University of North Florida Institutional Review Board Meeting. October 19, :00pm 2:31pm ORSP Conference Room Building 3, Room 2502

Transcription

1 University of North Florida Institutional Review Board Meeting October 19, :00pm 2:31pm ORSP Conference Room Building 3, Room 2502 Voting members present: Steven Ames, Richard Buck, Christopher Joyce, Juliana Leding, Krista Paulsen, Susan Perez, Janice Seabrooks-Blackmore, and Jennifer Wesely Quorum: yes (8 of 8 attending) Non-voting meeting attendees: John Kantner, Dawn Harmon-O Connor, Kayla Champaigne, and Eva Espique-Bueno Minutes I. Review, discussion, and vote on past meeting minutes from 9/21/2015 meeting - 9/21/2015 minutes unanimously approved as-is (6 in favor, 0 against, 1 abstained, 1 not present during vote and arrived afterwards for additional agenda items) II. Discussion of Compliance Concern - Materials Information was shared with IRB members via on October 16, Background There were allegations that a UNF faculty member was currently conducting research without an approved UNF IRB protocol. According to the UNF IRB Standard Operating Procedures (SOP), the chair of the IRB will review the allegations of noncompliance and determine if the alleged practices appear to (1) cause injury or any other anticipated problems involving risk to participants or others or (2) constitute serious or continuing noncompliance with IRB regulations. The IRB is responsible for reporting to appropriate officials (e.g., FDA, OHRP): o Any unanticipated problems involving risks to human participants or others; o Any instances of serious or continuing noncompliance with regulations or determination of the IRB; and o And suspensions or termination of IRB approval. The chair of the IRB has asked the PI to suspend the study activities while the IRB conducts an investigation. The PI has agreed to suspend his activities. If the investigation reveals a history of compliance issues then the IRB will need to address those concerns. The PI provided a response to questions raised by the chair of the IRB. The PI said that he doesn t intend to collect or analyze school children s data for the purposes of publication or research for this current project (Digi-Stars Science Project). In addition to the Digi-Stars Science Project, the PI also previously published articles that involved school children and UNF students. UNF IRB doesn t have records of any protocols for the PI. - IRB Discussion The PI has been invited to the November 2, 2015 IRB meeting. An IRB administrator said that although the PI has indicated that he will not publish the data on this Digi-Stars Science Project, the IRB can t assume that he won t collect, analyze data, or 1

2 publish data for other projects. The IRB administrator suggested that the PI s projects should be discussed independently. An administrator said what happened in the past cannot be changed. In order to move forward, the administrator suggested that the IRB focus on the current case of noncompliance because this is an active project that involves school children. The administrator added that the PI may need to be penalized in some way for noncompliance if deemed necessary. In discussions with the PI, the PI indicated that he didn t consider his project as research. After reviewing other institutions that have formal procedures for noncompliance, it seems clear that the IRB will need to decide if there has been serious or continuing noncompliance. Once the determination has been made, the IRB will need to create a corrective action plan to minimize the chances of further noncompliance. If the IRB has determined that this case involves serious or continuing noncompliance, the IRB will need to report this issue of noncompliance to the Office for Human Research Protections (OHRP). The corrective action plan will also be submitted to the OHRP. In the PI s , the PI mentioned a relationship between the Urban Professional Development School (UPDS) and Duval County Public Schools (DCPS). An IRB member said that this noncompliance may negatively impact that relationship because UNF and agreements with the local school district. The IRB member also said that there may be concerns regarding the various ways the PI is using the information and whether or not that information is presented outside of the university. In many cases, activities (e.g., photos, videos) conducted in the local schools are under the instructor s guidance and only the instructor uses that information. If the PI publishes the information than he is using the information for generalizable knowledge. However, many UNF student projects are for strengthening their teaching skills and knowledge. Although those activities may take place in the schools, they are not always research. The IRB member suggested obtaining a possible agreement with the school district to allow UNF to conduct projects/activities. The IRB member said that UNF could also obtain parental permission regarding the data and that the data will only be used for instructional purposes. An IRB administrator said that some of the student projects may be part of the normal educational practice for the College of Education and Human Services. However, those normal educational practices may be considered research when individuals decide to publish and get scholarly credit for the study. Researchers may not realize that they need to contact the IRB for guidance and/or assistance on these situations. An IRB member wanted more information regarding similar agreements between the UNF IRB and DCPS. An IRB administrator said that the process with the DCPS is not technically an IRB process. Although DCPS does hold a FWA and therefore have certain requirements, the DCPS review process is different from a true IRB process. The IRB administrator wasn t familiar with the process that the PI completed with DCPS. Based on discussions with administrators in DCPS, the administrators understand that DCPS usually requires UNF IRB review before they will issue their own approval. An IRB member commented that it may not be part of the culture to go through the IRB for teachers in training. Another IRB member commented that in the the PI mentions an agreement (e.g., photo release, video release) and that s a concern if children will be video recorded. An IRB member asked whether or not the PI s work is for the purposes of teacher training or research. The agreement of understanding mentioned by the PI seems to be for teacher training. Also, the PI wants to video tape the school children to observe their demeanor. 2

