Associate Professor, Jacobs Technion-Cornell Institute, Cornell Tech
• Saurabh Mehta, Professor, Nutritional Sciences
• Theresa Pendergrast, Research Associate, Global Development (prisoner representative)
• Leslie Shaw, Research Associate, Yang-Tan Institute on Employment and Disability
• Meryl Bursic, Senior IT Security Engineer (non-scientist alternate)
• Myles Gideon, IRB Manager (non-scientist alternate)
• Vanessa McCaffery, IRB Administrator (non-scientist alternate)
• Joyel Moeller, Senior IRB Administrator and Reliance Specialist (scientist alternate)
• Robert Scott, Executive Director, Cornell Prison Education Program (prisoner representative alternate)

Ex-Officio, Non-Voting Members

• Krystyn Van Vliet, Vice President for Research and Innovation, Institutional Official
• Lydia Galarneau, IRB Compliance Assistant
• Joshua Turse, Biosafety Officer, Environmental Health & Safety
• Valerie Ziarniak, IRB Administrator
• Julie Conyer, Associate Biosafety Specialist (Biosafety alternate)

2. IRB Authorization and Charge

Cornell University has a Human Research Protection Program (HRPP) which is guided by ethical principles, and federal, state, and local regulations regarding research involving humans as subjects. These guiding ethical principles have been set forth in the Nuremburg Code of 1947, the Declaration of Helsinki of 1964, and the Ethical Principles and Guidelines for the Protection of Human Subjects of Research of 1979, called the “Belmont Report.” Cornell University applies the principles of the Belmont Report—respect for persons, beneficence, and justice—to protect the rights and welfare of all human research participants involved in any Cornell study, regardless of funding source.

As part of this HRPP, Cornell’s Institutional Review Board for Human Participants (IRB) is responsible for the ethical review of research with human participants and for maintaining compliance with federal regulations, specifically the “Common Rule”. The IRB is an independent standing committee of the University Faculty. The Vice President for Research and Innovation serves as the Institutional Official for the IRB. Regulatory and administrative support for the IRB is provided by the Office of Research Integrity and Assurance (ORIA). As of June 1, 2024, there are five (5) full-time staff dedicated to supporting the IRB and Cornell’s broader Human Research Protection Program, reporting up to the Director of Research Assurance within ORIA.

The Cornell IRB Charge can be accessed here.

3. IRB Review Activities

The IRB and administrative staff review and approve the following categories of human participant research, based on the level of anticipated risk to participants:

1. Exempt Review – Certain types of minimal risk research projects are exempt from federal regulations, and do not require IRB committee review. At Cornell, these projects are reviewed and approved by IRB administrative staff. These commonly involve:
   • Observation of public behavior
   • Interactions with minimal risk, such as surveys or interviews
   • Benign behavioral interventions
   • Studies in educational settings using educational practices
   • Certain secondary analyses of data or specimens
2. Expedited Review – Research projects that cannot receive exempt review under the regulations, but pose no greater risk to participants than what they might experience in their everyday lives, can be reviewed and approved by a single member of the IRB. Such expedited review studies commonly involve:
   • Social/behavioral research interviews and surveys that do not qualify for exemption
   • Some minimally invasive biomedical procedures (e.g., most blood draws)
   • Certain uses of identifiable data or specimens
3. Full Board (Convened Committee) Review – Research that poses more than minimal risk to human subjects is reviewed by the convened IRB. Research that is otherwise considered minimal risk under the federal regulations may also be referred to the full board for review if it involves sensitive topics, or a complex research design that would benefit from a review by the breadth of expertise represented by convened committee. For the Ithaca and AgriTech campuses, studies that most commonly require full board review involve:
   • Invasive biomedical procedures
   • Research on sensitive topics
   • Research in which risk is uncertain but perceived to be high
   • Studies that involve populations especially vulnerable to coercion or undue influence, such as imprisoned individual.
4. Reliance (Authorization) Agreements – In cases where human participant research takes place at or involves investigators at multiple institutions, a reliance agreement—sometimes called an authorization agreement—may be used to formalize an arrangement whereby one institution takes responsibility for IRB review of the entire project, serving as the “Reviewing IRB,” “IRB of Record,” or “Single IRB” (sIRB). These agreements are used to avoid redundancy and streamline the initial review and any subsequent renewal or amendment processes. Changes to federal regulations in 2020 require such agreements for most federally funded collaborative projects.
5. Administrative Reviews – IRB administrative staff can review and approve submissions for activities that do not, for one reason or another, require IRB committee review. Current examples of submissions eligible for administrative review are prescreening approvals (used for sponsored research, when the human subjects research element of an award has not yet been finalized), as well as projects that do not to meet the regulatory definition of “human subjects research.”
6. Amendments – An amendment submission is required for all modifications to non-exempt research protocols. The IRB reviews amendments in the context of the entire protocol and must approve amendments before the researchers can implement the requested changes to their study. Certain types of minor amendments can be approved administratively by IRB staff. Changes made to exempt research protocols must also be communicated to ORIA, but they are only reviewed to confirm that the project is still eligible for exemption.
7. Continuing Review – The IRB conducts an annual review of ongoing research protocols that are deemed to pose more than minimal risk to participants (i.e., those requiring full board review), or those which require a continuing review by a funder or collaborating institution. This continuing review is conducted to ensure that the protection of human participants is consistent throughout the execution of the research project and that the protocol is revised, as appropriate, to include new knowledge generated since the last review.
8. Active Projects Registered with the IRB:

