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Human Subjects Research

GSB faculty and students conduct various research studies. Examples include studying the effects of political leadership, power of negotiation, labor market effect of company policies, and role design in creative work.

The common data collection methods implemented by the GSB faculty and students include:

  • Interventions (e.g., randomized control trial on marketing strategies, behavioral experiments on social network )
    • Observations (e.g., role play on negotiations)
    • Surveys/interviews (e.g., Qualtrics survey/interviews about addiction)
  • Secondary data (e.g., 10Ks for topic modeling, customer transactions for spending habits)

If your data collection involves human subjects, the following two questions should be considered: What is human subjects research? What are the next steps that need to be taken if your study meets the definition of human subjects research?

Definition

The definition of Human subject research is systematic, scientific investigation that involves human beings as research subjects for whom data or specimens are collected/used/analyzed through observations/interventions.

The most frequent questions that researchers ask regarding human subjects research is WHEN they need IRB approval. To answer this question correctly, you should determine the following two conditions for your proposed study:

  1. if your study is considered research
  2. If so, if your study involves human subjects

According to federal regulation, research is defined as:

A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge _

Then what is NOT research?

Operational activities, internal program evaluation, quality assurance work, or marketing studies are generally not considered research and thus do not require an IRB review.

Human Subjects are:

A living individual about whom an investigator (whether professional or student) conducting research

(i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or

(ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

The two words that are important in making a determination regarding human subjects are private and identifiable. The flip side of these keywords are public and de-identified.

  • Public data: Generally, public data does not require an IRB review because they are either not identifiable or made public for social good. If data are not individually identifiable, analysis would not involve human subjects.
  • De-identified data: If the original data has been stripped of all identifiers and cannot be traced back to the individuals from whom data was obtained, it is no longer identifiable and thus not considered human subjects research. However, this doesn’t apply when the researchers can link the data to individuals through keys or when the identity of individuals can be known through some other data provided in the dataset.

Although the human subject definition excludes the deceased, there are some exceptions where a study involving the deceased may require an IRB review (e.g., health information).

For more information on federal regulations and examples of human subject research, please visit the Office for Human Research Protections site. It is important to make a determination if your study meets the human subjects research definition because research studies involving human beings require a review by the Institutional Review Board (IRB).

IRB Review/Approval

If your study meets the definition of human subjects research as described above, you need to obtain IRB review and/or approval before you launch your study.

Things to Consider

  • Unit of analysis: If primary data is collected from humans but the data is about non-humans (such as companies or programs) or if humans provide labor to complete tasks, not their opinions, the study is not considered human subject research.
  • Review levels: There are three levels of IRB review: Exempt, Expedited, and Full. The common misconception is that you don’t need to submit an IRB protocol if your study falls into the Exempt category. Your protocol must be submitted even if your study qualifies for exempt review.
  • Timeline: The Stanford IRB panel meets monthly so it is recommended to budget time accordingly for IRB review and/or approval prior to the start of your study. After submitting the protocol, you will be often asked to provide additional information and/or clarifications. This can take months prior to final IRB approval.
  • Collaboration: GSB faculty members and students should always submit their IRB protocol for their human subject research studies unless the approval is obtained by a collaborator at another institution. In general, only one IRB review is necessary for each study.
  • CITI training: Faculty, students, and research staff that are listed on the IRB protocol must complete human subject research training. At Stanford, this can be done by completing the CITI training.
  • GDPR: The European General Data Protection Regulation (GDPR) is a new data protection law that took effect on May 25, 2018. This law concerns the processing of “personal data” of individuals in the European Economic Area. The breadth of what defines personal data is broader under GDPR than that of traditional IRB regulations in the US. For a compilation of GDPR guidance, please check here.

It is important to understand that the general guidelines may not always apply to specific situations. Activities that are generally not considered research can constitute as research if even a small part of the study meets the human subjects research definition. For more information about IRB requirements/policies or to determine if your study needs IRB review, please contact Adam Bailey (afbailey@stanford.edu) at Stanford IRB.