Does My Project Need IRB Review?

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:

1. 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.

2. 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)

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).

Important Note:

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 by using our Non Human Subjects Research Determination Electronic Form described in the panel below.

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 (described below) 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 the Memo about NHSRD (DOCX).

For further guidance on a particular type of project, please refer to the respective panels below.

As described in the preceding panel, the IRB is responsible for reviewing all human subjects research activities. If you are relatively sure that your upcoming project meets the definition of "human subjects research," you may go ahead and submit the study in the eIRB system. If, however, you are unsure whether your project needs IRB review, you should use our Non-Human Subjects Research Determination Electronic Form by clicking the button below. This form will indicate if the study needs IRB submission or not. If not, the study team is expected to keep a copy of the form responses as an attestation of the researchers' intent for the project. For more information, refer to the Memo About NHSRD (DOCX).The responses from the form and this memo can be provided to others as needed.

This form is solely for use by Emory faculty, staff, and students. You may first need to log in to your Office365 account (using your emory.edu email) in your internet browser before clicking the below link in order to view the form.

Carter Center Employees* must follow the below instructions to access the form

Form to Determine if an IRB Review is Needed

*Instructions for Carter Center Employees ONLY:

1. Go to Portal Office
2. Log out of your Carter Center account
3. When the login screen refreshes, select your Emory email
4. Log in with your NetID
5. Open a new tab in your browser
6. Navigate back to this page and click the link to the form

Case studies typically involve the collection and presentation of detailed information about a particular patient/person or small group to highlight an interesting condition, treatment, presentation or outcome.

To determine whether a case study or case series requires IRB review, recall the definition of human subjects research; specifically,that itis designed to contribute to generalizable knowledge. A case study, in contrast, tends to highlight one or a few particular cases for purposes of demonstration rather than for purposes of drawing generalized conclusions.

Below are some criteria that tend to be representative of either case studies or research; this list is to be used as a guide not as a definitive determination. Note that Emory has used five case studies as a threshold above which we normally wish to review the project as "research." While somewhat arbitrary, we found it necessary for consistency.

While HIPAA authorization may not always be required, there may be instances in which authorization from the patient may be needed to use their health information. Emory has a Case Study HIPAA Authorization template (DOCX) which can be used in these instances. In addition, if you will be using a photo from the patient, you may obtain their consent using a consent form for that purpose. The School of Medicine has a document you may use in their Emory School of Medicine website.

NOTE: If a trainee or student will work up the case(s) for publication, and the trainee/student does not have a clinical need to have access to the relevant record(s), they may obtain access for the case study under the "EHC Graduate and Undergraduate Medical Education PHI Policy." Please contact Darcelle Skeete in the EHC Office of Compliance before proceeding, for more information.

Many academic courses at Emory include instruction on research methods and research design; sometimes this is done through hands-on projects. On their face it may appear that these types of projects require IRB review, but there are actually many cases in which that is not the case. The reasoning goes back to the definition of generalizable; classroom activities are often meant specifically to satisfy a course requirement or to teach a particular lesson, they are oftentimes not intended to spread beyond the classroom in a way that would suggest generalizable research.

Another form of classroom activity is when instructors/professors innovate in order to improve their pedagogy. These can be systematic changes with data analysis from before and after the innovation. No IRB review is required when the intention is solely to improve the teacher's own teaching methods, or even when a whole department implements a new curriculum, which they want to evaluate to see how well it works. However, if an instructor or department/School has an academic interest is pedagogy, and they are using their classroom partly as a "laboratory" to test innovations with the goal of contributing to generalizable knowledge about pedagogy, IRB submission would likely be required (though we will probably determine the project to be "exempt" research).

Below are some criteria that tend to be representative of either classroom activities or research; this list is to be used as a guide not a definitive determination:

Public health practice is understood broadly as the collection and analysis of identifiable health data by a public health authority for the purpose of protecting the health of a particular community, where the benefits and risks are primarily designed to accrue to the participating community. Public health practice is dominated by the use of standard, accepted, and proven interventions to address known or suspected public health problems.

Per the Revised Common Rule, the following are considered Public Health Surveillance, not "Research" subject to the Common Rule:

• Public health surveillance activities conducted by a public health authority, 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 the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority.
  • Including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products.
  • Including 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).

As explained by the CDC Policy Distinguishing Public Health Research and Non-research (PDF):

For many public health practice activities, data are systematically collected and analyzed. Scientific methods are used in both public health research as well as public health practice activities. Knowledge is generated in both cases. Furthermore, the extent to which knowledge is generalizable might not differ greatly in research and nonresearch. Thus, nonresearch and research activities cannot be easily defined by the methods they employ. Three public health activities – surveillance, emergency response, and evaluation – are particularly susceptible to the quandary over whether the activity is research or non research.

The major difference between research and nonresearch lies in the purpose of the activity. The purpose of research is to generate or contribute to generalizable knowledge. The purpose of nonresearch in public health is to prevent or control disease or injury and improve health, or to improve a public health program or service. Knowledge might be gained in any public health endeavor designed to prevent disease or injury or to improve a program or service. In some cases, that knowledge might be generalizable, but the purpose of the endeavor is to benefit clients participating in a public health program or a population by controlling a health problem in the population from which the information is gathered.

To help discern whether your particular project will need IRB review, consider the following criteria which tend to represent one or the other. Please note, this list is to be used as a guide and is not a definitive determination:

Program evaluations are defined as:

Systematic collection of information about the activities, characteristics and outcomes of programs to make judgments about the program (or processes, products, systems, organizations, personnel, or policies), improve effectiveness, and/or inform decisions about future program development.

Below are elements that are common to evaluation and research projects. This list is not intended to be comprehensive and not all elements are required in order for a project to be considered research or evaluation. Rather, this list of elements can be used to assist faculty in determining whether an activity involves research requiring IRB review.

**See also the "Program Evaluation" section at left, as there can be overlap between these two areas.**

Quality assurance or quality improvement (QA/QI) projects can often seem like the type of human subjects research that the IRB needs to review. By their nature, QA/QI projects often include activities such as conducting surveys, reviewing identifiable data, drawing conclusions about problems, and suggesting methods for improvement. The key, however, is determining whether this type of project is designed to be generalizable to the extent of meeting the federal definition of research.

Typically, QA/QI projects are particularly focused on improving the performance of an institutional practice in comparison with an established standard or goal. They are focused on a local practice and consequently limit their scope to the specific institution. The results of the project are not intended to apply to anyone beyond the scope of the project, and conclusions are drawn only in relation to the particular practice at the institution. In other words, if the results of the project are shared outside the institution (i.e. published or presented), then it would only be for the purposes of sharing a successful improvement in practice; other institutions could then interpret the results and draw their own conclusions, but the key is that the institution conducting the QA/QI project is not drawing broad conclusions and is not using their participants as a representative sample.

For additional guidance, please refer to the following: OHRP website on QA/QI

Below are some criteria that tend to be representative of either QA/QI or research; this list is to be used as a guide and not a definitive determination: