Human Subjects Research Determination
Is this Human Subjects Research requiring IRB review?
The Human Research Protection Program (HRPP) has created a worksheet to assist investigators in determining whether or not a research project requires IRB review. Furthermore, a table that lists activities that may or may not require IRB review is provided as a general guide. Any investigator who is unsure of whether a proposal constitutes “human subjects research” must submit a human subjects research determination (HSRD) request to the HRPP office via iRIS. Please note that HSRD requests will not be considered over the phone or email.
- If a HSRD request form does not qualify as human subjects research, the HRPP will issue a memo stating that the project does not require IRB review or approval.
- If the project is determined to meet the regulatory definition of research, you will be prompted to complete a new project application for IRB review.
- Please note that the HRPP/IRB office will make the final determination on whether or not your project requires IRB review.
Resources
HRP-310 WORKSHEET: Human Research Determination
HRP-093 SOP: Activities that Require IRB Review
Who is required to submit to the IRB?
The Institutional Review Board (IRB) must review all research involving human subjects conducted by Texas A&M University faculty, staff, and students. IRB approval is required regardless of funding source (or lack thereof) and/or location at which the research will be conducted.
What is the definition of research?
Research projects meeting the regulatory definition of human subjects research require review and approval by an IRB. Federal regulations define Research (45CFR46.102(l)) as “a systematic investigation, including development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. For purposes of this part, the following activities are deemed not to be research:
- 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 individuals about whom the information is collected.
- Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters).
- Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.
- Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.
What is the definition of human subject?
Federal regulations define Human Subject (45CFR46.102(e)(1)) as a living individual about whom an investigator (whether professional or student) conducting research:
- Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
- Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
The regulations further define:
Intervention (45 CFR 46.102(e)(2)) includes both physical procedures by which information or biospecimens are gathered (e.g. venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes
Interaction (45 CFR46.102(e)(3)) includes communication or interpersonal contact between investigator and subject.
Private information (45 CFR46.102(e)(4)) 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 that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g. medical record)
Identifiable private information (45 CFR 46.102(e)(5)) is private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information.
Identifiable biospecimen (45 CFR46.102(e)(6)) is a biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen.
What Activities Require IRB Review?
The table below describes common research activities and whether or not the activity requires submission to the IRB. The table is taken from HRP SOP 093: Activities that Require IRB Review.
If you are unsure about whether or not your research activity requires review by the IRB you may request a determination.
Requesting a determination requires a truncated application in iRIS at iris.tamu.edu. In section 4.0 of the study application, select “yes” for the question: “I am requesting a determination – is my project human subjects research?” and fill out the next section with detailed information about your project.
Be sure to upload any supporting documents that may help with the determination.
Remember, you may not begin any research activity involving human subjects until the IRB has issued approval correspondence specific to that activity.
Research involving deceased individuals does not require IRB oversight.
HRPP/IRB Determination Required: NO
Retrospective review of a patient’s medical record with intent to document a specific situation or the experience of an individual without intent to form a research hypothesis, draw conclusions or generalize findings. Data is de-identified.
HRPP/IRB Determination Required: NO if using only 1-2 records. YES if using 3 or more records.
Prospective case study with clear intent, before recruiting or interacting with the participant, to use that data to draw conclusions and will publish or present to external groups.
HRPP/IRB Determination Required: YES
Normal educational activities conducted by the students designed to teach students methods or demonstrate course concepts AND the activities are not designed to create new knowledge AND are not generalized or presented outside the classroom.
HRPP/IRB Determination Required: NO
Educational activities conducted by faculty or instructors in the classroom or with students and the intent is to generalize the information outside of the classroom or publish. This includes use of student records, interviews, surveys or other student data for prospective or retrospective research.
HRPP/IRB Determination Required: YES
Experiments using an intervention, substance or test article on one or more human subjects to evaluate the effects of those interventions, products or test articles on health related biomedical or behavioral outcomes regardless of FDA status or applicability. Products include foods (dietary supplements that bear a nutrient content claim or a health claim, infant formulas, food and color additives), drugs for human use, medical or diagnostic devices for human use, biological products for human use, and energy emitting products used on humans.
