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Data Security Guidance for Human Subjects Research


Web Conferencing for Collecting Research Data

The use of web conferencing to conduct research interviews and/or to collect research data has increased significantly due to the COVID-19 pandemic. To comply with UConn Information Technology Services (ITS) guidelines and policies, researchers must use UConn approved software or services when conducting these activities. This guidance has been developed in conjunction between Research Compliance Services (RCS) and UConn’s IT Security to assist researchers in understanding what platforms may be appropriate.

The nature of the data dictates which platforms may be appropriate. For example, investigators who will collect identifiable sensitive data (e.g. personal health information, illegal behaviors, substance use, etc.) that could place research participants at risk if disclosed may use Microsoft Teams or WebEx to conduct remote research interviews. Investigators collecting research data that is not sensitive may also use Google Hangouts/Meet when conducting research interviews remotely. In all cases, researchers must ensure their data collection activities are properly secured against outside (non-invited) guests. Most platforms provide specific controls to help prevent inappropriate access; for example, please visit online instructions for WebEx.

Other web-based software may be allowable on a case-by-case basis, but must first be cleared through ITS and/or Procurement.

Some web conference software allows the researcher to record sessions, share screens, and automatically transcribe the recording. Please see the Collaborating and Communicating Remotely Guide for additional information regarding the recommended software.

When recording sessions, researchers are asked to ensure that the recordings are stored in one of the following ways: on a University secure server, UConn’s version of Office 365, NetApp, or SharePoint. For specific questions related to acceptable collection and storage of research data, please submit a ticket to Techsupport.

As a reminder, Principal Investigators are responsible for ensuring research data are collected, stored, and transmitted securely and that all personnel working on the study are aware of the safeguards that must be in place to protect the privacy of participants and the confidentiality of study data. Also, be sure to submit any changes regarding the use of technology to collect research data to the IRB (via an amendment to an approved protocol) for approval prior to implementation of the changes.

For specific questions related to the allowable use of other web-based software or questions related to data security and the use of web-based platforms for research data collection, please contact Chris Bernard, Chief Information Security Officer at chris.bernard@uconn.edu.


Internet Based Research

Computer- and internet-based methods of collecting, storing, utilizing, and transmitting data in research involving human participants are developing at a rapid rate. As these new methods become more widespread in research in the social, psychological, and social sciences, they present new challenges to the protection of research participants. The Institutional Review Board (IRB) reviews computer- and internet-based research protocols using the same considerations and standards of approval of research under 45 CFR 46.111 and 21 CFR 56.111 as all other research activities. All studies including those using computer and internet technologies must (a) ensure that the procedures fulfill the principles of voluntary participation and informed consent, (b) maintain the confidentiality of information obtained from or about human participants, and (c) adequately address possible risks to participants including psychosocial stress and related risks.

The purpose of these guidelines is to help researchers plan, propose, and implement computer- and internet-based research protocols that provide the same level of protection of human participants as more traditional research methodologies. The guidelines are comprised of requirements and recommendations that are consistent with the basic IRB principles applied to all research involving human participants. ITS has developed a Glossary of Terms related to data security, which may be helpful for researchers and students.

Recruitment:

  • Computer-and internet-based procedures for advertising and recruiting potential study participants (e.g., social media, internet advertising, e-mail solicitation, banner ads) must follow the IRB guidelines for recruitment that apply to any traditional media, such as newspapers and bulletin boards. All advertising and recruitment material must be reviewed and approved by the IRB prior to implementation.
  • Investigators are advised to review the University’s policy on Use of Official Email Lists prior to soliciting participants by email. If you plan on using LISTSERVs at UConn, please contact list moderators for individual list policies regarding solicitations for research.

Data Collection and Security:

  • All laptops, iPads, tablets, portable media such as USB drives, or devices that are used to collect or store personal identifiable information (PII) for research purposes must use encryption.
  • Any sensitive identifiable or confidential data that are collected from human participants over computer networks must be transmitted over the Internet securely and saved locally in an encrypted format. This helps insure that any data intercepted during transmission cannot be decoded and that individual responses cannot be traced back to an individual respondent. ITS and Research Compliance Services encourage the use of Microsoft OneDrive, EFS, Filelocker, Office 365, encrypted email, encrypted USB drive, or secure FTP to transmit sensitive data containing PII. Filelocker is an encrypted web-based application that is used to provide short term secure storage and an encrypted transport of files both across campus and anywhere with web access.
  • The level of security should be appropriate to the risk. For most research, standard security measures like whole disk encryption and secure socket layer (SSL) (commonly used for secure websites) will suffice. However, for sensitive data additional protections should include certified digital signatures for informed consent, or de-identifying data to ensure anonymity. The Office for Human Research Protections (OHRP) has additional guidance for obtaining informed consent electronically.
  • For international research, investigators are cautioned that encryption standards vary from country to country and that there are legal restrictions regarding the export of certain encryption software outside US boundaries.
  • Internet-based survey instruments must be formatted in a way that will allow participants to skip questions if they wish or provide a response such as “I choose not to answer.” Also, at the end of the survey, there should be two buttons: one to allow participants to discard the data and the other to submit it for inclusion in the study. Finally, if applicable, online surveys must include mechanisms for withdrawal. For example, if a participant decides to withdraw, there should be a mechanism for identifying the responses of a participant for the purposes of discarding those responses.
  • Researchers working with children online are subject to the Children’s Online Privacy Protection Act in in addition to human subjects regulations. Researchers are prohibited from collecting personal information from a child without posting notices about how the information will be used and without getting “verifiable parental consent”. For minimal risk research written permission may be obtained by paper, mail, or fax. If the research is more than minimal risk, parental permission should be obtained in a face-to-face meeting.

Online data collection software:

The UConn Office of Institutional Research & Effectiveness (OIRE) has obtained a license from Qualtrics as an on-line data collection tool. Faculty members, students, and staff with an UConn Net ID and password are able to utilize Qualtrics.