4. IRB Applications Reviewed

Between June 1, 2023, and May 31, 2024, the IRB held 9 duly convened meetings to review research protocols, discuss unexpected events and protocol deviations, and address other human participant research ethics and compliance-related topics. A total of 1,326 applications were approved by the IRB (via expedited or full board review), determined to be exempt, or completed an administrative review during that time.

These projects are reflected below:

*Most Expedited protocols do not require annual continuing review, per the Revised Common Rule.

**The “Other” category includes administrative and other reviews, primarily Reliance Agreements and Prescreening reviews.

5. IRB Initiatives (2023-2024)

1. Continual Improvement of the IRB Protocol Management System, RASS-IRB: In our second year using the RASS-IRB system, the ORIA IRB staff continued to seek feedback and refine the online platform, in coordination with staff from Research Administration Information Services (RAIS) and the system vendor, Novelution, in order to ensure the system continues to function smoothly and meet our users’ needs.
2. Internal Process Improvement: The IRB office engaged in two process assessment and improvement projects this year: completing a lengthy self-assessment using a tool provided by the Office for Human Research Protection (OHRP) and collaborating with ORIA Compliance Fellows—MPA students from the Brooks School of Public Policy—to map our protocol submission, review, and approval workflows. Both assessments helped the team identify pain points and propose remedies, which we are now pursuing.
3. Collaborative Projects

• Research Using Student Records: IRB staff continued to build upon our close, collaborative relationship with leadership from the Office of the University Registrar (OUR), regularly meeting with OUR colleagues to design research-related guidance on FERPA (Family Educational Rights and Privacy Act) and discuss individual cases that impact both OUR and IRB. See below under “New or Improved Tools and Guidance” for more details about this past year’s main project.

• Secure Data Collection, Transmission, and Storage Tools for Human Participant Research: While the IRB has had representation from the IT Security Office for many years, this past semester IRB staff began to hold focused meetings with the two IRB member representatives from that office (Bobby Edamala and Meryl Bursic), along with the Cornell Data Services Coordinator (Wendy Kozlowski), in order to better align on key research data security issues. We hope this closer collaboration will result in development of more accurate information collection during the protocol submission process, more transparent instructions for researchers on which data tools they should use in which circumstances, and clearer IRB/IT review workflows.

