Integrity in the governance of human research.
Most research organizations encounter IRB and regulatory challenges that require more than procedural knowledge. They require someone who has sat on both sides of the submission — who understands what a committee is evaluating and can translate that into defensible action. Glenwood Ethical Research Advisory provides that perspective: executive IRB authority grounded in more than 20 years across sponsor, CRO, site, monitoring, and IRB leadership functions, and informed by active practice at an AAHRPP-accredited commercial central IRB.
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Protocol Advisory & Pre-Submission Review
Sponsors and CROs routinely submit protocols that carry avoidable IRB concerns: risk-benefit framing that does not map to the applicable criteria under 21 CFR 56.111(a), consent documents missing required elements under 21 CFR 50.25(a) or (b), or vulnerable population considerations that surface as stipulations rather than being resolved before submission. Glenwood Ethical provides independent review at the chair level before submission reaches the committee, identifying those gaps and producing specific remediation language for each finding. The deliverable is not a gap list. It is a set of concrete revisions ready to implement. The objective is a cleaner submission, a shorter review cycle, and fewer stipulations. For sponsors on tight timelines or managing complex multi-site submissions, pre-submission advisory directly affects both cost and schedule.
IRB Stipulation & Deferral Response
IRB stipulations and deferrals are not administrative obstacles. They are regulatory determinations that identify a specific finding requiring substantive resolution. A response that addresses the literal language of a stipulation without understanding the underlying regulatory basis tends to generate a second round of committee review, extending timelines and increasing submission costs. Glenwood Ethical works from the regulatory basis of the determination, not just the surface language. This means identifying whether a stipulation arises from a consent element deficiency under 21 CFR 50.25, a risk-benefit finding under 21 CFR 56.111(a)(2), a vulnerable population safeguard requirement, or another discrete regulatory concern, and drafting responses and document revisions that close the issue at its root. This perspective is available because the advisory practice is led by an active IRB Executive Chair, not a former committee member or regulatory generalist. The applicable analysis reflects how a committee will evaluate the response, not just how to write one.
Fractional Regulatory Leadership
Some engagements require embedded advisory presence rather than project-based deliverables. Glenwood Ethical provides fractional and interim leadership across IRB operations, human research protection programs, and regulatory and clinical operations functions, structured to the organizational need. For commercial central IRBs managing scale, this may mean interim executive IRB chair coverage, reviewer infrastructure development, board governance support, or AAHRPP accreditation preparation. For sponsors and CROs without in-house IRB strategy expertise, it may mean ongoing advisory presence across IND or IDE regulatory pathways, submission strategy, and committee interface management. For research sites during leadership transitions, it may mean interim HRPP or regulatory compliance leadership to maintain operational continuity. Fractional engagements are scoped in advance, priced transparently, and designed to transfer capability to the organization rather than create dependency.
Inspection Readiness & Regulatory Interface
FDA BIMO inspections, AAHRPP site visits, and sponsor audits each test a different dimension of an organization's research oversight infrastructure. Organizations frequently discover gaps during preparation that were invisible during ordinary operations: consent documentation that does not meet the standard for the population enrolled, deviation reporting chains that are inconsistent with the IRB communication record, or regulatory binder content that does not align with what the committee file reflects. Glenwood Ethical supports organizations preparing for regulatory scrutiny across all three inspection types. Preparation work typically addresses consent documentation compliance, unanticipated problem and reportable event reporting chains, IRB correspondence records, and the regulatory interface between IRB obligations and FDA sponsor or investigator requirements under 21 CFR Part 312 or Part 812. This work is grounded in direct experience. Cyrus has led FDA inspection readiness activities at Univo IRB resulting in inspection closure without findings, and currently represents the organization in FDA inspections, AAHRPP site visits, and sponsor audits. That active experience informs what preparation actually requires, not what a checklist says it should.
Advisory shaped to the organization, not the other way around.
Sponsors & Biotech Companies
Drug, biologic, and device sponsors often encounter the IRB as a checkpoint rather than a partner. Glenwood Ethical changes that relationship. Pre-submission advisory, stipulation response strategy, and IND/IDE regulatory interface support give sponsors the perspective of an IRB chair before a determination is issued, reducing the friction, cost, and delay that typically accompanies IRB review of complex or novel protocols.