The use of on-line survey software should be administered by a professionally trained person with knowledge in computer and internet security. Access to the server should be limited to key project personnel. The server should receive frequent, regularly scheduled security audits.

Data Storage/Disposal:

  • If a server is used for data storage, personal identifying information should be kept separate from the data, and data should be stored in encrypted format. Social Security Numbers are not permitted to be used as an identifier.
  • It is recommended that competent data destruction services be used to ensure that no data can be recovered from obsolete electronic media.
  • Researchers must adhere to the UConn Information Security Office’s Confidential Data Security Standard Policy, and Data Storage Guidelines.

Informed Consent Process For Internet-Based Research:

  • For anonymous internet-based surveys, include “I agree” or “I do not agree” buttons on the Information sheet for participants to click to indicate their active choice of whether or not they consent to participate. For anonymous surveys sent to and returned by participants through email, include the IRB’s information sheet template and inform participants that submitting the completed survey implies their consent.
  • If the IRB determines that written consent is required, the consent form can be mailed or emailed to the participant who can then sign the form and return it via fax or postal mail.
  • Researchers conducting web-based research should be careful not to make guarantees of confidentiality or anonymity, as the security of online transmissions is not guaranteed. A statement in the informed consent form indicating the limits to confidentiality is required. The following statement may be used: “Your confidentiality will be maintained to the degree permitted by the technology used. Specifically, no guarantees can be made regarding the interception of data sent via the Internet by any third parties.”

Source material for this policy guidance was provided by the Pennsylvania State University and the University of Georgia IRBs. The UConn IRB gratefully acknowledges this support.

In addition, the IRB would like to acknowledge information provided by Chris Bernard, University Chief Information Security Officer.

Additional Resources:

UConn Security Policy Manual.pdf

UConn Password Standards

Information Security Office Security Tips

Information Security Office Confidential Data Handling Suggestions

September 2020

 

UConn COVID-19 Rapid Start Funding (COVID-RSF) Program

Purpose

COVID-RSF is an initiative of the Office of the Vice President for Research (OVPR) that supports the development of promising projects related to COVID-19.  Many funding agencies have responded to the pandemic by creating emergency/rapid funding mechanisms that address key scientific problems related to the detection, diagnosis, treatment, and prevention of this disease.  A recent and notable example is the NIH RADx-rad program, which seeks to advance capabilities related to COVID-19 testing.

This internal funding mechanism seeks to identify and support novel technologies and approaches with strong potential to be competitive for emergency funding opportunities addressing COVID-19.  Proposals should be able to make a compelling case that the technology/approach is unique and can have a significant impact on COVID-19 related challenges in the near term.  Given the rapidly-changing nature of the COVID-19 funding landscape, projects with the potential for this kind of impact will be considered regardless of whether a specific external funding opportunity currently addresses it.

COVID-RSF seeks proposals for potentially high-impact projects that are ready to launch in a short period of time.  As such, early-stage seed projects or other developmental work will not be competitive.  Applications will be collected and rapidly reviewed in early September, with funding to be released by October 1.  It is expected that COVID-RSF funding will be used to support a short ramp-up period for these highly-competitive projects while they are being submitted and considered for rapid-response external funding.

To give a sense of the NIH’s current interests related to COVID-19, some of the topics addressed by the recent RADx-rad program include:

  1. Wastewater detection of SARS-COV-2 (COVID-19)
  2. Exosome-based Non-traditional Technologies Towards Multi-Parametric and Integrated Approaches for SARS-CoV-2
  3. Chemosensory Testing as a COVID-19 Screening Tool
  4. Predicting Viral-Associated Inflammatory Disease Severity in Children with Laboratory Diagnostics and Artificial Intelligence (PreVAIL kIds)
  5. Multimodal COVID-19 surveillance methods for High Risk Populations in densely populated facilities
  6. Novel Biosensing for Screening, Diagnosis and Monitoring of COVID-19 From Skin and The Oral Cavity
  7. Automatic detection and tracing of SARS-COV-2
  8. RADx-rad will also have a Data Coordination Center (DCC) which will provide management, direction, and overall coordination across RADx-rad awardees in areas such as data sharing, data management standards, terminologies, and common data elements.

Other topics from across all disciplines will also be considered, so long as they have potential to make an immediate impact on the detection, diagnosis, treatment, and prevention of COVID-19.

 Timeline:

  • Proposals (brief whitepapers, plus budget and biosketches) due Friday, Sept 11 2020 by 12 noon.
  • Submissions should be made via the UConn Quest portal.
  • Award notices expected by Sept 18.  Award setup will begin immediate after notice, pending the completion of compliance review.

Program/Award Details:

  • Several awards of up to $50K will be made
  • As these are rapid-response grants, it is expected that projects would spin up quickly following award and the scope-of-work completed within a few months.  Projects with a scope longer than 6 months are strongly discouraged.

 

Eligibility

The COVID-RSF Program is available to UConn / UConn Health faculty members, within the following parameters:

  • UConn Primary Appointment: PIs must be full-time faculty whose primary appointment is at UConn/UConn Health. Investigators with primary appointments to CCMC, Jackson Labs, TIP companies, or other institutions are not eligible to lead projects, but they may be named as Co-PIs, collaborators, or consultants on an eligible PI’s project.  Proposals that include external Co-PIs should be careful to describe how responsibility for the project will be divided between institutions, and ideally they will include cost-sharing commitments from external partners
  • Effort and Salary: Although no minimum effort level is required for COVID-RSF projects, a UConn/UConn Health PI/Co-PI must have departmental research time available during the award period or address in the application how they will handle the time commitment required by the project. PIs/Co-PIs must each make significant and distinct intellectual contributions to the design and direction of the project. Generally speaking, awards are only available to UConn/UConn Health tenure-track and clinical faculty and in-Residence faculty at the Storrs/Regional campuses. UCH in-residence faculty and research faculty are not eligible to apply as PI but can be named as Co-PIs, collaborators, or consultants on an eligible PI’s project.
  • Application Limits: Eligible faculty may submit multiple proposals, so long as each are scientifically distinct. Investigators may serve as collaborator on multiple projects.

