Institutional Review Board

The Institutional Review Board (IRB) is an administrative body established to protect the rights and welfare of human subjects recruited to participate in a research study conducted under the auspices of the institution with which it is affiliated. The role of the IRB is to ensure the protection of human participants in a research study. Any institution that receives federal funding to conduct research with human participants is required to establish an IRB and to review and approve studies prior to collection of research data.

Although the question may seem straightforward, not all interactions with human beings or data collected from humans are considered research under IRB rules. If your project is not considered research, you do not need to submit an application to the IRB office. If your project is considered research under IRB rules, you must submit an application to the IRB office and receive approval before research can begin. 

• Research under IRB regulations (as specified under the ‘Common Rule’ issued by the Office of Human Research Protections, U.S. Dept. of Health and Human Services) is defined as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. 
• A human participant is defined as a living (not deceased) individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or obtains (2) identifiable private information about that individual. 
• Generalizable knowledge refers to information that expands the knowledge base of a scientific discipline or other scholarly field of study and can be expressed in theories, principles, or statements of relationships that can be generally applied to our experiences. Activities designed to contribute to generalizable knowledge are those designed to draw general conclusions, inform policy, or generalize findings beyond a single individual or an internal program. The information is collected to share with others in a discipline and is created to make a broad statement (conclusion) about a group of people, procedures, programs, etc. 
• An intervention can include physical procedures by which data are gathered (e.g., venipuncture) and manipulations of the subject or subject's environment for research purposes. 
• Interaction includes communication or interpersonal contact between the researcher and subject. 
• Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of a participant is associated with the information or may readily be ascertained by the investigator) in order for obtaining the information to constitute research involving human subjects. 

Not all interactions with human beings or data collected from humans are considered research under IRB rules. If your project is not considered research, you do not need to submit an application to the IRB office. If your project is considered research under IRB rules, you must submit an application to the IRB via eProtocol. Applications must be submitted to the IRB for review and approval before data collection begins. This includes proposed research involving existing secondary data and previously collected human fluid and tissue samples.  

Yes, if the study meets the definition for research with human participants, as explained above. All research being conducted under the auspices of this institution is subject to review and approval by the IRB. Written approval from the IRB must be in place before any interventions or interactions with human participants (e.g., recruitment) actually begin. 

Yes, if your research project involves active data collection. IRB regulations require that ALL research involving intervention or interaction with human participants, regardless of whether or not identifying information is being collected, must be submitted for review prior to beginning the study. If your research involves the use of existing data collected from human participants (e.g., secondary datasets, existing biological samples), but there are no identifiers linking human participants to the data/samples themselves, then the activity may not require IRB review and may be considered "not human participant research".  

Yes, studies conducted by undergraduate and graduate students need IRB approval, if the project fits the definitions of "research" and "human participants" as described above. If the project is to be used in the classroom setting only to teach research methods (i.e., only intended to meet a class requirement), the project may not constitute human participant research. However, this means that at no point during or after the conclusion of the course can the results or the data be used for publication, presentation, or other research purposes. Therefore, students should discuss these limitations with their instructor or faculty advisor so that they can determine whether IRB review is necessary. 
 
Please note, undergraduate and graduate theses and dissertations are considered research, and will require IRB approval if human participants are involved. 

Studies that meet the definition of regulated research under the Common Rule may fit within one or more categories of “exempt” research. This does not mean that such studies do not need IRB review. In order for a research study to be deemed "exempt", investigators will need to submit an application to the IRB office, along with study related materials (e.g., consent forms, surveys, questionnaires, interview scripts/outlines, etc.). Please note that this determination of exemption must be made by IRB staff.  

Research that involves the collection and use of oral histories or life histories to draw generalizable conclusions may meet the federal definition of "human subjects research" and require an application to the IRB office. However, not all oral history projects fit this description, and thus would not need IRB review.  

Pilot studies may not meet the regulatory definition of research in need of IRB review. If all of the following statements are true, then no IRB review or approval is needed for your pilot: 

1. The sole intent of this pilot study is to determine the feasibility of a larger study. It is exploratory in nature, helping refine data collection procedures and instruments or preparing a better research design. 
2. There is no intent to publish or disseminate the pilot study outcomes as research data. 
3. The pilot study will be conducted on a small scale (~10 or fewer participants). 
   Such a pilot study would not contribute to generalizable knowledge and therefore is not considered research. IRB review is not required. Data collection from the pilot cannot be used as research data. Investigators should still take proper care in protecting human participants (e.g., informed consent process, adequate data security procedures, etc.). If your pilot study will involve vulnerable populations or more than minimal risk research procedures, you must consult with the IRB prior to data collection.  

Projects that use multiple case studies to draw conclusions that are applicable in a generalizable context, or to address a hypothesis, may meet the federal definition of "human subjects research" and require review by the IRB office. Other projects involving case studies may not require IRB review. Please see Guidance on IRB Review of Projects Collecting Oral (or Life) Histories, Journalism or Case Studies for further information. 

Please review the Office of Health and Human Services document on Considerations for IRB Review of Research | HHS.gov. As of now, the use of AI is allowed for data analysis, but should be described in the study proposal and in the informed consent like any other procedures or analytic technique.  It is important that data is de-identified and participants know that while confidentially is a priority, it can never be 100% guarenteed. We will update this information as dedicated by HHS.  

Submitted proposals will normally be reviewed and responded to within three to four weeks of a completed submission. There are times when the volume of submissions to the IRB are unusually high and proposal reviews may be delayed, however, every effort will be made to review proposals in a timely fashion.

The approval process is essentially the same. The University of Hartford's IRB must approve a research proposal that includes a member of the University community (student, faculty, or staff). This may mean that a research proposal needs to be approved by more than one institution. In some cases, a single IRB will be used and an Institutional Authorization Agreement (IAA) will be completed to specify the IRB of record. If researchers are requested a single IRB, this information should be included in the Proposal Transmittal Form. 

Researchers wishing to use a subject pool at another college or university, at an outside clinic, or agency must first obtain written permission from the outside entity to access those subjects. For example, if students from another university are to be part of the subject pool, written permission from that institution must be obtained, and this approval must be included in the Proposal Transmittal Form submitted to the University of Hartford IRB. The same guidelines apply to clients of outside agencies or clinics.

Typically we do not allow research to be conducted by non-UHart investigators. Any proposed research using members of the University community as subjects must be approved by the University of Hartford IRB prior to initiation of the study. This approval process may also include obtaining approval from a specific department, faculty member or college dean in order to gain access to a specific population of the campus.