Frequently Asked IRB Questions

  • 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.(.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.(.102(d))

  • ARE THE FOLLOWING TYPES OF RESEARCH SUBJECT TO IRB REVIEW?
If the research/protocol is funded by an external funding agency, and it is unclear if it should be reviewed, submit an IRB application. The IRB will determine if review is necessary.

a. 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.
b. 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?
c. Marketing Research:
Marketing research that requires IRB review includes research designed with a clear intent to disseminate or publish the results/data.
d. 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.
e. Data sets
Public and/or published data sets not subject to Human Subjects Review include those that are accessible without restriction (e.g., password not needed*) and containing no readily identifiable, individual information.
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?
    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 are exempt from 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 would require IRB review.
    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, and honors theses. 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 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 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.

  • WHAT CRITERIA ARE USED TO REVIEW PROPOSALS?
    ONCE THE IRB HAS REVIEWED AND APPROVED MY RESEARCH, HAVE I FULFILLED MY OBLIGATIONS?
    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 FULFILED MY OBLIGATIONS?
    a. Report any significant changes in research activity related to the project. 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 Chair.
    b. All advertisements recruiting study subjects must receive prior approval by the IRB.
    c. The PI must promptly inform the IRB of all adverse and serious adverse events to subjects.
    d. When your study has been approved, it will 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.
    e. 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.

For questions or assistance, contact the IRB at irb@uccs.edu.