COVID-19 and Human Subjects Research Activities (last updated 5/21/20)

General Principles | Stage 1 | International Research | Minimum Requirements for in-person activities | Expectations of Research Participants | Health Pre-screening for Research Participants | Script for Use by Research Teams | Required Attestations | Frequently Asked Questions

This webpage has been substantively updated to provide guidance to the Brown University research community regarding staged resumption of human subjects research activities on-campus at Brown, at field sites and venues off-campus, and at international research sites. Much of the text that was previously on this page has been converted to Frequently Asked Questions found below. It is the responsibility of Principal Investigators or their study team to check this site regularly for updates.

General Principles for Staged Restarting of In-Person Human Subjects Research Activities

  • Brown continues to prioritize public health and the safety of faculty, staff, and students, while also maintaining our ethical obligation to protect individuals who volunteer to participate in research.
     
  • Plans to resume human subjects research activities that involve in-person procedures must align with all Brown policies, guidance from public health authorities and, when applicable, State of Rhode Island requirements.
     
  • Recognizing that the future remains uncertain, new human subjects research activities must be proposed in new IRB submissions in ways that enable the research community to be nimble and revert back to remote procedures or modified ways of conducting in-person interactions. This means that new IRB submissions must include both in-person and remote options for all procedures that involve in-person interactions with research participants, or otherwise state that a given procedure (e.g., blood draws) will only be conducted in a stage during which in-person procedures are permitted or otherwise authorized by the Office of the Vice President for Research (OVPR).

STAGE 1

General Requirements & Guidance

  • Human subjects research activities that can be conducted via remote procedures must continue to be conducted remotely.

    Exception requests will be considered on a study-by-study basis via a plan submitted by the Principal Investigator. Requirements for what must be in this plan and how to submit the plan can be found here. Please note that additional attestations, as described on this page are required to commence in-person human subjects research activities.
     

  • All research personnel must adhere to the Brown University COVID-19 Workplace Safety Policy regarding use of personal protective equipment (PPE), personal health and hygiene, disinfecting protocols, social distancing, and contact tracing, in the conduct of all on-campus human subjects research activities.
     
  • All on-campus human subjects research studies that are approved via an exception request/submission of a plan must abide by the Minimum requirements for in-person, on-campus human subjects research activities.
     
  • Implementing or enhancing cleaning and disinfecting protocols or PPE and other measures specific to minimizing transmission of COVID-19, such as health pre-screening, do not require an amendment to an IRB-approved protocol. Similarly, enhancing communications with research participants to describe precautions the study team or the research participant must take to prevent the spread of illness do not require an amendment to an IRB-approved protocol.
     
  • Local field research with human subjects is not permitted during Stage 1. More information about field research during Stage I can be found in the forthcoming Field Research Guidance document.
     
  • In instances where Brown has ceded oversight authority to another IRB via an IRB Authorization Agreement (IAA), Principal Investigators must complete an attestation affirming that they will adhere to the requirements of that IRB regarding protection of research participants from COVID-19 related risks.
     
  • If any human subjects research activities under an IAA involve in-person interactions with participants on-campus at Brown, the Principal Investigator must submit an exception request for these activities via a plan submitted to the OVPR, as noted above.

International Research

  • All faculty, students, and staff must abide by Brown’s COVID-19 Travel Restrictions.
     
  • Researchers currently located abroad at their planned study location may resume IRB/HRPP-approved in-person human subjects research activities if permitted in accordance with country-level and location-specific public health requirements. No exceptions to country requirements will be permitted (i.e., conducting biospecimen collection if social distancing is required).
     
  • All researchers who plan to resume in-person human subjects research activities abroad must submit an International Research Attestation Form to the Office of Research Integrity at [email protected] and receive approval prior to commencing human subjects research activities. The review and approval process may involve seeking additional information from the PI. Please note that these activities must include health and safety measures to be taken by Brown students, staff, or faculty as set forth in the attestation, including any health and safety measures (e.g., wearing a face covering) required at the international site.  
     
