Resource for Organizations Conducting Research in the Developing World Amid COVID-19 Pandemic

Firm Publication

This content was originally published on April 15, 2020. It was last updated as of Friday, May 29, 2020 at 12:40 p.m. CST.

American universities, hospitals, and other institutions currently have a wide variety of healthcare, research, education, and humanitarian projects underway all over the world, with some individual universities conducting projects in over 100 countries and individual hospitals and health systems conducting projects in several dozen countries. Pharmaceutical, device, and vaccine manufacturers are also conducting an increasing volume of research globally, and a review of clinical trial registrations on ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform shows that a significant and growing number are being conducted in countries classified by the World Bank as low- and middle-income countries (LMICs). Even without the COVID-19 pandemic, there can be a complex interplay of U.S. law; foreign law; grant term compliance; and various operational, political, and ethical considerations when conducting those projects, particularly when they involve human subjects research (HSR) in LMICs.

Many of these HSR projects have been modified or put on hold as a result of the pandemic because of participant safety, personnel or supply availability, medical resource conservation, mandatory quarantines, travel restrictions, or other considerations. Other HSR projects have not yet been put on hold due to local considerations, and still others cannot safely be put on hold. The Food and Drug Administration (FDA), the Office for Human Research Protections (OHRP), and other regulators of medical research around the world (including in India, South Africa, Kenya, Brazil, and Peru) have issued guidelines for what clinical research sponsors should consider when pausing or modifying studies, but such guidelines will not be available in many LMICs.

Restarting paused HSR projects in LMICs will present challenges unique to the LMIC environment. COVID-19 statistics in many LMICs can be unreliable or censored, and testing capacity with existing technologies will not match that of high-income countries (HICs), so it may be difficult to have situational awareness of the local outbreak. In addition, vaccines and treatments are likely to become widely available in HICs first, and some may never become widely available outside of HICs, so there may be a period of time when citizens of a particular country are at significantly higher overall risk than HIC staff working on-site alongside them.

There will also, of course, be projects that are started during the pandemic, including on COVID-19 vaccines, treatments, in vitro diagnostics, social and behavioral interventions, and epidemiology, or research on an emergency itself (e.g., research on the impact of cash transfers on women’s risk of violence during a health crisis). While much of the early phase safety work for vaccine candidates and investigational drugs is likely to be carried out in HICs and China, the bulk of this work will take place globally, and some will be conducted in LMICs exclusively. As of the middle of May, well over a thousand COVID-19 clinical trials were listed in the World Health Organization’s International Clinical Trials Registry Platform that were not also listed on ClinicalTrials.gov.

We provide here a resource for institutions conducting or participating in HSR in LMICs as they evaluate whether to modify or suspend HSR projects in LMICs and when and how to start or restart them. This content is based on the firm’s extensive on-the-ground work throughout the developing world on behalf of universities and hospitals, including on vaccine clinical trials and biological sample collection projects, as well as the firm’s work with a global organization dedicated to the development of vaccines against emerging infectious diseases, including COVID-19. Because of the complex and context-specific considerations involved in these projects, this resource is far from exhaustive, but we hope that it provides a good starting point for many of the relevant issues.

If you have any questions about conducting research or public health projects abroad during the COVID-19 pandemic, please contact the authors of this resource.

COVID-19 Considerations for Projects in LMICs

  • Funding Considerations

    Sponsored projects are subject to rules imposed by the funding entity, and U.S. government funding, in particular, is subject to complex pre- and post-award rules pertaining to cost principles, administrative requirements, and audit standards. The Office of Management and Budget (OMB) has issued several memoranda addressing relief measures to federal awardees. Those OMB measures are further explained by guidance from numerous federal awarding agencies, some of which are described below.

    Non-governmental foundations also support a significant number of overseas projects, and several of the major foundations have similarly issued guidance to awardees.

    National Institutes of Health

    The National Institutes of Health (NIH) issued a guidance notice and frequently asked questions website for recipients of federal financial assistance affected by COVID-19 providing flexibilities related to pre-award costs; extensions of post-award financial and other required reporting, including closeout reporting; prior approval requirement waivers; and extension of single audit submissions. The NIH also addressed funding considerations related to salaries and stipends and noted that many researchers may be unable to work as a result of COVID-19, so if a recipient organization’s policy allows for the charging of salaries and benefits during periods when no work is performed due to COVID-19, then charges to NIH grant awards will be permissible. Regarding the federal government’s heightened scrutiny of foreign influence at U.S. academic institutions, NIH had initially stated that if a post-doc on an active NIH grant must return home to a foreign country as a result of COVID-19 and work remotely this must be reported to NIH as a foreign component of the award; while NIH has apparently changed its mind on this, the answer may be different if more senior project personnel were working remotely in a foreign country. The NIH has stated in a YouTube video that the FAQs will be updated often, so we encourage awardees to check them regularly.

