Informed Consent Process and Documentation

1. Purpose

This SOP describes how [SITE NAME] obtains, documents and maintains the informed consent of trial participants. It covers who may obtain consent, control of consent versions, the consent discussion, consent by a legally authorized representative (LAR), parental permission and assent for minors, consent of people who do not read or speak English, remote consent and electronic consent (eConsent), signatures and dates, the HIPAA authorization, re-consent, ongoing consent, consent errors, and the limited situations in which the IRB may waive or alter consent.

2. Scope

This SOP applies to every study at [SITE NAME] that requires informed consent, including consent for pre-screening procedures, optional sub-studies, specimen banking and future-use consents. It applies to all staff who obtain consent or handle consent records, at every site location and for remote consent.

Determining who may legally act as an LAR, the age of majority, and any state-specific consent requirements depends on state law. This SOP does not list state rules. The site records them in Appendix A State Law Worksheet, and the IRB's determinations for each study govern.

Consent for trials that are federally funded is also subject to 45 CFR 46 (Common Rule). Most industry-sponsored trials at [SITE NAME] are subject to FDA regulations only. Withdrawal of consent is in SOP-309.

Where the protocol, sponsor or IRB requirement is stricter than this SOP, the site follows the stricter requirement.

3. Responsibilities

4. Definitions

5. Procedure

5.1 Who may obtain consent

• GCP and human subject protection training per SOP-103
• training on this SOP
• study-specific training on the protocol, the consent materials and the investigational product
• for eConsent, training on the platform
• at least [DEFAULT: one observed consent discussion and one consent conducted under observation by a staff member already delegated consent]

5.2 Consent materials and version control

• study, document title, language and population (for example adult, LAR, parental permission, assent by age group, short form, optional sub-study)
• version number and version date
• IRB approval date and the date the version is released for use at the site
• the version it supersedes and the date that version was withdrawn
• whether re-consent is required, and of which participants (section 5.13)
• for eConsent, the date the platform version was checked against the approved document
• the date staff who obtain consent were informed of the new version

5.3 Who gives consent

• the IRB has approved enrollment of adults who cannot consent for themselves for this study
• the person acting as LAR qualifies under the law of the state where the research takes place, as recorded in Appendix A and in [CENTRAL IRB NAME] policy
• the person obtaining consent has verified and recorded the basis of the LAR's authority (for example health care power of attorney, court-appointed guardianship, or a relationship that qualifies under the state's surrogate rules), and filed a copy of any document relied on

• whether permission of one or both parents is required (21 CFR 50.55(e)): one parent is sufficient for research under 50.51 or 50.52; both parents are required under 50.53 or 50.54 unless one parent is deceased, unknown, incompetent, not reasonably available, or only one parent has legal responsibility for care and custody
• whether assent is required, for which ages, and whether and how assent is documented (21 CFR 50.55(g))

5.4 Before the consent discussion

• checks F-301-02 and confirms the form in hand, or on the eConsent platform, is the current IRB-approved version for this population and language
• confirms all pages are present
• confirms they are delegated consent for this study on F-302-01
• arranges a private setting and enough time
• arranges an interpreter or impartial witness if needed (sections 5.7 and 5.8)

5.5 The consent discussion

• that the trial is research, its purpose, and what is experimental
• procedures, visits, duration, and what is expected of the participant
• foreseeable risks and discomforts, including to a partner, embryo, fetus or nursing infant where relevant
• possible benefits, or that no benefit is expected
• alternatives, including not taking part
• payment, expenses, costs and research-related injury
• confidentiality, access to records by the sponsor, monitors, the IRB and FDA, and the ClinicalTrials.gov statement where applicable
• that participation is voluntary, that the person may stop or withdraw at any time without penalty or loss of benefits, and what happens to their data if they withdraw
• whom to contact with questions about the study, about their rights, or about a possible injury

5.6 Signatures, dates and copies

• an investigator, if the IRB, sponsor or site decision in section 5.1 requires it
• an impartial witness, when the participant or LAR cannot read (section 5.8), or for the short form process (section 5.7)
• a parent or guardian giving permission, and the child where assent is documented
• an interpreter, if the IRB-approved form has an interpreter line

