"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.
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. The IRB CITI training is valid for a three-year period, after which the training must be repeated.
Additionally, if the study meets the definition of a clinical trial and is funded by NIH, Good Clinical Practice (GCP) Training is required for all personnel including PIs, Co-PIs, and Faculty Advisors (if applicable). You can learn how to register for the required GCP training on the GCP website.
Note - In order to qualify as a clinical trial, it must be funded by NIH and all of the following must be true:
- The study involves human participants.
- The participants are prospectively assigned to an intervention.
- The study is designed to evaluate the effect of the intervention on the participants.
- The study effect is evaluating a health-related biomedical or behavioral outcome.
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.(46.102(d))
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))
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. Note - If you plan to publish, and you anticipate a publisher wanting IRB review please submit an IRB application before you began your project.
- 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.
- 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?
- Marketing Research:
Marketing research that requires IRB review includes research designed with a clear intent to disseminate or publish the results/data.
- 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.
- 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.)
- 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.
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.
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.
- 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.
- 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.
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
If you are considering providing diagnostic test results to participants or use test results to alter care, there are things that should be considered in advance such as the Clinical Laboratory Improvement Amendments of 1998 (CLIA). Additional information is available in Special Topics: XXXI. Lab Certification (CLIA) of the University of Colorado Colorado Springs Standard Operating Procedures (SOPs). If you have questions, please contact the IRB at firstname.lastname@example.org for assistance and guidance.
Research involving human subjects may not proceed until written approval is received by the investigator from the IRB. Investigators may submit a completed IRB application, consent document(s), all supporting documents, 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 at email@example.com. 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 at firstname.lastname@example.org 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. The meeting schedule is available here.
When in doubt, ask the Chair of the IRB. Otherwise, follow these general guidelines:
- 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).
- 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.
- 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.
Note - Only the IRB can determine the level of review. Any project/activity involving human subject research have an IRB review.
Once human subject research has been approved, it is the Principal Investigator's (PI) responsibility to do the following:
- Risks to subjects are minimized.
- Risks to subjects are reasonable in relation to anticipated benefits.
- Selection of subjects is equitable.
- Informed consent will be sought from each prospective subject or the subjects legally authorized representative.
- Required elements of informed consent are present.
- When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.
- Whenever appropriate, there are provisions to protect the privacy of subjects and to maintain the confidentiality of data.
- 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.
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 and email@example.com.
- All advertisements recruiting study subjects must receive prior approval by the IRB.
- 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).
- 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 Renewal Application to the IRB before your expiration date.
- Once you have completed your study/research, keep all records including signed consent documents on record for 3 years after the conclusion of your study.
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 study is designed to minimize the risks to subjects
- The potential risks of the research are justified by the potential benefits.
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.
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).
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.
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.
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.
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.
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"):
- A statement of what the research is about.
- What the subject is being asked to do.
- What the risks are likely to be.
- What benefits there might be.
- Should discuss participation in the study with parents.
- Invite questions about the study.
- That participation is entirely voluntary.
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.
As a reminder, all changes are to be submitted and approved prior to implementation.
Minor changes can be made via a Request for Change, while more substantial changes might need a new protocol application. Minor changes have no impact on the original goals and protocols outlined in the original IRB application. Examples of minor changes include, but are not limited to: change of title, minimal changes in survey instrument, changes in any advertising or recruiting materials, addition or deletion of collaborators and/or co-investigators, change in faculty advisor, or adding additional sites for data collection. In addition, any research that increases the level of risk to the participant relative to the initial application must be submitted for a Request for Change. More substantial changes would include changes in the purpose or process of the research project. Examples might include a change in sampling population, significant changes to survey instrument or interview protocols, and administration of a medical treatment/diagnostic of any kind. In most cases, these will require a new IRB application. If a Request for Change is submitted and the reviewer determines that a new application is required, the IRB staff will request a new IRB application. In the case of a new IRB application being requested, the Request for Change will be closed.
Incentives that are provided in research should be appropriate and researchers must take great care to ensure there is no undue influence on participation. For research requiring participants to undergo a minor inconvenience or discomfort, no payment or a modest payment amount is usually adequate. Participants are often compensated based on the complexity of the study, the type and number of procedures to be performed, the amount of time involved, any travel required, and the anticipated level of discomfort or inconvenience. With this in mind, researchers need to justify the payment amount to the IRB based on these variables. The ethical principal of justice should be kept in mind while determining the payment amount.
The use of Amazon Mechanical Turk for recruiting purposes continues to grow. The compensation for tasks completed through Mechanical Turk is typically very small, usually less than $1. When using Mechanical Turk for recruitment, the same considerations for participants are the same as any other human subjects research.
Additionally, the following should be considered:
- Inform the potential participant if compensation is contingent on certain conditions.
- Make sure that the complexity of the task and expected time to complete the task is reasonable and communicated clearly in the consent process.
- Lotteries and raffles present ethical concerns as it may violate the principle of justice and create concerns of undue influence if the prize is large as compared to the amount of participation in the study. They should be avoided.
