Main IRB Focuses

• HARM: Is the risk of harm to research participants minimal? If there is some risk, is the harm itself not greater than that which would be encountered in everyday life? How is the risk of harm minimized? Do the benefits of the research outweigh potential harms?
  
  
• CONSENT: Is there a consent process that includes sufficient information about the research, assures that potential participants comprehend the information, and guarantees that participants participate voluntarily and are not coerced?
  
  
• VULNERABLE PARTICIPANTS: Members of some groups may not be completely free to refuse to participate in research or may struggle with comprehending information (children, developmentally delayed adults, prisoners, very poor people, members of politically oppressed groups, undocumented immigrants). Has the researcher gone to the necessary lengths to make sure that vulnerable participants are treated with extra care and sensitivity? Read more about research with children.
  
  
• CONFIDENTIALITY/PRIVACY/ANONYMITY: Can the researcher guarantee that the identity of the participants will not be revealed to anyone other than the people carrying out the research? Can the researcher guarantee that the information provided by the participants will be maintained in privacy so that no one who should not see it will see it?
  
  
• DECEPTION: Does the researcher need to mislead the participants in any way about the goals of the study, the process of participation, or both? If so, what steps can be taken to minimize the risk of deception-related harm to participants?

Other topics of importance to the IRB, covered in their own pages on this website, are the use of incentives in research, research involving the internet and social media, and international research. 

What is Research?

Research is defined by the federal government as "a systematic investigation...designed to develop or contribute to generalizable knowledge."

There are three general categories of research that require interaction with the IRB:

• Exempt research, which requires minimal interaction with the IRB and only to determine whether the research meets the criteria for exemption; see the homepage for exemption forms
  
  
• Expedited research, which requires a regular review but which can be carried out by a single member of the IRB (usually the chair) on a rolling basis; and
  
  
• Full Board review research, in which some aspect of the research (such as the likelihood that it will cause more than minimal harm) requires all members of the IRB to meet and determine whether the research can be approved, needs to be modified first or must be rejected on legal and/or ethical grounds.

Project Approval Considerations

What kinds of projects get approved most quickly and easily?

• Those that do not put participants at more than minimal risk of physical, legal, financial, employment, reputational, emotional/psychological, or any other kind of harm; projects with low-risk levels of harm can be approved but the less potential for harm, the easier the approval
  
  
• Those that only involve adults (people 18 or over)
  
  
• Those that only involve people who are completely free and able to refuse participation in your research (so not people under 18, prisoners, undocumented immigrants, people with developmental disabilities, economically disadvantaged people, or members of politically disadvantaged groups)
  
  
• Those with well-designed processes to gain the consent of participants
  
  
• Those that only use the following research methods: educational tests, questionnaires/surveys, interviews, focus groups, non-participant observation, or collection of data from voice, video, digital, or image recordings
  
  
• Those in which the research focuses on individual or group characteristics or behavior (e.g. perception, cognition, motivation, identity, language, communication, cultural beliefs/practices, or social behavior)
  
  
• Those that take place in educational settings and that focus on normal educational practices
  
  
• Those that involve the study of already collected data, documents, or records that are publicly available
  
  
• Those in which individual participants cannot be identified by name or, if they can, being identified does not put them at risk of harm
  
  
• Those that, if an organization is the topic of study, have already been approved by the organization in question

Note that even if your project does not require IRB review, you still must assure that your project addresses ethical and legal concerns about harm, informed consent, and the other categories of IRB concern. If your project does not require IRB review but you want to make sure that your project is legally and ethically appropriate, please contact the IRB chair.