Clinical Trial Informed Consent Discussion Note

Date/Time of Discussion: [Date and time]

Setting/Modality: [in-person / telephone / video]; [Location]

Language/Interpreter: [Language]; [Interpreter name/ID and modality] (Include only if interpreter used or discussion conducted in non-English language)

Participants Present:

• [Participant name or initials]
• [LAR name, relationship, authority basis] (Include only if applicable)
• [Witness name and role; reason required] (Include only if used)
• [Person obtaining consent: name, role/credentials]

Study & Consent Materials

• Protocol Title: [Protocol title]
• Protocol Number: [Protocol number]
• Sponsor: [Sponsor name]
• Site/Institution: [Site/Institution]
• IRB Identifier: [IRB approval number]
• NCT Number: [NCT number, or "unknown at time of note" if unavailable]
• Participant Status: [screening candidate / enrolled / re-consent / discussion only]
• ICF Version/Stamp Date: [IRB-approved version date or stamp date]
• ICF Language: [Language]
• Consent Modality: [paper / eConsent]
• HIPAA Research Authorization: [completed / waived by IRB / not required / pending]
• Optional/Ancillary Consents: [Genetic sub-study, biobanking, data sharing/future use — note decision for each: accepted / declined / deferred] (Include only if applicable)
• Copy Provided to Participant: [yes / no]; [paper / electronic]

Discussion Summary

[Concise narrative of topics reviewed: that this is research; purpose and design including randomization/blinding/placebo if applicable; key procedures and visit expectations; major foreseeable risks; potential benefits and uncertainty; alternatives including standard care; privacy and data access; costs and compensation if applicable; voluntariness and right to withdraw; contact information for questions, rights, and research-related injury] (Summarize what was actually discussed in plain language; omit non-applicable elements)

Participant Questions and Responses:

• Q: [Participant question] → A: [Response provided]
• (Add additional Q→A items as needed; if no questions asked, state opportunity was provided and participant had no additional questions)

Understanding & Voluntariness

• Decision-maker: [Participant with capacity / LAR with relationship and authority basis]
• Comprehension approach: [teach-back / paraphrase / other method used]
• Evidence of understanding: [Summary of what participant verbalized in own words regarding key elements: purpose, procedures, risks, benefits, alternatives, voluntariness, right to withdraw]
• Misunderstandings corrected: [Description] (Include only if applicable)
• Time provided to consider: [Duration/interval; materials provided for review]
• Voluntariness: [Statement confirming consent was voluntary and free of coercion or undue influence]

Consent Outcome

Outcome: [consented and signed / decision deferred / declined]

If Consented and Signed:

• Signatory: [Participant name] or [LAR name, relationship, authority basis]
• Person Obtaining Consent: [Name, role/credentials]
• Witness: [Name, role] (Include only if required/used)
• Date/Time Signed: [Date and time]
• Pre-consent procedures: [Confirm no study procedures occurred prior to consent, or describe IRB-approved exception if applicable]
• Process Notes: [For remote consent: identity verification and document delivery method; for short-form: reason, interpreter/witness roles, summary provided; for re-consent: trigger, changes reviewed, decision to continue/withdraw] (Include only if applicable)
• Immediate next steps: [Screening scheduled / research visit planned / coordination needs / none]

If Decision Deferred:

• Materials provided: [ICF copy, summary sheet, contacts]
• Follow-up plan: [Planned contact method and timeframe]

If Declined:

• Reassurance provided: [Confirm clinical care unaffected by decision]
• Reason for decline: [Participant-stated reason] (Include only if offered)

(Omit sections or elements not applicable to the specific study. For witness, interpreter, or LAR fields, include only when used. Avoid exculpatory language or wording implying waiver of participant rights.)