A Qualitative Case Study of the IRB Review Process and Consent Form through a Legal and Moral Framework

Informed consent documents (ICDs or “consent forms”) are a founding ethical principle of human subjects research designed to empower patients with the knowledge to choose. The consent form can be a particular mechanism of protection for vulnerable groups, such as oncology patients, who face unique health literacy challenges. Yet in the last 20 years, consent forms in the oncology setting have doubled in length and complexity, in part because research itself has become more complex, but also because the document has become cluttered with legal jargon intended to protect institutions and researchers rather than the patient (a legal framework versus a moral one). The lengthened, burdensome consent form in conjunction with low-to-average health literacy rates in the United States begs the question: How did we get here? Who is approving these documents and practices? This case study at Beacon Cancer Center seeks to better understand the role of the IRB in reviewing and approving consent forms in the oncology setting.