Which Type Of Irb Review Does Not Require An Irb Approval?

Which Type Of Irb Review Does Not Require An Irb Approval
Research Exemptions from IRB Review – “Exempt” human subjects research is a sub-set of research involving human subjects that does not require comprehensive IRB review and approval because the only research activity involving the human subjects falls into one or more specific exemption categories as defined by the Common Rule.

Exempt projects are not subject to continuing review Amendments are required only if changes to the project could alter the exempt determination An exempt determination does not lessen the investigator’s ethical obligations, including the completion of human subjects protections training (NIH or CITI) Review the Common Rule on exempt research: 45 CFR 46.104

What are some types of action research that will not require IRB approval?

Examples: personnel studies, cost-benefit analyses, customer satisfaction studies, biological sample processing (for a fee and not authorship or other credit), public park usage, IT usage, and software development. Research involving cadavers, autopsy material or biospecimens from now deceased individuals.

What types of research require IRB approval?

Research Requiring IRB Review – The IRB must review and approve all research involving live humans before any such research activities may begin. Which Type Of Irb Review Does Not Require An Irb Approval Research involving human subjects must receive IRB approval in accordance with federal regulations set forth by the U.S. Department of Health and Human Services (HHS) (known as the “Common Rule”) and the U.S. Food and Drug Administration (FDA). A project may be subject to one or both sets of regulations depending on whether the project meets the definition for Human Subjects Research (HHS) and/or Clinical Investigation (FDA).

HHS Definition of Research (Common Rule)
“A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.”
In general activities that contribute to generalizable knowledge are those that:

attempt to make comparisons or draw conclusions based on the data;
seek underlying principles that have predictive value and can be applied to other circumstances;
identify general explanations or themes that a reader can extrapolate to another situation.

Although publication is often viewed as evidence of research status, it is not the only criterion. In fact, “systematic investigations” often result in published information, yet they do not qualify as research because they were not designed to contribute to generalizable knowledge.

HHS Definition of a Human Subject (Common Rule)
Human subject – A living individual about whom an investigator (whether professional or student) conducting research:
(1) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens;
or
(2) Obtains, uses, studies, analyzes, or generates identifiable private information or biospecimens.

Intervention includes both physical procedures by which data are gathered (e.g. 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, as well as 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). Identifiable information means that the identity of the subject is, or may be readily ascertained (directly or indirectly) by the investigator (or others) or associated with the information.

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FDA Definition of a Clinical Investigation “Any experiment that involves a test article and one or more human subjects that is either subject to requirements for prior submission to the Food and Drug Administration under section 505(i), or 520(g) of the act, or is not subject to requirements for prior submission to the Food and Drug Administration under these sections of the act, but the results of which are intended to be submitted to, or held for inspection by the Food and Drug Administration as part of an application for a research or marketing permit.” The term does not include experiments that are subject to the provision of 21 CFR 58, regarding nonclinical laboratory studies. Under FDA regulations, the terms “research” and “clinical investigation” are synonymous. A test article means any drug (including a biological product for human use), medical device for human use, human food additive, color additive, electronic product, or any other article subject to regulation under the Federal Food, Drug and Cosmetic Act, FDA regulations generally require IRB review and approval of research involving FDA-regulated products (e.g., investigational drugs, biological products, medical devices and dietary supplements), FDA Definition of a Human Subject FDA Human subject – an individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy human or a patient.

Is IRB Approval Required?

What type of IRB review requires a determination?

Exempt Research – Although the category is called “exempt,” this type of research does require IRB review and the determination of exemption must be made by the IRB. The exempt determination process is much less rigorous than an expedited or full-committee review.

To qualify, research must fall into one or more of eight federally defined exempt categories.
These categories present the lowest amount of risk to potential subjects because, generally speaking, they involve either collection of anonymous or public data, or conduct of the least potentially harmful research experiments.

