Frequently Asked Questions (FAQ)What's an Institutional Review Board (IRB)? Do I have to submit my project for review? My protocol is approved. What do I do now? I still have work to do but my approved protocol will expire soon. What do I do? I'm finished with my project. How do I close my protocol? What's an Institutional Review Board (IRB)? An IRB is a committee that has been formally designated to review, approve, and monitor research involving humans as subjects. The intent of the IRB is to protect the rights and welfare of the research subjects. The University of Nevada, Reno, has two IRBs, one to review biomedical research and the other to review social behavioral research. Each board must be comprised of at least five members with varying backgrounds to promote complete and adequate review of the research activities commonly conducted by the institution. The IRB shall be sufficiently qualified through the experience and expertise of its members, and the diversity of the members, including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects. The board must include at least one scientific member, one non-scientific member, and one member who is not otherwise associated with the University. Do I have to submit my project for review? Projects must be submitted for review if they meet the federal definition of "research" AND if the project involves "human subjects". "Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge." [45 CFR 46.102(d)] Consider:
Two Possibilities:
Does the project involve "human subjects"?
Consider:
Three possibilities:
The first step to approval is understanding the roles and responsibilities of the researchers and the principles behind human subjects' protections. The researchers and their team members must complete basic training through CITI prior to an IRB's review of a protocol. Protocols submitted by researchers who have not (or whose team members have not) completed training will be placed on hold until completion can be verified. What is CITI training and why is it mandatory? CITI stands for "Collaborative Institutional Training Initiative." CITI offers online training that meets the federal standards and requirements associated with human subjects' protections. The University is required to ensure all research team members participating in a study that includes human subjects have been appropriately trained. Since the courses are online, researchers may access them at their convenience. The initial training requirement must be satisfied through completion of one of two Basic Courses for the Protection of Human Research Subjects, either the Basic Course for Biomedical Research or the Basic Course for Social Behavioral Research. See the CITI website for instructions on registering and completing the course. A passing score is 80%. The University will honor completion of this training for five (5) years. Extension of certification expiration dates of previously completed training, for both initial and continuing education, was automatically extended to five years. The extension does not apply to training requirements for research conducted at the VA Sierra Nevada Health Care System (VASNHCS). What level of review does my project need? Just as research studies are not one-size-fits-all, neither are the IRB processes that coincide with them. Some studies are rather simple and relatively low risk. Other studies are more complicated and invasive. There are three levels of review—Exempt, Expedited, and Full Board—to meet the varying levels of risk human subjects may encounter as participants in a research study. Exemption: [45 CFR 46.101(b)] Under Federal regulations, certain categories of activity are considered research, but can be declared exempt from further review by the IRB. This determination is made by the IRB itself, not the researcher. To qualify for an exemption, the study may not pose more than minimal risk to human subjects and may not recruit participants from vulnerable populations such as prisoners, rely on audio/ videotaping or incomplete disclosure, or link data to subjects. Researchers must submit an application for exemption. There is no deadline for applications. Approved applications are valid for three years and cannot be renewed. However, they may be resubmitted for a subsequent three years should more time be required. For more information on exemptions, please visit our Applications page. Expedited Review: [45 CFR 45.110] Studies that pose no more than minimal risk that don't qualify for an exemption, may be eligible for expedited review. Studies qualifying for expedited review must fall within a federally mandated list of seven categories that can be accessed here. Please review the list carefully and note the applicable category(s) on your application. Expedited review means that the protocol does not have to be read and discussed by the full board at a scheduled meeting. The appropriate IRB chair or a designated board member may conduct the review outside of regularly scheduled meetings. Consequently, there is no deadline for expedited review of a new protocol. Approvals are generally granted for a year (but may be less) and applications may be renewed through a continuing review process. However, time lapses between the expiration date and renewal may not occur. Continuing reviews should be submitted well in advance of the expiration date. Should a protocol expire prior to undergoing a continuing review, the protocol is closed; the recruitment and enrollment of human subjects as well as data collection on enrolled subjects must stop until a new protocol can be reviewed and approved. For more information on expedited reviews, please visit our Applications page. Full Board Review: [45 CFR 46.111] Human subjects research that is not classified as exempt or expedited requires review by the full IRB at a convened meeting. Applications for full board review must meet a submission date to be included on the agenda for a scheduled meeting. All board members will receive a copy of the protocol though typically one member will be assigned as the primary reviewer. This reviewer will present the protocol details and concerns to the board. Approvals are generally granted for a year (but may be less) and applications may be renewed through a continuing review process. However, time lapses between the expiration date and renewal may not occur. Continuing reviews should be submitted well in advance of the expiration date. Should a protocol expire prior to undergoing a continuing review, the protocol is closed; the recruitment and enrollment of human subjects as well as data collection on enrolled subjects must stop until a new protocol can be reviewed and approved. For more information on full board reviews, please visit our Applications page. How do I put together the application? The application is available on our forms page and should be read with the understanding that the IRB is charged with ensuring that human subjects are protected and informed. To this end, the application should clearly explain the purpose and procedures of the research and how the risks to the subjects have been considered and minimized. There must be adequate resources for informing subjects of what they will encounter and their rights as participants in the study. Subjects must be given the opportunity to make a conscious, well-informed decision about participating, and