Is my project considered research by the IRB?
“Research” is a systematic investigation designed to develop or contribute to generalizable knowledge. This is the definition of research given by the Common Rule (the federal regulations that guide us at Lourdes University).
So what does “generalizable knowledge” mean?
In order to contribute to generalizable knowledge, the activity’s conclusions are intended to be extended beyond the sample or internal program.
If you plan to share your findings with a scientific or professional audience it is probably fits the criterion of “generalizable knowledge.” Results may also be shared via the internet, professional conferences, peer-reviewed journals, etc.
Generalizable Knowledge includes one or more of the following:
- The data is geared for scholars, practitioners, and/or researchers within a specified field of study
- Results of the study are presented either by presentation and/or publication in order to illuminate some topic/issue within one’s field of study
- Results from the study are applied to some population in addition to the sample
- The study’s results can be replicated by others
- The study provides input into some field of study
Generally, research does NOT include:
- Classroom activities that teach research methodologies or simulate research activities
- Activities conducted to improve the quality of teaching in a particular classroom
- Activities required for quality assessment (QA) or quality improvement (QI)
- Institutional research studies that are not intended to be generalized beyond Lourdes University.
- Interviews of individuals where questions focus on things not on people(e.g. questions about policies, general facts about an organization or a business)
- Evaluation of speakers or other presentations conducted for the purposes of improving the presentation the next time
- Searches of existing literature or analysis of aggregate or public data that cannot be linked to a living individual (e.g. data sets available on the web that do not require any sort of privacy/confidentiality agreement or special request procedure, newspaper accounts, census data held in public libraries, published school test scores). However if access to data is limited to researches and not publicly available, then IRB review is needed.
If you are not sure if the research you are proposing is covered by these rules and regulations, check with the Office of the IRB.
Does my project involve human subjects?
The IRB only reviews research that involves human subjects.
So what is a human subject?
According to the federal regulations, a human subject is a living individual about whom a research investigator (whether a professional or a student) obtains (1) data through intervention or interaction with the individual or (2) identifiable private information.
The definition continues:
“Intervention includes both physical procedures by which data are gathered (for example, drawing blood) 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, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (e.g., a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects”
So what is Human Subject Research?
Putting these definitions together, human subjects research covers a wide variety of activities, including studies of:
- Data from surveys/questionnaires, interviews, focus groups (only if focus group information is generalized outside the group to the general population) and observation
- School or correction records
- Employment information or records of earnings
- Bodily materials, such as cells, blood, urine, tissues, organs, hair, nail clippings, or DNA, when these are linked to specific individuals
- Analysis of existing data (e.g., medical records, school records)
- Cognitive and perceptual experiments
- Case Studies
What is “exempt” research and could my project be exempt?
Exemption Doesn’t Mean You Don’t Apply
The IRB must determine whether your research is exempt by seeing if it fits into one of the covered categories. If you think your research falls into one of the categories below you need to fill out a brief form describing your research. We ask you to identify which category you think applies to your research that makes it exempt.
What Are The Exemption Categories, and Can You Give Me Some Examples?
The regulations are not easy to understand but examples help.
Research conducted in established or commonly accepted educational settings, involving normal educational practices such as
- research on regular and special education instructional strategies, or
- research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
An established educational setting is any place where instruction would take place. Typically this would be a school setting, but it might also include libraries, training centers, or workplaces such as hospitals.
Normal educational practices are activities that typically occur in a classroom or other educational setting. Examples of normal educational practices include:
- Test development
- Innovative instructional methods
- Assessment of attitudes about learning or curriculum
- Evaluation of classroom or school activities
- Use of educational tools such as computers or smart phones
When assessing a “normal educational practice”, the IRB will consider whether the proposed research involves an educational “best practice” that should benefit students and support the curriculum already required in that setting. Even when research is exempt, researchers using student education records must meet the requirements of FERPA.
Examples EXEMPT research under this criterion:
- Development and testing of a project-based science curriculum that meets state standards but presented in an innovative manner. Data are collected via tests, student attitude surveys, and classroom observations.
- Use of electronic “clickers” in the classroom to elicit immediate feedback from students on the understanding of lesson concepts. Data are collected via survey and evaluation of student grades.
- Comparing a new and a standard math curriculum both currently being implemented in the school. Researchers will observe classrooms as well as interview instructors about their experience implementing the instructional methods (but not about specific students).
- Assessment of classroom management strategies used in Special Education classrooms.
- A study comparing driver’s education curricula offered by area driving schools. The researchers will observe classes and compare driving test scores at the end of the courses.
- Evaluating the use of accepted or revised standardized tests.
