Why must some human participant research studies or
specific activities be paused?
Given the current COVID-19 coronavirus outbreak, the
risk/benefit ratio for in-person contact associated with research activities
must be assessed for each protocol. Ethical principles of research and federal
regulations for the protection of human research participants require an
acceptable risk/benefit ratio.
Which human subjects research may continue?
On-going trials with direct potential benefit to
participants may continue for enrolled subjects, pursuant to hospital
limitations.
Principal investigators are asked to voluntarily suspend
their trials if they can do so safely and if the suspension will not jeopardize
the scientific integrity of the trial. Consultation with the OHRA is strongly
advised. However, as the COVID-19 pandemic places increased stress on the
hospital, access for research personnel will be progressively restricted.
For all studies with federal funding (NIH, DoD, NSF,
etc.) which have incurred pauses must notify by email Suzanne.Locke@einsteinmed.org
with the following three pieces of information:
Name of PI
Name of Sponsor
Sponsor Number
Which studies or study procedures must be paused?
Studies or study procedures involving face-to-face
interaction with participants that have no direct therapeutic benefit must be
paused or modified.
Procedures such as telephone contact or remote monitoring or
remote data collection if part of such studies may continue.
Which studies may continue?
Studies which offer direct therapeutic benefit to
participants may continue, pursuant to hospital limitations. To the extent
possible, study activities that can be done remotely by telephone or
electronically, such as screening or follow-up, should be done in this
way.
Studies that do not involve face-to-face interactions with
participants may continue.
Studies conducted electronically or via telephone or
involving secondary data analysis may continue.
Does changing from an in-person research visit to a
remote (Zoom or phone) visit require pre-approval from the IRB?
No, pre-approval from the IRB is not required. Such changes
should be recorded as deviations and submitted to the IRB at the time of
continuing review. Surveys, focus groups, recruitment, or other minimal risk
activities may be done remotely without submitting an amendment to the IRB.
If Einstein/MMC changes institutional policies or
procedures in response to COVID-19 and this affects my research, do I need
approval from the IRB?
No, pre-approval from the IRB is not required. Any Einstein/MMC-wide procedures that are
being implemented to address the public health impact of COVID-19 do not
constitute a change to the research, but instead reflect changes to
institutional policy in response to a public health threat, which, in turn,
affect ongoing studies.
In general, changes made to research in response to a public
health threat can be made without first obtaining IRB review and approval
provided that the change in the research was made to eliminate apparent
immediate hazards to the subject.
Does a change in the consent process to enroll new
subjects remotely require pre-approval from the IRB?
Please contact irb@einsteinmed.org
for further guidance on this topic.
May we do phone consent for legally authorized representatives
(LARs) for clinical studies where the patients cannot consent?
Please contact the IRB at irb@einsteinmed.org
for guidance on this topic. We will consider these on a study-by-study
basis.
What is the process for emergency use of an
investigational drug?
The Emergency Use procedure has not changed. The Emergency
Use SOP may be found here.
Before beginning an application to the IRB, please contact
the FDA to receive the Emergency Use IND. The FDA may be reached at (888)
463-6332 or (301) 796-3400.
NOTE: FDA regulations only require that you notify the IRB
within 5 days of the use of the drug.
However, many sponsors require IRB acknowledgement before releasing the
drug to the physician.
To begin the process for the IRB application, submit an
Emergency Use Application in iRIS. To do so, log into iRIS and select “Add a
New Study” from the Study Assistant bar. In the Application section entitled
“Type of Application,” select “yes” to the question, “Is this an emergency use
of a drug or device.”
We advise emailing the IND to irb@einsteinmed.org as soon as you
receive it, along with the IRB# of the submission in iRIS, to expedite the
process.
How do I open a new study related to COVID-19?
Email irb@einsteinmed.org
to alert the IRB with the words “COVID-19 protocol” in the subject. The new submission will need to be done in
iRIS but we will prioritize these submissions.
If this will be a multi-site study under a Single IRB
arrangement, please submit a request at this link.
Please also refer to our sIRB
Reliance Procedure and sIRB
guidelines or email singleIRB@einsteinmed.org.
