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INFORMATION FOR

YSM Human Subjects Research Guidance Regarding COVID-19 (Novel Coronavirus) Pandemic

March 17, 2020

As of 03/17/2020 12:30pm

Our top priority remains the safety of our research participants, patients, staff, and faculty. We continue to monitor events to determine what actions are required to keep everyone safe and informed. As the university remains open, the HRPP and YCCI continuity plan for COVID 19 as of today will be to continue normal operations of administrative functions and clinical research resources unless a change is deemed necessary. Both offices will be staffed through a combination of social distancing, rotating schedules, and working remotely from home.

HRPP Operations and Yale IRB Capacity

The HRPP office and Yale IRB, currently expect to be able to continue reviewing studies per their normal schedule. Should this situation change, we will notify the research community. Please contact hrpp@yale.edu if you have questions.

Pausing Human Subject Research Studies

Non-interventional human studies protocols carried out in non-clinical care settings:

To date, we are aware of only two studies in this category which PIs believe cannot either be paused for at least three weeks or converted to a state where the research is conducted solely by means (such as video-conferencing) that do not involve face-to-face subject encounters. The two exceptions are carried out solely in Samoa which is currently without any cases of COVID-19. However, we recognize that other such exceptions may exist. Therefore, we are establishing the following procedures:

  1. If your protocol currently includes no face-to-face contact and it is not otherwise affected by the current pandemic, you can continue with research without any need for changes.
  2. All other protocols in this category will be placed on “pause” until the end of April (April 30, 2020). At the end of the three weeks we will decide whether it is necessary to extend the pause. Study-specific IRB approval is not required to place the temporary pause on each study, see note above related to “Blanket Yale HRPP communication”.
  3. If you have a study that will not be placed on pause, but instead will be converted to a non-direct contact model, study-specific IRB approval is not required, see note above related to “Blanket Yale HRPP communication”. Currently, the blanket approval applies only to studies under Yale IRB purview. We will work with external IRBs on their processes (more information with be forthcoming).
  4. If you have a protocol in this category, but do not want the protocol placed on “pause”, the procedure is to first obtain review and approval by your Department. Each Department is establishing an internal mechanism to review the need to keep the study open. Please follow the procedure in your Department and then the Department will contact us to report approval of the exception; that approval will be re-reviewed in the Dean’s Office.
  5. Note that both the YNHH-based HRU and the outpatient CSRU are non-clinical care settings. Therefore, protocols that will not be “paused” that utilize these units will need to apply to the Departmental Procedure to continue the studies during this timeframe.

Non-interventional human studies protocols carried out solely in clinical care settings:

The majority of these studies see the subjects/patients concomitant with a necessary clinical care visit.

  1. Non-interventional (non-therapeutic) studies which fit the model above, that is, all face-to-face contact is carried out simultaneous with a clinical care required visit, should be reported to the Department Procedures, approved by the Department, and then communicated centrally.
  2. If a study does not conform to the model above, then the Department will review that study and, if the Department feels that this is an appropriate exception, will follow the process outlined above for central approval of an exception
  3. If the PI wishes to convert some of the study visits (which may in fact also be clinical care visits) to a telehealth format, study-specific IRB approval is not required, see note above related to “Blanket Yale HRPP communication”. Currently, the blanket approval applies only to studies under Yale IRB purview. We will work with external IRBs on their processes (more information with be forthcoming).

Interventional (Therapeutic) human studies protocols:

These studies may be paused at the discretion of the PI or may be closed to new patients at the discretion of the PI, but neither is required since these studies have direct potential benefit to the subjects/patients and hence the risk/benefit ratio is fundamentally different from the subject, investigator, and public health perspectives. We will assume that all of these protocols are continuing as “active”. If a protocol is to be put on “pause” or temporarily closed to accrual, study-specific IRB approval is not required, see note above related to “Blanket Yale HRPP communication”. Questions can be directed to hrpp@yale.edu or Clinicalresearchresources@yale.edu.

We are developing documentation of the above plan that will cover all impacted studies. We will also provide you with a template note to file if your study is impacted. You also do not need to submit a Reportable New Information (RNI) documentation to the IRB indicating that you placed a voluntary pause on the study or enrollment. However, you will need to complete the above referenced survey.