- Testing or comparing a curriculum or lesson
- A program evaluation of pharmacy continuing education.
Examples of school based research that would NOT be exempt:
- Projects involving instructional or classroom management techniques that would not be considered educational best practice (e.g. implementation of an untested curriculum).
- Interviews or surveys that collect information focused on characteristics of the children rather than on the educational activity being evaluated.
Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior, unless:
- Information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and
- Any disclosure of the human subjects’ responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects financial standing, employability, or reputation.
Exemption 2 is limited to adults except for educational tests of public observation where the researcher does not interact with the child subjects.
Many survey/interview projects fall into this exemption, particularly where the data are collected anonymously.
Projects that collect identifying information but do not collect data that could pose a reputational risk to respondents also qualify for this exemption. Examples of information that might put the subject at risk of harm include disclosure of illegal activities, sexual behaviors, sensitive genetic or medical information or embarrassing behaviors in the workplace.
Examples EXEMPT research under this criterion:
- Minimal risk surveys of consumer attitudes and opinions collected monthly.
- Anonymous survey of sexual behavior. In this case, the IRB must be careful to ensure that the data cannot be linked back to the respondent in any way.
- Observation of behavior in a public park. Note that a school or place of business is not considered to be “public”.
- Surveying teachers, nurses or doctors about a technique or an outcome.
- Interviewing managers about a management style or best practice
- Conducting a focus group about an experience or an opinion of a community program
- A study involving a focus group with expectant mothers regarding their perceptions of parenting education.
- A study involving an anonymous survey regarding workplace satisfaction at area firms.
- An observational study of pedestrians crossing a street; the research takes notes of what occurs, recording sex, race, and type of clothing of pedestrians, but does not interact with subjects.
- A study involving interviews with college seniors about their plans after graduation. The answers to questions asked would present no risk to subjects if divulged outside the research and all subjects are over 18.
- A survey of college students on their use of the internet.
- Observing adult and child interactions at a soccer game (as long as the researchers do not interact with the subjects).
Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (b)(2) of this section, if: (i) the human subjects are elected or appointed public officials or candidates for public office or (ii) Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
This exemption is primarily used for surveys or interviews of public officials that would not meet the criteria for Exemption #2.
A public official is considered to be an elected or appointed official (or candidate for office). Public employees are not considered to be “public officials.” The superintendent of schools would be a public official; a teacher would not. A senator would be a public official; a member of their staff would not. There is clear guidance regarding the federal statutes referred to in the second part of Exemption #3.
An example EXEMPT research under this criterion:
- Interviews with public officials that solicit response to questions about politically sensitive issues that might have an impact on their reputation
Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
The key element of this exemption is that the data/specimens to be used for research must be in existence (“on the shelf”) at the time the IRB application is submitted. Also, in order for a project to be exempt, the research must first be considered to be research with human subjects, meaning that investigators must have access to identifiable private information. Projects involving the analyses of de-identified or coded data where the investigator does not have access to the key would not be considered to be research with human subjects and do not meet the criteria for this exemption.
Examples EXEMPT research under this criterion:
- Retrospective chart review where the researcher has access to identifiable data but does not record it for research purposes.
- Projects that use personally-identifiable public data such as drivers license information.
- Analyzing de-identified national test scores
- Analyzing census data about aging or housing
Research and demonstration projects which are conducted by or subject to the approval of Department or Agency heads, and which are designed to study, evaluate, or otherwise examine: (i) Public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs
This is Federal Government Research. Projects qualifying for Exemption #5 must be conducted pursuant to specific federal statutory authority. Researchers should consult with their funding agencies for guidance as to whether a project might qualify for this exemption.
An example EXEMPT research under this criterion:
- Research sponsored by the Department of Housing and Urban Development to assess the effectiveness of a housing subsidy program
Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
The key element of this exemption is that the research can only involve foods that are known to be safe.
Examples of EXEMPT studies under this criterion:
- Taste testing whole grain food products
- Comparing taste or smell of molasses, cheese or milk
- Sampling texture of ice cream
- A taste test of different varieties of a fruit to determine consumer preference, when the fruits do not have any additives and subjects are asked to indicate the fruit they prefer
None of this applies to my research, so what now?
Don’t worry. Although your research will need to be reviewed by the IRB, we are here to help you. You will need to fill out the IRB application that describes your research, the risks and benefits of your research including the risks to the patients privacy, how you will protect and recruit the subjects.
Your research may fit into one of the categories for expedited review if it is of minimal risk and fits into one of the 9 specific categories. Expedited reviews, as the name suggests, are reviewed more quickly than a full board review. We will do our part to move this along but will require you to respond promptly to questions and suggestions.