    The NIH also issued guidance specifically for NIH-funded clinical trials and HSR projects affected by COVID-19, directing grant recipients to take all steps necessary to ensure the safety of all participants and research staff and encouraging recipients to consult with their Institutional Review Boards (IRBs) and institutions regarding protective measures. In addition, the NIH acknowledged that recipients may incur unanticipated costs during this time, such as costs to arrange for participants to receive care locally or virtually, rather than the study site; supply chain disruptions; personnel shortages; additional lab testing for COVID-19; and increased transportation costs. Recipients may request administrative supplements from the funding institute or center, which will be addressed on a case-by-case basis.

    Centers for Disease Control and Prevention

    The Centers for Disease Control and Prevention (CDC) has published a frequently asked questions website for grantees addressing the effects of COVID-19 and directs grant recipients to the memoranda published by the OMB dated March 9, 2020, March 19, 2020, April 9, 2020, and April 10, 2020. These memoranda provide flexibility for awarding agencies with regard to application deadlines, no-cost extensions on expiring awards, charging salaries to the grant when personnel are not able to work due to COVID-19, permissibility of costs not normally chargeable to awards, prior approval requirement waivers, and extension of reporting and single audit submission requirements. The agency also addresses the reassignment of personnel. Grant recipients should maintain records and documentation related to grant flexibilities and assess the impact on programmatic activities as originally funded once normal activities resume, as there is no guarantee of additional funding.  Guidance on repurposing existing awards to support the emergency response to COVID-19 as well as implementation guidance for supplemental funding is also provided

    United States Agency for International Development

    The United States Agency for International Development (USAID) issued a memorandum authorizing COVID-19 flexibilities but emphasizes that in no circumstances can costs exceed the amount obligated in the award and clarifying that the agency will not reimburse any overspend. USAID notes that recipients must ensure all costs associated with repatriation, termination, and close-out are within budget and available within the amount of the award. The USAID memorandum discusses, among other things, no-cost extensions on expiring awards at the request of the recipient as well as extensions on reporting requirements, abbreviated non-competitive continuation requests, and the permissibility of charging salaries and other project activities in light of COVID-19 effects. Before incurring related costs, grant recipients must notify the applicable USAID Agreement Officer or Agreement Officer’s Representative. Similar to other funding agencies, USAID has issued FAQs that should be checked regularly. USAID has created a webpage specifically for guidance on COVID-19 funding requests and unsolicited proposals.

    NIAID Division of AIDS

    The Department of Health and Human Services (HHS) issued guidance on the potential impact of COVID-19 on the NIAID Division of AIDS (DAIDS) sponsored clinical research studies. DAIDS noted that it will expedite the review of clarification memoranda, letters of amendment, and amendments to address the effects of COVID-19 related to the implementation of protocols. DAIDS also provided guidelines for network leadership, protocol teams, site staff, and the management of clinical trials. DAIDS suspended all on-site monitoring visits through April 17, 2020. The organization also issued a memorandum addressing the use of alternative and remote informed consent processes. DAIDS has also provided a memorandum containing guidance for clinical research sites on resuming operations during the pandemic. Inquiries should be directed to DAIDS representatives in the Scientific Research Programs.

    National Science Foundation

    The National Science Foundation (NSF) has published answers to frequently asked questions and encourages grant recipients and proposers to monitor the NSF’s website for updates. The NSF has also encouraged international collaboration, as several countries are providing funds to support international collaborative research in partnership with U.S. research communities.

    Private Foundations

    Private foundations have also issued guidance for grantees on navigating uncertainties surrounding COVID-19 and its effects. Generally, established project budgets are not being expanded, but a reallocation of funds may be permissible.  Harvard University has created a resource page to collect funding information and resources for private foundations.

    For example, the Gates Foundation has a specific page on COVID-19 updates and new grant opportunities. The Global Fund is enabling countries to use up to 5% of currently approved grant funding to help protect and treat vulnerable communities related to COVID-19. Under the guidelines, the Global Fund is encouraging countries to redeploy underutilized assets; repurpose grant savings; and, in exceptional cases, reprogram funding from existing grants. Activities under the new COVID-19 guidelines include, but are not limited to, epidemic preparedness assessment, laboratory testing, sample transportation, use of surveillance infrastructure, infection control in health facilities, and information campaigns.  The Global Fund also issued a question and answer document on supporting grants during the COVID-19 pandemic.