Proposal Guidelines

Proposals for COVID-RSF Awards should contain the following elements and follow the structure and guidelines indicated.  All length guidelines assume 1” margins, 11-12pt fonts, single spacing and single side pages.

  • Cover Page: Title of Project, Principal investigator(s) with contact information, List of other team members, Specific funding mechanism targeted, Target submission date
  • White Paper: Briefly describe the project, how it will be conducted, and anticipated outcomes. White papers should address the following areas and should not exceed 2-3 pages in length:
    • Core Research Questions to be addressed and their significance
    • Currently available resources and personnel and how they will support the project
    • Proposed activities under COVID-RSF Award and how they will advance the project towards the goal of impacting the fight against COVID-19.  If you have a specific funding mechanism in mind for follow-up funding, also address how the work under this award will improve competitiveness for that mechanism.
  • Budget describing and justifying use of COVID-RSF funds.  You can use this budget template.
  • Biosketches / CVs for all PIs and Co-PIs: Please include an updated biosketch consistent with NIH (max 5 pg)/NSF (max 2 pg) format.  If your field is not typically funded by NSF/NIH, please include a brief CV following your discipline’s conventions.
  • NSF/NIH-style Letters of support from any facilities providing support during the COVID-RSF award period

Budget Guidelines

Below are general guidelines regarding allowable/unallowable costs that are consistent with other OVPR internal funding opportunities.  Given the unique nature of the COVID-RSF mechanism, we understand that these guidelines may not include all budget items that are necessary to enhance competitiveness for your targeted external mechanism.  If you have a budget need that does not fit within these guidelines, you may include it, but we ask that you provide strong justification in support of the request.  You can use this budget template.

  • Allowable costs include: graduate research assistant salary, Postdoc or other Research Assistant salary, Undergraduate Researcher salary, Course buyouts (approval letter from Department Head required), Fringe costs, equipment purchases, travel to conduct research or meet with collaborators (Provost approval may be required), materials and supplies, participant support costs, animal/animal care costs, contractual services
  • Unallowable costs include: faculty member salaries, clerical or administrative personnel salaries, including personnel whose primary purpose is to explore funding sources and/or prepare grant applications; service/maintenance contracts on equipment; laboratory renovations, or other infrastructure renovations; institutional memberships in professional organizations; travel to professional meetings to present the results of the research; travel to explore extramural funding opportunities; costs associated with the publication of results of the research, including page charges, purchase of reprints, or journal costs.

Review Criteria

  • Timing – Is the project capable of spinning up immediately?
  • Significance/Importance – Does this project address a significant scientific question / technical problem?
  • Innovation/Novelty – Does this project approach the problem in a new/innovative way?
  • Feasibility of Approach – Does this project have a clear and methodologically sound approach?  Is the plan of work described likely to succeed?
  • Environment/Resources – Are available resources/facilities sufficient to successfully complete the work?
  • PI/Team qualifications – Who will be working on this project, and how are they uniquely suited to accomplish this work?  Does the team have a strong track record of external grant success?
  • Outcome – Does the project promise to produce significant value / high impact?
  • Assessment – Does the project have a reasonable plan for measuring and determining success?
  • Budget – Are funds to be used efficiently and effectively to achieve project goals?

Post-Award Considerations and Reporting

  • Reporting requirements: PIs will need to prepare a brief report summarizing project progress within six months.
  • Further reports on project outcomes may be requested in the future to track return on investment.

Program Contacts

    • Administrative contact: Matt Mroz, PhD, OVPR Internal Funding Coordinator. research@uconn.edu;
    • Program Director: Mark Aindow, PhD, Executive Director for Innovation, External Engagement, and Industry Relations. m.aindow@uconn.edu

Guidance for Fall 2020 Lab, Field, and Human Subjects Research

As we approach the beginning of another unprecedented time in UConn’s history, my team and I have provided guidance on several topics related to the continued resumption of research. Since May, researchers have shown that with proper procedures, adherence to guidelines, and community commitment, it was possible to return to the critically important research projects happening throughout UConn. Throughout this process, the Office of the Vice President for Research (OVPR) has adhered to President Katsouleas’ message that in order to educate our students in a pandemic, we must all work together and to provide a safe learning environment. Students returning to UConn campuses must also commit to the “UConn Promise” to help keep the UConn community safe, including strictly abiding by rules that require a campus quarantine to start the semester, face mask usage at all times, and keeping physical distance from one another. Similar requirements of masking and distancing are mandated by the state for off-campus residents, as well as quarantines for those from most outside states. These guidelines will not only help to keep our students in the classroom, they will help to keep researchers in the lab, field, and clinic.

While most labs have already resumed activities under the current process, which requires approval from the OVPR, some faculty and students may have questions about what is required to continue or initiate new research projects in the fall. As of August 31, 2020 when the campus reopens, obtaining written approval from the OVPR for Resuming Research Activity is no longer necessary to engage in research on any of UConn’s campuses. The following guidance outlines additional aspects of conducting research at UConn for the Fall Re-Opening.