Contract Research Organizations
CROs managing multi-site submissions or regulatory strategy engagements on behalf of sponsors need IRB advisory that operates at the same level of precision they do. Glenwood Ethical provides submission quality review, stipulation response support, inspection readiness preparation, and fractional regulatory leadership for CROs that need senior-level IRB expertise without the overhead of a full-time hire.
Research Sites & Academic Medical Centers
Sites navigating the intersection of local IRB governance, central IRB reliance agreements, and sponsor expectations often operate without dedicated IRB strategy support. Glenwood Ethical assists sites with regulatory interface questions, consent documentation compliance, deviation and reportable event reporting obligations, and preparation for sponsor audits or FDA site inspections.
Commercial Central IRBs
Cyrus has led board operations, reviewer infrastructure, and service delivery at an AAHRPP-accredited commercial central IRB. That operational context makes the advisory work directly applicable to commercial IRBs managing growth, reviewer scalability, AAHRPP preparation, or board governance challenges. Fractional and interim engagement options are available for organizations in transition or expansion.
Active IRB executive authority. Cross-functional experience across every function in the research enterprise.
Cyrus has served as Executive IRB Chair of Univo IRB, an AAHRPP-accredited commercial central IRB, and as a Fellow of the Harvard Medical School Center for Bioethics. He founded Glenwood Ethical Research Advisory to make senior-level IRB and regulatory advisory available to organizations that need more than a compliance checklist: sponsors who want to understand what a committee will actually do with their submission, CROs managing complex regulatory interfaces, and research organizations building the governance infrastructure to withstand regulatory scrutiny.
Cyrus has spent more than 20 years across sponsor, CRO, monitoring, site, and IRB executive functions. Before joining Univo, he served for six years as a non-affiliated scientific board member at Advarra IRB, one of the largest commercial central IRBs in the United States, reviewing drug, biologic, and device studies across full board, expedited, and exempt pathways. That sustained board-level experience, combined with his background in clinical monitoring, sponsor-side CRO oversight, and IND/IDE regulatory strategy, produces a perspective that is genuinely cross-functional.
In his current role, Cyrus has led FDA inspection readiness activities at Univo IRB resulting in inspection closure without findings, and represents the organization in FDA inspections, AAHRPP site visits, and sponsor audits. He serves as Functional Owner of Board Service Delivery, with direct accountability for board governance, reviewer infrastructure, and operational performance within the organizational management system. His credentials include an MS in Clinical Research (Drexel University College of Medicine), an MBA (University of North Carolina Wilmington), and ACRP certifications as a Certified Project Manager, Certified Medical Device Professional, and Certified Clinical Research Associate.
Cyrus has a background as a registered nurse in neonatal critical care and emergency medicine that is not incidental to the advisory work. It means that risk-benefit analysis and human subject protection review are grounded in direct clinical experience with vulnerable patients, not regulatory abstraction. That clinical realism is visible in the quality of the advisory product.
Engagement options that match the situation.
Project-Based Engagements
Most engagements begin with a defined scope and a clear deliverable: a pre-submission protocol review, a stipulation response package, an inspection readiness assessment, or a regulatory interface memo. Project-based work is scoped in a written engagement letter, priced on a fixed-fee or hourly basis depending on the nature of the work, and delivered within an agreed timeline. There are no retainer minimums for project work.
Fractional & Ongoing Advisory
Organizations that need sustained IRB or regulatory advisory presence without a full-time hire can engage Glenwood Ethical on a fractional basis. Fractional engagements are structured with a defined scope of involvement, a regular cadence, and transparent pricing. They are designed to integrate with the organization's existing operations rather than operate as a parallel structure.
Rapid-Response Support
Some situations do not fit a standard project timeline. A deferral letter arrives with a response window. An inspection notice is received. A significant protocol amendment generates unexpected IRB concern. Glenwood Ethical maintains capacity for rapid-response engagements and will communicate availability and timeline at the time of inquiry.
Contact Glenwood Ethical through the inquiry form or directly via email. Initial consultations are available to discuss the situation, confirm whether the engagement is a fit, and outline scope and timing. There is no charge for an initial consultation.