1. Academic Integration Initiative: Cornell’s Ithaca-based IRB staff leadership continue to collaborate with their counterparts from Weill Cornell Medicine to help bridge the physical gap between the campuses and to better facilitate collaborative research. Human Research Compliance staff from both offices correspond frequently about cross-campus research projects, as well as shared challenges and ideas for streamlining approaches.
2. New or Improved Tools and Guidance:
   • FERPA & Research Flowchart: IRB staff, in collaboration with leadership from the Office of the University Registrar, developed a flowchart for investigators interested in using student records for research purposes, with details about when and how compliance with FERPA is required (along with human subjects research regulations). The flowchart will be posted to the researchservices.cornell.edu website this summer.
   • Regulatory Checklists and Worksheets: IRB staff created and implemented a set of internal-facing worksheets and checklists for IRB staff and committee members to better document compliance with federal regulations and policies.
   • IRB Policy #1: The IRB created a Policy Subcommittee this year to review and recommend approval of revised and new policies, SOPs, and guidance documents pertaining to human participant research. Revised Policy #1 (“Determining whether a Research Activity Needs IRB Review and Approval”) was the first such document recommended for approval by the subcommittee and approved by the full IRB.
   • New HPR Glossary: IRB staff have assembled a comprehensive set of definitions of human participant research terms into a new glossary, which will be posted on our website this summer.
   • IRB Protocol Lifecycle Resource: A sizable portion of IRB staff time is spent explaining the intricacies of the protocol submission, review, and approval process to new researchers—especially students. Our Compliance Assistant created a new narrative resource, written in approachable language, which explains each step of the process. This is being incorporated into our website resources.
   • RASS Guide Site: IRB and RASS staff continued to add new and revise existing how-to documentation to the RASS Guide website, which serves as a resource to help researchers and IRB members use the RASS-IRB system: https://guide.rass.cornell.edu/
3. Classes and Workshops: IRB staff regularly present to classes and workshops for undergraduate and graduate students, new researchers, and research staff. On occasion, the IRB Chairperson will also co-present. Groups visited in the past year (via Zoom or in person) include:

• • AEM 4415 and 5415: Field Research and Pre-Engagement with Social Enterprises in Emerging Markets, SC Johnson & CALS (undergraduate and graduate students)
  • ANTHR 6440: Proposal Development Seminar, Arts & Sciences (graduate students)
  • DEA 7100: DEA Graduate Pro Seminar, Human Ecology (graduate students)
  • NS 3980: Research in Human Nutrition and Health, Division of Nutritional Sciences (undergraduate students)
  • NS 6350: Introduction to Community Nutrition Research for Dietetic Interns, Division of Nutritional Sciences (dietetic interns)
  • PUBPOL 6810: Demography Training seminar, Brooks School (graduate students)
  • Research Administration Certification Program, Office of Sponsored Programs and Division of Financial Affairs (research administrative staff)
  • Research Data Safety Monitoring Group (RDMSG), Consultants’ Meeting (staff)

6. Challenges Faced by the Committee

1. New Tech (GenAI): This past year, an increasing number of Cornell faculty, students, and staff have been using Generative AI tools in research—both to test the tools themselves as well as to use them for other components of the research process. IRB staff and committee members have struggled to keep up with the new tools, both in terms of understanding how they operate and understanding their downfalls in the areas of data privacy and confidentiality. IRB and IT staff are working toward developing some clear guardrails, as well as ways to say “yes,” but the pace at which researchers are moving has been challenging.
2. IRB Membership: It remains a perennial challenge to recruit faculty to serve on the IRB. The IRB’s ability to continue to serve as an effective and balanced committee is inextricably linked to its ability to recruit faculty who have the expertise in the relevant subject matter areas and are willing to volunteer their time to conduct the reviews, participate in policy and guidance development, and attend monthly committee meetings.

1. Initiatives and Changes in the Coming Year
   • Improvement of Single IRB Documentation, Procedures: While RASS-IRB and the expansion of the IRB professional staff have, in recent years, allowed ORIA to better support multi-site collaborations and reliance agreement documentation, additional work in this area is planned. The RASS system vendor, Novelution, is building functionality that will allow for documentation of each individual site/institution, when Cornell is serving as the Reviewing IRB (i.e., the Single IRB or IRB of Record). In addition, we are aiming to have Cornell soon join the SMART IRB consortium, utilizing Global Agreement Version 3 when it is launched this fall. This will enable expeditious execution of reliance agreements with any of the 1200+ institutions that have already signed on to the SMART IRB Agreement. The Cornell IRB staff also continue to work closely with WCM human research compliance colleagues to synchronize reliance approaches and continue to streamline the process of Cornell faculty collaborations across campuses.
   • New and Revised Policies, Guidance, and Templates: Due to emerging areas of interest for human participant research, as well as changes in regulations and best practices in this field, the IRB committee and staff aim to regularly review standing policy and guidance materials, SOPs, and templates to identify documents in need of revision, as well as develop new documents as needed. Some key new and revised guidance/SOPs/templates this year will include:

