Tag Archives: research

Updates on NIH clinical trial policy

From FABBS:

Larry Tabak says that NIH has developed a plan to “address the shared interests of involved stakeholders” and that NIH was “prepared to move forward so that [they] can widely communicate the delayed enforcement and lenient implementation described in the plan.”

NIH’s plan to address the concerns about the reach of the clinical trials policies looks very promising, but of course, the devil is in the details, and many of those details are not yet known. Here’s what we know:

(1)  NIH will delay enforcement of a registration and reporting system for basic science involving humans until July 1, 2019.

(2)  NIH will allow scientists to register and report their basic science research involving humans through other portals such as Open Science. Eventually, NIH will pull data elements from these portals in order to track what they fund and comply with their own reporting requirements to Congress.

(3)  A Request for Information (RFI) will be released soon so that NIH can get feedback on what reporting standards are appropriate for the range of basic science research involving humans. FABBS will respond, and we welcome input from our member societies and affiliates. Once the RFI is released, we will share it with you and seek your input.

(4)  NIH will be “flexible” and “lenient” with regard to enforcement of other clinical trial policies for basic science. Although NIH’s plan is not specific, presumably this applies to the requirements that basic scientists whose research was defined as a clinical trial respond only to clinical trial FOAs and take good clinical practice training. NIH had previously told us that Review would not change for basic scientists responding to a clinical trial FOA. We would welcome feedback from our community about the last two review cycles, although NIH’s new plan may also alleviate the concerns.

(5)  NIH will issue a Basic Science Parent FOA by October 30, 2018. We will interact with NIH over the coming months regarding this since it will be important to our sciences as the policies evolve.

What is still uncertain is how NIH will define basic science vs. a clinical trial. The plan itself references “basic science trials,” “public health trials,” and “prospective interventional human trials.” We will continue to interact with NIH to ensure that the definition of a clinical trial does not continue to capture basic science research involving humans.

For now, we consider NIH’s plan and engagement with us to be a very promising step. In addition, NIH’s plan (to be described in a NIH Guide Notice, which we will circulate to you) to be flexible and lenient in its implementation of the clinical trial policies as they relate to basic science studies should provide some reassurance to the basic science communities that FABBS represents.

Broader impacts 101

From Heather Johnston, OARS, regarding a workshop of interest to those who are considering submission to NSF funding mechanisms:

In response to feedback provided through our February survey on professional development, OARS is pleased to offer a Broader Impacts 101 workshop on Friday, May 4, from 10:00 to 11:15am in 134 King Library (AIS). The workshop will provide a general overview of broader impacts, including:

  • The history of the National Science Foundation’s broader impacts (BI) criterion
  • Strategies for conceptualizing, developing, implementing, and evaluating BI activities
  • Tips for leveraging existing resources to build a “BI identity”
The presenter is Liz Nysson, a member of the steering committee for the National Alliance for Broader Impacts and assistant director of the Lockheed Martin Leadership Institute in Miami University’s College of Engineering and Computing.
Register today!

Undergraduate Research Forum next week

Most of you are likely aware of this–if not involved as mentors of students presenting–but I wanted to make sure to pass this on from Martha Weber, ORU:

Miami’s 24th annual Undergraduate Research Forum will honor our dedicated Miami mentors  and celebrate the intellectual accomplishments of our student researchers. Established in 1994, this university-wide forum has showcased the creative and scholarly activities of undergraduates engaged in research. During the interactive poster sessions both student researchers and mentors celebrate and promote undergraduate dedication to learning and scholarly achievement.

Over 560 Miami students are registered to present at the annual Undergraduate Research Forum on April 25, 2018. Fifty-two oral presentations involving 61 students will take place in rooms on the Shriver Center third floor. Three interactive poster sessions involving over 500 student presenters will take place in the Shriver John Dolibois Rooms. Student research on display covers a wide variety of topics and may have been carried out as part of a class, an independent study, a community project, a service-learning project, a creative project, etc.

You can find an ADA-compliant download of the program here.

