Does My Project Need IRB Review?
The IRB is responsible for reviewing human subjects research and FDA-regulated clinical investigations, and ensuring that they are conducted in accordance with applicable federal regulations and institutional policies. This page will help you determine if your proposed work falls into those categories.
Note: there are situations in which Emory is not "engaged" in human subjects research done with collaborators at other institutions, in which case Emory IRB approval would not be required. E.g., Emory is only analyzing completely deidentified data, is only informing people about a study but not enrolling, Emory personnel are performing clinical services for a fee that are routinely done for non-research purposes, and others. Please contact the IRB if you are unsure if Emory is engaged. (Funding flow may affect this determination.)
First we consider, what is "research?"
The DHHS "Common Rule," generally used by the Emory IRB to evaluate all human subjects research, defines "research" as:
"a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge." (45 CFR 46.102(l))
This leads to two further explanations:
- Systematic Investigation = An activity that involves a prospective plan that incorporates data collection, either quantitative or qualitative, and data analysis to answer a question. Often include surveys, interviews, data analyses, cognitive experiences, or medical chart reviews.
- Generalizable Knowledge = Knowledge from which conclusions will be drawn that can be applied to populations outside of the specific study population. This usually includes one or more of the following concepts: Knowledge that contributes to a theoretical framework of an established body of knowledge; the primary beneficiaries of the research are other researchers, scholars, and practitioners in the field of study; dissemination of the results is intended to inform the field of study (though this alone does not make an activity constitute research “designed to contribute to generalizable knowledge”); the results are expected to be generalized to a larger population beyond the site of data collection; the results are intended to be replicated in other settings.
Good news! The Common Rule says that the following are NOT "research" and are excluded from the regulations (but always good to double check with the IRB):
(1) 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.
(2) 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).
(3) 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.
(4) Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.
The FDA regulations, meanwhile, use the term "clinical investigation" to define which FDA regulations apply to studies. (For the purposes of FDA regulations, the terms research, clinical research, clinical study, study, and clinical investigation are synonymous.)
A clinical investigation has a couple definitions per the FDA. Note that studies can be "FDA regulated" and subject to some of their oversight even if they are not "clinical investigations" (e.g. studies involving any FDA-regulated products).
- Per the FDA sections on the protection of human subjects and IRB's (21 CFR Section 50 and 56), it is "any Experiment that involves a Test Article and one or more Human Subjects and that either is (1) subject to requirements for prior submission to the FDA under Section 505(i) or 520(g) of the FDA Act, or is (2) not subject to requirements for prior submission to the FDA under these sections of the FDA Act, but the results of which are intended to be submitted later to, or held for inspection by, the FDA as part of an application for a research or marketing permit. The term does not include Experiments that are subject to the provisions of Part 58 [of Title 21 of the CFR], regarding non-clinical laboratory studies."
- Per the FDA regs on Drugs, it is "any experiment in which a drug is administered or dispensed to, or used involving, one or more human subjects. For the purposes of this part, an experiment is any use of a drug except for the use of a marketed drug in the course of medical practice."
- The FDA regs on Devices says "Investigation means a clinical investigation or research involving one or more subjects to determine the safety or effectiveness of a device."
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 act or under sections 351 and 354-360F of the Public Health Service Act (42 U.S.C. 262 and 263b-263n)
Secondly, what constitutes a "human subject?"
The Common Rule defines a human subject as a living individual about whom an investigator conducting research obtains (1)information or biospecimens through intervention or interaction with the individual, and, uses, studies, or analyzes the information or biospecimens; or. 45 CFR 46.102(e) (2) uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens
The FDA regulations define a human subject as 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. [21 CFR Section 50.3(g)]. In the case of an investigational medical device (e.g. an assay, genetic test, in-vitro diagnostic device), a human subject/participant also means a human on whose specimen an investigational medical device is used (whether identifiable or not).
The results of a non-research activity could be used to develop or contribute to generalizable knowledge after the initial project is complete. If the initial purpose or a project is not to develop or contribute to generalizable knowledge, the project is not classified as research at the outset. However, if later someone decides to use identifiable private information from that project with the aim of developing or contributing to generalizable knowledge, that analysis may need IRB review.
Please do not attempt to determine for yourself that your project is not research involving human subjects or a clinical investigation. You should have the IRB make this determination.
If you think that your project is indeed research involving human subjects or a clinical investigation, you can go ahead and submit your project in the eIRB system for IRB review. Upon conducting it's preliminary review the IRB will confirm that it meets the definition and the review will move forward.
If not, you must use our Non Human Subjects Research Determination Electronic Form and save the responses as an attestation of your determination. You can contact us for questions about this process, but we will not offer letters from our office anymore. For more information, refer to this memo.
For further guidance on a particular type of project, please refer to the respective page in the left-hand menu.