University of North Florida Institutional Review Board Meeting

Transcription

1 University of North Florida Institutional Review Board Meeting July 25, :48pm ORSP Conference Room Building 3, Room 2502 Voting members present: Steven Ames, Richard Buck, Catherine Hough, Katherine Kasten, Maged Malek, and Krista Paulsen Quorum: yes (6 of 7 attending) Non-voting meeting attendees: Cheresa Hamilton, Dawn O Connor, and Kayla Champaigne Minutes I. Review and approval of minutes from 5/16/12 IRB meeting - 5/16 minutes 4 approved without adjustment, 2 abstained because they were not present at previous meeting II. Discussion of UNF Psychology department requirement that students participate in research. The one year pilot period has ended and the UNF Psychology department has requested to make the requirement permanent. a) Background: The requirement that was previously approved for a trial period of one year required students in entry level Psychology courses to either participate in research or complete alternative assignments pertaining to research as part of the course requirements. The alternative assignment involved reading a short article and then writing a one paragraph summary and a one to two paragraph description of what it would have been like to be a participant in the study described in the article. The trial period for the requirement was approved by the IRB July 2011 with the following stipulations: 1. The IRB requires that the course assignment be framed in such a way that it is clear that neither the written assignment nor participation in research is favored by the instructor. One suggestion is to frame the course requirement as an assignment to gain a better understanding of what it would be like to be a research participant. This course requirement could be fulfilled in one of two ways: i. Complete written assignment that includes a 1-paragraph article summary and a 1-2 paragraph description of what it would have been like to have been participant in study of interest. ii. Participate in Psychology research study at UNF 2. Introduction to Psychology course instructors are required to submit a report to the IRB at the end of each semester containing the following information: i. Percentage of students that chose each option (i.e., written assignment v. research participation) ii. A summary of any student complaints regarding this course requirement iii. Written student reflections about the participation experience with no individual identifiers.

2 3. Course requirement approved for a period of one year. The IRB will monitor activities related to this course requirement for a minimum period of one year and then reevaluate whether the course requirement should continue. A report was submitted in December 2011 containing information about the statistics about how many students completed each assignment and also student responses to the requirement. The IRB reviewed this report back in January 2012 and also again during this discussion. b) IRB Discussion: One IRB member noticed that the percentages in the report did not add up to 100%, they add up to 97% (How many students did all three hours in SONA? 45 students (22.5%), How many chose to do three written assignments? 0, How many did a combination of both to meet the requirement? 125 students (62.5%), How many did not complete the requirement or only partially completed it? 24 students (12%). The IRB member did not believe that this limitation was substantial enough to be an issue. One or more reviewers noticed that at least one student found the assignment difficult because of scheduling issues. This is something that should be kept in mind for future discussion. One or more IRB members remarked that they previously believed that the course requirement would only be for one research assignment rather than three. - However, the assignment was for three hours so it is possible that a student could participate in one very long study rather than 3 individual studies. - In reviewing the minutes from the original meeting, it is clear that the number of assignments was not outlined either way (as only one assignment or more than one assignment). - Because the IRB has not heard from students or others that the alternative assignment is overly burdensome, it does not seem necessary to revise the assignments at this time. One IRB member wondered if students fully understood that they could contact a third party (e.g., the UNF IRB) if they had questions about their rights as research participants. - Another IRB member indicated that there could be a department contact that students could go to if they had concerns about the requirement. - However, one IRB member said that it might be a better option to have instructors include on their syllabi and on the informed consent documents a statement that included the UNF IRB contact information. One IRB member questioned why the IRB needs oversight over these research activities. - Several IRB members indicated that the issue at hand is the protection of human subjects. When instructors target their own students as participants, there is a risk of undue influence due to the power differential instructors have over their own students. - One IRB member said that although it is the instructor s right to do research, it should also be the participant s right to decline participation. Therefore, if the instructors will require students to participate in research, there needs to be an alternative assignment to ensure that students are not being coerced into participating against their will. The point of the reports is to help the IRB evaluate whether the assignment is coercive and should be continued. - One IRB member said that the issue should not be whether the student liked the course requirement, because students do not always like course requirements. It is not the role of the IRB to undermine instructors authority when it comes to teaching. However, as

