IRB FAQ

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.
  1. Political polls, public opinion polls and journalism:
    In general, political polls, public opinion polls, and journalism do not meet the definition of research as defined by the Code of Federal Regulations. However, if poll results are intended to contribute to generalizable knowledge and/or if results are disseminated or used in news stories, then they would appear to meet the definition of research and should be reviewed by the IRB.
  2. Oral Histories:
    Oral histories in general, appear to be designed to create a record of specific historical events and therefore are not intended to contribute to generalizable knowledge. However, activities designed to contribute to generalizable knowledge (that is, designed to draw conclusions, inform policy, or generalize findings) would appear to be research as defined by the Code of Federal Regulations. Also, if archives are created for the purpose of providing a resource for others to do research, then the creation of that archive would appear to constitute research. Two questions can be used to determine if an oral history project is research as defined by federal regulations. 1) Are conclusions, generalizations going to be drawn? 2) Is there a record being produced that will potentially be available to the public?
  3. Marketing Research:
    Marketing research that requires IRB review includes research designed with a clear intent to disseminate or publish the results/data.
  4. Program Evaluation
    Program Evaluation is the inquiry into past, present, and potential programs to understand or clarify their need, working process or impact. there are three major categories of program evaluation: Needs assessments (formative evaluations) establish whether or not a program is feasible or necessary; process evaluations determine whether or not a program's implementation is congruous with its conception; impact evaluations (summative or outcome evaluations) ascertain whether or not a program meets its goals. Some program evaluations constitute human subjects research and others do not. Generally, program evaluations not requiring human subjects review involve data internally collected and analyzed for the normal course of business. these evaluations' goals range from simple descriptive statistics to qualitative information, and examples include program enrollment data, constituent demographics, and outcome analyses. therefore, irrespective of human subject involvement, these program evaluations remain internal and thus do not contribute to generalizable knowledge. However, if a program evaluation is research and uses human subjects, then it requires approval. Program evaluations that lead to publishing results in scholarly journals or making presentations outside your institution likely require approval. the assumption being that publishing/disseminating the findings generalizes the data. Moreover, evaluations connected to groups' or individuals' outcomes and affecting the development or implementation of other programs similar in nature, are generalizable human subjects research and require human subjects review. Furthermore, an evaluation building upon the replication of other programs or services and the population at large or public policy, should be reviewed and monitored.
  5. Data sets
    Public and/or published data sets include those that are accessible without restriction (e.g., password not needed*) and containing no readily identifiable, individual information. (Note only the IRB can determine if the research is exempt.)
    Examples include:

    • U.S. Bureau of the Census
    • National Center for Health Statistic
    • National Center for Education Statistics
    • National Election Studies
    • Public and/or published data sets, accessible without restriction (e.g., password not needed*), and containing readily identifiable information and where individuals can reasonably expect this information to be available to the public (examples include letters to the editor, blogs)
    • Public and/or published data sets, with restrictions to access, that contain data that is presented in aggregate form only; thus, individuals cannot be identified.
* or in those cases where you must register with a site or organization to gain access, the registration for login and password must be without qualification - that is, anyone could register with this site.

 

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. 

  1. Classroom Activities Involving Data Collection
    Courses sometimes require students to undertake small projects in which other people are interviewed, observed, or otherwise serve as human subjects. the purpose of these course projects is to provide students with a closer view of social, educational, or psychological processes, and/or with an opportunity to practice the same methods of observation customary to the various disciplines. Because such activities are not undertaken with the goal of developing or contributing to generalized knowledge, the IRB does not consider them to be research as such. Faculty are encouraged to discuss human subject protection issues with students involved in these classroom activities. 
  2. Student Research Projects
    Any student-initiated and/or student-conducted data collection activities designed to develop or contribute to generalized knowledge, and which use human subjects, require review by the IRB. this includes graduate theses, dissertation research, honors theses, and capstone projects. Note that all students conducting research must have a faculty advisor.Responsibility for obtaining the IRB approval for student research resides equally with the student and the faculty advisor. the student and faculty advisor are both required to complete IRB training.

 

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 irb@uccs.edu. 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 irb@uccs.edu 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:
  1. Exempt. the federal regulations provide for exemption from continuing review for certain kinds of research (e.g., reviews of existing data, documents, records, if the information is recorded in such a manner that subjects cannot be identified).
  2. Expedited. Research that poses only minimal risk to adult human subjects and does not deal with sensitive or personal aspects of the subjects behavior may be granted an expedited review.
  3. Full. Research involving more than minimal risk and/or vulnerable subjects must undergo a full IRB review. Vulnerable subjects include children under 18 years, prisoners, pregnant women, mentally/cognitively impaired persons, economically/educationally disadvantaged persons, and any subjects likely to be vulnerable to coercion or undue influence.
  4. Note- Only the IRB can determine the level of review. Any project/activity involving human subject research have an IRB review. 

 

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:
  1. Risks to subjects are minimized.
  2. Risks to subjects are reasonable in relation to anticipated benefits.
  3. Selection of subjects is equitable.
  4. Informed consent will be sought from each prospective subject or the subjects legally authorized representative.
  5. Required elements of informed consent are present.
  6. When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.
  7. Whenever appropriate, there are provisions to protect the privacy of subjects and to maintain the confidentiality of data.
  8. When some or all of the subjects are vulnerable research subjects, additional safeguards have been included in the study to protect the rights and welfare of these subjects.

 

Once the IRB has reviewed and approved my research, have I fulfilled my obligations?
  1. Report any changes in research activity related to the project including additional personnel. The PI must provide the IRB with all protocol and consent form amendments and revisions. IRB must approve these changes prior to their implementation. Submit one copy of the Report of Change Form to the IRB.
  2. All advertisements recruiting study subjects must receive prior approval by the IRB.
  3. The PI must promptly inform the IRB of all adverse and serious adverse events to subjects (within 5 days of the researcher becoming aware of the occurrence).
  4. When your study has been approved, it may be assigned an expiration date. UCCS IRB and federal regulations require review at least annually of all projects that are currently active. If you need to continue your project past the expiration date, you will need to request the project be renewed (before the expiration date). Submit one copy of the Request for Renewal Form to the IRB Chair before your expiration date.
  5. Once you have completed your study/research, keep all records including signed consent documents on record for 3 years after the consulsion of your study.

 

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:
  1. the study is designed to minimize the risks to subjects
  2. the potential risks of the research are justified by the potential benefits.
Scientific Review
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:
  • clarity of the research question
  • appropriateness and efficiency of design
  • rigor and feasibility of methods
  • qualifications and expertise of the research team
  • scholarship and pertinence of background material and rationale
  • adequacy of sample size and relevance of controls and
  • validity of the statistical analysis plan.
When necessary the IRB may ask consultants with additional expertise to review the research study.

 

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"):

  1. A statement of what the research is about,
  2. What the subject is being asked to do,
  3. What the risks are likely to be,
  4. What benefits there might be,
  5. Should discuss participation in the study with parents,
  6. Invite questions about the study,
  7. That participation is entirely voluntary.

 

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 irb@uccs.edu.