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    IRB Guidelines for Sociology

    The Institutional Review Board (IRB) Process at UNC:  A Guide for Applicants from the Department of Sociology

    Prepared by Guang Guo (Sociology’s pre-IRB review chair)

    *Based on a similar document prepared by Irene Handlon for Carolina Population Center researchers

    A New Process for Submitting IRB Applications

    In 2011, UNC’s Office of Human Research Ethics began the transition from a paper IRB application to an online application. The Behavioral IRB, to which all sociology applications are submitted, has made this transition.  All applications (including renewals) must now be submitted online.

    The new interface offers many improvements, but as with any IRB application, the procedures are difficult to design for a perfect fit to all research projects.  Please do your best to prepare a succinct yet thorough application, and feel free to ask me (guang_guo@unc.edu) questions along the way.  When you submit your initial submission it comes to me before anyone at the IRB office looks at it.  It is also sent to Kenneth Andrews so that he can fill in for me when I am unavailable or have a conflict of interest.

    Our review allows one of us to give advice based on the many applications we have seen and/or catch anything that might be missing.  If we have suggestions, you will get those to address before the application goes to the IRB office.  Once I (or Professor Andrews) approve the revisions, the application is then forwarded to the IRB office, and you will be in communication with them.  We are not copied on any further review-related correspondence.

    Getting Started

    To submit an initial IRB application, a renewal, or a modification, login to the IRB Information System (IRBIS) at https://apps.research.unc.edu/irb/index.cfm using your ONYEN and password.

    After you login, you will see options on the left-hand side of the screen to open

    • a new study
    • a renewal, or
    • a modification

    From the landing page you can also access a list of each study that names you as a member of the project personnel. To access this list, click on “My Studies,” also found on the left-hand side of the screen. By clicking on the IRB number of a study you will open the application and can access all submitted attachments and review the submission history.

    Notes about IRBIS

    • New Questions: The online application is similar to the original paper application in terms of the questions asked. However, the online system does introduce new questions. Before you initiate an application, or convert a paper application to the online system, you may want to spend some time reviewing the online application first to make sure that you have assembled all the information you will need.
    • Application Tailored to Study Type: The online system operates like a decision tree—as you work your way through the application the system should only ask questions that are relevant for the type of research you are conducting. For example, if your responses indicate that you are only administering surveys and not collecting biological samples, your application will not include questions about biological samples.  If you seem to be getting questions not well suited to your application, or if you seem to be missing requests for the appropriate supporting documents (questionnaires or interview guides, consent forms, etc…), go back and review that you have answered the preliminary questions correctly.
    • Screening Questions: The online application begins with screening questions to help the system identify what level of review your application requires—exempt (research with very minimal risk to human subjects as determined by regulatory guidelines, e.g., secondary data analysis when the data come with NO identifying information), expedited (research involving no more than minimal risk to subjects, e.g., survey research not collecting sensitive data or exclusively secondary analysis of data that contain identifying information), or full board review (Any study involving greater than minimal risk, including studies with vulnerable populations and sensitive questions as well as studies with the possibility of physical risk). Based on your responses to the initial screening questions, the system will determine how much of the application you need to complete. Regardless of whether you think your study is exempt, you still need to complete the online application.
    • Student Applications: When the IRB application was a paper process, many student projects did not require the submission of an IRB application; instead, students submitted a brief overview of their project on a form designated for the purpose. With the introduction of the online process, students and trainees complete the standard IRB application. However, their responses to the initial screening questions will usually result in their completing an abbreviated version. The system identifies student and trainee applications based on the response to one of the first questions in the application: “Will this project be led by a STUDENT (undergraduate, graduate) or TRAINEE (resident, fellow, postdoc), working in fulfillment of requirements defined by coursework at the University?”
    • Cover Memo Option: The final step of the application process includes an option to write a cover memo to the IRB. Take advantage of this opportunity to summarize the contents of the submission and to clarify any points that you feel may not have come through clearly in response to the standard questions.  When the application is converted to a PDF for viewing online or for printing, the cover memo will appear at the beginning of the application.
    • PDF Generation: At any point you can click on the PDF icon appearing at the top right-hand corner of an open application to generate a PDF of the full application. This is useful if you want to file a copy of the IRB application in your personal records or send electronic copies of the application to the PI or study team for review.

