Non-Clinical Human Subjects Research Resumption

Table of Contents

What Types of Non-Clinical Human Subjects Research Are Allowed Now?

What Types of In-Person Non-Clinical Human Subjects Research Are Allowed Now?

What’s Coming Next? Guiding Principles Re: Staged Resumption of Non-Clinical In-Person Human Subjects Research On Campus

What I Can Do While Waiting For My In-Person Human Subjects Research to Return to Campus?

What Do I Do When My On-Campus In-Person Human Subjects Research Is Allowed to Resume? Overview of Process

What If My Research Occurs Off Campus?

Other Important Issues To Consider When Resuming Human Subjects Research

Introduction

Research involving human subjects is an important part of Stanford’s research portfolio. Many of the most significant scientific discoveries about human behavior have been made by Stanford researchers across a variety of disciplines, with direct and indirect benefits to the individual and society. Human subjects research takes place at all corners of campus, including the School of Humanities and Sciences, the Graduate School of Education, the Graduate School of Business, the School of Medicine, the School of Engineering, School of Earth Sciences, and the School of Law.

The nonclinical human subjects research recovery working group has been meeting since May, 2020. The following document is a product of the working group’s meetings and is intended to help human subjects researchers on campus think about how to resume their research or prepare for resuming their research in the context of COVID-19.

 

What Types of Non-Clinical Human Subjects Research Are Allowed Now?

Studies that DO NOT involve in-person contact (e.g., on-line surveys, interviews conducted via phone or video chat) are currently allowable.

Acknowledging that this may require significant additional resources, researchers may nonetheless decide to change their study protocols from in-person sessions to remote sessions. If they do, they must obtain IRB-approval prior to making this change; department/school approval, however, is not required.

Specific types of in-person non-clinical human subjects research are currently allowable (see below).

 

What Types of In-Person Non-Clinical Human Subjects Research Are Allowed Now?

As with other types of research at Stanford, the resumption of non-clinical in-person human subjects research will occur in Stages according to the Research Recovery Handbook. Importantly, at all Stages, researchers must be prepared to return to an earlier, more restricted phase if warranted by epidemiological and healthcare utilization data. We are currently at Stage 2 of Research Recovery.

IN-PERSON NON CLINICAL HUMAN SUBJECTS RESEARCH CONDUCTED ON CAMPUS

Although we have been slowly resuming nonclinical in-person human subjects research on campus, most of this research has been on hold. The individual and societal problems that these studies address are significant and wide-ranging, including the growing rates of depression and addiction, the increasing spread of misinformation on social media, and the high levels of distrust between police and minority communities in the United States. Given the importance of this research for human health and well-being, we are currently ramping up the resumption of in-person human subjects research (clinical and nonclinical) on campus.

On September 30, we allowed the resumption of two longitudinal non-clinical in-person human subjects research studies at two campus facilities. These two studies are serving as pilots to ensure that we can resume nonclinical in-person human subjects research in a way that is safe for researchers and participants.

On October 14, we allowed in-person human subjects research on campus with Stanford affiliates currently living on campus to resume, and on October 21, we will allow in-person human subjects research on campus with community participants that are low-risk (i.e., who are not members of groups that are particularly vulnerable to COVID-19) to resume. Prior to resumption, all studies will need to be adjusted to comply with EH&S health and safety regulations, have IRB-approval, and be reviewed and approved for resumption by relevant departments and schools, as described below. In-person human subjects research on Stanford affiliates authorized to be on campus and their children, and on SHC/LPCH patients will continue to be allowed on campus under these broader policies.

RESEARCH WITH STANFORD AFFILIATES LIVING ON CAMPUS

As of October 14, Stanford affiliates (i.e., students, postdocs, staff and faculty) currently living on campus will be allowed to participate in IRB-approved, in-person human subjects research on campus that meets the following requirements:

