President Obama calls the quest to cure cancer the “moon shot” of his presidency. But if the federal government has its way, this rocket may never leave the launchpad.
The reason is sweeping changes proposed by the Obama administration to the rules that govern the use of human tissue in research. The government says the changes are needed “to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects.” But the changes would protect no one and serve only to slow the pace of innovation and discovery, thus harming countless patients and making a cure for cancer less likely.
At present, individuals who participate in certain categories of clinical studies must give informed consent. Researchers discuss with participants the nature of the study and pros and cons of taking part. When personally identifying information is collected as part of the study, subjects receive detailed information on how their privacy will be protected.
The Department of Health and Human Services and several other departments and agencies now want to expand the requirement of patient consent to a very different category of studies relating to the use of tissue called biospecimens. This is tissue that remains after a medical procedure or diagnostic test has been completed. Think of the leftover portion of blood samples taken during a physical or the spare tissue removed during a biopsy.
Existing rules already mandate that leftover biospecimens destined for research are stripped of information that would identify the person they came from. It is extraordinarily hard to re-identify this tissue, and HHS acknowledges that the risk is low. Institutions already have research review boards that approve and monitor what scientists are permitted to do with these materials.
This anonymous material can have tremendous value for medical research. It has played a role in understanding disease and will undoubtedly lead to better therapies for cancer, heart disease, neurological disorders, autoimmune disease and other conditions.
The consents proposed by the administration are known as broad consent, which offer the patient little more than a generic menu of possible uses for the tissue. If patients are disconcerted by these broad consents or don’t understand them, they may well decline to sign them. The unintended effect will be fewer biospecimens for scientific endeavor. Managing the paperwork of these consents will create an immense bureaucratic burden that will also slow innovation.
Health-care providers would be expected to obtain new biospecimen consents from every patient, every 10 years. Every doctor’s office will have to create a system for collecting, storing and reporting consent documents. At Weill Cornell Medicine, we estimate it could cost as much as $4 million annually to comply with the expanded regulations. The danger is that already overburdened offices will opt out and simply throw away their scientifically valuable biospecimens.
Implementing a needlessly more complex consent process will make it harder for patients and researchers to contribute to science. The new rules will curtail access to the biospecimens required to achieve the president’s “moon shot” to cure cancer and other vital health-care goals.
Dr. Glimcher is the dean of Weill Cornell Medicine in New York City and provost for medical affairs of Cornell University.