    The Wellcome Trust’s COVID-19 response page for grant holders notes that it may pay for certain costs if recipients are called to work on the coronavirus response for one month or more (e.g., carrying out clinical duties), among other things. Also, if grantees have paid costs for events or travel that have been canceled and are non-refundable, then grantees may be able to claim these against their grants.

     

  • Travel Considerations and Quarantines

    Travel restrictions, social distancing guidance, lockdown measures, contact tracing, and isolation/quarantines will have an impact on international projects that are difficult to overstate. On March 9, 2020, the CDC advised all institutions of higher education to consider postponing or canceling all upcoming student study abroad programs and also consider bringing back to the United States all students who were participating in study abroad programs at that time. On March 31, 2020, the U.S. Department of State advised U.S. citizens to avoid all international travel due to the global effect of the pandemic and further instructed U.S. citizens who live abroad to arrange for “immediate return” to the United States unless they are prepared to remain abroad for an indefinite period. Many U.S. personnel based or temporarily working overseas have returned to the country as a result of this State Department advice, and their ability to return to the locations of their projects will be impacted by both the U.S. State Department (whose guidance is heavily relied upon by U.S. institutions) and restrictions imposed by their host countries. The U.S. State Department is also maintaining a list of COVID-19 country-specific information and related resources. The World Health Organization (WHO) has noted that if countries lift travel restrictions too quickly, there could be a resurgence of the virus, and the NIH has discouraged travel for large meetings that are not mission-critical and is encouraging the use of tele/videoconferencing services where possible. In addition, institutions also may have private travel risk information available.  Many large pharmaceutical and device companies and U.S. institutions have contracts with private services that provide additional, and often more detailed, travel risk information than is available from the U.S. State Department.

    Internationally, there have been varying responses to COVID-19 and the degree to which government officials have placed restrictions on public gatherings and travel. Foreign travel restrictions, lockdowns, and quarantines will limit movement into or within a country, inhibiting the work of U.S. or host country personnel currently on the ground and travel of U.S. personnel to study sites. Some government officials have been extremely proactive in implementing social distancing measures, while others have been slower to respond. For example, in India, officials instituted a total lockdown, which drastically curtailed non-hospital based research projects in the country; however officials have begun gradually reopening business and commercial activities. Other countries, including Sierra Leone, Uganda, and Uzbekistan have imposed restrictions that could affect overseas projects. Nicaragua and Brazil, on the other hand, have taken relatively few actions in response. The Partnership for Evidence-Based Response to COVID-19 has published a report on the overall COVID-19 government responses in Africa. Some countries, including Chile and Vietnam, are requiring “immunity passports” or back to work permits to allow individuals who have recovered from COVID-19 entry into the country or to resume normal activity within the country. However, WHO has cautioned against using coronavirus antibody tests as the basis for issuing immunity passports, as there are concerns over false positive results and further research is needed into whether individuals testing positive are immune from secondary infections. Researchers have noted that immunity passports could be catalysts for corruption and implicit bias and impose an artificial restriction on which individuals can participate in civic and economic activities.

    These are just a few examples, and we expect most LMICs to impose some form of COVID-19 internal restrictions. Both Oxford University and the International Monetary Fund are tracking government policy responses and travel restrictions related to COVID-19 for most countries, but of course, local partners and any remaining in-country U.S. State Department and USAID personnel will have the most accurate and up-to-date information.

  • Labor Considerations

    There have been many articles addressing various U.S. labor and employment topics that have arisen from COVID-19 and interpreting recently passed legislation, particularly the Families First Coronavirus Response Act.  Topics addressed include employer frequently asked questions on COVID-19, workforce reduction options during the pandemic, HIPAA compliance for employers that are covered entities, and discussion on the CARES Act legislation. U.S. citizens working abroad are covered by some U.S. federal labor laws (e.g., ADEA, Title VII and ADA), except to the extent that an employer’s adherence to those laws would cause the employer to violate the laws of the country where the workplace is located.  See 29 USC § 623(f)(1), 42 U.S.C. § 2000e-1(b), and 42 U.S.C. § 12112(c)(1). Likewise, for covered entities, HIPAA is still applicable to employees located outside of the country and to the handling of protected health information of individuals located outside of the United States.

