IRB Submission Tips

Note: Below are tips to help make the IRB process go as smoothly as possible.  For a detailed explanation of the IRB review process, please see the SBS IRB website at https://sbsirb.uchicago.edu/page/irb-submission-and-review-process

• Determine whether your study needs IRB review -- The IRB has jurisdiction to review “research” with “human subjects” – those terms are defined in the federal regulations that govern human subjects research.   For a detailed explanation of this topic, see the guidance on the SBS IRB website titled “Does my Research need IRB Review?”  In light of the IRB’s mission to protect human subjects, and the potential regulatory consequences of not obtaining IRB review and approval for human subjects research, err on the side of caution and contact the IRB when you are uncertain whether your study is human subjects research or not.

Determine who will serve as the Principal Investigator -- If you are a student who plans to conduct research, determine who will serve as the Principal Investigator (PI) for your research project.  The University's policy on PI eligibility is at http://researchadmin.uchicago.edu/policies_compliance/policies/eligibility_principal_investigator.shtml

• Plan ahead – For most studies, the IRB review process takes 2 to 3 weeks from the time you submit your study to the IRB.  At times of the year when our submission load is running very high, the review process could take longer than 2 to 3 weeks.  If your study requires full board review, you should plan on possibly 2 months if the IRB has questions and concerns about your study that need to be addressed.  If the IRB feels that a study is more than minimal risk, the full IRB will need to discuss and vote on the study.

Human Subjects Protection Training – If your project is human subjects research and therefore will undergo IRB review and you have not taken human subjects protection training, you will need to complete human subjects training (as will anyone on the research team who will be obtaining informed consent, interacting with research participants, and/or analyzing data that contain identifiers).  For more information on the human subjects training requirement, see the SBS IRB website at https://sbsirb.uchicago.edu/page/human-subjects-protection-training-requirement.

• Plan appropriate data security measures – Consider the sensitivity of the data you will be collecting and the potential risks to research participants if there were a data breach.   Information about data security measures is available on the IT Services website at https://itservices.uchicago.edu/page/stay-safe

UChicago Box is a good option in many cases for managing and sharing research data in a secure manner.  For more information about UChicago Box, see https://itservices.uchicago.edu/services/uchicagobox.  IT Services also recommends activating 2-Factor authentication (https://cnet.uchicago.edu/2FA/index.htm).  2-Factor authentication enhances the security of your CNetID by using your device (mobile phone, landline, tablet, hardware token) to verify your identity -- this prevents anyone but you from using your account to log in to University websites, even if they know your CNetID password.

If you will be collecting sensitive data, it is a good idea to check with IT Services about appropriate data security precautions before you prepare your IRB submission.

Consent and assent forms -- Use the consent and assent templates on the SBS IRB website as your starting point for developing consent and assent forms.   You will save yourself considerable time using the templates rather than using obsolete versions of consent and assent forms or trying to develop such forms from scratch.

Types of Waivers -- A waiver of documentation of consent and a waiver/alteration of consent are not the same – be sure that you are requesting the correct type of waiver in the IRB submission form.   A waiver of documentation of consent is a waiver of the need to obtain the research participant’s signature on the consent form (ie, consent will be verbal or documented in other ways).   A waiver/alteration of consent is a full or partial waiver of the elements of informed consent.   A complete waiver of consent may be appropriate when a study only involves secondary data analysis and it would be impracticable for the researcher to obtain consent from the individuals whose data is being analyzed.   Studies that will use deception or incomplete disclosure must request a waiver/alteration of particular elements of informed consent.

The Protocol -- Your IRB submission documents must explain in detail the “who, what, when, where, how and why” of your study (or with amendments, the changes you are proposing to your study).  Many new submissions are delayed during the IRB review process because the research team did not provide sufficient detail on research procedures, subject population, recruitment methods, compensation plans, consent and assent procedures, etc.   Keep in mind that the IRB reviews hundreds of studies and does not have your expertise about your particular study – we need you to explain your research plans to us in detail.  For further detail, see the guidance on the SBS IRB website titled “Key Elements of a Social Science Research Protocol.”

