University of North Florida Institutional Review Board Meeting. November 19, :03pm 3:34pm ORSP Conference Room Building 3, Room 2502

Transcription

1 University of North Florida Institutional Review Board Meeting November 19, :03pm 3:34pm ORSP Conference Room Building 3, Room 2502 Voting members present: Steven Ames, Richard Buck, Daniel Dinsmore, Christopher Joyce, Juliana Leding, Krista Paulsen, and Jennifer Wesely Quorum: yes (7 of 9 attending) Non-voting meeting attendees: Cheresa Boston, Dawn Harmon-O Connor, Kayla Champaigne, and Eva Espique-Bueno Minutes I. Review and discussion on past meeting minutes from the 10/19/2015 and 11/02/2015 meetings - IRB Discussion Two sets of minutes were shared with the committee prior to the meeting. The 10/19 meeting minutes were not completed prior to the previous IRB meeting so they had not yet been reviewed and approved. The 11/02 minutes were new minutes from the previous IRB meeting minutes. IRB tabled further discussion about obscuring names on the IRB minutes and vote on the minutes to a future meeting. Chair will do some research on what to include in the minutes and will provide that information to the IRB at a future IRB meeting. II. Discussion of potential non-compliance - Materials Information provided by PI regarding Digi-Stars Science Project was shared with all IRB members via prior to meeting (e.g., and reports, funding documents) - IRB Discussion The IRB will need to decide what to do with the suspension and resolve the issues of the current project. An IRB member thought that the section of the regarding the impact of the project on the education profession was difficult to interpret but it seemed as though the PI was describing research when he discussed how the project impacted the education profession. Another IRB member noted the publications listed at the bottom of the report and said they were not necessarily related to what was being done for this project. The IRB member said the actual project does not look like it was disseminated. According to the note at the bottom of the page, the evidence for those publications was obtained from other projects. Several IRB members remarked about the similarities between his various project activities that resulted in publications and presentations and the currently suspended project An IRB member indicated that the suspended project would have likely resulted in publications if the IRB had not learned of it and suspended the activity. Several IRB members indicated that the IRB cannot know how the PI would have used the data because if the PI has not published it or otherwise used it for generalizable knowledge. One IRB member described how similar professional development, program improvement and research can be. Sometimes it just comes down to how the PI will use the data and the PI has not generalized this data. 1

2 After reviewing all of the documents, an IRB member disagreed and indicated that the project appeared to be research rather than a program development. The documents include a research hypothesis, a systematic investigation, obtaining information about living individuals and the report seemed generalizable. An IRB member said that the PI appeared to be progressing towards human subjects research but now is saying that he will not do human subjects research and will only use the information for the report to funding agency. If that is the case, his project may not be human subjects research. However, the PI has done human subjects research without IRB approval in the past. Although that is a concern, it should be considered separately than this specific project. With the current project, the IRB needs to determine if the PI was currently conducting human subjects research. The IRB member said the IRB needs to deal with the current situation and then deal with what had occurred in the past. Pre and post assessments do not necessarily make a systematic investigation. The IRB will need to designate to the PI where the information can be disseminated. If the PI only reports to the Cummer than that was not human subjects research. It could be quality improvement. An IRB member indicated that this current project seemed to be human subjects research and the PI already disseminated the information. The PI was focusing on how the students learn and not how the teachers teach better or how the teachers improve their teaching ability so it doesn t seem like professional development. Another IRB member asked whether or not researchers are allowed to disseminate professional development results to schools. An IRB administrator reminded the IRB that this is a multi-year project and the PI could have disseminated results from past years. An IRB member said that the PI mentioned that none of the activities for this project were disseminated at a conference or publication and was only submitted to the funding agency. An IRB member asked about a 2015 article in the Florida Reading Journal Teaching with technology: Utilizing digital storytelling to enhance literacy instruction. If that article appears to be research where the PI discusses the earlier years of this current project, than the project was human subjects research. The IRB member asked if the article could be brought to the screen for review. The article could not be found online and may be in press. Several IRB members indicated that they would like a copy of that 2015 article. An IRB member suggested continuing the suspension because the IRB cannot make a judgment at this time about whether the project in question was human subjects research. Several IRB members suggested lifting the suspension and requiring the PI to only disseminate to the funding agency as long as it was clear that the PI would complete the activities in the corrective action plan and go through the IRB for all future activities involving human subjects research. If the PI has questions about whether his project requires IRB review, he should contact the IRB for guidance. An IRB member was concerned about implications for other researchers. If this PI is required to come to the IRB for all determinations, even when the activities are unlikely to be research, the IRB may start receiving too many submissions from other researchers who might think they have to do that too. This would be a waste of both the IRB s and the faculty s time. Another IRB member commented that there are many faculty members that come to the IRB for guidance on whether or not their projects are considered human subjects research. It often does not require a formal submission, just an . Generally speaking, researchers should be consulting staff on these questions. 2

