DEVELOPING COLLABORATIONS WITH THE BRAIN HEALTH REGISTRY (BHR)
The Brain Health Registry (BHR) is a web-based, observational research study designed to effectively capture extensive amounts of data that may enable researchers to more efficiently identify, assess, and longitudinally monitor the cognitive changes associated with the progression of neurodegenerative diseases and brain aging.
Participants in the Brain Health Registry complete online questionnaires and cognitive tests that, over time, provide researchers with valuable information and allows them to better track changes in an individual’s health, lifestyle, and cognitive function. These changes could potentially be important indicators of a person’s brain health and could help identify and recruit ideal candidates for medical research and future clinical trials. Participants may also invite a study partner, such as a family member or friend, to answer questionnaires about the participant and him/herself. This is the first large-scale neuroscience project that leverages online possibilities in this way.
By creating a large pool of pre-qualified potential participants, the Brain Health Registry can make clinical trials for neurological diagnostics and treatments faster, better, and more innovative – all of which may accelerate the discovery of effective treatments for brain disease and disorders, such as Alzheimer’s, Parkinson’s, depression, PTSD, and many more.
This study is led by Principal Investigator (PI) Michael Weiner, MD, and Co-Investigators Scott Mackin, PhD, and Rachel Nosheny, PhD. BHR is overseen by the UCSF Institutional Review Board (IRB).
One of the goals of the Brain Health Registry is to assist with recruitment, assessment, and longitudinal monitoring of participants for neuroscience studies. We are eager to develop collaborations with other investigators who share the same goal of accelerating the development of improved diagnostic tests, effective treatments and preventative interventions for Alzheimer’s disease and other brain disorders.
In addition to the different methods of collaboration outlined below, we also encourage collaborators to utilize the Brain Health Registry when writing and carrying out grants. If you are interested in utilizing the Brain Health Registry in your grant, please email us at email@example.com.
Brain Health Registry currently offers different methods in which we can help facilitate clinical research:
1. De-Identified Data Sharing
BHR allows and encourages sharing of the entire BHR de-identified database with qualified investigators and research teams. This is regulated by a Data Use Agreement (DUA), which requires collaborators to agree to terms including but not limited to:
- Compliance with any rules and regulations imposed by their institution and its IRB in requesting data
- Prohibits any attempt to identify or contact any BHR participants
- Prohibits distribution to a 3rd party or disclosure of data beyond the uses outlined in the agreement
2. Co-Enrollment Programs
BHR offers the ability for collaborators to invite and track their research participants by having the research participants join BHR using a registration code. The goal of co-enrollment is to link study data collected by both research studies to create a more enriched dataset for analysis, papers and presentations, and to inform participants of future research projects.
Collaborators may opt for a modified BHR experience in which their co-enrolled participants are given a subset of questionnaires and/or cognitive tests. Communication, visit frequency, and the look and feel of the BHR experience can also be customized.
Co-enrollment programs function under both UCSF’s IRB and the Collaborator’s IRB.
3. Software as a Service (SaaS) Programs
BHR offers the use of its software to help collaborators run and manage their own studies. This software is available for collaborations of any type, and is run by the collaborator’s IRB. While BHR manages the software, such as backup, scaling, troubleshooting, and ongoing development, collaborators can enjoy features listed below, which will allow them to maintain control of their study.
Some features of SaaS include:
- Personalization and custom design of domain, as well as owning the look and feel
- Participant registration, including the ability to allow self-registration or registration by invitation only
- Online participation consent form
- Data collection, including the ability to view your custom study design, determine how often participants are returning, and the creation of custom automated email reminders
- A complete Study Partner Portal, which allows study partners of participants to login and register
- Participant communication, such as automated email reminders
- Referral management, in which collaborators can establish and manage their own referrals to sites
- Custom dashboards
Data collected using Brain Health Registry’s SaaS belongs to the collaborator. BHR staff does not have permission to access or use the data collected, unless explicitly granted through a Data Sharing Agreement. However, BHR can use the aggregate data for general metrics to evaluate usage and performance of the BHR platform. Additionally, individualized data may be accessed by the BHR Operations Team for the explicit purpose of debugging or troubleshooting.
4. Referral Programs
BHR offers two referral program options which are both conducted under UCSF’s IRB and the Collaborator’s IRB.
- Comprehensive Referrals: A referral originating from the pool of participants already enrolled in BHR. These referrals have completed one or more visits containing self-report questionnaires and often cognitive tests allowing for a more comprehensive screening prior to site referral.
- Direct to Site Referral: A referral without the requirement to enroll in BHR and complete questionnaires/cognitive tests. These referrals will be referred directly to a site from either a web-based form or landing page.
Potential collaborators are encouraged to join BHR to experience the full BHR protocol.
If you are interested in learning more about collaborating with the Brain Health Registry, please click the “Learn More” link for the specific collaboration type you are interested in.