Coronavirus/COVID-19 Compliance Resources

 COVID-19 CDC PictureImage credit: Alissa Eckert, MS; Dan Higgins, MAM

The Ethics, Compliance and Audit Services COVID-19 Compliance Resource page is an aggregator of resources for the various compliance functional areas.

Research Compliance

Clery Act Compliance

Export Control 

Other Resources

Research Compliance

Below we have linked to a few Higher Ed organizations resource pages (COGR and PRIM&R), the UCOP RPAC page, and the two largest federal funding agencies - NIH and NSF. Additionally, we link to the Food & Drug Administration's Coronovirus/COVID-19 resource page for clinical research compliance issues and to the Office of Research Integrity (ORI) for conducting research misconduct investigations during the pandemic.

  1. UCOP
  2. COGR
  3. DHHS OIG
  4. OHRP
  5. PRIMR
  6. NIH
  7. NSF
  8. FDA
  9. ORI
  10. OCR
  11. AAMC

UCOP

Research, Policy, Analysis and Coordination, RPAC, a unit of Research and Innovation, is coordinating with stakeholders across the UC system to develop guidance and share resources to support the UC research administration community in this rapidly changing environment. 
The page is updated daily and includes UC Guidance & Policy, State of California Agencies, Federal Agency Resources, and Higher Ed Associations. The page also includes links to COVID-19 sites for each campus, including LBNL and the main UC resource page.

COGR

The Council on Governmental Relations (COGR) has the most complex and up to date resource page for Federal Agency and Institutional Responses to the COVID-19 pandemic. 

DHHS OIG

U.S. Department of Health and Human Services Office of Inspector General COVID-19 portal that aggregates news, policy statements, and guidance addressing OIG's authorities during the COVID-19 pandemic. 

OHRP

DHHS Office of Human Subjects Protection issued guidance on April 8, 2020. This guidance represents the current thinking of the Office for Human Research Protections (OHRP) on this topic. This guidance does not create or confer any rights for or on any person and does not operate to bind OHRP or the public. OHRP guidance should be viewed as recommendations unless specific regulatory requirements are cited. The use of the word "must" in OHRP guidance means that something is required under the Department of Health and Human Services (HHS) regulations at 45 CFR part 46. The use of the word "should" in OHRP guidance means that something is recommended or suggested, but not required. An institution may use an alternative approach if the approach satisfies the requirements of 45 CFR part 46. https://www.hhs.gov/ohrp/regulations-and-policy/guidance/ohrp-guidance-on-covid-19/index.html

PRIM&R

COVID-19 presents enormous challenges to research ethics oversight. PRIM&R created collection of oversight-related resources in order to best prepare the research community for the operational and review concerns brought on by the viral outbreak. This list will be updated regularly: https://blog.primr.org/covid-19-and-coronavirus-updates-for-the-oversight-community/

NIH

National Institutes of Health Coronavirus (COVID-19) resource page.

NSF

National Science Foundation Coronavirus (COVID-19) resource page.
NSF Implementation of OMB Memorandum M-20-17, entitled, “Administrative Relief for
Recipients and Applicants of Federal Financial Assistance Directly Impacted by the Novel
Coronavirus (COVID-19) due to Loss of Operations” dated March 19, 2020

FDA

Food and Drug Administration Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic Guidance for Industry, Investigators, and Institutional Review Boards https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-guidance-conduct-clinical-trials-medical-products-during-covid-19-pandemic

NOT-FD-20-019 Flexibilities Available to Applicants and Recipients of Federal Financial Assistance Affected by COVID-19 https://grants.nih.gov/grants/guide/notice-files/NOT-FD-20-019.html

ORI - Office of Research Integrity, Department of Health and Human Services

ORI issued Guidance to Institutions Concerning Sequestration during Closure of Institutions due to COVID-19

The Office of Research Integrity (ORI) of the U.S. Department of Health and Human Services acknowledges that the COVID-19 pandemic is interrupting and delaying regular operations at institutions, including research misconduct (RM) proceedings. 

https://ori.hhs.gov/blog/ori-guidance-institutions-concerning-sequestration-during-closure-institutions-due-covid-19

OCR - HHS Office for Civil Rights

During the COVID-19 public health emergency, the HHS Office for Civil Rights (OCR) has provided guidance that helps explain civil rights laws as well as how the HIPAA Privacy Rule allows patient information to be shared in the outbreak of infectious disease and to assist patients in receiving the care they need.

https://www.hhs.gov/hipaa/for-professionals/special-topics/hipaa-covid19/index.html

Association of Academic Medical Centers (AAMC)

The AAMC continues to monitor guidance from federal, state, and local health agencies as it relates to the coronavirus (COVID-19). Find information and updates from AAMC on this emerging global health concern.

https://www.aamc.org/coronavirus-covid-19-resource-hub

 

Clery Act Compliance

ECAS and UC Legal Guidance RE COVID-19 Emergency Notifications- April 8, 2020

UC Legal and ECAS provide the following best practices recommendations concerning current and future COVID-19 emergency notifications to 1) ensure consistency across the UC system, and 2) balance between the April 3rd Department of Ed guidance and NACCOP’s concerns. Guidance Document.

