{"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__ethnography_qualitative_methods","archetype_slug":"deadweight_loss_reduction","domain_slug":"ethnography_qualitative_methods","title":"Risk-tiered review path for low-risk qualitative research","opportunity_summary":"The candidate proposes independently classifying low-risk ethnographic and qualitative protocols and routing eligible studies through a qualitative-risk-specific ethics review path while retaining consent, privacy, participant-agency, and community-harm safeguards. It targets classification mismatch rather than generic administrative delay, but the prevalence of that mismatch, the protection equivalence of the alternative path, and its incremental effects remain hypotheses.","adopter_authorizer":"An institution's duly authorized research-ethics body, with participant or community advisory input appropriate to the study class and subject to any governing mandates.","scores":{"meaningful_impact":{"score":3,"rationale":"Preserving field windows, methodological fit, and ethically permissible inquiry could materially benefit researchers and downstream evidence users, but the packet supplies no prevalence or effect-size evidence and acknowledges that fewer studies can sometimes reflect legitimate protection."},"stakeholder_pull":{"score":2,"rationale":"Researchers have a plausible interest in reducing disproportionate requirements, but the sealed candidate contains no demonstrated demand, complaints, adoption requests, or expressed support from ethics bodies, participants, or communities."},"incremental_advantage":{"score":3,"rationale":"The proposed path targets eligibility and risk classification rather than merely shortening forms or administration, creating a testable incremental claim; whether classification mismatch is actually the binding cause is unresolved."},"distinctiveness_plausibility":{"score":3,"rationale":"A qualitative-risk-specific classification path is conceptually distinguishable from generic transaction-cost reduction, but prior art is unsearched and the packet provides no basis for judging novelty or existing equivalent practices."},"technical_implementability":{"score":3,"rationale":"Routing, adjudication, monitoring, and rollback are administratively conceivable, but the required risk taxonomy, blinded eligibility procedure, threshold calibration, safeguard-equivalence standard, and delayed-harm measurement are not operationally defined."},"adoption_authority_feasibility":{"score":3,"rationale":"The candidate identifies the institutional ethics body as decision authority and constrains the pilot, but it explicitly notes that institutional authority may not extend to changing mandated review requirements."},"evidence_readiness":{"score":3,"rationale":"Observable outcomes, matched comparisons, problem and intervention falsifiers, and halt criteria are specified, but baseline prevalence, classifier validity, protection baselines, and preset harm boundaries must be established before a prospective pilot."},"safety_net_benefit":{"score":4,"rationale":"The proposal retains substantive safeguards, excludes higher-risk and coercive settings, monitors complaints and harms, and specifies suspension and reversion to ordinary review; rare, collective, and delayed harms remain difficult to detect."},"scalability":{"score":2,"rationale":"Scaling would require locally valid classification, trained reviewers, community-sensitive safeguards, monitoring, and compatibility with institutional mandates; the packet offers no evidence that these requirements generalize across institutions or study contexts."}},"score_confidence":"MODERATE","costs":{"first_evidence":{"band_2026_usd":"50K_TO_250K","scope":"A bounded retrospective baseline audit and blinded dual-classification exercise at one institution, including protocol sampling, outcome coding, participant or community advisory review, privacy controls, analysis, and decision criteria.","confidence":"LOW","assumptions":["Existing protocol and review records are accessible under appropriate governance.","The exercise does not alter live review decisions.","The sample is limited to one institution and independently screened qualitative protocols.","Resource-equivalent cost includes staff time, data preparation, advisory participation, compliance, and analysis."]},"initial_deployment_startup":{"band_2026_usd":"250K_TO_1M","scope":"Preparation for a one-institution controlled pilot, including taxonomy development, classifier calibration, safeguard-equivalence rules, legal and policy review, workflow configuration, reviewer training, adjudication procedures, monitoring design, and rollback readiness.","confidence":"LOW","assumptions":["No major information-system replacement is required.","Existing ethics staff can participate but their time is fully counted.","External mandates permit a bounded pilot.","Operational definitions and thresholds require substantial multidisciplinary coordination."]},"operational_launch":{"band_2026_usd":"250K_TO_1M","scope":"One review-cycle pilot at one institution with ordinary-path comparison, independent screening, case adjudication, ethics and community oversight, incident monitoring, distributional analysis, and formal renewal review.","confidence":"LOW","assumptions":["Only independently classified low-risk qualitative protocols are eligible.","Enrollment is modest and higher-risk cases remain on the ordinary path.","Monitoring includes complaints, privacy incidents, study changes, missed field windows, and community-level signals.","The band includes evaluation and partner-coordination resources."]},"annual_recurring":{"band_2026_usd":"250K_TO_1M","scope":"Ongoing operation at one institution after a favorable pilot, including screening, specialist review, adjudication, training, audits, incident surveillance, community input, reporting, and periodic recalibration.","confidence":"LOW","assumptions":["Volume remains within a single institution's qualitative-research portfolio.","The path supplements rather than eliminates ordinary ethics-review capacity.","Rare and delayed harms require continued follow-up.","Material policy changes or multi-institution expansion are excluded."]