05-research

05 - Research

This section demonstrates research data management with consent and provenance tracking, supporting academic institutions and clinical research organizations.

Target Audience

• End Users (Participants): Understand research consent rights
• Developers: Learn research data integration patterns
• Researchers: Implement consent-based data collection
• IRB/Ethics Boards: Audit consent compliance
• Research Institutions: Multi-site collaboration

Regulatory Context

Key Regulations

• Common Rule (45 CFR 46): US federal research regulations
• GDPR: EU data protection for research
• HIPAA: Healthcare research requirements
• ICH-GCP: International clinical trial standards
• Belmont Report: Ethical principles

How This System Helps

• Documented informed consent with timestamps
• Data anonymization tracking
• Multi-institution data sharing with consent
• Participant withdrawal support
• Complete audit trail for IRB review

Examples

01 - Study Enrollment

Participant consent for research study.

npx hardhat run examples/05-research/01-study-enrollment.ts --network localhost

Scenario:

Participant enrolls in study:
├── Informed consent process
├── Consent for specific study procedures
├── Optional consent for future use
└── Right to withdraw at any time

Demonstrates:

• Multi-purpose research consent
• Study-specific consent tracking
• Withdrawal workflow

02 - Data Anonymization

Track data de-identification for research.

npx hardhat run examples/05-research/02-data-anonymization.ts --network localhost

Scenario:

Data preparation for research:
├── Identifiable data collected
├── De-identification process
├── Transformation recorded
└── Anonymized data for analysis

Demonstrates:

• Data transformation tracking
• Anonymization provenance
• Linked data lineage

03 - Multi-Institution

Cross-organization research data sharing.

npx hardhat run examples/05-research/03-multi-institution.ts --network localhost

Scenario:

Multi-site clinical trial:
├── Participant consent at Site A
├── Data shared with coordinating center
├── Analysis by collaborating institution
└── All access tracked

Demonstrates:

• Cross-institution consent
• Data sharing agreements
• Multi-party access logging

04 - Publication Consent

Consent for research findings publication.

npx hardhat run examples/05-research/04-publication-consent.ts --network localhost

Scenario:

Publishing research results:
├── Data analysis complete
├── Request consent for publication
├── Consent for case study publication
└── Acknowledgment in publication

Demonstrates:

• Secondary use consent
• Publication authorization
• Consent verification before publication

Workflow Diagram

┌─────────────────────────────────────────────────────────────────┐
│                    Research Data Workflow                        │
├─────────────────────────────────────────────────────────────────┤
│                                                                   │
│  ┌────────────┐     ┌───────────────┐     ┌─────────────────┐   │
│  │Participant │────▶│Informed Consent│────▶│ ConsentReceipt  │   │
│  └────────────┘     └───────────────┘     └─────────────────┘   │
│                            │                       │             │
│                            ▼                       ▼             │
│  ┌────────────┐     ┌───────────────┐     ┌─────────────────┐   │
│  │ Researcher │────▶│ Collect Data  │────▶│ DataProvenance  │   │
│  └────────────┘     └───────────────┘     └─────────────────┘   │
│                            │                       │             │
│                            ▼                       ▼             │
│  ┌────────────┐     ┌───────────────┐     ┌─────────────────┐   │
│  │   Lab      │────▶│ De-identify   │────▶│ Transformation  │   │
│  └────────────┘     └───────────────┘     │ Tracking        │   │
│                            │              └─────────────────┘   │
│                            ▼                       │             │
│  ┌────────────┐     ┌───────────────┐     ┌─────────────────┐   │
│  │Collaborator│────▶│ Access Data   │────▶│ AuditLog        │   │
│  └────────────┘     └───────────────┘     └─────────────────┘   │
│                                                                   │
└─────────────────────────────────────────────────────────────────┘

Contract Mapping

Function	Contract	Purpose
Study consent	ConsentReceipt	Informed consent records
Data collection	IntegratedSystem	Consent-verified registration
Anonymization	DataProvenance	Transformation tracking
Sharing	DataProvenance	Access logging
Audit	ConsentAuditLog	IRB compliance

Ethical Compliance Mapping

Requirement	System Feature
Informed Consent	KantaraConsentReceipt with full disclosure
Voluntary Participation	Easy withdrawal via revokeConsent
Minimization	Purpose-specific consent
Transparency	getUserConsents for participant access
Accountability	Complete audit trail

Consent Types for Research

Consent Type	Description	Duration
Study Participation	Core research activities	Study duration
Data Collection	Specific data types	As specified
Sample Storage	Biospecimen banking	Long-term
Future Research	Broad consent	Indefinite
Publication	Case study/results	One-time

Next Steps

After completing these examples, explore:

• Healthcare - Clinical research patterns
• Compliance & Audit - IRB audit support
• Advanced Patterns - Delegated consent (guardians)