See section “Blanket Yale HRPP communication for COVID-19”

Human subject research that is conducted at clinical sites must include the research patients in the same screening processes being used for the regular clinical patients, that is, telephone screening pre-appointment and on-site screening. Research being conducted at non-clinical sites must pause the non-interventional human subjects research until processes are in place to provide the same telephone and on-site screening of the research subjects. We recognize that interventional human subjects research may need to continue similar to critical ambulatory clinical care; YCCI and Yale Medicine will assist investigators in establishing these processes with priority given to investigator groups and locations that are conducting interventional human subjects research in non-clinical sites.

All questions and concerns regarding setting up these processes during this time should be referred to Maryam Saeri, Chief Operating Officer (203-785-7557; maryam.saeri@yale.edu).

Clinical questions should be referred to Dr. Babar Khokhar (babar.khokhar@yale.edu)

Refer to HRPP guidance for additional information.

YCCI Operations and Clinical Research Capacity

The YCCI offices and clinical research facilities (HRU and CSRU), expect to be able to continue supporting faculty in the conduct of clinical research. However due to the unprecedented demand for inpatient clinical bed capacity this winter and the rapidly evolving challenge of Covid-19, we will be implementing changes in our policies for the HRU that would have been rolled out under any circumstances over the next half-year but will now be effective immediately. We are very fortunate that the Church Street Research Unit has been successfully opened in its expanded form which allows us to conduct appropriate risk studies in the more appropriate outpatient setting. Effective immediately, all studies that fit the criteria for use of the Church Street Unit will be moved to that unit. As always, the YCCI team will assist you in making this transition. For studies that will still require the HRU because of risk level or requiring a stay of greater than 15 hours or requiring transport during the study time to the research MR or PET Centers, any questions of prioritization for these resources will be determined by the leadership team. For assistance moving studies to the CSRU, contact Clinicalresearchresources@yale.edu.

Operations of all YSM Clinical Research Locations Seeing Study Participants

We are requiring all YSM clinical research locations seeing study participants to follow the same procedures as all YM/YNHH clinical ambulatory sites. This includes careful attention to social distancing. All staff in clinical research locations must have full training similar to that for the staff in clinical locations.

Important Signage

As part of our ongoing efforts to limit the spread of COVID-19, all locations seeing clinical research participants should utilize the sign at this link, but modified to give instructions to call 1-877-978-8343 (1-877-Y-STUDIES). Ideally, there is also a place for those arriving by another means of transportation to make the call from. Please post at your location an appropriate sign immediately.

FLYER FOR DOWNLOAD

“Prior to the Visit” Planning and Visit Intake

In keeping with the workflow instituted in the YM CARE Center, we ask that you please implement the following workflow for your schedulers and for the initial intake as patients arrive for appointments.

Research participants should be asked to complete a short screening for exposure to COVID-19 before in-person interactions:

  1. Have you travelled to China, Iran, Japan, any country in Europe, or South Korea in the past 14 days? (Note that all “level 3” and “level 2” countries/regions listed on the CDC website should be included here – the CDC website should be checked for the most current list).

  2. Have you had any of the following symptoms in the past 14 days without confirmation as something other than COVID-19 (such as a positive flu test, chronic medical condition, etc.)?
    Fever greater than 100.4 deg F? | Cough? | Difficulty breathing? | Sore throat?

  3. In the last 14 days, have you lived with, visited, cared for, or been in a room for a prolonged period of time with someone who is under investigation or has been confirmed for COVID-19/coronavirus infection?

If participants say “yes” to any of the questions, it is recommended that you reschedule testing for a later date and direct them to the YNHH COVID-19 Support Call Center: 203-688-1700 option 1.

Similar, for patients being scheduled for a visit, at time of scheduling, patients should be reminded that should they become symptomatic for COVID-19 on the day of their scheduled appointment, they should not attend, and instead call to reschedule the appointment.

Staff Training and Readiness

All front desk and clinical staff must receive training as to the appropriate questions and precautions necessary to provide a safe environment for subjects/patients and staff.

Test Kits and Supplies

We are working with YNHHS in the procurement of the appropriate levels of supplies, including PPE. If PPE is needed for non-interventional human subjects research, that research should be paused.

All questions and concerns regarding clinical operations during this time are best referred to Maryam Saeri, Chief Operating Officer (203-785-7557; maryam.saeri@yale.edu).

Remote Research Visits

You may consider the use of Epic telehealth capabilities to convert face to face visits to remote visits, where possible. Communications, including training modules for conducting telehealth visits, will be forthcoming, along with plans to manage communications with patients whose research visits may shift from in-person to video visits. Please see “IRB Requirements regarding necessary changes to research because of COVID-19” should you wish to implement remote research visits for your study.

