Sign Kentucky Permission Slip Fast

Document type sign permission slip kentucky fast

welcome to the Office of Research integrity Fast Pass video getting started institutional review board review although the acronym IRB stands for institutional review board the requirement for IRB review is federally mandated the IRB is review and oversight promote the protection of the rights and welfare of human subjects involved in research activities as prescribed by federal regulations the principal investigator or PII is ultimately responsible for the ethical and compliant conduct of the research the faculty adviser and or department chair who sign off on the application is responsible for providing guidance mentoring and ensuring the scientific validity of the research to learn more about the human subject research responsibilities please visit the website listed on your screen the Office of Research integrity serves as a communication conduit between the P I and the IRB as the administrative office for the IRB Ori provides regulatory guidance to researchers and IRB members however Ori does not make regulatory determinations to approve or disapprove research the IRB makes those determinations when research activities involve human subjects IRB review is required the common rule IRB regulations have specific definitions to help identify activities involving research and what constitutes a human subject as you can see these definitions are complex for instance some systematic activities may be done for interim purposes and not to contribute to generalizable knowledge publicly available information or decedent data may not meet the human subject definition for more information see the Fastpass video what needs ire be review or consult Ori Gaiden if the answer is unclear or an official not human subject research determination is needed contact IRI the next step in getting started involves training all study personnel on an IRB application must have current human subject protection also known as HSP training before the IRB can issue final approval initial and 3-year refresher HSP training is available to UK staff and students on the collaborative institutional training initiative or CIT I web based program city is a national education platform that provides training on multiple research related topics including human subject protection IRB member training and many other optional courses of interest contact RI for approval of HSP training completed elsewhere or to discuss options for non UK study personnel the UK link blu ID and password are also used to access the e ir be online submission system and the e IRB instructions video tutorials and live training sessions to become familiar with a IRB view video tutorials such as these er B works best on a desktop PC or Mac using either Chrome or Firefox browsers attachments only need to be uploaded once when uploading consent documents please choose the applicable document type so the system will recognize that the consent document needs an IRB approval stamp when completing the larger sections of the application such as the research description click the Save button often to prevent losing content should the connection timeout the following are general tips to help streamline the review the overall time to approval is impacted by the complex city of the protocol particularly in vulnerable populations are involved or additional regulations such as FDA or HIPAA apply carefully read instructions and refer to linked guidance provided throughout the application provide adequate information for each section of the application differentiate research from standard care or other non research components distinguishing the research from elements the participants will experience independent of the research will ensure that the IRB ease risk-benefit determination is based only on what your research brings to the equation attach relevant data collection tools questionnaires recruitment materials and draft informed consent documents yarby provides template consent documents to tailor to your research contact our eyes staff with questions the first item to answer in a new application is which IRB to submit to which is generally based on the p i's college however protocols originating from non-medical colleges that involve medical procedures or medical interventions may be transferred to a medical IRB in order to provide the expertise needed for the review the next determination is the process protocol type the IRB regulations include three process types for reviewing human subjects research exempt expedited and full convened review the following slides provide guidance on research that qualifies for each process type ultimately the IRB has the final authority to decide which review process is applicable research that presents no greater than minimal risk to participants meets specific categories may qualify for exempt or expedited review anything greater than minimal risk or research without an applicable exempt expedited category must be reviewed by the full convened IRB to meet the minimal risk definition the probability and magnitude of harm or discomfort anticipated in the research would be no greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological exams or tests consider whether the potential risks of harm are more likely or more significant than the risk of harm in everyday life exempt review protocols involve little to no risk and fit into one or more of the federal categories the categories do not apply to research with prisoners or surveys and/or interactions with minors public observation of minors may fit the exempt category as long as the investigator is not manipulating the environment or participating in the activities being observed here is an abbreviated list of the exempt categories to make an informed decision before submitting an application for exempt review see the Ori guidance document entitled issues to be addressed when conducting exempt review expedited review protocols also involve no greater than minimal risk and all activities must fit into one or more of the expedited review categories the expedited categories encompass diverse types of research and have fewer limitations than the exempt categories for detailed guidance on expedited review please see the Ori guidance document entitled issues to be addressed when conducting expedited review all other research will be reviewed by the full IRB at a convened meeting the p.i will be sent a date and time to attend the meeting to discuss the protocol and answer questions he or she is welcome to bring additional study personnel to participate in that discussion while most protocols will require revisions in order to meet the IRB approval criteria the discussion at the meeting may clarify concerns resulting in fewer or less substantive required revisions the University of Kentucky has for medical and one non medical IRB each meets approximately every three to four weeks all IRB meeting dates and the submission deadlines for the non-medical IRB are available on the Ori website here are a few examples of the types of studies which may qualify for exempt expedited and full review processes for additional help the Ori provided protocol development tools and sample applications for simulated studies to serve as guides and examples however there is no guarantee that using the sample language will affect your review or approval of your application each research proposal is unique with varying regulatory and ethical issues if you choose to use the sample language in your IRB submission include only what applies to your specific research only use descriptions for procedures you are able to implement by utilizing qualified staff systems or infrastructure to conduct your research even with the most well written submissions are likely to have required revisions it is important that you respond to the revisions as soon as possible if you do not understand a requested revision please contact our I address each and every requested revision or provide justification for the rationale for not making a requested change upon receipt of completed revisions the Ori will rotate further IRB review and notify the PI of the outcome additional resources are available on the Ori website contact the Ori with any additional questions thank you