Some examples of exempt research are:

anonymous surveys or interviews passive observation of public behavior without collection of subject identifiers retrospective chart reviews analyses of discarded pathological specimens without patient identifiers

Research involving minor children may be exempt only as it applies to categories 1, 4, 5, 6, 7 and 8. Research involving minors which falls under category 2 may be exempt for educational tests and observation (when the investigator does not participate in the activities being observed).

What is exempt from IRB approval?

Exempt Review: Institutional Review Board (IRB) Office Exempt human subjects research is a specific sub-set of “research involving human subjects” that does not require ongoing IRB oversight. Research can qualify for an exemption if it is no more than minimal risk and all of the research procedures fit within one or more of the exemption categories in the federal IRB regulations.

Studies that qualify for exemption must be submitted to the IRB for review before starting the research. Pursuant to NU policy, investigators do not make their own determination as to whether a research study qualifies for an exemption — the IRB issues exemption determinations. There is not a separate IRB application form for studies that could qualify for exemption – the appropriate protocol template for human subjects research should be filled out and submitted to the IRB in the eIRB+ system.

Although the HHS IRB regulations list eight exemption categories, NU has opted to implement six of those categories at this time (see the list below). Of the six exemption categories listed below, only exemption category 6 (for taste and food quality evaluation and consumer acceptance studies) applies to studies that are FDA-regulated.

The Belmont principle of Respect for Persons generally requires that subjects be given the opportunity to choose whether or not to participate in research. For this reason, voluntary informed consent should be obtained from participants for any exempt research where the investigator will be collecting data through interaction with participants.

For exempt research studies that will collect data through interaction with participants, the NU IRB expects that researchers provide participants with consent information that includes, at a minimum:

An explanation that they are being asked to participate in a research study.
The identity and affiliation of the researcher.
A clear description of the study procedures and how data will be used in the future.
A statement that participation in the research is voluntary.
Contact information for questions and concerns about the research.

Studies that qualify for an exemption do not undergo continuing review. Modifications do not need to be submitted for exempt studies so long as the research remains minimal risk and stays within the boundaries of the exemption categories that the IRB found were applicable to the research, If your study has received an exemption from the IRB, please contact the IRB if you are planning to:

add procedures that could affect risks to participants; or
add procedures that do not fit within the exemption categories; or
add new types of participants to your study that include vulnerable populations (e.g., adding children, individuals with cognitive impairments, prisoners, etc.)
change of Principal Investigator

Examples of changes that would likely require IRB review:

Removal of the consent process, or use of deception or incomplete disclosure.
Significant changes to the recruitment procedures.
Adding sensitive questions to a survey or interview process (e.g. questions regarding illegal activities; traumatic events such as childhood, sexual, or domestic abuse; suicide; or other probing questions that could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation).
Collection of new or additional identifiable information.
Changes to the data storage plan which may affect confidentiality.

Exempt studies may also be subject to the HIPAA Privacy Rule. For instance, a study involving medical record review to gather a dataset that would be eligible for Exemption Category 4 involves access to Protected Health Information (PHI) and should request a waiver of HIPAA authorization.

Exemption 2(iii) and Exemption 3 do not apply to research with children.
Exemptions other than Exemption Category 6 do not apply to FDA-regulated research.
OHRP Exempt Categories 45 CFR 46.104 – (HRP-312)
Category 1

Research conducted in established or commonly accepted educational settings that specifically involves normal educational practices that are not likely to adversely impact students’ opportunity to learn required educational content or the assessment of educators who provide instruction.

Evaluating the use of accepted or revised standardized tests
Testing or comparing a curriculum or lesson
A program evaluation of pharmacy continuing education

Category 2 Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior (including visual or auditory recording) if at least one of the following criteria is met:

The information obtained is recorded by the investigator in such a manner that the identity of the Human Subjects cannot be readily ascertained, directly or indirectly through identifiers linked to the subjects; OR
Any disclosure of Human Subjects’ responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation; OR
The information obtained is recorded by the investigator in such a manner that the identity of the Human Subjects can be readily ascertained, directly or indirectly through identifiers linked to the subjects, AND an IRB conducts limited IRB review. (See “WORKSHEET: Limited IRB Review (HRP-319).”)

