IRB Documentation Package

All documentation required for IRB review of Helio as a biospecimen vendor. All documents are provided for review and can be referenced in your IRB application.

Section 1

Informed Consent Template

Use this template as a starting point for your IRB-approved informed consent form. Modify bracketed fields to match your specific study protocol.

Section 2

Data Security Architecture Summary

Helio separates donor identity from research data using a three-tier architecture. No single system contains both personally identifiable information and health data.

1
Tier
Identity Vault
Encrypted, operations-only access. Contains: name, email, phone, date of birth, address, payment information. Never exposed to researchers.
2
Tier
Research Profiles
Anonymized and de-identified. Contains: age range, sex, conditions, medications, biomarkers. This is the only tier researchers access.
3
Tier
Helio ID
Random, non-sequential identifier. The only bridge between Tier 1 and Tier 2. Managed exclusively by Helio operations.
Researchers access Tier 2 only. Tier 1 is never exposed.
Section 3

Business Associate Agreement

Helio will enter into a Business Associate Agreement (BAA) with any covered entity or business associate as required under HIPAA.

BAA Coverage

  • Permitted uses and disclosures of Protected Health Information (PHI)
  • Administrative, physical, and technical safeguards for PHI
  • Breach notification within 60 days per HIPAA requirements, and within 72 hours per applicable state requirements
  • Return or destruction of PHI upon termination of the agreement
  • Subcontractor obligations and downstream BAA requirements

Contact us to request our standard BAA for execution.

Request BAA
Section 4

Adverse Event Protocol

Helio maintains a structured adverse event reporting protocol for all specimen collection events.

  1. Donor experiences complication during draw — phlebotomist provides immediate first aid and stabilization
  2. Phlebotomist reports the event to Helio within 4 hours of occurrence
  3. Helio reports to the research partner within 24 hours
  4. Donor receives follow-up contact from Helio within 24 hours
  5. Serious adverse events reported to IRB of record within 48 hours
  6. All adverse events logged, tracked, and available for audit
Section 5

Specimen Disposition Policy

Helio maintains clear chain-of-custody and disposition protocols for all biospecimens.

Storage & Destruction

  • Residual specimens are stored at the processing lab for up to 12 months
  • After 12 months, specimens are destroyed per OSHA/EPA biohazard waste standards

Donor Withdrawal

  • Specimens not yet distributed to researchers are destroyed within 30 days of withdrawal
  • Specimens already provided to researchers: the researcher is notified of withdrawal, but destruction follows their IRB protocol

Re-consent

  • Re-consent is required for any use of specimens outside the original consent scope
Section 6

Collection Facility Information

All specimens are collected through independently certified facilities that meet federal and state regulatory standards.

Facility Standards

  • All collection facilities are independently CLIA-certified
  • Facility CLIA numbers are provided with each specimen delivery
  • Phlebotomists are licensed per applicable state requirements
  • Chain-of-custody documentation accompanies every specimen

Contact us for specific facility credentials prior to your first order.

Request Facility Info