If you wish to amend an existing protocol to include
COVID-19, please contact the OHRA for guidance (irb@einstenmed.org).
May I open a new clinical trial for enrollment?
This will be decided by the IRB on a trial-by-trial basis.
The PI should provide a revised risk-benefit statement that explicitly takes
the COVID-19 risks into account.
Can new subjects be enrolled in trials that are
continuing?
This should be decided on a study-by-study basis.
Do I need to notify the IRB if I pause my research?
No, this does not need to be
reported to the Einstein IRB unless the study hold is initiated at the request
of an external funding agency or the study’s Data and Safety Monitoring group.
Please contact Suzanne.Locke@einsteinmed.org
if the study is federally funded.
Do we need approval from the
IRB for communications to study subjects explaining the pause in activities?
No. It is not necessary to submit
a modification.
May we continue to collect data
and follow up with subjects by telephone when in-person data collection has
been paused?
Yes.
May we continue conducting
telephone screening of potential subjects?
Yes.
May we conduct home visits to
collect data in studies with no potential direct benefit to participants?
No.
Rationale: While the real or
potential risk to participants of traveling to a research site, and aggregation
at the site, are absent from home visits, there may still be real or apparent
risk.
I have a progress report due in the near term and my
study is impacted by the pause. Should I include information relating to the
pause in my progress report?
Yes. The progress report form has been updated to include
space for this information. If you have further
questions, contact the OHRA (irb@einsteinmed.org).
I am conducting FDA-regulated research for which I am the
sponsor of an IND or IDE. Do I need to notify the FDA if I pause my study?
Yes. The FDA will need to be notified.
Should I notify the industry sponsor if my research
activities are paused on my clinical trial?
If the study needs to be paused, the sponsor will need to be
notified.
I am a PI of an investigational drug/device trial. Do I
need to pause my trial?
No, 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.
How should I proceed with a study that has no direct
benefit to a subject, but is conducted as part of routine clinical care? An
example is tissue collection for research studies while a subject is undergoing
standard of care surgery.
These should continue.
Rationale: There is no increased risk to the subjects
relating to COVID-19.
What if my study doesn’t clearly fall into any of these
categories?
Indicate what you think is the ethical basis for pausing or
continuing the study in an email to irb@einsteinmed.org. If you state that as the PI, you believe that
there is no increased potential or perceived risk from COVID-19, you may
continue the study pending IRB review.
I have a subcontract with another site in the greater New
York area. Do I need to pause as well, if the pause applies to my protocol at
Einstein/MMC?
Yes.
Rationale: The same ethical issues relating to the changed
risk/benefit ratio that apply to an Einstein/MMC site apply elsewhere.
If my study is being conducted off-site, may it continue?
The same policy will apply. Studies or study procedures
involving face-to-face interaction with participants that have no direct
therapeutic benefit must be paused or modified.
Procedures such as telephone contact or monitoring or remote
data collection if part of such studies may continue.
Rationale: The same rationale
applies regarding the risks relating to COVID-19.
How will the pause in research
impact studies conducted internationally?
The virus is an international pandemic, so the same policy
will apply. Studies or study procedures involving face-to-face interaction with
participants that have no direct therapeutic benefit must be paused or
modified.
Procedures such as telephone contact or monitoring or remote
data collection if part of such studies may continue.
If I am pausing study
procedures on a project reviewed by an external IRB of Record, must I notify
that IRB?
Yes, as soon as feasible, for
their awareness. The IRB of Record may require review/approval prior to
resumption of study procedures.
How do I obtain a signed informed consent from a patient who is in isolation and the COVID-19 infection control policy would prevent us from removing a document signed by the patient from their hospital room?
