Step 1: Is it Human Subject Research?

Is it Research?

Research is defined by DHHS as "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which 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”

Research is defined differently by the FDA and has additional requirements.*

Is it a Human Subject?

A Human Subject is defined by DHHS as “a living individual about whom an investigator (whether professional or student) conducting research obtains

(1) Data through intervention or interaction with the individual, or

(2) Identifiable private information

Human Subjects is defined differently by the FDA and has additional requirements.*  

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 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). It 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.

Do I need to submit?

All individuals engaged in human subjects research that is supported by Texas A&M University; conducted by or under the direction of any faculty, staff, student, or agent of Texas A&M in connection with his or her institutional responsibilities; conducted by or under the direction of any employee or agent of Texas A&M using any property or facility of Texas A&M; or involved in identifying and contacting human research participants or prospective participants, must submit an application to the IRB prior to commencement of any research activities.

How do I submit?

All required application and required materials must be submitted via the iRIS interface. See Step 3.

What if I am not sure?

If you have questions about whether an activity is Human Research, contact the Human Research Protection Program. A written determination will be provided when the request is submitted through the electronic system, iRIS. Determinations are not issued through emails or phone calls.

Next Step: What to Submit?