Which Projects Require IRB Review
All projects defined by the IRB as “research” involving “human participants” must be reviewed and approved by the IRB before any research activities involving potential participants are initiated. This includes honors theses, culminating graduate research papers, and Masters or Doctoral theses involving human participants. The IRB also reviews all data collection projects that involve more than minimal risk samples, topics, or procedures (see below).
Exempt versus Research Needing Review
As will be discussed further in the section on Review Process, some projects that the IRB reviews fit into the federal category of “Exempt”. This status should not be confused with “Not Research.” In the former case, the study meets the IRB’s definition for research needing review, but the review has determined that the study meets the criteria for Exempt(ion) from Continuing Review. In the latter case, “Not Research,” the project does not need IRB review in the first place because, in the judgment of the IRB, it does not fit the definition of human participants research.
Criteria for Research Needing Review
Please note that the process of determining whether or not a given project is “research” is often a nebulous undertaking. The IRB has spent considerable time working to define “research” as clearly and consistently as possible, in light of the federal regulations and balancing the need to oversee potential risks for human participants with the desire to avoid over-regulation of minimal risk projects. In some cases, the question simply requires a judgment call, which according to federal guidelines, must be made by the IRB. In questionable cases, investigators are encouraged to simply email the IRB Administrator and ask if review is required.
The considerations involved in determining if a project needs review are: 1) does it meet the IRB’s definition of research; 2) does it involve interaction with or information about living human beings; and/or 3) does the project involve more than minimal risk or vulnerable populations?
1. How does the IRB define “research”?
The first criterion for assessing if a given project requires review involves determining if the project meets the regulatory definition of research. Research is defined in the federal regulations at 45 CFR 46.102 (l) as “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program that is considered research for other purposes. For example, some demonstration and service programs may include research activities.”
Generalizable knowledge is typically interpreted by the IRB to include research findings or data that are intended to contribute to the existing body of knowledge on the topic. A strong indicator of the intention to contribute to general knowledge is when the results are intended for public dissemination or presentation. Public dissemination of knowledge may involve many formats, including broadcast email, poster presentation, scholarly paper, public bulletin board, web publication, or report to external sponsor (when the sponsor intends to draw generalizable conclusions and publicly disseminate the results).
Data collection activities that are conducted solely for institutional purposes, even if the results will be accessible by the public, are not typically considered research by the IRB, unless there is a dual, scholarly purpose involved or the researcher believes there may be in the future.
Research projects involving human participants that are conducted by students for the purpose of independent research papers, culminating graduate research papers, master’s theses, and dissertations are all considered research and must be reviewed by the IRB.
2. How does the IRB define human participants involvement?
The second criterion for determining if review is required is whether or not the project involves obtaining private information from or about living human beings. This may include obtaining information through interventions or interactions, or by accessing datasets or private records.
A. Obtaining private data FROM human beings. According to 45 CFR 46.102 (e), “Intervention includes both physical procedures by which information or biospecimens are gathered (e.g.,venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator 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….”
Thus, for example, if the researcher is planning to observe children in a public park but not expecting to interact with them in any way, the study does not need review. If the researcher is planning to observe adults in a public restroom, those individuals are obviously expecting some degree of privacy and the study does need review.
B. Obtaining private data ABOUT human beings. This involves obtaining individual-level information from datasets or records that may have been compiled for some other purpose and now are going to be used for research purposes. There are several considerations involved in regard to secondary data studies, including individual level vs. aggregate data, identifiable data vs. de-identified, and publicly-available vs. privately-held datasets.
Individual level data means that the information is recorded for each individual, rather than compiled into aggregate statistics. And it means that the data is actually about the individual, not some other entity (such as the organization they may work for). For example, if the researcher is asking school districts to provide the number of school psychologists they employ and what percentage have master’s degrees, IRB review is not needed. If the researcher is asking principals what their opinion is about the number of school psychologists they employ, the data is now about the individual principals and the study does need review. If the researcher intends to ask the districts to provide private information about each psychologist (e.g., birthdate, degree, number of years employed), then the study does need review.
Identifiable information is that which can either directly or indirectly identify an individual. Direct identifiers include name, address, telephone number, social security number, identification number, medical record number, license number, photographs, voice recording, and biometric information. Indirect identifiers are those items that taken together might enable a reasonably informed and determined person to deduce the identity of the participant, and include race, gender, age, zip code, IP address, and college major. Projects involving “de-identified” private datasets (e.g., a dataset you obtain from a state agency or another investigator) are commonly found Exempt from continuing review by the IRB, but they are considered research that must be reviewed. See Review Process for a full discussion of exempt determinations.
Publicly-available datasets are defined by the IRB as data that have already been compiled and are now available in a library or on the internet, and no permissions are required to access them. Privately-held datasets are those for which some type of permission is necessary to access the data and studies involving these typically require IRB review. (The IRB has made an exception for a few well-known, commonly used repositories of secondary data, such as the InterUniversity Consortium for Political and Social Research-ICPSR.) Research involving data that is both completely de-identified and publicly available without permission or application is not reviewed by the IRB.
3. Does the study involve more than minimal risk or vulnerable populations?
If a research project involves more risk than an individual might expect to encounter in the course of daily life, or involves groups or procedures that require special precautions, the study may need to be reviewed even if it does not fall within the above guidelines for research. For example, if the study involves children or other vulnerable populations, or the researcher will be asking about sensitive topics that may cause psychological harm or embarrassment, or the researcher will need to deceive the participants about the nature of the research, the study must be reviewed by the IRB even if it is a class project or other situation that would not normally be seen as formal research.
Examples of projects that the IRB does not typically review because they do not fit any of the above criteria are:
- Teacher and student evaluations used solely by the institution
- Class-related data collection projects (with adults and of no more than minimal risk) conducted solely for didactic purposes where the results are not disseminated outside the classroom
- Activities conducted for quality improvement/quality assurance intended solely for internal use and not designed to contribute to generalizable knowledge – these may include “institutional” surveys or other assessment projects that are less than minimal risk and are only intended for purposes of benchmarking or institutional assessment
- Data collection activities performed as a commercial service to inform business decisions regarding a specific process or product if the results will not be made public by the researchers, the business, and/or the sponsor
- Journalism articles
- Theatrical productions
- Art exhibits
- Secondary datasets available to the general public without permission (e.g., IPEDS data accessed through the National Center for Education Statistics website), or data obtained from well-known secondary public data sources that anyone can access but involve a standard registration process (e.g., data obtained from the ICPSR).
Examples of projects that typically are considered research needing review include:
- Oral history projects
- “Action” research conducted by graduate students or faculty in education settings
- Class or institutional projects that will be disseminated for a scholarly purpose, or that involve data collection on sensitive populations or subjects (e.g., minors and/or substance abuse, mental health, sexual identity), involve deception of potential participants, or otherwise present more than minimal risk to participants
- Taking blood or other biological samples from any person other than oneself, unless it is clearly for non-research purposes
- Secondary datasets obtained from a state agency, nonprofit organization, other university researchers, or other private source which are then going to be used for faculty or student research
It is possible that some activities will begin as non-research activities (such as course evaluations) and later spark a research question or otherwise evolve into research, at which time they fall under IRB jurisdiction, and it becomes necessary to obtain IRB approval to use data that has already been collected. When the intent of the activity becomes dissemination to a wider audience and contribution to the general knowledge base in a field, IRB approval is necessary.
Please note that retrospective approval cannot be granted for research studies that have already begun. Investigators must seek a determination and/or IRB review of projects that may fit the definition of research as described above, or risk being found in regulatory noncompliance, which typically results in a finding that the data be destroyed.