{"schema_version":1,"assessment_id":"eoa_inverse_innovation_exp03_opportunity320_20260801","source_experiment_id":"eoa_inverse_innovation_exp03_full320_20260801","cell_id":"deadweight_loss_reduction__psychology","archetype_slug":"deadweight_loss_reduction","domain_slug":"psychology","title":"Risk-Tiered Parallel Ethics Review for Minimal-Risk Behavioral Research","opportunity_summary":"Assess whether redundant routing and serial administrative loops materially delay independently eligible minimal-risk behavioral protocols, then test whether a risk-tiered, parallel workflow can improve decision timeliness and reviewer workload without weakening protection, equity, or authorized final review. Problem prevalence, causal attribution, effect size, and distinctiveness remain unverified.","adopter_authorizer":"The institution's authorized ethics-review body, with institutional research leadership and compliance administration supporting workflow implementation within applicable requirements.","scores":{"meaningful_impact":{"score":3,"rationale":"If the hypothesized avoidable delays cause abandoned or degraded studies and divert reviewer attention, reducing them could improve evidence production and oversight allocation. The sealed candidate supplies no prevalence, causal magnitude, or realized-impact evidence, so impact remains uncertain."},"stakeholder_pull":{"score":2,"rationale":"Researchers, administrators, and reviewers could value faster proportionate review, but the candidate provides no documented requests, complaints, adoption interest, or participant-community support. Some affected parties may also resist a fast path because protection failures are asymmetric."},"incremental_advantage":{"score":3,"rationale":"Risk-tiered intake, parallel review, response windows, and escalation directly address the proposed routing mechanism and are testable against ordinary review and the staffing-guidance-digitization rival. Advantage is uncertain because delay may instead come from incomplete submissions, investigator response, scarcity, mandatory steps, or substantive complexity."},"distinctiveness_plausibility":{"score":2,"rationale":"The proposed bundle is operationally specific, but the packet explicitly states that prior art is unsearched and provides no evidence distinguishing it from existing expedited review or risk-tiered ethics workflows. Distinctiveness cannot be inferred from specification quality."},"technical_implementability":{"score":4,"rationale":"The intervention is a bounded workflow redesign using a validated screen, single intake, parallel routing, escalation, authorized final review, monitoring, and rollback rather than an undeveloped scientific technology. Reliable risk classification, systems integration, and separation of protected checks from avoidable procedure still require validation."},"adoption_authority_feasibility":{"score":4,"rationale":"A clearly identified institutional ethics-review body can authorize an internal pilot while retaining mandated review and participant rights. Feasibility is not maximal because applicable requirements, local governance, reviewer cooperation, and the permissible boundary of expedited routing must be confirmed."},"evidence_readiness":{"score":4,"rationale":"The candidate defines an audit falsifier, an ordinary-review comparison, a prospectively bounded randomized pilot, outcome domains, exclusions, and rollback criteria. Readiness is limited by unspecified meaningful margins and by the inability of at most 30 protocols to establish noninferiority for rare consequential protection failures."},"safety_net_benefit":{"score":4,"rationale":"The design preserves authorized final decisions, excludes vulnerable and elevated-risk protocols, prohibits automated final classification, monitors protection and equity, and returns cases to ordinary review on defined concerns. Residual risk remains from misclassification, strategic understatement, displaced workload, and rare harms that a small pilot may not detect."},"scalability":{"score":3,"rationale":"A standardized intake and routing process could be repeated within additional units or institutions, but generalization depends on local rules, case mix, staffing, information systems, and classification reliability. The deliberately narrow first sample may not establish transferability."}},"score_confidence":"MODERATE","costs":{"first_evidence":{"band_2026_usd":"10K_TO_50K","scope":"Retrospective pathway audit at one institution, including protocol sampling, elapsed-time decomposition, resubmission and abandonment review, data extraction, governance review, and comparison of redundant-process time with investigator response, necessary substantive analysis, and reviewer scarcity.","confidence":"LOW","assumptions":["Records are accessible and sufficiently structured for retrospective reconstruction.","The audit is limited to one institution and a bounded historical cohort.","Costs include analyst, reviewer, compliance, privacy, and investigator-validation time but no new enterprise software."]},"initial_deployment_startup":{"band_2026_usd":"50K_TO_250K","scope":"Design and conduct the described 12-week feasibility pilot for at most 30 eligible protocols, including risk-screen validation, workflow configuration, staff training, randomization, preregistration, monitoring, data analysis, and independent review of protection and equity indicators.","confidence":"LOW","assumptions":["Existing submission and case-management systems can be configured rather than replaced.","Authorized reviewers participate within current institutional structures.","The pilot excludes elevated-risk protocols and vulnerable populations.","The trial is treated as feasibility and process-effect evidence, not proof of rare-harm noninferiority."]},"operational_launch":{"band_2026_usd":"50K_TO_250K","scope":"One-institution controlled operational launch after favorable evidence, including policy approval, production workflow integration, documentation, training, quality assurance, escalation coverage, communications, and staged evaluation.","confidence":"LOW","assumptions":["No statutory or regulatory change is required.","Existing ethics-review infrastructure remains the system of record.","Launch is institution-wide but does not include a multi-institution research program or major custom software procurement."]