the confidence to withdraw if they desire. The protocol itself consists of the application form (at minimum) and may include an expedited checklist, forms for vulnerable populations, consent forms, assent forms, information letters/flyers, recruitment materials, surveys/instruments, scripts, debriefings, sponsor-developed clinical protocols, site permission letters, and the like. Preparing a thoughtful, thorough, organized protocol will take time. Investigators and research team members must complete training prior to the study commencing. OHRP will screen and work with PIs to ensure the protocol is in order prior to IRB review. The IRB must evaluate the protocol, comments relayed to researchers, and perhaps revisions made all prior to the start of the research. Please give yourself adequate time to prepare the protocol and for the IRB to consider it. Do I need to use a consent form? Each protocol must identify an informed consent process. This process may or may not include a consent form. The consent process begins with the initial contact with potential human subjects and continues throughout the study. The purpose of informed consent is to ensure that individuals have the information they need to knowledgeably and voluntarily decide whether or not to participate in a study. Generally, consent starts with a conversation about the study and what subjects can expect as a participant. This conversation should include information about the risks and benefits of the study, how confidentiality will be handled, and who to contact to have questions answered. (A more complete list can be found on our Informed Consent page). The consent form is one way to document the consent process. This conversation should continue throughout the study and participants should be given any new information that may affect their desire to remain a research subject. If a consent form was signed by a participant upon entering a study, it may be appropriate for him/her to sign a revised version that has been approved by the IRB. Sometimes there are studies that do not require the use of a consent form. Usually, this arises when the consent form itself provides a link to data that would not otherwise exist, therefore, increasing risk for participants. Informed consent must still occur but a consent form is not used. Justification for using other methods such as verbal consent, information sheets, and cover letters should be included in the protocol. For more information, please go to our Informed Consent page or contact OHRP. What do I do if I need to use deception or incomplete disclosure in my study? Incomplete disclosure may be used as long as ALL of the following are true AND clearly explained in the protocol: (1) incomplete disclosure is truly necessary to accomplish the goals of the research, (2) there are no undisclosed risks to subjects that are more than minimal, and (3) there is an adequate plan for debriefing subjects, when appropriate, and for dissemination of research results to them. My protocol is approved. What do I do now? Create a binder—tangible or electronic—or similar resource for organizing the protocol. The PI is responsible for keeping complete records that can be easily produced and referenced. The approved protocol application should be kept in chronological order with the most currently approved at the forefront. The same applies to consent and recruitment materials, adverse event reports, modification requests, etc. Screening, enrollment, and withdrawal information, if applicable, should be kept in the binder as well as CVs, training certifications, financial disclosure information, etc. Keeping complete, organized records will likely simplify other OHRP processes that you may be required to go through throughout the life of the study. For example, current versions of protocol materials are required attachments to renewal requests; current, complete versions are required for quality improvement or compliance reviews; enrollment information is requested during renewals, modifications, and closures. For assistance with understanding or creating a binder, please contact our office. Do I have to follow the approved protocol as written or can I improvise? It is important for researchers to follow the approved protocol and to use the recruitment and consent materials approved by the IRB. If changes are necessary, they must be reviewed and approved by the IRB prior to being implemented. Some unexpected things have happened (or haven't happened) while conducting my project. What do I do? The PI must assess each adverse or unexpected event to determine if it must be reported immediately or if it can wait to be included in the next renewal. Any unanticipated problems with the study, adverse events to human subjects, and all deaths must be reported to the IRB within five business days. Unanticipated problems with the study may be outside direct problems with human subjects. For example, losing a laptop that contains confidential information would qualify as an unanticipated problem that must be reported within five business days. UNR OHRP provides a form for reporting adverse events and unanticipated problems as well as a log for tracking non-reportable problems on our website. If you are unsure about the reporting requirements for an event, please contact UNR OHRP for guidance. You may also find further guidance on our website. How do I make changes to my protocol? Changes must be reviewed and approved prior to implementation. Changes may be requested by submitting a Protocol Modification Form for changes to the body of the protocol or for requesting multiple changes, submitting an Investigator/ Research Personnel Form for adding or removing personnel other than the Principal Investigator, or submitting a Performance Site Change Form for adding or removing a performance site only. All of these forms may be found on the forms page of our website. Changes may not be implemented until the request for modification has been approved. Non-exempt protocols must undergo a continuing review at least once a year, though the IRB may elect for shorter periods such as every six months or quarterly. As a courtesy, the UNR OHRP sends a reminder approximately two months prior to the expiration date with the Research Status Report form attached. Continuing reviews generally require copies of the currently approved protocol application and collateral materials such as consent forms, assent forms, recruitment materials, etc. to be submitted with the Research Status Report form. OHRP approval letters identify the correct versions, usually by date. Submitting incorrect versions or omitting sections of the protocol may cause delays in the review process. Unfortunately, federal regulations do not allow expired protocols to be renewed. Once a protocol expires, it must be closed and research with human subjects halted. For the study to continue, a new protocol must be submitted, reviewed, and approved. I'm finished with my project. How do I close my protocol? To close a project, complete the Research Status Report form, indicating that the project is ending and submit it prior to the expiration date. You must keep pertinent records of the study for at least three years past the official closure date, maybe longer if a sponsor requires it. |
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Site last updated on March 1, 2012