HRPP/IRB Determination Required: YES
When discussing personal experiences or opinions and/or the focus is on people (e.g. how do you rate your ability to handle stress; how often do you run red-lights?)
HRPP/IRB Determination Required: YES
When discussing non-human topics and the focus is on things instead of people (e.g. discussions on the differences between product A and product B)
HRPP/IRB Determination Required: NO
Systematic investigation of innovations in diagnostic, therapeutic procedure or instructional methods in multiple participants in order to compare to standard of care or normal procedure. The investigation is designed to test a hypothesis, permit conclusions to be drawn, thus to develop or contribute to generalizable knowledge.
HRPP/IRB Determination Required: YES
The use of innovative interventions that are designed solely for therapeutic purposes to enhance the well-being of an individual patient with a reasonable expectation of success. The intent of the intervention is to provide diagnosis, preventive treatment, or therapy to an individual patient. Research is not involved.
HRPP/IRB Determination Required: NO
Online websites set up for the purposes of collecting human data regarding a particular topic. This may include the completion of questionnaires/surveys, personal data, etc.
HRPP/IRB Determination Required: YES
Harvesting, mining, profiling, observing or recording data from blogs, chat rooms, social media postings, etc.
HRPP/IRB Determination Required: YES
Submitting information or interacting with internet sites in order to measure influence on behaviors or other outcomes.
HRPP/IRB Determination Required: YES
Current FDA guidance indicates that IRB review is required for any IVD study involving human specimens/samples, even when the research involves no identifiers and the biological materials cannot be linked to any identifying information.
HRPP/IRB Determination Required: YES
An assessment of a body of published material that addresses a research question. Identifies or summarizes what is already known about an area of study or may identify questions a body of research does not answer.
HRPP/IRB Determination Required: NO
Pilot studies that meet the definition of human research, regardless of the number of subjects enrolled or the duration of the studies.
HRPP/IRB Determination Required: YES
Employees or agents of Texas A&M involved in human research projects carried out at other locations when the services performed merit professional recognition or publication privileges.
HRPP/IRB Determination Required: YES
Limited to those activities necessary to allow a public health authority to provide timely situational awareness or set priorities during an event or crisis that threatens public health. Researchers must have a written request, authorization or contract from a Public Health Authority.
HRPP/IRB Determination Required: NO
Systematic, data-guided activities involving humans designed to implement promising ways to improve outcomes, system performance or professional development - The activity usually occurs within standard of care or normal educational or business practices confined to the local setting.
Guidance: Intent is only one element considered. QI and research often overlap. The activity often involves an iterative process that may change over time in response to ongoing feedback. The plan may include mechanisms for assessment, intervention, analysis and implementation. One-time activities designed to meet personal educational requirements are generally not QA or QI.
HRPP/IRB Determination Required: YES - must have a determination
Proposed QI/QA activities that may have research intent, address a specific deficit in scientific knowledge or are intended to be generalized beyond the local setting require submission to the IRB for a determination.
HRPP/IRB Determination Required: YES
Proposed activity involves accessing student, health or other private records, data banks, repositories or any other mechanism by which identifiable human records, data, tissue, blood, or genetic materials will be obtained.
HRPP/IRB Determination Required: YES
Proposed activity involves accessing stored human tissue, blood, genetic material or private identifiable data that will be de-identified by study personnel at the time of collection or when the investigator has access to a code or link that enables re-identification of data or specimens.
HRPP/IRB Determination Required: YES
Private information or specimens are being collected specifically for the proposed research through interaction or intervention with living individuals.
HRPP/IRB Determination Required: YES
Proposed activity involves accessing specimens or cell lines from a commercially operated or established biorepository where the investigator does not receive under any circumstances personal identifiers, or links, or codes that enable identification;
HRPP/IRB Determination Required: NO
Proposed activity involves accessing PUBLICALY available specimens or data. NOTE: if subjects are inadvertently identified when combining more than one publicly available data sets you must contact the IRB, immediately.
HRPP/IRB Determination Required: NO
Oral histories or journalism that focuses directly on the specific individuals about whom the information is collected and there is no intent to generalize the information to others. Legal research must focus on the circumstances of specific plaintiffs or parties involved in a case; Legal research is not a particular field.
