Case Studies

Higher Education Studies

Multi-Institutional Study of Leadership

The Multi-Institutional Study of Leadership is large-scale study of students in higher education measuring achievement across a variety of educational and leadership-related outcomes. The MSL consists of over 400 variables, scales and composite measures, and is framed using the Social Change Model (HERI, 1996) and an adapted version of the I-E-O College Impact Model (Astin, 1993, 2001). It is available in the United States and internationally, with benchmarking data being collected for reporting use in the US.

The MSL was created as a collaboration between the original research team at the University of Maryland, College Park; SoundRocket; and institutions of higher education that had a need for student outcome data on leadership development. The collaboration followed a model that SoundRocket has used in several instances, where we help find creative ways to fund research through finding elements of value that organizations can justify spending money on. For the MSL, the entire data collection costs are supported by schools who pay a small fee to participate in the study in exchange for receipt of a summary report and analytic data file.

Learn more about the MSL at www.leadershipstudy.net.

Campus Climate Surveys: Sexual Misconduct / Diversity, Equity, & Inclusion

The National Campus Climate Survey is a gold standard service to collect high quality data on the topics of Sexual Misconduct or Diversity, Equity, & Inclusion in higher education settings. SoundRocket partnered with the University of Michigan to offer this service, based on the pilot study conducted at the University of Michigan in the spring of 2015. The study team has built a culture of science throughout all aspects of this research.

Various iterations of this study have been administered at numerous campuses in the United States.

Learn more about the NCCS at wwww.nationalcampusclimatesurvey.org/

Regulatory Compliance User Comprehension Studies

Carrier Screening, Genetic Health Risk, Pharmacogenetics Test, and Cancer Predisposition Screening FDA 510(k) Submission

Any genomics company who is interested in marketing a Direct-to-Consumer (DTC) genetic health risk product to the public must first obtain pre-market authorization from the U.S. Food & Drug Administration (FDA). The first company to obtain this type of premarket authorization was 23andMe in 2017.

Now, following in their footsteps, DTC genomics companies seeking FDA clearance must submit a 510(k), proving that their device is as safe and effective as the predicate – 23andMe’s Personal Genome Service Genetic Health Risk (GHR) test. If the FDA deems the new device to be substantially equivalent to 23andMe’s test, it will be ‘cleared’ for commercial distribution.

User comprehension studies to prove that an average consumer can accurately understand and interpret the test details and results is required for all FDA DTC authorizations. This is an area where we at SoundRocket have developed expertise, as we have been engaged in user comprehension testing for regulatory clearance since the get go. And, this experience has helped us refine our user comprehension methodology.

To demonstrate comprehension, the study must test a representative sample of content, including an education module, a consumer-facing website, pre-test information, frequently asked questions, a list of terminology, and the test report itself.

The FDA has identified domains (or key areas) where comprehension of the GHR report and supporting documents must reach 90%. These include: test purpose, test limitations, appropriate actions, other factors that may impact results.