FDA regulations generally require that the informed consent of a participant be documented by the use of a written consent form approved by the IRB and signed and dated by the subject or the subject's legally authorized representative at the time of the consent (21 CFR 50.27(a)). In light of COVID-19 infection control measures, the following procedure would satisfy documentation of this requirement if the patient signed the informed consent is in COVID-19 isolation.7
- If the technology is available, electronic methods of obtaining informed consent should be considered.8
- When it is not possible to obtain informed consent electronically, the sponsor should consider taking the following steps:
- An unsigned consent form is provided to the patient by a health care worker who has entered the room
- If direct communication with the patient in isolation is not feasible or safe, the investigator (or their designee) obtains the patient's phone number and arranges a three-way call or video conference with the patient, an impartial witness, and if desired and feasible, additional participants requested by the patient, (e.g. next of kin)
- To ensure that patients are approached in a consistent fashion, a standard process should be used that will accomplish the following:
- Identification of who is on the call
- Review of the informed consent with patient by the investigator (or their designee) and response to any questions the patient may have
- Confirmation by the witness that the patient's questions have been answered
- Confirmation by the investigator that the patient is willing to participate in the trial and sign the informed consent document while the witness is listening on the phone
- Verbal confirmation by the patient that they would like to participate in the trial and that they have signed and dated the informed consent document that is in their possession.
If the signed informed consent document cannot be collected from the patient's location and included in the study records, FDA considers the following two options acceptable to provide documentation that the patient signed the informed consent document:
- Attestations by the witness who participated in the call and by the investigator that the patient confirmed that they agreed to participate in the study and signed the informed consent
OR
- A photograph of the informed consent document with attestation by the person entering the photograph into the study record that states how that photograph was obtained and that it is a photograph of the informed consent signed by the patient.
A copy of the informed consent document signed by the investigator and witness should be placed in the patient's trial source documents, with a notation by the investigator of how the consent was obtained, e.g. telephone. The trial record at the investigational site should document how it was confirmed that the patient signed the consent form (i.e., either using attestation by the witness and investigator or the photograph of the signed consent). The note should include a statement of why the informed consent document signed by the patient was not retained, e.g., due to the contamination of the document by infectious material.
If the patient is unable to provide informed consent and there is a legally authorized representative, investigators must obtain consent from the participant's legally authorized representative in accordance with 21 CFR 50.27(a).
7 The procedures suggested do not apply to informed consent being obtained under 21 CFR 50.23 – (Exception from general requirements) or 21 CFR 50.24 (Exception from informed consent requirements for emergency research).
8 See Guidance for institutional review boards, investigators, and sponsors Use of Electronic Informed Consent In Clinical Investigations (December 2016), available at https://www.fda.gov/regulatory-information/search-fda-guidance- documents/use-electronic-informed-consent-clinical-investigations-questions-and-answers.
Clinical Trial (CT.gov) Best Practices during COVID-19 Pandemic
1. Two activities are happening on ClinicalTrials.gov as a result of the COVID-19 pandemic:
Registration of new clinical studies of COVID-19 disease.
- Applicable Clinical Trials (by law) and clinical trials that receive direct NIH funding (NIH policy); registration is due within 21 days of first participant enrolled.
- Registration should be prior to the first participant being enrolled to satisfy journal publication requirements.
Updates to existing ClinicalTrials.gov records of studies that have been impacted by the situational response to the COVID-19 pandemic, including delays or pauses, and changes to the design or conduct of the study.
- In general, ClinicalTrials.gov study records should be updated within 30 days of such changes.
2. If you are a Responsible Party or Member of a Research Team:
You are still responsible (by law) for addressing any Errors, Problems, and PRS Comments associated with your records. Approve and Release updated information to ClinicalTrials.gov.
- If any of your Records are Experiencing Delay or Pause Due to the COVID-19 Pandemic the Overall status of the record should be changed from 'Recruiting' or 'Enrolling by Invitation' to 'Suspended', within 30 days of the change.
- For the question Why Study Stopped? Please include: Temporarily paused due to COVID-19 and expected to resume. This is not a suspension of IRB approval.
- It is likely that due to the Pause the “anticipated” Primary Completion Date and the Study Completion Date will have to be moved forward. Please reassess these dates and any other areas of the record (i.e., anticipated enrollment number) that may be affected due to the pause. All milestone dates can be changed again later as needed.
Note: Once the research restrictions are lifted, the Overall Status will need to be edited to the category that best reflects study enrollment activity. This is required within 30 days of when research resumes.