Do I Need IRB Review?

A human subject is defined as a living individual about whom an investigator (whether professional or student) is conducting research. This means the investigator/researcher:

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 identifiable biospecimens. 45 CFR 46.102(d)(pre-2018)/45 CFR 46.102(e)(1) (1/19/2017)

To learn more click here: Involving Human Subjects.

• Projects involving only deceased persons.
  • All subjects included in the project must be deceased. Identifiable information about the deceased’s living relatives cannot be included.
• Projects involving access to only de-identified data or biospecimens.

Research is defined as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. 45 CFR 46.102(d)(pre-2018)/45 CFR 46.102(l)(1/19/2017)

Click here to learn more about QI versus Research.

Case Reports 

Case reports are not considered research. In medicine, a case report is a detailed report of the symptoms, signs, diagnosis, treatment and follow-up of an individual patient. Case reports are professional narratives that provide feedback on clinical practice guidelines. They can be shared for medical, scientific, or educational purposes.

Quality Improvement Projects

Quality improvement projects are focused on monitoring a process/policy in place to determine if it is reaching a target or measurable goal. QI projects, aimed solely at promoting adherence to or implementing a best practice, may not be considered research.

To be a quality improvement project, the project must be limited to:

• Assessing and ensuring compliance with a standard or regulation;
• Monitoring a process to see if it is reaching a target or measurable goal, or monitoring to meet requirements by a regulatory or accrediting body;
• Implementing a practice to improve the quality of a process;
• Collecting patient or provider data regarding the implementation of a practice for clinical, practical or administrative purposes; or
• Measuring and reporting provider performance data for clinical, practical, or administrative uses.

Scholarly and journalistic activities

Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individual about who the information is collected, is not considered research. 45 CFR 46.102(l)(1) (1/19/2017).

Public health surveillance activities

Public health surveillance activities, including collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. 45 CFR 46.102(l)(2)(1/19/2017).

Certain courses are designed to teach students how to conduct research. Class projects or assignments involving human subjects are generally conducted for educational purposes and training solely to fulfill a course requirement. Therefore, the element of “research,” defined as the “intent to develop or contribute to generalizable knowledge” is lacking to meet the regulatory definition of when IRB review is required.

However, when classroom projects are a systematic investigation designed to develop or contribute to generalizable knowledge (outside the classroom), it meets the definition of research and prior IRB review and approval is required.

Click here to learn more about Classroom Projects versus Research.

 

Class activities or assignments include those conducted by students enrolled in an official course, as well as activities in fulfillment of class assignments involving interactions with individuals other than the members of the class. These assignments are typically initiated and completed within a single term.

Thesis and Dissertation Projects

Thesis and dissertation projects are typically conducted with the intent to present or publish results and therefore are designed to contribute to generalizable knowledge. If human subjects are involved, prior IRB review and approval is required for thesis and dissertation projects.

Classroom Projects

Classroom research activities should be evaluated on a case-by-case basis on whether the activity meets the definition of research involving human subjects. Classroom projects where students conduct research involving human subjects do not need to be reviewed individually by the IRB if the following conditions are satisfied:

1. The intent of the project is to teach research methods, and not to be systematic and generalizable.
2. The results of the project will not be distributed, presented or used for publication, although the results may be presented to instructors or peers for educational purposes or as part of a class assignment.

This is not an inclusive list but, in general, the following activities will require individual students to obtain IRB approval for their project prior to beginning the study:

1. Graduate theses and capstone projects are clearly understood as research and fall within the IRB purview when human participants are involved.
2. If a student’s proposed research project involving human subjects may result in a formal publication or presentation.
3. There may be instances when a student or instructor wishes to use data for research that was previously collected for educational purposes. An application should be submitted to the IRB when a student or instructor wishes to analyze the data with the intent of contributing to generalizable knowledge.

Classroom project results may be presented within the class to the classroom instructor and classmates/peers for education purposes or as part of the assignment.

Classroom data can be shared at college or department-hosted learning forums or academic showcases. However, if results will be presented off-campus or to the public invited to an on-campus event, or published or generalized in some other way (i.e. published on-line), then it will be necessary to obtain IRB approval.

Data from class projects cannot be shared outside of the university community.

To qualify under the classroom project approval, forum presentations must be limited to:

1. Location: TAMU-CC campus or TAMU-CC owned properties.
2. Invitees: Invitees are limited to current faculty, staff and students only.
3. Advertisement: Limited to on-campus communications. Public invitation is not allowed.
   • Appropriate dissemination may include department flyers, on-campus monitor displays, or on-campus chalk displays. Electronic dissemination must be limited to the campus committee, such as restricted listserves to faculty, staff and students, and in-class Canvas posting.
4. Projects cannot be represented as “research”. No use of the word “research” is allowed. Labeling a project conducted under these parameters as “research” is inaccurate and misleading.

The project can involve minimal risk to participants (i.e., when “the risks of harm anticipated in the proposed research are not greater considering probability and magnitude, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests”).

The project cannot involve sensitive topics or confidential information that could place a participant at risk if disclosed (e.g. illegal activities).

The project cannot involve people from vulnerable populations as participants (e.g. prisoners, minors, pregnant women, those lacking capacity to consent, or other at-risk populations).

The project should involve the voluntary participation of individuals without any undue influence or pressure being placed on them to participate. See 1200.03 Template, Information Sheet for Classroom Projects.

This project may NOT be referenced as "IRB approved." 