 

Guidance for Fall 2020 Lab, Field, and Human Subjects Research

  • Approval from the OVPR for “Resuming Research Activity” will no longer be required for conducting research at any UConn campus.
  • Labs and research programs must continue to develop and maintain a written COVID-19 Research Safety Plan (Lab and Field Research COVID-19 Safety Plan or Human Subjects COVID-19 Safety Plan), but submission and approval of Research Safety Plans to the OVPR will no longer be required. Departments and administrative offices are required to perform a detailed risk assessment, set site-specific prevention protocols, and to have the resulting safety plan approved by their leadership. If your department does not already have an approved COVID-19 safety plan in place, please use the Return to Campus COVID-19 Protection Plan template to prepare to return to work on campus.
  • Research personnel must continue to be trained on the plan and documentation of the training must be maintained.
  • Research personnel must continue to complete COVID-19 Research Safety Training from the Division of Environmental Health and Safety. Documentation of completion must be retained as part of Research Safety Plan documentation.
  • Research Safety Plans may be amended as necessary. If a plan is amended, all personnel must be retrained on the amended plan and training must be documented.
  • Research Safety Plans should continue to address federal and state guidelines and requirements.
  • Lab and research personnel must follow University wide and campus specific COVID-19 requirements.
  • Research Safety Plans must allow for distancing of at least six feet, with the goal of maintaining an overall personnel density of 50% or less of the pre-COVID occupancy/density. If this is not possible then the Safety Plan must justify why and specify what measures will be put in place to minimize the potential of exposure.
  • For research involving human subjects, Research Safety Plans should should be developed based on the clinical requirements of UConn Health, even if those projects take place on another UConn campus. If this is not possible, the Research Safety Plan must justify why and specify what measures will be put in place to minimize the potential of exposure.
  • Labs and research programs should maintain a process to know when personnel are working in the labs or research areas. Labs and research programs may develop their own methods to achieve this goal. Signed daily logs will no longer be required as the only acceptable method. Other acceptable methods include key card access, electronic check-ins, or use of location-based apps. Some schools and colleges may also have processes in place for monitoring building density and access.
  • Labs and research programs should continue to have and refine plans to immediately halt or ramp down research activities, if required.
  • The summer requirements/processes for undergraduates to participate in research will no longer be required. Guidance for Fall Undergraduate Research and Independent Study Courses has been issued.

While we reopen UConn for academic activities, we thank you for your dedication to the health and safety of your labs and the UConn community. If you have additional questions, more information can be found on the OVPR website or by emailing ovpr@uconn.edu.

Innovation Funding Opportunities

Life Science

Program

Deadline

Description

Pfizer’s Centers for Therapeutic Innovation June 1: CTI Portal opens for non-confidential pre-proposal submission

Sept. 21: Deadline for PIs to submit pre-proposals to TTO

Sept. 28: Deadline for TTO to submit to CTI

CFP for innovative ideas for drug co-development through collaborative and sponsored research agreements, venture/seed investment, and drug co-development.

Contact: Ana Fidantsef, ana.fidantsef@uconn.edu

Bioscience Innovation Fund  October 16 Yale University, the University of Connecticut, and Quinnipiac University have joined forces with Connecticut Innovations and the Bioscience Innovation Fund to help you commercialize your biomedical technology innovation (medical devices, diagnostics and health information technology).

Our $1 million, two-year initiative provides up to $30,000 per project of much-needed gap funding to seedling companies or faculty and student groups associated with any Connecticut university.

CSL Seeking Research in B cell and Plasma Cell Depletion Programs
October 19 CSL is interested in research in the broader area of autoimmunity, with a focus on autoantibody, complement and T cell‑mediated diseases.

Contact: Ana Fidantsef, ana.fidantsef@uconn.edu

CSL Seeking Novel Drug Candidates and Targets for Progressive Fibrosing Interstitial Lung Diseases and Acute Respiratory Distress Syndrome
October 19 CSL is interested in respiratory therapeutics in the areas of Interstitial Lung Diseases (ILD) and Acute Respiratory Distress Syndrome (ARDS).

Contact: Ana Fidantsef, ana.fidantsef@uconn.edu

CSL Seeking Novel Drug Candidates and Targets for Cardiovascular Disorders
October 19 CSL is interested in research developing novel therapeutic candidates or exploring novel drug targets for cardiovascular disease, with a particular focus on rare cardiovascular diseases.

Contact: Ana Fidantsef, ana.fidantsef@uconn.edu

Research Awards Supporting Small Molecule Drug Discovery Through AI Platforms:Ligand Express Award:


October 31 Apply if your lab works on small molecule drug screening

Receive in-kind access to the Ligand Express online platform for 3 months, with the possibility of extension

Screen molecules against the human proteome to elucidate mechanisms of action, ADMET predictions, and repurposing opportunities

Research Awards Supporting Small Molecule Drug Discovery Through AI Platforms:

 

Ligand Design Award

October 31 Apply if your lab seeks novel small moleculesdrugs for your protein(s) of interest

Receive in-kind access to the Ligand Design technology for 6-12 months, with the possibility of extension

Collaborate with Cyclica’s applied scientists to design, optimize, and synthesize novel molecules for desired therapeutic targets, anti-targets, and ADMET properties

Tap into Cyclica’s network of venture capitals and pharmaceutical companies to advance the commercialization of novel small molecule IP

 

Physical Sciences

Program Deadline Description
TBA

 

Startup/Entrepreneurship

Program Deadline Description
TBA

 

COVID-19 Research Opportunities

 

Undergraduate Participation in On-Campus Summer 2020 Lab/Field Research

  • The Office of Undergraduate Research and the Office of the Vice President for Research have release guidance on undergraduate participation in on-campus lab/field research during the summer.

    Process to request Undergraduate Student participation in research:

    • The Undergraduate Student should complete and submit the Undergraduate Student Research Request Form. Once submitted, this will be emailed automatically to both the Office of Undergraduate Research and OVPR.
    • The faculty member wanting to add one or more undergraduate students to an approved safety plan should complete and submit the Request to Include Undergraduate Students Form.
    • Once BOTH forms are received, the OVPR will respond with an Approval to both the student and faculty member.
    • For questions or concerns contact the OVPR at ovpr@uconn.edu or Office of Undergraduate Research at our@uconn.edu.