3 Another IRB member said those videos will be shared with the pre-service teachers so the preservice teachers can understand the demeanors what to do in those situations. It is possible that those videos will be used as a teaching tool. The PI has indicated that he may post some of the videos on YouTube. However, an IRB administrator said that it is not clear on how the PI may be utilizing YouTube and who had access to those videos. Although the PI said in his that the Digi-Stars Science Project is about children exploring our world and communicating their discoveries to others, an IRB member said the PI wasn t clear about the purpose or procedures of the study. The IRB member would like the PI to provide additional information regarding the study and program. The PI mentioned a program in his in which he is working with children by teaching them sing and tell stories. If the PI wants to measure the effectiveness of the singing and storytelling and will only use that information for internal improvements at that school, then there may be no concerns. However, the publishing of that information or the use of that information in ways that may contribute to generalizable knowledge make it research that requires IRB review. The IRB member said that the PI doesn t outline what is being done in the study (e.g., procedures of the study, what is being done after the data is collected). The IRB member did not believe that the UNF IRB could decide if the project was human subjects research until the PI provides additional details about the study. These concerns were brought to the IRB because there are allegations that the PI video recorded school children without going through the IRB, conducted a systematic investigation of the videos, and may generalize the data. The PI has also indicated that he obtained parental/guardian permission to video record the children. An IRB administrator asked if the PI gained access to the student s artifacts for the Digi-Stars Science Project. Another IRB administrator said that the PI did a previous FCAT study that involved minors, their grades, and their artifacts. However, it wasn t clear if the Digi-Stars Science Project included artifacts. An IRB member said the first goal of the IRB would be to ensure the PI does not publish from this study. Another IRB member said that the PI could possibly publish the results if this study does not meet the definition of human subjects research. Before the November 2, 2015 IRB meeting, the PI will be asked to provide details of the study and will be informed that he may be asked questions about the study. After meeting with the PI on November 2 nd, the IRB can decide on whether or not the Digi-Stars Science Project is human subjects research. As part of the investigation, the IRB will also look at his other research. The PI has at least four to five articles published over the last several years but no protocols with the UNF IRB. He also has a couple of projects in press. An IRB member informed the IRB that the PI appears to have done the following other projects in addition to the Digi-Stars Science Project: o Collected data from 38 fourth grade students from a school located in Jacksonville o Analyzed student performance on the Reading-Level Indicator (RI) and the Florida Comprehensive Assessment Test (FCAT). This investigation resulted in a publication. o Collected data from 889 college students, who majored in elementary and secondary and enrolled in teacher education programs o Surveyed 25 freshmen and sophomore college students enrolled in the principles of issues in English for Speakers of Other Languages (ESOL). The surveys were on technology utilization and included preference ratings (in press). 3

