Does My Research Require Review?
The scope of the Institutional Review Board's (IRB) charge is broad. Generally, any research that uses humans, human tissue, surveys or interviews of human subjects, or human subjects' records requires IRB review, regardless of its funding source. The IRB's charge extends to research in the social and behavioral sciences as well as research in the health and biological sciences.
IRB review and approval is required for any research involving human subjects that: is conducted by University faculty, staff, students; is performed on the premises of the University (even if conducted by persons not affiliated with CSUEB); is performed with or involves the use of facilities or equipment belonging to the University (even if conducted by persons not affiliated with CSUEB); or involves University, students, staff, or faculty (even if conducted off-campus).
Some types of research may not require IRB review, or some research may not involve human research subjects.
Click on the following links to determine whether or not your research does require review:
- Research for University Courses
- Pilot Studies
- Oral History
- Secondary Analysis of Existing Data
- Content Experts / Consultants / Key Informants
- Research done at another institution
- Researchers Unaffiliated with CSUEB
- Research which may not require IRB review
Research conducted solely for pedagogical purposes may not need 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 within the confines of the institution, for instance, at a department research competition. However, if the results will be published, presented at a larger conference off-campus (such as the CSU Research Competition) or generalized in some other way, it will be necessary to obtain human subjects approval.
Pilot studies, no matter how small, must also get human subjects 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 committee 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 considered an oral history or not for the purposes of human subjects regulation. 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 informants’ stories stand on their own as a “testimonio” 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 participants in the event or time under investigation.
Oral history interviews are not analyzed as 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. Due to the fine distinction between research that qualifies as an oral history and research that does not, please contact the IRB for guidance prior to beginning your research.
Research involving the secondary analysis of existing data must be reviewed by the IRB to ensure that the original data were properly and ethically obtained and to ensure that the objectives of the secondary analysis are in keeping with those for which consent was obtained.
In order for the committee to evaluate research which includes secondary analysis, the researcher will need to provide:
1. A complete protocol for the secondary study;
2. The details of primary data collection (which may include the original protocol, consent and approval, if research), or the source of publicly available data; and
3. If the data are not publicly available, a letter from the source authorizing access to the data or, if the data were purchased commercially, a copy of the contract authorizing the use of the data.
After these documents are submitted, the committee will be able to decide if the research is exempt, non-exempt, requires a new consent, or does not need to be reviewed further.
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.
Existing data containing identifiers may need to be reviewed as non-exempt research.
Existing data that are publicly available or are recorded by the researcher in such a manner that the participants 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 participants.
Some research may not have to be reviewed by the IRB because the data are so anonymous that they no longer implicate human subjects. 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 necessary to get human subjects 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.
Human Subjects review will be required when a researcher is interviewing individuals about content, but there is a research question or hypothesis involved, or an “agenda.” The 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 not require human subjects 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 human subjects 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 interviewing entrepreneurs about the obstacles they faced in starting their own businesses, and how they overcame them, 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, CSUEB faculty, staff or students who are not the sole Principal Investigator on a project must receive approval from the CSUEB IRB before research may begin. If the researcher is the sole Principal Investigator on the project, the CSUEB IRB will review the other institution’s approved protocol.
Non-Principal Investigators must submit:
- A signed Protocol Approval Form, with signatures from the CSUEB faculty, (not faculty from the institution where research will be carried out.)
- A copy of the application to the research institute’s IRB. (If the institution has no IRB, indicate this and CSUEB can serve as the IRB of record.)
- A copy of the research institution’s IRB approval letter.
- A CSUEB protocol detailing the researcher’s role in the overall project, and the part of the research that he/she will be conducting.
- A letter from the PI giving you permission to use the data generated for your research.
Unaffiliated researchers are researchers from outside the University who are not connected in any way to CSUEB. The CSUEB IRB will review research protocols from unaffiliated investigators who plan to conduct a study that engages the University in research and involves human subjects if the investigator obtains a CSUEB faculty or staff sponsor. This sponsor must be listed on the protocol submitted to the IRB and a letter of support from the sponsor must accompany the protocol.
The following activities may not require IRB review. Please contact the IRB to help determine if review is required.
- “Self Improvement” studies (for example, where someone reviews their own teaching methods with an eye to becoming a better teacher).
- Key Informant Interviews where the information presented is about the program and not the individual.
- Curriculum Development where the curriculum is not being evaluated in the field.
- Needs Assessments and Program Evaluation with the sole intent of sharing the results internally with the agency, organization, etc.
- Oral History where the information is merely reported, but not analyzed.
- Web Design Evaluations, Product Design Assessments.
- De-Identified Secondary/Existing Data.
- Classroom projects: If a class project will not be published, it may not need IRB review.