CADS multidisciplinary funding opportunity

Allison Farmer, Director of Miami’s Center for Analytics and Data Science, announces a significant funding opportunity:

For the second year in a row, the Center for Analytics and Data Science (CADS) is pleased to offer a call for CADS Research Fellowship grants. The purpose of this funding is to seed new multidisciplinary research in analytics and data science that is likely to result in scholarly publications and external funding. To encourage stronger multidisciplinary proposals, CADS will focus resources to fund one proposal of up to $25K. Proposals must feature researchers from multiple departments. Proposals with researchers from different academic divisions are strongly encouraged. The award period is one year, beginning June 1, 2018. Proposals are due to me by March 30, 2018 and will be reviewed by a multidisciplinary committee.

Those who might be interested can see me for more information and application instructions, or contact Allison directly.

Opportunity for research participants in Chicago

This came across the Judgment & Decision Making listserv, but it is potentially more broadly applicable. In short, it is an opportunity for you to recruit participants through the University of Chicago for simple protocols and surveys:

The Center for Decision Research (CDR) at the University of Chicago Booth School of Business is renewing our “Call for Studies” for Winter and Spring 2018. We offer researchers at other institutions an opportunity to conduct behavioral science research in two of our laboratories – one on the UChicago campus (college student and community participants), and the other in downtown Chicago (≈50% college students from colleges and trade schools, ≈50% general public; very diverse in ethnicity and age).

Join a community of researchers from 30 institutions in ten countries who have taken advantage of this exciting opportunity!

Eligible studies will be added to our labs’ offerings to our participants, and we will cover the bulk of the overhead costs associated with conducting the study (i.e., facilities and equipment costs, costs of RA time spent in actual data collection). You will only be responsible for the generation of the materials, the payment of participant compensation (typically, we pay $1 per every 5 minutes of participation), and the cost of minimal RA time spent in preparing your study to run (a flat rate of $50 per study for our RAs’ time spent in preparing and submitting materials to our IRB, and other study-related preparations)

For more information, or to request participation please use this link.

Assistance with data analysis

Michael Hughes, manager of the Statistical Consulting Center, is soliciting proposals for analysis projects for his STA 475 course this semester. If you have current or backlogged data that might benefit from a supervised team of students, please let Michael know; he writes:

Advanced undergraduate statistics students (most in their final semester) enroll in STA 475. These students have had regression and experimental design (ANOVA) training, a statistical programming class, and other topics courses. Students in STA 475 work on problems brought to them by faculty members, graduate students and staff from university offices, and produce both oral and written presentations for clients and based on their analyses.

I am casting my net far and wide for projects. This could include, but isn’t restricted to: study design (e.g. determining sample sizes for a study, providing input on a survey or experimental design, etc.); data analysis (descriptive summaries, formal modeling);
report write-up and data visualizations

 

Student travel grants

The Council on Undergraduate Research sponsors travel grants for students who will be presenting research, and as an institutional member we are eligible to nominate students for these awards:

  • For the Psychology Division travel grant, there are two funding cycles annually but note that the deadline is February 15 for the current cycle (presentation at a spring conference, such as MPA).
  • For the Social Science Division travel grant, exclusively for those in social psychology, awards are made on a first-come, first-served basis. Note that we will be able to provide the matching funds required for this award through either Miami’s UPA or the department.

Qualtrics user group

If you are interested in joining a user group for Qualtrics, which would involve a mailing list and other possible events, workshops, etc. , please contact Lisa Sheard (CTE) who is organizing.

OARS winter and spring term workshops

OARS is sponsoring several workshops on using various systems at Miami for those that may not be familiar with them (click on the links from each date to register)

  • eSPA: Internal routing required for all external grant submissions (Jan 11; Feb 28)
  • HawksNest: Miami’s crowdfunding platform for research (Jan 23)
  • SPIN Plus: Funding opportunities database, search engine, and notifications (Feb 20)

See Heather Johnston in OARS or me for more information.

Three-minute thesis (3MT) competition

The Graduate School has announced this year’s 3MT competition, for which the top presenters get some significant prize money, and the winner goes on to a regional competition! From Lou Haines:

I am happy to announce that the Graduate School’s 5th annual 3MT will be held on Wednesday, March 7, 2018. We have a 3MT workshop scheduled for Friday, February 9th and preliminary rounds on four dates in February. Students may register at this Qualtrics link, and when they do, I will add them to the 3MT Canvas site where they will find a wealth of information on preparing for the competition.

This is a fantastic way for students to hone their presentation skills as well as learn how to explain their research to a diverse group.