    For more information on safely conducting research during the COVID-19 pandemic, visit the OVPR’s COVID-19 Resource page.

Guidance on Undergraduate Student Participation in Research

Process to request summer Undergraduate Student participation in research. Undergrads will need to be trained on the approved safety plan and have their training documented. The OVPR and Provost’s office will communicate the needed steps for participation in research during the fall semester once the process has been finalized.

  • The Undergraduate Student should complete and submit the Undergraduate Student Research Request Form. Once submitted, this will be emailed automatically to both the Office of Undergraduate Research and OVPR.
  • The faculty member wanting to add one or more undergraduate students to an approved safety plan should complete and submit the Request to Include Undergraduate Students Form.
  • Once BOTH forms are received, the OVPR will respond with an Approval to both the student and faculty member.
  • For questions or concerns contact the OVPR at ovpr@uconn.edu or Office of Undergraduate Research at  our@uconn.edu.

For information about Undergraduate research during the Fall 2020 semester, visit the Office of Undergraduate Research’s website.

Guidance for Reopening Research Involving Human Subjects

This document details the minimum safety procedures that must be in place in order for UConn and UConn Health investigators to be approved by the Office of the Vice President for Research (OVPR) to reopen or initiate new human subjects research. Principal investigators (PIs) must tailor their safety plans to meet the needs of each individual research situation. Environmental Health and Safety (EHS) is available to answer safety related questions from PIs. If you have safety related questions, please email ehs@uconn.edu if your human subject research activities are conducted at the Storrs or regional campuses or call (860) 679-2723 if these activities are taking place at UConn Health.

Guiding principles:

  • Careful planning is required to reduce opportunities for exposure.
  • No individual project involving human subject research activities may be re-started without prior approval from the OVPR.
  • Plan for and operate under the assumption that everyone is an asymptomatic virus carrier.
  • Physical distancing is critical. The recommended minimum distance between individuals is six feet.
  • The smallest number of study personnel possible should conduct approved research until UConn returns to normal operations. This may require the development of cohorts and non-overlapping shifts when scheduling.
  • Research or components of studies that can be conducted without face-to-face interactions or interventions should continue to be conducted remotely.
  • Guidelines will be continually updated as more information about COVID-19 becomes available. Updated guidance will be posted on the OVPR website and communicated to UConn/UConn Health faculty and staff. PIs are responsible for staying informed about changes that will impact human subjects research.
  • If there is a second surge of infection, it may be necessary for research to be ramped down again. During safety planning, consider which studies can be easily halted or delayed. PIs should develop a continuity plan for another potential research ramp-down.
  • Special attention must be paid to risks posed to more vulnerable research subjects (e.g., immunocompromised subjects, older adults with multiple chronic diseases) when evaluating the risks/benefits of subject visits to UConn research facilities.
  • If the facility where the research is being conducted has specific requirements or policies related to COVID-19, then the more restrictive of those or the policies described in this guidance must be followed.

Specific recommendations:

Screening

All participants must be screened for COVID-19 symptoms and exposure. Ideally, participants will be screened prior to entering the research facility (e.g. phone, email, or web-based assessment on the day of the visit) or otherwise being engaged with study interactions or interventions.

Screening Questions

  1. Have you or someone you live with been tested for or diagnosed with COVID-19 in the last four weeks?
  2. Are you experiencing any of the following?
  • Fever (100.4 or higher)
  • Chills
  • New or worsening shortness of breath or difficulty breathing
  • New or worsening cough
  • Muscle or body aches
  • Sore throat
  • Congestion or runny nose
  • Nausea or vomiting
  • Diarrhea
  • New loss of smell or taste

If, such as is currently the case at UConn Health, all individuals entering the facility or building will be screened for COVID-19 symptoms and exposure, then additional screening would not be necessary. If a participant screens positive, then their appointment must be cancelled or rescheduled and the individual should be encouraged to contact their primary care physician and/or the UConn Health COVID Call Center at (860) 679-7560. Temperature screening is not required, but PIs may choose to adopt this measure if it is consistent with campus/building recommendations.

Facial Covering/PPE Requirements

  1. A cloth facial covering or procedure mask must be worn by study personnel and by participants during face-to-face interactions and interventions when:
    • The participant responds NO to COVID-19 Screening AND
    • The participant is located in or from an area or facility with no or only isolated cases AND
    • The interventions are not aerosol generation procedures AND
    • At least six feet of physical distancing will be maintained at all times

Participants and study personnel may wear their own facial coverings. If participants do not provide their own coverings or if their covering fails to cover their nose and mouth, participants must be provided with a procedural mask. Similarly, procedural masks must be available for study personnel. Furthermore, study personnel must keep facial coverings in place regardless of whether participants are present. The use of physical barriers, such as plexiglass, should be considered as additional measures.

  1. Study personnel must wear a procedure mask and face shield during face-to-face interactions and interventions with participants when:
    • The participant responds NO to COVID-19 Screening AND
    • The participant is located in or from an area or facility with no or only isolated cases AND
    • The interventions are not aerosol generation procedures AND
    • At least six feet of physical distancing will NOT be maintained at all times

Participants must continue to wear their own facial coverings or a procedure mask to the fullest extent possible. Participants should remove their mask only briefly (few minutes) if needed for study procedures. If participants do not provide their own covering or if their covering fails to cover their nose and mouth, participants must be provided with a procedural mask. Similarly, procedural masks must be available for study personnel. Furthermore, study personnel must keep facial coverings in place regardless of whether participants are present.