Examples:

Surveying teachers, nurses, or doctors about a technique or an outcome
Interviewing managers about a management style or best practice
Conducting a focus group about an experience or an opinion of a community program

Category 3 Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection and at least one of the following criteria is met:

The information obtained is recorded by the investigator in such a manner that the identity of the Human Subjects cannot readily be ascertained, directly or indirectly, through identifiers linked to the subjects; OR
Any disclosure of the Human Subjects’ responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation; OR
The information obtained is recorded by the investigator in such a manner that the identity of the Human Subjects can be readily ascertained, directly or indirectly through identifiers linked to the subjects, AND an IRB conducts limited IRB review. (See “WORKSHEET: Limited IRB Review (HRP-319).”)

(i) For the purpose of this provision, benign behavioral interventions are brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing.

Provided all such criteria are met, examples of such benign behavioral interventions would include having the subjects play an online game, having them solve puzzles under various noise conditions, or having them decide how to allocate a nominal amount of received cash between themselves and someone else.

(ii) If the research involves deceiving the subjects regarding the nature or purposes of the research, this exemption is not applicable unless the subject authorizes the deception through a prospective agreement to participate in research in circumstances in which the subject is informed that he or she will be unaware of or misled regarding the nature or purposes of the research.

Healthy adult subjects are asked to take part in two two-hour-long assessments of memory, attention and information processing speed before and after 1 hour of cognitive enhancement exercise using specially designed computer software. The procedures are conducted during a single visit, and subjects are encouraged to take breaks when desired.

Category 4 Secondary research for which consent is not required: Secondary research uses of identifiable private information or identifiable biospecimens, if at least one of the following criteria is met:

The identifiable private information or identifiable biospecimens are publicly available; OR
Information, which may include information about biospecimens, is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained directly or through identifiers linked to the subjects, the investigator does not contact the subjects, and the investigator will not re-identify subjects; OR
The research involves only information collection and analysis involving the investigator’s use of identifiable health information when that use is regulated under 45 CFR parts 160 and 164 (HIPAA), subparts A and E, for the purposes of “health care operations” or “research” as those terms are defined at 45 CFR 164.501 or for “public health activities and purposes” as described under 45 CFR 164.512(b); OR
The research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information obtained for non-research activities, if the research generates identifiable private information that is or will be maintained on information technology that is subject to and in compliance with section 208(b) of the E-Government Act of 2002, 44 U.S.C.3501 note, if all of the identifiable private information collected, used, or generated as part of the activity will be maintained in systems of records subject to the Privacy Act of 1974, 5 U.S.C.552a, and, if applicable, the information used in the research was collected subject to the Paperwork Reduction Act of 1995, 44 U.S.C.3501 et seq.

Note: Exemption Category 4 only applies to the re-use of data and specimens that were or will be collected for non-research purposes or from research studies other than the proposed research study. The research materials typically will be publicly available materials, medical records, or existing repositories of clinical specimens.

A researcher is given two datasets that contain private, identifiable information. The researcher uses the identifiers to merge the two datasets but strips the resulting (merged) data of identifiers immediately after the merge and before conducting data analysis. The resulting data used for the analysis is completely de-identified with no link to identifiers.

Category 5 Research and demonstration projects which are conducted or supported by a Federal department or agency, or otherwise subject to the approval of department or agency heads (or the approval of heads of bureaus or other subordinate agencies that have been delegated authority to conduct the research and demonstration projects), and that are designed to study, evaluate, improve, or otherwise examine: public benefit or service programs, including procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs or procedures, or possible changes in methods or levels of payment for benefits or services under those programs.

(i) Each Federal department or agency conducting or supporting the research and demonstration projects must establish, on a publicly accessible Federal Web site or in such other manner as the department or agency head may determine, a list of the research and demonstration projects that the Federal department or agency conducts or supports under this provision.

The research or demonstration project must be published on this list prior to commencing the research involving human subjects. Category 6 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 Dept.

Is IRB required for all research?