5.7 People who do not speak or read English well

• the IRB has approved the English written summary (normally the English consent form) and the short form in the person's language
• a qualified interpreter presents the summary orally in the person's language
• a witness is present for the entire oral presentation; for non-English speakers the witness should be conversant in English and the person's language. FDA's 2023 Informed Consent guidance recommends an impartial third party not otherwise connected with the investigation (for example clinic staff not involved in the research, a patient advocate, or an independent interpreter). A qualified interpreter may serve as the witness if the IRB permits
• the participant or LAR signs and dates the short form only
• the witness signs both the short form and a copy of the summary
• the person obtaining consent signs a copy of the summary
• the participant or LAR receives a copy of the short form and a copy of the summary

5.8 People who cannot read, or cannot sign

5.9 Remote consent and eConsent

• send the current consent form to the person in advance by mail, secure email or portal
• conduct the discussion by phone or video, with the person holding the form
• verify the person's identity (section 5.9.4)
• the person signs and dates the form, and returns it by mail, secure upload or in person; the person obtaining consent then signs and dates with the actual date they sign
• record in F-301-01 the date and method of the discussion, the date of the person's signature, and the date the site received the signed form
• no study procedure takes place until the site has the signed form

• meet 21 CFR Part 11 for electronic records and signatures, including audit trails and signatures linked to their records
• link each electronic signature to a unique individual and record the printed name, date and time of signing and the meaning of the signature (21 CFR 11.50, 11.70, 11.100)
• record which version the participant signed
• give the participant a copy of the signed consent, electronically or on paper

5.10 HIPAA authorization

5.11 Documentation in source and consent QC

• the study, the consent version and language signed, and any optional choices
• the date (and time where relevant) of the discussion and of signature
• who obtained consent, and who else was present (LAR, parent, interpreter, witness)
• how capacity, LAR authority or parental status was confirmed, where relevant
• that the person had time to consider and that questions were answered
• the comprehension check and outcome
• for remote or eConsent, the method and identity verification
• that the participant received a copy
• that no study procedure took place before consent

5.12 Consent errors

• a missing signature or date is not added later with an earlier date; if the person whose signature is missing signs later, they write the actual date they sign, and the CRC records the late entry and the reason in F-306-01 Note to File
• if the wrong version was signed, the participant is consented on the current version at the earliest opportunity, dated with the actual date, and the original form is kept, not destroyed
• if a procedure took place before consent, consent is obtained before any further procedure, and the sponsor and IRB decide whether data from the earlier procedure may be used

5.13 Ongoing consent and new information

5.14 Exceptions, waivers and alterations

• waive or alter some or all elements of consent for a minimal-risk clinical investigation that meets 21 CFR 50.22
• waive documentation of consent under 21 CFR 56.109(c), in which case the IRB may require a written statement to be given to participants

5.15 Withdrawal of consent

6. Related Forms and SOPs

• F-301-01 Informed Consent Process Note
• F-301-02 Consent Form Version Control Log
• F-302-01 Delegation of Authority Log
• F-103-01 Staff Training Log
• F-306-01 Note to File
• F-308-01 Protocol Deviation Log
• F-502-01 Reportable New Information Assessment
• Appendix A State Law Worksheet
• SOP-103 Staff Qualification, Training and Training Records
• SOP-105 Oversight of Service Providers and Vendors
• SOP-203 IRB Submissions, Approval and Continuing Oversight
• SOP-300 Participant Recruitment, Pre-Screening and Advertising
• SOP-302 Delegation of Authority
• SOP-303 Screening, Eligibility Verification and Enrollment
• SOP-306 Source Documentation and Data Integrity (ALCOA+)
• SOP-308 Protocol Deviations and Noncompliance
• SOP-309 Participant Retention, Withdrawal and Lost to Follow-Up
• SOP-313 Decentralized Trial Elements (Remote Visits, Home Health, Direct-to-Participant IP)
• SOP-400 Participant Privacy and HIPAA in Research
• SOP-401 Computerized Systems and Electronic Records
• SOP-402 Record Retention, Archiving and Destruction
• SOP-502 Unanticipated Problems and Reportable New Information
• SOP-700 Internal Quality Control and Quality Assurance Audits
• SOP-703 Corrective and Preventive Action (CAPA)
• SOP-904 Shared Staff, Cross-Site Coverage and Central Services (Model N only)
• Appendix B Central and Site Responsibility Matrix (Model N only)

7. References