When a research protocol enters the IRB office, the coordinator and administrator assign each human research volunteer protocol to a specific category of review, depending on the purpose, methods, and risk-to-benefit ratio of that study.
The federal regulations detail the three categories of research review: full committee review, exempt review, and expedited review of non-exempt research. This section will describe each category, followed by examples of projects that would be assigned to that category.
The revision cycle includes an administrative screening, pre-review, return of necessary revisions, then assignment to the next available full committee meeting agenda. The committee generally requires further revisions before granting full approval in an emailed letter to the investigator.
"Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities." 45 CFR part 46.102(d)
"Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains
- Data through intervention or interaction with the individual, or
- Identifiable private information."
Intervention includes both physical procedures by which data are gathered (for example, venipuncture) 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 (for example, 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.? 45 CFR part 46.102 (f)
Examples of Non-Exempt Research (requires full committee review)
Research with vulnerable populations, defined by 45 CFR 46 as
pregnant women, fetuses, prisoners, and children. SFSU also considers cognitive impairment in determining vulnerability in research.
- Research on sensitive topics with vulnerable populations.
- Survey or interview research with children.
- Observations of private behavior, when the person being observed has a reasonable expectation of privacy, or where the researcher is a participant in the activities being observed.
- Research on social or attitudinal behavior in an educational setting.
- Research involving experimental or invasive methods, or manipulation of the participant?s environment.
- Research where disclosure of the participant?s identity might result in negative legal, financial, economic or social consequences).
- The use of deception in research. (Deception requires a justification by the researchers why this method is necessary. The researcher must not deceive the participants about any physical or emotional harm that might result from the procedures. Use of deception also requires a de-briefing session as soon as possible after the procedures).
Research protocols in categories defined by the federal regulations (46.101 (b), which exhibit no or very low risks, are assigned to the Exempt research category by the IRB office. This category of research does not undergo full committee review, but is reviewed administratively by IRB staff. Protocols determined Exempt do not expire.
To determine the research review status, the IRB office requires a full protocol submission, all related documents such as recruiting script, final survey or interview instruments, and an informed consent process and documents.
If ORSP-Human and Animal Protections (HAP) determines that a protocol is "exempt" from regulatory oversight, ORSP-HAP will not further review any other documents submitted with the protocol. However, any changes to the project must be submitted to ORSP-HAP with a Modification Form.
Faculty advisors and investigators are responsible for ensuring that all publicly viewable documents are clear of grammar, spelling, readability and formatting errors.
The IRB recommends that students conduct exempt research to avoid delay in registration for the culminating experience course.
Examples of Exempt Research:
Surveys or interviews of non-vulnerable adults about non-sensitive topics:
- a survey of small business about the effect of automobile and foot traffic flow on sales figures;
- a survey of business students to determine regional differences in expectations of getting work during economic recovery periods
- survey of emergency room asthma patients to determine if ethnic differences in symptom description affect ER care.
Normal Educational Practices Considered Exempt from Full Committee Review:
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).
- 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
Use of Existing Data
- Secondary analysis of existing data is exempt research, if the data sources are publicly available, or if data is reported in the aggregate. If not either of these, then the investigator must record the information so that volunteers cannot be identified, either directly (by name, address, etc) or indirectly through identifiers (school, grade taught, ethnicity).
- Existing data usage requires a brief protocol telling us what the researcher intends to do with the data, and a letter of permission from the owner of the data saying the current investigator may use the data, and what identifiers the data will come with, if any. Please be aware that in smaller samples, indirect identifiers may actually identify a volunteer.
- If the information is coded anyway, the owner of the data must state in the permission letter that the code key will never be revealed to the current investigator, or that the key has been destroyed and it will not be possible to identify the research volunteers.
Expedited review is carried out on protocols that fit very specific descriptions in the regulations. Please be aware that this type of review is not any faster, despite its name, than exempt review.
This category is assigned to research that is not exempt for some reason, according to the regulations, but is lower risk than research requiring full committee review, usually because the methods are non-invasive and the research is social/behavioral/educational.
SFSU will conduct an Expedited administrative review on the following categories of research:
- Research with materials (data, documents, records or specimens) that have been collected, or will be collected for non-research purposes (such as medical treatment or diagnosis).
- Research with voice, video, digital or image recordings in research that would otherwise be exempt. Risks need to be adequately described in the protocol and consent; the uses to be made of the recordings and their fate need to be stated explicitly; and recordings may only be of activities of a non-sensitive nature.
Research employing focus groups in studies that would otherwise be exempt. The research volunteers must be adults, the content of a non-sensitive nature, and the consent form must adequately present the risks associated with a focus group. (Each protocol must contain the paragraph addressing extra protections for focus groups found under ?informed consent? in Forms and Templates.)
Focus groups not eligible for expedited review include those where disclosure of the participant?s responses outside the research could reasonably place the participants at risk of criminal or civil liability or be damaging to the participants? financial standing, employability or reputation; where sensitive issues are discussed; where the research includes a manipulation; or where a vulnerable population is involved.
- Continuing review of greater-than-minimal-risk research previously approved by the convened IRB where: (a) the research is permanently closed to enrollment of new volunteers; all volunteers have completed research-related activities; and the research remains active only for long-term follow-up of volunteers or (b) no volunteers have been enrolled and no additional risks identified or (c) remaining research activities are limited to data analysis.
- Continuing review of research previously approved and determined, at a convened IRB meeting, to be research involving no greater than minimal risk, where no additional risks have been identified.
Utilization of the following category more fully for review of some low-risk protocols: Research on individual or group characteristics or behavior or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation or quality assurance methodologies. (this refers only to research that is not Exempt.)
Expedited review status will be determined, reviewed and approved by the IRB Committee Chair and Administrator, and reviewed by the Protocol Analyst and other IRB members as needed.
Examples of Expedited Review
- Focus groups with adults about non-sensitive topics. The informed consent document must adequately present the risk associated with a focus group, which is that the researcher cannot guarantee the confidentiality of the data collected. (Researcher must add the paragraph regarding focus group risk to the informed consent.)
- Research involving minor deception or omission that poses no risk of adverse effects to the participants.
- Research using data that has been or will be collected for non-research purposes.
- Continuing review of research originally determined at a full committee meeting to involve minimal risk, where administrative reviewers cannot identify any additional risks to the participants.