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Updated May 18, 2022

Can I still interact with my research subjects?  

The IRB allows face-to-face data collection at this time.  You should minimize in-person interactions following Sindecuse Health Center Recommended Precautions for Close Contacts.

When conducting in-person human subject research at ɫɫ��, the following considerations must be addressed before face-to-face research can begin:

1.  The risk/benefit ratio of research involving in-person interactions must be re-balanced to ensure appropriate methods to mitigate risk of infection or transmission of COVID-19 are implemented.

2.  Prospective research participants must be informed of the risks of COVID-19 related to research participation, their status or risk if they are particularly vulnerable to COVID-19, and of the COVID-19 infection mitigation strategies undertaken by the University, ORI, and your research team.

3.  The guidance issued by ORI, Sindecuse, and the ɫɫ�� IRB must be followed for the next phase of resuming human subject research involving in-person interactions with participants.

Study teams are responsible for adhering to the policies of the nation, state, county, city and organization in which the research is occurring and following the policy that provide the greatest COVID risk mitigation.  It is important to note the situation can change at any time, so we still encourage all human subjects research be conducted remotely if possible.

Please Note: Any change to your method of data collection (in-person or virtually) must be reviewed and approved by the ɫɫ�� IRB.

• Participant screening. In addition, ORI and ɫɫ�� IRB are asking research teams to conduct a short phone or email screening for exposure to the novel coronavirus COVID-19 or symptoms of illness before any study-related visits and in-person interactions. Research participants with possible exposure or symptoms of illness should not participate in in-person interactions until consultation with healthcare providers and state and local health departments.  See Sindecuse Health Center recommendations If You Are Sick or Suspect COVID-19.

• Appropriate screening questions might include the following, which could be modified to fit your participant population and the location of in-person interactions. Any YES answer should be considered sufficient reason to postpone in-person visits. Decisions about in-person visits should be especially conservative for people at higher risk per public health recommendations:

  Over 60
  Underlying health conditions including heart disease, lung disease or diabetes
  Weakened immune systems
  Pregnant

1. Have you had any of the following symptoms in the past two weeks, even if they were mild?
   Fever
   Cough
   Shortness of breath
2. Have you had * with a person who is under investigation for possible COVID-19?
3. In the past three weeks, have you visited a country or facility with sustained (ongoing) occurrence of COVID-19, such as:
   China
   Iran
   Italy
   Japan
   South Korea
   Life Care Center in Kirkland

• In addition, ɫɫ�� researchers should:
  Follow ɫɫ�� COVID-19 Coronavirus 2019 guidelines and instructions.
  Consider the participant population (e.g., are they considered “high risk” for COVID-19?) and the setting in which the interaction would occur.
  Develop possible alternatives to in-person study visits that are important for subject safety and monitoring.
  Ensure that hand sanitizer, hand washing facilities and/or cleaning wipes are readily available for screened participants, when in-person interactions will occur.

You may choose to hold study visits remotely if feasible for the study and in person visits are not required to conduct safety monitoring.  Additionally, you can use WebEx as a remote system.  The instance/subscription at ɫɫ�� meets HIPPA requirements, a Business Associate Agreement has been signed which is critical in meeting compliance. The technology is in place for compliance, but how WebEx is used is also part of compliance. For example, you can safely record sessions, but if you download and share that, that is outside of the WebEx environment and non-compliant.  You also need to take precautions to make sure unauthorized people don’t overhear any conversations you’re having via WebEx. Lastly users should use the “schedule a meeting option,” rather than “start a meeting,” just to be extra-sure that uninvited attendees do not enter the meeting.

You may use platform for surveys without face to face interactions.

You may also consider changing the schedule of study visits.

You will need to modify the protocol and submit the changes to the HSIRB before implementing any changes (unless they are necessary to eliminate apparent hazards to the participant and there is not time to obtain prior IRB approval) if the study is not exempt and the application specifies in person visits.

You do not need to modify the protocol in order to hold visits remotely if the IRB approved protocol does not describe whether the visit would be in person or remote or give specifics about visit schedule.

You might also consider whether you will need other flexibility in order to continue implementing the research. For example, many low risk procedures qualify for a waiver of written documentation (signed) consent. If the application describes signed/written consent, you may wish to modify it to remove that requirement to allow for easier remote implementation. Again, this should not be implemented prior to approval of the change by the IRB.

As always, please contact the IRB with any questions

*Close contact is defined by the CDC as (a) being within approx. 6 feet (2 meters) of a COVID-19 case for a prolonged period of time. 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 (b) having direct contact with infectious secretions of a COVID-19 case (e.g., being coughed on).