COVID-19 and Human Subjects Research Activities
**Please note that Brown's IRB and HRPP do not have authority to modify these guidelines. Decisions regarding loosening existing restrictions are the responsibility of the University's Research Continuity Committee. A subcommittee of this Committee is currently reviewing the human subjects research restrictions in light of recent University changes in guidelines and policies.**
General Principles | International Research | Minimum Requirements for in-person activities | Expectations of Research Participants | Health Pre-screening for Research Participants | Script for Use by Research Teams | Contact Tracing | Required Attestations | PREP Act | Frequently Asked Questions
This webpage has been substantively updated to provide guidance to the Brown University research community and align with updated University policies as they apply to human subjects research activities on-campus at Brown, at field sites and venues off-campus, and at international research sites. It is the responsibility of Principal Investigators or their study teams to check this site regularly for updates and to be familiar with the University's policies.
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.
Special Considerations for certain On-campus Research Activities
- If approved research requires use of the MRI, Brown will provide disposable surgical-type masks to research participants undergoing the MRI that are the same, or nearly the same as, the masks it will provide to Brown researchers. Please see below for PREP Act language that must be included in consent documents when a study participant will be entering the MRI as part of a research procedure.
Research conducted in community settings in Rhode Island or other sites within commuting distance is permitted, provided investigators have permission of the facility to conduct research on-premise, and investigators conform to all requirements of the facility (e.g., use of facial coverings, social distancing, and any other enhanced safety precautions).
- Researchers are not permitted to enter participants’ private residences at this time. Exceptions to this requirement will be considered on a case-by-case basis by the IRB with a written justification provided by the Principal Investigator.
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 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.
- 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.
All faculty, students, and staff must abide by Brown’s COVID-19 Travel Restrictions.
Please note that if the purpose of travel is to carry out essential field research, a Justification and Safety Plan must first be approved by Brown’s Field Research Subcommittee. Details about field research approvals are available on the Resuming Research webpage.
Researchers conducting international field research may resume or begin 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 or begin in-person human subjects research activities abroad must submit an International Research Attestation Form to the HRPP with the new IRB Application or IRB Amendment 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 in-person, on-campus human subjects research activities 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 and another health screening when the research participant arrives for each 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 if the study team will provide a face covering to a participant, including, but not limited to, participants undergoing MRI, the study team will inform that participant that Brown cannot guarantee that the facial covering will protect against the risks of COVID-19.
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.
Complete COVID-19 health screening questions with research personnel prior to coming to campus and 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.
Hand-washing 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.
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.
People with COVID-19 have had a wide range of symptoms reported – ranging from mild symptoms to severe illness. Symptoms may appear 2-14 days after exposure to the virus. People with these symptoms may have COVID-19.
Research participants must be asked if they are experiencing new or worsening signs of possible COVID-19. 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 tested positive as a result of a COVID-19 test.
- Have been in contact with anyone who has had positive COVID-19 test or someone suspected of having a 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.
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.
For studies conducted on-campus, contact tracing logs must include a participant's full name, phone number, location of contact, and date and time of contact, if contact with the participant meets Brown's criteria for contact tracing. Brown's criteria for contact tracing includes being within 6 feet of someone for a period of time greater than 15 minutes. Per Brown guidance, it is helpful to also document longer contact with others (>30 minutes) when in a Brown research facility even if you maintain at least 6 feet of distance.
For studies where it is expected based on study procedures that participants will meet criteria for inclusion in a Brown contact tracing log, participants must be told how the contact tracing logs will be stored and that the log information will be shared with the Rhode Island Department of Health as required by the State if a COVID-19 exposure occurs. Researchers must maintain contact tracing logs separate from any research data and securely shred the contact logs after 30 days.
Researchers are welcome to use this Contact Tracing Form for Research Participants. Use of this form is optional. The modifiable script has also been updated to include information regarding contact tracing.
