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Research protocols

A research protocol fixes, before data are collected, what a study asks, how it will answer and what would count as an answer: the hypotheses, the design, the controls, the outcomes, the sample and the analysis. Many failures of credibility trace back to a protocol that was vague, unwritten or changed after the data were seen. This page sets out how protocols are built, registered, reviewed and reported, and what ethics committees, editors and funders rely on when they accept a study's claims.

Systems · around this subjectDesign, not a record

Protocol and replication board

Research protocols · Labs · Quarter 3

Two replications runningGCRI · Nexus Labs

Protocols

PR-378 sensor driftField experimentYesApprovedRunning
PR-705 AI triageRandomisedYesConditionsSetup
PR-694 message recallSurvey experimentYesApprovedComplete
PR-360 heat exposureCohortNoPendingDraft

Replication R-25

Original effect
0.4 SD
Replication effect
0.2 SD
Verdict
Smaller, same sign
Published
with data and code

Testbed availability

Protocol and replication board: the screen's structure, terms and states for Research protocols.Placeholder names and illustrative values; a design, not a record or a live system.

Fig.Protocol and replication board. Design wireframe with placeholder names and illustrative values, not a record or a live system.

01In brief

The short answer.

A research protocol is the plan that fixes, before data are collected, what a study asks, how it will answer and what would count as an answer: hypotheses, design, controls, outcomes, sample and analysis. Many failures of credibility trace back to protocols that were vague, unwritten or changed after the data were seen.

02Geography

Hazards and exposure in World.

For research protocols, in GCRI's spatial-intelligence reading, the map opens on true-colour imagery, land cover and night lights, framed on World; every other NASA layer, live feed and forecast waits in the layer list.

The interactive map needs JavaScript; the layer list and sources are below.

Layers 3

Hazards and exposure, for this page

Latest available

NASA GIBS / EOSDIS · ASTER GDEM (METI, NASA) · Blue Marble (NASA) · © OpenStreetMap contributors (ODbL) · Natural Earth

Loading the latest NASA imagery.

Drag to move. Ctrl or ⌘ and scroll, pinch or the buttons to zoom; hover for the values under the pointer; reset returns to the region.

For research protocols, in GCRI's spatial-intelligence reading, the map opens on true-colour imagery, land cover and night lights, framed on World; every other NASA layer, live feed and forecast waits in the layer list.Satellite and model products as NASA publishes them, each with its own date; indicators, not assessments of any place; claim ceiling INTEGRATED.

Data: NASA GIBS · ASTER GDEM · Blue Marble · © OpenStreetMap contributors · Natural Earth · NASA EONET · GDACS · Copernicus Sentinel-2 L2ASources and licences