  • All researchers who receive approval to commence in-person human subjects research activities abroad must conduct a self-screen for any of the following new or worsening sings of possible COVID-19 infection before each contact with any research participant, and must not interact with research participants if exhibiting any of the following symptoms;
  1. Cough
  2. Shortness of breath or difficulty breathing
  3. Chills
  4. Sore throat
  5. New loss of taste or smell
  6. Feeling feverish or a measured temperature greater than or equal to 100 degrees Fahrenheit

*This list does not include all possible symptoms. Other less comment symptoms have been reported, including gastrointestinal symptoms like nausea, vomiting, or diarrhea. See the CDC website for more information.

Minimum requirements for in-person, on-campus human subjects research activities

All plans submitted to OVPR requesting to resume in-person, on-campus human subjects research activities during Stage 1 must include the following minimum information:

1) Affirmation that the study team will conduct a health pre-screening with research participants prior to their study visits. If the health pre-screening and research participants’ on-campus study visit are not within close proximity to one another, it is advised that the study team conduct another health screening when the research participant arrives for the study visit.

2) Affirmation that the study team will discuss with research participants the safety protocols implemented at Brown to reduce risk of transmission of COVID-19 prior to their study visit. This must include any Expectations of study participants.

3) Affirmation that the study team will inform research participants of the Brown University requirement that they wear a face covering during their study visit.

4) Affirmation that the study team will provide research participants with information about the Centers for Disease Control and Prevention groups determined to be at higher risk for severe illness, either verbally via a script or via an electronic method (for example, sent via email or Qualtrics). This will enable participants to make an informed decision about personal risks related to COVID-19.

5) Affirmation that the study team will remind research participants of the following Phase I State of Rhode Island guidance: “Older adults (65+) and those with underlying health conditions can go to work and go out for food or medicine. But in accordance with federal public health guidance, vulnerable individuals are strongly encouraged to otherwise stay home.”

In addition, research teams should consider the following when scheduling research participants for on-campus study visits:

  • Through what entrance/exit will research participants be instructed to access the building?
     
  • What additional precautions (e.g., maximum number of individuals in elevators, hand washing, use of bathrooms, etc.) will be required based on Brown Policy?
     
  • Allow ample time / a buffer between research participants’ scheduled visits to ensure multiple participants are not gathering or waiting for their scheduled appointments in the same area.
     
  • Ensure research team members greeting research participants are prepared to conduct a health screening, if necessary, and are aware of and comfortable with enforcing the requirement that research participants wear a face covering while in any Brown building.

Expectations of Research Participants

  • Complete COVID-19 health screening questions with research personnel prior to coming to campus and, if needed, an additional health screening on the day of the study visit.
     
  • Wear a face covering for the study visit. Guidance on appropriate face coverings can be found in Brown’s COVID-19 Face Covering Guidance.
     
  • Use specified public entrances, most likely the main entrances.
     
  • Handwashing will be encouraged/required as per study protocols in order to adhere to campus COVID-19 protocols.
     
  • Research participants must remain in their cars or otherwise remain outside the building until their research study visit is scheduled to begin. 
     
  • If the research participant requires assistance, only one parent/guardian/support person will be allowed into the building and elevators with the participant.

Health Pre-Screening for Research Participants

A health pre-screening must be conducted with each study participant prior to coming to campus and potentially again, upon arrival, depending on how much time elapses between the pre-screening and study visit.

Research participants must be asked if they are experiencing new or worsening signs of possible COVID-19, including*:

  • Cough
  • Shortness of breath or difficulty breathing
  • Chills
  • Sore throat
  • New loss of taste or smell
  • Feeling feverish or a measured temperature greater than or equal to 100 degrees Fahrenheit

*This list does not include all possible symptoms. Other less comment symptoms have been reported, including gastrointestinal symptoms like nausea, vomiting, or diarrhea. See the CDC website for more information

Research participants affirming any of the above symptoms must be rescheduled. In addition, research participants must be asked if they:

  • Have a lab-confirmed case of COVID-19
  • Have been in contact with anyone with a lab-confirmed or suspected case of COVID-19 and are currently under quarantine/stay-at-home orders

If either of the above is endorsed, the research participant’s study visit must be rescheduled.

