The Case Western Reserve University Institutional Review Board (IRB) has released a new exempt protocol template for initial submissions to the IRB on SpartaIRB.
This template can be used when:
- a faculty member believes their research may meet one or more of the exemption criteria;
- the research involves less than minimal risk; and
- the research does not utilize protected health information, as defined at case.edu/research/sites/case.edu.research/files/2018-04/PHI-under-HIPAA.pdf.
The following categories of research are defined as exempt by regulation:
- Research conducted in established or commonly accepted educational settings, involving normal educational practices.
- Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior.
- Research involving subjects who are elected or appointed public officials, or candidates for public office.
- Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if the information is recorded in such a manner that the participants cannot be identified, directly or through identifiers linked to the participants.
- Research and demonstration projects which are conducted by or subject to the approval of Federal Department or Agency heads.
- Taste and food quality evaluation and consumer acceptance studies.
See further information on this regulation at hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html#46.101(b).
The new exempt protocol template can be downloaded at spartairb.case.edu or case.edu/research/faculty-staff/education-and-training/spartairb-info/spartairb-protocol-templates. Note that this template is not being accepted for University Hospitals IRB submissions.
With questions, contact Kim Volarcik at 216.368.0134 or email@example.com.