COVID-19 Research FAQs Archive

Phase 4:

The following FAQs provide Phase 4 specific information that is supplemental to the Human Subjects Research Phases Table. 

Please read these FAQs before submitting an Individual PI Plan to resume or initiate Phase 4 research.  

 

What general considerations apply for human subjects research which may qualify to resume during Phase 4? 

Researchers must meet the requirements of the VPR Resumption of Research Phased Plan (training & individualized plan submission for Phases 2-4) before conducting any human subjects research. Both the researcher training completion and the individualized plan for research workspace/personnel are automatically routed by the VPR’s office to the respective department chair for evaluation. Each potential point of transmission risk should be carefully considered and detailed in the investigator’s plan, including clear descriptions of the ways that risk will be mitigated/controlled. Submit plans to resume or conduct research qualifying for Phase 4 at https://uky.az1.qualtrics.com/jfe/form/SV_0V3V83mWOAzdDzn.

Generally, conditions for research conducted in the community, inside the home of an individual human participant, or at an external facility, are outside of the investigator’s control.  In-person research in which transmission risks cannot be adequately controlled by the research teams, requires Pre-Approval by the Office of the Vice President for Research. Plans should address safeguards within the researcher’s capability, such as maximization of PPE and rigorous screening protocols. 

The same guiding principles of social distance/physical barriers, appropriate personal protective equipment (PPE), and performance of remote human subjects research activities, whenever possible, remain as first-choice options for all research eligible in Phase 4.  In addition, the VPR Phased Resumption Plan includes Key Points for Minimizing COVID-19 exposure and transmission at all phases (see Health and Safety Measures for specific workspace guidance).

What specific restrictions or requirements are there for Phase 4 research?  

Research conducted during Phase 4 must continue efforts to mitigate risk of transmission:

• Research with individuals who are “at risk” (e.g., elderly, pre-existing conditions) in which participation does not offer direct benefit to the individual should employ maximum safeguards to protect “at risk” volunteers.
• In-person interaction involving physical contact, should continue to employ safeguards such as minimal time exposure with a single participant, minimal staff present and applicable personal protective equipment (PPE) (e.g., N95 masks, gowns, gloves, eye protection or face shields or barriers). Brief interactions are less likely to result in transmission of virus. Thus, decisions should be made consistent with current CDC recommendations (https://www.cdc.gov/coronavirus/2019-ncov/php/public-health-recommendations.html),
• Where possible, research with in-person group meetings of 10 or more should be conducted outdoors or in facilities allowing a minimum 6-foot social distancing or physical barriers and adequate air exchange.  

• Regarding procedures involving aerosolized saliva, the American Thoracic Society recommends that pulmonary function testing be limited only to cases that are essential for immediate treatment decisions, and that measures to protect both the staff and individuals being tested should be put in place. Research procedures that result in aerosolizing saliva include, for example, sputum induction, pulmonary function tests in nonclinical space, sputum culture, pulmonary exercise tests, vigorous exercise resulting in increased and/or forceful respiration, and singing. The following protective measures are recommended: PPE that limits aerosolized droplet acquisition for staff (mask, eye protection, shield, gown, gloves), and enhanced sanitizing of the testing space. Other in-door research procedures or activities that result in aerosolizing saliva (e.g., vigorous exercise, singing) are advised to implement similar protective measures. 

In transitioning to Phase 4, are there specific human participants research populations that warrant additional safeguards or support? 

During human interaction, researchers should apply universal precautions as anyone is a potential carrier of COVID-19. However, the CDC has defined populations that may need extra support, access, or precautions (e.g., homeless people, people with disabilities, refugees, etc.). Population specific guidance is available at https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/index.html. 

Can undergraduates serve as research personnel in human participant research studies that take place during Phase 4?  

Consistent with the VPR Plan (Section D), during Phase 4, graduate students and postdoctoral fellows continue research. Undergraduates can participate in research but[SB1]  should be re-tested prior (7 days) to entering the laboratory and PI plans should be updated to include these and other researchers within their programs during phase 4, with attention to following safety guidelines. Human participants research that poses special situations where risk mitigation is complicated can be performed with special pre-approval (which requires submission of a revised PI plan describing the research personnel, space usage and approach needed to reduce risk as much as possible). In general, high school students are not allowed in research workspaces during Phase 4 unless they have been pre-approved within revised PI plans. This would include requirements for testing through UK Health Corps and receiving information on safety practices and procedures when performing research during the COVID-19 pandemic.

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  Phases for Resumption of Human Subjects Research

• What is the current status of human subjects research at UK? 

• How do I determine if I can conduct in-person research? 

• Human Subjects Research Phases Table

• Once I am permitted to resume the paused research, will there be any restrictions on locations?

• What if my research study is included in the “allowed” category, but I am not able to comply with precautions and safety guidelines related PPE, physical distancing, and maximum occupancy in a facility?

• When can I resume my community-based research?

• What are some issues I should be aware of when resuming community-based research?

• What precautions should I take if I am conducting in-person research?

• Should I implement any special procedures in my research space to protect study personnel and research participants from exposure?

• Do I have to call to pre-screen all participants before they come in for a scheduled research visit?

• What screening protocol should I use when interacting with research participants?

• Are positive COVID-19 test results reportable to the state of Kentucky?

• After research reopens if a subject or research team member is discovered to have tested COVID positive or presumptive positive with 2 weeks of an in-person research visit, would we promptly report to the IRB as an Unanticipated Problem involving Risks to Subjects or Others (UPIRSO)?

• What do I need to know to submit/conduct COVID-19 research? 

• What is the PREP Act and what should subjects in COVID-19 interventional trials be told in the informed consent about liability limits? 

• Are there other resources I can view for further guidance? 

• What if my research involves a public health authority or public health surveillance?

• What public health surveillance activities are deemed not to be human subject research under the revised Common Rule?

 

 

What is the current status of human subjects research at UK? 

Please refer to the VPR’s University of Kentucky Resumption of Research Phased Plan for guidance on the current phase and the ORI Human Subjects Research Phases Table to determine if your human research is allowed to resume in the current phase after meeting all requirements outlined below.

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How do I determine if I can conduct in-person research?

This determination is a combination of:

• Meeting the requirements outlined in the VPR Resumption of Research Phased Plan (i.e., waiver for Phase 1, training & individualized plan submission for Phases 2-4);
• Compliance with the Human Subjects Research Phases Table; and
• Permission from your Department Chair or Center Director.

The phased approach and these guidelines provide a baseline framework from which additional variables must be considered.

1. Continuing or resuming human research is contingent on active COVID-19 cases, available testing and contact tracing, and compliance with health authority guidance from national, state, local, and University authorities.
2. Polices and guidance will be dynamic and may accelerate or decelerate based on shifting information and incidence data. Researchers must be prepared to halt activities on short notice if this becomes necessary based on new information.
3. Resuming human research operations must be parallel to and consistent with the institutional and VPR’s plans, as well as specific facility, college, and/or unit mandates. 

Investigators may choose to be more stringent or cautious than phases allow. 

It is critical to keep research participants informed of study status and changes that could impact them. Respect participant wishes regarding resuming in-person interaction.

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                         Human Subjects Research Phases Table

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Once I am permitted to resume the paused research, will there be any restrictions on locations?

Please refer to the VPR Resumption of Research Phased Plan for UK locations. For other research locations/facilities, determine whether those locations/facilities have any restrictions or requirements for human subjects research. With pre-approval, human participants research that takes place in different settings such as homes, churches or other parts of the community, may resume; however, mitigating risk as much as possible will require advance coordination, contingency planning and responsiveness to evolving situations.

