Research Projects Involving Human Subjects Contingency Planning
Research projects involving human subjects are an important aspect of the University’s research enterprise. These projects come with considerable ethical responsibilities and regulatory oversight. Due to the COVID-19 outbreak, there are particularly pressing regulatory and operational questions facing researchers involved in human subjects research. Below we provide guidance on these questions. Please check this site often for updated guidance.
Our guiding principle in addressing these questions is maintaining the safety of the research subjects and the research team members.
Human Subjects Research Update
In follow-up to the action of limiting on-campus activities to only critical research activities, we are providing an update as it relates to our research activities involving human subjects.
To ensure safety of our researchers, staff, and research participants and to be aligned with the most recent NIH guidance, the Office of Research & Innovation is requesting that research involving person-to-person contact or gatherings of human research participants be paused as soon as possible unless needed for participant safety.
The duration of the pause is unknown, but to reduce disruption to the extent possible, we will be reassessing daily. Please visit this page for updates.
It is our responsibility to ensure the safety of all human participants and research staff involved in clinical trials and human subjects studies. We strongly recommend implementing the following measures:
- Limiting study visits to those needed for participant safety or coincident with clinical care. If a visit is necessary, please refer to our earlier guidance on Human Subject Recruitment and Data Collection section below.
- Conducting virtual study visits
- Arranging flexibilities for required laboratory tests or imaging needed for safety monitoring to occur at local laboratories or clinics
- Canceling gatherings of 10 or more people
- Limiting or suspending unnecessary travel
- Continue to maintain social distancing and personal hygiene during all research activity
If human participants in a study are at risk of harm from the research suspension, please document a plan to safely discontinue protocol activities and submit the plan via a Reportable New Information (RNI) to the IRB. This is recommended to ensure the safety of subjects and the IRB may not have the time to review and approve before the necessary steps need to be taken.
If pausing your activities requires a permanent change in your protocol, please submit an amendment to the IRB and notify your sponsor. Otherwise, see instructions above for submitting as RNI. If you have questions, please contact program staff at hrpp@drexel.edu.
Our federal sponsors recognize the significant effects this emergency is having on funded clinical trials and other human subjects studies. The NIH has published guidance to assist researchers during these times.
CHANGES TO IRB-APPROVED PROTOCOLS
- Changes to IRB-Approved protocols may occur due to this unprecedented outbreak. According to IRB policy, any changes in IRB-approved research procedures must be reported to the IRB and may not be implemented prior to review and approval by the IRB, except when necessary to eliminate apparent immediate hazards to the subject. This is permitted by both the Common Rule (38 CFR §16.108(a)(3)(iii)) and by FDA regulations (21 CFR §56.108(a)(4)).
- Beyond the regulation, we also have a responsibility to ensure the safety of our research team members and staff. Therefore, interim measures to reduce immediate hazards to research participants and staff may be warranted. This may result in deviations from IRB-approved study procedures prior to securing IRB approval. By policy, protocol deviations must be reported to the IRB within 5 business days.You must also submit these in COEUS as “Reportable New Information (RNI)”.
- If apparent immediate hazards will be sustained for a duration that would practicably allow for an amendment covering such changes to be developed, reviewed and IRB-approved, then a protocol modification must be sought.
- Instructions for submitting a Modification or an RNI are found on the IRB’s webpage [DOC].
- Assistance is available
- If you have any questions related to the information above or need assistance in determining whether a planned change to research procedures requires review, please contact hrpp@drexel.edu or call 267-359-2471.
- If you have any issues accessing COEUS or submitting a deviation and/or modification, contact coeus-help@drexel.edu and cc: hrpp@drexel.edu.
DREXEL HUMAN RESEARCH COMPLIANCE
- Our Human Research Protection Program (HRPP) and the IRB are fully functional and operating at standard capacity. We expect this to continue even if the University moves to remote work plan for contagion control purposes.
- Program staff are able, and ready, to work remotely if necessary.
- Program and staff email addresses continue to be monitored with the same or greater frequency.
- Please note when logging into https://drexel.zoom.us/ there is HIPAA compliant and standard variation. For human subjects research, they must choose the HIPAA compliant option.
- IRB meetings will be conducted via Zoom.
- We are also closely monitoring the impact of COVID-19 on research operations, including our own staffing levels and quorum for IRB meetings.
- New updates impacting human research will be communicated as soon as possible.
Provided below are operational considerations that research teams should evaluate when planning for potential disruptions to projects involving human subjects and to ensure the safety of research subjects and research team members conducting the research. It is STRONGLY encouraged that each team review and incorporate these considerations and complete the Research Project Management Contingency Planning Template [DOC] and consider these guidelines:
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Investigators are encouraged to implement procedures to screen research subjects at every encounter and to incorporate telephone screening prior to scheduled visits for potential infectious risk (see suggestions below). See the CDC’s Interim Infection Prevention and Control Recommendations for Patients with Suspected or Confirmed Coronavirus Disease 2019 (COVID-19) in Healthcare Settings. Note that incorporation of this screening does NOT require IRB approval.
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Please keep formal notes documenting all screening questions and answers.