3 An IRB member suggested that UNF have policies in place regarding Quality Improvement and research so faculty members could be better educated on what has to go through the IRB and the IRB could more easily enforce the policy. An IRB member suggested lifting the suspension upon receipt of clarification from the PI that he will not or has not published the data from this current project, has only disseminated the provided reports to the funding agency, will not attempt to generalize the data in the future, agrees to submit all other projects to the IRB for review prior to initiation and will comply with the corrective action plan once finalized. An IRB member said the corrective action plan should be educational rather than punitive. An IRB member suggested that the PI should submit the current project to the IRB. Another IRB member said if the PI submitted the current project, the project as human subjects research or determined not to be human subjects research. An IRB administrator said that the IRB does not retroactively approve human subjects research. An IRB member clarified that the new IRB application would only be able to apply for future activities An IRB member said that the down side to not to lifting the suspension would be that the PI s project would be delayed further. An IRB member commented that the IRB cannot determine whether the project was human subjects research or quality improvement because the IRB does not have a policy that was clear clearly articulates the difference between the two types of activities. Another IRB member added that the PI has not been clear or consistent in how he has described his activity. An IRB member said that the IRB was being careful and deliberate with the situation. An IRB member was torn because there was solid evidence in both directions. An IRB member commented that the PI s intentions would determine if the project was human subjects research. Another IRB member said that some IRB members weigh some concerns more heavily than other concerns which may account for the differences in views. An IRB administrator said that if the suspension was lifted, the project would only be temporarily lifted because the PI would have to submit the protocol if he wanted to use any of the information for generalizable knowledge. An IRB member commented that if the suspension was lifted then one IRB reviewer would have to make a determination on something that the committee was having difficulty trying to determine as a whole. An IRB member had concerns with the documents and s and thought that it might be easier to make a determination if there was a coherent protocol. If the PI submitted to the IRB, the documents would have a logical structure. Another IRB member said the committee could review the protocol as a group rather than send it to a single reviewer. An IRB administrator commented that the questions on the North Florida IRB Protocol would probably lead this project to being identified as not human subjects research because it has a question about generalizability and the PI is likely to say he will not generalize the data. An IRB member preferred to have one unified document with all the information including the CITI completion report rather than five documents that have conflicting statements. The IRB member said the submission would be a learning experience for the PI and the IRB would have a more familiar document for review. Another IRB member said the PI s submission to the IRB would formalize the project. 3

4 - Vote An IRB member moved that the IRB should request the PI to submit a conventional protocol on the current project that the IRB will review. The project activities could begin after a determination was made for that project (e.g., approval, exemption, not human subjects research). The suspension will continue until that new project has been submitted, reviewed, and received a final determination. An IRB member commented that if the project comes back as not human subjects then the PI will receive a waiver and will not be able to generalize the data just like any other PI. IRB Discussed how to process the new submission after it was submitted and decided that it should be reviewed by the committee at a full board meeting. However, it may not necessarily be a full board project even if it is reviewed at the full board (i.e., may still receive an expedited or exempt determination if applicable). An IRB member said that as part of the corrective action plan the PI would have consultation with UNF IRB administrators any time the PI has a project and more oversight and training. An IRB member said there may be ramification with other researchers who work with DCPS. The IRB member said this would be detrimental to the college. An IRB member commented that if the IRB was able to make a clear determination the IRB would have made the determination already. The IRB member said a determination could not have been made because there was lack of clear information provided by the PI. Another IRB member would not want this to affect the relationship with the DCPS. Project under investigation will be submitted in IRBNet for review and discussed at a convened meeting (6 in favor, 0 against, 1 abstained, 2 not present) III. Presentation by Dr. Phills and Dr. Brown from UNF Psychology department regarding deception and incomplete disclosure in research - Dr. Phills and Dr. Brown provided a PowerPoint presentation on deception and incomplete disclosure It is common in social psychology to use deception. 40% of study s use active deception and 35% of study s use passive deception In other behavioral research there is about 80% of a form of deception. It is normal practice to have deception in behavioral research studies. Discussed the implications of the Hawthorne Effect Discussed the need for incomplete disclosure and the role of social desirability and other factors that can influence research when deception is not involved Discussed debriefing and some of the potential challenges associated with disclosure IV. Discussion of deception and incomplete disclosure - Materials Reading material was shared with all IRB members (e.g., Nuremberg Code, Belmont Report, IRB Guidebook Chapter III, APA Code of Ethics, Bankert & Amdur chapter on Deception of Research, IRB Member Handbook (third edition) chapter on Deception of Research Subjects) - IRB Discussion An IRB member said this topic was brought to the IRB because of the regulations and the way the informed consent must be written. The IRB member also said that incomplete disclosure and deception is commonly used by researchers from Psychology. The IRB member said that IRB reviewers are responding in different ways. The IRB member would like the IRB to be consistent in the how the reviewers respond to incomplete disclosure and deception. One researcher attendee said that there is a way for the participants to remove their data from the study by choosing an option on the debriefing form. The study participants could still 4

