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Transparency of research purposes critical to informed patient biospecimen donation

March 4, 2015

Biospecimen Donation Consultation

Every day in their laboratories, researchers see first-hand why biospecimen research matters. High quality human biospecimens are necessary for a wide variety of research, including clinical trials to formulate pharmaceutical products or calibrate medical devices, or genetic sequencing to understand patient-specific treatment models and personalized medicine.

But while researchers have intimate knowledge of the purposes of biospecimen research, can they say the same about the patient perspective? Patient attitudes on donating biospecimens may be the single most influential factor on the supply of donated samples, so what affects donation rates? According to one study conducted by researchers at Michigan State University, the University of Michigan and the National Institutes of Health, and published in the Journal of the American Medical Association (JAMA), the purposes of the research can affect donation. It is therefore a logical assumption that the more the biomedical industry seeks to procure human biospecimens specifically for research use, the more important it will be to transparently share research purposes so patients can make the most informed donation decisions.

Understanding patient preferences
Researchers need a varied and steady supply of human biospecimens to continue their discovery, while patients must be informed about why and how their samples are being used. The results of the JAMA​ study show that traditional methods of blanket consent may not get to the root of patient concerns over which types of studies they would like to support. With higher transparency about specific research purposes, levels of donation were shown to change as compared to the blanket consent process that gave patients less detail.

Tom Tomlinson, Ph.D., director of Michigan State University's Center for Ethics and Humanities in the Life Sciences and lead author of the study, wanted to look at which types of research change patient willingness to donate biospecimens.

"We really wanted to document the concerns people have that may affect their desire to donate," Tomlinson said in a statement. "Biobanks are becoming more and more important to health research, so it is important to understand these concerns and how transparent these facilities need to be in the research they support."

Transparency of research purposes matters
Using an online survey, Tomlinson collected responses from almost 1,600 participants at least 18 years or older. Respondents were asked to answer several questions related to their willingness to donate.
Surprisingly, patients who would donate to one type of study said they would refuse to do the same for another. In total, when given general blanket consent forms, 1,122 of 1,593 respondents said they would donate tissue samples and medical information for research purposes – a 68 percent mark.

However, affirmative responses decreased in some cases as patients learned the specific research objectives of the hypothetical trials to which they would be donating blood, tissue or DNA samples. Moral, cultural, and religious leanings seemed to play a significant role: When their samples would be used to develop more advanced and safer abortion techniques, only 49.5 percent said they would give researchers access. On the contrary, studies that involved the use of patients' stem cells to grow tissues and organs for medical experimentation experienced a positive response of 70.1 percent – 2 full points above the average.

Implications for the future
While blanket consent may be simpler, detailing the purpose of research studies is important to patient decisions around donation. As the industry relies more on patient participation, this finding will be important as patient information and consent forms are designed for specific study purposes.