October 10 2024
Article submitted by the PSC Quality Control and Communication Subcommittee
Consent withdrawal occurs when a patient formally requests to end trial participation and cease contact and submission of further trial data. In order to maintain validity of the data and limit compromise, patients should be encouraged to continue follow-up even if they discontinue study treatment.Essential study data are crucial for assessing the safety and effectiveness of the research.
NRG Oncology provides a Consent Withdrawal Guidance Document, which emphasizes the need for clear documentation of a patient’s decisions regarding treatment, visits, specimens, scans, questionnaires, and other study specific requirements including reporting data. This document aligns with FDA Clinical Trial Data Retention Guidance and Good Clinical Practice standards.
To ensure patient safety, communication with the clinical investigator is essential prior to treatment withdrawal. The investigator should discuss the continuationof follow-up and data collection with the patient, making it clear that follow-up data will not include study-related interventions but will be obtained through standard medical care and chart review.Privacy and confidentiality will be upheld.The investigator must obtain the patient’s informed consent for limited participation, which should be documented in the research chart. Data collected up to the point of withdrawal should be preserved.
Clarifying Limited Participation Documentation:
- Treatment Withdrawal:The patient withdraws consent from study treatment but agrees to continue protocol-required activities such as visits, scan, labs, patient reported outcomes (QOL).Records may still be used and submitted for the study, and the study team may contact the patient for more information.
- Withdrawal with Limited Data Collection: The patient withdraws consent from participating in all protocol-required activities including optional sub-studies but agrees that data from routine visits may still be submitted to the study.Records may still be used and submitted, and the study team may contact the patient for further information.
- Complete Withdrawal: The patient withdraws consent entirely from the main study and optional sub-studies.No further data or information will be submitted.Information already collected will remain a part of the study, but records will no longer be used or submitted, and the study team will cease contact with the patient.
- Complete Withdrawal and Bio-specimen Destruction: The patient withdraws all consent and request any previously identifiable specimens or data collected for future research must be destroyed and removed from the study.
Additionally, it is beneficial to ask the patient if they wish to be contacted in the future for any new safety concerns.