COVID-19: Human Subjects

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Updates on COVID-19: Human Subjects (IRB)

Effective August 2, 2021, the Revised Standards for Human Subjects Research have been updated; the conditions for when additional COVID-safety reviews are required have changed.  

Researchers should review the Office of the Senior Vice President for Research's guidance for increasing on-campus research. 

This webpage addresses COVID-19-related questions as pertains the Penn State's IRB programs (Office for Research Protections and Human Subjects Protection Office). Penn State Health researchers and staff should also view Penn State Health-specific guidance. See the Penn State COVID-19 webpage for University updates.

Updated 8/11/21: FAQs updated.

 

Information on the Revised Standards

Revised standards for human subjects research 

  • The Revised Standards for Human Subjects Research have been updated, effective August 2, 2021. In-person research visits may resume without additional COVID-safety if they meet all six criteria, as outlined in the Revised Standards. 
  • If research does not meet all six critera, a researcher must follow the “Procedures to Request to Conduct In-Person Human Subjects Research During COVID-19” process.  This review of COVID-safety measures requires approval by the college dean or campus chancellor AND the Office of the Senior Vice President for Research. 
  • All modifications to research procedures require IRB review and approval prior to implementation, except those that are necessary to eliminate an immediate apparent hazard to a participant (these are then required to be submitted to the IRB afterward as an RNI).

Penn State Health observational studies

College of Medicine and all Penn State Health sites have allowed observational studies with subjects for non-clinical or research-only reasons since March 15.  Certain studies that meet the critera below do NOT require additional COVID-safety reviews through InfoReady: observational clinical research studies involving participants who are already on campus for a health care appointment and where all four of the criteria below are met:  

1.    The study only involves limited sample collections, AND
2.    The participant remains in one location for both the health care visit and research visit, AND
3.    Interaction between study staff and subject is fewer than 15 minutes, AND
4.    The subject’s face mask is not removed at any time. 

Observational clinical research studies that involve participants who are already on campus for a health care appointment that do not meet all four above criteria must be submitted for review through the University’s the InfoReady system.

See Revised Standards for further details.

 

Study location, including international research 

The Revised Standards apply to Penn State research, regardless of location. Research that does not meet the criteria outlined in the Revised Standards must be approved through the “Procedures to Request to Conduct In-Person Human Subjects Research During COVID-19” process. This includes international sites.

For allowable face-to-face research, PIs must be aware of any local restrictions and required safety protocols (e.g., hospital-specific requirements, country- or state-level ordinances, etc.).

 

Voluntary research pause

The PI may decide to voluntarily pause, delay, or reschedule interactions with subjects because of COVID-19 ; in such cases, there is no need to inform the IRB, regardless of review level. This is a temporary change to the IRB’s policy regarding submission of an RNI in these situations specifically related to the impact of COVID-19. However, you must:

  • ensure the voluntarily pause does not increase any risk to study subjects if the your study is a greater-than-minimal risk study that involves some type of patient care.
  • contact study subjects who will be affected by this suspension (e.g., a study visit will be cancelled, etc.).

Investigators should notify the study sponsor and any others necessary, as required.

Investigators are required to document the voluntary pause in the study records along with the justification and any actions taken in the event that this is needed during an audit.

Modifying visits from in-person to remote/virtual 

  • Changes to move from in-person study visits to virtual/remote or phone options must be approved in advance by the IRB as a modification to the approved study. Exempt studies do NOT need to submit a modification unless the change would alter the review level of the study, as per the Investigator Manual.
  • ORP/HSPO IRB offices will prioritize modifications related to COVID-19.  
  • All modifications to research procedures require IRB review and approval prior to implementation, except those that are necessary to eliminate an immediate apparent hazard to a participant (these are then required to be submitted to the IRB afterward as an RNI).
  • IRB analysts are available to discuss moving a study from face-to-face to remote interactions. Please contact your IRB analyst with questions, or email ORP: IRB-ORP@psu.edu HSPO: hspo@pennstatehealth.psu.edu.

Modifying consent forms

Consent forms do not need to be revised if the revised procedures do not introduce new or increased risks. When submitting modifications for procedures, IRB staff are evaluating whether changes to the consent are necessary.