VII. Clinical Investigations – 54. Does a physician, in private practice, conducting research with an FDA regulated product, need to obtain IRB approval? Yes. The FDA regulations require IRB review and approval of regulated clinical investigations, whether or not the study involves institutionalized subjects.

FDA has included non-institutionalized subjects because it is inappropriate to apply a double standard for the protection of research subjects based on whether or not they are institutionalized. An investigator should be able to obtain IRB review by submitting the research proposal to a community hospital, a university/medical school, an independent IRB, a local or state government health agency or other organizations.55.

Does a clinical investigation involving a marketed product require IRB review and approval? Yes, if the investigation is governed by FDA regulations, Also, see the information sheet entitled ” ‘Off-label’ and Investigational Use of Marketed Drugs and Biologics” for more information.

What is exempt limited IRB review?

What is limited IRB review? Limited IRB review is a process that is required only for certain exemptions, and does not require an IRB to consider all of the IRB approval criteria in §46.111. In limited IRB review, the IRB must determine that certain conditions, which are specified in the regulations, are met.

Do evidence based practice projects require IRB approval?

Determining whether a project is evidence-based practice (EBP), quality improvement (QI), or research can be challenging—even for experts! Some projects that appear to be EBP or QI may contain elements of research. Conversely, some projects that we refer to colloquially as research are actually EBP or QI.

Finding the correct determination is important for ensuring that projects are reviewed by the appropriate bodies since research projects require Institutional Review Board (IRB) review while EBP and QI projects do not. This guide is designed to clarify the definitions of EBP, QI, and research, and to provide insight into which projects meet the definition of research.

As a reminder, all MSHS nurse-led EBP, QI, and research projects must be reviewed by the Nursing Project Approval Council (NPAC) before they begin, NPAC will determine whether projects meet the definition of research and require IRB review. For more information about NPAC, please see our guide titled The Nursing Project Approval Council (NPAC): Who, What, Where, When, Why, and How to Submit Your Project,

Do you need IRB approval for a retrospective study?

Retrospective chart reviews of existing medical records do not require prospective IRB approval if any of the following intentions apply: 1) The intent is a non-generalizable investigative review such as for quality assurance or a review of a physician’s competency 2) The intent is for quality management issues such as

Do I need IRB approval for a focus group?

In social and behavioral science research, a focus group is seen as the best way to gather data from several participants in a short amount of time. An investigator’s use of focus groups can qualify for exemption from IRB Review, Focus groups are considered to be in the same category as surveys and interviews; data collected must come are from adults (at least 18 years old) and must not be both sensitive and identifiable.

Asking about an experience or an opinion of a community program
Asking outpatients who have diabetes to participate in a focus group about their exercise habits.
Interviewing managers about a management style or best practice
Discussion among professionals (e.g. social workers, counselors) discussing sensitive topics (e.g. approaches to treating domestic abuse survivors). Be advised these social workers, counselors, etc. may not reveal identifiable patient information.

Focus group research cannot qualify for exemption if:

participants are younger than 18 years of age,
the discussion involves the subjects revealing sensitive information about themselves (e.g. substance abuse, HIV status, domestic violence, etc.), even if the investigator does not link subject identifiers to the data *(see note below), or
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

* Note: If an investigator plans to use audio or video recording or responses and is collecting sensitive information, the IRB believes the investigator cannot guarantee that the focus group members themselves will keep the information confidential. Therefore, focus group research of this nature using recording devices must be submitted, at the minimum, for expedited review,

Conducting focus groups using video conferencing platforms While UMBC is in a state of Research Mode Maintenance, current UMBC lab facilities may not available for conducting in-person focus groups.
As such, PIs may plan to conduct research at non-UMBC venues (such as libraries, workspaces on conference rooms).

The Governor of Maryland has directed that many public placed be closed during the COVID-19 event. Note that such venues may not be able to provide space for the recommended social distancing. The ORPC recommends that PIs consider using telephone or virtual/online formats, such as WebEx, to interact with and/or conduct focus groups.