HRPP/IRB Determination Required: NO
Scholarly and Journalistic activities that involve the testing or confirmation of a hypothesis that is intended for generalization to others.
HRPP/IRB Determination Required: YES
Any human research were the investigator is also a subject (investigator self-experimentation) requires IRB review and approval.
HRPP/IRB Determination Required: YES
The collection of data about established and accepted diagnostic, therapeutic procedures, or instructional methods is intended for dissemination or contribution to generalizable knowledge.
HRPP/IRB Determination Required: YES
There is an alteration in patient care or assignment for research purposes or the alteration is in a way that standard diagnostic or therapeutic procedures are not completely up to the discretion of a practitioner.
HRPP/IRB Determination Required: YES
A diagnostic procedure is added to a standard treatment for the purpose of research.
HRPP/IRB Determination Required: YES
An established and accepted diagnostic, therapeutic procedure or instructional method is performed only for the benefit of a patient and not for research purposes.
HRPP/IRB Determination Required: NO
Thesis or dissertation projects involving human subjects research conducted to meet the requirements of a graduate degree.
HRPP/IRB Determination Required: YES
Interacting with participants directly or through third party survey administrators to answer a research question about humans requires submission to the HRPP/IRB for a determination even if not collecting identifiable information.
HRPP/IRB Determination Required: YES
Observing, recording, measuring or testing human behavior, cognition, interaction, performance, psychophysiology or anthropometry in a natural or laboratory environment for research applications.
HRPP/IRB Determination Required: YES
FAQs
Does a pilot study need IRB review?
Yes. It isn’t the number of subjects that determines if review is needed; the determining factor is whether or not human subjects are involved. Make sure the aims of study are clear in the purpose and background section of the protocol.
Does my funded project qualify for a “Delayed Onset Determination”?
There are some limited circumstances described by federal regulations (45 CFR 46.118) in which IRB approval or exempt status is not required before an award is made by the sponsoring agency, because definitive plans for human subjects involvement cannot be described in the grant application. This is referred to as delayed onset human research.
In the case of delayed onset human research, the principal investigator must submit an application to the IRB through the electronic system stating that the plans for human subjects are not fully developed and will occur during a future period of time. The explanation should contain as much detail as possible and indicate the portions of the grant that confirm the need for development of activities prior to the involvement of human subjects. Examples of developmental activities that are appropriate for a delayed onset determination include:
- Procedures or questionnaires under development or other novel research instruments;
- Completion of animal studies;
- Purification of compounds;
- Development of a device, assay or diagnostic test
- Delayed Onset Human Research status is not a type of IRB approval.
- Delayed Onset Human Research Status is not a substitute for IRB approval.
No human subjects activities can occur until any proposed Human Subjects Research activity has been granted exempt status, or complete IRB approval. Determinations are not issued through emails, phone calls or other means outside of a valid application through the electronic system.
Do I need IRB review for TAMU classroom-based research projects conducted by students?
TAMU recognizes that some student projects are conducted to fulfill course requirements and to teach students research methods. If these classroom activities are conducted by the students and not designed to produce new knowledge or to be generalizable or presented outside of the class, the IRB will not require review and approval. Please note that IRB templates and consent documents may not be used for research that will not be reviewed and approved by the IRB. Please contact the IRB staff if you have any questions.
However, there are some student research projects that will require IRB review if they involve human subjects: Doctoral dissertations; funded research; research conducted through collaborations external to TAMU, Master‘s theses, and honors theses. All of these must be reviewed and approved by the IRB before students may begin their research.
Do I need IRB review for TAMU classroom-based research projects conducted by faculty?
Educational activities conducted by faculty or instructors in the classroom or with students and the intent is to generalize the information outside of the classroom or publish, will require submission to the IRB for review and approval. This includes both prospective and retrospective research conducted by faculty or instructors using student records, interviews, surveys or other student data. IRB submission for review and approval is required prior to implementation of the research activities. Please note that research involving TAMU students or their data will also require the Registrar’s approval.