University of North Florida Institutional Review Board Meeting December 10, 2014 1:05pm 2:39pm ORSP Conference Room Building 3, Room 2502 Voting members present: Kathleen Bloom, Richard Buck, Brian Fisak, Krista Paulsen, Susan Perez, Janice Seabrooks-Blackmore, Jennifer Wesely, Ray Wikstrom Quorum: yes (8 of 10 attending although one member was absent during review, discussion and vote of minutes from 10/22/2014 IRB meeting) Non-voting meeting attendees: John Kantner, Cheresa Boston, Dawn O Connor, Kayla Champaigne, and Eva Espique-Bueno Minutes I. Review and approval of minutes from 10/22/2014 IRB meeting - 10/22/2014 minutes unanimously approved as-is (7 in favor, 0 against, 0 abstained, 3 not present) II. Discussion and review of new project submitted by Dr. Mary Lundy: IRB#14-105 (680116-1) The Impact of Technology Assisted Toy Play on the Independent Function and Quality of Life in Preschool Children with Disabilities - Materials: IRB members were given prior shared access to the project documents within IRBNet (IRBNet ID: 680116-1). - Background: Dr. Lundy has Transformational Learning Opportunity (TLO) funding for an Adaptive Toy Project on campus. The Adaptive Toy Project is a program that does not normally involve research. However, the PI would like to conduct research involving that program on campus. This is a new IRB submission that involves human subject research with children taking part in the Adaptive Toy Project. Study involves minors (ages 6 months to 5 years old) During a telephone conversation with an IRB administrator, the PI mentioned that she had been working with an individual from Delaware, who held a workshop at UNF. At the workshop, several therapists learned about the possible adaptive toys project and told the PI they knew of potential candidates for the project. The colleague from Delaware gave the PI his information. Therefore, once the project is approved by the UNF IRB, the PI plans to invite the therapists and families to a welcome session, where they would be given welcome packets that include a flyer about the research. There will be two separate groups to the project, a control group and an experimental group. The researchers propose to do pre-assessments of the children, modify the toys to make the toys more accessible to the children (e.g., including accessibility switches), modify the toys to include data collection mechanisms (e.g., heart rate sensors, O2 saturation sensors, pressure sensors), ask the children to play with the toys at home for 3 months (except for the control group which does not get to play with the toys), and then conduct a post assessment. 1
Then the PI would correlate the data that was collected and determine if play helped the child improve quality of life, stability, and other factors. The control group will receive adapted toys without data collection mechanisms after the three month period is complete. According to the PI, no children have received adaptive toys for the Adaptive Toy Project as of yet. - Discussion: Committee Review included, but was not limited to, evaluation of the following issues. Discussion of Missing Information: Several IRB members felt that there were missing details in the protocol documents. The lead reviewer indicated that the pre-review documents clearly identified many of the information gaps. IRB members agreed that that the pre-review was appropriate with some minor adjustments. The pre-review document was reviewed by the committee and several edits were made to remove a few unnecessary items. Other items were added as described below. Controverted Issue: whether the PI must include an all-inclusive list of adapted toys and their adaptations or just a list of toy and adaption types o Although some examples were given, the exact data to be collected from children via the sensors were not clear in the IRB documents. Additionally, it was not clear from the protocol documents what types of toys will be adapted. o The PI and Co-PI attended a portion of the meeting and indicated that flexibility is needed regarding the type of toy to be used since there will be a lot of variability among children participating in the project (varying ages and conditions). Similarly, the type of data to be collected (e.g., heart rate, pressure, O2 saturation, time played with toy) will also depend on the child s condition which will vary. o An IRB member suggested that the PI should include a list of possible toys if an all-inclusive list could not be provided. However, another IRB member wanted an all-inclusive list of the adapted toys to be used for research. o An IRB member felt it would be helpful if the PI stated the age range of the children and the types of toys that would be given to children in each age