  • We acknowledge the use of imagery provided by services from NASA's Global Imagery Browse Services (GIBS), part of NASA's Earth Science Data and Information System (ESDIS). Colours redrawn from the published colour map; values averaged into H3 cells where shown (modified). NASA open data
  • We acknowledge the use of imagery provided by services from NASA's Global Imagery Browse Services (GIBS), part of NASA's Earth Science Data and Information System (ESDIS). Colours redrawn from the published colour map; values averaged into H3 cells where shown (modified). NASA open data
  • VIIRS near-real-time products (flood, land surface temperature, snow cover, corrected reflectance), NASA LANCE; imagery via NASA GIBS. Colours redrawn from the published colour map; values averaged into H3 cells where shown (modified). NASA open data
  • MODIS land products (vegetation indices, gross primary production, land cover), NASA LP DAAC and LANCE; imagery via NASA GIBS. Colours redrawn from the published colour map; values averaged into H3 cells where shown (modified). NASA open data
  • VIIRS Black Marble night-time lights, NASA Goddard Space Flight Center; distributed by the NASA Level-1 and Atmosphere Archive and Distribution System (LAADS DAAC); imagery via NASA GIBS. Colours redrawn from the published colour map; values averaged into H3 cells where shown (modified). NASA open data
  • Center for International Earth Science Information Network (CIESIN), Columbia University. 2018. Gridded Population of the World, Version 4 (GPWv4): Population Density, Revision 11. NASA Socioeconomic Data and Applications Center (SEDAC). Licensed under CC BY 4.0. Colours redrawn from the published colour map; values averaged into H3 cells where shown (modified). CC BY 4.0
  • ASTER GDEM is a product of METI and NASA (ASTER Global Digital Elevation Model V003, NASA LP DAAC); imagery via NASA GIBS. Colours redrawn from the published colour map; values averaged into H3 cells where shown (modified). NASA open data
  • Made with Natural Earth. Free vector and raster map data @ naturalearthdata.com. Public domain
  • © OpenStreetMap contributors (ODbL), via NASA GIBS (coastlines, boundaries, roads and place names). Colours redrawn from the published colour map; values averaged into H3 cells where shown (modified). ODbL
  • Blue Marble, NASA Earth Observatory; imagery via NASA GIBS. Colours redrawn from the published colour map; values averaged into H3 cells where shown (modified). NASA open data
  • Context on the globe and flat map: coastlines, boundaries, roads and place names from NASA GIBS reference layers (OpenStreetMap data, ODbL, © OpenStreetMap contributors); Blue Marble imagery as an optional base; 3D terrain and the elevation read-out from the ASTER GDEM elevation colour index (5 m to 200 m classes, exaggerated for legibility). Boundaries are drawn as published and imply no position on any territory.
  • Globe: MapLibre GL JS 6.9.1, BSD-3-Clause, © MapLibre contributors.
  • Live: NASA EONET Events are indicative, not official warnings.
  • Live: GDACS (EC JRC / UN OCHA) Events are indicative, not official warnings.
  • Observed (EO): Copernicus Sentinel-2 L2A (contains modified Copernicus Sentinel data 2026), Microsoft Planetary Computer
  • Optional layers (35 sources in the layer list: live, forecast, observed and context) print their provider credit on the map and here when switched on; forecasts are model output and derived indices are estimates.

Layers and dates

  • True colour: VIIRS NOAA-20 corrected reflectance, NASA LANCE · 13 Oct 2026
  • Land cover type (IGBP), yearly: MODIS Terra and Aqua land cover (MCD12Q1), NASA LP DAAC · 2024
  • Night-time lights, daily: VIIRS Black Marble (VNP46A2), NASA LAADS DAAC · 12 Oct 2026
  • Population density, 2020: Population: CIESIN, Columbia University, Gridded Population of the World v4.11 (2018), NASA SEDAC, CC BY 4.0 · static
  • Flood water, 3-day composite: VIIRS Global Flood Product, NASA LANCE · 14 Oct 2026
  • Land surface temperature, day, 8-day composite: VIIRS NOAA-20 Level 3, 8-day, NASA LANCE · 14 Sep 2026

03The question

Research protocols: how the risk develops.

Hypotheses, controls and scientific acceptance. The dossier below sets out how the risk develops, what is measured, where the data come from, how it is modelled and who decides.

Mechanism

Flexibility becomes bias

When outcomes, exclusions, covariates or stopping rules are chosen after the data are seen, many analyses become possible and the most striking one tends to be reported. Each choice looks reasonable alone; together they inflate false positives and effect sizes.

Mechanism

Weak controls confound results

A missing control, unblinded assessment or non-random allocation lets something other than the intervention explain the difference. Design flaws cannot be repaired by analysis; they travel into every result and review built on the study.

Mechanism

Underpowered designs mislead twice

Small samples miss real effects, and the effects they do detect tend to be overestimated. Underpowered studies that reach significance seed literatures that later, larger replications cannot match.

Mechanism

Deviations go unreported

Protocols change for good reasons, such as slow recruitment or a safety signal. When a change is not dated, explained and reported, readers cannot tell a justified amendment from outcome switching, and reviews pool what should not be pooled.

04Key terms

Terms used on this page.

Each term as this page uses it. Where a standard-setting body defines the term, the wording follows that body.

