Research Compliance News
02/03/17 - International Shipping
02/03/17 - Good Clinical Practice (GCP) Training Required for NIH Awardees Involved in NIH-funded Clinical Trials
12/01/16 - ORI Releases Updated Learning Modules and New Infographics Series
12/01/16 - Federal Lobbying Activities Report is Due January 5
11/01/16 - Strategies for Complying with Federal Public Access Policies
11/01/16 - Ethics in the Workplace: Helping Your Staff Make Good Decisions
10/01/16 - New Lecture Series on OHRP Website
10/01/16 - DD Form 2345 Militarily Critical Technical Data Agreement
09/01/16 - Not All Agreements Provide Funding
09/01/16 - 5 Ways Supervisors Can Promote Research Integrity
Most items, as well as some software and information, are subject to U.S. export controls. The impact of these controls on a particular shipment depends on the item, the country it's being shipped to, the entity or individual who will receive it, and the intended end use. There are additional U.S. restrictions on transactions — including but not limited to shipping — with certain countries, entities, and individuals. The fundamental research exception does not apply to physical shipments from the United States. When you export samples, equipment, or instruments abroad or take equipment or instruments with you on an airplane, ship, or boat to attend a conference or conduct research internationally, you are effectively exporting and are subject to certain restrictions and procedures. It is typically not what you know but what you don’t know that will delay customs clearance and can ultimately cost hundreds of thousands in export fines and penalties. In addition, most export violations or customs delays are unnecessary and caused by lack of information and preparation.
When exporting from the United States, make sure to verify the import and paperwork requirements in the destination country to ensure smooth customs clearance. You need to allow sufficient time for export processing and license determination. You should start by determining whether you need an export license to export your equipment/instrument/materials from the United States and help the University secure such license. It may take several months to process a license application.
FSU is the shipper of record, responsible for shipping correctly, and getting the paperwork right. FedEx, UPS, DHL, or a freight forwarder may help or offer advice, and they record the shipment in the government's Automated Export System, but if there's a problem, it's FSU’s problem, not theirs.
Some items are hazardous (biological materials, chemicals, batteries and fuel cells, radioactive materials, etc.), and need to be packaged and labeled appropriately. Please consult the FSU Safety Manual for additional guidance.
Bear in mind that every export from the U.S. is an import somewhere else — your shipment will need to go through Customs in the destination country. Some items may be prohibited or require prior authorization. Some items may incur duty or VAT costs. There are several ways to find the import requirements of the destination country. You can start with the receiving party who should be able to contact their local customs authorities or a customs broker to verify what documents will be needed to clear the shipment through customs. In addition, FedEx has a list of country import requirements on their website which can be helpful in determining import restrictions abroad: http://www.fedex.com/us/international-resource-center/profiles.html.
Exercise judgment when delegating any of the shipping and classification duties to a freight forwarder. Their business is to move freight and not to classify products and determine export license requirements. You should always know what it is that you export and determine whether you need an export license.
FSU requires that individuals responsible for shipping and/or receiving research materials must evaluate, for export control purposes, all items and associated documentation which are intended to be sent to foreign destinations.
The individual handling shipping and/or receiving is the final “gatekeeper” on all controlled outbound shipments from an anti-diversion[i] standpoint. Therefore, it is critical this individual understands the scope of the proposed export and has at his/her disposal all available information in the file (such as screening records and, where applicable, a copy of the export license) in which to make an independent judgment as to the compliance of the export. It is best practice for the individual shipping or receiving an item to double check the terms and conditions of a license against the ship-to instructions associated with a proposed export.
Likewise, when FSU receives items into inventory, certain regulatory requirements (customs and export controls) must be anticipated. For example, when an ITAR item is imported, the item will need to be handled consistent with ITAR physical security access restrictions.
For more information on export controls, please consult FSU’s Export Controls Compliance Plan
[i] Anti-diversion: The United States Bureau of Export Administration requires all exports to be shipped with a destination control statement that states the destination of the exported goods, and the law prohibits the goods from being diverted to any other destination.
National Institutes of Health Policy NOT-OD-16-148, effective January 1, 2017, establishes the expectation that all NIH-funded investigators and staff who are involved in the conduct, oversight, or management of clinical trials should be trained in Good Clinical Practice (GCP), consistent with principles of the International Conference on Harmonisation (ICH) E6 (R2).
GCP training may be achieved through a class or course, academic training program, or certification from a recognized clinical research professional organization. FSU Faculty, staff and students can sign up for the free Collaborative Institutional Training Initiative (CITI) for Good Clinical Practice course to obtain the applicable training. Registration and login instructions are published here.
Completion of GCP training will demonstrate that individuals have attained the fundamental knowledge of clinical trial quality standards for designing, conducting, recording and reporting trials that involve human research participants. GCP training should be refreshed at least every three years in order remain current with regulations, standards and guidelines. Recipients of GCP training are expected to retain documentation of their training.
