Float Research Collective (FRC)

2. Float Research Collective (FRC) • Educational resource for the float industry • Need more researchers • Need more published research (and replication) in respected peer-reviewed scientific journals • Collecting data @ recreational float centers • Integrated cloud-based data collection (e.g., RedCap) using tablets (connected to the network via Wi-Fi) • Obtain data in such a way that it can: • easily be collected at centers across the country (and eventually the world) • easily be sorted and analyzed to answer questions of interest • later be published in peer-reviewed scientific journals

3. www.ClinicalFloatation.com Within-subject crossover RCT in 30 anxious/depressed patients Open-label trial in 50 anxious/depressed patients

4. Important Websites • Office for Human Research Protections (OHRP): https://www.hhs.gov/ohrp/ • The Belmont Report: https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html • 45 CFR 46: https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html • Determining When Institutions are Engaged in Research: https://www.hhs.gov/ohrp/regulations-and-policy/guidance/determining-when-institutions-are-engaged-in-research/index.html • Human Subject Regulations Decision Charts: https://www.hhs.gov/ohrp/regulations-and-policy/decision-charts/index.html

5. Clinical Trials • https://grants.nih.gov/policy/clinical-trials/definition.htm • NIH Clinical Trial definition: A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. • Intervention: manipulation of the subject or subject’s environment for the purpose of modifying one or more health-related biomedical or behavioral processes and/or endpoints. Examples include: drugs/small molecules/compounds; biologics; devices; procedures (e.g., surgical techniques); delivery systems (e.g., telemedicine, face-to-face interviews); strategies to change health-related behavior (e.g., diet, cognitive therapy, exercise, development of new habits); treatment strategies; prevention strategies; and, diagnostic strategies

6. Informed Consent

7. Institutional Review Board (IRB) • Option 1: Is the float center "engaged in research"? • if yes, each center would need to be individually certified to conduct research by an IRB, and each person administering the informed consent would have to be CITI-certified • this option would cost thousands of dollars per center (so that they can be IRB-certified), would require many hours of training personnel to ethically-conduct research, and would require annual IRB renewal and reporting of all research activities (which presents additional costs in terms of time and money) • Option 2: Create an online study which can be advertised at float centers across the country • the online study would be approved through a single IRB protocol (linked to an institution which was IRB-certified), and all informed consents would also be obtained online • Option 3: Data collection without informed consent and without an IRB • only self-report "surveys" would qualify and no incentive could be provided • essentially with this option we can only collect surveys from a "convenience sample" and all-comers would have the option to participate without any coercion • all data needs to be deidentified in such a way that it can never be linked back to the individual subject (which may pose problems for tracking longitudinal changes) • need to request an "exemption determination letter" from the IRB (one-time service fee of ~$900) • this letter can later be used when trying to publish the data • would allow for the creation of a centralized data repository that can later be mined • would also allow for the rapid collection of new questions of interest

9. Different models for conducting float research • Traditional IRB model • Clinical research float center (e.g., LIBR) • Recreational float center (e.g., Andy Larson/Dr. Terri deRoon Cassini) • Multisite study at recreational float centers (e.g., Neuroverse; AmrinderBabbra) • Non-traditional IRB model (e-consents at recreational float centers) • No IRB • nocontrolled trials and no target populations (this is a convenience sample only) • no promise of benefit and no compensation • completely deidentified data only (no ability to longitudinally track an individual)

11. Action Items • Create a private, non-searchable FRC online group where we can post messages, updates, and questions to members of the collective • Reach out to individuals who are conducting non-IRB approved research to educate them about the significant risks which this poses to the community • Look into whether option 2 or 3 could be conducted under a separate 501c3 (e.g., by officially making the FRC a nonprofit organization) or under an existing entity (e.g., Neuroverse or FTA) • Look into possibility of getting an exemption and whether or not the IRB is going to consider floating an "intervention" • Other items???