Participants should be informed about the topics that will be discussed and who will participate in the focus group so that they may make an informed decision to participate beforehand. This is especially important for research that will engage sensitive topics and are considered more than minimal risk.
Participants should be informed before the focus group if the session will be audio or video recorded. Participants should also be informed about what will be done with these recordings. If audio or video from the focus groups will be used for something other than data analysis for the approved protocol (i.e. – future research studies, educational purposes, conference presentations, etc.) then participants must explicitly agree to this in the form of a checked box agreeing to or not agreeing to have their video/audio used for the above purposes in the consent form.
The nature of a focus group is such that confidentiality cannot be guaranteed. The researchers must provide participants with the procedures in place to maintain confidentiality of the research data and they must inform participants not to repeat what is said in the focus group to others.
All focus group studies must include a reminder to the group to keep the discussion confidential. This should be included in the consent information and in the facilitator’s introduction to the group.
Suggestions for consent form wording can be found in the IRB’s Adult consent template.

return to IRB special topics

Why would the IRB not approve a study?

Most Common Reasons why protocols are not approved by the IRB | Research

Research is to be conducted at a non-UVA site. Additional documentation required for research conducted at a non-UVA site has not been submitted. (e.g., letter of cooperation from school).
The application is incomplete; requires completion of additional documentation such as approvals from other UVA Compliance Committees.
Research team members have not completed the required CITI modules
Documentation concerns:

Significant discrepancies exist between the protocol and consent form (e.g., sample size, duration of research procedures, description of risks).
Recruitment and the informed consent process are not adequately explained in the protocol.
Risks to the participants are not adequately justified or explained.
Safeguards to protect health information and research data from an erroneous breach of confidentiality are inadequate.

: Most Common Reasons why protocols are not approved by the IRB | Research

What is an IRB exempt protocol?

Exempt Protocols – The 2018 Federal Regulations (45 CFR 46) exemption categories define specific protocols that are exempt from the federal regulation requirements. Protocols that qualify for exemption are still submitted to iProtocol for limited IRB review. The following categories are most likely to be used in a social and behavioral sciences study: Comparing Exempt and Full Board Protocols

Flexible consent procedures : the Board can allow more flexibility in how consent is provided and documented (if at all). No full board review: An exempt protocol does not need full board review; modifications do not need to be reviewed at a full board meeting unless the protocol modifications change the exemption status. Shorter review time: Limited IRB review time should be shorter, generally two to four weeks depending on the protocol load. A full board protocol is reviewed at the full board as well as any continuations or major modifications (some minor edits can be approved administratively), which can take a month or longer. Continuation review not required: Exempt protocols only need to be reviewed once (unless a protocol needs to be modified or there is an unexpected adverse event). You will complete an annual Protocol Status Update to verify that the protocol is still active. Submission requirements and pre-review requirements are the same.

Maintaining an Exempt Protocol

Modifications: Your protocol should always reflect your study’s practice and if it doesn’t, you need to modify the protocol, Exempt modifications receive limited IRB review but please consider grouping modifications into one submission. If you are changing personnel, use the Personnel Management Tool instead of submitting a modification for this change. Update Protocol Status: Exempt protocols do not require an annual continuation review; rather you will be asked on an annual basis to update your protocol’s status (if you haven’t submitted a modification for review over the previous year). You will receive an email notification one month prior to your protocol’s annual notification date with information about how to complete the simple Protocol Status Update form. Failure to complete the form could result in study closure. Unexpected Event Report : Research doesn’t always go according to plan and if that happens, you may need to submit an unexpected event report, Study Closure : Once a study is complete, the protocol needs to be closed,

Can you publish research without IRB?

Response: – For the past decade, most IRBs – including yours – are working to facilitate research by offering guidance and tools to reduce the burden of unnecessary IRB review. I strongly urge you to work with your IRB to help you decide if this activity meets, and if so, whether it meets,

It is important to remember that the criteria for whether IRB review is required is not based on whether the resulting data will be published; sometimes research that requires IRB review never gets published, and sometimes research that does not require IRB gets published. The assessment may also depend on your role, and whether you are providing consultation only or whether you are considered engaged in the research.