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What if my research study is included in the “allowed” category, but I am not able to comply with precautions and safety guidelines related PPE, physical distancing, and maximum occupancy in a facility?

Research must be included in the allowable category AND meet safety guidelines to resume operations.  This includes PPE and sufficient space or barriers to allow physical distancing.

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When can I resume my community-based research?

In general, most community-engaged research protocols will fall into phase 4 research resumption. For guidance, see the Human Subject Research Phases Table. Much of community-engaged research involves face-to-face interaction or group activities; research teams that interact with individuals in community settings potentially pose a public health risk to both data collectors and to the communities in which they work.

In-person community-engaged research protocols should not resume unless standard safety recommendations can be implemented (social distancing, hand washing, mask wearing, and overall risk mitigation to the extent possible) and contact tracing is in place. For guidance, see the FAQ: What precautions should I take if I am conducting in-person research? Once research meets the phased criteria to resume, travel to and from community sites may be permitted, if compliant with university limitations/restrictions, interaction with members of the public is minimized, and the above safety recommendations are maintained. Even in phase 4, in-person research in which transmission risks cannot be fully controlled by the research team (e.g., research in public settings, participants’ homes, churches, etc.), will require pre-approval by the Office of the Vice President for Research.

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What are some issues I should be aware of when resuming community-based research?

Community-engaged research protocols offer special challenges to the health and safety of research personnel and participants. While investigators must follow the same research resumption protocols as their non-community-engaged researcher colleagues (Department Chair/Center Director permission), guidance below is meant to assist generally to promote safety and well-being. For protocol-specific inquiries, contact ORI with the applicable protocol number and request an IRB consult to discuss resumption of research activities.

Investigators must determine appropriate local and community restrictions, requirements, and limitations pertinent to the conduct of the community-engaged research protocol. In an effort to prevent exposure of potential participants, research teams, and the general public to the COVID-19 virus, please follow any restrictions or requirements issued for/by the locations/facilities in which the human subjects research takes place.

If the research involves special circumstances or populations (e.g., minors in a school or other settings such as a community center), it is important to abide by the rules of the location but also make sure that parents and others who give consent are fully informed about risks and any measures taken to minimize those risks.

Unlike on-site research interactions, community-based research interactions may reach extensive networks of people, increasing the potential for rapid and mass exposure. Such exposure may make contact tracing with suspected or confirmed cases more challenging.

Research staff and participants may not know they are COVID-19 positive and could be carriers of the virus. For guidance on pre-screening potential research participants prior to in-person interaction, see the FAQ What precautions should I take if I am conducting in-person research?

When resuming community-engaged research activities, investigators and their teams are encouraged to provide educational resources to their participants. See the UK Community Resources for COVID-19 website.

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What precautions should I take if I am conducting in-person research?

As in-person research interactions are permitted under the phases, researchers must consider how to modify in-person participant interactions to reduce the risk of COVID-19 transmission for both participants and the research team.

Researchers must: 

• Develop robust testing protocols for staff testing, contact tracing, and self-isolation should a study team member test positive (along with reporting to the Kentucky Department of Public Health).
  • Before coming to work, all faculty and staff are required to self-screen each day for signs of COVID-19 symptoms.   
  • Research staff who work at any UK Healthcare facility complete the UK Healthcare Staff Screening - https://covid-19.ukhc.org/employee-screening-for-covid-19/.
  • Employees scheduled to work on-site but who are not feeling well and/or are experiencing any symptoms of illness must stay at home, and immediately contact their supervisor.
  • Temperature checks may be performed prior to entering select research spaces or at discretion of investigator.
• Avoid all participants with confirmed or presumptive positive COVID-19 infection or who require potentially aerosolizing procedures, unless this is the focus of the study.
• Require the use of and supply Personal Protective Equipment (PPE). Address training status for nonclinical research personnel who need to be within 6 feet of participants, if appropriate for the study. Address sources of PPE for research use for staff and participants. Address methods to reduce PPE usage by all personnel, including combining research with clinical blood draws.
• Decrease potential exposure for participants and study staff at increased risk of severe illness from COVID-19. People at higher risk include people who:
  • are over 60 years of age,
  • have underlying health conditions including heart disease, lung disease, or diabetes,
  • have weakened immune systems,
  • are pregnant,
  • are caregivers of children with underlying health conditions or adults who meet any of the criteria listed above.

Inform participants who may be vulnerable to contracting COVID-19 to review the  
CDC guidelines for Groups at Higher Risk for Severe Illness. Enable participants to make an informed decision about personal risks related to COVID-19 and respect their wishes. 

• Reduce face-to-face interactions with research participants and minimize the amount of time (e.g., < 15 minutes) of any required contact. Strategies may include physical barriers between research personnel and participants, or using technology (e.g., telephone, FaceTime, email, intercoms) to conduct interviews and obtain data.
• Continue remote telework for researchers or research staff whose responsibilities do not require on-site activities (e.g., regulatory specialist, administrative staff, survey researchers). Limit in-person research team meetings to those which allow personnel to maintain physical distancing procedures.
• Develop contingency plans in the event of staff illness or exposure.
• Close access to common areas where possible (e.g., waiting areas, staff break areas, etc.).
• Have a protocol for noncontact screening of participants and study staff for active symptoms of acute respiratory infection possibly related to COVID-19 or high risk of infection. This may be accomplished by communication with participants, care providers, chart review, screening surveys, or other options prior to approaching potential research participants. Individuals with active symptoms or in social isolation (e.g., due to travel history or exposure to someone with COVID-19 symptoms) should be avoided.
• Comply with UK and CDC guidance regarding sanitation of facilities and workspaces.
• Maintain targeted occupancy limits that permit physical distancing. This may require both physical separation of study personnel and staggered schedules and may require flexibility in work scheduling.
• Stagger participant visits so participants do not congregate at the research site and maintain at least six feet of separation between any participants who are present.

Researchers should also:

• Follow any guidelines or instructions from the specific facility (e.g., college, hospital, clinic) where the participant interaction would occur (e.g., screening).
• Consult with the study sponsor, when appropriate.

• Encourage remote monitoring by industry monitors or representatives. In-person sponsor visits may not occur until restrictions are lifted by local or institutional authorities.

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Should I implement any special procedures in my research space to protect study personnel and research participants from exposure?

Please refer to the VPR Resumption of Research Phased Plan on personnel safety. 

Identify the specific sources of COVID-19-related risks. Specific issues to consider include:

• Minimizing the number and duration (<15 minutes) of close interactions or actual physical contact between participants and your study team and/or other participants (e.g., a blood draw or physical exam) as much as possible.
• The feasibility of physical distancing and maintaining target occupancy limits.  
• Use of physical barriers to reduce transmission risks.
• The availability of appropriate personal protective equipment (PPE).
• Screening before participant interactions.
• The necessary equipment or other items that will be used with multiple participants (e.g., a virtual reality headset, a computer-administered questionnaire, or a sensing device).
• What surfaces and objects will be touched by participants, including items at the research location (e.g., chairs, desktops, research equipment and devices, doorknobs).
• The availability and frequency of disinfection and cleaning procedures for frequently touched surfaces.
• Provision of adequate hand washing and sanitizing stations, etc.
• If the research procedures include testing participants for SARS-CoV-2 or serological antibodies, identify any restrictions (e.g., CLIA lab analysis) or requirements that apply (e.g., care referral and reporting for positive cases).
• All labs receiving COVID-19 patient specimens must have approval from the Institutional Biosafety Committee (IBC). Labs with current approvals for human source material will need to submit an amendment to their protocol. Registration information is available at https://ehs.uky.edu/Biosafety/ and protocols are submitted via https://topaz.uky.edu/. Email biosafety@uky.edu with questions regarding new protocol submissions or amendment creation.