5 remain anonymous if that debriefing was connected to the data and no identifiers were required to remove the data. An IRB administrator said that a vast majority of the studies that involve incomplete disclosure and deception undergo exempt or expedited review at UNF and both of those reviews pertain to research that is minimal risk. The IRB administrator said the IRB has not made a formal decision as a committee on what is allowable for exempt projects. Unfortunately, there is no federal guidance about whether deception and incomplete disclosure research can be exempt and there is a lot of variation among IRB around the country with regard to this issue. Some IRBs say incomplete disclosure can be exempt from review while deception cannot be exempt, while some IRBs say that projects involving any incomplete disclosure or deception cannot be exempt. There are also levels of incomplete disclosure and deception. Some incomplete disclosure can be very distressing (e.g., not told that they will be reading an explicit rape scenario in the research) while some deception research is very low risk (e.g., tell potential participants that they are reading a real article about an innocuous topic when it is fake). Another IRB administrator did not have concerns thought projects involving incomplete disclosure could be exempt but projects involving deception should be elevated. An IRB member said both incomplete disclosure and deception are on a continuum so it is difficult to make a blanket determination about it. An IRB administrator said that for exempt review, a project is only reviewed to see if the project is eligible for an exemption. PIs are not currently required to submit a consent form or a debriefing for exempt review. This means that the protections generally undertaken for research involving deception (e.g., requiring a justification for the deception, reviewing the consent form, reviewing debriefing, requiring alteration of consent) are not present for exempt research. An IRB member said there needs to be guidance for researchers on what should be included on the informed consent and the debriefing forms when deception is involved. There also needs to be some consistency. An IRB administrator briefly discussed the Belmont Report and some of the UNF requirements that go along with that. For example, when a project involves incomplete disclosure and is expedited or full board, many reviewers have been asking PIs to either include a statement on their consent forms to indicate to subjects that they are being invited to participate in research of which some features will not be revealed until the research is concluded or explain in Attachment A why this statement would make their studies infeasible. This is consistent with the Belmont Report. A researcher attendee commented that including that statement may cause more harm by increasing suspicion and changing the participant s behavior. An IRB administrator indicated that the UNF IRB can decide how to deal with incomplete disclosure and deception but suggested that they come up with a consistent procedure so there is a fair and reasonable framework for decision-making. One option is to require all researchers who propose to use incomplete disclosure or deception to submit both their consent and debriefing forms regardless of review type. However, the IRB would need to be clear about what they are looking for in those documents at the different levels of review. A researcher attendee indicated that most psychological researchers have both informed consent and debriefing forms so it would not be difficult to submit them. The forms also teach psychology students and provide the participants the purpose of the research, references, and contact information. The IRB will continue to discuss deception and incomplete disclosure at future meetings V. Due to time limitation, the IRB was not able to discuss the following items that were on the Agenda: 5

6 - Discussion of subgroup topics: Serious and Continuing Non-Compliance Incidental Findings and Contingency Plans Continued discussion of subgroup topic: Class Projects - 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? IRB Projects Approved, Declared Exempt, or Waived since last convened meeting: Original Exempt ( ) Osborne, Raine (FA: Dinsmore, Daniel) 10/30/ ( ) Ehrlich, Suzanne 11/2/ ( ) Ehrlich, Suzanne 11/4/ ( ) Leding, Juliana 11/10/ ( ) Maxis, Sophie 11/10/2015 Expedited ( ) Indelicato, Natalie 11/6/2015 Full Board Contingent Amendment Contingent Amendment Extension 6

7 Expedited Full Board ( ) Jahan-mihan, Alireza 11/3/2015 Contingent Extension Extension & Amendment Waived or Not Engaged IRB Number PI: Waiver Date: Reason: ( ) Wolff, Jennifer 11/6/2015 All data was obtained under an approved IRB protocol from another institution and all interactions and interventions with human subjects for this project are completed. Additionally, the UNF IRB also understands that there is no identifiable information contained in the dataset and no possible way to re-identify individuals; Waiver sent 11/06/2015 N/A Not formally BEAM update (consulted Will, Jeffry 11/9/2015 submitted JW) N/A Not formally Clarke School Contract Will, Jeffry 11/9/2015 submitted (consulted JW) N/A Not formally submitted Dinsmore, Daniel 11/10/2015 UNF not engaged, UNF personnel (Dr. Dinsmore) will only be analyzing anonymized data and will 7

8 N/A Not formally submitted Pascale, Amanda 11/16/2015 never have access to identifiers All data was obtained under an approved IRB protocol from another institution and all interactions and interventions with human subjects for this project are completed. Additionally, the UNF IRB also understands that there is no identifiable information contained in the dataset and no possible way to re-identify individuals; Waiver sent 11/16/2015 Class Project Waivers 8