IRB News IRB and Covid-19

IRB News

New!IRB and Covid-19

Guidance for Conducting Human Subjects Research During the COVID-19 Pandemic

August 25, 2020

General Guidelines:

Fairfield University recognizes the critical importance of human subjects research during the COVID-19 pandemic. Fairfield University researchers conduct human subjects research both on campus (with students, faculty, staff, and community members as researcher participants) and in the field (with community members, and patients and staff at clinical sites as research participants).  Whenever possible, given this current pandemic, it is recommended that all research be done remotely, without in-person interaction. However, we recognize that there are research studies in which in-person interaction is essential. 

The need to engage in research undertaken by our faculty and students must be balanced against the risks and benefits, if any, to participants of engaging in this research, while also considering risks to the researchers themselves.

On March 25, 2020, in response to the global pandemic, the University issued guidance noting that studies involving in-person interaction with participants with no direct therapeutic benefit to participants should be postponed until further notice.  As the University begins reopening research for new or already approved studies, previously approved research studies may need to be amended in order to continue subject enrollment.  Changes to the Institutional Review Board (IRB) application or supporting materials (e.g., informed consent, protocol, drug or device administration, recruitment procedures) can be made following the amendment process detailed at www.fairfield.edu/irb.

Previously approved studies:

a)       Studies previously approved that do not involve in-person interaction (e.g., online studies) can continue as planned, without any amendment.

b)      For studies previously approved for in-person contact that are changing to an online context, the researcher should submit an amendment discussing proposed changes to the procedure, including online consent, data security, and confidentiality issues.  Researchers should use the online consent template available on the IRB information page (go to Preparing Protocols tab → informed Consent → Information About Consent for Online Surveys and Experiments).

c)       Protocols that had been previously approved for in-person contact, however were paused as per the March 25th suspension may proceed, following the submission and approval of an amendment to address additional COVID-related safety guidelines outlined in the sections below.

New Protocols:

New studies that involve in-person interaction should include a COVID-19 safety procedure where the researcher addresses steps taken to ensure that appropriate safeguards are in place (e.g., masks worn by research team and subjects, social distancing in research spaces and waiting areas, cleaning of any touched surfaces such as desks and computer keyboards between participants, plan for contacting participants should contact tracing be necessary).  If participants will be tested off campus, include information about the facility’s procedure.  New protocols can be submitted to the IRB for approval, but approval will be contingent on the phased reopening of in-person research as detailed below.

New studies that involve no in-person interaction (e.g., online studies) should describe the procedure and include detailed information about online consent, data security, and confidentiality issues.  Use the online consent template available on the IRB information page (go to Preparing Protocols tab → Informed Consent → Information About Consent for Online Surveys and Experiments).

Additional Guidelines

There will be two stages to reopening, and research will begin with Stage 1 research focused on clinical encounters among registered nurses and their patients taking place in clinical settings. In-person research that does not fall into this category remains suspended. Details for this stage are outlined below:

As of 8/21/2020, registered nurses, including nurse faculty, completing human subjects research in clinical research sites may initiate or resume in-person data collection at those sites provided that they are compliant with the infection control policies in those clinical facilities. Clinical sites are expected to have established plans for regular employee screening including temperature screening, COVID testing, facemask protocols, and contact tracing. For example, an advanced practice nurse is working with patients in a community clinic, and would like to include patients with hypertension in a study examining different methods to manage hypertension. As part of clinic protocol, all patients undergo temperature checks, and patients and staff are required to wear face-masks. Therefore, these safety procedures would also be part of the research protocol.  In these instances, it should be clear in the protocol that the risks of participating in research do not increase risk of exposure beyond what the normal clinical interaction would require.

Researchers with previously approved research involving in-person interactions must submit an amendment for already approved protocols to describe the safety procedures that need to be implemented to address the COVID-19 pandemic and to describe any changes to the consent process before resuming research.  Both already approved and new protocols involving in-person data collection in clinical settings must specifically address any additional COVID-19 risk exposure that is greater than what would normally be experienced in the community. All researchers and research participants should complete a COVID-19 test prior to commencing in-person contact and complete a health monitoring check prior to each in-person contact. These risks must be described in the IRB protocol and disclosed to participants as part of the consent process. These protocols must also describe how the benefit to the research participant outweighs the potential risk of COVID exposure, and the benefits of participation must clearly outweigh these risks.  For studies where the Fairfield University IRB delegates its review authority to an extremal IRB, be sure to include information about the facility’s safety procedures in your application and upload a copy of the external IRB approval letter from the external IRB.

Stage 2: Date TBD:  Human subjects studies that require in-person participant contact outside of clinical settings. In-person research that falls outside of stage 1 will resume at a later date, to be determined. For additional information about stage 2 requirements, please contact the Chair of the IRB, Dr. Alison Kris.

Preparations for possible suspension of research

COVID-19 presents challenges that can rapidly change. Importantly, any changes made to research protocols, including the need to modify a protocol in light of rapidly changing community conditions, must be submitted to the IRB for approval. These modifications can typically be submitted as amendments to the original protocol.  However, in the event of an emergent situation that requires deviation from a previously approved study protocol, principal investigators should act to ensure the safety of themselves and their research subjects, and submit adverse event documentation at a later date.

For additional Fairfield University Health Guidance on Human Subjects Research during COVID-19, please visit the IRB website at www.fairfield.edu/irb, and for the most recent information regarding Fairfield University’s plans for Fall 2020, visit the Stags Come Home site. 

If you have any questions, e-mail the IRB Chair or e-mail the IRB administrative liaison at IRB@fairfield.edu