COVID-19 Alert

The UTHSC IRB is following the University’s guidelines in regards to the COVID-19 (coronavirus) pandemic at https://uthsc.edu/coronavirus/campus-updates/index.php

Further, the UTHSC IRB advises following the UTHSC Clinical Trials Governance Board Guidelines Regarding Human Subjects Research Activities at UTHSC (for Non-COVID-19 Studies) During COVID-19 Pandemic that can be found here. 

General Guidance

1. In the presence of the COVID-19 pandemic, revisions in human subject research studies may be warranted to minimize risk to subjects, as the Code of Federal Regulations at 45 CFR 46.111 and 21 CFR 56.111 requires that “Risks to subjects are minimized.”

2. Changes/Modifications to a study should be implemented as necessary to minimize risk to subjects, such as:

   • Replacing in-person visits with remote options such as telephone visits or use of digital technology;

   • Eliminating study visits/procedures that do not impact subject safety or the integrity of the data;

   • Incorporating screening procedures to identify COVID-19 exposure.

3. Subjects may be informed of changes in the research via a revised consent form or by way of notification that is not a new consent form, such as an addendum consent, information sheet, letter, etc.

4. Any changes/modifications to a study should be submitted to the UTHSC IRB via a Form 2: Change Request and Amendment in iMedRIS.

5. Please note that federal regulations do allow for modifications to be implemented prior to IRB approval only when it is necessary to eliminate apparent immediate hazards to the subject (§46.108 (a)(3)(iii) and 21 CFR 56.108(a)(4)).Consequently, revisions necessary to protect the welfare of subjects may be implemented immediately while awaiting IRB approval.

6. If modifications to a study are implemented prior to IRB approval (see item #5 above), such an event is considered a deviation from the IRB approved protocol and you should make the appropriate documentation in the research records. In addition, if such a protocol deviation (a) has harmed or has posed a significant risk of substantive harm to the individual research subject or (b) has compromised the scientific integrity of the data collected for the study, then a report of such a protocol deviation should be submitted to the UTHSC IRB via Form 4: Unanticipated Problemsin iMedRIS.

7. Research procedures that involve in-person procedures must align with all UTHSC policies, guidance from public health authorities, and State of Tennessee requirements.

8. Policies of UTHSC-affiliated clinical sites regarding COVID-19 that affect the conduct of human research must be followed. Any revisions of approved research procedures necessitated by these policies may be implemented immediately and submitted for IRB review and approval.