November 12 2024
Obtaining informed consent is one of the most important tasks when conducting human research studies. The rules and regulations concerning human research and informed consent are integral to conducting ethical research. Informed consent allows individuals to decide voluntarily whether to participate in a study after understanding the research goals and any associated risks. This process goes beyond just signing a form—it requires clear communication about what the study involves.
Many research studies include optional specimen components, allowing patients to contribute data or biological specimens for future research. While this is a valuable aspect of advancing science, it also introduces challenges in ensuring these optional collections are managed correctly.
In practice, specimens collected from study participants who graciously donate for future research can often present operational management challenges. Proper accountability and management of optional specimens are essential components of maintaining participant trust in the research process.
Missing collection requirements or time points or not carrying out a participant’s consent choices for optional specimen collection are some of the challenges sites face. Here are some best practices to mitigate challenges associated with optional sample collection and management:
- Study Calendars and Schedules:
For paper-based systems, create a study calendar that outlines optional and mandatory study elements and timelines side by side. This ensures optional collections are tracked along with other study assessments. - Real-Time Consent Checks:
Prior to concluding the consent process and copying a signed consent form for the subject, review it carefully to ensure all signatures, initials, and selections/checkboxes are complete. If anything is missed, the subject can still make their choice while present. Updates to a signed consent form must be implemented appropriately. - Electronic Tracking Systems:
For online systems, use tracking grids or spreadsheets to monitor each subject’s progress, including optional study requirements and timepoints. Mark optional collections as completed in real-time to avoid missing deadlines. - Sticky Notes and Calendar Alerts:
Use tools such as EPIC sticky notes or Outlook calendar reminders to track optional collections. These reminders can include non-PHI information like study timepoints, lab visits, or specimen collection kits. - Training:
Provide training sessions for study teams/coordinators on specimen collection, handling, storage, and submission. This should include courier service coordination. - Withdrawal Process:
Remembering that informed consent is an ongoing process; establish a site process that supports clear communication with participants, documents changes in consent wishes and follows those changes through study operations. - Conduct Internal Audits:
Conduct internal audits to include study specimen requirements, including optional studies adherence. - Once Agreed to No Longer Optional:
Once a participant agrees to participate in optional specimen collection in the signing of the informed consent document, that specimen collection is no longer optional. The collection of those specimens is then required for that study participant unless consent is withdrawn and clearly documented in the medical record.
Additionally, it is important to note that in the US optional studies participation is optional for the study participants not optional for sites. US sites are not permitted to remove the optional specimen component from the protocol or the consent form. The protocol document will define optional specimen collection and submission requirements. International participation may differ by protocol.
By establishing internal processes and providing training and education to our site staff, we can ensure the proper use of these valuable patient-donated samples, ultimately contributing to better research outcomes and patient care.
Written by:
- Belinda Buehl, BS Regulatory Specialist, University of Wisconsin, Dept of Human Oncology – Radiation Oncology Team, with contribution from, Marissa Weiss, Kristin Font, Lisa Sanchez, Nick Anger, and Dillon Gamette (Radiation Oncology Research Team, University of Wisconsin).
- Dr. Prabha Pulipparacharuvil; Project Manager, Big-Data –Initiative Program, Dept. of Radiation Oncology, UT Southwestern Medical Center , Dallas , Texas.
- Michele Harmon RN, BSN, Southeast Clinical Oncology Research Consortium Inc, NCORP Administrator