3.6.12 Human Subjects
(including Informed Consent Form)
Human Subjects Research
The Institutional Review Board (IRB) has found that this human subjects research protocol qualifies for the expedited review process and a waiver of documented consent. However, the investigators still must provide an informational document to subjects (see below), inform the IRB of any changes to the protocol, and undergo an annual review.
1. Risks to the Subjects
a. Human Subjects Involvement and Characteristics
Tree Star will analyze data produced by expert cytometry technicians and make gates with a computer analysis tool. This gating activity is performed in the pursuit of technicians' usual employment in consulting laboratories, or on Tree Star's behalf at the cooperating site to create baseline gating data. Tree Star does not know the identity of the technician, Tree Star has no interest in the identity of the technician, identity has no bearing on the outcome of the study, and identity will be disconnected from the data before Tree Star receives it. Collaborators will enter into a formal agreement prohibiting the release of the information to Tree Star under any circumstances, until the individuals are deceased.
The operators will interact with cytometer data collected from human or animal sources. This data is not the subject of Tree Star's research and was collected before the project began. Some of that data will describe subjects with the characteristics of the disease under study by the cooperating lab, and some will be healthy subjects. It is the range and accuracy of the gating behavior of analysis personnel that is of interest to us rather than the condition of the subjects. This data likewise will be kept anonymous, and the identity of the source has no bearing on this project.
The subject population will consist of Tree Star's application scientist employees, cytometry analysis technicians employed by cooperating labs in the pursuit of the laboratory’s research goals, and summer interns of high school age, hired with grant funds. The subject population includes a range of ages, genders, and ethnicities. Technicians are persons selected by the lab for their professional qualifications. No special classes of people will be included or excluded. Tree Star wishes to qualify the results compared to those of the existing pool of workers, however the pool is composed. Tree Star's collaborating sites are engaged in their own research and will not be performing research on Tree Star's behalf. Rather, they will supply Tree Star with ancillary data collected pursuant to their own research goals.
b. Sources of Materials
• No data concerning the identity of the technician performing the analysis will be present. That the operator was qualified to perform the analysis is certified by the collaborating laboratory. No other operator data is relevant to this study.
• Lab directors will know to whom the analysis work was assigned but will enter into an agreement with Tree Star prohibiting the release of the information to Tree Star under any circumstances, until the individuals are deceased.
• Tree Star's baseline gating performance data will consist of a mixture of
2) Gating procedures performed by technicians, lab employees, and interns on legacy FCS files as needed.
Collaborating sites include:
• Dr. Jörn Schmitz, Division of Viral Pathogenesis, Department of Medicine at Beth Israel Deaconess Medical Center, Boston, Massachusetts
• Dr. Ryan Brinkman, Terry Fox Laboratory, BC Cancer Research Centre, Vancouver, British Columbia, Canada
There are no potential risks to subjects other than those posed by the routine pursuit of their everyday software analysis work outside this project.
2. Adequacy of Protection against Risks
a. Recruitment and Informed Consent
Depending on developments as the project continues, Tree Star may need to collect gating examples of a type not available in the legacy data of cooperating laboratories. In this case collaborators agree to provide data ad hoc from their cytometry technicians.
Subjects will receive a brief written description of the scope of the project and give signed permission for the anonymous gating performance data to be used.
In case of need, Tree Star's cooperating lab directors may arrange for technicians to perform analysis procedures on Tree Star's behalf. Directors will provide subjects with the information document required by the IRB.
Information document follows:
Information for Participants in the FlowDx Research Study
Principal Investigator: Treister, Adam S. (541) 201-0022
Introduction: You are being asked to participate in a research study. The study is called Clinical Cytometry Analysis Software with Automated Gating. FlowDx LLC will use the findings of the study to develop a software application to isolate populations of interest in flow cytometry data using mathematical algorithms in the place of conventional methods of manual gate definition. The resulting commercial software program will be called FlowDx. Tree Star anticipates a two-year development period and may ask again for your participation during that time.
Purpose: The study seeks a body of manually drawn gates as a standard by which to measure the success of clustering algorithms. Working from a written procedure, you will perform a series of familiar analytic steps in the FlowJo software program. A single analysis procedure should take no more than an hour. To establish baseline (consensus) gates for a given data set, the study will collect and codify the gating choices you make. The present step requires three sessions, each lasting about 1-2 hrs .
Procedures: You will be asked to perform a familiar software analysis task in FlowJo so that the data you identify can be similarly identified in software.
Risks: There are minimal risks to participation in this research, similar to those you encounter in the regular performance of your job.
Benefits: The chief benefit of success in this study is the reduction of repetitive labor necessitated by large-scale studies with high throughput.
Reimbursement/Compensation for Illness/Injury During Study: There is no reimbursement or compensation for your participation in this research.
Confidentiality: Data will be de-identified as the work is performed and before it is handed over for use by the FlowDx study. However, the following groups may gain access to information that identifies you by name: your lab director; the U.S. Food and Drug Administration (FDA); the Office for Human Research Protections (OHRP); and UAB’s Institutional Review Board (IRB). The results of the study will be published for scientific purposes. These results could include your analysis data. Once the study is complete, personal information connected with the data and held by the cooperating lab will be destroyed.
Legal Rights/Patient Consent: You are not waiving any of your legal rights by agreeing to this informed consent document.
Voluntary Participation/Withdrawal: Your participation is voluntary. Whether or not you participate will not affect your relationship with your employer or FloxDx LLC. You are free to withdraw from the study at any time without penalty. Researchers reserve the right to end the study or your participation at any time.
Research Subjects' Rights: If you have any questions, concerns, or complaints about the research or a research-related injury, please contact Principal Investigator Adam S. Treister, FlowDx LLC 340 A Street, Ashland, OR 97520 541 201-0022
If you have questions about your rights as a research participant, or concerns or complaints about the research, you may contact the Southern Oregon IRB, 541 789-4626, 2825 East Barnett Rd, Medford, OR 97504. Office hours of the IRB are 8:00 a.m. to 5:00 p.m. PT, Monday through Friday. You may also call this number in the event the research staff cannot be reached or you wish to talk to someone else.