IRB & Human Subjects Research
Research at the University of Notre Dame which involves human subjects must be reviewed and approved before any interaction with human subjects or data collection can begin. The Institutional Review Board (IRB) is the group which is required to review all human subjects research activities. Notre Dame Research maintains a site devoted to Human Research; key information from this site is collected below.
- 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?
What is "human subjects research"?
While the scope 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 one of the first steps you take.
Human Subject
A “human subject” is a living individual, about whom an investigator:
- obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
- obtains, uses, studies, analyzes, or generates identifiable private information or biospecimens.
Note that a human subject is not any person with whom an 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), as well as 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
“Research” is a systematic investigation which is designed to develop or 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.
Generalizable knowledge is when an investigation is designed 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.
The following activities are not human subjects research:
- Biography
- Oral history designed only to create a record of events
- Service or course evaluations
- Case reports
- Literary criticism
- 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 the University
- Quality improvement or assurance methods
A student thesis, dissertation, or academic research project may or may not constitute research, depending on the application of the definitions above. While some institutions determine status as “human subjects research” based on these designations, this is not an appropriate method of classification.
Do I need to submit anything to the IRB?
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. 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 (compliance@nd.edu).
Non-human Subjects Research
If a project meets the definition of research, but does not include a human subject, it falls under a category of review called “not human subjects research.” The IRB can complete a formal review of projects like this through the eProtocol form, which provides the researcher a determination letter. While the IRB makes this determination optional, some Departments or organizations require that research conducted with their support complete this step.
Exempt
Human subjects research activities that fall under a list of categories that are identified as particularly low risk are considered exempt from Common Rule regulation (the rules governing IRB review and approval). For research to qualify as exempt, it must meet the definition of “minimal risk” and fit within one or more of the Exempt research categories. Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
Expedited
Human subjects research that is minimal risk but does not fall under an exempt category, may be considered for Expedited review if all the research activities can be included in several specific categories.
Full Board
Human subjects research that does not fit under an Exempt or Expedited category, or presents greater than minimal risk to subjects is reviewed by the full IRB at a regular monthly meeting.
How will the IRB review my research?
When protocol submissions are first received by NDR Administration and Compliance, we complete a preliminary pre-review to identify any omitted information or documents, suggest edits, and more before sending the submission on to a reviewer. In some cases, two cycles of comments will be received- at initial pre-review, and then after IRB review.
- Non-human subjects research and Exempt protocols 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.
Please note: none of the above IRB protocols are subject to submission deadlines, and are assigned for review at the time they are received.
- 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 NDR Administration and Compliance as comments are sent in the eProtocol system, and make sure to carefully review all information before you submit it.
Identify Subject Populations
It is important to consider who is a human subject in the research. When identifying human subjects, both those who are interacted with and those who may not be interacted with but have private identifiable information about them collected should be included. This means a “human subject” could be a living person or a specific set of data points.
In the IRB protocol, the “Subject Checklist” provides a list of specific populations which require additional information or consideration for any potential vulnerabilities. In particular, studies which include children (minors), prisoners, and pregnant women prompt specific considerations by the IRB to ensure that their inclusion in the research is appropriate and risks are adequately mitigated.
In the “Subject Population” tab, the investigator is asked to describe the subject population. Non-exempt studies are required to provide a total number of subjects, and all research must include a description of criteria that include or exclude individuals from the subject population.
Risks
The IRB is tasked with ensuring that all risks to human subjects presented by research are minimized, and researchers must have a plan for anticipating reasonably foreseeable risks and implementing protection procedures to reduce or eliminate them. The protocol will ask for a description of risks related to the research, and an assessment of whether the investigator believes the research presents "minimal risk" to subjects.
Physical risks
Physical risks include physical discomfort, pain, injury, illness or disease brought about by the methods and procedures of the research. A physical risk may result from the involvement of physical stimuli such as noise, electric shock, heat, cold, electric magnetic or gravitational fields, and so on. Physical risks could also be presented by activities that subjects are asked to complete, such as physical endurance testing, exercise, and other repetitive movement tasks.
Psychological risks
Psychological risks include the production of negative affective states such as anxiety, depression, guilt, shock and loss of self-esteem and altered behavior. Emotional distress resulting from psychological harm is not always possible to anticipate, but some research may involve particularly sensitive subject matter which can reasonably be expected to increase psychological risk.
Social/Economic risks
Social/Economic risks include alterations in relationships with others that are to the disadvantage of the subject, including embarrassment, loss of respect of others, labeling a subject in a way that will have negative consequences, or in some way diminishing those opportunities and powers a person has by virtue of relationships with others. Economic risks include loss of wages or other income and any other financial costs, such as damage to a subject's employability, as a consequence of participation in the research.
