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

Determine if your proposed activity is "human subjects research"

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. Complete this form and upload here.

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

Currently, federal regulations recognize six categories of research that are exempt from IRB review. However, in an ironic twist, the IRB must determine if your research fits one of these categories. Having fun yet? Below, you will find the six categories. If your project appears to fit into any of the exempt categories, you can describe it in the Exemption Determination form and upload to IRB.

Category 1

Research conducted in established or commonly accepted educational settings, involving normal education practices, such as:

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

Research involving only the use of education tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:

  1. information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; AND
  2. any disclosure of the human subjects’ responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation

NOTE: The exemption under Category 2 DOES NOT APPLY to research involving survey or interview procedures or observation of public behavior when individuals under the age of 18 are subjects of the activity except for research involving observations of public behavior when the investigator(s) do not participate in the activities being observed.

Category 3

Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, or observation of public behavior that is not exempt under Category 2, IF:

  1. the human subjects are elevated or appointed public officials or candidates for public office, OR
  2. federal statue(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter
Category 4

Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified directly or through identifiers linked to the subjects.

Category 5

Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine:

  1. public benefit or service programs;
  2. procedures for obtaining benefits or services under those programs;
  3. possible changes in or alternatives to those programs or procedures; OR
  4. possible changes in methods or levels of payment for benefits or services under those programs

Note: To qualify for this category, project must be conducted pursuant to a federal statute.

Category 6

Taste and food quality evaluation and consumer acceptance studies,

  1. if wholesome food without additives are consumed; OR
  2. 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 or approved by the Environmental Protection Agency or the Good Safety and Inspection Service 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. At Purdue, we have two IRBs, biomedical and social sciences.

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 (biomedical and social sciences).

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 five years. For training requirements, see the training section.

Protocol Submission

Submit your protocol application for review

There are two ways to submit protocol application documents for review:

  1. Coeus Lite is still available for use if preferred, but submission through it is not required.
  2. Investigators with Purdue career accounts may utilize the file uploading portal recently created for protocol submission.

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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