TermDefinition
PreregistrationRecording a study's hypotheses, design and analysis plan in a public registry before data collection or analysis.
Registered reportA format in which a journal peer reviews and accepts a study's protocol before results are known.
Reporting guidelineA checklist, such as CONSORT or PRISMA, listing what a study report must include, collected by the EQUATOR Network.
05Indicators

What is measured, and how well.

Each indicator carries its unit, its cadence, the kind of source behind it and the evidence label a value would carry. No values are shown: a programme supplies them under its own authority.

IndicatorUnitCadenceSource typeLabel
Registration before data collectionpercent of studies with a time-stamped registrationannualTrial and study registriesOFFICIAL
Primary outcome consistencypercent of reports matching the registered primary outcomeannualRegistry and publication comparisonOBSERVED
Sample size justificationpercent of protocols with a power or precision rationaleannualProtocol auditOBSERVED
Reporting guideline adherencepercent of applicable checklist items reportedper studyAssessment against CONSORT, PRISMA, ARRIVE or STROBEESTIMATED
Protocol amendmentscount per study, each with a stated reasonper studyRegistry history and ethics committee recordsOFFICIAL
Registered report availabilitynumber of journals offering the formatannualCenter for Open Science journal listREPORTED
Results posting timelinessmonths from primary completion to posted resultsper studyTrial registriesOFFICIAL
Randomisation and blinding reportedpercent of eligible studiesannualRisk-of-bias assessmentsESTIMATED
06Canvas

From sources to decisions.

The topic as a computational graph: named sources feed the methods, an evidence review gates the outputs, and the decisions stay with the authorities that hold them.

Pipeline canvas · Research protocols as a run graphDesign, not a record
Research protocols: systematic evidence synthesisA question is framed with its owner and a protocol registered; records are searched, screened and checked for eligibility by two reviewers; data are extracted, synthesised and graded for certainty before a brief is written. Design of the process, not a record of a run.

Fig. 02Nodes carry their type, two metric rows and a state; connectors show what feeds what; dashed frames name the owners; the timeline is the cadence. Design of the pipeline, not a record of a run.

07Sources

Where the evidence comes from.

Named public datasets and institutional records, each with its licence class. Sources by agreement are used only under their terms and never republished.

SourceWhat it givesLicence class
OSF Registries (Center for Open Science)Time-stamped preregistrations and registered report protocols across disciplinesOpen, licence per registration
ClinicalTrials.gov (US National Library of Medicine)Registered trials, protocol change history and posted resultsPublic domain
WHO International Clinical Trials Registry PlatformSearch across primary national trial registriesFree, WHO terms of use
PROSPERO (NIHR)Registered protocols for systematic reviewsFree access, terms of use
protocols.ioVersioned, citable step-by-step laboratory and field methodsOpen, CC BY for public protocols
EQUATOR Network libraryReporting guidelines by study design, with extensionsFree access, licence per guideline
Crossref metadataLinks between registrations, articles, corrections and fundersOpen metadata, no restrictions
08Decisions

Who decides, and what the evidence serves.

Nexus Labs prepares evidence. The decisions below are taken by the authorities named, under their own rules, and never by the platform.

Who decidesThe questionEvidence this page serves
Research ethics committees and institutional review boardsWhether a protocol's risks, consent and design justify approval, and whether an amendment needs fresh reviewComplete protocol, sample size rationale, amendment history with reasons
Journal editorsWhether to accept a registered report in principle, or whether a submitted analysis matches its planTime-stamped registration compared line by line with the manuscript
Research fundersWhether a proposal's design can answer its question before money is committedPower or precision rationale, control conditions, data management plan
Medicines and device regulatorsWhether trial evidence was generated under the protocol submitted to themRegistry history, deviation logs, results posting record

Outputs this topic produces

  • Protocol templates stating hypotheses, controls, outcomes and analysis plans before data collection
  • Registration records with time stamps and version history
  • Deviation logs that date and explain every amendment
  • Reporting checklists completed against the relevant EQUATOR guideline
09Core questions

What experts ask of any protocol.

