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ICMR 2017 aligned · 42 review sections · IRB-ready

Ethics-Committee Submissions
From Protocol to Approval

7 ethics domains. 42 review sections. 14 AI actions. Built on ICMR 2017, GCP-ICH E6 (R2), and Schedule Y.

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ethics.rsminds.com / submission
01IRB Protocol · 8 sections
02Safety & AE · 7 sections
03Consent Builder · 6 sections
04Bias & Integrity · 6 sections
07Compliance Checker · 5 sections
+ 2 more domains — see full workflow below
0

review sections — full IRB package

0

AI actions — drafting, audit, classification

0

ethics domains — IRB to compliance

₹0/mo

starts here · 7-day money back

How EthicsMinds works

7 domains. 42 sections.

Each domain is its own AI-assisted workflow. Outputs flow forward — your IRB risk tier informs the consent form; deviations feed into compliance; everything assembles into a submission-ready package.

01

IRB Protocol

8 sections

Inputs

Study overviewPopulationDesign type

AI action

suggestEthics + suggestPrivacy

Output

Risk tier, vulnerable-population protections, benefit analysis, 45 CFR 46.116 consent map, data-privacy plan, 13-item submission checklist.

Saves 4–6 hours of IRB protocol drafting
02

Safety Monitoring

7 sections

Inputs

Intervention typeAE historyAuthority list

AI action

generateSafetyProtocol + causalityAssess

Output

AE/SAE/SUSAR definitions, event registry, WHO-UMC + Naranjo causality, DSMB charter, emergency unblinding procedures.

Saves 3–5 hours and aligns with ICH E2A–E2F
03

Informed Consent

6 sections

Inputs

Study contextPopulationRisks

AI action

generateConsentForm + scoreReadability

Output

45 CFR 46.116 mapped consent form, special-population variants, Flesch-Kincaid readability audit, multi-language ready.

Saves 2–4 hours and catches readability gaps
04

Bias & Integrity

6 sections

Inputs

DesignVariablesData source

AI action

auditBias + auditDataIntegrity + suggestMitigation

Output

RoB2 5-domain audit, fabrication-risk score, confounding control plan, per-domain mitigation strategy.

Saves 2–3 hours of bias-narrative work
05

Protocol Deviations

5 sections

Inputs

Deviation eventPhaseSite

AI action

classifyDeviation + suggestCorrective

Output

Severity classification, root cause analysis, CAPA plan with timelines, report formatted for regulatory submission.

Saves 1–2 hours per deviation event
06

COI Disclosure

5 sections

Inputs

Investigator profileInterests

AI action

assessConflict

Output

Financial and non-financial interest documentation, severity scoring, management plan with review frequency.

Saves 1 hour per investigator and audit-ready
07

Compliance Checker

5 sections

Inputs

Protocol textReporting standard

AI action

auditCompliance + generateComplianceReport

Output

Item-by-item audit against CONSORT/SPIRIT/STROBE/PRISMA, gap analysis with priority, compliance certificate with score.

Saves a half-day of standards mapping

Domain coverage

7 ethics domains — all covered

From the IRB protocol to the compliance certificate. Every domain has chip-driven sections, AI assistance, and ICMR 2017 mapping for Indian ethics committees.

IRB Protocol

8 sections

  • Study Overview

    Design type, category, population chips.

  • Risk Assessment

    9 risk-factor chips, risk-level tier.

  • Vulnerable Populations

    6 groups + protection chips (AI).

  • Benefit Analysis

    Direct + societal benefits, mitigations.

  • Informed Consent

    15 × 45 CFR 46.116 section chips.

  • Data Privacy

    Anonymisation + storage chips (AI).

  • Submission Checklist

    13-item document-readiness chips.

  • Document Export

    IRB protocol markdown + DOCX.

Safety & AE

7 sections

  • Event Definitions

    AE/SAE/SUSAR/UP + CTCAE grade chips.

  • Event Registry

    Add / edit / remove adverse events.

  • Reporting Timelines

    Per-event timeline + authority chips.

  • Causality Assessment

    WHO-UMC + Naranjo algorithm (AI).

  • DSMB Charter

    Composition + stopping-rule chips (AI).

  • Emergency Procedures

    Unblinding + safety-action chips.

  • Safety Protocol Export

    AI synthesis + download.

Consent Builder

6 sections

  • Study Context

    Design + population + procedures.

  • Risk & Benefit Disclosure

    Risks + benefits + alternatives (AI).

  • Consent Sections (15)

    Toggleable CFR section chips (AI).

  • Special Populations

    Special form + language chips.

  • Readability Audit

    Flesch-Kincaid grade + chips (AI).

  • Consent Export

    DOCX / PDF / Markdown.

Bias & Integrity

6 sections

  • Study Setup

    Design + variables + data source chips.

  • ROB2 Bias Audit

    5-domain + overall rating chips (AI).

  • Data Integrity

    Integrity tool + fabrication risk (AI).

  • Confounding Control

    Confounder + control method chips.

  • Mitigation Strategies

    Per-domain mitigation chips (AI).

  • Bias Report Export

    Consolidated report download.

Protocol Deviations

5 sections

  • Study Context

    Design + phase + site chips.

  • Deviation Log

    Per-event category + severity chips.

  • Root Cause Analysis

    Root cause + factors chips (AI).

  • CAPA Plan

    Corrective + preventive + timeline (AI).

  • Deviation Report

    Report-to chips + AI summary.

COI Disclosure

5 sections

  • Investigator Profile

    Role chips + institution.

