Guidance re: Modification of Clinical Research Involving Human Subjects

Due to rapidly changing information and circumstances related to COVID-19, GW investigators may need to adapt their research to protect their participants and themselves. In addition to this guidance, investigators are expected to follow COVID-19 requirements and guidance released by local and national public health agencies as well as by clinical site(s).

It is possible that some studies may be temporarily halted or permanently discontinued by study sponsors, regulatory agencies or other bodies. Any such halting or discontinuations of study procedures where participants are actively receiving clinical treatment should be reported to the Institutional Review Board (IRB) within 10 business days via a promptly reportable information form (PRIF) that includes a plan for managing safety and follow-up with actively enrolled participants.
Remote pre-screening of participants for symptoms and history of potential COVID-19 exposure or infection signs is advisable and likely required by clinical sites as a site-wide precaution. Investigators may implement procedures to pre-screen participants for COVID-19 infection risk without IRB approval, except if investigators intend to use such data for research purposes.
Temporary changes may be made to research procedures to reduce in person contact or to accommodate travel restrictions or other disruptions. These changes may include altering in person data collection to be performed via phone or video call, flexibility in scheduling study visits, use of home visits rather than clinic visits, or study visits at alternate locations. These changes can be made without IRB approval when the changes reduce apparent immediate hazards to participants (see Common Rule 45 CFR 46.108(3)(iii) and FDA regulations 21 CFR §56.108(a)(4)).
1. When such temporary changes are made, the research team should document the modified procedures, and a log should be kept of every study procedure that is not carried out according to the original protocol. During the COVID-19 outbreak, these ‘deviations’ shall be considered to be deviations from the IRB-approved protocol that do not affect data integrity or subject safety, rights, or welfare. The GW IRB does not need to be notified of, or approve, these deviations from the IRB-approved protocol due to COVID-19 in advance of implementation; however, these deviations should be reported at the time of the next continuing review. If the study received expedited review and does not undergo continuing review, these deviations should be reported to the IRB via PRIF within 10 business days.
2. Examples of temporary changes that would be considered minor protocol deviations include:
  - missed study visits or out-of-window visits,
  - elimination of minor assessments that do not affect the evaluation of participant safety,
  - elimination of protocol-required data collection (e.g., research laboratory assays) that does not affect the evaluation of participant safety or the research integrity of the study,
  - changing the platform under which data is collected or safety is monitored (such as changing from clinic visit to phone call),
  - home-delivery and/or administration of drugs/devices,
  - changes in use of home-based study equipment or data collection (e.g., collection of sleep data by actigraphy and/or sleep diary) to accommodate disruptions in personal contact or travel
3. For clinical research on a sensitive topic, such as HIV research, investigators should take precautions to protect participant privacy and confidentiality when changing in person data collection to occur remotely. These precautions may include:
  - following clinical site requirements regarding privacy and confidentiality during phone or online communications with participants or family member
  - developing processes to confirm the identity of the participant before sharing sensitive information
  - obscuring reference to study titles or other information about the study topic when appropriate
4. If any temporary changes are intended to become permanent protocol changes that will remain in place after the COVID-19 outbreak subsides, a protocol modification should be submitted to the IRB as soon as is practicable to reflect the permanent change.
Other protocol changes that may reflect a major protocol deviation and may affect participant management or clinical care require submission of a modification to the IRB. However, as per current guidelines, immediate measures that are necessary to protect participant safety may be made without prior IRB approval. In these cases, investigators must report the revision to the IRB as soon as is practicable via a study modification in iRIS. For these modifications, please note in the modification submission that it is related to COVID-19. These amendments will be given priority for IRB review/approval. Examples of changes that need to be reported to the IRB are:

reducing the numbers of study visits,
change in the frequency of safety monitoring,
elimination of critical study visits,
change in drug/device administration or composition

Communications between research teams and study participants related to updates about COVID-related disruptions and changes to study procedures do not require IRB approval.

For research conducted under INDs or IDEs, sponsor reporting requirements and FDA reporting requirements are different from IRB reporting requirements. Please consult with the FDA’s guidance on COVID-19 and clinical trials and check with your study sponsors to be sure you have met all reporting requirements.

Additionally, multi-site research may be subject to local IRB/ethics committee guidance or site related guidance. Investigators may share this document to facilitate planning and multi-site coordination. Additionally, if the GW IRB is not the IRB of Record, the research team must follow guidance/policy supplied by the IRB of Record, as well.

Guidance re: Modification of Clinical Research Involving Human Subjects

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