If you secured a Not Human Subjects Determination, you may include the following statement can be included in any publications or presentations: "TAMU-CC-IRB-XXXX-XXXX: This project was reviewed and determined to not meet the definition of research involving human subjects by the TAMU-CC Institutional Review Board." 

Once you have received IRB approval from the IRB, you can keep this protocol active to cover multiple semesters. To keep the IRB approval for the course active, you will need to submit a continuing review application prior to the expiration date to give the IRB an update on student projects that have occurred under this application.

If there are any modifications, the classroom application must be modified through an amendment, including changes affecting course numbers, titles, descriptions, and scope or nature of the classroom assignments.

There may be instances when a student or instructor wishes to use data for research that was previously collected for educational purposes. An application should be submitted to the IRB when a student or instructor wishes to analyze the data with the intent of contributing to generalizable knowledge.

1200.03 Template, Information Sheet for Classroom Projects Previously Completed

If a student research project intended only for class purposes develops into disseminated research, IRB approval must be obtained immediately. Please note that the IRB cannot grant retroactive approval.

Service learning is defined as a “course-based, credit bearing educational experience in which students (a) participate in an organized service activity that meets identified community needs, and (b) reflect on the service activity in such a way as to gain further understanding of course content, a broader appreciation of the discipline, and an enhanced sense of personal values and civic responsibility” (Bringle & Hatcher, 2009, p.38).

If data collection and analysis for the service learning project is being done for instructional purposes only within the context of the course, without the intent of communicating it beyond the instructor and students of the course, IRB review is not required. Please see information on classroom project above for additional details.

If a student research project intended only for class purposes develops into disseminated research, IRB approval must be obtained immediately. Please note that the IRB cannot grant retroactive approval.

Quality improvement (QI) is a systematic, formal approach to the analysis of practice performance and efforts to improve performance.

Activities limited to the following is not considered research:

• Assessing and ensuring compliance with a standard, regulation or current policy/practice;
• Monitoring a currently implemented process to see if the process is reaching a target or measurable goal;
• Monitoring performance to meet requirements by a regulatory or accrediting body;
• Implementing a practice to improve the quality of patient care;
• Collecting patient or provider data regarding the implementation of the practice for clinical, practical or administrative purposes; or
• Measuring and reporting provider performance data for clinical, practical, or administrative uses.

The following characteristics will be considered for determining if the project is research:

• The purpose of the project is aimed at testing a hypothesis or establishing a practice or standard or procedure where none exists;
• Attempts to create a general explanation about how thing happen to predict future occurrences or generates knowledge to be applied generally;
• Described as testing an “experimental”, “innovative”,  “novel”, or “new” procedure, treatment or intervention or is referred to as research; or
• Has an assigned Investigational New Drug (IND) number or an Investigational Device Exemption (IDE) by the FDA.

Quality improvement projects with no elements of research are not considered research. For example, projects implementing a practice and collecting data for non-research administrative purposes would not be required to undergo IRB review.

However, quality improvement projects that contain elements of research are considered research and would require IRB review. For example, quality improvement projects also designed to as prove or disprove the effectiveness of an intervention would fall within the definition of research and require IRB review.

No. OHRP has indicated, “Intent to publish is an insufficient criterion for determining whether a quality improvement activity involves research.” OHRP, FAQ, https://www.hhs.gov/ohrp/regulations-and-policy/guidance/faq/quality-improvement-activities/index.html.

Planning to publish an account of a quality improvement project does not necessarily mean that the project fits the definition of research. People seek to publish descriptions of non-research activities for a variety of reasons, if they believe others may be interested in learning about those activities.

Conversely, a quality improvement project may involve research even if there is no intent to publish the results.

Failure to secure IRB review prior to performing research involving human subjects is a serious non-compliance issue.  Therefore, it is advisable to seek consultation prior to starting a project to ensure it does not require IRB review.

The NHS Determination process aids in determining whether a project requires IRB review or not.

If successful, then a letter will be received stating the project is either not research or does not involve human subjects. The project may then proceed without prior IRB review. This letter can be provided to journals if they ask for IRB review during the publication process.

In Section 4.0, Submission Type, select submission type "Determine if my project is considered "regulated research."

Click here to learn how to submit a Not Human Subject determination form.

If you received a Not Human Subject Determination then your project was determined to either NOT be research or NOT involve human subjects.

If the determination was based upon not involving research, then calling the project research is misleading. 

If the project was reviewed by the IRB and was determined not to be human subjects research, the following statement can be used in any communication: “This Project was reviewed and determined to not meet the criteria for human subjects research as defined by 45 CFR 46.102 by the TAMU-CC Institutional Review Board. IRB# (add the IRB # found on your determination letter).”

No. The Office of Research Compliance can only issue a determination through the iRIS application process. This is required to ensure:

• All relevant information is obtained to issue a correct determination and
• To document the analysis justifying the determination made in compliance with federal regulations and university policies.

An email requesting a review via email will be replied with instructions on how to submit a Not Human Subject (NHS) Determination through iRIS.

Complete submissions can take as little as 24-48 hours. Incomplete submissions will be returned to the team for additional information and can delay getting a determination.

Check our IRB metrics NHS Dashboard.

The Office of Research Compliance or the IRB cannot issue a determination after the research has been conducted. So it is highly encouraged to submit a determination request before you begin the project.

If the project has already been conducted, please contact the Office of Research Compliance immediately.

If your funder is requiring a letter as a condition of funding, then you will need to submit to the IRB to get an official determination letter. If you do not feel IRB review is required then you can submit your proposed research and receive a determination that compliance committee review is not required through Requesting a Not Human Subject (NHS) Determination.