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Changes to the Common Rule
NEW: The Final Rule expands activities deemed not to be research.
As of July 19, 2018, there are four new activities that will be deemed to not be research. Please note that the list below refers to SPECIFIC ACTIVITIES, not to ENTIRE DISCIPLINES.
- Scholarly and journalistic activities (e.g. oral history, journalism, biography, literary criticism, legal research, and historical scholarship);
- Public health surveillance activities authorized or required by a public health authority (e.g., an outbreak of disease or other event or crisis that threatens public health);
- Collection and analysis of information, biospecimens, or records required for criminal justice or criminal investigative purposes; and
- Certain activities in support of intelligence, homeland, security, defense, or other national security missions.
The following types of activities may not qualify as research under the federal definition but they are not specified in the Final Rule:
- Program improvement
- Quality assurance and quality improvement
- Ethnographic research
Some types of research may be exempt from full IRB review, and some research may be excluded from IRB oversight.
Current Guidelines Regarding IRB Review of Research
Does Your Study Require IRB Oversight?
Research is defined as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. A project requires IRB review if it includes both research and human subjects. The IRB must make the final determination of whether or not a study requires review.
If you think that your study does NOT constitute research involving human subjects, please contact the IRB. Consult the Comparison of Research versus Non-Research Table for more information.
Research is: A systematic investigation of generalizable knowledge.
- Typically predetermined method for studying a specific topic, answering a specific question(s), testing a specific hypothesis(es), or developing theory.
- A scientific or scholarly activity involving qualitative or quantitative data collection and/or data analysis that sets forth an objective(s) and a set of procedures intended to reach the objective(s), i.e., to acquire knowledge, develop a theory, or to answer a question.
INCLUDES: observational studies, interview or survey studies, group comparison studies, test
development and interventional research
NOT SYSTEMATIC INVESTIGATIONS: oral histories, journalism, phenomenological activities
GRAY AREA: Program Evaluation – need to assess design and intent
- The intent or purpose of the systematic investigation is dissemination of findings (publication or presentation) outside of The College at Brockport.
- Intended to have an impact (theoretical or practical) on others within one’s discipline.
- Dissemination with the intent to influence behavior, practice, theory, future research
designs, etc. are contributing to generalizable knowledge.
- CONSIDER: Would this project be conducted as proposed if the PI knew that he or she would never receive any form of academic recognition for the project, including publication of results or presentation of the project at an academic meeting? If the activity would remain exactly the same, the project is likely NOT research.
A human subject is: A living individual about whom an investigator (whether professional or student) conducts research:
- Obtains information or through intervention or interaction with the individual, and uses, studies or analyzes the information; or
- Obtains, uses, studies, analyzes or generates identifiable private information
- Intervention: Includes physical procedures by which data are gathered and manipulations of the subjects or the subjects’ environment that are conducted for research purposes.
- Interaction: Includes communication or interpersonal contact between investigator and subjects. The interaction may be as remote as an anonymous, online survey
- About whom: The investigator must be gathering information about the individual.
The following decision flowcharts can help you determine whether your project requires IRB oversight:
Please note that intent to publish does not determine whether or not your study fits the definition of human subjects research.
In addition, below is a list of activities that may (or may not) constitute research involving human subjects. The table is intended to provide examples and is not a definitive determination of whether a specific activity requires IRB review or exemption.
|Scholarly or Scientific|
|Generalizing Findings – Activities that obtain data about individuals, systematically performed with the intent to generalize findings||Yes|
|Viewing Identifiable Private Information – Identification of potential participants for a study or use of living individuals’ data for research purposes, whether or not the data will be recorded in an identifiable manner||Yes|
|Coded Data – Study or use of data that cannot be readily associated with the living individual about whom the information relates||
No, with some exceptions.
Contact IRB for assistance
|Quality Improvement – Activities involving individuals intended solely for internal use, performed to improve services or develop new services or programs, (e.g., satisfaction surveys) without intent to generalize findings, even if results will be presented or published; audits (internal or external) performed as a part of organizational operations||No, with some exceptions|
|Data Banking – Collection and storage of private information, if the data may be used in the future for research purposes, whether or not the data will be recorded in an identifiable manner||No|
|Social Science, Behavioral, Educational|
|Survey, Interview, Observation – Collection of individuals’ data using surveys, interviews, or observation with the intent to generalize findings||Yes|
|Audio- or Videotaping – Taping individuals for study in situations not normally expected to be recorded or when individuals can be identified from recordings||Yes|
Not all survey, questionnaire, or interview research is minimal risk. For example, a survey or interview that asks questions about sensitive topics (e.g., childhood abuse, sexual functioning) likely to cause emotional stress or discomfort may require full IRB review. Some survey research may be classified as exempt from committee review if the information obtained is recorded in a way that the subject cannot be identified (either directly or through a code numbers or link); in other words, if the research data are anonymous.
A survey or interview study may also be considered exempt from committee review even when the data are not anonymous if the information being gathered could not reasonably place the subject at risk of criminal or civil liability or be damaging to the subject's financial standing, employability, or reputation.