Modifications to change from signed consent:

Researchers are encouraged to modify their study protocol to replace written informed permission/assent/consent with verbal permission/assent/consent if their study meets the regulatory criteria for a waiver of documentation. The regulatory criteria for a waiver of documentation can be found within HRP-411- Checklist- Waiver of Written Documentation of the Consent Process.

Modifications to obtain consent via telephone/telemedicine:

If a study was previously approved with a plan to obtain signed consent from study participants in person, a modification to the study would be needed in order outline procedures for obtaining a signature remotely (e.g. email, mail, fax) prior to starting any research procedures or to request a waiver of documentation. A waiver of documentation of consent would allow the researcher to obtain consent remotely without obtaining a signature (e.g., verbally or in another format that is not signed).

If the current IRB-approved study protocol includes a waiver of documentation (signed consent was not required) and previously consent occurred in- person (verbally or in another format that was not signed) the researcher would be able to consent individuals remotely (e.g., via Zoom or telephone) without a modification to the currently approved study protocol.

 

Important notes for modifications to perform research remotely

When submitting a modification, please note in the submission to the IRB that the PI is adding the option to perform research remotely under the COVID-19 revised standards for human subjects research. Include in the modification that once in-person research is allowed again, the study will return to previously approved procedures.  (Doing so will eliminate the need to submit another modification later when/if the PI wishes to resume normal study activities.)

In the modification, please consider and address the following, where applicable:

  • Potential impact on subject safety and protections
  • Potential privacy and confidentiality concerns.
  • Data security requirements and obtaining IT security approval.
  • Explain how recordings are to be made remotely. Non-Penn State Health investigators: Zoom is a viable option for Level 1 and Level 2 data; for Level 3 and 4 data, contact Office of Information Security Security@psu.edu. Please note the non-Penn State Health Zoom is NOT HIPAA compliant for storing Level 3 or Level 4 data.  
  • Potential impact on scientific integrity and/or benefits of the study
  • Plan for how existing subjects will be notified (if their participation will be affected by the Modification)

Modifications for COVID-19 safety 

The following applies to in-person studies approved by the dean and Office of the Senior Vice President for Research to conduct in-person research via Procedures to Request to Conduct In-Person Human Subjects Research During COVID-19:

Modifications to research procedures for COVID-19 safety may need to be submitted to the IRB for review and approval. Changes to research procedures and IRB approved study protocol – such as changing an in-person visit to a telephone visit, combining study visits, eliminating procedures, or reducing the overall duration of subject participation – do require review and approval by the IRB prior to implementation of the change. If restarting research safely requires such changes, the researcher must submit a modification in CATS IRB and obtain IRB approval prior to restarting your research.  For questions regarding whether the planned change requires a modification, please contact the researcher’s IRB Analyst. 

The following changes generally do not require IRB review and approval:

  • Screening procedures, including temperature screenings (as long as the information collected will not be retained and used as research data).
  • Procedures for cleaning/sanitizing that are consistent with CDC recommendations, PA DOH recommendations, and University recommendations/requirements.
  • Practicing social distancing.
  • Use of face coverings or face masks.

 

 

Modifications that cannot wait for IRB approval

If it is in the best interest of the subject to eliminate an immediate apparent hazard to one or more participants and there is no time to obtain prior IRB approval, a researcher may do so. The PI must then submit this modification as reportable new information (RNI) within 5 business days to the IRB for review.

How to submit a modification 

Information on how to submit a modification to an approved study can be found at https://www.research.psu.edu/irb-modification.

Sponsor changes to a study

If a sponsor provides sites with guidelines for conducting the research study, a modification request must be submitted. The Modification Summary must indicate that the modification request is to disclose sponsor correspondence due to the COVID-19 pandemic; upload the sponsor documentation on the Basic Information page.

Also, the site-specific section of HRP-595 must be updated to include the alternate process(es) that the site will follow based on the sponsor’s guidance document. The PI should be sure to indicate that these processes will be followed only during the PSH/PSU/COM Revised Standards for Human Subjects-Related Research Visits during COVID-19. Note that the site will return to the usual process(es) when the revised standards are removed by PSH/PSU/COM. Adding this wording provides a definitive end-point that will be University wide, thereby removing the requirement to submit a modification request to the IRB to return to the usual process with the revised standards are removed.