  • What exactly is the hypothesis, and what result would count against it?
  • What is the comparison: a control group, a baseline period, a counterfactual model or a randomised arm?
  • Which outcomes are primary, which are secondary, and how will each be measured?
  • What sample, duration or number of runs is needed to detect an effect of the size that matters?
  • What would make the team stop early, for safety or for futility, and who decides?
  • What will be published if the result is null or the experiment fails?
10Mechanisms and drivers

Why experiments drift without a protocol.

Every experiment involves choices: which observations to exclude, which covariates to adjust for, which time window to use. Each choice may be reasonable alone, but when they are made after seeing the data, the number of possible analyses grows quickly and one of them will usually show something. This is the problem methodologists call analytic flexibility, and it is a central reason why published effects often shrink or vanish when repeated.

Interdisciplinary work adds its own drivers. Disciplines differ in what they treat as a control, how they handle missing data and what level of evidence they expect. A hydrologist, an economist and an epidemiologist may each consider a design rigorous by their own standard while disagreeing about what it shows. A protocol forces those differences into the open before work starts.

Incentives matter too. Positive, novel findings are easier to publish and fund, which rewards flexibility and penalises null results. Pre-registration and registered reports are the main structural responses.

11Methods and data

Tools protocols draw on, and where they stop.

  1. 01

    Pre-registration

    A time-stamped record of hypotheses and analysis plans. It limits post hoc changes but cannot stop a poorly chosen question.

  2. 02

    Power and design analysis

    Estimates how much data is needed to detect a meaningful effect, using probability and statistics. It depends on assumed effect sizes that are often uncertain.

  3. 03

    Causal designs

    Randomisation, difference-in-differences, regression discontinuity and instrumental variables from causal inference. Each rests on assumptions that must be stated and, where possible, tested.

  4. 04

    Acceptance criteria

    Pre-agreed thresholds for when a method, model or prototype is considered to work. They make success testable but can be gamed if set too loosely.

A protocol cannot make a bad measurement good or fix a biased sample. Deviations from protocol are permitted when justified, but are reported with their reasons.

12Methods

How it is studied, and what the methods cannot say.

  1. Probability and statisticsSample size and power planning · Meta-analysis with bias assessmentApplied here
  2. Causal inference and impact evaluationRandomised pilots and stepped rollouts · Quasi-experimental programme evaluationApplied here
  3. Uncertainty quantification and model validationMeasurement uncertainty budgets · Sensitivity analysis of simulation modelsApplied here
  4. Systems engineeringRequirements to verification traceability · Stage-gate readiness reviewsApplied here
13Questions

Questions and answers.

What is the difference between a preregistration and a registered report?
A preregistration is a time-stamped plan deposited before analysis. A registered report is a journal format in which the plan is peer reviewed and accepted in principle before results exist, so publication does not depend on the outcome.
Does preregistration forbid exploratory analysis?
No. It separates the two. Planned analyses are reported as confirmatory; analyses suggested by the data are reported as exploratory, with that label, so readers can weigh them accordingly.
Which reporting guideline applies to my study?
It depends on the design: CONSORT for randomised trials, SPIRIT for trial protocols, PRISMA for systematic reviews, ARRIVE for animal research, STROBE for observational studies. The EQUATOR Network keeps the current list and extensions.
Can a protocol be changed after registration?
Yes, with a dated amendment and a stated reason, and with fresh ethics review where the change affects participants. What damages credibility is undisclosed change, not change itself.
Is pre-registration required for every Labs study?
It is designed to be the default for confirmatory work. Exploratory work is welcome but is labelled as exploratory, so that its findings are treated as hypotheses rather than conclusions.
Can a protocol change during a study?
Yes, for good reasons such as safety or an unforeseen data problem. Each change is dated, justified and reported alongside the result.
Who writes the protocol?
The research team writes it; a subject reviewer independent of the team is designed to check it before work begins.
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