Frequently Asked Questions

Only the IRB may make the determination that research fits into an exempt category per federal regulations. Additionally, UNI IRB policies require that all human subjects research must be reviewed, even if the research is in an exempt category.

When should a protocol be submitted for review?

• Protocols may be submitted at any time, but those requiring full board review must be received at least 14 days before the scheduled meeting.
• Protocols that fall under exempt or expedited review may be submitted at any time.

How long does the review process take?

• Protocols requiring full IRB review are considered at the regularly scheduled meeting, so long as the IRB has a quorum. Investigators will receive a notification in Cayuse stating the IRB's decision, approximately one week after the meeting date.
• Protocols requiring expedited usually are completed within 2-3 weeks of the date the protocol was received. Longer review times may occur during high traffic periods, such as near Thanksgiving and Spring Break.  
• Approvals under an exempt category will be made and communicated to the investigator usually within 2-3 weeks from the date the protocol was received by the IRB.
• Please Note: Very few protocols are approved outright at first review. If the IRB seeks clarification or requires revisions to the protocol, consent form or both, the review process will be lengthened to an extent determined by the PI's responsiveness.

What is the IRB looking for when it reviews a protocol?

• That the participation of all subjects is voluntary.
• That the rights and welfare of all subjects will be adequately protected.
• That the consent process will be conducted in accordance with federal regulations.
• That the potential harms (risks) to the subjects are outweighed by the potential benefits to science and society. Note that this determination can only be made if the protocol contains a clear and comprehensive description of the study procedures.
• Please Note: The IRB can only review the information that is actually submitted in the protocol. Therefore an incomplete or inadequately prepared protocol will be returned to the investigator for revision/clarification.

• See also Application and Screening Process.

What kinds of risks should be considered?

When answering questions about risk on the application, please consider all of the following types of risk or discomfort:

• Physical Risks:  These risks include physical discomfort, pain, injury, illness or disease brought about by the methods and procedures of the research. These risks are not commonly encountered in social and behavioral science research.
• Psychological Risks:  Psychological risks may be experienced during participation in the research and/or afterwards as a result of participating in the research. These risks include anxiety, stress, fear, confusion, embarrassment, depression, guilt, shock, loss of self-esteem, and/or altered behavior.
• Social/Economic Risks:  Social and economic risks include alterations in relationships with others that are to the disadvantage of the subject, and may involve embarrassment, loss of respect of others, labeling with negative consequences, or diminishing the subject’s opportunities and status in relation to others. These risks include payment by subjects for procedures, loss of wages or income, and/or damage to employability or insurability.
• Legal Risks:  Legal risks include risk of criminal prosecution or civil lawsuit when research methods reveal that the subject has or will engage in conduct for which the subject or others may be criminally liable.
• Loss of Confidentiality:  Confidentiality is presumed and must be maintained unless the investigator obtains the express permission of the subject to do otherwise. Risks from breach of confidentiality include invasion of privacy, as well as the social, economic and legal risks outlined above. Loss of confidentiality is the most common type of risk encountered in social and behavioral science research.

• See also Risks and Benefits.

What is the difference between "confidential" and "anonymous" data?

• Anonymous data are recorded so that the information can never be linked to the subject who supplied it.
• Confidential data are recorded so that the information is not immediately identified with the subject who supplied it, but such a link is possible. Confidential data are usually "coded" - that is, the subject is assigned a unique identifier that will be used to identify the data. This code is usually numerical or alphanumerical. The code identifies the data and the subject's identify is kept separate from the code and data. Coded data are not anonymous.

• See also Privacy and Confidentiality.

When can the study be started?

• No subjects may be recruited or enrolled until the investigator receives IRB approval.
• Investigators are strongly advised against scheduling subjects for enrollment before formal approval has been granted.
• Anyone who schedules subjects for enrollment without confirmation of IRB approval runs the risk that the study will not be approved by the enrollment date.

How frequently must the protocol be reviewed and re-approved by the IRB?

For full board studies only, the IRB may approve a study for a period of up to 12 months. No recruitment or data collection may take place after the study is expired, until new or renewal approval is granted. Automatic reminders are generated in Cayuse when it is time to submit a Renewal Submission. Any data generated during the period of the suspension/expiration may not be used for research purposes. 

See also Continuing Review and Project Closure.

Does qualitative research need to be reviewed?

Studies that involve the interviewee’s subjective perceptions are considered human subjects research and require IRB review.

Oral history projects may be an exception; an Oral History Screening Form, found on the Forms and Samples page, should be submitted to the IRB to determine the appropriate level of review. Special considerations for these types of projects are:  1) Are the conditions of use or publication of the recording clearly conveyed in advance by the researcher? 2) Is the interviewee given an opportunity to provide effective consent to the interview? and 3) Are there adequate protections of the privacy of any third parties who may be named in the interview?

See also Which Projects Require IRB Review.

I’m conducting a survey of employees/students in my UNI department or unit, does that require review?

If the information will NOT be presented publicly in a report or published, then it may not require review. If it will be presented publicly or published, then it must undergo review and approval prior to the data being collected. Even if the project does not require review, you may wish to consult the IRB Administrator for suggestions about how to make sure the information is gathered in a way that ensures confidentiality of responses and respects the rights of the participants.

See also Which Projects Require IRB Review.

I teach a class that involves students conducting a small research project—do these projects require review and approval by the IRB?

At many universities, all research requires review and approval. At UNI, the current policy is to allow classroom projects to proceed without formal review (with the instructor ensuring that appropriate consent and participant protections are in place) if the following conditions are met:

• The findings will not be shared or presented outside the classroom
• The research activities are minimal risk (like those encountered in day-to-day life)
• The population of interest does not include minors (under 18) or vulnerable populations (individuals who are cognitively impaired, pregnant, or prisoners)

Please note that if the findings are to be presented publicly or will become part of a larger project (e.g., a student thesis), then the project must be reviewed and approved prior to beginning the project.

See also Class Projects.