As you noted, most journals require proof of IRB approval when manuscripts are submitted for publication. Even if your project does not meet the definition of human research, many journals now require certification by the IRB or the institution that IRB review was not required so it is clear it was not just the researcher deciding their research did not need review.

I looked at the publicly-available policies for your institution.
Your institution’s IRB, like many others, offers a checklist or tool to help guide the decision about whether the proposed project requires IRB review.
This completed tool may be used as documentation to show a sponsor, funding agency, or journal editor that IRB review is not required for the proposed activity, and that the determination was not made by the researcher alone.

Working collaboratively with the IRB to determine the need for IRB review may save you time in the long run if you seek to publish your work. Our experts answer your research ethics and oversight questions, and share the (anonymized) answers as a resource for our industry.

Do you need IRB approval for literature review?

Only if your research deals with living subjects, which is unlikely when doing a literature review. All research need to be reviewed and approved or rejected.

Does action research require IRB approval?

Action Research proposals need to be approved by the Institutional Review Board (IRB). Since Action Research falls under the purview of research involving human subjects, graduate students need to use IRB Form A, Form B, and Informed Consent (see template) (or Waiver of Informed Consent ) for the proposal.

Why would an IRB not approve a research study?

Most Common Reasons why protocols are not approved by the IRB | Research

Research is to be conducted at a non-UVA site. Additional documentation required for research conducted at a non-UVA site has not been submitted. (e.g., letter of cooperation from school).
The application is incomplete; requires completion of additional documentation such as approvals from other UVA Compliance Committees.
Research team members have not completed the required CITI modules
Documentation concerns:

Significant discrepancies exist between the protocol and consent form (e.g., sample size, duration of research procedures, description of risks).
Recruitment and the informed consent process are not adequately explained in the protocol.
Risks to the participants are not adequately justified or explained.
Safeguards to protect health information and research data from an erroneous breach of confidentiality are inadequate.

: Most Common Reasons why protocols are not approved by the IRB | Research

Can you publish research without IRB?

It is important to remember that the criteria for whether IRB review is required is not based on whether the resulting data will be published; sometimes research that requires IRB review never gets published, and sometimes research that does not require IRB gets published.
The assessment may also depend on your role, and whether you are providing consultation only or whether you are considered engaged in the research.

I looked at the publicly-available policies for your institution.
Your institution’s IRB, like many others, offers a checklist or tool to help guide the decision about whether the proposed project requires IRB review.
This completed tool may be used as documentation to show a sponsor, funding agency, or journal editor that IRB review is not required for the proposed activity, and that the determination was not made by the researcher alone.

Does Autoethnography require IRB approval?

Autoethnography Submissions to the IRB – The most common instance when a researcher should submit their autoethnography to TC IRB for review is when a student researcher plans to conduct an autoethnography as part of their dissertation. TC Office of Doctoral Studies (ODS) requires that an IRB approval letter be included along with a completed dissertation proposal,

Thus, any doctoral student who plans to conduct an autoethnography as part of their dissertation must submit a proposal to the IRB. If the research study only involves an autoethnography (autobiography), students can select, ” Not Human Subjects Research ” as the review category. Researchers should still complete the IRB application ; in any section that asks about human subjects’ participation or recruitment, indicate “not applicable” as the researcher will not be including participants.

Researchers should still describe how the data will be presented (e.g., data is only personal narrative with no one else identified in the data). Another case in which a researcher should submit their research to the TC IRB is when the autoethnography involves the use of documents, data, or recorded materials that include information about other individuals.

For example, if a researcher wants to examine transcripts of interviews with locals alongside their personal notes, the transcripts are considered human subjects data and the project should be submitted to the IRB for review.
Hand notes or personal observations (autobiographical in nature) are not considered human subjects research; however, the inclusion of other participants’ data alongside those personal notes qualifies the study for IRB review.

Obtaining IRB approval is complex when the autoethnography method extends beyond personal notes to include identification of others or when it includes narratives from underrepresented, marginalized, or oppressed communities. Authoethnographers should consider the best ways to protect the rights and welfare of others.