Guidance re: Modification of Non-clinical (Social/Behavioral/Educational/Observational) Research Involving Human Subjects During COVID-19

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 any research sites.

  1. A particular challenge facing non-clinical research during this time is potential loss of participant confidentiality. Loss of confidentiality is often a primary risk of study participation in non-clinical research. As such, non-clinical researchers must take care when changing study procedures from in-person to remote. The confidentiality of remote data collection should be carefully considered, and changes in confidentiality protections assessed when data collection platforms are changed. Examples of considerations related to confidentiality when changing from in person to remote data collection are:
  • Collection of IP addresses
  • Data ownership considerations related to the data collection platform; researchers should use GW partnered platforms such as GW WebEx, GW Box, and GW Google accounts whenever possible
  • Collection of email addresses or telephone numbers to facilitate remote data collection
  • Confidentiality and privacy of streaming video interactions
  1. Interactions with participants should be performed remotely (e.g., by phone, WebEx, or other means) whenever possible. Unless such a change is necessary to eliminate an apparent immediate hazard, any change from an approved IRB protocol must be approved prior to implementation as a study modification submitted in iRIS. For these modifications, please note in the modification submission that it is related to COVID-19, describe the proposed changes, effect of the change on study benefits, and any new or different confidentiality concerns.
     
  2. When conducting essential in-person HSR, remote pre-screening participants for symptoms and history of potential COVID-19 exposure or infection signs is advisable and likely required by research sites as a site-wide precaution. Investigators may implement procedures to pre-screen participants for COVID-19 infection risk without IRB approval.
     
  3. Communications between research teams and participants related to updates about COVID-related disruptions and changes to study procedures do not require IRB approval.

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