If sponsor’s guidance provides optional processes to follow, only the processes the site with actually follow must be included in the revised HRP-595. If the entire sponsor guidance document contains only optional processes and the site chooses to not follow any of the processes, indicate this on the Modification Summary and do not revise HRP-595. 

Consent forms do not need to be revised if the revised procedures do not introduce new or increased risks. When submitting modifications for procedures, IRB staff are evaluating whether changes to the consent are necessary.

Studies using Doximity

If your study procedures already involved phone calls and you are now using Doximity to make those phone calls, you do NOT need to make any changes to any of your documents.  

If you are now performing phone calls in lieu of in-person visits or adding additional phone calls, you need to update your protocol documents (HRP-591, HRP-595, etc, -- depending on the type of research) to reflect this. 

If you were not collecting phone number prior to the change, you will also need to update HRP-598 to indicate that phone number will be stored. 

 

Reportable New Information (RNI) for a sponsored study

For changes to subject visit or enrollment procedures (new COVID-19 procedures), submit a modification to the HRP-595.

Submit RNI for sponsored study for the scenarios listed below. The IRB is prioritizing these reviews and acknowledging daily.  

  • Sponsor recommendations and guidance during COVID-19, received by study teams: 

    • Suspending or holding enrollment (Note: if no subjects are enrolled, this does not necessitate any further actions by the site)
    • General notifications to sites
  • A process was altered prior to IRB approval to eliminate an immediate or apparent hazard to one or more of the participants and there is no time to obtain IRB approval.

 

Participant safety monitoring

We encourage study teams to continue remote study sponsor and monitor visits for clinical trials or other human subject-related research. However, exceptions for in-person visits for site qualification, site initiation, study closeout, or monitoring, may now be allowable if permission is granted. Importantly, these visits must follow the College of Medicine and Penn State Health policies for vendors and require pre-approval before a visitor is allowed on campus. Note that there are required actions of both the monitors and the study team as described in the pre-approval intake form.

 

More information and link to the online pre-approval form can be found here.

Modifications to safety monitoring procedures should be approved in advance by the IRB, except when necessary to eliminate apparent hazards to a participant and there is not sufficient time to obtain IRB approval.

If a PI does need to change an approved monitoring procedure to eliminate immediate possible danger, please report it to the Penn State IRB within 5 business days, following the Reportable New Information (RNI) procedures described in the Investigator Manual (HRP-103) on page 52. 

Information for Researchers Planning COVID-19 Research

Notifying the IRB of a new study or modification related to COVID-19

To ensure timely processing of submissions related to COVID-19, we ask that the researcher identify a submission in the following way:

New Study Submission:

  • Include COVID-19 in the short title (question #2 in the short form)

Reportable New Information (RNIs):

  • Include COVID-19 in the RNI short title (question #1)

Modification:

  • Use the “Add Comment” feature in CATS IRB to add “COVID-19” as a comment to your submission and check “IRB Coordinator” under item #3 in the pop up box. Note: The “Add Comment” button is found left side of the screen on the main study workspace in CATS IRB. 

Failure to identify a submission as outlined above may result in delays in review.

COVID-19 research and specimens 

Research on COVID-19 is evaluated on a case-by-case basis. If a PI is working with materials related to Covid-19/SARS-CoV-2/Coronavirus, the Institutional Biosafety Committee strongly recommends researchers review the CDC’s guidelines daily to ensure the lab is meeting the latest safety standards. Note, it is possible that some materials can be ordered at BSL 1 but are now being handled at BSL 2 per the CDC’s guidance. Please contact the IBC Email prior to initiating work and/or if you have any additional questions. Resource Links: IBC Applications, CDC’s Website & ABSA International Website

For Penn State Health: Due to biosafety concerns, and in conjunction with the CDC recommendations for specimen handling from COVID-19 patients, any study that aims to enroll COVID-19 subjects will require a modification to the protocol for IRB approval, which will include a biosafety review. COVID-19 patients cannot be enrolled on existing protocols without this modification approved. 

 

COVID-19 related activities that are not human subjects research

 Penn State is ready to assist researchers and clinical care providers who are planning COVID-19-related activities that may intersect or overlap with public health authority activities and/or FDA emergency authorizations for diagnostics. In some cases, IRB approval will not be required. Penn State can assess the circumstances, provide advice, and issue determination letters (if warranted).  

