1. Purpose

To ensure that informed consent is obtained and documented from every research subject, or the subject's legally authorized representative, before any study procedure is performed, and that consent remains an ongoing process throughout participation.

2. Scope

Applies to all studies requiring informed consent, including screening-only consent, consent by legally authorized representatives, assent of children, re-consent, and consent obtained remotely or with translation.

3. Responsibilities

• Principal Investigator: Retains overall responsibility for the consent process and delegates consent administration only to trained, logged staff.
• Delegated Consent Administrator: Conducts the consent discussion, assesses understanding, and completes documentation.
• Clinical Research Coordinators: Verify the consent version, file the original, and provide a signed copy to the subject.
• Quality Assurance: Audits consent documents for completeness, correct version, and timing relative to study procedures.

4. Definitions

Legally authorized representative (LAR)

An individual authorised under applicable law to consent on behalf of a prospective subject to participation in the research.

Assent

A child's affirmative agreement to participate; mere failure to object is not assent.

Re-consent

Obtaining consent again using a revised document, or after new information relevant to the subject's willingness to continue.

Short form consent

A written statement that the required elements were presented orally, used with a witnessed oral presentation and written summary.

5. Procedure

1. Confirm before every consent discussion that the document being used is the current IRB-approved version, and that the approval has not expired.
2. Perform no study procedure of any kind, including screening laboratory tests, imaging, questionnaires or washout of medication, before the subject or LAR has signed and dated the consent document.
3. Conduct the discussion in a private setting, in language understandable to the subject, allowing sufficient time and opportunity to ask questions without coercion or undue influence.
4. Cover all required elements: purpose, expected duration, procedures and which are experimental, foreseeable risks, potential benefits, alternatives, confidentiality including how protected health information will be used, compensation and injury provisions, voluntary nature, and whom to contact.
5. Assess comprehension using open-ended teach-back questions and document the assessment; re-explain any element the subject cannot describe in their own words.
6. For a subject unable to consent, confirm and document the LAR's legal authority, obtain the LAR's signature, and obtain the subject's assent where the subject has capacity to assent.
7. For children, obtain parental permission from the number of parents required by the IRB and document the child's assent according to the IRB-approved age-appropriate process.
8. Where the subject does not read or speak English, use an IRB-approved translated consent document, or the short form process with a qualified interpreter and an impartial witness, and document the method used.
9. Have the subject or LAR personally date their own signature, and ensure the person conducting the discussion signs and dates on the same day; never pre-date, back-date or sign on the subject's behalf.
10. Verify that the signature date and time precede the first study procedure, and record the consent time when procedures occur on the same day.
11. Provide a fully signed copy of the consent document, and the HIPAA research authorisation, to the subject or LAR, and document that the copy was given.
12. File the original signed consent in the subject's research record, record the consent event in the source documents and consent log, and note the version signed.
13. Re-consent subjects when a revised consent version is approved that contains information relevant to their continued participation, when new safety information arises, or when a subject regains or loses decisional capacity; document the reason and timing.
14. Report any consent deviation, including missing signatures, wrong version, or procedures performed before consent, to the Principal Investigator the same business day and file a deviation report under CON-002.
15. Retain consent documents for the retention period in DAT-003 and make them available for monitoring, audit and inspection.

6. References

• 21 CFR Part 50 — Protection of Human Subjects, informed consent
• 21 CFR Part 56 — Institutional Review Boards
• 45 CFR Part 46, Subparts A and D — Common Rule and additional protections for children
• 45 CFR 164.508 — Uses and disclosures for which an authorization is required
• ICH E6(R3) Good Clinical Practice
• HIP-001 HIPAA Privacy Rule in Research

7. Revision History

• v3.0 · Nov 14, 2022 — Added teach-back comprehension assessment.
• v4.0 · Jan 20, 2025 — Added remote consent and interpreter documentation requirements.
• v4.1 · Mar 09, 2026 — Clarified same-day consent timing documentation.