The most common classification for survey, questionnaire, or interview research is expedited approval. If the study is not anonymous and contains information that, if known, could be damaging as described above, but it does not rise to the level of more than minimal risk, it may be given expedited approval. Although the proposal application gives the investigator the opportunity to indicate a classification, the IRB makes the final determination as to the classification of exempt or expedited.
Normal education practices are considered exempt from committee review, but must still be reviewed and approved by the IRB office.
Kinds of Data
- students' curriculum-related written work, test scores, grades, artwork and other work samples produced by children
- students' curriculum-related oral and non-verbal communicative responses individually, such as in an interview, in small groups and with the whole class
- students' responses (written, oral or behavioral) to curriculum-related activities
- students' level of active participation in curriculum-related activities
A “normal educational setting" means preschool, elementary, secondary, and higher educational facilities, and after-school programs (if the project relates to tutoring, or homework help).
In Special Education, normal educational practices correspond to the Individualized Educational Program (IEP), which is tailored to each student with an identified disability and may be implemented in diverse settings (e.g., school, home, work, community).
- videotapes and photographs of curriculum-related classroom activities
audio tapes of teacher-student and student-student discourse related to the assignment
- teacher's non-participant observation of curriculum-related activity of individual children or groups of children, noting what will be observed and how it will be analyzed, or whether it will be used as anecdotal evidence in the study
- teacher's commentary on students' curriculum-related written work, artwork and other artifacts produced by children
- student journals and communication books related to the curriculum
- student grades and test scores
- teacher journals, notes and reflective comments on student responses and participation in curriculum-related activities
- questionnaires or interviews with students, parents and family members, teachers and administrators
- non-participant classroom observations by colleagues, with the class teacher's permission, stating what will be observed and how it will be used (i.e. how data will be analyzed or whether it will be used as anecdotal evidence).
- videotapes and photographs of curriculum-related classroom activities
Research conducted solely for pedagogical purposes may be excluded from IRB review, under the following conditions:
- the instructor's intention is to teach professional research methods such as interviewing, surveying, or experimental design
- the data are gathered solely for the purposes of teaching how to analyze them
- the results will remain in the classroom.
These data can be presented at the end of the semester within the confines of the institution, for instance, at Scholars Day/Scholars Night. However, if the results will be published (including on Digital Commons), presented at a larger conference off-campus, or generalized in some other way, it will be necessary to obtain IRB approval.
If a class project evolves into a research project that the student/instructor wishes to publish or generalize, then the research will need to undergo IRB review. This should occur as soon as it is known that the data will be used for research. If this is not determined until after the research is completed, the investigator should submit a protocol to the IRB requesting permission to use existing data.
Pilot studies with human research volunteers, no matter how small, must obtain IRB approval. You can include the pilot study as a smaller section of the complete protocol, or you can get approval for the pilot study first, then come through the IRB again for a review of the full "parent" study. At this stage, you may have modified your research to take into account the results of the pilot study. (For example, you may decide to change the survey questions as a result of the pilot study, or change inclusion/exclusion criteria.)
The researcher's intention plays a large part in determining whether research is an oral history or not. If the intention is to interview informants who have a unique perspective on a particular historical event or way of life, and the researcher also intends to let the informant's stories stand on their own as a "testimonial" or in an archive, with no further analysis, the research is most likely oral history.
However, if the surveys or interviews are conducted with the intention of comparing, contrasting, or establishing commonalities between different segments or among members of the same segment, it is safe to say your research will be regular survey/interview procedures, because you will be generalizing the results.
Historians explain a particular past; they do not create general explanations about all that has happened in the past, nor do they predict the future.
Moreover, oral history narrators are not anonymous individuals, selected as part of a random sample for the purposes of a survey. Interviewees are selected because of their personal relationship to the topic under investigation. An oral history interview provides one person's unique perspective. A series of oral history interviews offers up a number of particular, individual perspectives on the topic, not information that may be generalized to all research volunteers in the event or time under investigation.
Oral history interviews are not analyzed in the same way that qualitative data is generally analyzed. No content analysis, discourse analysis, coding for themes or other qualitative analysis methods of data analysis are performed on the interviews. They stand alone as unique perspectives.
It is primarily on the grounds that oral history interviews, in general, are not designed to contribute to "generalizable knowledge" that they are not subject to the requirements of 45 CFR part 46 and, therefore, can be excluded from IRB review.
Research involving the secondary analysis of existing data must be reviewed by the IRB to ascertain whether or not it requires IRB oversight.
Such research will be considered exempt if:
- the sources of such data are publicly available; OR
- the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects; OR
- the dataset has been stripped of all identifying information and there is no way that the data could be linked back to the subjects from whom it was originally collected
Such research will be qualify for an expedited or full-board review if:
- the source of the data is not publicly available data and/or contains private identifiable information about living individuals
Terms useful in discussing Secondary Analysis of Existing Data:
Existing data are data that exist at the time the research is proposed.
