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Updated NIH Policies & Procedures related to Human Subjects Research

NIH has broadened its definition of clinical trial, and it may impact your future applications (new, resubmission, or revision) and awards.

NIH’s definition of clinical trial now includes some research approaches not traditionally considered clinical trials. For example, many behavioral or biobehavioral studies that focus on underlying mechanisms of development may now be considered clinical trials. Also, conducting experiments that involve human subjects may be considered a clinical trial. If you are conducting studies involving human subjects, it is very important that you understand this definition and determine whether it applies to your research.

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Don’t Nudge Me: The Limits of Behavioral Economics in Medicine

Whenever I talk to physicians about outcomes that are worse than you’d expect, they are quick to point out that noncompliance — when a patient does not follow a course of treatment — is a major problem.

Sometimes prescriptions aren’t filled. Other times they are, but patients don’t take the drugs as prescribed. All of this can lead to more than 100,000 deaths a year.

A thorough review published in The New England Journal of Medicine about a decade ago estimated that up to two-thirds of medication-related hospital admissions in the United States were because of noncompliance, at a cost of about $100 billion a year. These included treatments for H.I.V., high blood pressure, mental health and childhood illnesses (it can be difficult to get children to take their medicine, too).

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NIH SOBC Program FOAs: Announcement

The NIH SOBC Common Fund Program held two Technical Assistance Webinars in October for the Program’s current Funding Opportunity Announcements (FOAs) in one of the two Science Of Behavior Change (SOBC) Technical Assistance Webinars for the Program’s current Funding Opportunity Announcements (FOAs). A list of all the FAQs generated from both webinars, a link to a recording of the October 26, 2017 webinar, and a transcript will be posted on the SOBC Common Fund website soon. A link to the webinar recording, transcript, and FAQs is also provided below. Note that the audio begins at about 3.5 minutes.

As a reminder, please check the “Coming Soon Measures” list on the SOBC Measures Repository page. We expect in total more than 100 measures to be available prior to the receipt date for the FOAs, including additional measures in the interpersonal and social processes and stress reactivity and stress resilience domains.

Webinar Recording: https://nih.webex.com/nih/ldr.php?RCID=129ee916f4eeaf1ee644086197417364

Webinar Recording and Transcript Access: https://commonfund.nih.gov/behaviorchange/webinar

FY18 FOAs FAQs: https://commonfund.nih.gov/behaviorchange/faq17

Be ‘Mindful’ of the Hype

“Mindfulness” is touted as a cure-all for many modern ills, from stress and pain to depression.

But little to no scientific evidence backs up most of the health claims surrounding the practice, said Willoughby Britton, director of Brown University’s clinical and affective neuroscience laboratory.

There’s not even an agreed-upon definition of mindfulness that researchers can use to test the concept’s effectiveness, Britton said.

“Meditation researchers are concerned the exaggerated claims of mindfulness benefits will mislead vulnerable people and keep them from receiving evidence-based treatment,” Britton said.

In a new paper, Britton and 14 other experts say it’s time to replace the hype with serious scientific rigor.

Mindfulness has become a billion-dollar industry. Countless practitioners and more than 1,500 smartphone apps promise to help people become calm and focused despite the turbulence surrounding them, Britton said.

The idea is based on an obscure Buddhist concept dating back 2,600 years, according to the American Psychological Association. It generally refers to a state of moment-to-moment awareness of existence, without any judgment placed on that awareness — essentially, living in the moment.

UIC Researchers Create Voice-Enabled Coach to Manage Type 2 Diabetes

More than 30 million Americans had diabetes in 2015, according to the American Diabetes Association. That’s just over 9 percent of the U.S. population.

The vast majority of those with the disease have Type 2 diabetes, which most often occurs in middle-aged adults and older adults, according to the National Institute of Diabetes and Digestive and Kidney Diseases.

While there is no cure for the disease, it can be managed through medication and healthy behaviors such as exercising, eating nutritious meals and quitting smoking.

“A lot of these lifestyle changes can be very stressful,” said Olusola Ajilore, associate professor of psychiatry in the University Illinois at Chicago College of Medicine. “I teach a class on diabetes and emotions for patients with Type 2 diabetes and some of the challenges they bring up are having to change their diet or increasing their physical activity or exercise.” read more »

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New SOBC Funding Opportunities

The NIH is now accepting revision applications to R01, U01, and R34 clinical trials as well as new R21 awards to accelerate the adaptation, validation, and translation of SOBC assays. Eligible assays can be found on the SOBC Measures Repository page.
Applications are due December 5, 2017.

For more information, please visit our Funding Opportunities page.

Two informational webinars will be held for potential applicants:

Thursday, October 26, 2017 1:00 PM – 2:30 PM, EST (Register)
Monday, October 30, 2017 12:00 PM – 1:30 PM, EST (Register)

Each webinar will cover the same information and address all four funding opportunities.

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Perceiving oneself as less physically active than peers is linked to a shorter lifespan

Would you say that you are physically more active, less active, or about equally active as other people your age? Your answer might be linked to your risk of premature death decades from now — no matter how physically active you actually are, according to research by Stanford scholars Octavia Zahrt and Alia Crum. The research, appearing July 20 in Health Psychology, finds that people who think they are less active than others in a similar age bracket die younger than those who believe they are more active — even if their actual activity levels are similar. “Our findings fall in line with a growing body of research suggesting that our mindsets — in this case, beliefs about how much exercise we are getting relative to others — can play a crucial role in our health,” Crum said.

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How mHealth Apps Drive Patient Behavior Change, Motivation

mHealth apps targeted toward weight loss must leverage strong educational features to help frame patient attitudes regarding healthy eating to drive patient behavior change and motivation, according to a study published in the Journal of Medical Internet Research.

Many healthcare professionals recommend mHealth apps for their overweight or obese patient populations working to adopt healthier eating habits. Research has suggested that these apps are effective in driving patient behavior change and motivating patients. However, little information exists about the mechanisms by which diet and nutrition apps drive patient behavior change.

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How to help social and behavioral research findings make their way into practice settings

Behavioral interventions are often complex, resource intensive and extend beyond healthcare settings. Combined with the lack a market driven, regulatory structure of medical interventions; behavioural interventions often fail to be adopted. Facilitating the adoption of these interventions is now the priority of the Office of Behavioral and Social Sciences Research (OBSSR). Here to discuss the challenges and opportunities associated with this priority is William T. Riley, author of a commentary on this topic published in Translational Behavioral Medicine.

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A new show features ‘Biggest Loser’ winners who regained weight — reveals a deeper truth about weight loss

The truth hit Ryan Benson when he couldn’t fit into a seat on his son’s favorite roller coaster: He’d regained the weight he’d fought so hard to lose as a contestant on “The Biggest Loser.”

In 2005, Benson was crowned the first winner of the popular TV show, which ran for 12 years and has since ballooned into a multi-million-dollar franchise. Benson lost 122 pounds and won $250,000, but he’s since returned to his pre-show weight.

That problem wasn’t unique to Benson — a 2016 study from the National Institutes of Health (NIH) followed more than a dozen former “Biggest Losers” and found that of the 14 people studied, 13 regained a significant portion of the weight they lost on the show. Four were heavier in 2016 than they were before they set foot on the set. read more »

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