Human Research Protection Program Office of Research

Getting Started

The steps below provide a guided procedure from beginning to end of the IRB process. Reference these steps to navigate the most common steps of an IRB protocol application.

Before Submission

Does the IRB need to review my study?

Purdue adheres to federal definitions of research and human subjects. If your activity will utilize data collected from human participants for research purposes, your project must be reviewed by the Purdue IRB.

Some examples:

  • Graduate work such as a thesis or dissertation involving the use of human study participants
  • Exploratory or feasibility studies involving human feedback or opinion data
  • Use of a non-public dataset with identifiable data.
  • Data collected for research projects intended for publication or presentation

If your study does not seem to be like those listed above, it may not meet the definition of "human subjects research". If it is not "human subjects research", it does not need to be reviewed by IRB.

To determine if your research requires review, please use Cayuse IRB.

Does your "human subjects research" fit the criteria for exemption from IRB review?

Currently, federal regulations recognize eight categories of research that are exempt from IRB review. Below, you will find the most commonly used exemption categories. For full descriptions, please see our Standard Operating Procedures (SOPs). If your project appears to fit into any of the exempt categories, please describe it using our online system, Cayuse IRB.

Category 1

Research conducted in established or commonly accepted educational settings that specifically involves normal educational practices that are not likely to adversely impact students' opportunity to learn required educational content or the assessment of educators who provide instruction, including:

  • Research on regular and special education instructional strategies.
  • Research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
Category 2

Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior (including visual or auditory recording), if at least one of the following criteria is met:

  • The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects; or
  • Any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation; or
  • The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination that there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data. (This limited IRB review option may not be used for research involving children)
  • The information obtained is the result of straight-forward survey, testing, or interview procedures which do not employ an intervention, application of independent variables, or experimental or quasi-experimental design.
Category 3

Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection and at least one of the following criteria is met:

The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects; or

  • Any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation; or
  • The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination that there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
  • If the research involves deceiving the subjects regarding the nature or purposes of the research, this exemption is not applicable unless the subject authorizes the deception through a prospective agreement to participate in research in circumstances in which the subject is informed that he or she will be unaware of or misled regarding the nature or purposes of the research.
Category 4

Secondary research for which consent is not required: Secondary research uses of identifiable private information or identifiable biospecimens, if at least one of the following criteria is met:

  • The identifiable private information or identifiable biospecimens are publicly available; or
  • Information, which may include information about biospecimens, is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained directly or through identifiers linked to the subjects, the investigator does not contact the subjects, and the investigator will not re-identify subjects; or
  • The research involves only information collection and analysis involving the investigator's use of identifiable health information when that use is regulated HIPAA, for the purposes of health care operations, research, or public health activities and purposes as defined at 45 CFR 164; or
  • The research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information obtained for non-research activities, if the research generates identifiable private information that is or will be maintained on information technology that is subject to and in compliance with federal regulations.
Category 6

Taste and food quality evaluation and consumer acceptance studies:

  • If wholesome foods without additives are consumed, or
  • If a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration (FDA) or approved by the Environmental Protection Agency (EPA) or the Food Safety and Inspection Service (FSIS) of the U.S. Department of Agriculture.

If your study does not fit the criteria for exemption, complete a non-exempt application form and associated consent/assent documents

The IRB reviews all non-exempt research to ensure that risks to participants are minimized and balanced with the benefits to society. The extent of IRB review is based on the level of risk and defined terms within federal regulations. There are two types of IRB review:

Expedited Review - Federal regulations allow certain research activities to be reviewed by a subset of the IRB (Chair and his/her designees). This review type occurs on a rolling basis and may be submitted for initial review at any time.

Full Review - In the case where risk to a study participant may be greater than the risks encountered in everyday life, the study must be reviewed by the IRB at a convened meeting. The meeting must include a majority of board members. To facilitate the review process, protocol applications for full board review must be submitted two weeks prior to the convened meeting in order to be added to the board's agenda.

Train all personnel who interact with or analyze data from human subjects

All personnel interacting with human participants or their identifiable data must complete training prior to receiving IRB approval. Purdue University utilizes the CITI program (www.citiprogram.org). Training is valid for four years. For training requirements, see the training section.

Protocol Submission

Submit your protocol application for review

Use Cayuse IRB for all submissions. Login to Cayuse with your BoilerKey (preferred browser is Google Chrome).

Respond promptly to any requests for more information or revisions. Revisions will come to the principal investigator on the study and any identified proxies.

Submission instructions (requires Purdue career account)

After Approval

After approval, protocols sometimes change, need to be renewed, and ultimately need to be closed

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