Overview
Informed consent is one of the most fundamental ethical requirements in clinical research, and its proper documentation is critical for regulatory compliance and participant protection. This checklist provides a systematic approach to reviewing informed consent documentation, ensuring that the consent process meets all regulatory requirements and adequately protects research participants.
Use this checklist when conducting monitoring visits, preparing for audits, or performing quality assurance reviews of informed consent documentation. Each item should be verified against source documents and regulatory requirements applicable to the trial.
Consent Form Version Control
- Current IRB/IEC-approved version identified and documented
- Version date and version number clearly displayed on form
- IRB/IEC approval date documented and matches filed approval letter
- All previous versions catalogued with effective dates
- Version tracking log maintained accurately at site
- Superseded versions clearly marked or removed from use
- Process for transition between versions documented
Required Elements of Informed Consent (21 CFR 50.25 / ICH GCP)
Basic Elements Present
- Statement that study involves research
- Explanation of purposes of the research
- Expected duration of subject participation stated
- Description of procedures to be followed
- Identification of any procedures that are experimental
- Description of reasonably foreseeable risks or discomforts
- Description of benefits to subject or others reasonably expected
- Disclosure of appropriate alternative procedures or treatments
- Description of confidentiality maintenance for records
- Explanation of compensation for participation (if applicable)
- Explanation of compensation for research-related injury (if applicable)
- Explanation of treatment available for research-related injury
- Contact information for questions about research
- Contact information for questions about subject rights
- Contact information for research-related injury
- Statement that participation is voluntary
- Statement that refusal to participate involves no penalty
- Statement that subject may discontinue at any time without penalty
Additional Elements (When Applicable)
- Statement that treatment may involve unforeseeable risks
- Circumstances under which participation may be terminated
- Additional costs to subject for participation
- Consequences of subject's decision to withdraw
- Statement that significant new findings will be provided
- Approximate number of subjects in study
- Statement about use of genetic information (if applicable)
- Statement about biospecimen use (if applicable)
- Statement about future research use of data/specimens
- Statement about commercial profit potential
- Statement about clinically relevant results disclosure
- Statement about investigator financial interest (if applicable)
HIPAA Authorization Elements (US Sites)
- Description of protected health information to be used/disclosed
- Persons authorized to use/disclose the information identified
- Persons to whom information may be disclosed identified
- Description of each purpose of use/disclosure
- Expiration date or event stated
- Subject's signature and date
- Statement of subject's right to revoke authorization
- Description of how to revoke authorization
- Statement that information may be re-disclosed
- Statement about conditioning treatment on authorization
Consent Form Execution Review
For Each Subject Consent Reviewed
- Subject (or LAR) signature present and legible
- Subject signature date present and complete
- Signature date is same as or before first study procedure
- Person obtaining consent signature present
- Person obtaining consent signature date present
- Person obtaining consent listed on delegation log
- Person obtaining consent trained and authorized
- All pages of consent form present
- All pages initialed (if required by site/IRB)
- No blank spaces in areas requiring completion
- Correct consent form version used for enrollment date
- Original filed in site records
- Copy provided to subject documented
For Legally Authorized Representative Consents
- LAR signature present with relationship indicated
- LAR authority documented and appropriate for jurisdiction
- Subject unable to consent documented appropriately
- Assent obtained if subject capable of providing assent
- Assent form properly executed (if applicable)
For Witness Requirements
- Witness signature present (when required)
- Witness printed name present
- Witness date present and matches other dates
- Witness present during entire consent process documented
- Witness not a member of study team (unless appropriate)
- Short form consent procedures followed correctly (if applicable)
Consent Process Documentation
- Time allowed for subject consideration documented
- Subject questions documented and answered
- Subject understanding assessed and documented
- Coercion absence documented
- Discussion participants documented (subject, family, translator)
- Language of consent process documented
- Translator use documented (if applicable)
- Certified translation used (if applicable)
Re-Consent Documentation
- Re-consent obtained for significant protocol amendments
- Re-consent obtained for significant new safety information
- Re-consent date appropriate to amendment effective date
- All subjects requiring re-consent have been re-consented
- Subjects who declined re-consent documented appropriately
- Continuing subjects consented on current version
Special Population Considerations
Pediatric Subjects
- Parent/guardian consent obtained
- Both parents consented (if required)
- Age-appropriate assent obtained
- Assent form appropriate for subject age
- Transition to adult consent at age of majority addressed
Cognitively Impaired Subjects
- Capacity assessment documented
- LAR consent obtained appropriately
- Subject assent obtained when capable
- Ongoing capacity monitoring documented
Emergency Research (If Applicable)
- Exception from informed consent criteria met
- Community consultation documented
- Public disclosure documented
- Family notification procedures followed
Quality and Compliance Issues
- No unapproved consent form versions used
- No expired consent form versions used
- No study procedures performed before consent
- No missing consent forms for enrolled subjects
- No consent dates altered or inconsistent
- Corrections made according to proper procedures
- Any deficiencies reported and corrected
Review Summary
Subjects Reviewed: _________________
Consent Version(s) Reviewed: _________________
Issues Identified: Document any deficiencies or concerns
Corrective Actions Required: Document required corrective actions
Reviewer: _________________ Date: _________________
