IRB & Human Subjects Research
The University of Notre Dame reviews all human subjects research conducted by University students, faculty, and staff. The group tasked with this review is called an Institutional Review Board (IRB), and their role is primarily to determine if the research meets certain ethical standards and principles.
- What is "human subjects research"?
- Do I need to submit anything to the IRB?
- How will the IRB review my research?
- How do I submit a protocol to the IRB?
- Who do I contact for help?
The IRB is required to review certain categories of “human subjects research.” While the definition of the phrase “human subjects research” may seem obvious, the federal regulations that govern IRB review define it more narrowly than many assume. Not every interaction with a person constitutes “human subjects research,” and comparing your proposed research with the actual definition of "human subject" and "research" should be among the first steps you take.
A “human subject” is a living individual, about whom an investigator conducting research obtains:
1. data through intervention or interaction with the individual, OR
2. identifiable private information
Please note that a human subject is not simply any person with whom the investigator interacts- the interaction must result in data about the person, themselves. Intervention and interaction can include procedures done actively in person (interviews), passively (observation), and those done electronically (phone calls, emails, and electronic surveys). Intervention may also include manipulation of a subject’s environment.
Private data is information about characteristics or behavior in a context in which a person can reasonably expect no observation or recording is taking place. Examples may include a medical record, bank account information, and similar types of information. However, it may also include personal beliefs or responses, which a subject would not otherwise publicize.
Identifiable information allows an observer to determine the identity of the source, whether that is through identifiers like name, date of birth, address, phone number, and more, or it may be through the use of a code or other data maintained to linking research information to the source.
“Research” is defined as:
1. a systematic investigation,
2. which is designed to contribute to generalizable knowledge
Systematic investigation means the researcher has identified a plan to collect data in order to answer a research question. This can include both data collection through communication with subjects, or secondary analysis of already-collected data.
When an investigation is designed to contribute to generalizable knowledge, it is intended to provide general conclusions, which can be applied beyond a single individual, population, internal program or organization. Publication of results alone is not determinative when considering whether a project has been designed to contribute to generalizable knowledge. You should consider carefully who will be informed by the results to your investigation.
Examples of activities that are not typically considered to contribute to generalizable knowledge include:
- oral histories designed only to create a record of events
- service or course evaluations
- services, courses, or concepts not intended to be shared outside of a particular class, school, organization, or the immediate University of Notre Dame community
- some classroom exercises, if they are not intended to result in information which will inform populations outside of the University
- quality improvement or assurance methods
Please note that a thesis, dissertation, or academic research project may or may not constitute research. While some institutions determine status as “human subjects research” based on these designations, but this is not an appropriate method of classification.
If your project is “research,” as defined above, and it involves “human subjects,” then it must be reviewed by the IRB. “Human subjects research” that is initiated without or before IRB review and approval can result in project suspension, or additional This review may be completed in several different ways, depending on the appropriate level of review for the project.
In addition to reviewing all human subjects research, the University of Notre Dame provides a review of projects that require a determination that it does not meet the definition of human subjects research. If your research involves interaction or intervention with “human subjects” as described above, but you do not believe it meets the “research” definition, you may submit an abbreviated protocol for "Non-human Subjects Research" confirmation by Notre Dame Research Compliance.
Level of Review
The method by which your proposed research is reviewed can vary depending on the purpose, scope, and procedures involved. The level of review under which a projects falls cannot be determined simply by assessing risk to subjects, or making an overall judgment about the type of research. Many factors are involved, and if you find yourself unsure about the appropriate level of review for your project, please contact Notre Dame Research Compliance (firstname.lastname@example.org). To review some general areas of research, and where they likely fall within a level of review, their office provides the following chart.
Non-human Subjects Research
Projects that do not meet the definition of human subjects research above, but involve interaction with individuals or access to their data, may be submitted for review. This review is brief, and simply a determination as to whether the project meets the definition. A submission can be useful when a publisher, sponsor, or department request that a project receive review.
Research that is minimal risk and fits within one of five categories of research can be reviewed and determined to be “Exempt” from regulations governing IRB review. A brief submission can be completed, describing the research. If the project is determined to be Exempt, several requirements (renewal, written informed consent, etc.) would not apply to the research.
Research that does not fall within an Exempt category but is still minimal risk may fall within one of seven categories of research called “Expedited.” While the name can sometimes be accurate in terms of the length of time a project is under review, it is intended to describe a review process that bypasses the full IRB. Instead of sending Expedited projects to the monthly Board meeting, these can be sent to individual reviewers as they are received from researchers. Expedited and Full Board are the two types of research that are responsible for following regulations covering IRB review of research.
Any research that cannot fit within Exempt or Expedited categories, and any research that is greater than minimal risk, must be reviewed by the full IRB at a monthly meeting. Any research reviewed by the full board must be re-submitted for review on an annual basis, unless the IRB determines the research to be minimal risk at initial review.
When protocol submissions are first received by the Compliance Office, we do a preliminary pre-review to identify any omitted information or documents, suggest edits, and more before sending the submission on to a reviewer.
Exempt and non-human subjects research are reviewed by the Notre Dame Research Compliance Office as these proposals are received. These proposals are typically reviewed and (depending on revisions or additional information requested) approved within about a week of submission.
Expedited submissions are pre-reviewed, then sent on to an individual IRB member for review outside of the meetings. This review can take anywhere from two to three weeks.
Full Board submissions are assigned to the next full board meeting. New studies should be submitted no later than two weeks before an IRB meeting to be assigned to the agenda for that date.