  1. Study personnel must wear an N95, procedure mask, face shield, and gown during face-to-face interactions and interventions with participants when:
    • The participant is known or suspected to have COVID-19 OR
    • The participant is located in or from an area or facility with known or a high likelihood of cases and/or transmission OR
    • Study procedures will not allow the participant to wear a mask or face covering for an extended period of time OR
    • The interventions are aerosol generation procedures

If N95 masks are required, study personnel are required to complete EHS training and certification in order to gain approval for N95 mask usage as outlined in EHS’ Respirator Program Policies, Programs, and Procedures. Medical clearance is also required for study personnel who will be wearing N95 masks. For student personnel, this clearance can be obtained through UConn’s Student Health and Wellness; for other research staff, clearance can be obtained through an Occupational Medicine provider (Storrs and Regional Campus researchers can contact CorpCare in South Windsor). Please contact EHS with any questions pertaining to N95 mask usage.

Relevant Resources

Cleaning/Disinfecting

  1. Research procedure areas, data collection areas, and equipment must be carefully cleaned and disinfected prior to and following use by participants or study personnel. This will include a regular wipe down of shared research equipment and spaces (e.g., desktops) after each participant visit plus a wipe down of shared research equipment and spaces at the end of the day. If participants wish to also wipe down apparatus, they must be provided with disinfectant wipes and encouraged to wear gloves when using them. Please note that any cleaning done by participants does not substitute for the required cleaning by study personnel. If participants are using keyboards, study personnel should put a smooth covering over them. Participants using a shared piece of equipment should also be offered hand sanitizer containing at least 60% alcohol and gloves for optional use during the visit. Participants who choose to wear gloves should be provided with instructions on how to remove and dispose of gloves safely. Hand sanitizer should be available to participants throughout their study visit.

Relevant Resources

To allow for cleaning and ventilation, avoid scheduling immediate and consecutive participant visits to research spaces. If more than one clinic or procedural space is available, use a staggered schedule to alternate visits among rooms. Windows should be open when possible to aid in ventilation.

    Other Considerations

    If study personnel are visiting off-campus, non-UConn affiliated facilities (e.g., schools/camps, clinics, etc.), PIs must adhere to the rules for the site. In all cases, the more stringent of the UConn or site guidelines must be followed. Recommendations for study personnel and participants regarding the wearing of facial coverings/masks, maintaining physical distancing whenever possible, and frequent handwashing must always be followed. Research visits to study participants homes should only be conducted if they can be “contactless,” such as deliveries and pickups of samples. Research visits to long-term care facilities and nursing homes must be conducted in accord with state DPH guidelines.

    UConn Storrs/Regional Campus PIs should contact EHS at ehs@uconn.edu with specific questions about research spaces; UConn Health investigators should contact (860) 679-2723.

    References:

    CDC Infection Control Guidance for Healthcare Professionals about Coronavirus (COVID-19)

     

     

    Guidance for Reopening Research Involving Human Subjects

    The Office of the Vice President for Research (OVPR) has developed new guidance related to resuming human subjects research. The guidance outlines the minimum safety procedures that must be in place in order for UConn and UConn Health investigators to be approved by the OVPR to reopen or initiate new human subjects research. Principal investigators (PIs) must tailor their safety plans to meet the needs of each individual research situation.

    Environmental Health and Safety (EHS) is available to answer safety related questions from PIs. If you have safety related questions, please email ehs@uconn.edu if your human subject research activities are conducted at the Storrs or regional campuses or call (860) 679-2723 if these activities are taking place at UConn Health.

    For more information, visit the OVPR’s COVID-19 Resource page.

    Guidance on the Preparation of NIH Research Performance Progress Report (RPPRs) and COVID-19 Impacts

    The NIH has recently issued guidance regarding the preparation of Research Performance Progress Reports (RPPRs) and the reporting of effects of the COVID-19 pandemic on research projects.

    If an investigator is unable to complete a scheduled RPPR by the due date, a notice should be sent to the Grants Management Specialist and the Program Official to let them know that the report will be late and that research outcomes are not available at that time, as well as an outline of when the investigator will be able to include details related to the disruptions to the research efforts. This notification should be completed as soon as possible and should be developed and coordinated with Sponsored Program Services (SPS). Please work with your SPS Project Officer (UConn Health) or Post-Award Team (Storrs) to develop and submit a notice related to the ramping down of laboratory research on March 23, 2020 and the ramping up of laboratory research on May 20, 2020. Please be aware that the continuation grant award will be delayed and will not be issued until the RPPR has been received and accepted by the NIH.

    RPPRs that are due in the next 90 days and that can be submitted and were affected by COVID-19 should include an explanation on the effect that COVID-19 has had on the project, the steps that have been taken to mitigate the disruption, and plans to address these in the coming award period. If certain research outcomes are not available at the time that the RPPR is submitted, those should be outlined and a timeline should be provided as to when they will be addressed.

    Sponsored Program Services is here to assist you with this process and to answer any questions that you may have related to RPPR preparation and submission. Please contact Paul Hudobenko or your Project Officer at UConn Health or your Pre-Award Grant Specialist at Storrs and the regional campuses as early as possible if you have any questions regarding the preparation and submission of RPPRs. Please also see the following site for information about the ramp up of research at UConn. See NOT-OD-20-086 for additional details on late submission.

    Lab Preparedness Guide & Guidance on Submitting NIH RPPRs

    The OVPR’s COVID-19 Resource page has been updated with new guidance on several aspects of ramping up research activity prior to May 20, 2020, including:

    UConn Research Lab Ramp-Up Preparedness Guide

    The OVPR and Environmental Health and Safety have developed a guide to help researchers safely prepare labs to ramp up research activity after May 20, 2020.

    Guidance on the Preparation of NIH Research Performance Progress Report (RPPRs) and COVID-19 Impacts

    Sponsored Program Services has created guidance for investigators related to submission of NIH Research Performance Progress Reports (RPPRs) during the suspension of research due to COVID-19.

    Contact ovpr@uconn.edu with questions.

    Guidance on Animal Rebreeding in the Vivarium and New Animal Orders

    Version 1, May 5, 2020

    To prepare to resume research on May 20, 2020, researchers will be allowed to begin some rebreeding activities and animal orders.

