Patients as Partners – Why Biospecimen Consent Matters

We have received many emails about a recent Op-Ed in the New York Times – “Your Cells. Their Research. Your Permission?”
By Rebecca Skloot (Dec. 30, 2015). In her piece, Ms. Sloot correctly points out that patient consent is a significant issue regarding the use of biospecimens in research: “Tissues from millions of Americans are used in research without their knowledge. These “clinical biospecimens” are leftovers from blood tests, biopsies and surgeries. If your identity is removed, scientists don’t have to ask your permission to use them. How people feel about this varies depending on everything from their relationship to their DNA to how they define life and death. Many bioethicists aren’t bothered by the research being done with those samples — without it we wouldn’t have some of our most important medical advances. What concerns them is that people don’t know they’re participating, or have a choice.”

Indeed, we at Novaseek agree with this basic premise. This is why transparency in the consent process has been a primary objective in the Novaseek model from the very beginning, reflecting a commitment to respect for the rights of patients to decide how their specimens and data will be used.  Novaseek’s IRB-approved consent form appears to have anticipated the changes proposed to the Common Rule – not surprising given the fact that Novaseek’s approach to consent and privacy was developed in collaboration with thought leaders in the fields of biospecimen science and research ethics. As recommended by the Common Rule Notice of Proposed Rulemaking, patients are provided with clear information about everything from compensation to genetic research use. Ultimately the vast majority of patients are happy to donate their left over specimens and data for use in research – ​but the key is that they are given the choice, preserving the relationship of trust between hospitals and patients.

Importantly, the Novaseek approach is also pragmatic, recognizing that the ultimate goal of participating patients, hospitals, and researchers is to ensure that important research advances rather than becoming stalled in onerous administrative requirements.  So Novaseek provides turnkey consent materials along with expert support to help hospitals create an effective research consent process that does not burden patients or staff.
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With or without changes in legislation, Novaseek and our partners are committed to respectful partnerships between hospitals, patients, and biomedical researchers as we work toward the common goal of a healthier future for all.