For all submissions, timing of the review depends on many factors: the complexity of the proposal, the quality of the submission, the responsiveness of the investigator, as well as the availability of the IRB reviewer. Please be sure to maintain contact with the Compliance Office as comments are sent back to you in the eProtocol system, and make sure that you have carefully reviewed all information before you submit it.
A crucial part of developing a research project is careful thought about any risks to subjects who participate. No human subjects research is without risk. Whenever you interact with a subject there is a potential that the individual could be made uncomfortable by the interaction. Even the most innocuous of interviews or tasks can result in discomfort. Anytime private, identifiable data is accessed and recorded, there is the potential for the loss of confidentiality, or that someone outside the research learns the identity of a participant or information about them. In addition to these risks, you should consider any risks presented by individual procedures within your project. For example, a study drawing blood from subjects carries the risk that a subject becomes bruised at the site of the draw. A study which conducts a focus group with multiple participants at once carries the risk that one of them becomes embarrassed discussing the topic, or that another subject shares information outside of the session. Risks should be identified that can be reasonably anticipated considering the procedures completed by participants.
For all risks, you should consider methods for protecting against them. For risks like the loss of confidentiality, consider establishing a protocol by which data is de-identified as early as possible. For risks like becoming uncomfortable when asked certain questions, always allow subjects to end their participation if they wish to do so. For risks that are physical, consider a plan to address these as they arise.
Informed consent is the process by which a potential subject is provided adequate information about the research to make a decision about their participation. All individuals approached about your project must be voluntarily willing to participate before you include them.
Informed consent is not just a document to be signed; it includes all information provided to a subject regarding the study. If you provide a consent form in person to potential subjects, it must be used within the context of a discussion that covers any questions a subject might have. If you provide consent information electronically, or not in person, you must include your contact information so that each potential subject’s concerns or questions can be answered.
Exempt research does not require written informed consent (a signature on a consent form). However, we strongly recommend that you consider drafting a consent form without a signature line at the bottom to provide as a resource during recruitment.
Expedited research requires written informed consent, or a waiver. You can find an Informed Consent template in the Resources Library (https://research.nd.edu/our-services/resource-library/). This template should be revised to fit your individual project, but there are certain elements that must be included on an informed consent form. These elements are found in headings on the Informed Consent template at the link provided.
Waiver of Documentation of Informed Consent
When appropriate, you may request a waiver of the requirement that you get a signed informed consent form from each subject. This does not remove the requirement that a subject be provided information about the research, and a verbal consent would need to be obtained from all subjects. Circumstances that may suggest this waiver is appropriate may include:
- Study interactions which only take place over the phone or internet
- Interviews or surveys in which no other identifying information is recorded, and possibly involving sensitive subject matter
Waiver of Consent
It may be appropriate to request a waiver of the entire consent process. This means subjects would be enrolled without providing their consent. Several criteria must be met for this to be approved, including explanation for why the research would be “impracticable” to complete without the waiver. These are typically requested for projects that only involve analysis of already-collected data, or where subjects never interact with the researchers.
The IRB is required to consider whether a researcher has implemented appropriate protections for any subjects falling under a category considered “vulnerable.” These specific categories are children, pregnant women, and prisoners.
Minors in the jurisdiction in which research takes place cannot provide their own informed consent to participate in research. Any research that includes minors must consider the process by which the informed consent of parents (or parental permission) will be obtained. In addition, a level of risk specific to children must be determined.
Prisoners cannot be included in Exempt research. Projects including prisoners must meet one of four categories of research involving prisoners, and careful consideration will need to be made regarding concerns like benefits resulting from participation in the research.
Special consideration must be given to research enrolling pregnant women, both regarding any risk to the mother and child, as well as any potential benefit to both.
The categories identified above are not the only groups who may be particularly vulnerable as research subjects. You should think carefully about any vulnerabilities of subjects you recruit, including individuals lacking capacity to provide consent, economically disadvantaged, and more. Also worth considering are situational vulnerabilities, such as a student being asked by their instructor to participate in research, or an employee being asked by their employer to do the same.
Human subjects research conducted by University of Notre Dame faculty, staff, and students must be reviewed by the IRB, whether or not it takes place on campus, including projects that are designed to be conducted overseas. When reviewing international research, the IRB considers factors that may be involved, including:
- Any language barriers, or experience the study team has speaking local languages
- Local review required, including IRB (or equivalent), government, and/or any entities identified as study sites
- Cultural considerations that present risks unique to the subject population
- Methods for storing data and securing any sensitive information
Researchers wishing to conduct international research are strongly encouraged to make an effort to identify any additional steps that may be required early, to avoid delay during IRB review. Laws and regulations can vary significantly from country to country. It would be advisable to enlist the help of someone with experience, either conducting research in the location you plan to visit, or with experience in that particular culture.
A faculty advisor must be identified by any student who wishes to conduct human subjects research. This advisor should be someone who is able to review your proposed research and offer guidance about your study design, subject population, planned interventions, and more. We recommend that the advisor have carried out research in the past, although this is not a requirement. In addition to assisting with your research design and implementation, the advisor must have completed CITI human subjects research training.
All submissions to the IRB, including Non-human subjects research, are completed using the eProtocol system. To access the system, please go to https://nd.keyusa.net.
All investigators conducting human subjects research (Exempt, Expedited, Full Board) must complete the prerequisite CITI human subjects training. One of the following two courses must have been completed within the past three years:
- Biomedical Research (Basic Course); or
- Social & Behavioral Research (Basic Course)
To complete these courses, or search to see if you have already completed them, please login through the University of Notre Dame account, at the following link: https://www.citiprogram.org/?pageID=668.
Notre Dame Research Compliance is available to assist you with questions about your research, as well as IRB submission and review. Please email them at email@example.com.