    Effective immediately:

    • Researchers and research staff may work from 1:00 PM to 7:00 PM.
    • The availability and access to procedure rooms is as usual.
    • No more than a total of two people are allowed in a room at a time. Research groups must coordinate room access among themselves to maintain this density.
    • All individuals must have been previously trained and given access to the vivarium. New individuals without previous access or training are not allowed. Individuals do not need to have been previously listed on a Critical Research Infrastructure request form.
    • Everyone must wear a cloth face covering or the mask provided by vivarium at all times.
    • The Facility Manager for the UConn vivarium or Center for Comparative Medicine staff for the UConn Health vivarium must be contacted a day in advance if assistance will be needed, such as needing large numbers of new cage set-ups for breeding, drug orders, veterinary staff help, or other needs.
    • An amendment should be submitted as soon as possible to the IACUC if the animal number on the approved protocol needs to be increased.
    • Research employees who are not feeling well and experiencing any symptoms of illness should remain at home, not report to work, and immediately contact their manager or supervisor. For more information see Guidance on Research Employees Returning to Work.

    Orders for new animals can resume Monday, May 11, 2020.

    Guidance on Expanding Cell Lines, Propagating Plants, and Initiating Rebreeding of Non-Vivarium Housed Animals/Insects

    Version 1, May 5, 2020

    To prepare to resume research on May 20, 2020, researchers will be allowed to begin some other activities, such as expanding cell lines, propagating plants, and rebreeding of non-vivarium houses animals/insects.

    Effective Immediately:

    • Researchers and research staff may work from 6:00 AM to 7:00 PM, with a limit of no more than four hours per day.
    • No more than two people are allowed in a room/area at a time. Each Research Group must self-coordinate room/area access. For large areas such as large shared labs or research spaces, the greenhouses and fields, personnel density may be more than two, but must ensure at least six feet distancing in all directions for all individuals.
    • Only individuals who have been previously approved on a Critical Research Infrastructure request form are allowed. CRI requests should be amended as needed.
    • Everyone must wear a cloth face covering at all times unless doing so would pose a risk to an individual’s health or safety because of a medical condition.
    • People must come in, do what is necessary, and then leave. No “hanging out,” initiating research activities or experiments, doing other tasks, etc. is allowed.
    • Each researcher is responsible for cleaning/disinfecting all areas where they have worked upon completion.
    • Suspension of research ramp-up may occur at any time depending on circumstances and state guidelines. This could require an immediate discontinuation of all work. All researchers must bear this in mind when considering which research reagents to re-initiate.
    • Research employees who are not feeling well and experiencing any symptoms of illness should remain at home, not report to work, and contact their manager or supervisor. For more information see Guidance on Research Employees Returning to Work.

     

    Guidance on Research Employees Returning to Work

    Version 1, May 5, 2020

    If you are a research employee who is returning to work and you are not feeling well and/or are experiencing any symptoms of illness, please remain at home, do not report to work, and contact your manager immediately.

    If you are experiencing COVID-19 symptoms (e.g., fever, dry cough, body aches, loss of smell or taste, headache), you may wish to contact your personal physician or you should immediately call the UConn Health COVID-19 Call Center at 860-679-3199 for further guidance and then contact your manager. If you are experiencing symptoms, you should not report to work unless cleared by a physician to do so and you may be asked to wait until at least one week or longer has passed since the onset of symptoms, symptoms have improved, and you have been free of fever without any fever-reducing medications for at least 72 hours.  

    If you have been exposed outside of work to a COVID-19 symptomatic or positive individual, you should call the UConn Health COVID-19 Call Center at 860-679-3199 for further guidance and also contact your manager. If you have been exposed for a prolonged period of time to a co-worker who is positive for COVID-19 and it is known to the University, you will be contacted by your manager. You may be instructed, depending on the date of last known contact or length and circumstances of the contact, to self-isolate and self-monitor for a recommended period of time up to 14 calendar days from the date of exposure. If you are determined to be at low risk, you may be instructed to self-monitor and can report to work as normal. 

    If you were not in prolonged close contact and are considered to be an individual who is at low risk for exposure, you may be eligible to continue working. A close contact is defined as an individual who has been within six feet for a prolonged period of time (i.e., for longer than 15 minutes) or has had direct contact with the infectious secretions of a COVID-19 case (for example, being coughed on while not wearing any PPE). Close contact does not include a brief or passing interaction with an individual.

    If you have any questions and work at UConn Health, please contact HR-EmployeeResources@uchc.edu. If you work at Storrs or any one of the regional campuses, please contact hr@uconn.edu.

     

    Message from the Office of the Vice President for Research – COVID-19 Update

    Consistent with Governor Lamont’s April 30th Update on Connecticut’s Coronavirus Response Efforts, the OVPR is targeting a phased reopening of UConn and UConn Health research programs to begin on May 20, 2020 (Phase 2 in the posted Ramp-Up: Phased Process for Reopening Research at UConn and UConn Health). This document provides guiding principles and processes for a phased approach to reopening research at UConn and UConn Health while addressing state and federal directives and guidelines related to COVID-19. Instituting a similar process will be established for the Arts and Humanities that reflects the specific needs and concerns of scholarly activity in those areas.

