GUIDANCE AND FREQUENTLY ASKED QUESTIONS RELATING TO HUMAN SUBJECTS RESEARCH DURING THE COVID-19 OUTBREAK

 

LSUHSC-NO and its Human Research Protection Program (HRPP) are committed to protecting the rights and welfare of all individuals who participate as participants in research. The HRPP is monitoring the release of information related to COVID-19 from LSUHSC (https://911.lsuhsc.edu/coronavirus/) and from federal agencies. The information provided below is for researchers with non-exempt active protocols that include human subjects; it will be updated as conditions warrant.

NOTE: If you are conducting studies at Non-LSUHSC sites please follow the COVID-19 policies and procedures of the site even though it may contradict the guidance presented here.

 

GUIDANCE

 

Stay at Home Order Removed

Posted 05/13/2020

  • Louisiana will move to Phase One under the White House COVID-19 guidance on May 15, which removes the Stay at Home order for Louisianans. With removal of the Stay at Home Order, the suspension, or requirement of remote conduct, of non-essential research study visits issued on March 23 (below) is also rescinded effective May 18, 2020. Please note that under Phase One, all individuals are expected to “limit their exposure to the novel coronavirus when in public by wearing a facial covering like a cloth mask, practicing good hygiene, including frequent handwashing, and maintaining at least six feet of social distance from people who are not in their households.” In addition, “high risk individuals should continue to stay at home, except for essential activities, like getting food or medical care.” Given these expectations, investigators should use their best judgment in determining which in-person research visits can be conducted safely and under what conditions. Investigators should also provide clear instructions and support (e.g., face masks) to research participants prior to and during the research visits. Investigators may continue to conduct remote visits, if in their opinion, that is the safest option for the research participants. Resumption of in-person study visits does not require prior approval by the IRB.

 

Stay at Home Order Issued by Governor John Bel Edwards

Posted 03/23/2020

  • Pursuant to the Stay at Home Order issued on 03/22/2020, all research study visits that do not involve medical care and treatment or other similar vital services for the participant must be suspended or conducted remotely via email, telephone, video-conference interviews, web-based surveys or similar methods until the Stay at Home order has been lifted. This type of protocol change, in response to the Stay at Home Order, does not require prior approval by the IRB. This waiver is effective only while the Stay at Home order is in effect. Please document the protocol change in the study regulatory binder and report it as a minor deviation during the next annual continuing review or the triennial status update.
     
  • Click here to review the full Stay at Home Order.
     

Obtaining and Documenting Consent and HIPAA Authorization for Research

Posted 03/21/2020

  • The IRB has determined that is impracticle to obtain in-person signatures on consent forms when study visits are remote. If research has the potential of DIRECT BENEFIT that is critical to participant safety and enrollment requires a signed consent form, the IRB waives the requirement for signed consent. When this occurs, researchers should document that oral consent has been obtained and should make every attempt to obtain a signed consent document upon the cessation of social distancing requirements.This waiver is only in effect for studies which PROVIDE DIRECT BENEFIT to participants.
     
  • For studies that DO NOT PROVIDE DIRECT BENEFIT to the participant, a complete informed consent process must be conducted for participant enrollment, unless previously waived by the IRB. Acceptable remote methods of consent include mailing, emailing, and faxing of consent documents and telephone or video contact with potential research subjects. For studies that do not provide direct benefit to the participant but the research is directly related to the COVID-19 pandemic, and the participant does not have acces to a scanner** or fax machine, the IRB will, given the time-sensitive nature of the research, allow the participant to take a photo of the consent document (either the entire document or the signature page) and text or email it to the researcher. The participant should mail the signed consent form at his or her earliest convenience.
     
  • When accessing, using or disclosing PHI a signed HIPAA authorization form is required. Acceptable remote methods of obtaining authorization include mailing, emailing, and faxing of HIPAA authorization forms.
     
  • The IRB has determined that it is impracticle to obtain in-person signatures on HIPAA authorization forms when study visits are remote. If research has the potential of DIRECT BENEFIT that is critical to participant safety and enrollment requires a signed HIPAA authorization form, the IRB waives the requirement for HIPAA authorization for research. Unlike research consent, oral authorization for HIPAA is not allowed. Researchers should document that the requirement of HIPAA authorization has been waived by the IRB due to the COIVD-19 pandemic and should make every attempt to obtain a signed authorization upon the cessation of social distancing requirements. This waiver is only in effect for studies which provide DIRECT BENEFIT to subjects.
     
  • You must use HIPAA compliant practices when emailing or faxing documents which may contain PHI when paired with a signature (e.g. diagnoses).
     
  • For FDA regulated research, you must ensure all electronic records are Part 11 compliant.

 

Research Teams Should:

Posted 03/18/2020

  • Consider Evaluating Research Participants for Potential Infectious Risk Prior to In-Person Visits: If researchers will have in-person interactions with research participants, all study teams should be prepared to evaluate research participants for potential infectious risk prior to any interaction and incorporate screening prior to scheduled study visits at the research site. Any screening procedures, however, should conform to the guidance and protocols developed by your institution and based on federal or state public health professions. The incorporation of this screening procedure does NOT require IRB approval.

  • Consider Developing a Script for Participants:  Research teams should consider developing a script outlining for research participants how LSUHSC-NO is making the environment as safe as possible when they come in for their research visit.

     
  • Consider Developing Alternative Data Collection Methods: To capture critical data from participants. These methods could include use of phone, video-conference interviews, web-based surveys, etc.
    • Protocol changes such as these DO require prior IRB approval by the IRB of Record (either the LSUHSC IRB or an external IRB on which LSUHSC is relying).