4 The IRB member commented that these studies would all likely be considered human subjects research. An administrator said that there is a history of intended generalizability and a corrective action plan is needed to ensure future compliance. An IRB member asked whether the administrator thought the PI s previous studies were human subjects research that didn t have an IRB approval. The administrator responded that it appears that the PI has conducted human subjects research in the past without IRB approval. An IRB member said that the UNF IRB has purview to address concerns of broader noncompliance as part of the correction action plan. The IRB member suggested that the PI should meet with the IRB during the November 2, 2015 meeting to provide clarifying information on his current project. Based on that meeting, and any information obtained from the PI before then, the IRB can discuss and create the corrective action plan. Several IRB members found it difficult to understand the PI s recent . One IRB member asked if the Digi-Stars Science Project was listed on the PI s dossier and CV. If so, how it would be helpful to know how it was listed (i.e., research or service). The IRB doesn t have access to the PI s dossier. Although it would be helpful to have a copy of his CV, several IRB members agree that it was unnecessary to have a copy of his dossier. An IRB member wanted to know whether or not education journals request copies of IRB approval before they will publish works that involve work with humans. Another IRB member indicated that some education journals do not request IRB approval. However, it seems like educational journals may be more frequently requesting the IRB approval. It really depends on the journal. An IRB administrator conducted an internal search of the IRB databases to verify if there was any IRB approval for the PI s work or the work with his collaborators. The IRB administrator could not find evidence of IRB approvals for any of the projects. Additionally, it appears that the PI may have been previously involved as an administrator for some of the journals to which he submitted articles for publication. An IRB member said that most of peer reviewed journals require blind peer review. Another IRB administrator said there may be an overlap between the program evaluation aspects and research. A Project can be both if the program evaluation is conducted with intent to allow others replicate the program, promote policy change, draw general conclusions or other factors. An IRB member was interested in the PI s understanding of what constitutes human subjects research. In order to create a correction action plan, the IRB has to address the PI s understanding of what constitutes human subjects research. An IRB administrator commented that IRB doesn t require everyone to submit a formal IRB application to learn if their projects require UNF IRB review prior to initiation. IRB administrators often receive s about projects and can often use that information to determine of those projects involve human subjects research. is necessary to ensure the information and determinations are documented for the record but a formal submission is often not required. An IRB member would like to see additional information from the PI before the next IRB meeting. The IRB member wants the PI to describe the Digi-Stars Science Project with specificity. The IRB member also added a MOU with DCPS does not provide a UNF IRB approval. An IRB member doesn t want the IRB to be overly punitive. If the projects are deemed human subjects research a corrective action plan will be necessary. 4