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Do I have to call to pre-screen all participants before they come in for a scheduled research visit?

Continued pre-screening is recommended consistent with your approved plan.  For instance, rigorous pre-screening may be indicated for approval during Phase 4 to conduct research in the participant’s home or external facilities.

COVID-19 pre-screening calls do not require submission of a Modification Request as long as done for safety purposes and not research data collection. More details about screening are provided below.

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What screening protocol should I use when interacting with research participants?

All research teams are advised to review and comply with facility, location, and/or department procedures for screening all participants.

Research teams are encouraged to initiate these screening procedures in advance of scheduled research visits and to cancel or reschedule visits for persons with current symptoms of a lower respiratory infection. Participants must “pass” screening to be seen in an academic or medical space.

In general, the following screening questions should be asked in advance of the scheduled visit:

• Has the participant had close contact with a confirmed COVID-19 positive individual for at least 15 minutes within the past 14 days? Close contact is defined by the CDC as:
  1. being within approximately 6 feet of a COVID-19 case for a prolonged period. Close contact can occur while caring for, living with, visiting, or sharing a health care waiting area or room with a COVID-19 case, or
  2. having direct contact with infectious secretions of a COVID-19 case (e.g., being coughed or sneezed on).
• Has the participant traveled to any locations confirmed by the Centers for Disease Control and Prevention to have widespread community transmission of COVID-19 in the past 30 days? See https://www.cdc.gov/coronavirus/2019-ncov/travelers/index.html for an updated list of areas with widespread community transmission.
• Does the participant have symptoms of a lower respiratory tract infection (e.g., cough, fever, sore throat, or shortness of breath, or loss of smell/taste) or gastrointestinal symptoms (e.g., diarrhea, nausea)?

If the answer to any of the questions above is “Yes,” terminate the visit and refer the participant to a medical facility for screening and care.

If interaction is taking place in a medical facility, follow medical facility directions on management of COVID-19 positive participants.

Screening outcomes:

• Document participant responses.  If all is well, proceed with scheduling the visit and inform participant and/or caregiver regarding applicable visit procedures for on-site screening (e.g., registration screening; temperature checks), requirement to wear masks, and prohibition on bringing guests to the visit.
• If at least two weeks have passed since leaving an area of widespread transmission or exposure to a known COVID-19 case, and they have no symptoms of a lower respiratory tract infection, then the study visit may occur.
• If it is less than two weeks since their potential COVID-19 exposure and the participant has no symptoms, the study investigator should assess the potential risks and benefits of continuing the research visit versus rescheduling the visit until after the two-week period, if feasible.
• If the participant has symptoms of a lower respiratory tract infection, the investigator should consult the appropriate hospital resources to determine the next steps for evaluation and management. 

Once participant is on-site, conduct screening procedures consistent with facility requirements, unless screening performed by facility staff upon entry or registration staff. 

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Are positive COVID-19 test results reportable to the state of Kentucky? 

Yes, positive or presumptive positive SARS-CoV-2 results must be reported to public health authorities in the state of Kentucky. They may not accept results that come from a lab which is not certified by the federal CLIA program or state equivalent. If you obtain a positive result, report it to the state of Kentucky and, if required, UK HealthCare. If the test is not a recognized/verified test, you should tell the participant about the result and the limits of that test, then encourage them to get a valid test from a healthcare facility. Find instructions under the “Healthcare Providers” section under “Resources” on the Kentucky Public Health COVID-19 website: https://govstatus.egov.com/kycovid19.

Guidance from the Office for Human Research Protections (OHRP) Guidance on COVID-19 states: “Legally Required Reporting: When required by law to provide information related to an individual's COVID-19 test results to a public health authority, including individually identifiable information about individuals who are research participants, the HHS protection of human subjects regulations do not prevent investigators or institutions from fulfilling this requirement (even if doing so would be inconsistent with statements made in the study's consent form). The existence of a Certificate of Confidentiality[3] does not alter an investigator's ability to disclose a research participant's COVID-19 test results when required by federal, state, or local laws. For example, if a research participant tests positive for COVID-19, an investigator may provide this test result to a public health authority if required to do so under applicable state or federal law. In such circumstances, investigators should inform the participant of the required reporting of results.” [https://www.hhs.gov/ohrp/regulations-and-policy/guidance/ohrp-guidance-on-covid-19/index.html]

For Questions About Screening, Testing or Tracing? Contact Our Health Corps.
Call 859-218-SAFE(7233)
Email healthcorps@uky.edu
Hours of Operations:
Monday-Friday 8 a.m. - 8 p.m.
Saturday-Sunday 10 a.m. - 5 p.m.

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After research reopens, if a subject or research team member is discovered to have tested COVID positive or presumptive positive with 2 weeks of an in-person research visit, would we promptly report to the IRB as an Unanticipated Problem involving Risks to Subjects or Others (UPIRSO)?

An Unanticipated problem involving risks to subjects or others (UPIRSO) - includes any incident, experience, or outcome that meets all of the following criteria:

1. Unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are described in the protocol-related documents, such as the IRB-approved research protocol and informed consent document; and (b) the characteristics of the subject population being studied;
   Consider whether unexpected in frequency given the presumed measures that in place to mitigate risks.  Might be expected for COVID-19 research.
2. Related or possibly related to participation in the research; and
   Could it have occurred because of an in-person research interaction/intervention? Likely if interaction is for research and not concurrent with other interaction.
3. Suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.

Answer: Likely so since a positive result (including presumptive positive) suggests others are at greater risk of virus transmission than was previously known or recognized.

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What do I need to know to submit/conduct COVID-19 research?

The document below includes information on submitting new or updating existing research which focuses on COVID-19.

Conduct and Submission of COVID-19 Research in Human Subjects [PDF]

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What is the PREP Act and what should subjects in COVID-19 interventional trials be told in the informed consent about liability limits?

On March 10, 2020, the HHS Secretary issued a Public Readiness and Emergency Preparedness (PREP) Act Declaration which was amended effective March 27, 2020 that provides liability immunity (except for willful misconduct) for claims of loss caused, arising out of, relating to, or resulting from manufacture, distribution, administration or use of countermeasures to diseases, threats, and conditions determined by the Secretary to constitute a public health emergency to entities and individuals involved in the development, manufacture, testing, distribution, administration, and use of such countermeasures.

PREP limits legal rights to sue covered persons engaged in select COVID-19 countermeasures (including select treatment research) and provides compensation for eligible individuals who suffer injuries from use of covered products. 

Covered Countermeasures may include vaccines, drugs, or medical devices to be used to treat, diagnose, cure, prevent, or mitigate COVID-19. 

Products must be:

1. a qualified pandemic or epidemic product;
2. a security countermeasure;
3. a respiratory protective device approved by NIOSH;
4. approved, licensed, or cleared by FDA;
5. authorized under an Emergency Use Authorization (EUA) issued by FDA;
6. described in an Emergency Use Instructions (EUI) issued by the CDC; or
7. used under either an Investigational New Drug (IND) application or an Investigational Device Exemption (IDE).

In addition to meeting the scope of the act, reasonable precautions must be taken to facilitate the safe use of covered countermeasures.  See the PREP Act Q&As and PREP Act Glossary for detailed information.

CONSENT LANGUAGE:

The following statement should be added to the informed consent for applicable COVID-19 studies, in order to inform participants regarding their legal rights.