• • • GenAI and human participant research, in collaboration with ITSO
    • Recommended transcription tools for human participant research, in collaboration with ITSO
    • Interactive tool for determining need for IRB submission
    • University Policy on Human Participant Research, in collaboration with WCM
    • Data privacy laws and human participant research (revising GDPR guidance, expanding to include UK GDPR, PIPL, PIPA, and more), in collaboration with the Offices of General Counsel and University Privacy
    • Revised informed consent form templates.
  • Post-Approval Monitoring and Quality Assurance for IRB Protocols: IRB staff have been working on revamping a quality assurance program for IRB protocols, with the intention of better ensuring post-approval compliance with federal and state regulations, and university and IRB policy. The program’s approach will emphasize education and relationship-building. The QA protocol checklist and policy will be finalized in Fall 2024, with implementation of the revamped program shortly thereafter.

2022-23, 2021-22, 2020-2021, 2019-2020, 2018-2019, 2017-2018, 2016-2017, 2015-2016, 2014-2015, 2013-2014

To: Dean De Rosa

From: Frank Pugh, Chair

Date: June 27, 2023

Subject: RAC Annual Report

The Research Advisory Committee (RAC) is the Faculty Senate committee that provides advice to the Vice President for Research and Innovation (OVPRI) on issues relating to the University research enterprise. During Fiscal Year 2024 (July 1, 2023–June 30, 2024), the RAC contributed to Cornell’s research excellence by reviewing and advising on the top candidates for limited submission grant and award programs (see Table 1).

Table 1: Summary of RAC productivity for FYs 2022, 2023 and 2024

The attached Excel file documents limited submission competitions from 2016 to present, including applicant data, internal competition outcomes, and sponsor outcomes. The number of limited submission programs fluctuates from year-to-year as new programs are added and some no longer exist or do not recur annually.

We highlight below the recipients of several highly competitive and prestigious limited submission programs that were reviewed by the RAC[1]:

• Two faculty were the recipients of Individual Biomedical Research Awards (IBRA) from The Hartwell Foundation – Rong Yang (Assistant Professor, Chemical & Biomolecular Engineering) and Ashley Nelson (Assistant Professor, Pediatrics). The IBRA funds early-stage research that is strategic or translational in nature and addresses an unmet need to improve health outcomes for children in the U.S. As a result of the two faculty awards, Cornell was also awarded two Hartwell Postdoctoral Fellowships.
• Professor Rong Yang also received a 2024 Camille Dreyfus Teacher-Scholar Award, which supports the research and teaching careers of talented early career faculty in the chemical sciences. The award recognizes a researcher’s independent body of scholarship attained in the early years of their appointment and their demonstrated commitment to education.
• Owolabi Legunsen (Assistant Professor, Computer Science) received an Intel Rising Star Faculty Award. This annual award honors early-career academic researchers who have the “potential to disrupt the industry” through technological advances and novel contributions in the fields of computer science, electrical engineering, computer engineering, and chemical engineering.
• Noah Stephens-Davidowitz (Assistant Professor, Computer Science) was awarded a 2023 Packard Fellowship. These Fellowships allow the nation’s most promising early-career scientists and engineers flexible funding to take risks and explore new frontiers in their fields of study.

RAC Recruitment and Membership:  Each year, OSP provides a list of potential new members to the VPRI, who invites faculty to join the committee. The list is compiled through recommendations from Research Deans from the colleges, departing RAC members, and OSP. The work required for the RAC to perform internal proposal reviews is significant, which has made it challenging to recruit and retain members. Suggestions and additional support for the successful recruitment of RAC members would be welcomed.