- Investigators are encouraged to use their judgment when considering approaches to reduce the risk to subjects and study staff. Examples could include:
- Conducting study visits by phone rather than in-person (e.g. surveys, focus groups)
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Allowing study visits “out of window” or cancel them if not safety related.
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Given this considerable uncertainty, the University strongly encourages its research community to suspend new human subjects research projects involving in-person participant contact and/or domestic or international travel. If delay is not possible, researchers are advised to submit IRB protocols that includes study procedures that allow for flexibility / alternatives to in-person participant contact.
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Cancellations
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While some research participants may self-elect to cancel appointments, Investigators may also consider conducting interviews/assessment remotely. Rescheduling cancellations should be done in consideration of the ongoing situation and in accordance with University guidelines.
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(Update 1 - 03/14/2020 4:45PM) Pre-Screening for Participants Prior to Coming Onsite for Research Participation
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For research studies that continue to bring in enrolled participants, we recommend the following screening procedures:
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Call participants prior to their appointment. Remind them of CDC guidelines and screen participants with the following questions:
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Have you been in contact with anyone suspected or known to have Coronavirus or to anyone who is in quarantine?
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Have you traveled outside of the U.S. in past 21 days?
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Have you been to New York, California, or Washington in the past 21 days?
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Have you had a fever (>100.4°F) within the last 21 days?
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Have you been sick (fever, coughing, sneezing) in the past 14 days?
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Are you currently having any of the following symptoms?
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Cough
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Shortness of Breath
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Sore Throat
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Malaise (feeling poorly)
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Chills
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Pneumonia
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Altered Mental Status
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Vomiting
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Severe headache
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Muscle aches
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Recommendation: If individual response yes to any of the questions, it is recommended that participant be refused and contacted at a later time for re-screening/enrollment.
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A copy of this questionnaire is available for use here [DOC].
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Research Projects That Have Groups
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At this time University guidelines does not recommend gatherings of groups larger than 100 individuals. For groups smaller than this, investigators should ask the following additional questions:
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Does the meeting/program require personal interaction or contact?
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Will participants be from the high-risk categories, including individuals over the age of 60 and/or those that have chronic diseases like heart disease, diabetes and lung disease.
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Are participants coming from high risk locations/areas?
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Are there elevated risk for investigators conducting the program?
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If the answer to any of these questions is "yes"– it is recommended to set up a Zoom option for your program/meeting if available.
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If the answer to all of these questions is "no" – conduct the recommended individual pre-screening (above) for each group member.
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Ensure remote access, wherever possible, to files, data, servers, etc. Check that all members of your research team who might need to work remotely have access to computers that are able to connect to research files and meeting software (such as Zoom).
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Privacy and confidentiality provisions remains critically important at all times, even when working remotely. Please note that access to, storage and treatment of sensitive information, including data governed by HIPAA regulations, must comply with university and other policies for security of research data.
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Research teams should obtain contact information for research participants should they need to reach out to them. This information should be accessible remotely yet stored securing following University guidance (see above).
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Do not use personal email to conduct clinical research activities or for correspondence of any kind.
It is recommended that investigators consider a plan for maintenance for their individual lab/research spaces and in particular focus on ensuring regular cleaning of any space, equipment, etc that may continue to be regularly used or shared.
Immediate Measures to Avoid/Reduce Transmission in Research Settings
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Personnel who are feeling unwell are REQUIRED to stay home until they no longer have symptoms.
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Students who do not feel well should immediately call Drexel Student Health Center at 215.220.4700.
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Faculty/Staff who do not feel well should contact their primary care provider for guidance and testing. Immediately after calling your provider, please email covid19@drexel.edu and provide your name and a phone number that a Drexel representative can contact you at. It is imperative that Drexel University is aware of any exposure risk to the members of the Drexel community.
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Practice the recommended personal hygiene measures regularly.
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Wash hands frequently with soap and warm water for 20 seconds. Hand sanitizer is not a substitute for hand washing in the laboratory.
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Disinfect common rooms/laboratory areas and touch points, at least daily,
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Utilize the disinfection method found in this guidance [PDF]
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Touch points include but are not limited to doorknobs, sink handles, refrigerator/freezer doors, fume hood sashes, telephones, pipets, shared equipment, etc.
This guidance is also available here [PDF]
Methods for Disinfecting COVID-19 from Surfaces
NOTE: If you have an existing Biosafety Protocol please follow the disinfection techniques detailed in that protocol.
As campus remains open for research and other activities that do not involve gathering of large number of people, it is important to continue to practice good hand hygiene. In addition, we recommend that high touch surfaces (e.g. door knobs and handles) as well as lab benches be treated with agents that will kill viruses. EPA has issued a list of commercially available agents, which can be accessed by clicking here. If commercially available agents are not readily available, the following can easily be prepared and filled in spray bottles for use:
Spray the surfaces and wipe them down after the appropriate dwell time (above) to achieve disinfection.
References:
This guidance is also available here [PDF]
Additional Resources
Additional Resources can be found on the ORI Research Preparedness for COVID-19 Pandemic website.