Due to the coronavirus public health emergency, the federal government has issued an order that may limit your right to sue if you are injured or harmed while participating in this COVID-19 study.  If the order applies, it limits your right to sue and recover losses from the researchers, healthcare providers, any study sponsor, distributor or manufacturer involved with the study. However, the federal government has a program that may provide compensation to you or your family if you experience serious physical injuries or death. To find out more about this “Countermeasures Injury Compensation Program” please go to https://www.hrsa.gov/cicp/about/index.html or call 1-855-266-2427.

If participants have questions about the Countermeasures Injury Compensation program (CICP) direct them to the CICP website which provides Requester FAQs, Fact Sheet and contact information.

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Are there other resources I can view for further guidance?

• UK Vice President for Research (VPR) COVID-19 Guidance for Researchers https://www.research.uky.edu/resources/covid-19-guidance-researchers
• UK Institutional Biosafety COVID-19 Guidance - https://ehs.uky.edu/biosafety/ (Scroll down to COVID-19)
• UK Healthcare COVID-19 Website -  https://covid-19.ukhc.org/ includes guidelines, TeleCare Toolkit, FAQs, Infection Prevention and Control, UKHC Employee Screening and Resources. 
• UK Healthcare Staff Screening - https://covid-19.ukhc.org/employee-screening-for-covid-19/
• UK COVID-19 FAQs -  https://www.uky.edu/coronavirus/faqs
• Employee and Human Resources Information - https://www.uky.edu/coronavirus/faqs#hr
• Campus Restart - https://www.uky.edu/coronavirus/faqs#restart
• Kentucky Public Health -  https://govstatus.egov.com/kycovid19  (Scroll to RESOURCES for Guidance by Topic and Healthcare Provider Information on Case Reporting)
• Kentucky COVID-19 hotline provides guidance for individuals in the state of Kentucky with symptoms 800-722-5725
• Centers for Disease Control and Prevention Coronavirus website https://www.cdc.gov/coronavirus/2019-ncov/index.html
• Council on Governmental Relations (COGR) Research Ethics & Compliance Committee - Human Subjects FAQs May 4, 2020 (Version 1.0) 
  https://www.cogr.edu/sites/default/files/FAQS%20ON%20HUMAN%20SUBJECTS%20for%20REC%20final%20may%204%202020.pdf
• Food and Drug Administration (FDA) "Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment" https://www.fda.gov/regulatory-information/search-fda-guidance-documents/assessing-covid-19-related-symptoms-outpatient-adult-and-adolescent-subjects-clinical-trials-drugs
• "FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency" (Updated September 21, 2020)https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-guidance-conduct-clinical-trials-medical-products-during-covid-19-public-health-emergency
• Food and Drug Administration (FDA) "FDA Digital Health Policies and Public Health Solutions for COVID-19"
  https://www.fda.gov/medical-devices/digital-health/digital-health-policies-and-public-health-solutions-covid-19
• National Cancer Institute Central IRB (NCI-CIRB) "Memorandum On Interim Guidance For Patients On Clinical Trials Supported By The NCI Cancer Therapy Evaluation Program And The NCI Community Oncology Research Program (NCORP)"
  https://www.ncicirb.org/announcements/memorandum-interim-guidance-patients-clinical-trials-supported-nci-cancer-therapy
• National Cancer Institute Central IRB (NCI-CIRB) "Interim Guidance for Patients on Clinical Trials Supported by the NCI Cancer Therapy Evaluation Program and the NCI Community Oncology Research Program (NCORP)" (March 13, 2020)
  https://www.ncicirb.org/announcements/memorandum-interim-guidance-patients-clinical-trials-supported-nci-cancer-therapy
• National Cancer Institute Central IRB (NCI-CIRB) "Additional Guidance Regarding Alternative Procedures for Clinical Trials Supported by the NCI Cancer Therapy Evaluation Program(CTEP) and NCI Community Oncology Research Program (NCORP) Affected by the Spread of the Novel Coronavirus" (March 23, 2020)
  https://ncicirb.org/sites/ncicirb/files/Memo_Additional_Guidance_Clinical_Trial_Activities_Affected_Coronavirus.pdf
• National Institutes of Health (NIH) has issued notices on the NIH Extramural Response to Natural Disasters and Other Emergencies website
  https://grants.nih.gov/grants/natural_disasters.htm
• Office for Civil Rights (OCR) "Notification of Enforcement Discretion for Telehealth Remote Communications During the COVID-19 Nationwide Public Health Emergency"
  https://www.hhs.gov/hipaa/for-professionals/special-topics/emergency-preparedness/notification-enforcement-discretion-telehealth/index.html
• Office for Human Research Protections (OHRP) Guidance on COVID-19 https://www.hhs.gov/ohrp/regulations-and-policy/guidance/ohrp-guidance-on-covid-19/index.html

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What if my research involves a public health authority or public health surveillance?

If you think your work is public health surveillance in addition to (or instead of) research, please fill out a UK Not Human Subjects Research (NHR) form after obtaining documentation (e.g., email) that describes the specifics of any involvement of a public health authority. You should include the following in the summary of the NHR form:

• a brief description of the role of the public health authority (e.g., design, coordination, direction);
• clarification of whether the public health authority plans to use the data to make decisions; and
• if so, when and for what purpose the data will be used.

This information is important because it impacts the type of IRB review required (if any).  

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What public health surveillance activities are deemed not to be human subject research under the revised Common Rule?

• The activity must be a public health surveillance activity (45 CFR 46.102(l)(2));
• The activity must be conducted, supported, requested, ordered, required, or authorized by a public health authority (45 CFR 46.102(k) and 46.102(l)(2)); and
• The activity must be limited to that necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products) (45 CFR 46.102(l)(2)).

However, FDA regulations may apply if this involves use of an investigational in-vitro diagnostic device.

Detailed guidance is available from the Office for Human Research Protections (OHRP).

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The following provides guidance for human research regarding studies:

Which human subject research studies should be paused during the COVID-19 pandemic?

Studies that involve contact with study subjects but have no direct benefit to the subject should be paused until further notice.

Examples of paused studies include:

• Studies collecting human samples or imaging that require study subject contact (e.g., phlebotomy, surveillance biopsy, radiographic imaging, physical examination) without direct diagnostic or therapeutic benefit;
• Interview studies that can’t be conducted remotely;
• Observational studies involving group gatherings;
• Community studies.

Examples of studies not included in the pause:

• Clinical trials with treatment arms (e.g., oncology clinical trials, interventional studies for devices or therapies with significant benefit to subjects). For purposes of the pause, it is assumed that trials with investigational treatments, including drugs and devices, provide the potential for benefit and should continue.  Investigators should weigh the benefits of the treatment arm against the risks of COVID-19 exposure for study staff or research subjects as they make a decision about continuing these projects;
• COVID-19 studies, observational or interventional;

• Data collection only that can be conducted remotely (e.g., EMR, previously collected) Studies that do not involve any subject contact (e.g., UK Healthcare Zoom, UK Telehealth, REDCap). Refer to UK IT Cybersecurity Best Practices When Working Remotely. (Updated 3/30/20)

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Phase 3:

The following FAQs provide Phase 3 specific information that is supplemental to the Human Subjects Research Phases Table. 

Please read these FAQs before submitting an Individual PI Plan to resume or initiate Phase 3 research.  

 

What general considerations apply for human subjects research which may qualify to resume during Phase 3? 