  1. Prior to restart, PIs must prepare SoPs that detail how study protocols will meet each of the requirements below. These SoPs must: (a) incorporate lab SoPs and requirements; (b) incorporate local unit and building SoPs; (c) be in compliance with all EH&S requirements; and (d) be approved by the local unit leadership, Chair and/or Institute Director, Dean/School. If researchers must change protocols to accommodate health and safety guidelines, they will need to submit these protocol revisions to their human subjects research institutional review boards (https://researchcompliance.stanford.edu/panels/hs).
  2. Researchers must use a calendar (including who, where and when) to record research sessions and maintain a record of participants’ contact information for contact tracing. To maintain participant confidentiality, researchers must protect these data and ensure limited access to this information. Researchers who have access must be able to provide participant contact information in case it is needed for contact tracing
  3. Because study participants are Stanford affiliates, they must have approval in the Onsite Role Management System (ORMS) and must receive approval from the PI to be on-site on the specific date(s) they are scheduled to participate in the study. If on-site approval is not provided in ORMS, the participant will show up as not authorized to be onsite in the school/unit COVID compliance report.
    1. Each PI should identify project coordinators who are responsible for ensuring that study participants have on-site approval in ORMS no later than the day before the study session. If PIs or their project coordinators are not currently authorized to access ORMS as an Assignment Administrator, the PI should request authorization from their local unit (i.e., department) HR Manager or Director of Finance Operations, who can grant access to ORMS and help direct PIs and/or their project coordinators to ORMS training.
    2. If the study participant is not currently in ORMS, PIs or project coordinators must create a new record for each study participant to authorize entry to the building where the research will take place on the day of the study session. In the ORMS record, PIs or project coordinators must specify the name of the PI and the department authorizing the individual to be on-site; must set the essential business category to “Research;” and must include the date that the study session will take place, using the custom date range.
    3. If the study participant is already approved in ORMS to be on-site by a different school/unit on the day of the study, the project coordinator must add text to the notes field in ORMS indicating the participant is approved for a one-time on-site visit to (insert department name), as well as contact information for questions (insert name and contact phone # for study coordinator).

Additional information:

  1. Prior to the session, researchers will send materials describing the research process, required face coverings and PPE, physical distancing and density requirements, and COVID-19 symptom check to participants before they arrive at the research site on campus.
  2. Prior to the session, researchers will send a letter (see template) on Stanford letterhead to participants stating that the participants have permission to enter the zone of the research facility and may only visit the approved zone. Researchers will let participants know that they must bring the letter with them when they come to campus for the research session.
  3. Prior to restart, researchers must place floor markings throughout the research area indicating to participants where they should stand and sit during the entire research session.
  4. Researchers will ask participants to complete the Health Check tool 1-2 hours before the study session. Researchers will ask participants to show their Health Check badge prior to building entry; only participants who have a green Health Check badge will be allowed to enter the building and participate in the research study. If participants do not have access to the electronic version of Health Check, researchers will ask participants to complete a paper copy of Health Check prior to arrival and to bring their signed and completed paper copy of Health Check with them when they arrive at the research site. Only participants who do not report COVID-19 symptoms will be allowed to enter the building and to participate in the research study.
  5. Researchers and participants will wear face coverings and additional PPE as needed before entering the building and during the session. Researchers will provide face coverings if participants do not have them.
  6. Researchers and participants will sanitize their hands upon building entry. Researchers will provide hand sanitizer.
  7. Researchers and participants must adhere to current physical distancing and density requirements throughout the research session.
  8. Researchers will escort participants out of the building after the research session.
  9. Researchers must disinfect and sanitize all surfaces and equipment used according to EH&S guidelines prior to and immediately after the research session.
  10. When scheduling study sessions, researchers must allow sufficient time for thorough cleaning and disinfection (including time for air filtration and purification if possible) in between study sessions.

*****ALL APPROPRIATE APPROVALS MUST BE OBTAINED PRIOR TO RESTART*****

RESEARCH WITH COMMUNITY PARTICIPANTS THAT ARE LOW RISK (I.E., WHO ARE NOT MEMBERS OF GROUPS THAT ARE PARTICULARLY VULNERABLE TO COVID-19).

The following set of characteristics describe individuals who are particularly vulnerable to COVID-19, and who therefore are not allowed to participate in in-person human subjects research on campus at this time:

  1. Individuals over the age of 65, unless they are already coming in to SHC for a medical visit (see Stage 2 Clinical Research Guidelines)
  2. Any individual with an underlying medical condition for which the CDC says they are at increased risk of severe illness from COVID-19 (see People with Certain Medical Conditions), unless the individual is participating in a clinical trial or clinical research investigating their medical conditions. As of October 20, this list includes: Cancer, Chronic kidney disease, COPD, Heart conditions, Immunocompromised state, Obesity, Severe Obesity, Sickle cell disease, Smoking, and Type 2 diabetes mellitus.