    Foreign labor law presents unique challenges for U.S. institutions. Most foreign countries’ labor laws are more pro-employee than U.S. laws are, and it is often difficult to ascertain what the relevant laws require. The Rwandan labor code, for example, is issued in several official languages, and there are conflicts between the French, English, and Kinyarwandan versions. For this reason, U.S. institutions navigating a foreign country’s labor laws should consult local counsel. Organizations should take into consideration any applicable foreign rules or protocols around collective bargaining agreements, leaves of absence, workforce reduction processes, furlough policies, and employee data privacy. Additionally, COVID-19- specific policies, such as whether an employer may lawfully conduct temperature checks or require an employee to see a health care provider, will need to conform with applicable foreign law. The International Labour Organization is monitoring policy responses by country for measures that governments, employers, and worker organizations have implemented to address the effects of COVID-19.

  • Other Practical Considerations

    There is a host of other issues institutions and companies will need to consider as they navigate COVID-19 challenges of conducting projects in LMICs, such as safety and security of staff and participants, the extent to which provisions in memoranda of understanding (MOUs) with host governments will still be honored, availability of supplies and subcontractors, and the terms of institutional insurance.

    The Nuffield Counsel on Bioethics published a report titled Research in Global Health Emergencies in January 2020 (Nuffield Report), which includes a discussion of practical issues faced by front-line workers that will need to be handled, such as fair treatment of employees and other ethical concerns. Some of these concerns institutions may need to address include challenges in meeting supply needs, staff being a source of danger for study participants, responding to violence or physical threats, and providing support for the emotional impact of public emergencies on staff.

    The safety and security of employees, and employees of key partners and subcontractors, is understandably a top concern for institutions and companies. In addition to concerns over researchers and staff contracting or transmitting COVID-19, particularly in LMICs already experiencing strain on healthcare systems, resulting in social and political upheavals will need to be continuously monitored for risks to the safety of researchers and other staff.  For example, there have been protests and police violence in many countries as government officials seek to contain the spread of COVID-19. Medical professionals in several countries, including Mexico, Columbia, Brazil and the Philippines, have been attacked by individuals concerned about contracting COVID-19. In addition, there has been a documented increase in anti-foreigner sentiment worldwide, including in Cameroon, China, and Ethiopia.

    Many research projects benefit from exemptions or privileges available through MOUs with host governments. Institutions must confirm whether these MOUs will still be honored in light of COVID-19 challenges and whether MOUs have been impacted by changes in laws or other emergency measures in the host country as a result of the pandemic. In addition to confirming that MOUs are still in effect with regard to the host country signatory, institutions should also determine whether their MOUs present conflicts with the directives of any local or provincial health authorities, which can sometimes be inconsistent with national ministerial guidance.

    The availability of necessary supplies and disruptions to supply chains, particularly in LMICs, as a result of the pandemic will also need to be addressed. COVID-19 will likely have a long-lasting effect on global supply chains. The U.S. and more than 50 other countries are restricting or considering restrictions on, exports of supplies that are needed to mitigate the effects of COVID-19 locally. Internationally, the World Trade Organization and the World Customs Organization issued a joint statement noting the disruptive impact of COVID-19 on global supply chains and pledged to cooperate to facilitate trade in essential goods. The Global Fund is monitoring and assessing global health product supply chains on an ongoing basis. The Center for Infectious Disease Research and Policy of the University of Minnesota is monitoring ongoing supply chain issues.  WHO, the Global Fund, Wellcome Trust, and the Coalition for Epidemic Preparedness Innovations, among others, have created Access to COVID-19 Tools (ACT) Accelerator, a global collaboration to increase access worldwide to health technologies and related coronavirus response resources.

    Companies and institutions will also need to evaluate the terms of their institutional insurance policies to determine whether COVID-19 may have an impact on coverage for medical, travel, or liability claims that may arise. For example, many institutional medical and security evacuation policies do not cover activities in countries designated as a Level 4 risk by the U.S. State Department. Prior to the pandemic, only a few countries (e.g., Somalia, Yemen, Afghanistan, Syria, and the Central African Republic) were in this category. Currently, however, there is a U.S. State Department Level 4 Do Not Travel advisory globally. Likewise, other policies should be considered for language that may be implicated by COVID-19 and its effects on project coverage.

    In these times of increased global uncertainty, companies and institutions may also consider reminding employees and researchers that the organization’s compliance with the U.S. Foreign Corrupt Practices Act (FCPA) remains in full effect. The FCPA penalizes bribing or offering, authorizing, or promising to bribe foreign officials, and good motivations are not a defense to a violation. Many enforcement actions involve bribes paid for transactions that are beneficial both to the payor and the country in which the bribe was paid. Amid a global pandemic, the risk for corruption may be heightened because individuals may feel traditional rules preventing such behavior have been suspended, both in the United States and abroad.