The involvement of the investigator's students or subordinates as human research participants may occur in the social and behavioral sciences. Care should be taken to eliminate or reduce the risk that undue influence by the investigator or coercion that affects student/subordinate participation in research. No matter how well intentioned the investigator, students/subordinates may feel compelled to participate, believing that failure to do so will negatively affect their grades/review and the attitude of the investigator toward them. For this reason, the IRB generally will not permit an investigator to use his/her own students or subordinates as subjects in the investigator's research project. Attention should be given to whether they are being solicited because they are a convenient and accessible sample, rather than as a representative sample for the research inquiry.
Should you invite your own students or subordinates to participate in your research study, please pay attention to the following:
- The research must present no more than minimal risk to subjects.
- The recruitment should involve only indirect methods such as being recruited through the posting of an IRB approved flyers/ads or through IRB approved communications sent out to a larger group.
- Consent should be conducted by a third party. For example, if the investigator wants to administer pre- and post-tests to determine the efficacy of a particular curriculum, the necessary consent forms could be obtained, and the tests administered by a colleague at times when the investigator was not present. A graduate teaching assistant in the class in which the subjects are enrolled does not qualify as a third party for collecting data on behalf of the investigator.
- If the research is conducted within a classroom setting, the instructor should be blinded to the identity of the participants and data cannot be analyzed until final grades have been posted.
The majority of colleges, schools, centers, and departments within the University of Colorado Colorado Springs do not function as covered medical entities under HIPAA. UCCS is a covered entity that has chosen hybrid status. Therefore certain areas of the University have to comply directly with HIPAA. The UCCS HealthCircle Clinics are considered to be covered parts or covered healthcare components of the UCCS covered entity.
PHI may be involved if any of the following are involved:
- Accessing or collecting information from a medical record
- Adding information to the hospital or clinical record
- Creating or collecting information as part of health care
- Using information collected from the study to make health care decisions
Please note that if your research involves PHI and is subject to HIPAA, a Privacy Board review is required prior to obtaining IRB approval. If you have questions about how HIPAA may impact human subjects research contact Privacy Board at Comply@uccs.edu.
FERPA data include educational records of any kind that may personally identify a student, such as name, address, ID number, or another personal or indirect identifier. In addition, a record is identifiable if it includes "other information that, alone or in combination, is linked or linkable to a specific student that would allow a reasonable person in the school community, who does not have personal knowledge of the relevant circumstances, to identify the student with reasonable certainty." For more information about FERPA please click here.
If your research involves PII or FERPA, approval from the Office of the Registrar will be required in order to be able to obtain the data (prior to submission of your IRB application). The approval received from the Office of the Registrar will need to be submitted with your IRB application. Additionally, training might be required. You may contact the Office of Registrar at 719-255-3361 or email firstname.lastname@example.org to determine what needs to be done.
If your research meets the definition of a clinical trial and is funded by NIH, registration and reporting of the clinical trial at ClinicalTrials.gov is required. Additional information is available on the UCCS IRB NIH Clinical Trial Overview website or in Special Topics XXXII: IRB Policy for NIH Funded Clinical Trial Compliance of the University of Colorado Colorado Springs Standard Operating Procedures (SOPs).
Researchers may serve as participants in their own studies. Note typically UCCS considers this type of research (self-experimentation) as human subject research and requires the same review and approval as research that recruits other people as participants.
Though self-experimentation may not raise the conventional ethical concerns outlined in the Belmont Report, all human subject research should undergo ethical review to assure the safety of participants involved and the integrity of the research at the university. While researchers may be aware of the risks of self-experimentation, they may also be more willing to accept risks that are ill-advised. An IRB review allows a neutral third party to raise concerns and/or propose measures to promote the welfare of researchers.
The Common Rule also require that informed consent be obtained from all research participants unless certain conditions are met. The IRB recommends researchers provide a consent document based on the template provided at the UCCS IRB website with the IRB application which will serve as the basis for documentation of informed consent when the experimentation involves the researcher.
A Letter of Access is a document obtained from the appropriate authority in order to gain access to a facility or organization. It should be requested during the application process and submitted along with the IRB application. Please keep in mind that the appropriate authority figure might be different than your assumption. For example, a Captain in the military cannot provide access to a military facility and the Principal of the school is not always the person that can provide access to a school (It might be the superintendent for the school district or another contact person).
Recruitment materials that are seen or heard by prospective participants to solicit participation in a study are considered part of the consent process and must have IRB approval prior to their use. These items include flyers, informed consent, recruiting messages/emails, etc. Please note that it is NOT acceptable to recruit/confirm participation for particular participants prior to the submission and approval of the IRB application.
NOTE: The IRB has received complaints from individuals in the general population who believe their privacy was invaded because they received correspondence from unfamiliar investigations. When contacting subjects directly (e.g., via mailed letter or emailed message), the introductory paragraph should explain the right to access and include a general statement regarding how the investigator obtained the potential participants’ contact information (e.g., “I am contacting members of the XXX association regarding….” Or “You are receiving this questionnaire because you previously agreed to be contacted for further research studies.”)