Science Policy For All

Because science policy affects everyone.

Science Policy Around the Web – January 8, 2016

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By: Sophia Jeon, Ph.D.

This could be your blood! Photo source: photopin.com

Bioethics and Health Policy

Your Cells. Their Research. Your Permission?

Since 2011, the U.S. Department of Health and Human Services has been involved in a major effort to revise the Federal Policy for Protection of Human Subjects, or more commonly known as the “Common Rule,” that governs any research involving human subjects. Rebecca Skloot, the author of “The Immortal Life of Henrietta Lacks” recently wrote an opinion piece in the New York Times, encouraging the public to weigh in on what researchers can or cannot do with their biospecimens. This timely article was published just a week before the public comment period for the Common Rule closed this past Wednesday on Jan 6th.

The current Rule has a loophole where biospecimens could be used without consent as long as they are unidentifiable and cannot be traced back to the individual. This is why one of the major proposed changes to the new Rule that is receiving much attention is the concept of “broad consent.” Because the new rule will require consent whether or not the biospecimens are identifiable, broad consent allows researchers to store and use unidentifiable biospecimens indefinitely (except for the case of new sample collection, which is allowed only up to 10 years following consent) once participants give consent to any “broad” range of future, unspecified research. This is similar to a recent change E.U. has made in their legislation regarding personal health data.

There are concerns that not many non-scientist citizens know about this change while it is mainly the scientist community who have been giving public input for the new rule. Respecting autonomy and letting participants have control over their own tissues and cells is important but others also voice the concern that the new rule may increase the administrative burden on researchers and clinicians. (Rebecca Skloot, New York Times)

Research Workforce and Career Development

Fellowships are the future

Do you see any overworked, under-appreciated, and dissatisfied post-docs in your lab? If the answer is yes, there are many reasons for this: poor job prospects (here is how you may get around that issue); research culture that does not leave room for proper work-life balance; a lack of freedom in career development; and a feeling that you are stuck in a limbo phase where you are neither a trainee or an employee.

Currently, the majority of post-docs are treated as trainees under supervision of their PIs. Only about 16% of US post-docs are paid through a training grant or fellowship while most post-docs are supported by their PI’s grants. This means that post-docs have very little independence both scientifically as well as financially, which leaves almost no time for their own career development activities. In order to succeed as an independent scientist, or to prepare for next steps in their career, post-docs should be able to develop and pursue their own scientific interests, or explore different career options and gain relevant experience.

In last month’s issue of Nature, Viviane Callier and Jessica Polka suggest that government-funded post-doctoral fellowship awards may be the stone that kills two birds. With more post-docs who are independently funded, they argue that this mechanism would not only train post-docs to be better scientists, but also solve the problem of creating too many post-docs in the first place, as they would have to successfully compete for a limited number of fellowships. (Viviane Callier & Jessica Polka, Nature)

Technology and Regulatory Science

Brain game-maker fined $2 million for Lumosity false advertising

Lumos Labs, the company that sells a subscription-based game called Lumosity, has been fined $2 million by Federal Trade Commission (FTC) for falsely claiming that Lumosity can not only help perform better at work but also reduce cognitive impairment associated with diseases such as Alzheimer’s disease and post-traumatic stress. The money will be used to compensate consumers who purchased the game under the false impression that it would make them smarter.

There recently has been an explosive growth in number of medical mobile apps and devices that claim to enhance brain function. Unfortunately, many of these claims are unfounded or without strong scientific evidence. Since 2014, some healthcare mobile apps are considered as medical devices by the Food and Drug Administration (FDA)’s definition and therefore, FDA has authority to exercise enforcement over these apps if they are marketed, promoted or intended for use in the diagnosis, prevention or treatment of disease. Unlike FDA that mainly regulates “labeling,” FTC regulates both labeling and advertising that includes endorsements on blogs and social media. (Emily Underwood, ScienceInsider)

Have an interesting science policy link?  Share it in the comments!

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Written by sciencepolicyforall

January 8, 2016 at 9:00 am

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