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This content was originally published on April 15, 2020. It was last updated as of Friday, May 29, 2020 at 12:40 p.m. CST.

American universities, hospitals, and other institutions currently have a wide variety of healthcare, research, education, and humanitarian projects underway all over the world, with some individual universities conducting projects in over 100 countries and individual hospitals and health systems conducting projects in several dozen countries. Pharmaceutical, device, and vaccine manufacturers are also conducting an increasing volume of research globally, and a review of clinical trial registrations on ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform shows that a significant and growing number are being conducted in countries classified by the World Bank as low- and middle-income countries (LMICs). Even without the COVID-19 pandemic, there can be a complex interplay of U.S. law; foreign law; grant term compliance; and various operational, political, and ethical considerations when conducting those projects, particularly when they involve human subjects research (HSR) in LMICs.

Many of these HSR projects have been modified or put on hold as a result of the pandemic because of participant safety, personnel or supply availability, medical resource conservation, mandatory quarantines, travel restrictions, or other considerations. Other HSR projects have not yet been put on hold due to local considerations, and still others cannot safely be put on hold. The Food and Drug Administration (FDA), the Office for Human Research Protections (OHRP), and other regulators of medical research around the world (including in India, South Africa, Kenya, Brazil, and Peru) have issued guidelines for what clinical research sponsors should consider when pausing or modifying studies, but such guidelines will not be available in many LMICs.

Restarting paused HSR projects in LMICs will present challenges unique to the LMIC environment. COVID-19 statistics in many LMICs can be unreliable or censored, and testing capacity with existing technologies will not match that of high-income countries (HICs), so it may be difficult to have situational awareness of the local outbreak. In addition, vaccines and treatments are likely to become widely available in HICs first, and some may never become widely available outside of HICs, so there may be a period of time when citizens of a particular country are at significantly higher overall risk than HIC staff working on-site alongside them.

There will also, of course, be projects that are started during the pandemic, including on COVID-19 vaccines, treatments, in vitro diagnostics, social and behavioral interventions, and epidemiology, or research on an emergency itself (e.g., research on the impact of cash transfers on women’s risk of violence during a health crisis). While much of the early phase safety work for vaccine candidates and investigational drugs is likely to be carried out in HICs and China, the bulk of this work will take place globally, and some will be conducted in LMICs exclusively. As of the middle of May, well over a thousand COVID-19 clinical trials were listed in the World Health Organization’s International Clinical Trials Registry Platform that were not also listed on ClinicalTrials.gov.

We provide here a resource for institutions conducting or participating in HSR in LMICs as they evaluate whether to modify or suspend HSR projects in LMICs and when and how to start or restart them. This content is based on the firm’s extensive on-the-ground work throughout the developing world on behalf of universities and hospitals, including on vaccine clinical trials and biological sample collection projects, as well as the firm’s work with a global organization dedicated to the development of vaccines against emerging infectious diseases, including COVID-19. Because of the complex and context-specific considerations involved in these projects, this resource is far from exhaustive, but we hope that it provides a good starting point for many of the relevant issues.

If you have any questions about conducting research or public health projects abroad during the COVID-19 pandemic, please contact the authors of this resource.

COVID-19 Considerations for Projects in LMICs

  • Funding Considerations

    Sponsored projects are subject to rules imposed by the funding entity, and U.S. government funding, in particular, is subject to complex pre- and post-award rules pertaining to cost principles, administrative requirements, and audit standards. The Office of Management and Budget (OMB) has issued several memoranda addressing relief measures to federal awardees. Those OMB measures are further explained by guidance from numerous federal awarding agencies, some of which are described below.

    Non-governmental foundations also support a significant number of overseas projects, and several of the major foundations have similarly issued guidance to awardees.

    National Institutes of Health

    The National Institutes of Health (NIH) issued a guidance notice and frequently asked questions website for recipients of federal financial assistance affected by COVID-19 providing flexibilities related to pre-award costs; extensions of post-award financial and other required reporting, including closeout reporting; prior approval requirement waivers; and extension of single audit submissions. The NIH also addressed funding considerations related to salaries and stipends and noted that many researchers may be unable to work as a result of COVID-19, so if a recipient organization’s policy allows for the charging of salaries and benefits during periods when no work is performed due to COVID-19, then charges to NIH grant awards will be permissible. Regarding the federal government’s heightened scrutiny of foreign influence at U.S. academic institutions, NIH had initially stated that if a post-doc on an active NIH grant must return home to a foreign country as a result of COVID-19 and work remotely this must be reported to NIH as a foreign component of the award; while NIH has apparently changed its mind on this, the answer may be different if more senior project personnel were working remotely in a foreign country. The NIH has stated in a YouTube video that the FAQs will be updated often, so we encourage awardees to check them regularly.

