Institutional Review Board (IRB) - Frequently Asked Questions

What is an IRB?

  • IRB is short for Institutional Review Board for the Protection of Human Subjects
  • All institutions involved in research with human subjects, that also receive federal funds, are required to have an IRB
  • IRBs are composed of volunteers (at universities they are mostly faculty members) who meet on a regular basis

What does an IRB do?

  • Reviews all proposed research activities at their institution that involve human subjects
  • Reviews such proposals submitted by faculty, staff, and students
  • And proposals from external researchers (e.g., state or federal government agencies, faculty from other universities) who want to do research with members of the institution
  • The Board’s primary mission is to protect the rights of human subjects
  • The Board ensures that researchers comply with federal regulations governing studies involving human subjects
  • The IRB approves only proposals that adhere to federal regulations
  • Proposals that do not comply with the rules and regulations are returned to the author and may be revised and resubmitted to the IRB for further review

Who must submit an IRB proposal?

  • Anyone associated with the university who plans to conduct research involving human subjects (any human subjects, not just those associated with the university) must submit an IRB Proposal
  • All students intending to conduct research with human subjects should submit an IRB Proposal to determine what review is required
  • No data may be collected before the proposal is approved by the IRB

What happens if I perform human subjects research without IRB approval?

  • COLLECTING DATA FROM HUMAN SUBJECTS WITHOUT IRB APPROVAL VIOLATES FEDERAL LAW
  • Breaking federal laws regarding human subject research can have very serious consequences for both the researcher and the university
  • Consequences include jeopardizing all federal funding received by the university (e.g., Federally Insured Student Loans)

What do I need to do to get the IRB to consider my research proposal?

  • Anyone seeking to perform any type of research involving human subjects must file an IRB Proposal Form (available in the FORMS tab)
  • In the vast majority of cases, proposals must be accompanied by a “Consent to Participate” (“Consent” form for short, also available in the FORMS tab) written specifically for that study

What does “Principal Investigator” mean?

  • The Principal Investigator (or PI) is the person responsible for overseeing a research project
  • The PI is also the contact person if IRB members or any human subjects who participate in approved research have any questions about the project

Is a faculty research sponsor required for a student research project?

  • Although a student who proposes a study (including a Graduate Research Project or Thesis) is considered the Principal Investigator for that research project, he or she MUST HAVE a Faculty Research Sponsor
  • The Sponsor co-signs the proposal and ensures that it has been approved by the IRB before any data are collected
  • The Sponsor is also responsible for ensuring that the student conducts the study as described in the IRB-approved proposal

Can a researcher begin collecting data before receiving IRB approval?

  • PIs (and sponsors) will receive an Approval Memo from the IRB when their proposal has been approved
  • ONLY AT THAT POINT may the researchers begin to collect data

How can I find out the status of my submitted IRB application or get more information about the IRB itself?

  • Contact the Office Graduate Studies and Sponsored Programs via email at irb@tamusa.edu.