Department of Education April 3, 2020, Guidance

https://ifap.ed.gov/electronic-announcements/040320UPDATEDGuidanceInterruptStudyRelCOVID19

Notifications Regarding an Immediate Threat to Health or Safety (§ 668.46)
The Clery Act and its implementing regulations require institutions to notify the campus community upon the confirmation of a significant emergency or dangerous situation involving an immediate threat to the health or safety of students or staff occurring on campus. The Department does not interpret the statutory language as requiring institutions to give regular, on-going updates on COVID-19 or to proactively identify positive COVID-19 cases within the campus community. The Department also does not interpret the statutory language to apply to positive COVID-19 cases among individuals who are not attending classes, working, or residing on campus or to require notifications to such individuals.

An institution may satisfy the emergency notification requirements of the Clery Act and § 668.46 as follows: (1) provide students and employees a single notification through the regular means of communicating emergency notifications informing them about COVID-19 and necessary health and safety precautions, as well as encouraging them to obtain information from health care providers, state health authorities, and the CDC’s COVID-19 website; or (2) create a banner at the top of the institution’s homepage containing that same information, including a statement about the global pandemic and a link to the CDC’s website.

Campus Resources

UCSB https://ucsb.edu/COVID-19-information

UCSD https://coronavirus.ucsd.edu/news-and-updates/updates-to-campus/index.html

Clery Center

Coronavirus FAQs https://clerycenter.org/article/covid-19-clery-act-faqs/ 

NACCOP - National Association of Clery Compliance Officers and Professionals 

https://www.naccop.org

 

Export Control

U.S. Customs and Border Protection (CBP)

CBP COVID-19 Updates and Announcements

In an effort to coordinate inquiries regarding the import of medical supplies and personal protective equipment, CBP's Pharmaceuticals, Health and Chemical Center of Excellence and Expertise has established the COVID-19 Cargo Resolution Team (CCRT). This team is a multidisciplinary team to triage incoming inquires, coordinate with affected ports, and respond directly as appropriate. CCRT can be contacted at COVID19_RELIEF_IMPORTS@cbp.dhs.gov. This email address will be used as CBP's coordinating mechanism for receiving and responding to inquiries concerning the items below items. Assigned staff will also coordinate with the ports and other government agencies to ensure that legitimate shipments are not unnecessarily delayed.

Types of inquires that should be sent to the mailbox are:

(1) Facilitation requests from other government agencies and private industry

(2) General inquiries regarding the import of medical instruments

To assist CBP in expediting the release of COVID-19 relief materials, please include as much data about the shipment as possible. Ideally, this will include the following:

  • Shipment information: manifest or air waybill numbers, tracking numbers, entry numbers, mode of transport information
  • Conveyance information: carrier name, mode of transportation, flight number, vessel/voyage number, port of arrival, port of entry
  • Cargo description: complete description of the goods being shipped
  • Country information: country of manufacture, country of export
  • Parties involved: names and locations of manufacturers, shippers, importers, and consignees

Department of Commerce, Bureau of Industry and Security (BIS)

BIS currently considers SARS-CoV-2 to be distinct from the SARS-CoV virus and as such will continue to classify the SARS-CoV-2 and its specific genetic elements as EAR99. An export license is generally not required for export of this virus or its genetic elements to most destinations. However, exporters are reminded that certain end-users, end-uses, and destination countries may require a license for the export of EAR99 items. Exporters should continue to screen all requests in accordance with Supplement No. 3 to Part 732 of the Export Administration Regulations (EAR), the General Prohibitions in Part 736 of the EAR, and the end-user and end-use-based controls in Part 744 of the EAR. And complete restricted party screening of recipients before exporting.

Note: University of California faculty and staff have access to Visual Compliance software which combines government restricted party lists into one easy screening tool. Click here to sign up for this tool. Or contact your location Export Control Officer for assistance. Please contact your location Export Control Officer for assistance if you determine that your activity involves an entity on one of these federal lists and for assistance with a license determination based on the requirements above.

U.S. Department of State, Directorate of Defense Trade Controls (DDTC)

Core functions in Licensing, Compliance, Policy, and Management continue to operate. “However, staffing and other adjustments across the Department and interagency are being made in accordance with OPM guidance”.

  • Licensing - new licenses continue to be accepted for processing. There is a likelihood of longer than normal processing times due to a reduction in the availability of staff in multiple organizations to review application.
  • Commodity Jurisdiction and General Correspondence requests continue to be processed, but responses may be delayed by this current operational environment.

DDTC has established a new option to submit disclosures and related information such as exhibits, extension requests, responses to DTCC inquires, by allowing submissions on company letterhead and in PDF format by email to DTCC-CaseStatus@state.gov.

See here for more information.

 

Other Resources

Centers for Medicare and Medicaid Services

COVID-19 Daily Newsletter

https://www.cms.gov/outreach-and-educationoutreachffsprovpartprogprovider-partnership-email-archive/2020-04-09-mlnc

Coppersmith|Brockelmen Lawyers

COPPERSMITH BRIEFS: UPDATES ON KEY LEGAL DEVELOPMENTS RELATING TO COVID-19

http://www.cblawyers.com/covid-19/

 UCOP Guidance on the use of ZOOM

Zoom Bombing https://www.ucop.edu/local-it-client-services/_files/security-tips-on-sharing-zoom-meeting-links-and-zoom-settings.pdf

Zoom Best Practices https://security.ucop.edu/resources/zoom-best-practices.html