Do I Need IRB Review?

Not all proposed projects involving people are considered Human Subjects Research (HSR) under the federal regulations. Whether your project requires IRB review depends on what you are doing, why you are doing it, and what information you will collect or use.

To determine whether your project requires IRB review, consider the following two questions:

Under the federal regulations, research is defined as:

  • “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge."

This means the activity follows a planned approach to answer a question and is intended to develop knowledge that extends beyond the specific individuals, setting, program, or organization being studied.

Activities involving people that are conducted as part of a thesis or dissertation generally meet the definition of research because they are intended to contribute to generalizable knowledge. Certain activities conducted solely to fulfill a course requirement may not meet the definition if they are designed only for instructional purposes and are not intended to contribute to generalizable knowledge.

Under the federal regulations, a human subject is defined as a living individual about whom an investigator 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.

This may include activities such as interacting with participants through interviews, surveys, focus groups, or observations, as well as accessing identifiable private information or identifiable biospecimens for research purposes.

If the answer to both questions is YES:

  • Your project is considered Human Subjects Research and must be submitted through Cayuse Human Ethics for IRB review. Research activities may not begin until the appropriate IRB determination or approval has been issued. Refer to the Cayuse Human Ethics webpage for more information on how to submit an application.

If the answer to one or both questions is NO:

  • Your project may not meet the federal definition of Human Subjects Research and formal IRB review may not be required. However, if you need formal determination for documentation purposes (e.g., dissertation committees, publishers, professional presentations, or other documentation purposes), refer to How to Request a Not Human Subjects Research (NHSR) Determination below for more information. 

Note: IRB approval cannot be granted retroactively. If you are unsure whether your project requires IRB review, obtain a determination before beginning any research activities, including recruitment.

 

Common Projects That May Not Require IRB Review

Some activities involving people or information about people may not meet the federal definition of Human Subjects Research and therefore may not require IRB review. Common examples include certain secondary data analyses, quality improvement or program evaluation activities, classroom activities, oral history or journalism projects, case studies, and research involving deceased individuals. The examples below provide general guidance but may not apply to every project.

For additional examples, review Examples of Activities that May or May Not Require IRB Review.

 

Unless the research is subject to FDA oversight, whether IRB review is required for research involving existing data or human biological specimens usually is determined by the investigator’s ability to ascertain the identity of the individual to whom the data or specimen pertains.

When determining whether IRB review may be required, it is important to understand the difference between anonymous, de-identified, coded, and identifiable data or specimens.

  • Anonymous: The investigator is unable to ascertain the identity of the individual because no identifying information is included with the data or specimens and there is no other method available to the investigator to determine to whom the data or specimen pertains.
  • De-identified: Data or specimens have been stripped of all direct identifiers, and the investigator receives them without identifiers or codes that would allow them to be linked back to an individual.
  • Coded: Identifying information that would enable the investigator to readily ascertain the identity of the individual has been replaced with a number, letter, symbol, or combination thereof (i.e., a code). A separate key exists that enables the coded data or specimen to be linked back to the individual.
  • Identifiable: The investigator can readily ascertain the identity of the individual to whom the data or specimen pertains.

Research involving existing anonymous, de-identified, or coded data or specimens may not constitute Human Subjects Research when the investigator cannot readily ascertain the identity of the individuals, does not have access to identifiable private information, and will have no interaction or intervention with the individuals from whom the data or specimens were obtained.

Research involving identifiable private information or identifiable biospecimens may constitute Human Subjects Research and require IRB review. In some circumstances, research involving existing identifiable information may qualify for Exempt review; however, Exempt determinations must be made by Research Integrity & Compliance (RIC).

Note: Additional requirements may apply when accessing or using Protected Health Information (PHI) or when the research is subject to FDA oversight. If you are unsure whether your use of data or specimens requires IRB review, submit a Not Human Subjects Research (NHSR) Determination Request through Cayuse Human Ethics.

Projects limited to analyzing de-identified data contained within a publicly available dataset may not constitute Human Subjects Research. Examples of publicly available data sources include data files from ICPSR (Inter-university Consortium for Political and Social Research), the Centers for Disease Control and Prevention, Bureau of Economic Analysis, and FBI Uniform Crime Reporting Program, unless you are accessing restricted-use data.