On October 21, IRB-approved clinical and non-clinical longitudinal and cross-sectional in-person human subjects research on campus with community participants that are low risk (i.e., who are not members of groups that are particularly vulnerable to COVID-19, see above) will be allowed to resume if they meet the following requirements:

  1. Prior to restart, PIs must prepare SoPs that detail how study protocols will meet each of the requirements below. These SoPs must: (a) incorporate lab SoPs and requirements; (b) incorporate local unit and building SoPs; (c) be in compliance with all EH&S requirements; and (d) be approved by the local unit leadership, Chair and/or Institute Director, Dean/School. If researchers must change protocols to accommodate health and safety guidelines, they will need to submit these protocol revisions to their human subjects research institutional review boards (https://researchcompliance.stanford.edu/panels/hs).
  2. Researchers must use a calendar (including who, where and when) to record research sessions and maintain a record of participants’ contact information for contact tracing. To maintain participant confidentiality, researchers must protect these data and ensure limited access to this information. Researchers who have access must be able to provide participant contact information in case it is needed for contact tracing
  3. Prior to the scheduled research session, researchers will send materials describing the research process, required face coverings and PPE, physical distancing and density requirements, and COVID-19 symptom check to participants before they arrive on campus.
  4. Prior to the research session, researchers will send a letter (see template) on Stanford letterhead to participants stating that the participants have permission to enter the zone of the research facility and may only visit the approved zone. Researchers will let participants know that they must bring the letter with them when they come to campus for the research session.
  5. On the same day of the session, prior to arriving on campus, researchers will call participants and assess whether they have COVID-19 related symptoms. Only participants who do not report COVID-19 related symptoms will be allowed to participate in the research session. Only participants who do not report COVID-19 symptoms will be allowed to enter the building in which the research is being conducted and to participate in the research study.
  6. If participants are coming from off-campus, researchers will meet participants when they arrive on campus, at an assigned outdoor space (e.g., parking lot) prior to building entry. Researchers meeting participants will wear appropriate face coverings and PPE and maintain the minimum of 6 feet physical distance between the researcher and the research participant. Researchers will provide face coverings and any additional PPE as needed to participants, who will put them on immediately upon meeting the researcher.
  7. Researchers will ensure that they and the research participants will wear face coverings and any additional PPE required before entering the building and during the research session.
  8. Researchers and participants will sanitize their hands upon building entry. Researchers will provide the hand sanitizer.
  9. Researchers and participants must adhere to current physical distancing and density requirements throughout the research session.
  10. Prior to restart, researchers must place floor markings throughout the research area indicating to participants where they should stand and sit during the entire research session.
  11. After the research session, researchers will escort participants back to their vehicles, or location where they met the participant, to ensure that participants leave campus immediately after their study participation. If participants are Stanford affiliates, researchers will escort participants out of the building immediately after the session.
  12. Researchers must disinfect and sanitize all surfaces and equipment used according to EH&S guidelines prior to and immediately after the research session.
  13. When scheduling study sessions, researchers must allow sufficient time for thorough cleaning and disinfection (including air filtration and purification if possible) in between study sessions.
  14. ****Note that if participants are Stanford affiliates (i.e., students, postdocs, staff, and faculty) living on or off campus, all of the requirements in the Oct 14 policy apply in addition to the above.

*****ALL APPROPRIATE APPROVALS MUST BE OBTAINED PRIOR TO RESTART*****

IN-PERSON NON CLINICAL HUMAN SUBJECTS RESEARCH CONDUCTED OFF CAMPUS

Most in-person non-clinical human subjects research conducted off-campus is not currently allowed.

Non-clinical human subjects field research will not be permitted until the CDC risk assessment for the Stanford researchers’ home base (i.e., the location from which the researcher has resided for at least 14-days before travel to the field research site) and the location of the field research have dropped to limited community transmission (Level 1).

Exception for research conducted by local partners

However, given that the prevalence and risks of COVID transmission vary significantly across countries, CDC travel guidelines and Stanford health and safety requirements may ultimately be more restrictive than the policies of national public health authorities. Therefore, in countries in which national authorities have permitted the resumption of in-person human subjects research, Stanford researchers may request an exception to begin research that will be conducted by local partners (e.g., collaborators at the field site) or Stanford affiliates who are already at the field site if their research meets the following criteria:

  1. There is a compelling rationale for why the research must be conducted in person at this time and why it cannot be conducted remotely.
  2. The policies of national public health authorities are seen as credible by public health experts, and researchers can provide clear evidence that the risks of community transmission are low.
  3. Stanford affiliates adhere to all university travel restrictions.
  4. The risk of exposure to COVID-19 and any study related risks are appropriately balanced by or outweighed by the benefit(s) of research participation.
  5. Study participants are not members of groups that are particularly vulnerable to COVID-19 transmission.
  6. Stanford researchers will communicate Stanford safety and health requirements to local researchers. Both parties will consider both Stanford guidelines and guidelines from national public health authorities when conducting research. Additional precautions may be suggested in the context of considering an exception.