bracket to ensure that the toys were age appropriate. For example, a six month old child should not be placed in a motorized toy car. o During the discussion when the PI and Co-PI were present, the PI indicated that age was taken into account during toy selection and gave an example of a peek a boo bear to be used with very small children. The peek a boo bear will be modified so that children can activate the toys by a large switch rather than a squeezing the bears paw. This will help children who do not have well developed motor skills. She also discussed the toy car example and how mobility is a need for many of the children in the study population. However, she also reiterated the need for flexibility when deciding on the most appropriate toy and the best adaptation for the child. The PI and Co-PI indicated that they do not have a set variety of toys for the study which is why they were not able to provide an allinclusive list. o Similarly, they do not have a set list of sensors that will be used. However, they confirmed that sensors will all be purchased off the shelf from those that are 2
already commercially available. The most common sensors will include pressure sensors, heart rate sensors, O2 saturation sensors, and sensors to detect time duration of play. For example, a pressure sensor will record where a child is leaning so the researchers can obtain information about how much the child is relying on the sides of the toy car for support and if that reliance dissipates over time. o One IRB member indicated that he or she would like to know the locations of the sensors. o Several other IRB members indicated that they at least wanted some parameters about the sensors. However, they did not believe specific information about the location of the sensors or the exact sensors for each condition or age group would be necessary. The Co-PI had an idea of possible commercial sensors to use the toys and offered to provide a sample list. The researchers would like to use cheaper sensors just in case the sensors break when the children are playing with the toys so they could be easily replaceable. o An IRB member asked if the PI planned to collect any data that could elevate the risk to the children. The PI indicated that could not imagine how any of the proposed data could increase the risk of the children in the study. The IRB member responded that the IRB needs to feel comfortable with the written material and the range of information collected by the sensors. The PI discussed several other studies involving similar sensors and reiterated that she did not anticipate risks for child participants. o An IRB member suggested that the PI include a list of the types of data to be collected from the sensors (e.g., pressure, temperature, stability, heart rate, time played with toy, O2 saturation). An amendment could always be submitted to add additional sensors later. As outlined, the protocol is missing key information about the types of data to be collected and the information that is provided is inconsistent throughout the documents. o Several IRB members expressed privacy concerns that could be applicable if the toys will include GPS sensors or video/photo/audio recording devices. The PI and Co-PI indicated that the toys will not include GPS sensors or video/photo/audio recording devices. However, this information was not included in the protocol documents. o Resolution: IRB members agreed to ask the researchers to provide some examples of the toys that may be adapted for this project and more details about the types of adaptations that may be made. They will also ask the PI to provide a list of the general sensor types that she anticipates using for her research and to confirm in the protocol documents that she will not use GPS sensors or video/photo/audio recording devices in any of the adapted toys. Although this does not provide the specificity that some members would have preferred, it was sufficient to minimize the privacy risks identified by IRB members. IRB members will review the information provided to determine if more specific information is needed and to ensure risks to participants are minimized. 3
