COVID-19 and Human Subjects Research
May 3, 2021
Subject: Resumption of In-Person Human Subjects Research (HSR)
Dear Lewis & Clark Faculty and Staff,
The decision by the Institutional Review Board (IRB) at Lewis & Clark College to suspend in-person human subjects research (HSR) in mid-March last year (see below) was based on the COVID-19 situation facing our community and to minimize the risk that in-person HSR posed to research participants and research team members at that time. With LC currently planning on resuming most pre-COVID-19 operations in the fall, the IRB will begin accepting proposals for in-person HSR to resume in the Fall of 2021.
The evolving circumstances of the COVID-19 pandemic will continue to drive decisions regarding in-person HSR activities but, for now, the IRB wants to offer some guidelines to researchers submitting new proposals or looking to amend previous ones for the time being;
- All institutional, site-specific, and local policies and procedures regarding PPE, social distancing, sanitization, and other COVID-19 safety practices must be followed by researchers and research participants at all times.
- All activities that can be conducted remotely, that is not in the presence of a study participant, should be conducted remotely (e.g. completion of screening procedures and forms should be conducted remotely before study participants arrive on campus). In addition, a section explaining the necessity of in-person research needs to be included in the research proposal.
- Researchers and participants will undergo appropriate health screenings for COVID-19 related symptoms or risk factors prior to engaging in-person research procedures.
- Records that allow for adequate contact tracing in the event of a positive COVID-19 case must be maintained by the PI. Those records may be shared with research participants, institutional officials, or public health authorities as appropriate.
- Details regarding COVID-19 itself, precautions the researchers have taken, and expectations for maintaining a safe environment for participants, must be shared with participants.
- If a research participant requests additional accommodations for their safety during participation, researchers should make reasonable efforts to accommodate those requests.
- Research proposals should include a detailed back-up plan for data collection should remote only research need to be resumed.
These guidelines and other decisions by the IRB and Lewis & Clark institutional leadership may be adapted as objective public health evidence suggests appropriateness of loosening or tightening restrictions on in-person research. Any questions regarding resumption of in-person research can be emailed at email@example.com.
March 17, 2020
Subject: IRB response to COVID-19
Dear Lewis & Clark Faculty and Staff,
In the context of rapidly evolving circumstances regarding COVID-19 and to further the efforts of Lewis & Clark College’s commitment to promote social distancing and protecting members of our community, the Institutional Review Board (IRB) has issued some revised standards related to human subjects-related research visits. In summary, research visits should be performed remotely (e.g., by phone, Zoom, or other means) whenever possible. Studies involving face-to-face interaction with no direct drug or therapeutic benefit are to be postponed until further notice, effective immediately (March 17, 2020).
Changes to a study’s protocol to replace in-person research visits with “remote” options must be approved in advance by the IRB as a Modification to the Study. For more expedited review, be sure to email your revisions to firstname.lastname@example.org and put COVID-19/study protocol in the subject line, so that staff can get your revisions to committee members as quickly as possible.
Currently, the IRB is still accepting new applications for review and will continue to review application revisions throughout the academic school year. However, priority will be given to all inquiries, requests, and modifications related to SARS-CoV-2 or COVID-19. If a new study has face-to-face contact with human subjects, it will not be approved at this time. Additionally, faculty advisers of student research projects will be expected to disseminate this information to students and ensure that these standards are held in compliance. Any questions can be emailed to IRB staff at email@example.com.
As decisions are made on how to best respond to the COVID-19 infections, the IRB wants to reiterate that our primary concern is for the safety of our research participants and the research team members who represent Lewis & Clark College. We appreciate your flexibility and patience as we continue to work within these challenging contexts.