By Micki Duerre (Principal Clinical Research Associate)
In clinical research, informed consent is far more than a signature on a form – it is the foundational process that supports ethical participation and regulatory compliance. As clinical trial professionals, we understand that the consent process is not just an ethical obligation; it is a legal requirement, both federally and internationally, to ensure that potential study participants are fully informed and educated before enrolling.
Why Informed Consent Matters
The FDA and global regulatory bodies mandate informed consent; it is the cornerstone of ethical research. But true compliance goes beyond handing over a document. It’s about guiding potential participants through a thoughtful decision-making journey. This includes clearly explaining the study’s purpose, outlining potential risks and benefits, presenting available alternatives, and verifying that they understand the nature and requirements of their participation.
The Impact on Inaccurate Consenting: 2023 BIMO Inspection Insights
Recent metrics from FDA’s 2023 Bioresearch Monitoring (BIMO)1 inspections revealed that protocol compliance remains a top concern. Within this category, several recurring issues related to Informed Consent Forms (ICFs) were identified:
- ICF not aligned with the investigational plan
- Revised consent not obtained or not obtained in a timely manner
- ICF not obtained prior to screening, reconsent, or investigational product administration
- ICF missing at rescreening
- ICF not obtained at all
- ICF not obtained for sub-studies
These findings underscore the importance of implementing robust oversight and standardized procedures. Conversely, inadequate governance in clinical research can lead to legal ramifications, ethical concerns, threats to patient safety, reputational harm, and suboptimal patient outcomes.
Monitoring the Informed Consent Process Is Rigorous: The Key Elements
With 30 years in the clinical research industry, Micki Duerre has participated in numerous BIMO audits and developed deep expertise in the informed consent process. Her work focuses on ensuring compliance, ethical standards, and participant protection through meticulous consent documentation and monitoring practices.
When reviewing the consent process during monitoring visits, I focus on several critical elements and here are the TOP TEN recommendations I have for all sites:
- Regulatory Binder Review: Track all Independent Review Board (IRB)/Ethics Committee (EC)-approved consent versions and know the difference or elemental changes between the versions. I recommend maintaining a spreadsheet for easy tracking.
- IRB/EC Requirements for Reconsent: Understand whether updated consents apply to all participants or only new enrollees. Review the IRB/EC letter to determine if the reconsent must be documented via the updated consent form, or if the changes to the consent can be verbally communicated and documentation in the research record. NOTE: if the IRB/EC approval letter does not specify instructions for reconsent, you may want to seek documented guidance from the IRB/EC.
- Consent Version Validity: Confirm the version used is the IRB/EC-approved version for the visit.
- Are all pages present (look at the consent and count the pages).
- Is the original, signed version on file?
- Did the participant receive a copy of the consent form2 (if following ICH GCP, the participant should receive a copy of the signed and dated written informed consent form prior to participation)3
- Signatures and Dates: Verify that both the participant and consenter signed and dated the form appropriately (the participant must sign AND date their own consent). If a Power of Attorney (POA) has been signed, ensure documentation is on file, is valid and provides permission for medical decisions. Verify the dates are the same. If the dates are not the same ensure there is proper documentation explaining the difference in dates (e.g., consent was mailed to the participant).4
- Consent Notes: Look for contemporaneous documentation of the consent discussion, especially if dates differ or if the process was conducted remotely.
- Case History: Ensure that the case history or consent note documents that informed consent was obtained prior to participation in the study.5
- Remote Consent: Confirm IRB/EC approval for remote consent and verify that the digital signature platform is CRF Part 11/Annex 11 compliant. In addition, the investigator or designee should have measures in place to ensure the identity of the participant (or legally acceptable representative) in accordance with applicable regulatory requirements.
- Language Considerations: Ensure translated consent forms are available for each approved version and the site’s Standard Operating Procedures for non-English-speaking participants has been followed. NOTE: Ask the Research Coordinator for their consenting SOPs.
- Consenter Documentation: Check that the consenter is listed on the Delegation of Authority (DOA) log and has received proper training.
- Timing of the Consent: Is the participant consenting just prior to a procedure? If so, did they have adequate time to make an informed decision? Verify the informed consent was obtained prior to initiating any study-related procedures by cross-checking the consent time with the documented timing of other study required procedures.
My Personal Consent Monitoring Checklist
To streamline the review process, I use both an excel spreadsheet (to track consent versions and approvals) and a OneNote checklist that includes:
- Consent version: [what is the version date of the consent]
- Participant signature date: [what date did the participant sign]
- Consenter signature date: [what date did the consenter sign]
- Date of contact: [what is the date of consent or the date the participant was contacted]
Check for the following:
✅ Correct version and completeness of the form
✅ All pages are present
✅ Original is on file
✅ Consenter is on DOA
✅ Patient signed and dated their own consent
✅ Patient received a copy
✅ Consent note documents that consenting the participant took place prior to any study-related procedures
Notes on any anomalies or deviations: [I would use this section to document details of the consent process, including whether it was conducted remotely or on-site, electronically or in writing. Note if a translated consent form was used and whether it was administered appropriately. Include any additional observations or clarifications that may be helpful for future reference.]
Final Thoughts
Consenting a research participant may seem straightforward, but the nuances are many. From regulatory compliance to ethical considerations, every step in the process matters. By staying vigilant and methodical, we can uphold the integrity of our studies and protect the rights of our participants.