},"annual_recurring":{"band_2026_usd":"50K_TO_250K","scope":"Annual operation at one institution, including intake and reviewer labor attributable to the pathway, classifier quality checks, equity and protection monitoring, audits, training, escalation, system maintenance, and periodic outcome evaluation.","confidence":"LOW","assumptions":["Protocol volume is moderate and can be handled largely by existing staff with allocated effort.","Monitoring remains substantive because rare harms cannot be ruled out by the initial pilot.","The estimate excludes major incident response, litigation, and replacement of institutional review systems."]}},"research_burden":"HIGH","earliest_credible_horizon":"3_TO_12_MONTHS","pipeline_gates":{"recognizable_externally_supportable_problem":{"status":"UNCERTAIN","reason":"The candidate specifies recognizable observables and an audit falsifier, but delay prevalence, attribution to redundant process, abandonment, and reviewer-capacity consequences are all explicitly hypothetical and lack external support in the sealed packet."},"identifiable_adopter_or_authorizer":{"status":"YES","reason":"The institution's authorized ethics-review body is explicitly identified as the pilot authorizer, subject to applicable requirements, with institutional leadership and administrators positioned to implement the workflow."},"distinct_testable_incremental_claim":{"status":"YES","reason":"The proposal makes a separable claim that risk-tiered intake and parallel routing improve timeliness and workload relative to ordinary review without crossing protection or equity boundaries, and distinguishes this from adding reviewers, guidance, or digitization."},"bounded_next_evidence_step":{"status":"YES","reason":"A retrospective pathway audit is a bounded, non-deployment diagnostic step that can compare sources of elapsed time and falsify the proposed problem before any prospective workflow test."},"no_unresolved_safety_or_authority_stop":{"status":"YES","reason":"The candidate preserves authorized final review and required participant protections, excludes elevated-risk and vulnerable-population cases, prohibits automated final decisions, and provides immediate pause and ordinary-route rollback. Rare-harm evidence remains a research limitation rather than an identified authority stop."},"implementation_cost_scope_and_range":{"status":"YES","reason":"The candidate bounds an initial one-institution audit and a 12-week pilot of at most 30 protocols, permitting broad resource bands despite uncertainty about local staffing, systems, compliance requirements, and protocol volume."}},"blocking_evidence":["Whether eligible minimal-risk protocols experience materially long or variable approval times under the existing route.","What share of elapsed time and rework is caused by redundant routing rather than investigator response, poor submissions, necessary substantive review, mandatory steps, or reviewer scarcity.","Whether a risk screen can classify eligibility reliably without systematically disadvantaging less powerful investigators or participant groups.","Whether parallel routing reduces median and upper-tail decision time by a pre-specified meaningful margin without merely shifting work to amendments, monitoring, or downstream review.","Whether protection quality and equity can be evaluated with validated leading indicators, since a 30-protocol pilot cannot establish safety equivalence for rare consequential failures.","Whether applicable rules and local governance permit the proposed workflow details.","Whether the bundle is distinct from existing expedited-review practice or prior workflow interventions."],"next_evidence_step":"Conduct a retrospective, one-institution pathway audit of a pre-specified cohort of independently classified minimal-risk behavioral protocols. Compare total and upper-tail elapsed time, queue time, administrative rework, investigator-response time, substantive-review time, mandatory-step time, missed recruitment windows, and abandonment across pathway stages. Do not begin live deployment. Falsify the problem claim if most delay is attributable to investigator response, necessary substantive analysis, mandatory requirements, or unavoidable scarcity rather than redundant routing, or if existing review is already proportionate.","research_questions":["How many protocols meet a defensible, independently applied minimal-risk eligibility definition, and how reliably do reviewers agree?","Where in the current pathway do median and upper-tail delays arise, and which portions are avoidable versus required or substantively protective?","Are missed recruitment windows, design degradation, or abandonment associated with review delay after separating investigator-caused time?","Does the proposed workflow outperform ordinary review and the nearest rival of added capacity, better guidance, or digitization on timeliness and total workload?","Which validated leading indicators can detect degraded consent, privacy, deception, debriefing, welfare, and equity protections in a small feasibility trial?","Does faster routing displace workload into amendments, monitoring, appeals, or later corrective action?","What local rules, approvals, system changes, staffing, and escalation coverage are required?","How closely does the bundle resemble existing expedited-review pathways, regulations, studies, and workflow pilots?","What staged sample and monitoring duration would support decisions beyond feasibility without treating absence of rare events as safety equivalence?"],"recommendation":"VALIDATE_PROBLEM_FIRST","uncertainty_constraints":["Closed-book assessment: no external evidence was consulted.","Problem prevalence, delay magnitude, causal attribution, stakeholder demand, and realized impact are unmeasured.","World novelty and prior art are unmeasured; distinctiveness is neither established nor disproven.","Cost bands are broad resource-equivalent estimates conditioned on a one-institution scope and unknown local systems and rules.","The proposed 30-protocol pilot is too small to demonstrate noninferiority for rare serious protection failures.","Applicable legal, regulatory, and institutional requirements are not supplied and must be confirmed before prospective testing.","Scalability beyond the narrow eligible population and one institutional setting is unknown."],"closed_book_prior_art_boundary":"Prior art is explicitly unsearched. This assessment makes no claim that risk-tiered, expedited, parallel, or otherwise proportionate ethics-review workflows are novel, uncommon, or absent. A bounded review of applicable regulations, institutional expedited pathways, risk-tiering research, and workflow pilots is required before any distinctiveness claim."}