    The NIH also issued guidance specifically for NIH-funded clinical trials and HSR projects affected by COVID-19, directing grant recipients to take all steps necessary to ensure the safety of all participants and research staff and encouraging recipients to consult with their Institutional Review Boards (IRBs) and institutions regarding protective measures. In addition, the NIH acknowledged that recipients may incur unanticipated costs during this time, such as costs to arrange for participants to receive care locally or virtually, rather than the study site; supply chain disruptions; personnel shortages; additional lab testing for COVID-19; and increased transportation costs. Recipients may request administrative supplements from the funding institute or center, which will be addressed on a case-by-case basis.

    Centers for Disease Control and Prevention

    The Centers for Disease Control and Prevention (CDC) has published a frequently asked questions website for grantees addressing the effects of COVID-19 and directs grant recipients to the memoranda published by the OMB dated March 9, 2020, March 19, 2020, April 9, 2020, and April 10, 2020. These memoranda provide flexibility for awarding agencies with regard to application deadlines, no-cost extensions on expiring awards, charging salaries to the grant when personnel are not able to work due to COVID-19, permissibility of costs not normally chargeable to awards, prior approval requirement waivers, and extension of reporting and single audit submission requirements. The agency also addresses the reassignment of personnel. Grant recipients should maintain records and documentation related to grant flexibilities and assess the impact on programmatic activities as originally funded once normal activities resume, as there is no guarantee of additional funding.  Guidance on repurposing existing awards to support the emergency response to COVID-19 as well as implementation guidance for supplemental funding is also provided

    United States Agency for International Development

    The United States Agency for International Development (USAID) issued a memorandum authorizing COVID-19 flexibilities but emphasizes that in no circumstances can costs exceed the amount obligated in the award and clarifying that the agency will not reimburse any overspend. USAID notes that recipients must ensure all costs associated with repatriation, termination, and close-out are within budget and available within the amount of the award. The USAID memorandum discusses, among other things, no-cost extensions on expiring awards at the request of the recipient as well as extensions on reporting requirements, abbreviated non-competitive continuation requests, and the permissibility of charging salaries and other project activities in light of COVID-19 effects. Before incurring related costs, grant recipients must notify the applicable USAID Agreement Officer or Agreement Officer’s Representative. Similar to other funding agencies, USAID has issued FAQs that should be checked regularly. USAID has created a webpage specifically for guidance on COVID-19 funding requests and unsolicited proposals.

    NIAID Division of AIDS

    The Department of Health and Human Services (HHS) issued guidance on the potential impact of COVID-19 on the NIAID Division of AIDS (DAIDS) sponsored clinical research studies. DAIDS noted that it will expedite the review of clarification memoranda, letters of amendment, and amendments to address the effects of COVID-19 related to the implementation of protocols. DAIDS also provided guidelines for network leadership, protocol teams, site staff, and the management of clinical trials. DAIDS suspended all on-site monitoring visits through April 17, 2020. The organization also issued a memorandum addressing the use of alternative and remote informed consent processes. DAIDS has also provided a memorandum containing guidance for clinical research sites on resuming operations during the pandemic. Inquiries should be directed to DAIDS representatives in the Scientific Research Programs.

    National Science Foundation

    The National Science Foundation (NSF) has published answers to frequently asked questions and encourages grant recipients and proposers to monitor the NSF’s website for updates. The NSF has also encouraged international collaboration, as several countries are providing funds to support international collaborative research in partnership with U.S. research communities.

    Private Foundations

    Private foundations have also issued guidance for grantees on navigating uncertainties surrounding COVID-19 and its effects. Generally, established project budgets are not being expanded, but a reallocation of funds may be permissible.  Harvard University has created a resource page to collect funding information and resources for private foundations.

    For example, the Gates Foundation has a specific page on COVID-19 updates and new grant opportunities. The Global Fund is enabling countries to use up to 5% of currently approved grant funding to help protect and treat vulnerable communities related to COVID-19. Under the guidelines, the Global Fund is encouraging countries to redeploy underutilized assets; repurpose grant savings; and, in exceptional cases, reprogram funding from existing grants. Activities under the new COVID-19 guidelines include, but are not limited to, epidemic preparedness assessment, laboratory testing, sample transportation, use of surveillance infrastructure, infection control in health facilities, and information campaigns.  The Global Fund also issued a question and answer document on supporting grants during the COVID-19 pandemic.

