Do I need to get consent for my exempt study?


Although not required by federal regulations, UW institutional policy requires a consent process for exemptions when there is some kind of interaction with subjects, such as in most research exempt under Category 1 (educational practices) and Category 2 (interviews, surveys, focus groups, observations of public behavior).  The consent process usually includes an information sheet or an oral consent script.  A consent template designed for use with exempt research studies is available here.

What issues need to be considered when planning a consent process for exempt research?
Category 1 exemptions:
  • For studies in which participants will complete study activities solely for research purposes, such as an evaluation of clinical skills for residents, study teams must obtain consent from participants prior to conducting the study activities.
  • For studies in which participants will complete activities as part of an educational experience and not solely for research purposes, the study team must obtain consent prior to obtaining data for research, such as grades or other results on the participants.
  • Members of the study team who may have a status relationship with the prospective participants of a category 1 study should not conduct the consent process.  See additional guidance about the enrollment of participants with a status relationship.  This guidance should be observed if applicable to the category 1 exemption.
  • If student records will be used in the category 1 exemption study, the Family Education Rights and Privacy Act (FERPA) may apply.  If this is the case, there are additional consent requirements and exceptions that must be adhered to in the consent process, including the possibility that signatures may be required.  Guidance about FERPA is located here.
Category 2 exemptions:
  • Survey studies may supply abbreviated consent information to participants in a variety of ways, such as in an email, an information sheet, or in an introductory section at the beginning of the survey.
  • Interview studies benefit from a more detailed information sheet.  If the interview is to be audio- or video-recorded, this must be included in the consent information.  An oral consent script may be used instead of or in addition to the information sheet.
  • Focus group studies may use an oral consent script and/or a consent information sheet.  If the focus group is to be audio- or video-recorded, this must be included in the consent information.  Also, researchers should remind focus group participants that what is discussed in the focus group should be kept confidential.
  • If your study collects identifiable health information and members of the study team are within the Health Care Component of the University of Wisconsin or are UW Health employees, HIPAA Privacy Rule requirements need to be met.  See the UW HIPAA website for information about HIPAA and research.
  • Observations of public behavior generally do not require a consent process, as long as the behavior is truly public.  Observations of clinical practices and workflow are not considered public behavior and cannot be considered to be exempt under category 2.

Keywords:exempt, exemption, category 1, category 2, interviews, surveys, focus groups, observation, education, educational practices, consent, information sheet, script, oral   Doc ID:55039
Owner:Monica E.Group:Health Sciences IRBs
Created:2015-08-13 11:17 CDTUpdated:2015-10-13 15:14 CDT
Sites:Health Sciences IRBs
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