OHSU Institutional guidance on collaboration and other activities with foreign entities

In August 2018, Francis Collins, director of the NIH, sent a letter to more than 10,000 research institutions across the U.S. The letter expressed concerns about foreign influence on researchers who are funded by or perform peer review for the NIH. Specifically, the NIH and other agencies that fund biomedical research are concerned on three fronts:

1. Protecting confidentiality in peer review (e.g., not sharing proposals, applications, or meeting materials)
2. Undisclosed foreign financial conflicts (or not fully disclosed during grant application, Just-In-Time, or award)
3. Undisclosed conflicts of commitment (such as other affiliations or positions that come with resources, whether financial or in-kind)
    

OHSU believes that international collaborations are critical for scientific progress

In speaking on the importance of international collaborations, Joe Gray, Ph.D., said:

At the same time, to be compliant with federal agencies and so OHSU can help you, it’s critical that you disclose the required information through the proper channels.

What you need to do

Faculty and staff responsibilities as outlined by both OHSU policy, NIH and other federal agency regulations mostly concern disclosure and reporting of foreign support, interests, and collaboration. The other area is traveling outside the U.S. and hosting international scholars, both short- and long-term.

For disclosure and reporting, you will need to:

• Report all research support, including foreign support, in accordance with sponsor requirements at the proposal stage, and in progress reports. (See NIH Grants Policy Statement Section 2.5.1).
• Assure your Conflict of Interest (CoI) disclosure is up to date, including disclosing outside activities in advance as described under the  "Disclosures" section below.
• Work with the appropriate OHSU offices.

For traveling outside the U.S. and hosting international scholars and reporting, you will need to:

• Understand the NIH’s prior approval requirements for a foreign component on an NIH award (See NIH Grants Policy Statement Section 8.1.2). 
• Work with the appropriate OHSU offices described under the “Foreign travel and foreign visitors” section below.

Disclosures

To protect yourself and your research, review the guidance provided by OHSU’s experts.

Office of Proposal & Award Management

OPAM is the “office of record” for all extramural funding at OHSU. Compliance of complex federal regulations is key to OPAM’s processes as it monitors and reports all OHSU members’ funding.

Key information that you need to provide:

• “Other Support”: Include ALL research projects, regardless of whether you devote effort (current or proposed) on your Other Support/Current and Pending Support. This includes support you receive through OHSU, directly to you, in direct support of your research (for example, lab space or materials from a foreign entity) or through a paid or unpaid appointment at another organization.
• Biosketch: Include significant international academic relationships (for example, academic appointments including courtesy appointments), collaborations or other professional activities.
• Update your OPAM contact when new collaborations or other outside activity with foreign entities arises after award of federal funds that was previously not disclosed.
• Proposal Submission to non-US Sponsor: As soon as you are aware that you want to submit a proposal to a non-US sponsor, let OPAM know. OPAM will review the guidelines and the sponsor and seek institutional approval if necessary. The goal is to keep your proprietary proposed research safe!
• If you have paid or unpaid appointments with resources at foreign institutions, be sure to have a discussion with your program officer to ensure full transparency and disclosure.  You will find that program officers are generally supportive of these collaborations and can offer advice when needed.

Learn more about the Office of Proposal & Award Managenment

OHSU Research Integrity Office – conflict of interest

Given increased scrutiny regarding foreign influence on intellectual property, there is an increased need for transparency. Similar institutions to OHSU have struggled with appropriate processes and disclosures and have suffered severe consequences for lack of transparency or process.

In general, you should: 

• Disclose appointments with other external organizations as outside activities on your CoI disclosure form. Your disclosures must include all work for or financial interests received from a foreign entity.
• Include any support in the form of lab space being provided by an external entity, or other remuneration such as living allowances to conduct research at a foreign entity.
• Note also that sponsored travel must also be reported by those with federal funding, if the amount of travel per entity exceeds $5000 in a 12-month period.  While US government agencies are exempt, foreign governmental agencies are not.

Further guidance: 
Learn more about the OHSU Research Integrity Office - Conflict of Interest
Conflict of Interest Disclosure Requirements
Conflict of Interest: Outside Activities

OHSU Technology Transfer

Technology Transfer’s goal is to protect your innovations and the intellectual property stemming from them. Here are a few steps you should take in advance of any interactions, collaboration or otherwise, with foreign entities:

• A Non-Disclosure Agreement or similar agreement protecting proprietary unpublished data and information should be entered into prior to any discussions or sharing of information.
• Prior to the start of any research collaboration, a Research Collaboration Agreement or similar agreement should be entered into in order to clearly identify the collaborative research to be conducted and the ownership and management of intellectual property.
• Any research materials or research data to be sent outside the United States must be preceded by the execution of an appropriate agreement (Material Transfer Agreement, Data Use Agreement, etc.)
• All departments at OHSU hiring new staff need to ensure that an OHSU Confidentiality and Intellectual Property Assignment Agreement is executed by the new staff member prior to or as soon as they begin employment with OHSU.
• Promptly disclose all forms of intellectual property to the office of Technology Transfer  as required under OHSU Policy No. 04-50-001, and remind your group members to do the same.