    The Wellcome Trust’s COVID-19 response page for grant holders notes that it may pay for certain costs if recipients are called to work on the coronavirus response for one month or more (e.g., carrying out clinical duties), among other things. Also, if grantees have paid costs for events or travel that have been canceled and are non-refundable, then grantees may be able to claim these against their grants.

     

  • Travel Considerations and Quarantines

    Travel restrictions, social distancing guidance, lockdown measures, contact tracing, and isolation/quarantines will have an impact on international projects that are difficult to overstate. On March 9, 2020, the CDC advised all institutions of higher education to consider postponing or canceling all upcoming student study abroad programs and also consider bringing back to the United States all students who were participating in study abroad programs at that time. On March 31, 2020, the U.S. Department of State advised U.S. citizens to avoid all international travel due to the global effect of the pandemic and further instructed U.S. citizens who live abroad to arrange for “immediate return” to the United States unless they are prepared to remain abroad for an indefinite period. Many U.S. personnel based or temporarily working overseas have returned to the country as a result of this State Department advice, and their ability to return to the locations of their projects will be impacted by both the U.S. State Department (whose guidance is heavily relied upon by U.S. institutions) and restrictions imposed by their host countries. The U.S. State Department is also maintaining a list of COVID-19 country-specific information and related resources. The World Health Organization (WHO) has noted that if countries lift travel restrictions too quickly, there could be a resurgence of the virus, and the NIH has discouraged travel for large meetings that are not mission-critical and is encouraging the use of tele/videoconferencing services where possible. In addition, institutions also may have private travel risk information available.  Many large pharmaceutical and device companies and U.S. institutions have contracts with private services that provide additional, and often more detailed, travel risk information than is available from the U.S. State Department.

    Internationally, there have been varying responses to COVID-19 and the degree to which government officials have placed restrictions on public gatherings and travel. Foreign travel restrictions, lockdowns, and quarantines will limit movement into or within a country, inhibiting the work of U.S. or host country personnel currently on the ground and travel of U.S. personnel to study sites. Some government officials have been extremely proactive in implementing social distancing measures, while others have been slower to respond. For example, in India, officials instituted a total lockdown, which drastically curtailed non-hospital based research projects in the country; however officials have begun gradually reopening business and commercial activities. Other countries, including Sierra Leone, Uganda, and Uzbekistan have imposed restrictions that could affect overseas projects. Nicaragua and Brazil, on the other hand, have taken relatively few actions in response. The Partnership for Evidence-Based Response to COVID-19 has published a report on the overall COVID-19 government responses in Africa. Some countries, including Chile and Vietnam, are requiring “immunity passports” or back to work permits to allow individuals who have recovered from COVID-19 entry into the country or to resume normal activity within the country. However, WHO has cautioned against using coronavirus antibody tests as the basis for issuing immunity passports, as there are concerns over false positive results and further research is needed into whether individuals testing positive are immune from secondary infections. Researchers have noted that immunity passports could be catalysts for corruption and implicit bias and impose an artificial restriction on which individuals can participate in civic and economic activities.

    These are just a few examples, and we expect most LMICs to impose some form of COVID-19 internal restrictions. Both Oxford University and the International Monetary Fund are tracking government policy responses and travel restrictions related to COVID-19 for most countries, but of course, local partners and any remaining in-country U.S. State Department and USAID personnel will have the most accurate and up-to-date information.

  • Labor Considerations

    There have been many articles addressing various U.S. labor and employment topics that have arisen from COVID-19 and interpreting recently passed legislation, particularly the Families First Coronavirus Response Act.  Topics addressed include employer frequently asked questions on COVID-19, workforce reduction options during the pandemic, HIPAA compliance for employers that are covered entities, and discussion on the CARES Act legislation. U.S. citizens working abroad are covered by some U.S. federal labor laws (e.g., ADEA, Title VII and ADA), except to the extent that an employer’s adherence to those laws would cause the employer to violate the laws of the country where the workplace is located.  See 29 USC § 623(f)(1), 42 U.S.C. § 2000e-1(b), and 42 U.S.C. § 12112(c)(1). Likewise, for covered entities, HIPAA is still applicable to employees located outside of the country and to the handling of protected health information of individuals located outside of the United States.