5 An IRB member asked the IRB administrators if there was a systematic approach for researchers when it comes to determining whether or not the study is human subjects research. An IRB administrator said there are several guidance s on the IRB website. The UNF IRB Decision Chart and the UNF IRB Definitions documents were brought up on the screen for review and discussion. The chair of the IRB ed the PI and requested the following information: what the PI is seeking to investigate?, what is being measured or addressed in the study?, describe your access to this population and participant selection, assent and consent procedures, what activities are being videotaped?, and how are plans for the use and dissemination of the results?. An IRB member would also like to ask the PI (1) what is being done? and (2) what are your procedures and/or methods? The IRB member said the PI mentioned in his an assessment of the children and that they are engaged in routine formal measures (e.g., worksheets, rubrics, and projects), so it seems that the PI has been accessing artifacts. More information about this is needed. Another IRB member said this project could probably be exempt review. An IRB administrator said if the study was exempt category 1, then the IRB would need to determine whether it was normal educational practices. However, the use of children and the use of artifacts or records may complicate matters. An IRB member suggested that the PI be informed that the board didn t think that their initial questions were addressed and the board is asking again to please provide a written response prior to the November 2 nd IRB meeting. An IRB member said that the PI has two articles in press (1) Relationship among storytelling, values, and resilience of college students from Eastern and Western cultural backgrounds and (2) Enhancing the effectiveness of teaching and learning in an online ESOL course. The IRB member isn t sure if either of those articles are for the Digi-Stars Science Project. An IRB member asked if there were any situations where an individual could publish information without it being considered a contribution to generalizable knowledge. The IRB member said it would be hard to come up with one situation where an individual published and not meet that criterion. An IRB administrator responded that this is a gray area. The chair of the IRB will send a second to the PI and request for the details of the study. III. Discussion of subgroup topic: Serious and Continuing Noncompliance - Background The current version of the UNF IRB Definitions document includes a definition of Noncompliance. The current UNF IRB Standard Operating Procedures (SOPs) offer limited information about what to do when noncompliance occurs. The current SOPs include very broad and non-specific information about where to start with an investigation and the reporting requirements but offer little else. The subgroup worked on developing definitions for serious noncompliance and continuing noncompliance. The IRB administrators would also like to eventually have a standard operating procedures or guidance for those instances of noncompliance. - IRB Discussion The subgroup agreed that no changes were necessary to the existing definition of noncompliance in the definitions document. The subgroup researched information about best practices of other institutions regarding serious noncompliance and continuing noncompliance and used Brown University, Cornell University, and Emory University as a guide when 5

6 developing the definition of serious noncompliance and continuing noncompliance. One IRB member liked how the other institutions provided examples of the various types of noncompliance and used that in the UNF definitions. With regard to the definition of serious noncompliance, the subgroup discussed whether to include noncompliance that compromises the integrity of the human research protection program vs. noncompliance that compromises the integrity of the human research protection plan or the research. The subgroup asked the rest of the IRB for their thoughts. With regard to the definition of continuing noncompliance, an IRB member highlighted the potential for flexibility with regard to the time period (e.g., days, weeks). An IRB member suggested leaving out the time frame in the definition of continuing noncompliance and making it more open ended to allow for flexibility. Noncompliance can take place over a period of years and it isn t the time period that makes it continuing. Another IRB member remarked that the time period seems important to severity in some cases. If a researcher engages in noncompliance and then does another act in quick succession that also constitutes noncompliance that may increase the need for concern. Another IRB member said there may be a pattern of noncompliance that doesn t have a timeframe and agreed that some flexibility was needed. The statement A repeated pattern may be specific enough because the timeframe is not the most important feature of the continuing noncompliance. An IRB administrator asked if the IRB had suggestions of what would be considered continuing noncompliance. Although the administrator recognized that the IRB may want to evaluate these situations on a case by case basis, the IRB has an obligation to report continuing noncompliance so it would be nice to have basic framework for decision making and evaluation to ensure consistency. The IRB administrator wants the IRB to have a standard process to ensure the IRB meets its reporting obligations. Several IRB members agreed that continuing noncompliance should not be given a specific number (e.g., after 3 instances of noncompliance it becomes continuing noncompliance that must be reported). The IRB will need to assess each instance on a case by case basis. Several IRB members indicated that the risk posed by the noncompliance may factor into the decision. Another IRB member also indicated that it matters also if the PI is aware of (or should have been aware of) the fact that their activities constitute noncompliance and continued to engage in those activities. If they were informed of the noncompliance and did the activity again, that may be continuing. IRB administrator indicated that a repeated failure on the behalf of a PI to submit materials for continuing review can be continuing noncompliance if the IRB notes a pattern (Federal Guidance on Continuing Review). An IRB member indicated that PIs should be given a chance to present information about compelling mitigating circumstances to explain noncompliance and this may allow some flexibility. An IRB member suggested striking out the time frame from the definition of continuing noncompliance. No other IRB members objected to this so the change will be made to the definition document. With regard to the definition of serious noncompliance, several members agreed that the use of the language compromises the integrity of the human research protection plan or the research was best. No one objected to this so the change will be made to the definition document. No other comments were made about the definitions. The definition of the serious and continuing noncompliance will be included on the UNF IRB Definitions document. 6

