COVID-19 and Human Subjects Research Activities (last updated 7/6/20)
General Principles | Stage 2 | International Research | Minimum Requirements for in-person activities (Updated!) | Expectations of Research Participants | Health Pre-screening for Research Participants | Script for Use by Research Teams (Updated!) | Contact Tracing (NEW!) | Required Attestations | PREP Act | Frequently Asked Questions (Updated!)
This webpage has been substantively updated to provide guidance to the Brown University research community regarding Stage 2 resumption of 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.
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).
General Requirements & Guidance
Human subjects research studies currently and successfully administering procedures using remote options are strongly encouraged to continue to do so.
Human subjects research studies that can be conducted remotely, but would be more effective on-site and in-person (e.g., the effect size of the intervention would be diminished if the work is conduct remotely) may be permitted with the submission and approval of a Plan. This Plan should provide a brief justification of the need for on-campus, in-person human subjects research activities. There will be a streamlined review and approval process for studies that already received approval for on-campus activities in Stage 1 and want to make changes to their Plan for Stage 2.
- In studies where some, but not all, procedures cannot be done remotely, careful consideration should be given to minimizing in-person, on-campus visits. For example, an initial in-person visit to conduct requisite in-person procedures can also be used to train participants to self-administer study procedures at home to minimize future on-campus visits.
Special Considerations for certain On-campus Research Activities
Interventions conducted in groups on campus are now permissible, provided groups are limited to 15 or fewer individuals, with all individuals spaced at least 6 feet apart and wearing face coverings, in spaces large enough to accommodate such groups while adhering to social distancing guidelines.
- 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.
Research conducted in community settings in Rhode Island or other sites within commuting distance is permitted, provided groups are limited to 15 or fewer individuals (e.g., focus groups), 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).
Surveys conducted outdoors in the community are permitted with mask wearing and social distancing of at least 6 feet.
- Researchers are not permitted to enter participants’ private residences during Stage 2.
Continued Requirements from Stage 1
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.
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.
- In instances where Brown is the IRB of Record for an external clinical site with its own IRB (in a multi-site study), and that clinical site wishes to resume in-person procedures with participants, the Brown Principal Investigator must submit written documentation to [email protected] from the clinical site's IRB affirming that the proposed in-person procedures are permissible at the clinical site. In accord with the Stage 2 resuming research requirements, all research occurring in non-Brown-controlled spaces or areas must satisfy and be performed in accordance with the state, local, and other applicable requirements and guidelines in place for the space or area where the research occurs. This includes the public health guidelines of local government(s) and policies of collaborating institutions. This research is subject to all applicable United States, University and local travel restrictions.
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;
- Shortness of breath or difficulty breathing
- 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.
All plans submitted to OVPR requesting to resume in-person, on-campus human subjects research activities during Stage 2 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 the study team will remind research participants of the following Phase II 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.”
6) *NEW* 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.
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.
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*:
- Shortness of breath or difficulty breathing
- 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.
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 during Stage 2, 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 for Stage 2 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 during Stage 1:
1) To resume in-person human subjects research activities for international research when you are currently abroad, 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].
The Secretary HHS issued a Public Readiness and Emergency Preparedness (PREP) Act Declaration for certain COVID-19 countermeasures on March 10, 2020. The Declaration covers covered countermeasures (described below).
As an example, the PREP Act applies to Brown research protocols which initiate a clinical trial studying therapeutic treatment of COVID-19 using a drug under an IND. When the PREP Act applies, the Declaration limits a participant's legal right to sue covered persons. Covered persons in these situations include the federal government, manufacturers, trial sponsors, healthcare providers engaged in countermeasures, or others.
While a participant's right to sue for significant injuries (including death) is restricted under the Declaration, U.S.-located or other certain participants with a U.S. NEXUS may be able to seek compensation from Health Resources & Services Administration’s (HRSA) Countermeasure Injury Compensation Program (CICP) for certain serious physical injuries.
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 has provided an additional statement to be included in study consent forms.
**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.
If your study uses a COVID-19 covered countermeasure, add the following language verbatim in the "What are the risks" section of the informed consent document:
"Due to the coronavirus public health emergency, the federal government issued a Declaration under the Public Readiness and Emergency Preparedness (PREP) Act. If it applies, this Declaration limits your right to sue the researchers, healthcare providers, any study sponsor or manufacturer or distributor involved with the study. However, the federal government has a program that may provide compensation to you or your family if you experience serious physical injuries or death. To find out more about this “Countermeasures Injury Compensation Program” go to https://www.hrsa.gov/cicp/about/index.html or call 1-855-266-2427."
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.
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: 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.
Q: What are the IRB / HRPP review priorities at this time?
- The IRB/HRPP is prioritizing Just-in-Time requests and research protocols with external sponsored funding and internal funding awards. Please include "Funded Research" in the subject line of your email submission so we know to prioritize your application in our review queue.
- The Office of Research Integrity is also reviewing Plans and Attestations submitted by research teams proposing to resume or modify in-person procedures during Stage 2. Questions about Attestations should be submitted to the main ORI email address: [email protected]
- The IRB/HRPP is not prioritizing new IRB applications or amendments in its queue that are limited to in-person international and domestic Brown-sponsored travel. This will continue until the University alters its restrictions on Brown-sponsored travel.
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.
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 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.
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.