Waiver Request for Face-to-Face Research

Face-to-face human subjects research has been suspended due to the pandemic.  SCSU has now established procedures for faculty to request a waiver of this policy.  Waivers will be based upon the demonstrated benefits to participants and the ability of the research to abide by recommended safety protocols.  Waiver requests will be reviewed by a panel.

Individuals who are requesting will:

  • Submit a protocol for the research to the IRB
  • Upon completion of the IRB Review, file an amendment requesting the waiver.

The waiver request requires

  • A full description of the benefits and a justification for the need of the research,
  • Documenting appropriate safety training for all research staff (see link below), 
  • Submitting a Lab/Studio safety plan (see link below)

While researchers may not submit a waiver request until regular IRB review has been completed, the safety training and safety plan link should be consulted in preparation. 

This plan will be in place starting October 6, 2020.

All Southern campus community members requesting a waiver to conduct face-to-face human subjects research are required to review the “Returning to Research” Training Course. This course was developed by the University of Connecticut and has been adopted with their permission. Please note that this training will be used in combination with SCSU specific policies and procedures.

After viewing the UCONN course, individuals must indicate on the waiver amendment that all study personnel have reviewed and understood the content of the course.

 

Access the Training Materials

Researchers will use the Research Lab Ramp-up Guide to develop a COVID-19 Safety Plan specific to their research.  The Safety Plan will be submitted with the waiver request amendment for review.   The approval of the COVID-19 Safety Plan is required before the research can be initiated.

Labs, research programs, studios, or research areas must have the appropriate PPE and cleaning supplies onsite before resuming activities. Faculty must contact Lisa Korfelt (SCSU Department of EHS) to secure PPE and cleaning supplies.

 

COVID-19 Safety Plan Template

 

COVID-19 Exposure Risk

Study Activities and Examples

Mitigation Strategies

None

 

  • Studies conducted using fully online/distance methods or remote activities

Example Activities:  Online surveys, web-based experimental tasks, virtual interviews and focus groups, phone interviews, remote chart/record review

N/A

Low

  • In-person interactions and procedures that require no physical contact and that can maintain social distancing, minimum 6 ft, between all individuals
  • Can be conducted with limited number of research team members (max 2)

Example Activities:  Behavioral experiments or interventions without physical contact, computerized tasks, onsite chart/record review  

  • Personnel training on handwashing, face coverings, disinfection (course?)
  • COVID-19 symptom screening for researchers and participants
  • Social distancing plan to maintain 6 ft between all individuals
  • No more that 30% normal room occupancy.
  • Face coverings for researchers
  • Increased cleaning/disinfecting 

Medium

  • In-person non-invasive interactions and procedures that require minimal physical contact (including exchanging paper or other materials) but can otherwise maintain social distancing
  • Physical contact with the participant limited to one research team member
  • Can be conducted with limited number of research team members (max 2)

Example Activities:  Large group  Behavioral experiments or interventions without physical contact, computerized tasks,  Instrument setup including MRI, TMS, ERP, DEXA, eye tracking, physical examinations such as balance testing and neurological exam, blood pressure measurements, sleep evaluations, audiology assessment, studies with infants and young children that are not anxiety-provoking

  • Personnel training on handwashing, wearing PPE, disinfection
  • COVID-19 symptom screening for researchers and participants
  • Social distancing plan to minimize physical contact and otherwise maintain 6 ft between all individuals
  • No more that 30% normal room occupancy.
  • Face coverings/Surgical grade mask,
  • Gloves for researchers when papers and materials must be exchanged.
  • Increased cleaning/disinfecting 

High

  • In-person interactions, interventional activities and procedures that require physical contact less than 15 mins and involve collection of biofluid samples through non-aerosolizing methods;

Example Activities:  Collection of blood, urine, saliva samples, contact with mucosa

 

  • Personnel training on handwashing, wearing PPE, disinfection
  • Personnel training on procedures for safe handling of biofluid samples where required
  • COVID-19 symptom screening for researchers and participants
  • Social distancing plan to minimize physical contact time
  • No more that 30% normal room occupancy.
  • Surgical grade mask, gloves for researchers
  • Additional PPE including gown and eye protection may be required for post-collection processing of biofluid samples
  • Increased cleaning/disinfecting 

Highest

 

  • In-person interactions, interventional activities and procedures that may or may not require physical contact but likely produce aerosols
  • Activities and procedures that require direct or close physical contact lasting more than 15 mins
  • Studies involving face-to-face interaction with patients with current COVID-19 diagnosis, under investigation,  or those with active symptoms consistent with COVID-19

Example Activities:  Studies involving exercise, cardiovascular stress testing, pulmonary function tests, infant-child studies that may induce crying, research studies involving COVID-19 patients

  • Personnel training on handwashing, donning/doffing full PPE, disinfection
  • Procedures for safe handling of biofluid samples where required
  • COVID-19 symptom screening for researchers and participants
  • Social distancing plans to minimize physical contact time
  • No more that 30% normal room occupancy.
  • Full PPE for researchers including N-95 grade mask, gloves, gown, eye protection
  • Increased cleaning/disinfecting
  • Consider COVID-19 testing of study participants 72 hours prior to intervention  
  • Adequate ventilation1

1Adequate ventilation:  Where possible, research in the HIGHEST exposure category should be conducted in spaces with negative-pressure ventilation.  If negative-pressure ventilation is not available, pauses between participants should be included to allow for adequate air circulation, air replacement, and disinfecting.  Guidance can be obtained through Facilities Management.   Adapted from Johns Hopkins University.  Revised at SCSU July 11, 2020