Script for Use by Research Teams

The Brown HRPP provides this modifiable script to research teams that receive OVPR approval to conduct in-person, on-campus human subjects research activities involving research participants. This script can serve as a verbal script or be converted to an email or a Qualtrics survey for research participants. Please note that this script will be updated over time as the State of Rhode Island enters into new Phases.

Required Attestations

There are two circumstances under which Attestations must be submitted during Stage 1:

1) To resume in-person human subjects research activities for international research regardless of whether Brown is the IRB of record: download the International Research Attestation Form. Please submit this attestation to [email protected].

2) For any protocol for which Brown has ceded oversight authority to another IRB via an IRB Authorization Agreement (IAA), Principal Investigators must complete an attestation affirming:

  • They will adhere to the requirements of that IRB regarding protection of research participants from COVID-19 related risks; and
  • If any human subjects research activities under an IAA involve in-person interactions with participants on-campus at Brown, they have submitted an exception request for these activities via a plan submitted to the OVPR and will await approval from Brown prior to engaging in these activities.

Click here to download the IAA Attestation. This Attestation should be submitted after you receive approval from OVPR for your resuming research plan if your plan involves on-campus, in-person research activities at Brown. This Attestation is not required if you have submitted the International Attestation Form for an international study. Please submit this attestation to [email protected].

FREQUENTLY ASKED QUESTIONS

Submission Requirements | Review Priorities | Technology Options for Remote ProceduresFDA Guidance | International Studies | Public Health Surveillance Activities | ClinicalTrials.gov

Submission Requirements

Q: If my new IRB Application or Amendment to an existing protocol involves in-person procedures, do I also have to include remote procedure options?

Yes. Any new IRB Application or Amendment submission that involves in-person procedures must include an alternative method(s) to conduct those procedures remotely. If remote conduct of certain procedures (e.g., blood draws) cannot take place remotely, the IRB Application or Amendment must specifically state this.

Building in this flexibility will enable researchers to conduct remote procedures during research ramp-up phases during which in-person contact is not permissible, and seamlessly transition to in-person procedures during later phases when conditions permit without having to submit an amendment to the Brown IRB/HRPP. Importantly, given the unpredictability of the current pandemic, it is possible that researchers may need to revert back to earlier phases that prohibit in-person contact, and this approach will give you the flexibility to do so.

Q: What do I need to include in my IRB Application or Amendment if I am proposing to study COVID-19?

The COVID-19 pandemic affects everyone and those experiences may be situational across participant populations. If you intend to use surveys, interviews, or measures, etc. on or about the effects of COVID-19 as a research procedure, please include the following with your submission:

1) A risk assessment of the impact the questions may have on your study population. This assessment must address if the questions you ask about COVID-19 increase risk for participants beyond the other activities involved in your study. Include this brief assessment in the risk assessment section of your submission form.

2) A list of resources/referrals for participants and a description of how / when the list will be provided to participants. This list must be applicable to the study population and research topic with easily accessible contact information. Some available resources include the National Alliance on Mental Illness COVID-19 Resource and Information Guide and the Centers for Disease Control and Prevention COVID-19 Resources for Stress and Coping

Q: I am amending my approved protocol to add remote procedures with no other changes. Is there a special amendment form that I should submit?

Yes. The HRPP created the Amendment Request Form-Remote Procedures to help facilitate the addition of remote procedures. Researchers may use this form to request additions/changes to study procedures. **IMPORTANT** Please do not include other changes to your study in these special amendment submissions beyond those required to conduct study procedures remotely.

Review Priorities

Q: What are the IRB / HRPP review priorities at this time?

  • The HRPP/IRB is continuing to prioritize amendments to active protocols to add study procedures to serve as alternatives to in-person participant contact and Just-in-Time requests.
  • The HRPP/IRB is also prioritizing IRB applications that involve studying COVID-19 for which the PI has secured internal (seed funding) or external sponsored funding. Please include "COVID-19 Research" in the subject line of your email submission so we know to prioritize your application in our queue. 
  • The HRPP IRB is also reviewing plans and attestations submitted by research teams proposing to resume in-person procedures during Stage 1. Questions about attestations should be submitted to the main ORI email address: [email protected]
  • HRPP/IRB is not prioritizing new IRB applications or amendments to IRB applications in its queue that involve international and domestic Brown-sponsored travel. This will continue until the University alters its restrictions on Brown-sponsored travel.