The same guiding principles of social distance/physical barriers, appropriate personal protective equipment (PPE), and performance of remote human subjects research activities, whenever possible, remain as first-choice options.  In addition, the VPR Phased Resumption Plan includes Key Points for Minimizing COVID-19 exposure and transmission at all phases. PIs should consider revising their protocols to minimize the number of research personnel, limit the time of exposure, revise use of PPE, and any other measures that reduce the possibility of infectivity. 

Community, societal, and scientific benefit must be justified and be measured against risk of research participant exposure to COVID-19. Each potential point of transmission risk should be carefully considered and detailed in the investigator’s plan, including clear descriptions of the ways that risk will be mitigated/controlled. Studies that cannot adequately mitigate risk of transmission cannot be conducted until Phase 4. 

What specific restrictions or requirements are there for Phase 3 research?  

Since Phase 3 research does not offer direct benefit to the individual human subject, the following restrictions or requirements should be employed:  

• Research with individuals who are “at risk” (e.g., elderly, pre-existing conditions) in which participation does not offer direct benefit to the individual should not take place until Phase 4.  
• In-person interaction involving physical contact, should be limited to a brief period (e.g., 15 min as recommended by the CDC) with a single participant, minimal staff present and employing the highest level of safety precautions (e.g., N95 masks, gowns, gloves, eye protection or face shields or barriers). Brief interactions are less likely to result in transmission of virus. Thus, decisions should be made consistent with current CDC recommendations (https://www.cdc.gov/coronavirus/2019-ncov/php/public-health-recommendations.html), as there is growing evidence of transmission risk before onset of symptoms.
• Generally, research conducted inside the home of an individual human participant is not advisable as mitigation of risks cannot be controlled.   
• Research with in-person group meetings of 10 or more should be conducted outdoors or in facilities allowing a minimum 6-foot social distancing or physical barriers and adequate air exchange.  
• Regarding procedures involving aerosolized saliva, the American Thoracic Society recommends that pulmonary function testing be limited only to cases that are essential for immediate treatment decisions, and that measures to protect both the staff and individuals being tested should be put in place. Research procedures that result in aerosolizing saliva include, for example, sputum induction, pulmonary function tests in nonclinical space, sputum culture, pulmonary exercise tests, vigorous exercise resulting in increased and/or forceful respiration, and singing. Such research should not take place until Phase 4, unless the following protective measures are implemented: personal protective equipment (PPE) that limit aerosolized droplet acquisition for staff (mask, eye protection, shield, gown, gloves), and enhanced sanitizing of the testing space. Other in-door research procedures or activities that result in aerosolizing saliva (e.g., vigorous exercise, singing) will need to implement similar protective measures or the research should be delayed until Phase 4.   

In transitioning to Phase 3, are there specific human participants research populations that warrant additional safeguards or support? 

During human interaction, researchers should apply universal precautions as anyone is a potential carrier of COVID-19. However, the CDC has defined populations that may need extra support, access, or precautions (e.g., homeless people, people with disabilities, refugees, etc.). Population specific guidance is available at https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/index.html. 

Can undergraduates serve as research personnel in human participant research studies that take place during Phase 3?  

Consistent with the VPR Plan (Section D), high school students are not allowed to serve as study personnel on research protocols including human participants during Phase 3. Generally undergraduates serving as study personnel on research protocols with human participants should only be permitted in cases with minimal incidental risk. Undergraduates are prohibited from participating in COVID-related research, but exceptions will be considered if risk is adequately mitigated. In order to maximize health and safety during Phase 3, both justification and a description of risk mitigation is required in the PI plan for specific undergraduates to serve as research personnel in  research protocols with human participants. Please include the name and contact information for the undergraduates in the PI plan. Prioritization should be given to undergraduates taking research course credits for degree completion and to undergraduates in paid research positions. 

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Please note: you must meet the requirements of the VPR Resumption of Research Phased Plan (training & individualized plan submission for Phases 2-4) before conducting any human subjects research. Both the researcher training completion and the individualized plan for research work space/personnel are automatically routed by the VPR’s office to the respective department chair for evaluation.  Unless otherwise indicated, protocol-specific IRB approval to resume research that has been paused due to COVID-19 concerns is not required.

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Phases for Resumption of Human Subjects Research

• When and how will human subject research be permitted to resume?

• What is the current status of human subjects research at UK? (Updated 8/26/20)

• How do I determine if I can conduct in-person research? (Updated 6/10/20)

• Human Subjects Research Phases Table

• Once I am permitted to resume the paused research, will there be any restrictions on locations?

• To whom do I submit a request to resume the paused research?

• What if my research does not involve or require in-person contact?

• What if a study without direct participant benefit permits some, but not all, interactions to coincide with existing events where the participant is already at the facility? (Updated 6/2/20)

• What if I’m conducting a comparative, survey, or observational study that does not have direct participant benefit, but the in-person interactions align with existing visits or in-patient admissions?

• What if my research study is included in the “allowed” category, but I am not able to comply with precautions and safety guidelines related PPE, physical distancing, and maximum occupancy in a facility?

• When can I resume my community-based research?

• What are some issues I should be aware of when resuming community-based research?

• What precautions should I take if I am conducting in-person research?

• Should I implement any special procedures in my research space to protect study personnel and research participants from exposure?

• Do I have to call to pre-screen all participants before they come in for a scheduled research visit?

• What screening protocol should I use when interacting with research participants?

• Are positive COVID-19 test results reportable to the state of Kentucky?

• After research reopens if a subject or research team member is discovered to have tested COVID positive or presumptive positive with 2 weeks of an in-person research visit, would we promptly report to the IRB as an Unanticipated Problem involving Risks to Subjects or Others (UPIRSO)?

• What do I need to know to submit/conduct COVID-19 research? (Added 6/1/20)

• What is the PREP Act and what should subjects in COVID-19 interventional trials be told in the informed consent about liability limits? (Added 6/1/20)

• Are there other resources I can view for further guidance? (Updated 9/22/20)

• What if my research involves a public health authority or public health surveillance?

• What public health surveillance activities are deemed not to be human subject research under the revised Common Rule?

 

 

When and how will human subject research be permitted to resume?

Paused human subjects research will resume in phases along with the Vice President for Research (VPR) Resumption of Research Phased Plan and the Governor’s Healthy at Work Reopening Plan. These phases are based on environmental factors beyond the control of UK/UK Healthcare and, therefore, dates (even tentative) cannot be provided.

In light of the UK phases for resuming research, considerations when resuming human subjects research may be viewed as conservative. However:

1. Research participants are volunteers.
2. Many studies do not provide direct benefit to individual participants.
3. It is difficult to ascertain risks due to COVID-19 at a location because there are so many variables.
4. It is essential to monitor and control the number of studies being conducted as we resume research to ensure appropriate occupancy and safe management of resources (e.g., research space, staffing densities, and the availability and use of PPE).

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What is the current status of human subjects research at UK? (Updated 8/26/20)

Please refer to the VPR’s University of Kentucky Resumption of Research Phased Plan for guidance on the current phase and the ORI Human Subjects Research Phases Table to determine if your human research is allowed to resume in the current phase after meeting all requirements outlined below.

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How do I determine if I can conduct in-person research? (Updated 6/10/20)

This determination is a combination of:

• Meeting the requirements outlined in the VPR Resumption of Research Phased Plan (i.e., waiver for Phase 1, training & individualized plan submission for Phases 2-4);
• Compliance with the Human Subjects Research Phases Table; and
• Permission from your Department Chair or Center Director.

The phased approach and these guidelines provide a baseline framework from which additional variables must be considered.

