Clinical and technological advancements have made it possible to plan groundbreaking oncology study designs and innovative cancer therapies. From a human subject protection perspective, however, these incredible advances also create potential challenges for the research community.
Communicating complex scientific and medical concepts and long lists of potential risks—all while the clock is ticking for the patient—is not easy. Therefore, while effective education is always critical, it is even more so when it comes to contemporary cancer research.
For example, the National Immunotherapy Coalition (NIC), under the Cancer MoonShot 2020 initiative, is establishing the nation’s most comprehensive cancer collaborative initiative to accelerate next generation immunotherapy as a viable treatment for cancer. Novel therapies and study designs like those planned for the program create unique challenges in protecting study participants.
Cancer MoonShot 2020’s Quantitative Integrative Lifelong Trial (QUILT), specifically, seeks to test combinations of therapies on up to 20,000 patients, and an expected 15,000 research sites will participate in the Phase II combination immunotherapy trials across the U.S. as part of the initiative.
Due to the massive scale and complex nature of such innovative cancer research, Schulman IRB, the industry leader in technology and advanced oncology expertise, will serve as the national IRB for Cancer MoonShot 2020 and will help to ensure appropriate protections are in place for those participating in the studies. When it comes to the informed consent process, the specific areas of concern for IRBs are the same for any innovative oncology research initiative or study, even on a smaller scale:
Equitable selection of participants is addressed through careful evaluation of the study eligibility criteria, including potential drug interactions that may be associated with co-morbidities from standard treatment.
Particular attention should be paid to protecting those made vulnerable by socio-economic situations or by the disease itself to avoid potential manipulation or misinformation when the patient considers research participation.
Potential participants need enough time to process their diagnosis and prognosis prior to considering a research treatment option, and the patient’s participation should be an ongoing conversation, especially as risks and benefits change over time.
Impact on Quality-of-Life
Quality-of-life impact, financial risks, and other inconveniences related to research participation may need to be dealt with during the study and must be a part of the consent process.
Collection of biospecimens with associated genomic, epigenetic, and phenotypic data is standard in oncology research. The collection and the possibility of future research must be carefully detailed and discussed throughout the informed consent process.
Complex Concepts, Long Forms
Oncology research consent forms are typically lengthy and complicated. Utilizing eConsent technology instead of printed text to present consent form information and educate subjects and their families may be of particular value in cancer research.
Innovative research can benefit from thoughtful, contemporary human protection processes and tools such as those designed and offered by Schulman IRB. By carefully considering the challenges inherent in oncology research and discussing them with potential study participants effectively and frequently, we can both respect the participants’ valuable contribution, and conduct quality, responsible research to gain a greater understanding of this terrible disease and its treatment.
Stephanie Pyle, MFA, is Manager of Community and Communications at Schulman IRB, the industry leading IRB for technology and customer service. She manages Schulman’s community outreach and many of its educational initiatives, including Schulman’s popular free webinar series. She received her MFA from the Pennsylvania State University. She is a member of PRIM&R and ACRP and currently serves on ACRP’s Professional Ethics Committee.