Technology options for remote procedures

Q: What technology options does Brown recommend for the conduct of remote procedures?

If your IRB Application or Amendment involves platforms not already vetted by CIS, then it will take longer to start your research.

ZOOM

Brown CIS and the IRB/HRPP strongly recommend Zoom be used for all remote procedures that involve remote, face-to-face interactions with participants.  This includes administering interventions via video conferencing. Zoom is a CIS-vetted platform and is secure to use for all data risk levels, including Risk Level 3 data.

For studies that wish to use a HIPAA-compliant version of Zoom, please submit a ticket to [email protected] for your request to be authorized. The HIPAA-compliant version of Zoom does not allow for any cloud-based recording. Instead, it will only allow for recording locally, meaning that you must have encryption turned on for the device you will use for recording (i.e., Brown-owned laptop) or saved directly to a Risk Level 3 compliant local server.

QUALTRICS & REDCaP

Brown CIS and the IRB/HRPP strongly recommend Qualtrics be used for remote data collection procedures. Qualtrics is a CIS-vetted platform and is secure to use for all data risk levels, including Risk Level 3 data. If a Brown investigator has a co-investigator/collaborator at an affiliated site with an instance of REDCaP, it, too may be used for data collection for all data risk levels including Risk Level 3 data.

FDA Guidance

Q: I have an FDA-regulated study. Do I need to report a pause or alteration of research procedures related to COVID-19 to the FDA?

The FDA confirmed that there is no requirement to report to the FDA for now; however, the FDA recommends that if a pause in research extends for a few months or more, the PI may request inactivation so that no annual reports will be necessary. The FDA released more comprehensive guidance that can be found here.

International Studies

Q. I am already at my international study location. May I resume research involving in-person interactions with research participants?

Researchers currently located abroad at their planned study location may resume in-person human subjects research activities if permitted in accordance with country-level and location-specific public health requirements. No exceptions to country requirements will be permitted (i.e., conducting biospecimen collection if social distancing is required).

All researchers who plan to resume in-person human subjects research activities abroad must submit an International Research Attestation Form to the Office of Research Integrity at [email protected] and receive approval prior to commencing those activities. The review and approval process may involve seeking additional information from the PI.

Public Health Surveillance Activities

Q: How do I know if the activities I am proposing are public health surveillance and not human subjects research?

The Revised Common Rule provides the following description of public health surveillance activities that are deemed not to be research (and, therefore, do not require IRB review):

"Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters)."

A "public health authority" means "an agency or authority of the United States, a state, a territory, a political subdivision of a state or territory, an Indian tribe, or a foreign government, or a person or entity acting under a grant of authority from or contract with such public agency, including the employees or agents of such public agency or its contractors or persons or entities to whom it has granted authority, that is responsible for public health matters as part of its official mandate."  The Rhode Island Department of Health, as an example, would meet the definition of a public health authority.

If your proposed activities do not meet the above description and instead the collection of data will be used in whole or in part for research purposes, an IRB Application will be required.

Q: If I am conducting public health surveillance activities, can I still publish?

Yes. A determination that an activity is public health surveillance and not human subjects research has no bearing on your ability to publish your work. 

Q: Are there any special considerations for studies registered on ClinicalTrials.gov?

Certain studies registered on ClinicalTrials.gov that have paused recruitment or otherwise altered their research design should be mindful of updating corresponding ClinicalTrials.gov records, as needed. Study teams should also assess whether any alterations to recruitment status are needed, and whether the Primary Completion Date and the Study Completion Date need to be extended based on COVID-19 related research delays. 

 

 

Need assistance with preparing a new IRB protocol or an amendment? Determining if a proposed project requires IRB review? Applying IRB-related policies or procedures?

Contact an appropriate HRPP team member to set up a time to discuss.

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Did you know about NIH's New Funding Opportunities for Basic Experimental Studies Involving Humans? Read more here.