Controverted Issue: Whether or not the adaptive toys would be considered a medical device under the FDA regulations (21 CFR 812): o The IRB members were provided with the medical device regulations including a definition of medical device and information about the applicability and scope of the FDA device regulations o A medical device is "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is: recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them, intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes." (see http://www.fda.gov/medicaldevices/deviceregulationandguidance/overvi ew/classifyyourdevice/ucm051512.htm for the full text) o 21 CFR 812 applies to all clinical investigations of devices to determine safety and effectiveness, except as provided in paragraph (c) of this section. (see 21 CFR 812.2 for full text). o The lead reviewer emailed the FDA prior to the IRB meeting, but the reply was generic and did not help the lead reviewer determine if the FDA regulations apply to this project o An IRB member wanted to the PI to include an explanation for why she doesn t consider the adapted toys to require FDA oversight so the IRB could then provide that information to the FDA so the FDA could make a determination about whether or not FDA review and approval is required. o The UNF IRB is not authorized to review FDA regulated projects and would need to seek outside assistance. o The IRB reviewed the applicability of 21 CFR 812 and confirmed that the FDA regulations would only apply if the researchers were trying to evaluate the safety or the effectiveness of the devices. The lead reviewer expressed concern that the researchers might be trying to determine how effective the adaptive toys are at improving postural stability or other conditions which might make the toys medical devices. o When the PI and Co-PI attended a portion of the IRB meeting they were asked to speak about this topic. They indicated that it was never their intent to test the safety or effectiveness of the sensors or the adapted toys. They clarified that it was the ability to play that they hoped would allow the children to make improvements and not the adapted toys. They indicated that by adapting the toys 4
they are only making normal over the counter commercial toys more accessible to children with disabilities. These are children who would normally have to rely on their caregivers for almost all tasks including help with play. The adapted toys will allow normally depending children to be able to play without as much help and the researchers believe the play may help to improve quality of life and may also help to improve other factors such as postural stability. According to the researchers, the toy are not intended to mitigate or treat the conditions or affect the structure or function of the body nor are the sensors. o Resolution: Based on the information provided by the researchers at the meeting, the IRB determined that the FDA device regulations do not apply to this project. However, they also determined that research integrity administrators should contact the FDA to confirm. The IRB will ask the PI to provide an explanation within the IRB documents describing why the FDA device regulations do not apply. However, administrators do not have to wait to obtain this explanation before contacting the FDA. Discussion of photo and video recordings and the consent forms for release of recordings o Consent forms were submitted taking videos and photos of participants. However, not much information was included in the protocol regarding what would be video recorded or photographed. The PI will be asked to provide this information in the protocol application. o During the meeting the PI indicated that pictures would only be taken in the UNF laboratory as the children use the toys. The PI planned to use the videos and photos for illustration purposes and not as part of the assessment. The PI also confirmed that toys will not be modified to include cameras. o The PI also confirmed that children will still be allowed to participate in the research if the parent does not allow photos of the child to be used. o Although the PI stated at the meeting that photos and videos will not be used for research, the release forms include a provision asking parents to allow the photos and videos to be studied by the research team for use in the research. IRB members felt that this was acceptable since the PI may just want to be able to use the photos and videos for research publications and presentations if they show something interesting. o The parent/guardian permission form did not contain much information about what will be video recorded or photographed. The IRB would like the PI to include more specific information about the recordings on those release forms. Discussion of HIPAA applicability o A HIPAA authorization form was submitted with the IRB documents and an IRB member questioned whether HIPAA was applicable to this study since the PI does not appear to be affiliated with a covered entity o When the PI and Co-PI were asked about the HIPAA aspects of this study the PI indicated that they will not obtain any medical records from the participants. Just the history/background information on the form and the form would state that the PI is a Physical Therapist who would be providing direct access, which she is 5