    Foreign labor law presents unique challenges for U.S. institutions. Most foreign countries’ labor laws are more pro-employee than U.S. laws are, and it is often difficult to ascertain what the relevant laws require. The Rwandan labor code, for example, is issued in several official languages, and there are conflicts between the French, English, and Kinyarwandan versions. For this reason, U.S. institutions navigating a foreign country’s labor laws should consult local counsel. Organizations should take into consideration any applicable foreign rules or protocols around collective bargaining agreements, leaves of absence, workforce reduction processes, furlough policies, and employee data privacy. Additionally, COVID-19- specific policies, such as whether an employer may lawfully conduct temperature checks or require an employee to see a health care provider, will need to conform with applicable foreign law. The International Labour Organization is monitoring policy responses by country for measures that governments, employers, and worker organizations have implemented to address the effects of COVID-19.

  • Other Practical Considerations

    There is a host of other issues institutions and companies will need to consider as they navigate COVID-19 challenges of conducting projects in LMICs, such as safety and security of staff and participants, the extent to which provisions in memoranda of understanding (MOUs) with host governments will still be honored, availability of supplies and subcontractors, and the terms of institutional insurance.

    The Nuffield Counsel on Bioethics published a report titled Research in Global Health Emergencies in January 2020 (Nuffield Report), which includes a discussion of practical issues faced by front-line workers that will need to be handled, such as fair treatment of employees and other ethical concerns. Some of these concerns institutions may need to address include challenges in meeting supply needs, staff being a source of danger for study participants, responding to violence or physical threats, and providing support for the emotional impact of public emergencies on staff.

    The safety and security of employees, and employees of key partners and subcontractors, is understandably a top concern for institutions and companies. In addition to concerns over researchers and staff contracting or transmitting COVID-19, particularly in LMICs already experiencing strain on healthcare systems, resulting in social and political upheavals will need to be continuously monitored for risks to the safety of researchers and other staff.  For example, there have been protests and police violence in many countries as government officials seek to contain the spread of COVID-19. Medical professionals in several countries, including Mexico, Columbia, Brazil and the Philippines, have been attacked by individuals concerned about contracting COVID-19. In addition, there has been a documented increase in anti-foreigner sentiment worldwide, including in Cameroon, China, and Ethiopia.

    Many research projects benefit from exemptions or privileges available through MOUs with host governments. Institutions must confirm whether these MOUs will still be honored in light of COVID-19 challenges and whether MOUs have been impacted by changes in laws or other emergency measures in the host country as a result of the pandemic. In addition to confirming that MOUs are still in effect with regard to the host country signatory, institutions should also determine whether their MOUs present conflicts with the directives of any local or provincial health authorities, which can sometimes be inconsistent with national ministerial guidance.

    The availability of necessary supplies and disruptions to supply chains, particularly in LMICs, as a result of the pandemic will also need to be addressed. COVID-19 will likely have a long-lasting effect on global supply chains. The U.S. and more than 50 other countries are restricting or considering restrictions on, exports of supplies that are needed to mitigate the effects of COVID-19 locally. Internationally, the World Trade Organization and the World Customs Organization issued a joint statement noting the disruptive impact of COVID-19 on global supply chains and pledged to cooperate to facilitate trade in essential goods. The Global Fund is monitoring and assessing global health product supply chains on an ongoing basis. The Center for Infectious Disease Research and Policy of the University of Minnesota is monitoring ongoing supply chain issues.  WHO, the Global Fund, Wellcome Trust, and the Coalition for Epidemic Preparedness Innovations, among others, have created Access to COVID-19 Tools (ACT) Accelerator, a global collaboration to increase access worldwide to health technologies and related coronavirus response resources.

    Companies and institutions will also need to evaluate the terms of their institutional insurance policies to determine whether COVID-19 may have an impact on coverage for medical, travel, or liability claims that may arise. For example, many institutional medical and security evacuation policies do not cover activities in countries designated as a Level 4 risk by the U.S. State Department. Prior to the pandemic, only a few countries (e.g., Somalia, Yemen, Afghanistan, Syria, and the Central African Republic) were in this category. Currently, however, there is a U.S. State Department Level 4 Do Not Travel advisory globally. Likewise, other policies should be considered for language that may be implicated by COVID-19 and its effects on project coverage.

    In these times of increased global uncertainty, companies and institutions may also consider reminding employees and researchers that the organization’s compliance with the U.S. Foreign Corrupt Practices Act (FCPA) remains in full effect. The FCPA penalizes bribing or offering, authorizing, or promising to bribe foreign officials, and good motivations are not a defense to a violation. Many enforcement actions involve bribes paid for transactions that are beneficial both to the payor and the country in which the bribe was paid. Amid a global pandemic, the risk for corruption may be heightened because individuals may feel traditional rules preventing such behavior have been suspended, both in the United States and abroad.

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