There are two circumstances under which Attestations must be submitted to the HRPP:
1) To resume in-person human subjects research activities for international research when you are currently abroad, or to begin a new study abroad where an investigator is already at the study site, regardless of whether Brown is the IRB of record: download the International Research Attestation Form. Please submit this attestation to the HRPP as part of your new IRB Application or IRB Amendment.
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 with your new IRB Application or IRB Amendment and after you have submitted to OVPR 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 the HRPP.
The Secretary of HHS issued a Public Readiness and Emergency Preparedness (PREP) Act Declaration for certain COVID-19 countermeasures on March 10, 2020. In August and September 2020, the FDA and HHS released expanded guidance, allowing Brown to refine the applicability of the COVID-19 countermeasures covered by the Declaration and update the required consent language.
When does the PREP Act not apply?: Brown requires all participants wear an appropriate face covering to protect themselves and those around them when they come to campus. If a participant visits without a face covering or the face covering does not meet Brown requirements, the University will provide them with 3 reusable face coverings. Wearing masks are standard; any risks from them are consistent with everyday life and are not specific to research.
When does the PREP Act apply?: The PREP Act only applies to Brown research protocols which specifically provide covered countermeasures (i.e. face masks, face shields, gowns) to participants as part of an approved research procedure, instead of allowing participants to use a face mask they may have for personal use. For example, due to the safety protocols at the MRI Research Facility (MRF), participants asked to use the MRI as a research procedure, are required to wear a face mask provided by the MRF that is safe to use in the MRI.
New Consent Form Language for COVID-19 Countermeasures
Human subjects protection regulations require that participants be informed if any of their legal rights are affected, and what recourse is available. To comply with this, Brown University requires that the following additional statement be included in study consent documents.
**As a note, this additional language is unique to COVID-19 countermeasures and does not replace the risks of study procedures that must be included in order for participants to make an informed decision about study participation.
"Due to the coronavirus public health emergency, the U.S. government issued a Declaration under the Public Readiness and Emergency Preparedness (PREP) Act. This Declaration may apply to this study if it involves procedures or other actions that are related to or in response to coronavirus. If it applies, this Declaration limits your right to sue the researchers, healthcare providers, study sponsors, manufacturers, distributors, and potentially others that are involved with this study. However, the U.S. government has a program that may provide compensation to you or your family if you experience serious physical injuries or death related to procedures or other actions taken in this study. To find out more about the 'Countermeasures Injury Compensation Program,' please visit https://www.hrsa.gov/cicp."
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 can be found on the COVID-19 Resources page.
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. As such, the HRPP/IRB strongly encourages you to use CIS-approved platforms in your research unless there is a valid scientific reason not to do so.
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.
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.
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 main IRB email address and receive approval prior to commencing those activities. The review and approval process may involve seeking additional information from the PI.
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.
Yes! As outlined in 42 CFR 11.64(a)(1)(ii), if a protocol is amended in such a manner that changes are communicated to human subjects in the clinical trial, the regulations require that updates to any relevant clinical trial information be submitted not later than 30 calendar days after the protocol amendment is approved by a human subjects protection review board. Additional details can be found in the clinicaltrials.gov FAQs.
It remains important to ensure that accurate and up-to-date clinical trial information is available to the public on ClinicalTrials.gov, particularly for COVID-19 related research. However, due to the potential exceptional impact of this public health emergency on research-related staff availability, NIH acknowledges that delayed updates and corrections may be unavoidable. Refer to the Top Questions from Responsible Parties Related to COVID-19 for information on specific questions.
NIH will allow late submission of results reporting for recipients covered by the NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information that are unable to submit results reporting information on-time in ClinicalTrials.gov due to COVID-19. Recipients should notify the funding Institute of Center (IC) of the delay along with documentation of the effects of COVID-19 on the study.
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.
Learn more about the centralized submission, review, negotiation and approval process for Data Use Agreements here!
Did you know about NIH's New Funding Opportunities for Basic Experimental Studies Involving Humans? Read more here.