1. Continuing or resuming human research is contingent on active COVID-19 cases, available testing and contact tracing, and compliance with health authority guidance from national, state, local, and University authorities.
2. Polices and guidance will be dynamic and may accelerate or decelerate based on shifting information and incidence data. Researchers must be prepared to halt activities on short notice if this becomes necessary based on new information.
3. Resuming human research operations must be parallel to and consistent with the institutional and VPR’s plans, as well as specific facility, college, and/or unit mandates. 

Investigators may choose to be more stringent or cautious than phases allow. 

It is critical to keep research participants informed of study status and changes that could impact them. Respect participant wishes regarding resuming in-person interaction.

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                         Human Subjects Research Phases Table

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Once I am permitted to resume the paused research, will there be any restrictions on locations?

Please refer to the VPR Resumption of Research Phased Plan for UK locations. For other research locations/facilities, determine whether those locations/facilities have any restrictions or requirements for human subjects research.

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To whom do I submit a request to resume existing human subject research?  

Submit your plan to resume human subjects research, using the VPR template, for review by your Department Chair or Center Director. 

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What if my research does not involve or require in-person contact?

Research that does not involve in-person contact (e.g. record review, secondary data analysis) or studies modified to fully remote interactions with participants or staff were not paused and may continue.

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What if a study without direct benefit permits some, but not all, interactions to coincide with existing events where the participant is already at the facility? (Updated 6/2/20)

Unless a study provides potential direct benefit or long-term risk if not resumed, all research-only in-person interactions must be changed to either remote visits or be rescheduled to coincide with existing events/encounters where the participant will already be on site. Research-only in-person interactions for studies which do not offer potential individual benefit will be allowed to resume at stage 3 or 4 respectively. 

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What if I’m conducting a comparative, survey, or observational study that does not have direct participant benefit, but the in-person interactions align with existing visits or in-patient admissions?

In general, these studies can only resume at Stage 3.  The intent is to limit and control the number of studies that are being conducted at one time in order to maintain safe space densities and PPE inventories.  

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What if my research study is included in the “allowed” category, but I am not able to comply with precautions and safety guidelines related PPE, physical distancing, and maximum occupancy in a facility?

Research must be included in the allowable category AND meet safety guidelines to resume operations.  This includes PPE and sufficient space or barriers to allow physical distancing.

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When can I resume my community-based research?

In general, most community-engaged research protocols will fall into phase 4 research resumption. For guidance, see the Human Subject Research Phases Table. Much of community-engaged research involves face-to-face interaction or group activities; research teams that interact with individuals in community settings potentially pose a serious public health risk to both data collectors and to the communities in which they work. Thus, while ramping up research activities (for example, scheduling future events or assembling research materials on-site) may begin to take place in phase 3, resumption of such interaction necessitates waiting until phase 4. For guidance, see the FAQ: How do I determine if I can conduct in-person research?.

In-person community-engaged research protocols should not resume unless standard safety recommendations can be implemented (social distancing, hand washing, mask wearing and, overall, risk mitigation) and contact tracing is in place. For guidance, see the FAQ: What precautions should I take if I am conducting in-person research? Once research meets the phased criteria to resume, travel to and from community sites may be permitted, if compliant with university limitations/restrictions, interaction with members of the public is minimized, and the above safety recommendations are maintained.

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What are some issues I should be aware of when resuming community-based research?

Community-engaged research protocols offer special challenges to the health and safety of research personnel and participants. While investigators must follow the same research resumption protocols as their non-community-engaged researcher colleagues (Department Chair/Center Director permission), guidance below is meant to assist generally to promote safety and well-being. For protocol-specific inquiries, contact ORI with the applicable protocol number and request an IRB consult to discuss resumption of research activities.

Investigators must determine appropriate local and community restrictions, requirements, and limitations pertinent to the conduct of the community-engaged research protocol. In an effort to prevent exposure of both potential participants and research teams to the COVID-19 virus, please follow any restrictions or requirements issued for/by the locations/facilities in which the human subjects research takes place.

If the research involves special circumstances or populations (e.g. minors in a school or other settings such as a community center), it is important to abide by the rules of the location but also make sure that parents and others who give consent are fully informed about risks and any measures taken to minimize those risks.

Unlike on-site research interactions, community-based research interactions may reach extensive networks of people, increasing the potential for rapid and mass exposure. Such exposure may make contact tracing with suspected or confirmed cases more challenging.

In the absence of widespread testing, research staff and participants may not know they are COVID-19 positive and could be carriers of the virus. For guidance on pre-screening potential research participants prior to in-person interaction, see the FAQ What precautions should I take if I am conducting in-person research?

When resuming community-engaged research activities, investigators and their teams are encouraged to provide educational resources to their participants. See the UK Community Resources for COVID-19 website.

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What precautions should I take if I am conducting in-person research?

As in-person research interactions are permitted under the phases, researchers must consider how to modify in-person participant interactions to reduce the risk of COVID-19 transmission for both participants and the research team.

Researchers must: 

• Develop robust testing protocols for staff testing, contact tracing, and self-isolation should a study team member test positive (along with reporting to the Kentucky Department of Public Health).
  • Before coming to work, all faculty and staff are required to self-screen each day for signs of COVID-19 symptoms.   
  • Research staff who work at any UK Healthcare facility complete the UK Healthcare Staff Screening - https://covid-19.ukhc.org/employee-screening-for-covid-19/.
  • Employees scheduled to work on-site but who are not feeling well and/or are experiencing any symptoms of illness must stay at home, and immediately contact their supervisor.
  • Temperature checks may be performed prior to entering select research spaces or at discretion of investigator.
• Avoid all participants with confirmed or presumptive positive COVID-19 infection or who require potentially aerosolizing procedures, unless this is the focus of the study.
• Require the use of and supply Personal Protective Equipment (PPE). Address training status for nonclinical research personnel who need to be within 6 feet of participants, if appropriate for the study. Address sources of PPE for research use for staff and participants. Address methods to reduce PPE usage by all personnel, including combining research with clinical blood draws.
• Decrease potential exposure for participants and study staff at increased risk of severe illness from COVID-19. People at higher risk include people who:
  • are over 60 years of age,
  • have underlying health conditions including heart disease, lung disease, or diabetes,
  • have weakened immune systems,
  • are pregnant,
  • are caregivers of children with underlying health conditions or adults who meet any of the criteria listed above.

Inform participants who may be vulnerable to contracting COVID-19 to review the  
CDC guidelines for Groups at Higher Risk for Severe Illness. Enable participants to make an informed decision about personal risks related to COVID-19 and respect their wishes. 

• Reduce face-to-face interactions with research participants. Strategies may include physical barriers between research personnel and participants, or using technology (e.g., telephone, FaceTime, email, intercoms) to conduct interviews and obtain data.
• Continue remote telework for researchers or research staff whose responsibilities do not require on-site activities (e.g., regulatory specialist, administrative staff, survey researchers). Limit in-person research team meetings to those which allow personnel to maintain physical distancing procedures.
• Develop contingency plans in the event of staff illness or exposure.
• Close access to common areas where possible (e.g., waiting areas, staff break areas, etc.).
• Have a protocol for noncontact screening of participants and study staff for active symptoms of acute respiratory infection possibly related to COVID-19 or high risk of infection. This may be accomplished by communication with participants, care providers, chart review, screening surveys, or other options prior to approaching potential research participants. Individuals with active symptoms or in social isolation (e.g., due to travel history or exposure to someone with COVID-19 symptoms) should be avoided.
• Comply with UK and CDC guidance regarding sanitation of facilities and workspaces.
• Maintain targeted occupancy limits that permit physical distancing.  This may require both physical separation of study personnel and staggered schedules, and may require flexibility in work scheduling.
• Stagger participant visits so participants do not congregate at the research site and maintain at least six feet of separation between participants.

