Stage 2 Clinical Human Subjects Research

Clinical Human Subjects research includes research that is focused on medical disorders and symptoms, including research on treatments, risk-factors, diagnosis, prognosis and clinical outcomes. All Clinical Human Subjects Research that can be conducted virtually should continue virtually.

In Stage 2, the following categories of In-Person, Clinical Human Subjects Research can proceed with the appropriate approvals.

Category 1. Ongoing treatment studies that provide critical therapeutic support for our patients, and/or where cessation of the treatment could negatively impact patient outcomes, safety or care, can continue with in-person visits, given the Principal Investigator/Project Lead has obtained the required approvals. Similarly, clinical research that obtains critical, in-person observations or laboratory measures on vulnerable patients or populations where not obtaining these observations could negatively impact patient outcomes, safety or care, can continue with in-person visits, given the Principal Investigator/Project Lead has obtained the required approvals (see Approval Process below).

Category 2. New treatment studies or new clinical observation studies requiring in-person visits, that a Principal Investigator/Project Lead and their Chair and/or Institute Director determine could negatively impact patient outcomes, safety or care if they were not to take place, can be initiated, given the Principal Investigator/Project Lead has obtained the required approvals (see Approval Process below).

Category 3. New or ongoing clinical research studies involving outpatients or inpatients who are already coming into Stanford Health Care or Stanford Children’s Health for medical care, can occur if the Principal Investigator/Project Lead obtains the required approvals (see Approval Process below). Further, patients coming into the clinical setting on campus for a medical visit, can go to another School of Medicine building, on the same day, to participate in the research protocol (see Approval Process below).

Category 4. COVID-19-related research studies involving human subjects. In Stage 2, COVID-19 research involving Clinical Human Subjects still requires approval (see Approval Process below).

STAGE 2: CLINICAL HUMAN SUBJECTS RESEARCH APPROVAL PROCESS:

For Categories 1 and 2 Clinical Human Subjects Research, in order to proceed, a) initial approval needs to be obtained from the Department Chair or designee, and/or Institute Director; and b) final approval should be obtained through adjudication by the Clinical Human Subjects Committee, in the Office of the Senior Associate Dean for Research, School of Medicine. For details contact Pooneh.Fouladi@stanford.edu.

For Category 3, i.e. new or ongoing clinical trials or clinical research studies involving patients who are already coming into Stanford Health Care or Stanford Children’s Health for medical care, and which will be conducted in the clinical care setting, the necessary procedures and approvals can be obtained from the Departmental Chairs and/or Institute Directors and do not require additional approval from the Office of the Senior Associate Dean for Research. For details, please contact your Department or Institute DFA.

However, if patients already coming to campus for a medical visit will participate in research in another School of Medicine building, then a) initial approval must be obtained from the Department Chair or designee, and/or Institute Director; and b) final approval obtained through adjudication by the Clinical Human Subjects Committee, in the Office of the Senior Associate Dean for Research, School of Medicine. For details contact Pooneh.Fouladi@stanford.edu.

For Category 4, COVID-19-related Research involving Clinical Human Subjects must still obtain approval from the COVID-19 Clinical Research Review Panel (CCRRP). For details contact Pooneh.Fouladi@stanford.edu.

 

Research on clinical patients from Stanford Health Care or Lucille Packard Children’s Hospital

  1. Effective Sept 23, 2020, clinical patients already coming in to SHC or LPCH for a medical visit can also go for clinical or non-clinical human subjects research to non-SoM Buildings, e.g. CNI or Wu Tsai, using similar SoPs as applied to SoM buildings such as Lucas, or the Stem Cell building. SoPs will:
    1. incorporate lab SoPs and requirements;
    2. incorporate local unit and building SoPs;
    3. be in compliance with all EH&S requirements; and
    4. be approved by the local unit leadership, Chair and/or Institute Director, and the SAD-R Human Subjects Committee.

    If patients are entering a different academic zone for research purposes, they will require a letter (see template) on Stanford letterhead from the investigator stating that the patients have permission to enter a different zone.

  2. Effective Sept 23, 2020, clinical patients coming in for a clinic visit who cannot complete clinical or non-clinical human subjects research on the same day may return on another day for the research component, either to the same clinical setting or the SoM or non-SoM building.

Expansion of clinical and non-clinical in person human subjects research on campus (10/16/20)

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 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:

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*****