The procedures for a single patient emergency use of an investigational drug or device remains unchanged during this time. The policy for Emergency Use of an Investigational Drug or Device is on the HSPO website. Read about the FDA Guideline.

Other Frequently Asked Questions

Effective August 2, in-person research may resume BUT it requires additional COVID-safety review through the InfoReady process unless the study meets all six criteria outlined in the Revised Standards for Human Subjects Research If research cannot meet the outlined six criteria, a researcher must follow the “Procedures to Request to Conduct In-Person Human Subjects Research During COVID-19” process.  

For the College of Medicine and all Penn State Health sites, observational studies with subjects for non-clinical or research-only reasons have been allowed since March 15 . 

  • Studies without prior approval will need to be reviewed at both the College of Medicine and the University through the InfoReady process. 

For College of Medicine and all Penn State Health sites, the only studies which are excluded from the InfoReady process are observational clinical research studies involving participants who are already on campus for a health care appointment and where all four of the criteria below are met:  
1.    The study only involves limited sample collections, AND
2.    The participant remains in one location for both the health care visit and research visit, AND
3.    Interaction between study staff and subject is fewer than 15 minutes, AND
4.    The subject’s face mask is not removed at any time. 

Observational clinical research studies that involve participants who are already on campus for a health care appointment that do not meet all four above criteria must be submitted for review through the University’s the InfoReady system.

 

It depends.  Effective August 2, if the research meets all six criteria outlined in the Revised Standards for Human Subjects Research AND there are no changes to study procedures from the original protocol, no additional paperwork is required.  However, if a study does NOT meet the criteria outlined in the Revised Standards, it must submit for a COVID-safety review through InfoReady following the “Procedures to Request to Conduct In-Person Human Subjects Research During COVID-19” process.  

Also, if a study is being modified from its original IRB protocol, a modification will be required in CATS IRB.  As stated above, the following COVID safety changes generally do not require IRB review and approval:

  • Screening procedures, including temperature screenings (as long as the information collected will not be retained and used as research data).  Screening should follow University guidance.
  • Procedures for cleaning/sanitizing that are consistent with CDC recommendations, PA DOH recommendations, and University recommendations/requirements.
  • Practicing social distancing.
  • Use of face coverings or face masks.

 

In order to meet the criteria outlined in the Revised Standards, participants must be screened PRIOR to participating in the study.

Email and phone scripts for University Park and Commonwealth campuses are available here.

Penn State Health researchers and staff should view Penn State Health-specific guidance and screening script.

 

Remote activities are generally those that involve no in-person, face-to-face interaction. Examples of remote activities may include the conduct of surveys online or by telephone, the conduct of interviews via Zoom, etc. In person, face-to-face interactions are those that cannot be conducted remotely and involve, to some extent, being in the same physical location as a subject for some period of time and may involve physical contact. Activities that do not clearly fit into one of these categories should be discussed with the dean of your college to determine whether the “Procedures to Request to Conduct In-Person Human Subjects Research During COVID-19” must be followed in order to restart these activities. The IRB should be consulted regarding the need for changes to the study protocol for such activities.

The researcher must first consult each school district or school where the research is taking place, as each may have different requirements and guidelines on contact of previously enrolled participants, re-consent, study-specific data collection procedures, and data protections. Some school districts or schools may have restrictions on human subjects research activities or only allow certain types of activities. Based on the new information, you must submit a modification that includes any revised procedures, consent forms, and data collection materials, as applicable.  A reminder that regardless of the school's masking policies, Penn State researchers MUST be masked at all times, regardless of vaccination status, when conducting research.

Yes. Even if the research is paused for the time being, the PI must still submit the Continuing or Administrative Review to ensure that the study stays active. This will allow research to begin again immediately when appropriate and/or permitted. Failure to submit will result in study closure. If the study is closed, the study cannot be re-opened and all human research activities must stop.

The Human Research Protection Program is fully operational. Staff are working remotely and meetings are being held virtually. The physical offices are currently closed; please do not visit the office in-person. Staff are happy to arrange Zoom meetings or conference calls with researchers as needed.