Researchers should also:

• Follow any guidelines or instructions from the specific facility (e.g. college, hospital, clinic) where the participant interaction would occur (e.g. screening).
• Consult with the study sponsor, when appropriate.
• Encourage remote monitoring by industry monitors or representatives. In person sponsor visits may not occur until restrictions are lifted by local or institutional authorities.

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Should I implement any special procedures in my research space to protect study personnel and research participants from exposure?

Please refer to the VPR Resumption of Research Phased Plan on personnel safety. 

Identify the specific sources of COVID-19-related risks. Specific issues to consider include:

• Minimizing the number close interaction or physical contact of participants with your study team or with other participants (e.g., a blood draw or physical exam). The feasibility of physical distancing and maintaining target occupancy limits.  
• Use of physical barriers to reduce transmission risks.
• The availability of appropriate personal protective equipment (PPE). Screening before participant interactions.
• Equipment or other items that will be used with multiple participants (e.g., a virtual reality headset, a computer-administered questionnaire, or a sensing device).
• What surfaces will be touched by participants, including items at the research location (e.g., chairs, desktops, research equipment and devices, doorknobs).
• The availability and frequency of disinfection and cleaning procedures for frequently touched surfaces, and adequate hand washing and sanitizing stations, etc.
• If the research procedures include testing participants for SARS-CoV-2 or serological antibodies, identify any restrictions (e.g., CLIA lab analysis) or requirements that apply (e.g., care referral and reporting for positive cases).
• All labs receiving COVID-19 patient specimens must have approval from the Institutional Biosafety Committee. Labs with current approvals for human source material will need to submit an amendment to their protocol. Registration information is available at https://ehs.uky.edu/Biosafety/ and protocols are submitted via https://topaz.uky.edu/. Email biosafety@uky.edu with questions regarding new protocol submissions or amendment creation.

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Do I have to call to pre-screen all participants before they come in for a scheduled research visit?

Yes, for continued in-person visits, you must pre-screen all participants prior to the visit. You must call participants prior to their visit to screen them before they arrive and cancel visits for those who give positive responses during the phone screening. Participants must be screened again when they arrive on site.

COVID-19 pre-screening calls do not require submission of a Modification Request as long as done for safety purposes and not research data collection. More details about screening are provided below.

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What screening protocol should I use when interacting with research participants?

All research teams are advised to review and comply with facility, location, and/or department procedures for screening all participants.

Research teams are encouraged to initiate these screening procedures in advance of scheduled research visits and to cancel or reschedule visits for persons with current symptoms of a lower respiratory infection. Participants must “pass” screening to be seen in an academic or medical space.

In general, the following screening questions should be asked in advance of the scheduled visit:

• Has the participant had close contact with a confirmed COVID-19 patient within the past 14 days? Close contact is defined by the CDC as:
  1. being within approximately 6 feet of a COVID-19 case for a prolonged period. Close contact can occur while caring for, living with, visiting, or sharing a health care waiting area or room with a COVID-19 case, or
  2. having direct contact with infectious secretions of a COVID-19 case (e.g., being coughed or sneezed on).
• Has the participant traveled to any locations confirmed by the Centers for Disease Control and Prevention to have widespread community transmission of COVID-19 in the past 30 days? See https://www.cdc.gov/coronavirus/2019-ncov/travelers/index.html for an updated list of areas with widespread community transmission.
• Does the participant have symptoms of a lower respiratory tract infection (e.g., cough, fever, sore throat, or shortness of breath, or loss of smell/taste) or gastrointestinal symptoms (e.g. diarrhea, nausea)?

If the answer to any of the questions above is “Yes,” terminate the visit and refer the participant to a medical facility for screening and care.

If interaction is taking place in a medical facility, follow medical facility directions on management of COVID-19 positive participants.

Screening outcomes:

• Document participant responses.  If all is well, proceed with scheduling the visit and inform participant and/or caregiver regarding applicable visit procedures for on-site screening (e.g., registration screening; temperature checks), requirement to wear masks, and prohibition on bringing guests to the visit.
• If at least two weeks have passed since leaving an area of widespread transmission or exposure to a known COVID-19 case, and they have no symptoms of a lower respiratory tract infection, then the study visit may occur.
• If it is less than two weeks since their potential COVID-19 exposure and the participant has no symptoms, the study investigator should assess the potential risks and benefits of continuing the research visit versus rescheduling the visit until after the two-week period, if feasible.
• If the participant has symptoms of a lower respiratory tract infection, the investigator should consult the appropriate hospital resources to determine the next steps for evaluation and management. 

Once participant is on-site, conduct screening procedures consistent with facility requirements, unless screening performed by facility staff upon entry or registration staff. 

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Are positive COVID-19 test results reportable to the state of Kentucky? (Updated 10/14/20)

Yes, positive or presumptive positive SARS-CoV-2 results must be reported to public health authorities in the state of Kentucky. They may not accept results that come from a lab which is not certified by the federal CLIA program or state equivalent. If you obtain a positive result, report it to the state of Kentucky and, if required, UK HealthCare. If the test is not a recognized/verified test, you should tell the participant about the result and the limits of that test, then encourage them to get a valid test from a healthcare facility. Find instructions under the “Healthcare Providers” section under “Resources” on the Kentucky Public Health COVID-19 website: https://govstatus.egov.com/kycovid19.

Guidance from the Office for Human Research Protections (OHRP) Guidance on COVID-19 states: “Legally Required Reporting: When required by law to provide information related to an individual's COVID-19 test results to a public health authority, including individually identifiable information about individuals who are research participants, the HHS protection of human subjects regulations do not prevent investigators or institutions from fulfilling this requirement (even if doing so would be inconsistent with statements made in the study's consent form). The existence of a Certificate of Confidentiality[3] does not alter an investigator's ability to disclose a research participant's COVID-19 test results when required by federal, state, or local laws. For example, if a research participant tests positive for COVID-19, an investigator may provide this test result to a public health authority if required to do so under applicable state or federal law. In such circumstances, investigators should inform the participant of the required reporting of results.” [https://www.hhs.gov/ohrp/regulations-and-policy/guidance/ohrp-guidance-on-covid-19/index.html]

For Questions About Screening, Testing or Tracing? Contact Our Health Corps.
Call 859-218-SAFE(7233)
Email healthcorps@uky.edu
Hours of Operations:
Monday-Friday 8 a.m. - 8 p.m.
Saturday-Sunday 10 a.m. - 5 p.m.

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After research reopens, if a subject or research team member is discovered to have tested COVID positive or presumptive positive with 2 weeks of an in-person research visit, would we promptly report to the IRB as an Unanticipated Problem involving Risks to Subjects or Others (UPIRSO)?

An Unanticipated problem involving risks to subjects or others (UPIRSO)- includes any incident, experience, or outcome that meets all of the following criteria:

1. Unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are described in the protocol-related documents, such as the IRB-approved research protocol and informed consent document; and (b) the characteristics of the subject population being studied;
   Consider whether unexpected in frequency given the presumed measures that in place to mitigate risks.  Might be expected for COVID-19 research.
2. Related or possibly related to participation in the research; and
   Could it have occurred because of an in-person research interaction/intervention? Likely if interaction is for research and not concurrent with other interaction.
3. Suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.

Likely so, as suggests others at greater risk of virus transmission than was previously known or recognized.

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What do I need to know to submit/conduct COVID-19 research?

The document below includes information on submitting new or updating existing research which focuses on COVID-19.

Conduct and Submission of COVID-19 Research in Human Subjects [PDF]

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What is the PREP Act and what should subjects in COVID-19 interventional trials be told in the informed consent about liability limits?