Existing samples must already be "on the shelf" (meaning, they must have already been gathered) at the time the research is proposed. For example, existing blood samples, existing tissue samples, completed surveys, existing interview notes, and existing audio- and video-tapes.
De-identified data are data from which all identifiers have been removed. Identifiers include obvious information such as name, address, social security or medical record numbers, photographs, address, telephone number, etc. as well as things such as biometric identifiers (voice and finger prints) and even zip code, if there are less than 20,000 people in the geographic area. A birth date coupled with a diagnosis may be sufficient to identify an individual in many research populations.
Non-exempt review Existing data containing identifiers may need to be reviewed as non-exempt research.
Exempt review Existing data that are publicly available or are recorded by the researcher in such a manner that the research volunteers cannot be identified (de-identified data, or data for which the key to identities will not be provided the secondary researcher) may qualify for exempt review.
When new consent is required
If the purpose of the secondary data analysis is found to differ significantly from the purpose of the original study, the IRB may require that informed consent for secondary data analysis is obtained from the research volunteers.
Some research may not have to be reviewed by the IRB because the data are so anonymous that they no longer implicate human research volunteers. For example, some public health data, amalgamations of median income and average longevity, statistics from the U.S. Census Bureau are pooled such that anonymity is ensured.
It may not be necessary to get IRB approval if interview questions are with experts about a particular policy, agency, program, technology, technique, or best practice. The questions are not about the interviewee themselves, but rather about the external topic. For instance, questions will not include demographic queries about age, education, income or other personal information.
IRB reviewwill be required when a researcher is interviewing individuals about content, but there is a research question or hypothesis involved and when a researcher intends to analyze and generalize the results--that is, look for common themes in the collected data, try to universalize the interviewees’ experiences, or quantify the results in some way.
Examples of content expert projects that may be excluded from IRB review:
In all the following examples, the questions are focused on the facts about the program, policy, software, curriculum, procedures or project. The researcher will simply report the facts as they are related by the content experts. You may not need to submit a protocol or an informed consent form for IRB approval if:
- you are interviewing managers in a company about their billing procedures, or their use of a particular software program, or
- you are interviewing or surveying teachers about what should be included in the development of a particular curriculum unit, or
- you are asking a panel of nurses and doctors to review your antismoking program for teens for correct medical content, or
- you are interviewing social agency directors about their client intake procedures.
To conduct research at another institution, College at Brockport faculty, staff or students must receive approval from the College at Brockport IRB before research may begin. The College at Brockport IRB will review the other institution's approved protocol and issue an approval of outside determination.
Principal Investigators must submit the following as a single PDF or Word document:
- The application to the research institute's IRB.
- The research institution’s IRB approval letter.
If the College at Brockport faculty, staff or student is not the Principal Investigator, they must also include:
- A letter from the PI giving you permission to use the data generated for your research.
The IRB office has identified categories that may not need IRB review, such as:
- a supervised internship or field practicum/field study
- a community health needs assessment
- an Instructional Technology web design evaluation
- a Design and Industry product design assessment
- a field study designed to improve one's own teaching practice
- a program evaluation, model curriculum, or a needs assessment, which does not lead to research activities such as field testing, and is not generalizable to the larger community (meaning that the results will be delivered only to one school or agency for the purpose of quality improvement, and will not be compared with other assessments, etc.)
- a quality improvement project
- an interview with content experts or consultants about factual issues only, in which no personal information is obtained from the interviewees
- an oral history project which collects personal stories about particular events or periods of time, to let them stand on their own as testimonials or archived historical documents. The stories will not to be compared with each other, analyzed in any way, or used to prove an agenda or hypothesis.
- a case study that reports on treatment strategies that have already been applied to one patient in the course of treatment and are not meant to be generalizable to all patients. A report that "tells a story" of what has already been tried in the course of treatment is considered a case study.
Examples of project descriptions that indicate human research volunteers are not involved:
- "I will use field notes, a reflective journal and children's work samples to improve my own teaching practice and to chart my own progress in teaching preschoolers about gardening."
- "I am developing a curriculum for second graders to integrate writing and reading strategies. Methods will include a lit review and interviews with three writing development experts."
- "I am collecting personal recollections of the urban redevelopment program in the Fillmore District during the 1960's, to archive in the History Department."
- "I am consulting experts in the field of teaching reading to construct a model of a curriculum for first grade reading classes. I will not be field testing this curriculum."
- "I am writing a case study of physical therapy treatment for a patient I have worked with."
- "I am conducting a needs assessment for an agency that works with adolescent girls, to help them improve their programs. The data will be given to the agency only, for quality improvement purposes."
A project that has been identified as a needs assessment, program evaluation or curriculum model development, and which does not contain any elements of research such as field testing, can be published or presented without any review by the IRB. A notice from the IRB that your project does not need further review because it has been determined to be a needs assessment, etc. is sufficient for journal publication or conference presentation.
Adapted from the SFSU and OSU IRB websites