• Payment for research participation -- Recruitment materials (including flyers, emails, etc.) should not emphasize the payment or amount to be paid by such means as larger or bold type.  It is appropriate to describe the payment for research participation in recruitment materials but the payment/amount to be paid should not be emphasized.

Payment cannot be described in consent and assent forms/procedures as a “benefit” of study participation – instead, payment should be discussed in a separate section on “financial information.”

Remuneration includes cash or cash equivalents (such as checks and gift cards) provided to research subjects as compensation for the time and effort they spend participating in a research study.  The Internal Revenue Service (IRS) treats remuneration as taxable income to the recipient. This means the recipient is supposed to report the payment when he or she files a personal tax return at the end of the year.  If the University pays $600 or more to a research participant during the calendar year, then the University is required to report the payments to the IRS and issue the recipient a Form 1099 (payments to foreign nationals are reported on a Form 1042-S). 

Reimbursement (payments to research subjects to cover out-of-pocket expenses they incur while participating in research, e.g., reimbursement for taxi fare or parking) based on receipts is not considered taxable income.

The University of Chicago’s policy on research subject payments is available at http://finserv.uchicago.edu/payroll/independent/subjects.shtml

Illinois Mandatory Reporting Law – In June 2012, a long-standing Illinois law was amended to expand the definition of “mandated reporters” of child abuse and neglect to include “all personnel of institutions of higher education.”  This law means that all University of Chicago personnel are “mandated reporters” and must report to a 24-hour hotline any instance where there is reasonable cause to believe that a child known to them in their official capacity is being abused or neglected.  University personnel covered by this requirement include, but are not limited to, all staff employees, academic appointees, postdoctoral researchers, student employees, and volunteers.  For more information, please see https://provost.uchicago.edu/handbook/clause/mandatory-reporting-suspected-child-abuse-and-neglect

Amendments – When you have received IRB approval for your study, any subsequent changes you make to research procedures, subject population, compensation, recruitment, consent/assent, etc. must be reviewed and approved by the IRB before you can implement changes to your study.   If your study received an exemption and afterward you want to make changes to your study, you must still submit an amendment to the IRB so the IRB can determine whether your study continues to qualify for an exemption.  If you submit an amendment, it is not enough to fill out the amendment form.  You must consider what parts of your protocol are affected by the changes and revise your protocol accordingly in AURA.  For example, if you revise your procedures, your compensation, and your consent/assent forms, you must revise any sections of the IRB protocol that are affected by those changes and upload revised consent/assent forms.

Continuing Review -- Studies that are exempt do not undergo continuing review.  Studies that are approved via expedited review or by the full IRB must undergo continuing review.  For federally funded studies and studies that are more than minimal risk, the IRB must review the study at least once a year.  For many studies that are minimal risk and not federally funded, the SBS IRB grants 3-year IRB approvals.  It is your responsibility to keep track of the date on which IRB approval will expire.  Submit your continuing review application at least 2 to 3 weeks before the expiration date of IRB approval.  The IRB needs time to review the continuing review application and resolve any questions or concerns before renewing approval for a study.  If IRB approval expires, all research activities involving human subjects MUST STOP, including subject contact, data collection, and data analysis.  The only exception to this requirement is for activities that should be continued for reasons of participant safety.  No new subjects may be enrolled after IRB approval lapses.

Educational Research – There are a variety of especially complex issues related to doing research in schools.   You should check whether the school district(s) in which you wish to do research require review by a school district research review board (Chicago Public Schools does require review by their own Research Review Board as well as by the University IRB).  In addition, there are laws that can impact research carried out in schools and with educational records (e.g., the Family Educational Rights and Privacy Act (FERPA) and the Protection of Pupil Rights Act (PPRA)).  For a discussion of FERPA and PPRA and how those laws can impact the informed consent process, see the guidance on the SBS IRB website at http://sbsirb.uchicago.edu/page/research-schools-and-education-records.