In order to request an exception, researchers should follow the field research approval process outlined in the Research Recovery Handbook. The request will be reviewed by members of the field research working group to determine whether the research should be granted an exception and whether the safety plans are adequate. The members will make recommendations to the relevant Dean’s Office, who will grant the final approval.

Please note that there are additional policies governing temporary employment and activity outside of the U.S. as a result of the COVID-19 pandemic. In most cases, employment of Stanford affiliates including faculty, staff, postdoctoral scholars and graduate students who are residing outside the U.S. requires approval of the school dean. Please consult with your school dean’s office for additional requirements.

What’s Coming Next? Guiding Principles Regarding Staged Resumption of Non-Clinical In-Person Human Subjects Research On Campus

The working and policy groups recognize the importance of resuming in-person human subjects research as soon and as safely as possible. The resumption of paused human subjects research will occur in phases that will be linked to the Stages guiding the University’s resumption of non-human subjects laboratory and non-human subjects field research. Given the nature of COVID-19 transmission, the working group and policy groups are considering various factors when making policy decisions regarding the types of in-person human subjects research that are allowed to resume on and off campus. These factors include the degree to which:

  1. Santa Clara County health and safety requirements can be maintained in study protocols.
  2. In cases where they cannot, Stanford Environmental Health and Safety (EH&S) approved mitigations have been made to ensure that the risk of transmission of COVID-19 to researchers or study participants is not increased.
  3. Similar types of research are being conducted at peer institutions.
  4. Participating in the research provides benefits to study participants.
  5. Bringing participants to campus does not increase risk of transmission to researchers and the broader Stanford community.
  6. Post-study communication with study participants is possible.
  7. Based on available data, study participants are not members of groups that appear to be particularly vulnerable to contracting or spreading COVID-19.
  8. Research is time-sensitive.
  9. COVID-19 testing is available to researchers and participants.

Human subjects researchers should check the research recovery website for regular updates to allowable non clinical human subjects research. Changes will also be announced in the weekly newsletter to Chairs and Institute Directors.

What I Can Do While Waiting For My In-Person Human Subjects Research to Return to Campus?

Although the working and policy groups are actively coming up with policies to restart research as safely and as quickly as possible, we recognize the frustration and stress of researchers who are not currently allowed to do their research. Below are some things researchers can do while waiting for their research to be allowed to resume.

  1. Consider whether there are ways of modifying your protocols to collect data remotely (i.e., without in person contact via phone or video)
  2. If your research must be conducted in-person, prepare for resumption of research by considering
    1. How you would modify your protocols to meet current safety and health requirements
    2. How you would monitor your participants after the in-person session(s)
  3. Communicate with the non-clinical human subjects research recovery committee (nchsrecovery@stanford.edu) about peer institutions that currently allow your type of research
  4. Abide by the current policies and periodically check the Research Recovery Handbook for updates about allowable research. Note that some human subjects research falls under other categories (e.g., clinical, laboratory, field), and therefore, researchers are encouraged to look at other chapters in the research recovery handbook related to these types of research.
  5. Discuss any concerns, questions, or suggestions you have with your local (e.g., departmental) research recovery committee

What Do I Do When My In-Person Human Subjects Research Is Allowed to Resume? Overview of Process

Prior to beginning in-person human subjects research, PIs must obtain departmental/school approval to ensure that the research protocol has met current safety and health requirements. If the PI has made any changes to the study protocol, these must be submitted to the IRB for approval. Research may not begin until all relevant approvals have been obtained.

Step 1: Develop Restart Plans and Standard Operating Procedures (SOPS)

In developing restart plans and standard operating procedures, PIs should first consult the Research Recovery Handbook. To the extent possible, in-person human subject research protocols should conform to the requirements for Laboratory Research at this Stage, which include:

  1. Physical distancing: At least a 6 foot separation must be maintained between people.*
  2. Density: No more than one person per 250 sq. ft. of interior room area.*
  3. Face coverings: Researchers and participants must wear face coverings.*
  4. Ventilation: if indoors, research should be conducted in well-ventilated rooms with effective filtration.
  5. Hygiene: Researchers and participants must wash / sanitize hands before and after each interaction.
  6. Disinfection: Surfaces and items that might be touched (including head mounted displays, physiological sensors, etc.) must be disinfected after each use
  7. Vulnerability: No high-risk individuals can participate in non-clinical human subjects research.
  8. Community: Only individuals authorized to be on campus may participate.
  9. Traceability: Participant contact information, suitable for tracing, must be collected.†
  10. Calendaring: Researcher and participant data should be stored in a department/building calendar that can be easily accessed for contact tracing if needed.†
  11. Screening: Researchers and participants should complete Health Check prior to participation.†
  12. Anonymous reporting and consent procedures must be made clear to researchers and subjects.