3 long as the statement was framed in such a way students know that they have someone they can contact if they feel their rights have been violated, that seems reasonable. - Conclusion: Participating Psychology instructors must include a statement on both their syllabi and on their informed consent documents that describes the course requirement including alternatives, emphasizes the voluntary nature of participating in research, and reminds students that they can contact the UNF IRB if they have questions or concerns about their rights as a research participant. With respect to the statement about the rights of research participants, one suggestion is to include the following text Please contact the UNF IRB by calling (904) or ing irb@unf.edu if you have questions or concerns about your rights as a research participant. The IRB was not in agreement about whether a report should continue to be submitted to the IRB on a semester, annual, or on a biennial basis (controverted issue). - Conclusion: The IRB would like to see the report from spring This issue will be revisited when the IRB can review that report. III. IV. Discussion of Important IRB Definitions (draft document): - Some but not all of the terms in this draft document are straight from the federal regulations (45 CFR 46) or from the federal guidance for the regulations. However, some of the terms are not defined by those sources. Therefore, it is up to each institution to come up with its own definitions. In creating these definitions, staff used other institutions as resources in addition to those listed above. The sources are included at the end of the definition document. - One or more members appreciated that the links to the primary sources were included on the definition document. - Definitions for exempt and expedited review should include more information about what might elevate a project to the next level of review (expedited or full board respectively). - The definition for full board should acknowledge the IRB has the option to review something at a full board meeting if deemed necessary. - This document must have a table of contents so that it is easy to navigate for researchers. Discussion of participant compensation and the institutional requirement to collect names, addresses, and social security numbers from participants receiving compensation. The controller s office is considering adopting a threshold of compensation for which social security numbers etc. would not need to be collected (e.g., If compensation is $75 or less researchers would not need to collect that information). - The UNF IRB supports the idea of a threshold because it makes research easier for researchers and increases participant privacy. The amount of the threshold is an institutional issue rather than an IRB issue. The UNF IRB should not be responsible for tracking compensation for tax purposes because this is beyond the scope of the IRB. V. Discussion of the procedure for participants who want to collaborate with external institutions (e.g., Mayo Clinic) - Mayo Clinic does not allow a blanket agreement for working with external institutions like UNF. Therefore, collaborative agreements must be processed on a case by case basis.

4 - The UNF IRB has agreed to accept other institutions applications in lieu of Attachment A with the understanding that the researchers may be asked to provide additional and/or clarifying information about their projects. - It is no longer required by the regulations that collaborating institutions put each other on their respective FWAs. - One or more IRB members emphasized the need for a streamlined process for researchers working with Duval County Public Schools as this is a common collaborative relationship. VI. VII. Continued discussion of contingency plans in the event of incidental findings in research - This issue previously discussed in detail at the 5/16/12 IRB meeting. - Incidental findings should be reported when there is relative certainty that the incidental finding is valid and could maximize benefits or minimize harm for participants. - Details about IRB recommendations will be discussed at a future meeting after additional research and discussion has taken place. Fall IRB meetings - The UNF IRB will not meet in August unless a full board project requires it. - The IRB would like to continue to schedule meetings two times a month for planning purposes. Meetings can always be cancelled if necessary. IRB Projects Approved since last convened meeting: Original Approvals: Exempt: ( ) Bilyayeva, Tetiana (Wallace) 5/30/ ( ) Alloway, Tracy 6/11/ ( ) Hogan, Gerard 6/12/2012 Harrison, Debra ( ) (Loriz) 6/14/ ( ) Jaffee, David 6/15/ ( ) Schmuller, Joseph 6/22/ ( ) Allen, Ashley 6/28/ ( ) Wynn, Richmond 7/19/ ( ) Wynn, Richmond 5/30/ ( ) Fisak, Brian 6/12/ ( ) Vernoski, Barbara (Bloom) 7/23/ ( ) Sealey-Potts 7/24/2012 Full Board: NONE Extension Approvals:

5 Leding, Juliana 5/16/ Toglia, Michael 6/1/ Vose, Brenda 6/7/2012 Zimmerman, Adam (Ybarra) 6/7/2012 Barr, Elissa & Moore, Michele 6/13/ Leone, Christopher 6/20/ Leedy, Aaron (Toglia) 6/20/ Harrington, Shana 6/21/2012 Full Board (reviewed by expedited procedure): Boling, Michelle 6/7/2012 Amendment Approvals: Exempt: Holland, Christine (Daniel) 6/15/ Ancheta, Irma 5/16/ Harrington, Shana 5/17/ Ancheta, Irma 6/5/ Ancheta, Irma 6/7/ Hogan, Gerard 6/8/ ( ) Rodriguez, Judith 6/12/ Allen, Ashley 6/14/ ( ) Guess, Dominik 6/18/ Wirth, Jim 6/20/2012 Extension & Amendment Approvals: NONE Full Board: NONE Contingent Approvals: IRB Number: ( ) PI: Contingent Approval Date: Pearson, Phyllis (Kasten) 5/17/ ( ) Allen, Ashley 7/5/2012 Reason for Contingency require DCPS IRB approval and CCPS LOS Contingently approved 7/5/12 (requires IRB approval from the Florida Coalition Against Domestic Violence IRB before

6 final approval can be generated). Recruitment, informed consent, and data collection not permitted until final approval. Contingent Amendment Approvals: IRB Number: PI: Contingent Approval Date: Ancheta, Irma 5/22/2012 Contingent Extension Approvals: IRB Number: PI: Contingent Approval Date: Leone, Christopher 5/25/2012 Reason for Contingency PI requested permission to receive contingent approval to allow for recruitment only (no IC and data collection permitted for phase III is allowed at this time) Reason for Contingency PI mentioned that he wanted to change data collection format to electronic which affects data security. For this reason, the reviewer indicated that data collection using new procedures would require amendment prior to implementation Withdrawn Projects: None Class Project Waivers: None Projects Declared Not Human Subject Research: Project Number: PI: Waiver Date: Comments N/A Rodriguez, Sheila 5/17/2012 Not officially submitted so project does not have an IRB Number, determination made by reviewer via correspondence. N/A Casella, Peter 5/24/2012 Not officially submitted so project does not have an IRB Number, determination made by reviewer via correspondence.