Institutional Review Board
The purpose of the Tennessee Department of Mental Health and Substance Abuse Services (TDMHSAS) Institutional Review Board (IRB) is to support research activities designed to develop or contribute to general scientific knowledge while minimizing risk and protecting the confidentiality of all subjects. Current IRB policy applies to all research involving TDMHSAS, and includes any request to use patients/service recipients, heir records, or specimens for research purposes.
The TDMHSAS IRB is scheduled to meet the 3rd Friday of each month for proposal review and/or to conduct other business. The chairperson, however, has the authority to convene meetings as needed. Research proposals submitted for review must be received within twenty (20) days of scheduled TDMHSAS-IRB meetings. Proposals received outside the window of scheduled meeting date should allow at least thirty (30) days for review. Researchers/investigators submitting amendments or proposals for continuing review must submit before the oversight approval date expires to avoid suspension of research activities.
IRB OVERSIGHT ISSUES
Research proposals and/or amendments submitted prior to January 21, 2019, will be subject to pre-2018 Common Rule requirements. Research proposals and/or amendments submitted on or subsequent to January 21, 2019, will be subject to 2018 Common Rule requirements. The TDMHSAS IRB reserves the right to require greater oversight than proposed through the 2018 requirements. Thus, the TDMHSAS IRB will not implement broad consent at this time. Moreover, we will not immediately implement the single IRB review option. The TDMHSAS IRB has until January 20, 2020 to make a decision regarding this option.
The following requirements are valid under the 2018 Common Rule and will be adhered to by the TDMHSAS IRB:
- Exemption status will be determined by the IRB, not the researcher/investigator. At minimum, exempted studies may require limited IRB, particularly if they contain sensitive and/or identifiable information or biospecimens. Limited IRB review is required to ensure adequate privacy safeguards and maintenance of confidentiality for participants/service recipients.
o The Subpart B population (i.e., pregnant women, human fetuses, and neonates) is eligible for exempt status under all 2018 Common Rule exemption categories.
o The 2018 Common Rule requirement is a change from the pre-2018 rule for Subpart C subjects/participants (i.e., prisoners). Exemptions can now apply to research involving a broader subject/participant population if the research only incidentally includes prisoner
o Secondary research of information or biospecimens for Subpart C subjects/participants can be exempted under the 2018 Common Rule if that research is not seeking to examine prisoners as a subpopulation.
o The 2018 Common Rule allows subjects/participants to continue in exempt research if they become prisoners during the course of the study.
o Under the 2018 Common Rule, exempt research involving children (i.e., participants covered by Subpart D) may fall into categories 1, 4, 5, 6, 7 or 8. Exemption is not allowable if the information/biospecimens include identifiable information and is reviewed under a limited IRB review.
o The 2018 Common Rule does not allow exemption for, research involving the public behavior of children if the researcher/investigator participates in the activities being observed. Thie requirement is consistent with the pre-2018 rule.
o Research in which children participate in surveys or interviews may not be exempt under the 2018 Common Rule, as was the case with the pre-2018 rule.
- Researchers/investigators must continue to submit any changes to the research to the IRB for approval. This includes minor changes, such as changes to the principal investigator (PI), as well as major changes to the research.
- Researchers/investigators must continue to report adverse events and noncompliance issues such as protocol deviations.
If you have any questions or concerns about the TDMHSAS IRB, please call Dr. Chappell at (615) 741-9476 or email Edwina.Chappell@tn.gov.