Researchers are primarily responsible for providing masks, gloves, and disinfectants. If a protocol does not initially meet these criteria, researchers should first work diligently and creatively to attempt to redesign the protocol such that it can be conducted while conforming. In cases where a modification would substantially reduce the integrity of the research, researchers should check with Environmental Health & Safety (EH&S) for assistance with assessing risk levels and identifying possible appropriate safety control measures at health-alerts@stanford.edu or 650-723-0448. If no safe modification can be made, research will not be allowed to resume.

* It may be possible to waive these requirements, if essential for research integrity. For instance, researchers should consult the Stanford Workplace COVID-19 Risk Matrix to determine whether disposable gloves or N95 respirators would be appropriate. Testing negative for the SARS-CoV-2 virus prior to the experiment on the same day may be an acceptable substitution for glove or respirator use. For high-density protocols, standard operating procedures should address airflow and movements that would impinge on physical distancing. Researchers should contact Environmental Health & Safety (EH&S) for assistance with assessing risk levels and identifying appropriate safety control measures at health-alerts@stanford.edu or 650-723-0448.

† It may be possible to waive these requirements, if essential for research integrity. The study protocol should include an initial screening of the participant for symptoms of COVID-19, equivalent to Health Check, and cease if symptoms are reported. The protocol should also include collection of contact information sufficient for later contact tracing, and the recording of times, locations, and people involved in all in-person interactions in a calendar maintained by Stanford for use in contact tracing.

In addition to the items listed above, the SOP should describe the nature and purpose of the study, list the equipment that is used and how it will be disinfected, the steps taken to recruit and screen participants, and a diagram of the research space that shows how physical distance will be maintained between people.

SOPs will likely differ by unit; however, to help PIs develop their SOPs, PIs may consult the templates developed by the Psychology Department Research Recovery Committee for research conducted at the Stanford Center for Cognitive and Neurobiological Imaging (CNI) and the psychology department found here (SOP for neuroimaging at CNI; SOP for behavioral study).

Step 2: Seek Approval from Department and/or School

SOPs need to be approved by departmental units or schools. In reviewing SOPs, departments and schools will assess whether protocols meet safety and health requirements. No research may begin until it receives approval from the School/Department. Because departments and schools differ in their procedures for obtaining these approvals, PIs should consult their local units for further guidance about how to obtain these approvals. Specific types of research (e.g., human subjects field research) may require additional approval from another unit if departments/schools do not have expertise to evaluate whether SOPs/plans meet safety and health requirements.

Step 3: Revise IRB protocols if necessary

IRB protocols should be modified when targeted subject populations or research procedures change as a result of changing conditions in the local research environment. For example, when participants are current Stanford employees, the consent process should emphasize that the decision of whether or not to participate has no impact on employment status. Such modifications need to be approved before they may be implemented. The approved IRB protocol should always reflect the actual procedures being conducted. PIs should consult the IRB website for current procedures: (https://researchcompliance.stanford.edu/panels/hs). If no modifications are made, additional IRB approval does not need to be obtained.

Step 4: Begin Human Subjects Research

Once the relevant approvals are obtained, allowable human subjects research may begin. PIs are encouraged to share experiences with their department heads or the non-clinical human subjects working group (nchsrecovery@stanford.edu). Any problems should be reported to the department chair/unit head, IRB, and/or EH&S.

What If My Research Occurs Off Campus?

Most off-campus non-clinical in-person human subjects research is not currently allowable (see exception process for research conducted by local partners). However, researchers are encouraged to consider the following guidelines to help them think about the adjustments they may need to make once their research becomes allowable.

Guidelines for Planning Research Conducted at Local (< 50 miles of Stanford) Schools and Other Community Settings

Although local, off-campus in person non-clinical human subjects research is not currently allowed, researchers should begin by thinking about key factors that are relevant when advocating for research return:

  1. Their relationship with the local site. Did the researcher have a presence at the site prior to COVID-19? Does the researcher have ongoing obligations to the site? For example, a research partnership with a school might require the researcher to report time-sensitive data back to the school.
  2. Their relationship to participants at the local site. Will the researcher be able to have ongoing communication with participants and families (e.g., for potential contact tracing)?
  3. The nature of the research. What procedures can be modified or conducted remotely? Do these modifications require changes to the researcher’s IRB protocol? What aspects of the research are longitudinal or time-sensitive? What additional accommodations are needed if the research involves child participants?