  • Financial Interests

    Interest type + amount chips.

  • Non-Financial Interests

    Non-financial type + relations (AI).

  • Risk Assessment

    Severity + impact area chips (AI).

  • Management Plan

    Action + review-frequency chips (AI).

Compliance Checker

5 sections

  • Select Standard

    CONSORT / SPIRIT / STROBE / PRISMA / ...

  • Protocol Input

    Input method + textarea chips.

  • Item-by-Item Audit

    Per-item status chips (AI).

  • Gap Analysis

    Critical gaps + recommendations (AI).

  • Compliance Certificate

    Score + grade + download.

Compliance

Built on the standards
your IEC expects

Integrated

ICMR 2017

National Ethical Guidelines (India)

Integrated

GCP-ICH E6 (R2)

Good Clinical Practice — integrated addendum

Integrated

Schedule Y

Indian Drugs & Cosmetics Act — clinical trials

Integrated

Declaration of Helsinki

WMA — ethical principles for human research

Integrated

Belmont Report

Respect, Beneficence, Justice — US foundational

Integrated

CIOMS Guidelines

International ethical guidelines, low-resource settings

Integrated

DPDP 2023

Digital Personal Data Protection Act (India)

Integrated

45 CFR 46

US Common Rule — human subjects protection

Integrated

45 CFR 46.116

Required elements of informed consent

Integrated

ICH E2A–E2F

Safety reporting and pharmacovigilance

Integrated

CTCAE v5.0

Common Terminology Criteria for Adverse Events

Integrated

WHO-UMC

Causality assessment — adverse drug reactions

Integrated

Naranjo Algorithm

ADR probability scoring

Integrated

ROB2

Cochrane Risk of Bias — randomised trials

Integrated

21 CFR Part 11

Electronic records & signatures

Integrated

HIPAA · GDPR

Data privacy and subject-rights frameworks

Your submission package is graded against every applicable standard in real time.

Why this matters

ICMR 2017 alignment,
section by section

Other tools

Generate text. Hope it lands.

You get a generic ethics narrative — no mapping to ICMR 2017 chapters, no flagging of missing elements, no second pass on whether your consent form satisfies Section 4.1 or your DSMB charter satisfies Section 5.6. The IEC catches gaps you didn't know existed.

EthicsMinds

Every section graded against ICMR 2017.

All 42 review sections are scored in real time against ICMR 2017 chapters. Gaps are flagged before you submit — with the specific clause, the missing element, and a one-click suggestion to fix it.

  • Per-section ICMR 2017 chapter and clause mapping.
  • Real-time gap analysis — flagged before, not after, submission.
  • Cross-checks against Schedule Y and GCP-ICH E6 (R2).
domain 1 / IRB protocol · ICMR 2017 alignment scorecard

Sections graded

42 / 42

every section · scored continuously

ICMR 2017 chapters

12 mapped

cross-linked to clauses

Alignment

96.4%

3 gaps flagged · fix before submit

Plans

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  • All 7 ethics domains
  • 42 review sections
  • ICMR 2017 alignment scoring
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FAQ

Frequently asked questions

Common questions from PIs, sub-investigators, and IEC member-secretaries.

Does this work for multi-centric studies?

Yes. The IRB Protocol domain captures multi-site information (sponsor category, site list, PI per site) and the Safety domain accommodates centralised vs decentralised reporting timelines. ICMR 2017 multi-centric requirements are mapped in real time.

Can I prepare submissions for pediatric or vulnerable populations?

Yes. The Vulnerable Populations section covers 6 protected groups (pediatric, pregnant women, prisoners, cognitively impaired, economically/socially disadvantaged, terminally ill) with population-specific protection chips. The Consent Builder includes special-population assent forms and LAR provisions.

Does it cover biobank or genomic study consent?

Yes. The Consent Builder maps 15 × 45 CFR 46.116 elements including future-use, broad-consent, and tissue/data sharing clauses. ICMR 2017 chapter 11 (biological materials) cross-references appear inline.

Can I generate annual progress reports for the IEC?

The Protocol Deviations and Safety domains keep a running event log throughout the study. At any point you can export an annual-progress-report (APR) draft covering enrolment, deviations, SAEs, and DSMB recommendations.

Is the platform DPDP 2023 compliant?

Yes. Data privacy is a first-class section in the IRB Protocol domain with DPDP 2023 chip mapping (purpose, retention, cross-border transfer, consent withdrawal). Your study data stays in your account; we never train models on it.

Will my ethics committee accept the output?

Output structure matches ICMR 2017 and the CDSCO/DCGI Schedule Y submission template. Indian and international IECs recognise the format. Every line is editable — you retain final editorial control before submission.

How does ICMR 2017 alignment scoring work?

Each of the 42 sections is graded continuously against ICMR 2017 chapter clauses. The dashboard shows your overall alignment percentage and lists specific gaps (e.g. "Section 4.1: missing capacity-assessment statement"). Fix and re-score with one click.

What if I run out of Mindful Tokens mid-submission?

Top up any time with Boost (₹149), Lab (₹349), or Project (₹699) packs. Top-up tokens never expire while you remain subscribed. Your draft is preserved either way.

Can I import an existing protocol?

Yes. Paste any synopsis or protocol text and the tool extracts study context, design, population, and risk factors to pre-fill multiple sections — no re-typing.

Can I cancel anytime?

Yes — cancel from Settings. Access continues to the end of the paid period. Your submission documents export and are yours to keep even after subscription ends.

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