Loss of Confidentiality
In all research involving human subjects, confidentiality of identifiable information is presumed and must be maintained unless the investigator obtains the express permission of the subject to do otherwise. Subjects have the rights to be protected against injury or illegal invasions of their privacy and to preservation of their personal dignity. The more sensitive the research material, the greater the care that must be exercised in obtaining, handling, and storing data. In order to minimize the risk for loss of confidentiality, investigators should only collect personal information that is absolutely essential to the research activity. If personal data must be collected, it should be coded as early in the activity as possible and securely stored so that only the investigator and authorized staff may access it. Identities of individual subjects must never be released without the express consent of the subject. In addition, if an investigator wishes to use data for a purpose other than the one for which it was originally collected and the data are still identifiable (e.g. a code list for the data still exists), the investigator may need to obtain consent from the subjects for the new use of the data.
Legal risks
Legal risks exist when the research methods are such that the subject or others will be liable for a violation of the law, either by revealing that the subject or others have or will engage in conduct for which the subject or others may be criminally or civilly liable, or by requiring activities for which the subject or others may be criminally or civilly liable.
Informed Consent
In research where a human subject is interacted with, informed consent may be an ethical expectation (in Exempt research) or a regulatory requirement (In Expedited and Full Board research). In all cases, the process of obtaining effective informed consent should be carefully planned by the investigator.
Consent for participation in research requires an informed consent process. This process involves an information exchange and on-going communication that takes place between the investigator and the potential research participant.
The consent process starts with the initial presentation of a research activity to a prospective subject (including advertisements and notices), continues with a discussion and information exchange between the researcher and the prospective subject, and requires documenting that consent was obtained. The process may also be ongoing through the research activity until the participant decides to end his or her participation or until the study closes.
To ensure an effective informed consent process, researchers should do the following:
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Conduct the process in a manner and location that ensures participant privacy, as appropriate
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Obtain the prospective subject’s voluntary agreement to participate
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Give adequate information about the study in a language understandable to the potential subject
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Document the consent
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Provide adequate opportunity for the potential subject to consider all options
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Provide copies of the consent documents to the subjects, if requested
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Respond to the potential subject’s questions or concerns
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Continue to provide information as the subject or research requires
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Ensure the potential subject’s comprehension of the information provided
Several additional considerations are important for obtaining effective informed consent:
Timing
Informed consent from the subject and/or his legally authorized representative must be obtained prior to initiating any research activities, including screening procedures unless the IRB grants a waiver to do otherwise.
Communication During Study
While the initial verbal explanation and dialogue with the subject are critical so that subjects know what they are agreeing to before they consent, ideally the consent process should be an ongoing conversation throughout the course of the study. Throughout the study, investigators should be available to answer questions and encourage subjects to ask questions or voice concerns, tell subjects about changes in the study procedures or risks or alternatives, and allow subjects to withdraw from the study for any reason at any time.
Qualifications of Person Obtaining Consent
Principal Investigators are responsible for assuring that all investigators obtaining consent are qualified and appropriately trained to explain the research and assess participant comprehension as described below. Any person who may obtain consent in a study should be listed in the IRB application.
Decision-making Capacity
Participants should be able to understand the nature and consequences of the study. If they cannot, consent from a legal authorized representative may be required. Depending on the subject population, the research interventions, and the context of the study, a plan for assessing a potential subject's capacity may need to be included in the IRB protocol.
Sample IRB Protocols
Examples of completed protocols- Full Board, Expedited, and Exempt- are available in the eProtocol system. After logging into eProtocol, navigate to the "Information Resources" frame at the bottom of the investigator dashboard. Annotated protocols that have been approved are provided as a reference.
Vulnerable Populations
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.
Children
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
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.
Pregnant Women
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.
Others
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.
International Research
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.
Faculty Advisor
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.
How do I submit a protocol to the IRB?
EProtocol
To submit a request for approval or to track or review information related to human subjects research, please use the eProtocol system: https://nd.keyusa.net/. Please note, access to the eProtocol system requires a Notre Dame NetID and password.
CITI Training
The University of Notre Dame requires that any researcher conducting human subjects research (interacting with subjects, or accessing private identifiable data), as well as faculty advisors, must complete Collaborative Institutional Training Initiative (CITI) training prior to approval to work with human subjects.
Following the link above, users should select "Login Through My Institution," and then search for the University of Notre Dame. CITI will then log the user into their system using the NetID of the individual accessing the program. By then navigating to the "Learner Tools" and choosing "Add a Course" the researcher can select the course that they need to add. For all human subjects research, individuals can choose to complete either Social and Behavioral Research (ID:3572) or Biomedical Research (ID:3571) courses, depending on which course they believe most appropriately covers the research they plan to conduct.
For amended protocols, any personnel being added to the protocol must have completed CITI training within the past three years. The Principal Investigator is responsible for ensuring that personnel listed in the protocol have completed the CITI Training requirements.
All researchers will be required to renew their CITI training every three years. If a CITI human subjects course was completed through an external institution within the past three years, the training certification may be accepted at Notre Dame. In such cases, it is the responsibility of the researcher to provide the completion certification from the previous institution in the IRB protocol attachments.
Questions?
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 compliance@nd.edu.