Participant Data Platform for Collaboration

Participant Data: Individual and Research Use

For the Foundation to accomplish its goal of advancing learning and knowledge about how exercise, diet, relationships, and health care fit together to benefit mental health, collecting and using high quality data are fundamental. Our philosophy and policy is that the data each participant contributes will always be privately available to them as an individual, to use as desired. For example, if you participate in a study that collects data on your level of exercise and anxiety symptoms, you could choose to make that data about you available to your doctor, via your account in the Foundation Portal.

At the same time, the larger the number of individual data records that can be combined into group data, the greater will be the analytic capability to scientifically answer questions using that data, accelerating research productivity and scientific advancement [6, 7]. As a rule, names and other identifiers will be removed from these grouped data.

At present, all studies carried out by the Foundation will be reviewed and approved by an Institutional Review Board (IRB) in accordance with the regulations provided by the Office of Human Research Protection.

For the future, in addition to ongoing IRB review and oversight, a goal of the Foundation is to support sharing of health-related data as a process that is patient-driven, transparent, secure, reliable, and interactively dynamic [8-12]. To reach this goal, the Foundation intends to establish transparent and clear expectations, policies, and rules for how we will manage research data access for scientific collaboration [13, 14]. While the emergence of new platforms for data sharing such as i2b2 [15] and the PEER (Platform for Engaging Everyone Responsibly) tool of the Genetic Alliance [16] point toward growth in a global data sharing infrastructure, it is not clear how well these and other existing platforms automate and record the specific processes and sequences of processes (i.e., workflows) necessary to most efficiently and transparently share data at both investigator and participant levels.

Collaboration Hub: Shared Tools, Standards, Processes, and Data

The Foundation serves as a center for in-depth community based participatory research (CBPR) on exercise and mental health. A key aspect of the center, enabled by state-of-the art scientific methods and web and mobile technology platforms and tools, is to serve as a Collaboration Hub for local, regional, and global partners and collaborators interested in this research area and application to practice. Benefits to participants include:

  • promoting research collaboration between institutions
  • strengthening proposals and likelihood of funding
  • supporting a general implementation science methodology
  • jointly meeting criteria of potential donors
  • a central resource for individual research study operations and productivity
  • recruiting subjects into studies
  • providing modern consent engagement, tracking, and knowledge workflow
  • a secure yet user-friendly way for researchers to share and access research data sets
  • supporting translational processes and activities
  • a scientific data foundation for individualized services to the community.

In serving as a Collaboration Hub, the Foundation seeks to promote qualified access to de-identified data in order to increase the number of scientists collaboratively analyzing the data and more quickly making results available.

There are a variety of known barriers to effective and efficient data sharing [17-20] that hinder conducting clinical and public health research. The complex sets of regulations around data are barriers to effective sharing [21]. Privacy and sharing rules, and the difficulty in interpreting them and applying them increase the time and cost both for sharing and for administrative processes. This increased complexity slows and blocks research activities from participant recruitment to publication, impeding the collaborations that can accelerate scientific advancement [22, 23].

The majority of patients are willing to participate in research [24] and to share their data [25, 26]; however, the most current understanding of research ethics emphasizes the need for clear and effective mechanisms for consent and changes in consent. A 2007 study by the Institute of Medicine shows that roughly 40% of patients would want to provide specific consent each time their data is shared [27], a strong preference held by parents whose children participate in research studies [28]. To be truly patient-centered and dynamic, consent must be ‘revocable’ [29], and must enable ongoing communications between participants and researchers [30].

It is known that participants’ understanding of the information in a consent form varies, and is overall less than satisfactory [31, 32]. It is often unclear what information should be included or prioritized [33, 34]. For pragmatic trials, a less complex level of consent that is more practical to embed in routine clinical care workflows may be consistent with research ethics and regulatory requirements [35]. As research designs evolve, new concepts and standards for ethical frameworks defining different levels of consent are needed, and are in development [8].

In general, reducing disparities and barriers to participation in research and other activities and programs is integral to patient involvement in and governance of a national rapid and continuous learning healthcare system (LHS) [5, 36, 37]. The LHS has a goal of decreasing the gap between innovation discovery and implementation from the well-known median of 17 years to less than one year, and increasing the scope of innovation as a process that includes patients interacting with researchers, clinicians, public health officials, and other members of the health care community [38, 39].