The UWF IRB pretty much follows the guidelines of OHRP at the one-year anniversary of an IRB approval. Not all of the questions posed below are requested because they are not relevant to the UWF context (no multi-center trials). If data collection will persist beyond the 1-year anniversary, researchers are required to submit a second (renewal) application for another year of data collection.
As far as I can determine, these regulations only apply to the collection of data. Other aspects of research (data analysis, manuscript preparation, submission to conferences, publication) do not involve interaction with human participants and cannot impose risks to them. As such, I don't think they are subject to these regulations. One exception might be for data files that contain confidential information that might be linked to specific individuals. In these cases, I would expect that the full IRB review would have included stipulations about how these data are secured, how confidentiality is protected, both in maintaining the data file and in dissemination of results. Such an IRB approval might include reporting regular reporting requirements that these stipulations are adhered to that might extend beyond the period of data collection. Annette doesn't indicate that her project is in (or not in) this category. Information from the Office of Human Research Protection on purposes and procedures for continuing review (the 1 year summary reports): http://www.hhs.gov/ohrp/humansubjects/guidance/contrev0107.htm#WHAT_OCCURS_IF_THERE_IS_A_LAPSE_IN_CONTI In conducting continuing review of research not eligible for expedited review, all IRB members should at least receive and review a protocol summary and a status report on the progress of the research that includes: � the number of subjects accrued; � a summary of any unanticipated problems and available information regarding adverse events (in many cases, such a summary could be a simple brief statement that there have been no unanticipated problems and that adverse events have occurred at the expected frequency and level of severity as documented in the research protocol, the informed consent document, and any investigator brochure); � a summary of any withdrawal of subjects from the research since the last IRB review; � a summary of any complaints about the research since the last IRB review; � a summary of any recent literature that may be relevant to the research and any amendments or modifications to the research since the last IRB review; � any relevant multi-center trial reports; � any other relevant information, especially information about risks associated with the research; and � a copy of the current informed consent document and any newly proposed consent document. Later on this site (cases where the 1 year review does not occur and IRB approval lapses): *WHAT OCCURS IF THERE IS A LAPSE IN CONTINUING REVIEW?*** The IRB and investigators must plan ahead to meet required continuing review dates. If an investigator has failed to provide continuing review information to the IRB or the IRB has not reviewed and approved a research study by the continuing review date specified by the IRB, the research must stop, unless the IRB finds that it is in the best interests of individual subjects to continue participating in the research interventions or interactions. Enrollment of new subjects cannot occur after the expiration of IRB approval. When continuing review of a research protocol does not occur prior to the end of the approval period specified by the IRB, IRB approval expires automatically. Such expiration of IRB approval does not need to be reported to OHRP as a suspension of IRB approval under HHS regulations. Claudia J. Stanny, Ph.D. Director Center for University Teaching, Learning, and Assessment Associate Professor School of Psychological and Behavioral Sciences University of West Florida 11000 University Parkway Pensacola, FL 32514 – 5751 Phone: (850) 857-6355 or 473-7435 [email protected] CUTLA Web Site: http://uwf.edu/cutla/ Personal Web Pages: http://uwf.edu/cstanny/website/index.htm --- You are currently subscribed to tips as: [email protected]. To unsubscribe click here: http://fsulist.frostburg.edu/u?id=13090.68da6e6e5325aa33287ff385b70df5d5&n=T&l=tips&o=5447 or send a blank email to leave-5447-13090.68da6e6e5325aa33287ff385b70df...@fsulist.frostburg.edu
