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"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:
Generally, research does NOT include:
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.
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:
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
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:
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:
Examples of school based research that would NOT be exempt:
Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior, unless:
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.
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:
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.
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.
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:
Class projects with the limited objective of teaching proficiency in performing certain tasks or using specific tools or methods do not require IRB approval. Instructors and departments should provide guidance about ways to handle topics such as privacy, confidentiality and professional ethics when class projects are part of the course syllabus. IRB chairs and staff can share expertise related to managing risks of deductive disclosure, coercion-free recruiting, informed consent, and special considerations for projects that include potentially vulnerable individuals.
Examples of common scenarios:
CLASS PROJECTS involving secondary data analyses that are assigned and conducted as educational exercises, using data that is either publicly available, de-identified or otherwise impossible to be linked to personal identities.
→ No IRB action required (neither approval nor determination of human research status) because there are no identifiers and no interaction with people.
CLASS PROJECTS involving secondary data analyses that are assigned and conducted as educational exercises, and that use data sets that include private information and codes that link to identifiers, but the students do not have access to the identifiers or the code key. Note - activity must be limited to class project use only.
→ No IRB action required (neither approval nor determination of human research status)
Class instructor and department are responsible for providing the necessary training in respecting the confidentiality of the data.
CLASS PROJECTS or PRACTICA that involve direct interaction (e.g., in person, via mail, email, web surveys, or telephone), but where the purpose is training, an educational exercise or professional development, and is not for research purposes. The project or practicum is not “research” even if students ask people questions as part of learning how to conduct interviews or surveys, take histories, administer assessments, or perform “in-house” evaluations as requested by the practicum site.
→ No IRB action required (neither approval nor determination of human research status) → but may be requested if instructor or students are unsure, or if documentation is required by gatekeepers (e.g., schools, businesses) for access to participants.
Class instructor and department are responsible for providing the necessary training in respecting the privacy of the individuals and the confidentiality of any resulting information, along with training in the relevant professional ethics.
The Instructor should provide information about the assignment for the students to distribute to people who participate in these class projects. The information should list the instructor as the appropriate contact person should questions arise.
CLASS PROJECTS or PRACTICA that involve direct interaction or an intervention or secondary analyses of private identifiable data and are undertaken as both an educational experience and as research (e.g., results of these activities will be presented publicly or otherwise disseminated, or the data will be stored and used by the students or others as research data).
→ IRB approval required → When there are several students in a class doing similar projects, a single IRB application may be submitted by the course instructor as PI, listing all students who will be involved. The similarities and differences must be clearly explained on the application and in the protocol. If projects vary greatly, then submit individual IRB applications with the instructor as PI or faculty investigator.
The instructor and all student researchers must complete research ethics education and submit certificates of completion along with the IRB application, if certificates are not already on file with the IRB.
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.
Patrice McClellan, Ed.D.
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