Precision medicine-medicine that is tailored to the unique characteristics of different patients or patient groups-is at the forefront of biopharma research today. Gone are the days of “one-size-fits-all” approaches, and scientists are working harder than ever to study disease variation across afflicted populations. To conduct all of this research, characterized human biospecimens are in great demand, but procuring them has long been difficult for the research community.
Increasingly, hospital-based and commercial labs are being leveraged as a source of patient biospecimens and associated data for research. But how do patients feel about this? A new study commissioned by iSpecimen, but conducted independently, indicates that Americans are largely supportive of the use of their leftover clinical specimens for research, particularly when they learn that these specimens will otherwise be discarded and that their privacy can be ensured. Based on the study, it appears that Americans view this as a way they can contribute philanthropically to the advancement of medicine. Let’s take a closer look.
Traditionally, individual participation in medical research has largely been limited to enrollment in clinical trials for a specific disease. But today, with biomarker discovery and validation programs being such an essential component of pre-clinical research, individuals can participate in medical research far earlier and in a very meaningful way by simply making their specimens and some de-identified medical records data available. Specimen-based research happens long before a true clinical trial and has spurred some of the most important diagnostic and therapeutic breakthroughs that have ever been made, such as the discovery and production of Herceptin for breast cancer.
More and more, leftover patient biospecimens no longer needed once clinical testing is complete are being combined with data sets that are stripped of protected health information (PHI) and moved into research programs. While many studies have been conducted on patient attitudes about this and related practices and generally show patients are supportive, most are now years old and not representative of the US population. Particularly given our entry into the age of precision medicine, an updated look at how Americans feel about the research use of their biospecimens is warranted and useful.
With this context and curiosity in mind, iSpecimen commissioned an independent, third-party market research firm towards the end of 2015 to understand how willing Americans are today to participate in medical research and, specifically, allow the use of their de-identified, remnant biospecimens. Four-hundred English-speaking U.S.-based adults over the age of 18 were surveyed and balanced to the national population census in terms of age, gender, income and ethnicity.
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Questions were asked about previous interaction with the healthcare system, health status, nature of intended research that would make use of the biospecimens, pre-existing philanthropic behavior, emotional drivers, thoughts on disclosure and consent and any concerns. A link to the final research paper is provided at the end of this article.
What became clear from the survey results is that people largely want to help. The majority of Americans (83%) is willing to allow use of de-identified clinical remnants and associated data for medical research. Additionally, nearly two-thirds of those surveyed were willing to donate an extra tube of blood, drawn at the point-of-care, expressly for research purposes. Two-thirds of the study population also indicated that they would agree to be contacted at a later date by their healthcare provider about potential specimen donation requests, should they arise.
The main reasons why patients want to help were overwhelmingly benevolent, indicating that today’s American patients are medically philanthropic. They want to give a part of themselves to help the health and well-being of others-and especially others like them. This concept of a “philanthropic patient” can also be seen in other documented and studied behaviors, such as registering for organ donation, giving blood and enrolling in clinical studies. Not surprisingly, according to this study, prior blood donors and registered organ donors were even more willing to allow the use of their remnant specimens, coming in at 91% and 90%, respectively.
The top three reasons that emerged about why patients are willing to allow specimen use were: to help medical researchers learn about disease, to help improve patient care and to help medical researchers develop new diagnostics or treatments. Interestingly, when the term “medical researchers” was switched out with “pharma/biotech companies,” the respondents’ willingness fell slightly by about 25%, indicating a difference in perspective depending on where the research is conducted. Yet still, even with this drop, the majority of respondents were supportive.
The Issue of Consent
A condition of remnant specimen use-whether or not patients would like to be asked or told about the process beforehand-emerged as an issue important to patients. While current federal law, under the Department of Health & Human Services’ (HHS) Common Rule, does not require disclosure of use to patients (as long as the specimens are leftover and de-identified), the survey revealed patients really do prefer to know and take part in the decision. Consistent with this finding, in September 2015, HHS proposed changes to the nearly 25-year-old Common Rule, including the requirement of consent for remnant specimen use. Proposed changes are expected to be decided upon later this year.
When asked about what might hold them back from allowing the use of their biospecimens, about a quarter of respondents expressed concern that their identity might accidentally be revealed. About a quarter also expressed concern that they did not know who would be profiting-while data showed that respondents want to contribute to advancements in diagnostics, treatments and patient care, they seemed more comfortable with the advancements being led by hospitals and academic researchers rather than biotechnology and pharmaceutical companies.