When planning for research at local schools, museums, and other community settings, PIs should work directly to co-author a plan with site-specific leadership:

  1. Familiarize yourselves with the formal rules and restrictions for the area where the research will be conducted. The research plan must comply with all national, regional, and local regulations and recommendations, abiding by the most conservative.
  2. Work with the leadership and administrators of the site to understand the precautions and procedures practiced at the site. Researchers should have a site-specific understanding of:
    1. Day-to-day operations during COVID-19
    2. The participant population and the participants’ abilities to comply with Stanford’s and the local site’s safety procedures and guidelines (participants who are minors may require additional accommodations), following the most restrictive when there are discrepancies in the policies
    3. Available spaces where research can be conducted, which allow for adequate physical distancing and mechanical ventilation/ air filtration
    4. Space occupancy restrictions
    5. Availability of PPE and disinfecting supplies that are effective against COVID-19 at the site
    6. Procedures for cleaning and disinfection
    7. Policies for scheduling and tracking visitors
    8. Requirements for COVID-19 safety training
    9. Requirements for COVID-19 testing and reporting
  3. Communicate Stanford’s research-specific protocols to appropriate administrators at the site and subsequently obtain written documentation of authorization to conduct research in the site, from both the site and Stanford.
  4. Work closely with administrators, teachers, and/or staff at the site to create a safety plan that:
    1. Demonstrates knowledge of site-specific COVID-19 policies;
    2. Includes a comprehensive description of their research activities and plans for minimizing risk of coronavirus transmission to themselves, their human subjects and the local community;
    3. Site contact information for potential contact tracing communications
    4. Includes a discussion of how their research activities are compliant with
      1. Stanford’s best practices for prevention of COVID-19 transmission;
      2. Site-specific policies and practices;
      3. Local public health policies
  5. Anticipate and develop plans for responsible temporary suspension or cancellation of research activities on short notice in the event of increased restrictions or researcher illness.
  6. Assemble and arrange to transport an adequate supply of PPE, hand sanitizer or ensure soap and water are available, cleaning supplies, and a contactless thermometer, unless these are already supplied at the site. Researchers should anticipate PPE needs specific to the research design and participant population. For example, studies at museums may involve having children explore toys, and researchers may be required to wear gloves when handing over objects between individuals, and disinfect toys in between participants. PPE may also need to be available in child sizes.
  7. Develop a plan for symptom screening that is self-reported by the participant, with overall result recorded by the researcher
  8. Review current Stanford rules and guidelines for travel to off-campus sites. Stanford researchers should complete the Health Check tool prior to each site visit. Plan to minimize the number of researchers traveling to a fieldsite at one time. Researchers should travel to the off-site location in a vehicle alone whenever possible. If research will be conducted at multiple sites, plan to assign fixed researchers to a site to avoid crossover between sites.
  9. Review current Stanford rules and guidelines for safe conduct of research activities.
  10. Plan to assess and mitigate risks of research activities generating more campus to campus points of contact (i.e. how many Stanford campus members directly interact with school/community campus members, and under what contexts?).

Other cases and considerations for research in community settings:

Mobile Vehicle Labs – If research will be conducted inside a vehicle, such as a mobile lab, researchers should consider:

  1. Can the research be conducted with single occupancy in the vehicle?
  2. If multiple researchers must be present for the research, partitions may be needed inside the vehicle space for adequate physical distancing. Ensure windows are rolled down when the vehicle is occupied.
  3. Justification for research procedures that need to happen inside the space, and alternatives such as:
    1. Conducting procedures remotely
    2. Conducting procedures outdoors or in an open space, while maintaining participant confidentiality
  4. Disinfection of touch points within the vehicle

Considerations for Working with Child Participants*

If research participants will be children, researchers should plan to:

  1. Inform participants of all safety procedures using age-appropriate language and obtain assent per Stanford IRB-approved guidelines.
  2. Inform parents or guardians of all procedures and resources.
  3. Consider if research activities can be physically distanced. In some instances, children may not be wearing face coverings during interactions. Ensure that there is available PPE that accommodates a variety of child sizes.

* Research with children of Stanford affiliates authorized to be on campus is currently allowable (see above)

Again, the above suggestions are meant to help human subjects local field researchers think about adjustments they might have to make when their research can resume. Once human subjects field research becomes allowable, the necessary approvals and the process for obtaining them will be posted here.

