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 SFSU); is performed with or involves the use of facilities or equipment belonging to the University (even if conducted by persons not affiliated with SFSU); 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 here to check using one of our checklists:

Research that does not require IRB review
Faculty Pre-Proposal Checklist

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 SFSU

Research for University Courses [back to top]

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 at the end of the semester within the confines of the institution, for instance, at the SFSU Graduate Project Fair. 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.

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 human subjects 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, it may be possible to submit a protocol to the human subjects committee, requesting permission to use existing data.

Pilot Studies [back to top]

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.)

Oral History [back to top]

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 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.

Secondary Analysis of Existing Data [back to top]

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.

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 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.

Content Experts/Consultants/Key Informants [back to top]

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.
  

Research Done at Another Institution [back to top]

To conduct research at another institution, SFSU faculty, staff or students who are not the sole Principal Investigator on a project must receive approval from the SFSU IRB before research may begin. If the researcher is the sole Principal Investigator on the project, the SFSU IRB will review the other institution’s approved protocol.

Non-Principal Investigators must submit:

• A signed Protocol Approval Form, with signatures from the SFSU 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 SFSU can serve as the IRB of record.)
• A copy of the research institution’s IRB approval letter.
• An SFSU 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 Investigators [back to top]

The SFSU Committee for the Protection of Human Subjects Office will charge a fee for IRB review to unaffiliated investigators who plan to conduct a study that engages the University in research and involves human subjects. This applies to researchers from outside the University who are not connected in any way to SFSU. See Unaffiliated Investigators for fee schedule.

Research that may not need IRB Review: [back to top]

The CPHS office has identified several 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.

How to let us know you are not using human subjects:

Students doing these types of projects are instructed to state their intentions clearly on the Culminating Experience form, by choosing either an 898 form for “No Human Subjects” or checking the box on the 895 form that indicates they are not using human subjects.

If the Culminating Experience form clearly indicates that the project does not involve human subjects, or is not the kind of research the IRB has to review, the Grad Studies office will be able to approve it immediately and the student may proceed with the project as described on the CE form.

Examples of CE form descriptions that indicate human subjects 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.