Learn more about OHSU Technology Transfer

Foreign travel and foreign visitors

If you are planning to travel to foreign countries, or if you are considering bringing foreign collaborators or visiting scholars to OHSU, here is guidance on maintaining compliance:

Export Controls

The Office of Export Controls at OHSU works to help faculty, students, researchers and staff navigate the increasingly complex environment of export regulations and laws in this evolving climate. Fortunately, many of the activities at OHSU are exempt from some of the more stringent rules and regulations. 

Here are the important things to do prior to travel or hosting: 

• Complete the Export Controls Travel form at least 30 days prior to travel outside the US. A list of equipment being taken (excluding laptops and cell phones) should be emailed to the Export Controls Officer separately, when applicable.
• OHSU members hosting foreign visitors must provide: Full name and nationality of the visitor, their host institution/employer, dates of visit, reason for visit, visa type, sources of funding, and areas of physical and electronic access.

Learn more about the Office of Export Controls

Risk Management

Risk Management provides a comprehensive risk management program that contributes to the health, safety and protection of faculty, staff, students, and visitors while also protecting OHSU’s physical and financial resources. 

To protect yourself while abroad and access OHSU resources:

• Off-Campus Authorization:  Complete the International Off Campus Authorization at least 30 days prior to travel outside the US.  Registration helps OHSU coordinate services in response to adverse events while traveling.  In addition, OHSU Policy requires all International travel on OHSU business be registered in order to receive travel reimbursement.
• On Call International: 
  • On Call assists during critical emergencies such as illness/injury that may require evacuation or during a political or natural disaster event that may threaten your safety.  On Call also provides Pre-Trip Information, Lost/Stolen Document Replacement and Translator services.  A full summary of benefits is emailed to travelers once they complete an International Off-Campus Authorization.
  • Add On Call to the mobile phone you’ll be using abroad. Send a text message to 444-999 that says OnCallOHSU and you’ll receive a link to easily add a digital content card right to your phone contacts in just a few taps.
• US Department of State
  • Review Travel Advisories to learn more about your destination Travel to countries or regions with a Level 3 or 4 Travel Advisory may be subject to further review by OHSU.
  • US Citizens:  Enroll in the Smart Traveler Enrollment Program (STEP) prior to travel in order to receive updates and enroll your trip with the nearest U.S. Embassy or Consulate
  • Non-US Citizens:  Check with your embassy or consulate for additional travel resources.
• Incident reporting:  Things can happen overseas that have broader implications for you and for OHSU.  Whether it’s an injury/illness that occurred while abroad, a computer suddenly acting strange, or anything in-between make sure to report it to someone at OHSU as soon as possible.  Risk Management, Public Safety, ITG, Occupational Health and HR are all available to discuss incidents that happen while traveling on OHSU business.

Learn more about Risk Management 

Office of International Affairs

The Office of International Affairs (OIA) will provide you and your collaborators with the appropriate Immigration paperwork to enter the U.S. and visit OHSU.

Be sure to contact OIA for these needs:

• Any foreign nationals planning to visit OHSU under an OHSU sponsored visa must have approval and paperwork from OIA to visit OHSU, regardless of the length of the visit.  This includes B-1s, ESTA (visa waiver applicants), J-1s, H-1Bs, TNs, E-3s, etc.
• Advice and resources on immigration questions/needs

Learn more about the Office of International Affairs

OHSU Office of Visitors & Volunteers

The Office of Visitors and Volunteers will help you bring collaborators on board. They will help you navigate the necessary registration process.

Be sure to contact OVV for these needs:

• Any visiting scientists planning to visit OHSU as part of a collaboration need to follow the policies, steps and processes identified by the OHSU Office of Visitors and Volunteers.

Learn more about the Office of Visitors and Volunteers

Protecting researchers and the institution

OHSU leadership has been closely monitoring the evolving national landscape and has engaged with peer institutions and advocacy groups, including AAMC and COGR, to stay abreast of the requirements necessary to protect the OHSU research community. While OHSU has significant controls and processes in place to protect the research community and the institution, the environment is changing rapidly and additional controls may be necessary for researchers, depending on the type and location of international collaboration.