|What does "IRB" stand for?|
|"Institutional Review Board" means any board, committee, or other group formally designated by an institution to review, to approve the initiation of, and to conduct periodic review of, research involving human subjects. the primary purpose of such review is to assure the protection of the rights and welfare of the human subjects.|
|What training is required for researchers involved in human subject research?|
CITI Training is required for all personnel including PIs and Co-PIs involved in human subjects research. Faculty Advisors must complete the training before submitting a protocol for review. You can learn how to register for the required CITI training on IRB website.
|How do the federal regulations define human subjects?|
|Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual, or identifiable private information regardless of its source.(adapted from 46.102(f))|
|How do the regulations define research?|
|Research means a systematic investigation (i.e., the gathering and analysis of information; including research development, testing and evaluation) designed to develop or contribute to generalized knowledge.(adapted from 46.102(d))|
|Are the following types of research subject to IRB review?|
|If the research/protocol is funded by an external funding agency or unfunded, and it is unclear if it should be reviewed, submit an IRB application. the IRB will determine if review is necessary.
|Would pilot studies, with no intention to publish the results, need IRB review?|
|Yes, "Generalizable" knowledge means more then formal publications and presentations. In a pilot study, the outcome has predictive value so the concepts or principles elucidated by the research can be applied to other circumstances, thus building upon knowledge base.|
|What about students collecting data from humans as part of classroom research?
What about faculty collecting data from students? Is IRB review needed?
It depends? All academic units collect routine data about class or program effectiveness (e.g., FCQs, exit/senior interviews, student surveys assessing perceptions of a class or academic program) these activities do not require IRB review. However, assessment activities that address students' personal lives (e.g., dating behaviors, drug/alcohol use, mental health, social life, etc.) may involve some element of risk to subjects and/or investigators, and thus IRB review is recommended. Due to a potential increase in risk classroom research involving vulnerable populations must be submitted for IRB review.
Additional information regarding Classroom Research may be found in the IRB Standard Operating Procedure Special Topics: XXVIII Student/Classroom Research Projects.
|What if the research is being conducted off campus?|
|All research involving humans carried out by students, faculty, or staff, whether funded or unfunded, sponsored or unsponsored, on or off campus, is covered by the Standard Operating Procedures (SOPS) of the UCCS Institutional Review Board for the Protection of Human Subjects.|
|How do I get my research approved by the IRB?|
|Research involving human subjects may not proceed until written approval is received by the investigator from the IRB. Investigators may submit a completed IRB request for review, a research summary, consent document(s), and a copy of the Methods and Human Subjects section(s) if funding has been applied for or received for your project. the items above must be submitted via email to the IRB Chair at firstname.lastname@example.org. Exempt and Expedited Requests for IRB Review are usually processed within 10 business days. For research needing Full review, investigators must submit an electronic copy to the IRB Chair at email@example.com no later than ten (10) business days before the monthly IRB meeting. Typically Full reviews may take more than 25-50 business days to review and approve. the Board usually meets on the last Tuesday of the month during the academic calendar; summer meetings are scheduled if necessary.|
|What are the level of reviews?|
|When in doubt, ask the Chairperson of the IRB. Otherwise, follow these general guidelines:
|What general criteria used to review proposals?|
|Once human subject research has been approved, it is the Principal Investigator's (PI) responsibility to do the following:
|Once the IRB has reviewed and approved my research, have I fulfilled my obligations?|
|Can the IRB preform a scientific review to better understand the study design?|
|When UCCS research involves human subject research participants the IRB may consider research design under 45 CFR 46.111 other ethical codes; such as, the Nuremberg Code and the Declaration of Helsinki to address the IRB's obligation to review the design or other aspects of a protocol/study that may affect the scientific quality of the research . IRB reviewers may ask questions about study design to better understand what researchers are proposing. the IRB reviews research to ensure that:
the Common Rule and corresponding FDA regulations require the IRB to determine that the study is designed so that risks to participants are minimized and justified by potential benefits (refer to 45 CFR 46.111(a)). therefore, the IRB will carefully consider the study design and overall scientific quality of each study, particularly those studies that are investigator-initiated and/or unfunded. In evaluating the scientific design, the primary reviewer (exempt and expedited studies) or the primary reviewer and convened IRB (full board studies), will consider the following:
|Is parental permission always required?|
|Yes, unless specific criteria for the exception are met. There is a parental permission requirement for each of the four categories of allowable research. With this in mind, under certain circumstances the IRB may waive the requirements for obtaining parental or guardian permission it makes and documents the findings under either 45 CFR 46.116(c) or (d). (See Checklist)|
|Are there are circumstances in which getting parental permission may be against the best interests of the child?|
|The specific example cited in 45 CFR 46.408(c) is a study of abused or neglected children. In that case, the IRB may waive the requirement for parental permission, provided that adequate other protections are in place to protect the rights and welfare of the child. Appropriate protections would be very study-specific; for the example cited, there may be a person-appointed by a court or a child protection agency who would be an appropriate person to approve (or not) the inclusion of the child in the study.|
|When is permission from both parents required?|
|It depends which of the 4 categories of review are determined (described above). Permission from one parent may be sufficient for research conducted under 46.404 or 46.405. Research conducted under 46.406 and 46.407 permission must be obtained from both parents, unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child.|
|When is a child capable of assent?|
|There is no absolute regulatory or ethical standard for assent. 45 CFR 46.408(a) requires that "adequate provisions are made for soliciting the assent of the children, when in the judgment of the IRB the children are capable of providing assent." In short, it is determined by the IRB reviewing the protocol. But some guidance is offered: "In determining whether children are capable of assenting, the IRB shall take into account the ages, maturity, and psychological state of the children involved."
Taking this guidance into account, UCCS's IRB typically requires researchers to obtain written assent from all subjects between the ages of 6 and 18 (or age of consent when the research is taking place) unless a clear justification of waiver or alteration of assent is provided and approved.
|What about documenting assent?|
|There is no absolute regulatory or ethical standard for documentation of assent. 45 CFR 46.408(e) states: "When the IRB determines that assent is required, it shall also determine whether and how assent must be documented."
The IRB expects investigators to describe what they are doing about assent of minors in research, and how they're documenting it. In many cases, the researcher will be asked to use the UCCS "IRB Assent Form" template.
An oral assent process with less detailed documentation may certainly also be acceptable, especially in studies of low risk.
|What should be covered in an assent process?|
|Although the regulations provide little guidance, there are best practices that the UCCS IRB expects researcher to follow. The essential elements of the consent information should be provided, at a level and to the extent that the child is able to understand it. A lot of the formulaic elements (like compensation) can be omitted, but one should include (see "IRB Assent Form"):
|What if the research is being conducted within a school district?|
|Typically school districts have their own policies and procedures with regards to conducting research within their district. Please see the guidance resources page for more details.
For questions or assistance, contact the IRB at firstname.lastname@example.org.