    Sections of the Application Requiring Specific Responses to Facilitate Processing

    • “Project Personnel” Section: The online application has a Project Personnel section where all personnel having access to personally identifying information should be listed.  NOTE:  If you are affiliated with a research center on campus, please make sure you do not enter that as your affiliation here.  Only put “Sociology” under the “Department Name.”
    • Administering Department: If the study is to be administered by a research center or institute, such as CPC, that should be listed in this section.
    • IT Contact: Depending on your response to questions about personal identifiers and sensitive data, you may be prompted to enter the name of an IT contact.  For the Department of Sociology, our contact is John d’Adesky , dadesky@unc.edu, 919-283-9442.

    Timing and the Review Process

    • PI & Department Review: If the person filing the application is not the PI (such as a project manager), after the application is submitted, the PI will receive an email to review and certify the application. After the PI certifies, the application moves to the next stage, which for an initial application will involve review and sign off by the PI’s home department as well as, for studies administered by a UNC research center or institute, review by those designated reviewers.
    • Review Stages: After the home department and administering department reviewers (as applicable) have certified the application, the application is sent to the IRB for processing. If the reviewers have concerns about the application, the PI will be notified and asked to address any of the problem areas and resubmit.  NOTE:  Please write brief descriptions of how each comment was addressed in the memo created under “Routing Comments.”  This will help speed up the second review.
    • Internal Review: Investigators should allow at least two weeks for the internal Sociology review. This includes the review and resolution of any problem areas flagged by the reviewers.  Once internal review is complete and the application approved, the application is received at the IRB office and further correspondence is not received by the Sociology pre-IRB chair/reviewers.  The IRB office will be in direct contact with your for the rest of the review process.
    • Expedited Review: The majority of IRB applications qualify for expedited review by the IRB. The IRB review process can be very quick for expedited applications, which are reviewed on a continual basis by the IRB Chair. Although sometimes the review process can take as little as week or less, to be safe, plan on the IRB review process taking two weeks. At the end of the review process the IRB almost always sends a letter (via email) outlining stipulations that must be addressed before approval can be granted.  Do not be discouraged if approval is not automatic for primary data collection projects that involve human subjects, it rarely is.  Once the issues are sufficiently addressed, an approval letter will arrive via email.
    • Full Board Review: For applications requiring full board review, the review occurs during one of the monthly IRB meetings. The IRB meeting schedule—which includes submission deadlines as well as the meeting dates—can be found at:  http://research.unc.edu/offices/human-research-ethics/researchers/dates-deadlines/index.htm.

    Common Issues to Address

    • Use the “Brief Summary” section for exactly what it states, a brief, non-technical description of the study in the three subheadings of purpose, participants, and procedures (methods).  This will be useful for orienting the IRB reviewer/s to the main points and methods of your application.  Note that “participants” refers to study participants/sample.  If you are submitting a multi-method project, make it clear what the different data collection methods are and it is advisable to then use these distinctions as sub-headings in other sections of the application.
    • If you are conducting semi-structured interviews, you will be asked the level of risk for emotional distress, embarrassment, and breach of confidentiality.  Most studies have some (if only rare) risk of these, so be forthcoming and provide information as to how you will deal with this.  Usually it involves making sure participants understand the interview is voluntary, they can stop at anytime or skip any questions, and that you will be observant of body language and halt the interview if you perceive any problems.  Sometimes it requires having referral information available if you sense that they might like to speak to a professional about anything that comes up during conversation.  For deductive disclosure, you will work to keep all data confidential and avoid anyone being able to recognize participants if their responses are quoted in any presentation or publication of the results of the research.
    • Think carefully about any identifying information you might be collecting, even if it is only in the process of recruiting participants.  In this case, you can keep a separate file with this information completely separate from the data, and you can promise to destroy this information as soon as recruitment and data collection is finished.
    • Do not forget to include any data collection instruments (e.g., survey questionnaires, interview guides/schedules).  If the IRB application needs to be submitted before these instruments are finalized, you can submit a draft and promise to submit the final version as a modification to the application before any data collection begins.
    • Remember to include all necessary consent/assent forms.  The system has templates to help you build these forms.

    Example Applications

    • Exempt from IRB approval
    • For Educational Purposes, Classroom Project (and multi-method project)
    • Expedited Review
    • Undergraduate Honors Thesis Example
    • Master’s Paper Example
    • Dissertation Example

    Other Resources

    Sociology Pre-IRB Review Committee

    • Guang Guo, Associate Professor, 166 Hamilton Hall, 962-1246, guang_guo@unc.edu
    • Kenneth Andrews, Alternate Reviewer, 209 Hamilton Hall, 843-5104, kta1@email.unc.edu

    IRB Office: 966-3113 or  irb_questions@unc.edu

    Links:

    IRB Guidelines: http://research.unc.edu/offices/human-research-ethics/regulatory-documents/sop/index.htm

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