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
In addition, the UTHSC IRB advises following the Continuity of Research Operations at https://uthsc.edu/research/covid-19-notice.php
- 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.”
- Changes/Modifications to a study may be necessary to eliminate apparent immediate hazards, 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.
- 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.
- Any changes/modifications to a study should be submitted to the UTHSC IRB via a Form 2: Change Request and Amendment in iMedRIS.
- 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.
- 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.
- Research procedures that are intended to directly benefit the subjects should continue as necessary to protect the welfare of subjects. These procedures include administration of treatments, diagnostic procedures, monitoring procedures, etc. that are performed as components of approved studies.
- Research procedures that are not intended to directly benefit research subjects should be revised or halted as follows:
- If research procedures that are not intended to directly benefit subjects can be performed without interpersonal contact (e.g., administration of health questionnaires by phone), then revisions should be submitted to the IRB to conduct these interactions through alternative modalities.
- If research procedures that are not intended to directly benefit subjects can only be performed with interpersonal contact, then they should be stopped unless appropriate revisions to these procedures can be implemented to minimize the risk of transmission of COVID-19 between subjects and research staff.
- Recruitment for non-therapeutic research studies should be halted.
- Studies that involve ONLY research procedures that are not intended to directly benefit subjects and involve ONLY research procedures that require interpersonal contact should be halted until further notice.
- 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.
- The FDA issued guidance regarding the conduct of clinical trials during the COVID-19 (coronavirus) pandemic at https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-issues-guidance-conducting-clinical-trials
- This IRB policy is effective immediately (March 20, 2020) and will remain in effect until further notice.
If you have any questions about this information, please contact the IRB at (901) 448-4824.
UTHSC IRB Administration