Federal Guidance Related to Human Research Protection and COVID-19

This webpage provides links to guidance and resources provided by federal agencies or departments related to human subject research protection and COVID-19. Please note that information and guidance can evolve rapidly as part of the COVID-19 pandemic. Please visit the federal department or agency’s website for the latest information.

For information about sponsored programs considerations, please visit MSU Sponsored Programs Administration COVID-19 webpage

U.S. Food and Drug Administration

The U.S. Food and Drug Administration has issued guidance on the conduct of clinical trials of medical products during the COVID-19 pandemic. The guidance provides general considerations to assist sponsors, investigators, and Institutional Review Boards in assuring the safety of trial participants, maintaining compliance with good clinical practice (GCP), and minimizing risks to trial integrity during the COVID-19 pandemic. The appendix to the guidance further explains those general considerations by providing answers to questions about conducting clinical trials that the FDA has received during the COVID-19 pandemic. 

On April 16, 2020, the FDA added content to the question-and-answer appendix in its guidance titled “Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency.” The updated guidance includes new content on conducting remote clinician-reported outcome or performance outcome assessments; remote site monitoring; electronic common technical document requirements; investigational product administration by a local health care provider who is not a sub-investigator; and information for sponsors on who they should contact at the FDA regarding certain changes to ongoing trials. There is also updated information about obtaining informed consent from a patient who is unable to travel to the clinical trial site due to COVID-19 illness or travel restrictions in situations where electronic informed consent is not an option.

On May 11, 2020, the FDA added content to the question-and-answer appendix in its guidance titled “Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency.” The updated guidance includes new content with considerations for using alternate laboratories or imaging centers, holding trial participant visits via video conference, and conducting required postmarketing clinical trials. The guidance also includes updated information about managing protocol deviations and amendments to ongoing trials, and about consulting with the FDA regarding administering investigational product infusions at home rather than at the clinical trial site. (Updated May 12, 2020)

On June 3, 2020, the FDA added content to the question-and-answer appendix in its guidance titled “Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency.” The updated guidance has a new question-and-answer pertaining to 21 CFR Part 11 compliance for electronic systems used to generate electronic signatures on clinical trial records. The guidance cites the COVID MyStudies App as an example of an electronic method for obtaining informed consent securely when face-to-face contact is not possible. In addition, the guidance further expands on an existing question-and-answer about remote clinical outcomes assessments (COAs) to include four types of COAs: performance outcomes, interview-based clinician-reported outcomes, patient-reported outcomes, and observer-reported outcomes. (Updated June 8, 2020)

On July 2, the FDA added content to the question-and-answer appendix in its guidance titled “Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency.” The updated guidance clarifies two previously suggested methods for obtaining informed consent from a hospitalized patient in isolation. In addition, the guidance includes a new question-and-answer regarding how to obtain informed consent from a prospective trial participant in certain circumstances where the enrollment timeframe is limited and the patient can receive a copy of an informed consent document electronically but cannot sign it electronically or print it out for signature. The guidance also clarifies recommendations on documenting details when using video conferencing for trial visits.

On September 21, 2020, the FDA added content to the question-and-answer appendix in its guidance titled “Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency.” The updated guidance includes a new question-and-answer regarding a clinical trial investigator’s responsibility to review all investigational new drug application safety reports, including reports that will not result in a change to the investigator brochure, informed consent, or protocol.

On January 27, 2021, the FDA added content to the question-and-answer appendix in its guidance titled “Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency.” The updated guidance includes a new question-and-answer regarding whether FDA considers receipt of medical products authorized under an emergency use authorization for use in clinical care, such as a vaccine to prevent COVID-19, or a monoclonal antibody to treat COVID-19, to be receipt of “investigational” medical products. This information may be relevant when sponsors are considering eligibility criteria that exclude patients from enrolling in clinical trials if they have received certain medical products.   

On August 30, 2021, the FDA updated its guidance titled “Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency.”

On June 2, the U.S. Food and Drug Administration published the guidance titled "Institutional Review Board (IRB) Review of Individual Patient Expanded Access Requests for Investigational Drugs and Biological Products During the COVID-19 Public Health Emergency Guidance for IRBs and Clinical Investigators." FDA issued this guidance because of the substantial increase in the number of requests by physicians seeking to treat their patients with investigational drugs under the agency’s individual patient expanded access (EA) pathway during the COVID-19 public health emergency.  The recommendations in the guidance address establishing procedures for single IRB member review in response to physician waiver requests for exemption from full IRB review, as well as factors to consider when assessing benefits and risks for a particular patient being treated under expanded access. (Updated June 8, 2020)

U.S Office for Human Research Protections

On April 8, 2020, OHRP issued “OHRP Guidance on COVID-19.” The guidance responds to questions OHRP received from the research community regarding how the Department of Health and Human Services (HHS) human subjects protection regulations (45 CFR part 46) apply to actions taken by institutions and investigators in response to the COVID-19 outbreak. OHRP offers guidance on the following topics: (i) Public Health and Clinical Activities; (ii) Excluded Public Health Surveillance Activities; (iii) Legally Required Reporting; (iv) Research Changes to Eliminate Apparent Immediate Hazards; (v) Proposing and Reviewing Study Changes; and, (vi) Whether Suspensions of Research Must be Reported. (April 8, 2020)

National Cancer Institute

The NCI CIRB has created a central location for all COVID-19 related announcements that pertain to the NCI CIRB, covered clinical studies, or stakeholder responsibilities. It has been developed as a single collection point for all COVID-19 information to help the research community when addressing the outbreak of COVID-19 within the context of CIRB approved clinical trials. Please refer to this NCI COVID-19 webpage daily to keep apprised of COVID-19 developments and announcements. 

National Institutes of Health

The NIH publishes policy notices of updates to the NIH Grants Policy Statement. The NIH issued a notice, Guidance for NIH-funded Clinical Trials and Human Subjects Studies Affected by COVID-19 (NOT-OD-20-087) that provides guidance outlining the flexibilities available to recipients conducting NIH-funded clinical trials and human subject studies that are impacted by the declared public health emergency for COVID-19. (March 16, 2020)

Office for Civil Rights at the U.S. Department of Health and Human Services

During the COVID-19 national emergency, which also constitutes a nationwide public health emergency, covered health care providers subject to the HIPAA Rules may seek to communicate with patients, and provide telehealth services, through remote communications technologies. Some of these technologies, and the manner in which they are used by HIPAA covered health care providers, may not fully comply with the requirements of the HIPAA Rules. OCR has issued a notification of enforcement discretion for telehealth remote communications during the COVID-19 nationwide public health emergency.

Please note that researchers who are covered health care providers should work with the covered entity if telehealth is necessary to provide both standard of care and research to patients.