What are the different types of IRB review? 

• Many protocols require review by the fully convened IRB; however,

• Some minimal risk research may receive "Expedited Review" if it falls into one of seven categories defined by the regulations; and,

• Other minimal risk research may be granted an exemption from continuing IRB review if it meets specific criteria defined by the regulations. Note: Exemption determination is discretionary on the part of the IRB.

 Who determines if research is exempt from continuing IRB review?

Only the IRB may make the determination that research is exempt from continuing IRB review.

When should a protocol be submitted for review?

• Protocols may be submitted at any time but those requiring full IRB review must be received in the Office of Sponsored Programs 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 will be reviewed at the regularly scheduled meeting so long as the IRB achieves a quorum. Investigators will receive a letter outlining the IRB's decision usually about one week from the meeting date.

• Protocols requiring expedited review will be reviewed and investigators will receive a letter outlining the IRB's decision usually within 2-3 weeks of the date the protocol was received.

• Decisions regarding exemptions will be made and communicated to the investigator usually within 1-2 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 extended an additional 1- 2 weeks upon re-submission.

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

A protocol will not be approved unless in contains adequate information for the IRB to determine the following:

• 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.

I don’t do medical or health-related research – so what kinds of risks can there be? 

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:  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.

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.

When can the study be started?

No subjects can be enrolled until the investigator receives confirmation from the IRB that the study has been approved. 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?

 The IRB may approve a study for a period of up to 12 months.  A Continuing Review Progress Report must be submitted to the IRB in time for the Board to review and approve the protocol before the end of the current approval period.  If approval is not received, for whatever reason, the study will be administratively suspended – participant recruiting will not be permitted and any data generated during the period of the suspension may not be used for research purposes. 

Does qualitative research need to be reviewed?

Studies that involve the interviewee’s subjective perceptions are considered human subjects research and are subject to IRB review.  It is not the intent of the IRB to interfere inappropriately with the researcher’s or interviewee’s freedom of expression, all oral history projects should be submitted to the IRB to determine the appropriate level of review.  Special considerations in 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?

 I’m doing 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 Human Participants office 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.

I teach a class that includes having students conduct 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 projects.