Clinical research flexibilities during the COVID-19 public health emergency
Recognizing the significant effects that COVID-19 has had on clinical research, the federal government has issued multiple guidance documents related to clinical research flexibilities to support continued research during the pandemic.
Office of Human Research Protections (OHRP) guidance
In a guidance document dated April 8, 2020, the OHRP addresses COVID-19-related compliance questions and indicates an intent to be flexible with institutions and investigators when doing so will not compromise research subject safety. The OHRP clarifies the following:
- Public health and clinical activities: (1) Clinical or public health actions that are not taken for research purposes, such as screening all facility visitors for COVID-19, do not require institutional review board (IRB) approval; (2) most public health surveillance activities authorized by a public health agency can be incorporated into a research study without IRB approval; and (3) when investigators are required by law to provide COVID-19 test results to public health authorities, they can do so despite contrary consent and confidentiality agreements.
- Research changes to eliminate hazards: Pursuant to 45 CFR 46.108(a)(3)(iii), when changes are necessary to eliminate apparent immediate hazards, investigators are not required to obtain prior approval from the IRB but should report changes when possible. For example, OHRP clarified that an investigator does not need IRB approval to conduct planned, in-person visits over the phone.
- Study suspension: Under the existing regulatory framework, if an investigator or institutional official suspends or terminates approved research, the investigator is not required to report such action.
National Institutes of Health (NIH) guidance
In a guidance document released March 16, 2020, the NIH encourages funding recipients to initiate measures to protect study participants from COVID-19 and outlines flexibilities afforded to NIH-funded clinical trials during the COVID-19 public health emergency. The document outlines the following:
- Late required submissions: Recipients may submit late financial and progress reports and carryover unobligated balances on active grants without requesting prior approval when the delay is due to COVID-19.
- Delays in research progress: Recipients may extend the final budget period of the approved project on active grants one time for up to 12 months without prior approval. Recipients may also apply for additional extensions, including mid-project period extensions, when the extensions are necessitated by COVID-19. NIH will allow project periods to extend beyond the seven-year timeframe when the need for such extension is related to COVID-19.
- Unanticipated costs: Recipients may request additional funding from the awarding institute or center when unanticipated costs are identified due to COVID-19.
Food and Drug Administration (FDA) guidance
In a guidance document released March 18, 2020, and updated April 2, 2020, the FDA provides general considerations to support sponsors of FDA-regulated research during the COVID-19 public health emergency in assuring the safety of participants, upholding compliance with good clinical practice and minimizing threats to trial integrity. Much of the FDA’s guidance overlaps with the guidance provided by the NIH and OHRP. When appropriate modifications cannot be made to protect study subjects and personnel, the FDA suggests terminating or postponing the study until it can be conducted safely. The appendix includes an FAQ section on conducting clinical trials during the COVID-19 pandemic.