Guidelines for Planning Domestic and International Human Field Research (>50 miles of Stanford)

Although most human subjects field research is not currently allowed (see exception process for research conducted by local partners), researchers should begin thinking about how they might have to modify their travel and research plans in response to COVID-19 when human subjects field research is allowable. Although community transmission will be limited at that time, researchers will still need to take precautions to prevent spread.

When planning their research, PIs should:

  1. Keep informed about the rates of COVID-19 infection, hospitalization, death, and recovery and the states of testing in their fieldsite.
  2. Familiarize themselves with the formal policies and restrictions regarding travel, public meetings, mask-wearing, etc. at the field site. Research plans should comply with all national, regional, and local regulations and recommendations, abiding by the most conservative. If there is a discrepancy between Stanford guidelines and these policies and restrictions, PIs should describe what they will do to address the discrepancies, and these plans should be approved as safe by EH&S.
  3. Familiarize themselves with the actual practices and precautions that are the norm in the area of the field site, which may differ from the formal policies and restrictions (e.g., What are the norms regarding PPE? How are normal everyday exchanges conducted in streets, markets, cafes, shops and homes?). This information should be gathered, when possible, from contacts in the area prior to the beginning of the fieldwork. Again, if there is a discrepancy between Stanford guidelines and what is normative at the research site, PIs should describe what they will do to address the discrepancies, and these plans should be approved as safe by EH&S.
  4. Consider the meaning of different safety measures in the local communities and their implications for the research (e.g., What does wearing a mask signal in the communities where work is to be carried out?)
  5. Review current Stanford rules, regulations, and recommendation for safe travel (air and ground) to and from field site, as well as protocols for screening, testing, and quarantining to minimize risk of transmission when arriving at and before departing the field site
  6. Consult with Office of Risk Management to obtain medical travel insurance, evacuation insurance, and information on medical resources at their destination.
  7. Purchase refundable tickets or budget for last-minute changes in travel
  8. Assemble and arrange to transport an adequate supply of masks, hand sanitizer and cleaning agents, and a reliable thermometer unless these can be acquired in the field.
  9. Select living arrangements during research that follow Stanford guidelines for reduction of COVID transmission, including low density housing with separate bathrooms and kitchen facilities for each household unit.
  10. Anticipate and develop plans for responsible temporary suspension or cancellation of research activities on short notice in the event of increased restrictions or researcher illness.
  11. Review current Stanford rules and guidelines for safe conduct of research activities, both indoor and outdoor, and where possible revise research plans to comply with these rules and guidelines. See Research Recovery Handbook (new sections are still being added, so the most recent information must be checked). For instance, researchers should consider ways to minimize in-person contact when possible. In cases where in-person contact must occur, researchers should consider how safety precautions might affect interaction with human subjects. Possible adjustments to protocols may include:
    1. Ensuring that participants are comfortable with meeting in-person
    2. Meeting participants in public and outdoor spaces – cafes, tea houses, parks, squares – as much as possible.
    3. Avoiding physical contact – such as handshakes and hugs- unless this would be considered offensive in the local context.
    4. Maintaining physical distance from participants, as well as any other persons not a member of the researcher’s household. Explain that this is to protect the informants.
    5. If invited to a participant’s home, finding out if there are any individuals residing in the household who are high-risk for severe COVID-19 illness. If so, not visiting the household. If visiting a participant’s home, try to meet in outside spaces at the home and wear PPE. Explain that these measures are to protect them and their relatives.
    6. If offered food or beverages in a home or from a restaurant/café, accepting only if physical distancing can be maintained as this will entail removal of masks.
  12. If planning to work with a research assistant or interpreter, make sure they are briefed about observing COVID-19 safety precautions at home and in interactions with human subjects.

Again, the above suggestions are meant to help human subjects field researchers think about adjustments they might have to make when their research can resume. Once human subjects field research becomes allowable, the necessary approvals and the process for obtaining them will be posted here.