7 The IRB would also like a link to the updated UNF IRB Definitions document included in the SOPs (i.e., make the terms Serious Noncompliance and Continuing Noncompliance hyperlinks to UNF IRB Definitions document in the SOPs document). Additional future actions with regard to noncompliance may include revising the SOPs to include additional details about the procedures that will be used for investigations of noncompliance in the future An IRB administrator will draft the changes and the changes will be brought to the IRB for review and discussion. IV. Continuing Education: Brief Presentation on the Belmont Report PowerPoint shared with IRB members via prior to meeting PowerPoint was brought up on the screen for presentation and discussion V. Due to time limitations, the IRB was not able to discuss the following items that were on the Agenda: - Discussion of subgroup topics: Incidental Findings and Contingency Plans - Discussion of Compensation/Incentives for Research including when withholding payment may cause undue influence and when it is appropriate or necessary to prorate payments to participants - Other potential discussion items Substantive changes to exempt projects: how should these be described in the SOPs? Continued discussion of subgroup topic: Class Projects Research Involving Deception: method for developing SOPs and/or guidance to standardize how the UNF IRB handles projects involving deception and incomplete disclosure The above items will be discussed during the next IRB meeting if time allows. IRB Projects Approved, Declared Exempt, or Waived since last convened meeting: Original Exempt IRB Number PI Exemption Date ( ) Hogan, Gerard 9/17/ ( ) Richardson, Stephen (FA: Gupton, Sandra) 9/21/ ( ) Cosgrove, Madelaine 9/22/ ( ) Fuglestad, Paul 9/24/ ( ) Mann, Angela 9/29/ ( ) Hogan, Gerard 9/17/ ( ) Schnusenberg, Oliver 10/6/ ( ) Indelicato, Natalie 10/6/ ( ) Ehrlich, Suzanne 10/7/ ( ) Osborne, Raine (FA: Dinsmore, Daniel) 10/13/2015 Expedited 7

8 ( ) Alloway, Tracy 9/22/ ( ) Lee, KoSze 10/5/ ( ) Webb, Kristine 10/6/ ( ) Brown, Elizabeth 10/8/ ( ) Joyce, Christopher 10/8/2015 Full Board Original Contingent Amendment Exempt IRB Number PI Date Approval Documents sent ( ) Schonning, Alexandra 10/1/ ( ) Johnson, Christopher 10/9/ ( ) Kaplan, Leslie 10/9/2015 Expedited Full Board (through Expedited procedure) IRB Number PI Date Approval Documents sent ( ) Jahan-mihan, Alireza 10/12/ ( ) Jahan-mihan, Alireza 10/12/2015 Contingent Amendment Extension Expedited IRB Number PI Date Approval Documents sent ( ) Clark, Kerry 10/5/2015 8

9 ( ) Livingston, Beven 10/7/2015 Full Board Contingent Extension Extension & Amendment Expedited IRB Number PI Date Approval Documents sent ( ) Evors, Pamela (FA: Scheirer, Elinor 9/23/ ( ) Dinsmore, Daniel 9/24/ ( ) Alloway, Tracy 10/1/ ( ) Miller, Judith 10/5/2015 Full Board Waived or Not Engaged IRB Number PI: Waiver Date: Reason: N/A No Formal IRB Submitted N/A No Formal IRB Submitted Marchut, Amber 9/22/2015 Paulsen, Krista (student Rebecca Dingler) 10/13/2015 UNF not engaged (only involved recruiting a few UNF students into a larger study with Gallaudet University IRB approval) - No UNF affiliates engaged Project does not involve obtaining information about living individuals. Class Project Waivers Class Project Number PI: Waiver Date: CP# Varma, Tulika 9/30/2015 9

10 CP# Truelove, Heather 10/7/2015 CP# Fuglestad, Anita 10/12/