    Important Documents

     

    Principles

    • The health and safety of faculty, staff, students, patients, the public, and human research subjects will be protected.
      • Directives and guidance from local, state, and federal authorities to minimize disease spread and exposure will be followed, such as restrictions related to essential businesses, social distancing, reduced density, stay-at-home, and masks.
      • Faculty, staff, and students are not required to work in either on-campus research or in field research while stay-at-home directives are in effect, or in a manner contrary to current and applicable directives and guidance from local, state, and federal authorities. Faculty, staff, and students may choose to work either on campus or in field research while stay-at-home directives are in effect, but their choice to do so must be made voluntarily and without undue influence or coercion. Any request to work on campus or in field research can be declined at any time without any fear of retaliation or retribution while work-from-home directives are in place. Any concerns can be reported anonymously through the REPORTLINE by calling a toll-free number at (888) 685-2637, the Office of University Compliance’s website, or the Ombuds Office. The University welcomes and encourages good-faith reporting. As such, individuals who submit a report or participate in a compliance investigation in good faith are provided protection from retaliation per the University’s Non-Retaliation Policy.
      • On-campus or field research can proceed only to the extent it can be done safely and in compliance with regulatory requirements and University policies. Safety must be rigorously maintained. All University policies and requirements, as well as all local, state, and federal regulatory requirements remain in place and must be followed, unless there is written guidance or documentation that they have been modified or suspended.
      • Research involving human subjects can proceed only to the extent it can be done safely and in a manner that protects the health of the subjects, researchers, and research staff. Human subjects research must follow current applicable directives and guidance from local, state, and federal authorities to minimize disease spread and exposure. All University policies and requirements, as well as all local, state and federal regulatory requirements remain in place and must be followed, unless there is written guidance or documentation that they have been modified or suspended.
      • Undergraduate students will not be involved or allowed to participate in on-campus or field research activities until the University opens and these students are allowed to return to campus.
      • Principal Investigators (PIs) remain responsible for providing direction and oversight of their projects, labs, and/or research sites, and personnel including graduate students, postdoctoral fellows, and staff.
    • Researchers must maintain plans and be prepared to halt all activities on short notice if this becomes necessary.
    • The ramp up of research will be through a transparent and phased process.
      • A publically available working document outlining the phased approach will be maintained and serve as guidance for the ramp up process.
    • Two groups have been established by the Vice President for Research, Innovation and Entrepreneurship (VPRIE) to provide guidance and oversight for the process:
      • The Critical Infrastructure Workgroup comprised of five associate research deans. This group reviews and approves projects, and also provides expert guidance on research needs.
      • Research Ramp up Advisory Group. This group is comprised of senior representatives from various areas, providing a broad range of infrastructure expertise, such as Environmental Health and Safety, Public Safety, Facilities, the Graduate School, Office of the Provost, Core Facilities Directors, Human Resources, and others. This group provides guidance on the support infrastructure that is required to allow research to move forward.

    Phased Ramp Up

    Phase 0: Maintain Critical Research Infrastructure (March 13, 2020 – Present)

    This includes unique reagents, unique cell lines, equipment, liquid nitrogen stocks, and certain long-term experiments where data integrity would be compromised by halting or stopping the projects. The process for review and approval of these projects using the Critical Research Infrastructure Inventory (CRI) form has been in place since March 23rd. This process is also in place to approve the initiation of new projects directly related to COVID-19. Researchers should continue to use this process for applicable projects.

    Pilot/Limited Research Activity Approval

    The Critical Research Infrastructure process is being expanded to allow immediate time-limited access to on-campus research labs in order to generate targeted research to support impending grant deadlines and contract resubmissions, competitive renewals, response to manuscript or other reviewer comments and other similar needs.

    This is not a ramping up or reopening of the labs and research areas to resume usual research. The process for the Phased reopening of research after May 20th is under development.

    Project Criteria for Pilot/Limited Research Activity Approval:
    • Work can be conducted with a limited number of individuals in the lab at any one time
    • All work can be fully completed within two to four weeks
    • The work is necessary to produce data in support of an application due within the next 45 days
    Submission Process:

    Questions should be sent to ovpr@uconn.edu

    Phase 1: Prepare to Resume Research (Present – May 19, 2020)

    • Activities conducted by a limited number of people, with time limited access to minimize personnel density
    • Develop and require training on COVID-19 related to University, state, and federal guidelines, directives, and requirements
    • Begin re-breeding, expansion of cell lines, plant propagation, etc.
    • Limited, reopening of work areas and labs to assess readiness and needs to restart, check, and restart equipment, and identify needed supplies
    • Allow reordering of supplies, materials, animals, chemicals, biologicals, etc. needed to restart projects
    • Coordinate with other units such as facilities, purchasing, and finance to identify and address cross unit impact of ramp up
    • Re-open core research facilities

    Related Guidance

    Phase 2: Limited Reopening (Begins May 20, 2020)

    • Personnel density increased in a manner that is consistent with federal and state guidelines and directives
    • Requests for Phase 2 projects are submitted using the Resuming Research Activity form (currently only available for Phase 1) and include a COVID-19 Safety Plan
    • Identify projects halted or stopped as part of ramp-down not involving chemical or radiological hazards and prioritize for phased restart
      • Prioritization of groups such as graduate students and postdocs close to completing their degree/term of appointment; grants within three months of their end dates and where the funding agency has not provided flexibility in no cost extensions.
    • Restart field studies depending on conditions/requirements/restrictions at field sites, such as travel restrictions, stay-at-home directives, and density and social distancing requirements
    • Humanities, arts, and social science research that requires access to single occupancy spaces (e.g., office, private studio)
    • Restart human research projects involving direct subject interactions and interventions conducted at UConn Health or University facilities that were halted or stopped as part of ramp-down

    Phase 3: Expanded Reopening (To be determined)

    • Personnel density increased in a manner that is consistent with federal and state guidelines and directives
    • Requests for Phase 3 Projects are submitted using the Resuming Research Activity form (currently only available for Phase 1) and include a COVID-19 Safety Plan
    • Identify projects halted or stopped as part of ramp-down involving chemical or radiological hazards and prioritize for phased restart
    • Restart human research projects involving direct subject interactions and interventions conducted off campus that were halted or stopped as part of ramp-down
    • Restart humanities, social science, and arts research/scholarship involving direct interpersonal interactions or engagement

    Phase 4: Transition to Research as Usual (To be determined)

    • Begin initiation of new projects
    • Project submissions no longer required to use the CRI process
    • Open all research facilities