Other Important Issues To Consider When Resuming Human Subjects Research

  1. Possibility of Coercion
    Given the risk of COVID-19 transmission and the limited opportunities for research, PIs and researchers should ensure that both researchers and study participants are willing to participate in research resumption activities. Because members of the research team may be concerned that their research and degree progress, relationship with their PI, status in the lab, future opportunities, etc. may be negatively impacted if they do not participate in the research, they may participate in research even if they do not feel safe or comfortable doing so.
    PIs should: (1) ensure that team members are aware of whom they should contact if they have safety or health concerns (see below), (2) remember that participating in research as a subject must always be voluntary, (3) provide opportunities for alternative projects if members of research team are concerned about their safety with in-person human subjects protocols.
    To ensure willingness to participate, volunteers should be solicited by students or staff rather than by PIs or immediate supervisors, and the identities of those who have volunteered or declined to volunteer should be confidential.
  2. Vulnerability of researchers and study participants
    Although new data are emerging, specific characteristics appear to be associated with increased vulnerability to transmitting and contracting COVID-19 (e.g., individuals of specific ages, comorbidities), as indicated by the Center for Disease Control (CDC) (https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-at-increased-risk.html). If possible, these vulnerable individuals should not participate in in-person human subjects research. If they are involved in research, vulnerable individuals should be notified prior to participation that they are at risk so that individuals can provide informed consent.
  3. Concerns about safety and non-compliance
    Members of the research team who have concerns about their own safety and/or the safety of others, or concerns about noncompliance have several options. Individuals may discuss these concerns with their PI. If this is not possible, individuals should discuss with the local contact appointed by their department or unit. Individuals who have safety concerns may contact EH&S. For confidential and anonymous reporting, members of the research community may raise concerns or ask questions via the Ethics and Compliance Helpline. For allegations of noncompliance regarding protection of human subjects, concerns may be reported by phone or in writing to the IRB.
  4. Maximizing equity and access
    Because non-clinical human subjects research will resume incrementally, PIs should be aware of issues related to equity and access when making decisions regarding which projects will restart earlier than others, about which participants to include in studies, about who has access to their offices. Some decisions that are intended to address one need may inadvertently result in inequities (e.g., providing one group access to their offices may make it harder for another group to begin their research).
  5. Research outdoors
    The risk of spread of transmission is lower outdoors than indoors, and therefore, research studies that can take place outdoors in approved and authorized spaces are encouraged (please see Research Recovery Handbook Group Meeting Policy). Departments and units can contact schools for guidelines in creating designated “outdoor safety zones” near their buildings. If approved by the department and/or school, these outdoor safety zones may be used for conducting allowable human subjects research. They must be treated in the same way as indoor space, with required scheduling, calendaring, and disinfection procedures.

What Happens If I or One of My Study Participants Tests Positive for COVID-19?

If study participants or researchers test positive for COVID-19, they must report this to the appropriate office listed here: https://healthalerts.stanford.edu/covid-19/self-reporting/.

If researchers are concerned that they may have COVID-19 symptoms, they should go to this link (https://healthalerts.stanford.edu/covid-19/prevention-care/can-i-work-on-campus-if-i-have-symptoms/) to determine next steps.

If you are a PI, and someone in your lab tests positive for COVID-19, please go here:
https://cardinalrecovery.stanford.edu/research/pi-frequently-asked-questions/.

Comments, Questions, and Concerns

PIs who have comments, questions, and concerns are encouraged to contact the members of the Non-Clinical Human Subjects Research Recovery Working Group here (nchsrecovery@stanford.edu).

Members of the Working Group
Jeanne Tsai, Professor, Psychology (Chair)
Tim Stearns, Professor, Chair of Faculty Senate, Biology
Ruth O’Hara, Senior Associate Dean, Research and Professor of Psychiatry and Behavioral Sciences
Garry Gold, Professor and Vice Chair for Research and Organization, Radiology
Nick Hall, Associate Director, Behavioral Lab, Graduate School of Business
Bruce McCandliss, Professor, Education
Sylvia Yanagisako, Professor, Anthropology
Steve Collins, Associate Professor, Mechanical Engineering
David Strick, Director of Safety and Emergency Management, SoM
Adam Bailey, Non-Medical IRB Manager, RCO
Serena Rao, Senior Associate Dean for Finance and Administration, Vice Provost Dean of Research
LeAnne Amoroso, Health Physicist, EH&S
Kemi Oyewole, Doctoral Student, Education

We thank the faculty and students who helped with and provided feedback on this document, including:
Jeremy Bailenson, Communication
Scott Delp, Bioengineering
David Laiton, Political Science
jem jebbia, Religious Studies
Tomas Jiminez, Sociology
Byron Reeves, Communication
Stephanie Robbilard, Graduate School of Education
Jeremy Weinstein, Political Science
Alex Lindley White, Graduate School of Education
Duana Fullwiley, Jim Ferguson, Matthew Kohrman, Thomas Hansen, Sharika Thiranagama, and other members of the Anthropology department

The Department of Psychology Research Recovery Committee (Anthony Norcia, Ian Gotlib, Hyo Gweon, Russ Poldrack, Anthony Wagner, Jamil Zaki, Harry Bahlman, Lisa Ewan)