authorized to do in the state of Florida. The PI does not plan to report any findings to primary care or anything in that nature. She included HIPAA documentation because she was modeling her documentation off of other more invasive studies and thought she needed to do so o Standalone HIPAA authorization agreements are not under the purview of the UNF IRB. Additionally, the IRB does not believe that HIPAA applies to this study. Discussion of exclusion criterion: children who are wards of the state o IRB reviewed 46.409 to ensure that the exclusion criteria did not conflict with the regulations. The IRB determined that the exclusion criteria was acceptable. Discussion of whether it was acceptable for one parent/guardian to consent on behalf of the children or if two parent/guardians must consent o IRB members had no concerns about parent/guardian permission being obtained from one parent/guardian since the study was not elevated to 46.406 or 46.407 review. Whether it was appropriate for participants to contact the PI and Co-PI rather than the IRB regarding research related injuries, concerns, or complaints o Because potential participants will be provided with IRB contact information and the PI and Co-PI should be informed if any participants experience research related injuries, concerns, or complaints, the IRB decided that the contact information was okay as outlined in the parent/guardian consent form. - Vote (modifications required): The PI needs to provide an explanation as to why the FDA device regulations do not apply to this study An IRB administrator needs to contact the FDA to verify that FDA device regulations do not apply to this project Modifications required: Review memo will be sent to the researchers detailing the required modifications. Revisions will need to be brought back to the full board for review (8 of 8 attending voted in favor of this outcome, 2 not present). III. Due to time limitations, IRB was not able to discuss the following items that were on the Agenda: - Digital commons, theses and dissertations discussion of whether these contribute to generalizable knowledge - Discussion of Incidental Findings and Contingency Plans (e.g., when are contingency plans needed and when are they not?; what is a good contingency plan?) - Discussion of Exempt categories 1 & 4 vs. Expedited category 5 (educational opportuinity) The above items will be discussed during the next IRB meeting if time allows. 6
IRB Projects Approved since last convened meeting: Original Exempt IRB Number PI Exemption Date 14-075 (654949-1) Sweeney, Kristi 10/23/2014 14-088 (642577-1) Truelove, Heather 10/24/2014 14-089 (665494-1) Gregg, Elizabeth 10/27/2014 14-093 (672475-1) Guess, Dominik 10/29/2014 14-095 (669953-1) Goel, Lakshmi 10/31/2014 14-091 (661162-1) Monaghan, Patrick 10/31/2014 14-090 (672055-1) Antonio, Lilyeth & Leding, Juliana 10/31/2014 14-096 (673077-1) Williamson, Steven 11/7/2014 14-099 (675474-1) Alloway, Tracy 11/12/2014 14-092 (669699-1) Fisak, Brian 11/12/2014 14-101 (676334-1) Rodriguez, Judith 11/20/2014 14-100 (676939-1) Paulson, Steve 11/25/2014 14-109 (659749-1) Toglia, Michael 12/08/2014 Expedited Full Board IRB Number PI Approval Date 14-067 (641786-3) Jahan-mihan, Alireza 11/17/2014 Contingent Amendment Exempt Exempt PI IRB Number Confirmation Date 13-079 (510996-7) Truelove, Heather 10/27/2014 13-083 (517129-5) Jahan-Mihan, Alireza 11/6/2014 Expedited IRB Number PI Approval Date 12-080 (382444-9) Truelove, Heather 10/30/2014 14-046 (562182-4) Nicholson, Jody 11/12/2014 7
14-019 (551847-5) Lange, Lori 11/13/2014 14-038 (574627-3) Wesely, Jennifer 11/13/2014 07-166B (635029-3) Cosgrove, Madelaine 11/18/2014 07-166B (635029-4) Cosgrove, Madelaine 11/24/2014 Full Board (through expedited means) IRB Number PI Approval Date 14-050 (612734-6) Lange, Lori 10/23/2014 Contingent Amendment Extension Expedited IRB Number PI Approval Date 12-080 (382444-10) Truelove, Heather 11/7/2014 Full Board Extension & Amendment Expedited Approval PI IRB Number Date 13-078 (509624-6) Truelove, Heather 10/22/2014 13-073 (508515-5) Zoellner, Brian 11/7/2014 09-134 (674271-2) Balasubramanian, Chitra 11/14/2014 10-090 (660389-3) Full Board Balasubramanian, Chitra 11/14/2014 Waived or Not Engaged IRB Number PI: Waiver Date: N/A Not formally Burrell, Jessica 10/13/2014 8
submitted to the IRB N/A Not formally submitted to the IRB N/A Not formally submitted to the IRB N/A Not formally submitted to the IRB N/A Not formally submitted to the IRB (FA: Lange, Lori) Cook, Terri 10/16/2014 Cosgrove, Madelaine 10/24/2014 Will, Jeffry 11/3/2014 Landes, Scott 11/17/2014 Class Project Waivers IRB Number PI: Waiver Date: CP#14-013 Fuglestad, Paul 11/5/2014 CP#14-015 Landes, Scott 12/5/2014 9