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 Huron. Please note that HSRD requests will not be considered over the phone or email.
Please note that the HRPP/IRB office will make the final determination on whether or not your project requires IRB review.
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.
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?
HRP SOP 093: Activities that Require IRB Review describes common research activities and whether or not the activity requires submission to the IRB.
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 submission in Huron. Learn how to request a Not Human Subjects Research Determination (NHSR) in Huron.
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.
FAQs
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.
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.
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.
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 be routed to the Registrar’s office for ancillary review.