The RAC is categorized into two disciplinary groups: Life Sciences and Physical Sciences/Engineering. The vast majority of limited submission programs are within STEM disciplines, and the standing committee members are faculty from these disciplines. RAC does not currently include a standing committee member for the Social Sciences or Humanities as the number of limited submission competitions within these disciplines does not warrant a full-time member. Ad hoc review panels are convened in response to limited submission competition announcements for these disciplines. Ad hoc review panels are also convened for limited submission funding opportunities with compressed timelines that do not allow sufficient time for a RAC review. The Associate Vice Provosts in OVPRI and Limited Submissions Manager work together to coordinate expedited, ad hoc reviews in these cases.

Table 2: RAC Members for FY24

Internal Review Process:  The RAC’s workload is spread throughout the year, with fewer reviews occurring in the summer months. Each member is expected to read and provide feedback on all applications (unless they have a conflict of interest with an applicant), independent of area of research. The broad expertise represented on the RAC helps make certain that the most competitive proposals are selected to advance in a competition. Committee members may often be associated with internal applicants evaluated by the RAC. It is recognized that often those conflicted with an applicant may be in the best position to review the technical aspects. A member who declares a conflict of interest does not formally review the application or vote on competition outcomes, but may be asked to provide comments and expertise to the committee.

RAC members reserve Mondays, 3-4pm, on their calendars for a standing review meeting. However, the RAC meets only when there are reviews due—approximately once per month—with unnecessary meetings being canceled well in advance. Typically, at least two weeks are given to complete a review, with additional time allotted if multiple competitions are under review at the same time. For each competition, reviewers are asked to (1) rate the competitiveness of each application (highly competitive, competitive, or less competitive; (2) indicate their own proximity of expertise to an applicant’s research area; and (3) provide additional comments about each application. For large competitions (i.e., those with >10 applications), each reviewer is assigned a limited number of applications based on their areas of expertise. RAC members may choose to review all the applications, but are obligated to submit written reviews for only those assigned to them.

For each competition, a compilation of the raw review data and a summary of the review is distributed to the committee prior to meeting, which serves as the basis for larger RAC discussions. The RAC Chair facilitates discussion and solicits comments about the applications from reviewers. After discussion, a vote is called to select Cornell’s applicant/nominee. The outcome of a review is communicated to internal applicants in a timely manner. A summary of the committee’s feedback is shared with each applicant. Individuals who are selected to advance are also given detailed information about next steps for applying to the funder.

For all Foundation programs as well as some key Federal programs (e.g., NSF MRI Program), reviewers are provided with a written synopsis of the competition that outlines the sponsor’s program, funding preferences, key selection criteria, and previous awardees. For competitions in which University Foundation Relations & Corporate Philanthropy (UFRCP) is Cornell’s designated liaison to a Foundation, the RAC also receives guidance from UFRCP staff.

Note re joint competitions with Weill Cornell Medicine (WCM): For most limited submission opportunities, Cornell Ithaca and WCM may submit proposals separately as distinct institutions. However, there are several Foundation programs in which Cornell Ithaca and WCM submits as one institution (e.g., Keck Research Program Grants, Packard Fellowships, Pew Biomedical Scholars). Ithaca and WCM have a cooperative process for reviewing internal proposals for these shared programs. Each campus holds an internal competition for its investigators, after which each RAC reviews and selects its top candidate. The top candidates from each campus then go to a joint review conducted by the two RAC Chairs to determine the overall strongest candidate. The shared process is coordinated by Ithaca’s Limited Submissions Manager and WCM’s Assistant Dean for Research, who meet regularly to discuss upcoming competitions and create a streamlined process with aligned focus, timing and outcomes.

Administrative support: The Limited Submissions Manager coordinates all administrative aspects of the RAC and internal reviews, including maintaining the review schedule and communicating requests for reviews, compiling reviews ahead of a RAC meeting, collating the feedback into a summary for applicants (in consultation with the RAC Chair), and notifying applicants of competition outcomes. Additionally, the Limited Submissions Manager prepares the competition synopses that are shared with RAC members prior to a review.

[1] As of the publication of this report, outcomes from funders for a number of limited submission opportunities are still pending.

2022-23, 2021-22, 2020-2021, 2020-2019, 2019-2018, 2018-2017, 2016-2017, 2015-2016, 2011-2012, 2009-2010, 2008-2009, 2007-2008, 2006-2007, 2004-2005