On March 10, 2020, the HHS Secretary issued a Public Readiness and Emergency Preparedness (PREP) Act Declaration which was amended effective March 27, 2020 that provides liability immunity (except for willful misconduct) for claims of loss caused, arising out of, relating to, or resulting from manufacture, distribution, administration or use of countermeasures to diseases, threats, and conditions determined by the Secretary to constitute a public health emergency to entities and individuals involved in the development, manufacture, testing, distribution, administration, and use of such countermeasures.

PREP limits legal rights to sue covered persons engaged in select COVID-19 countermeasures (including select treatment research) and provides compensation for eligible individuals who suffer injuries from use of covered products. 

Covered Countermeasures may include vaccines, drugs, or medical devices to be used to treat, diagnose, cure, prevent, or mitigate COVID-19. 

Products must be:

1. a qualified pandemic or epidemic product;
2. a security countermeasure;
3. a respiratory protective device approved by NIOSH;
4. approved, licensed, or cleared by FDA;
5. authorized under an Emergency Use Authorization (EUA) issued by FDA;
6. described in an Emergency Use Instructions (EUI) issued by the CDC; or
7. used under either an Investigational New Drug (IND) application or an Investigational Device Exemption (IDE).

In addition to meeting the scope of the act, reasonable precautions must be taken to facilitate the safe use of covered countermeasures.  See the PREP Act Q&As and PREP Act Glossary for detailed information.

CONSENT LANGUAGE:

The following statement should be added to the informed consent for applicable COVID-19 studies, in order to inform participants regarding their legal rights.

Due to the coronavirus public health emergency, the federal government has issued an order that may limit your right to sue if you are injured or harmed while participating in this COVID-19 study.  If the order applies, it limits your right to sue and recover losses from the researchers, healthcare providers, any study sponsor, distributor or manufacturer involved with the study. However, the federal government has a program that may provide compensation to you or your family if you experience serious physical injuries or death. To find out more about this “Countermeasures Injury Compensation Program” please go to https://www.hrsa.gov/cicp/about/index.html or call 1-855-266-2427.

If participants have questions about the Countermeasures Injury Compensation program (CICP) direct them to the CICP website which provides Requester FAQs, Fact Sheet and contact information.

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Are there other resources I can view for further guidance? (Updated 1/15/21)

• UK Vice President for Research (VPR) COVID-19 Guidance for Researchers - https://www.research.uky.edu/resources/covid-19-guidance-researchers
• UK Institutional Biosafety COVID-19 Guidance - https://ehs.uky.edu/biosafety/ (Scroll down to COVID-19)
• UK Healthcare COVID-19 Website -  https://covid-19.ukhc.org/ includes guidelines, TeleCare Toolkit, FAQs, Infection Prevention and Control, UKHC Employee Screening and Resources. 
• UK Healthcare Staff Screening - https://covid-19.ukhc.org/employee-screening-for-covid-19/
• UK COVID-19 FAQs -  https://www.uky.edu/coronavirus/faqs
• Employee and Human Resources Information - https://www.uky.edu/coronavirus/faqs#hr
• Campus Restart - https://www.uky.edu/coronavirus/faqs#restart
• Kentucky Public Health -  https://govstatus.egov.com/kycovid19  (Scroll to RESOURCES for Guidance by Topic and Healthcare Provider Information on Case Reporting)
• Kentucky COVID-19 hotline provides guidance for individuals in the state of Kentucky with symptoms 800-722-5725
• Centers for Disease Control and Prevention Coronavirus website https://www.cdc.gov/coronavirus/2019-ncov/index.html
• Council on Governmental Relations (COGR) Research Ethics & Compliance Committee - Human Subjects FAQs May 4, 2020 (Version 1.0) 
  https://www.cogr.edu/sites/default/files/FAQS%20ON%20HUMAN%20SUBJECTS%20for%20REC%20final%20may%204%202020.pdf
• Food and Drug Administration (FDA) "Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment" https://www.fda.gov/regulatory-information/search-fda-guidance-documents/assessing-covid-19-related-symptoms-outpatient-adult-and-adolescent-subjects-clinical-trials-drugs
• "FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency" (Updated September 21, 2020)https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-guidance-conduct-clinical-trials-medical-products-during-covid-19-public-health-emergency
• Food and Drug Administration (FDA) "FDA Digital Health Policies and Public Health Solutions for COVID-19"
  https://www.fda.gov/medical-devices/digital-health/digital-health-policies-and-public-health-solutions-covid-19
• National Cancer Institute Central IRB (NCI-CIRB) "Memorandum On Interim Guidance For Patients On Clinical Trials Supported By The NCI Cancer Therapy Evaluation Program And The NCI Community Oncology Research Program (NCORP)"
  https://www.ncicirb.org/announcements/memorandum-interim-guidance-patients-clinical-trials-supported-nci-cancer-therapy
• National Cancer Institute Central IRB (NCI-CIRB) "Interim Guidance for Patients on Clinical Trials Supported by the NCI Cancer Therapy Evaluation Program and the NCI Community Oncology Research Program (NCORP)" (March 13, 2020)
  https://www.ncicirb.org/announcements/memorandum-interim-guidance-patients-clinical-trials-supported-nci-cancer-therapy
• National Cancer Institute Central IRB (NCI-CIRB) "Additional Guidance Regarding Alternative Procedures for Clinical Trials Supported by the NCI Cancer Therapy Evaluation Program(CTEP) and NCI Community Oncology Research Program (NCORP) Affected by the Spread of the Novel Coronavirus" (March 23, 2020)
  https://ncicirb.org/sites/ncicirb/files/Memo_Additional_Guidance_Clinical_Trial_Activities_Affected_Coronavirus.pdf
• National Institutes of Health (NIH) has issued notices on the NIH Extramural Response to Natural Disasters and Other Emergencies website
  https://grants.nih.gov/grants/natural_disasters.htm
• Office for Civil Rights (OCR) "Notification of Enforcement Discretion for Telehealth Remote Communications During the COVID-19 Nationwide Public Health Emergency"
  https://www.hhs.gov/hipaa/for-professionals/special-topics/emergency-preparedness/notification-enforcement-discretion-telehealth/index.html
• Office for Human Research Protections (OHRP) Guidance on COVID-19 - https://www.hhs.gov/ohrp/regulations-and-policy/guidance/ohrp-guidance-on-covid-19/index.html

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What if my research involves a public health authority or public health surveillance?

If you think your work is public health surveillance in addition to (or instead of) research, please fill out a UK Not Human Subjects Research (NHR) form after obtaining documentation (e.g., email) that describes the specifics of any involvement of a public health authority. You should include the following in the summary of the NHR form:

• a brief description of the role of the public health authority (e.g., design, coordination, direction);
• clarification of whether the public health authority plans to use the data to make decisions; and
• if so, when and for what purpose the data will be used.

This information is important because it impacts the type of IRB review required (if any). 

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What public health surveillance activities are deemed not to be human subject research under the revised Common Rule?

• The activity must be a public health surveillance activity (45 CFR 46.102(l)(2));
• The activity must be conducted, supported, requested, ordered, required, or authorized by a public health authority (45 CFR 46.102(k) and 46.102(l)(2)); and
• The activity must be limited to that necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products) (45 CFR 46.102(l)(2)).

However, FDA regulations may apply if this involves use of an investigational in-vitro diagnostic device.

Detailed guidance is available from the Office for Human Research Protections (OHRP).

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Page created 3/19/2020 10:00 am

Updated 6/11/2021 1:45 pm