Note: IRB review may be required if the publicly available data set contains identifiers or if the merging of multiple datasets might result in identification of the individuals. If either applies to your project, submit an IRB application through Cayuse Human Ethics.

Program evaluation, Quality Improvement (QI), or Quality Assurance (QA) activities designed specifically to assess or improve performance within the department, organization, program, or other specified setting may not constitute Human Subjects Research when the intent is not to generate conclusions that can be applied outside the immediate environment where the activity will occur.

For example, distributing a survey to SMU students to gather feedback on library hours for the purpose of improving services and addressing student needs would be considered program evaluation rather than research.

Note: If you plan to distribute a survey to members of the SMU community (i.e. alumni, donors, prospective or current students, and employees), you must receive approval from the SMU Survey Oversight Committee and, if applicable, any additional approvals required by your department or the site where the activity will occur. Submit your survey for review and approval at www.smu.edu/survey. Contact assessment@smu.edu with questions.

Course-related activities designed specifically for educational or teaching purposes may not constitute Human Subjects Research when data is collected from or about students as part of a routine classroom exercise or curriculum assignment and is not intended for use outside of the classroom.

Note: IRB review may be required if an instructor or department has an academic interest in pedagogy, and uses the classroom is to test innovations with the goal of contributing to generalizable knowledge about pedagogy.

Oral history and journalism activities may not constitute Human Subjects Research when they are limited to documenting a specific historical event or the experiences of specific individuals without the intent to draw conclusions or generalize findings.

Examples may include open-ended oral history interviews, biographies, autobiographies, or journalistic activities focused on documenting particular individuals or events.

Note: IRB review is required when these activities are intended to produce generalizable conclusions (e.g., when the information collected will be used to test economic, sociological, anthropological, or other models or theories).

A case report or retrospective analysis of one, two, or three medical or educational cases may not constitute Human Subjects Research when the activity is limited to describing or analyzing the cases and nothing was done to the individuals with prior research intent.

If more than three cases are involved in the analytical activity, the project may constitute research and require IRB review.

NOTE: If a case report includes an individual’s Protected Health Information (PHI), the use of that information must be authorized by the individual per HIPAA regulations. Contact Research Integrity & Compliance if PHI will be included in a case report to ensure the applicable requirements are addressed.

A pilot program is a small-scale test of the methods and procedures that may later be used on a larger scale. Pilot activities designed to assess the feasibility or acceptability of an approach, rather than to test a hypothesis about the effects of an intervention, may not constitute Human Subjects Research.

For example, a pilot activity may involve testing the feasibility or usability of survey questions before they are used in a larger research study.

Research involving only deceased individuals generally does not meet the federal definition of Human Subjects Research because the definition of a human subject applies to a living individual.

Examples may include analysis of cadaveric tissue or review of death certificates.

 

 

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How to Request a Not Human Subjects Research (NHSR) Determination

If you need an official determination (e.g., dissertation committees, publishers, professional presentations, or other documentation purposes) that your project does not meet the federal definition of Human Subjects Research, submit a Not Human Subjects Research (NHSR) Determination Request through Cayuse Human Ethics. Research Integrity & Compliance (RIC) will review your submission and issue a determination letter documenting whether the project requires IRB review.

All SMU employees (faculty and staff) have access to Cayuse using their SMU SSO credentials. Active SMU students who need access to Cayuse must submit a Cayuse Account Request Form using their SMU SSO credentials before beginning an NHSR request.

To submit an NHSR request:

  1. Log into Cayuse using your SMU SSO credentials.
  2. From the Products dropdown in the upper-right corner, select Human Ethics.
  3. Click + New Study (blue button) to create a new project.
  4. Click the + New Submission (blue button) and select Initial.
  5. Click the grey Edit button with the pencil icon to begin the application.
  6. Complete the prompted questions. Be sure to select Not Human Subject Research (NHSR) Determination Request as the type of project.
  7. When the application is complete, click Complete Submission, and then Certify your submission.

Once the request has been certified by the PI and Faculty Advisor, if applicable, it will be routed to Research Integrity & Compliance (RIC) for review.