}},"research_burden":"HIGH","earliest_credible_horizon":"12_TO_36_MONTHS","pipeline_gates":{"recognizable_externally_supportable_problem":{"status":"UNCERTAIN","reason":"The candidate clearly defines the alleged mismatch and observable consequences, but explicitly labels prevalence and consequence claims as hypotheses and supplies no external or baseline evidence that disproportionate review is consequential."},"identifiable_adopter_or_authorizer":{"status":"YES","reason":"The institution's duly authorized research-ethics body is specifically identified as the decision authority, with study-appropriate participant or community advisory input."},"distinct_testable_incremental_claim":{"status":"YES","reason":"The candidate claims that changing risk classification and routing will outperform ordinary review and generic administrative streamlining by reducing consequential delay without worsening participant or community outcomes; both benefit and harm falsifiers are stated."},"bounded_next_evidence_step":{"status":"YES","reason":"A one-institution retrospective audit and blinded dual-classification exercise can compare independently screened low-risk protocols with matched ordinary-review cases without changing live approvals, and can reject the premise if disproportionate requirements or consequential effects are absent."},"no_unresolved_safety_or_authority_stop":{"status":"UNCERTAIN","reason":"Exclusions, monitoring, suspension, and rollback address foreseeable safety risks, but classifier validity, protection-equivalence thresholds, delayed and collective harms, and institutional authority under governing mandates remain unresolved."},"implementation_cost_scope_and_range":{"status":"YES","reason":"A one-institution evidence exercise and controlled pilot can be bounded by review cycle, protocol class, staffing, governance, monitoring, and evaluation, permitting broad resource-equivalent cost bands despite low confidence."}},"blocking_evidence":["Baseline evidence that independently low-risk qualitative protocols experience requirements disproportionate to their plausible risks and that these requirements cause consequential delay, missed field windows, method degradation, or abandonment.","An operational qualitative-risk taxonomy with reproducible blinded eligibility decisions, adjudication rules, and acceptable misclassification performance.","A defined protection-equivalence standard covering consent, privacy, participant burden, power asymmetry, equitable exposure, and individual and community harm.","Preset complaint, incident, distributional, and delayed-harm boundaries tied to suspension and rollback decisions.","Confirmation that the authorized ethics body may lawfully and institutionally operate the proposed path.","Evidence distinguishing classification mismatch from incomplete submissions, legitimate substantive scrutiny, and raw reviewer scarcity."],"next_evidence_step":"Conduct a preregistered, retrospective one-institution audit using a bounded sample of completed qualitative protocols: have independent blinded reviewers apply a draft risk taxonomy, compare protocols classified as low risk with complexity- and completeness-matched ordinary-review cases on review duration, repeated risk-irrelevant requirements, study changes, withdrawals, complaints, privacy incidents, and documented community concerns. Reject progression if classification agreement is inadequate, mismatch is not observed, consequential outcomes are not associated with the alleged mismatch, or the draft path would omit material safeguards.","research_questions":["How prevalent are risk-irrelevant requirements and consequential delays among independently classified low-risk qualitative protocols?","Can low-risk eligibility be defined and applied reproducibly without strategic understatement or systematic exclusion of collective, delayed, or power-related harms?","Are observed delays primarily caused by classification mismatch, submission incompleteness, legitimate substantive scrutiny, or reviewer scarcity?","What safeguards and outcome thresholds would establish protection equivalence between the proposed and ordinary paths?","Which participant or community groups would receive benefits or bear additional exposure under the alternative path?","What institutional or external mandates constrain the ethics body's authority to change routing and review requirements?","How long must monitoring continue to detect rare, delayed, privacy, and community-level harms?","Does the proposed path add value beyond shorter forms, clearer guidance, or added reviewer capacity?"],"recommendation":"PARTNERED_RESEARCH","uncertainty_constraints":["Problem prevalence, consequence magnitude, stakeholder demand, intervention effect, and scalability are unsupported by the sealed packet.","The proposal cannot yet distinguish disproportionate classification from necessary ethical scrutiny or reviewer scarcity.","The low-risk classifier and protection-equivalence standard are unspecified and unvalidated.","Rare, delayed, collective, and distributionally concentrated harms may not appear during a short pilot.","Institutional authority depends on mandates not established in the packet.","Cost bands are planning-level resource equivalents, not observed costs.","No inference about market size, adoption prevalence, realized impact, or world novelty is warranted."],"closed_book_prior_art_boundary":"Prior art is unsearched and unverified. This closed-book assessment makes no claim that the qualitative-risk-specific review path is novel, uncommon, or absent from existing institutional practice, policy, scholarship, or regulation."}