Understanding Exemption Category 2 in Survey Studies

Office of the Vice President for Research Human Subjects Protection Program IRB Submission Process Module 2 Survey Studies Exempt Category 2 2024

Please review the content of Module 1 Common Steps for All Submissions prior to reviewing this presentation.

Survey Research Research activity that is limited to the use of surveys will most often qualify for exempt status because there is no more than minimal risk involved. The IRB will determine if the research qualifies for exempt status and reserves the right to require a higher level of review. For example, a survey about a sensitive topic that may cause emotional stress or discomfort may require expedited review or be referred to the convened board for review. Because most survey research qualifies for exemption, this presentation is intended to serve as a general guideline to complete the final steps (Steps 7 and 8) for an IRB submission for a Survey Study under Exemption Category 2.

Exemption Category 2 Exemption Category 2 is defined as follows: Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude achievement), survey procedures, interview procedures, or observations of public behavior (including visual or auditory recording) if at least one of the following criteria is met: (i) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects; (ii) Any disclosure of the human subjects responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects financial standing, employability, educational advancement, or reputation; or (iii) the information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to ensure there a adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data. (Note: children may not be included in research deemed exempt per category 2iii.)

Step 7: Complete the Protocol & Other Documents Because every study design is unique it is not possible to provide a list of all documents required. The documents common for a survey study submitted for review under Exempt - Category 2 are: The application checklist previously mentioned in Module 1 A research protocol: this is a document which sets out a plan for a research project. A well written protocol works like a road-map. It helps to focus ideas and provides direction to guide a project through all phases of planning, implementation and evaluation of a research activity. Use of UConn Health IRB Protocol template is strongly encouraged. If another protocol format is used the IRB reserves the right to still require completion of this form. NOTE: Protocol Template is available on the IRB website

Step 7: Complete the Protocol & Other Documents, continuation The Request for Exemption Form A cover letter or introductory paragraph the informs the participants about the research (sample available) The survey or surveys that will be administered If Applicable: Recruitment material that will be used (Sample available) Checklist for Recruitment Material If the survey involves the use/collection of protected health information a HIPPA Authorization If the survey is administered outside of the USA this may not be applicable (e.g. international student research project). If conducted outside the USA, if possible data should be brought back to the USA in a de- identified format and a Certification of De-identification should be provided If conducted outside of the USA and identifiers must be retained a HIPAA Waiver should be requested to bring the identifiable data back Letter of Permission to conduct the survey (Sample available) NOTE: Forms and samples available are found on the IRB website

Translated Documents Regardless of the level of review, if your study will include participants that are non-English speaking all study related documents that will be used for interactions with the subjects must be translated (e.g. surveys, questionnaires, cover letter or Informed Consent, HIPAA Authorizations). Translated documents must be approved by the IRB prior to use. The IRB recommends getting approval of the English version first, and then have the documents translated and submit the translated version for approval. NOTE: Read the 2011-013.0 Translation Policy posted on the IRB website

Step 8: Complete the On-line Application in iRIS iRIS is the electronic system used for IRB submissions. The URL is https://imedris.uchc.edu/. The IRB application form is to be completed and the study documents that have been created will be uploaded and attached to this application form. UConn Health employees and Students can log in with their UConn Health user ID and PW. Individuals external to UConn Health who need access should request an account in iRIS by going to the URL and clicking the Request New Account button.

Step 8: Complete the On-line Application in iRIS Investigators are strongly encouraged to attend an iRIS training sessions before using the iRIS electronic submission system for the first time. To schedule an iRIS training session e-mail irb@uchc.edu. There are iRIS User Manuals available within the iRIS system s Home Page under the Help Button Download The Basics of Project Management Chapter 1 to learn how to build and submit an Initial Submission Form to the IRB.

IRB Process After the IRB Application Form has been submitted in iRIS The following section describes the cycle of review once the application and related documents have been provided to the IRB: Once the Study team complete their sign off steps the Initial Submission in iRIS will be sent to the IRB. An IRB Regulatory Specialist (R.S) will conduct a pre-review of the submission. If the R.S considers the submission to be complete and the content in the documents is appropriate the IRB may grant the exemption and issue an approval letter. On the other hand if the R.S finds discrepancies between the content of the documents and /or there are missing documents, the submission will be returned to the study team in a Submission Correction Form or Response Form with a description of the corrections to be made. The study team must make the corrections and resubmit the material to the IRB. The submission will be approved when the study team satisfies all the contingencies imposed by the IRB. It is recommended to submit a closure form when the study has been completed.

Questions irb@uchc.edu