       
  • Consider Pausing Study Procedures: For studies where appropriate, individual investigators may choose to temporarily pause enrollment. PIs need to assess whether any reduction in staff makes it unsafe to complete the planned research procedures.  Even routine research interventions might not be easy or safe if experienced staff are not available.

     
  • Prepare Contingency Plans: Study teams should proactively prepare contingency plans for their active research protocols.  Assess if the disruption of a research protocol might impact the safety of your research participants.
    • Investigational Drugs: If research participants are on investigational drugs, please consider what the plan would be if the investigational drug could not be dispensed to your research participants.
    • Timely review of research data: If research team members are not available, integration of research care such as reviewing lab results in a timely manner might not be possible and will require special attention under the direction of the study PI. Study teams should consider the availability of appropriate back-ups to the PI to make safety assessments.
    • Home Visits: Study teams should consider alternatives, such as phone or video-conference interviews, to home visits for collection of data in studies with no potential direct benefit to participants.
       
  • Consult the LSUHSC-NO “2019 Novel Coronavirus” Website: Researchers should consult the LSUHSC-NO 2019 Novel Coronavirus website for the latest updates to institutional policies, procedures and resources relating to the COVID-19 outbreak.

     

FREQUENTLY ASKED QUESTIONS

 

Will HRPP continue to operate as usual?

Yes.  The HRPP and IRB Office are currently operating per standard  procedures but all staff are working remotely. Please submit IRBManager applications as per standard protocol and all other applications and queries via email to the relevant mailbox: either IRBOffice@lsuhsc.edu (for regular submissions) or CIRB@lsuhsc.edu (for external IRB or IRB reliance related submissions). 
 

Do I need IRB approval in order to contact subjects to determine potential COVID-19 exposure or symptoms?

No.  If you implement procedures, such as administration of questionnaires, in order to identify subjects whose visits should be postponed, modified, or delayed, you do not need to modify the IRB application because this activity is not a research procedure. Any procedures, however, should conform to the guidance and protocols developed by your institution and based on federal or state public health professions.

If a subject endorses answers that may indicate exposure or symptoms, direct them to their primary care physician.
 

Can I still conduct research procedures and interact with subjects?

Procedures that do not require in-person contact with subjects can continue as approved in the IRB application.  Procedures that are approved as in-person may need to be modified or postponed (See “Do I need to modify my study to make changes for alternatives to in-person study visits?”)

Researchers should be considering ways to limit in-person interaction with subjects and considering alternative ways to continue study procedures in the event that in-person visits are not possible.  For example, interviews may be conducted by phone or the schedule of visits may be safely modified or delayed.

The protocol will need to be modified through the regular pathway in IRBManager if the study is not exempt and the approved application prohibits the activity from taking place in that manner.

Please contact IRBOffice@lsuhsc.edu with questions.
 

If a subject does not make a scheduled visit due to COVID-19 concerns, is this a protocol deviation? Is rescheduling a visit a protocol deviation?

These are minor deviations; generally, they do not place the subject at increased risk. Record the absence or rescheduling event in the reportable event log of the study-specific regulatory binder and report the event at the time of the continuing review application or study status update.

If the missed visit places the participant at increased risk, make every effort to contact the participant and report the deviation immediately (within 5 (five) business days) to the IRB.
 

May I continue to collect data and follow up with subjects by telephone when in-person data collection has been paused?

Yes. If this methodology has been approved for the protocol by the IRB. If this methodology was not previously approved by the IRB, please submit an amendment/modification to the study. The modification will be reviewed expeditiously.

Rationale: There is no increased risk to participants relating to COVID-19.
 

May I continue conducting telephone screening of potential subjects?

Yes. If this activity is approved for the protocol by the IRB. If this activity was not previously approved by the IRB, please submit an amendment/modification to the study. The modification will be reviewed expeditiously.

Rationale: There is no increased risk to participants relating to COVID-19.
 

Do I need approval from the IRB for communications to study subjects explaining any pause in research activities?

No. It is not necessary to submit a modification.
 

Do I need to modify my study to make changes for alternatives to in-person study visits?

During the Stay at Home Order

Please consult the guidance above posted on 03/23/2020. 

 

After the Stay at Home Order is lifted

Any changes to a NON-EXEMPT study must be approved in advance by the IRB as a Modification to the study , unless they are necessary to eliminate immediate apparent hazards to participants.  Modifications should be submitted through the regular process in IRBManager. 

You will need to modify your application if the study is not exempt and the application specifies in person visits.

You DO NOT need to modify the application in order to hold visits remotely or change the schedule of study visits if the study is EXEMPT or if the IRB application does not describe whether the visit would be in person or remote or give specifics about visit schedule.

If you submit a modification related to COVID-19, you should email the IRB Office  to prioritize these modifications. Please contact IRBOffice@lsuhsc.edu with questions.
 

What if a participant reports possible COVID-19 exposure or symptoms during a study visit?

Please follow institutional policy of the site where the visit took place. If possible, place a surgical mask on the subject and direct them to a private room with a door that can close.
 

May we enroll new subjects on existing studies?

Only if the enrollment can be conducted remotely according to the instructions posted above on 03/21/2020.
 

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 may continue.

Rationale: There is no increased risk to the subjects relating to COVID-19.
 

If I am pausing study procedures, do I need to notify the IRB of Record, for studies relying on an external IRB?

Yes, as soon as feasible. The regulations allow implementation of a change to study procedures without prospective IRB approval when it is necessary to avoid imminent hazards to subjects. The IRB of Record will need to approve resumption of study procedures.
 

If I am pausing study procedures and these changes are approved by an external IRB of Record, do I need to have documentation from the  LSUHSC IRB for these changes before proceeding?

No. As soon as feasible, update your study in IRBManager by attaching the approval letter from the external IRB.