Refer to HRPP guidance for additional information.

Sponsor Monitoring

We have instituted two changes relevant to study sponsor visits: 1) a restriction on visitors to campus; and 2) only staff whose work is deemed essential for critical operations will be expected to report to work on the Yale University campus.

Visits March 16 through April 1, 2020 (date subject to change)

Effective immediately, all monitoring visits, including site qualification, site initiation, interim monitoring, and close out visits scheduled through April 1st, must be postponed.

Visits April 2 through May 10, 2020 (date subject to change)

Visits scheduled from April 2nd through May 10th, must be postponed or converted to one of the following virtual options: 1) email, 2) telephone, or 3) Zoom with video.

IRB Requirements regarding necessary changes to research because of COVID-19

Refer to HRPP guidance for additional information.

To reach Kelly Anastasio, Alyssa Gateman, Amy Hummel, or Rhoda Arzoomanian please use this email: Clinicalresearchresources@yale.edu

Submitted by Liz Pantani on April 16, 2020

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Other Research Related Questions - as of 3/17/2020 12:30PM

Question: Do I need approval to modify any protocol activities (example: convert in-person visits to remote visits) or decide to pause research activity?

Answer: Refer to HRPP guidance for additional information.

Additionally, most sponsors require notification. For government sponsors, contact Yale Grants and Contracts or your departmental business office for guidance. For guidance on notifying industry sponsors, contact Alyssa Gateman at Clinicalresearchresources@yale.edu.

Question: For FDA-regulated research in which the PI is the sponsor of an IND or IDE, will the FDA need to be notified of modifications to any protocol activities (example: convert in-person visits to remote visits) or decide to pause research activity?

Answer: Yes. For IND/IDE assistance, contact YCCI at Clinicalresearchresources@yale.edu.

Question: For multi-site trials in which I am the sponsor PI or lead site, do I need to communicate COVID-19 plans to participating sites?

Answer: Yes. As the sponsor or lead site, you should communicate all trial-related COVID-19 plans to participating sites, including notification of all modifications to any protocol activities (example: convert in-person visits to remote visits). For assistance, contact YCCI at Clinicalresearchresources@yale.edu.

Question: If I change my study enrollment status, is an update to Clinicaltrials.gov required?

Answer: Yes. For studies subject to ClinicalTrials.gov requirements, Responsible Parties should update their records within 30 days of a change to any of the following: Recruitment Status and Overall Recruitment Status data elements on ClinicalTrials.gov. Changes to anticipated or actual Study Start Date, Primary Completion Date and Study Completion Date data elements must also be made within 30 days. In addition, it is strongly encouraged that any IRB approved protocol amendments that will reflect in public ClinicalTrials.gov protocols (e.g. inclusion/exclusion criteria) be updated within 30 days of approval.

It is recommended that the Record Verification Date be updated at least every 6 months for studies that are not yet completed, even if there were no changes to the record.

For further clarification on the required updates to ClinicalTrials.gov data elements, see page 11 of this document.

Question: Can I conduct COVID-19 research?

Answer: Refer to HRPP guidance for additional information

Question: What if I want to ship investigations study drugs to a research participant to limit COVID-19 exposure?

Answer: The YNHHS Investigational Drug Service (IDS) is developing guidance on the proper way to get study drugs to research participants. Do not mail study drugs to research participants without receiving guidance regarding the proper way to do this.

YNHHS Investigational Drug Service (IDS) issued the following guidance on the proper way to get study drugs to research participants: Yale Investigational Drug Service Guidance for COVID. Do not mail study drugs to research participants without receiving guidance regarding the proper way to do this. If research participants are on investigational drugs, work with the IDS (IDS Phone: 203-688-4872, IDS Oncology: 203-200-3100, IDS Pager: 203-412-6248) to determine what the plan would be if the investigational drug could not be dispensed to your research participants. Most clinical trial protocols or sponsors prohibit the shipping of Investigational Products to participants, without written authorization from the sponsor to ship drugs. In cases where the participants are unable to come in-person for follow up visits, IDS will work with research teams to determine the best means of providing continued services to our study participants. As part of the YNHH Department of Pharmacy Services, IDS plans to stay open to support research participants. Contact IDS directly (IDS Phone: 203-688-4872, IDS Oncology: 203-200-3100, IDS Pager: 203-412-6248) or email questions to clinicalresearchresources@yale.edu.