Investigator: The individual responsible for the conduct of the clinical trial at a trial site. If a clinical trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator.
Clinical trial staff: Individuals, identified by the investigator, who are responsible for study coordination, data collection and data management. The central focus of clinical trial staff is to manage participant recruitment and enrollment, to maintain consistent study implementation, data management, and to ensure integrity and compliance with regulatory and reporting requirements. These individuals may also seek informed consent from prospective participants, enroll and meet with research participants, and collect and record information from research participants. Clinical trial staff may also be called the research coordinator, study coordinator, research nurse, study nurse or sub-investigator.
Questions about this training requirement may be addressed to Diana Key, Director, Research Compliance Programs.
The U.S. Department of Health and Human Services’ Office of Research Integrity has released a revised edition of its popular learning module, "Avoiding Plagiarism, Self-plagiarism, and Other Questionable Writing Practices: A Guide to Ethical Writing." They also updated their Basic Research Concepts learning module, which is designed to train research support staff who have little formal training in research.
Twelve new infographics are now available on topics related to the responsible conduct of research (RCR) and the handling of research misconduct. These infographics are designed to help young as well as experienced researchers to identify with their role in detecting and preventing research misconduct and promoting a culture of research integrity. They offer specific tips around delicate issues, such as knowing when, and how, to report questionable activity.
Federal regulations require that FSU report to the U.S. House and Senate all time and expenses related to federal lobbying activities conducted by its faculty and staff. To aid us in completing those reports accurately, employees who participate in federal lobbying related to University activities should report those activities to FSU’s Office of Federal Relations. The Federal Lobbying Activities Report covering the period October-December 2016 should be submitted to the Office of Federal Relations no later than January 5, 2017. To access the form and additional information, please visit the Federal Relations website.
Over the past few years, many major funding agencies have adopted new public access policies for funded research. This means that many faculty and grad students at FSU are now required to make journal articles and data sets derived from funding openly accessible as a condition of continued or future funding. Detailed guidelines for complying with these new policies are available in FSU’s Public Access and Research Data Management Policies.
Because funder public access policies are still relatively new, many journal publishers have not yet adjusted their publishing agreements to accommodate the new requirements. Consequently, FSU authors need to be diligent in reviewing their publishing agreements to ensure that they retain the right to make their journal articles publicly available within 12 months of publication. If a publishing agreement does not include this provision, then it is incompatible with the new funder requirements. Funded authors can use the following strategies to ensure that they do not enter into incompatible publishing agreements:
- Do not consent to a publishing agreement before closely reviewing the terms to ensure that applicable funder requirements can be met.
- If an agreement does not permit you to make your article available within 12 months of publication, contact the journal’s editors to explain that you are bound by funder requirements that are incompatible with the terms of the agreement.
- Request that the editors grant you permission to make the accepted version of your article available in accordance with the terms of your funder’s policy.
- Request that the editors revise their standard publication agreement to include a provision for other authors who are subject to funder public access policies.
- Point out that major academic journal publishers have already established best practices in this regard. (For instance, Wiley’s standard agreement includes language about compliance with funding agency policies and a link to information for authors on funder agreements.)
- Mention that it is in the publisher’s best interests to accommodate the new requirements, since doing so will ensure that the publisher can continue to solicit and publish article submissions from grant-funded authors.
- If the publisher is reluctant to accommodate the new requirements, contact your funding agency to ask if they would be willing to negotiate with the publisher on your behalf.
- For personalized assistance with reviewing the terms of publishing agreements and negotiating with publishers, contact Devin Soper (Scholarly Communication Librarian, firstname.lastname@example.org).
In addition to public access requirements for journal articles, almost all funding agencies also require researchers to submit detailed data management plans (DMPs) with new grant proposals. University Libraries' Data Services team is available for consultations and assistance in preparing DMPs that meet these new requirements. Additionally, FSU researchers can utilize DMPTool, which provides templates for DMPs by agency. Questions about data management can be sent to email@example.com or directed to Renaine Julian (STEM Data and Research Librarian, firstname.lastname@example.org).Questions about FSU or Federal policies may be directed to Diana Key (Director, Research Compliance Programs, email@example.com).
Do the right thing. Uphold our values. Always act with integrity. These are the kind of messages you’ll typically find in our code of conduct and compliance training. But what about those grey areas? Our training tells employees to ask for help anytime they encounter an issue they’re unsure about. However, before they ask, most people try to find the right path on their own. This is often where poor decision making can get organizations and individuals into trouble.
The good news is this: as a manager, you can help your employees avoid unethical business practices. And in fact, our training messages come to life when you reiterate them. Research has shown that people typically make poor decisions for one of four reasons: lack of understanding, pressure, lack of accountability and self-interest. Here are ways you can support your team in ethical decision making around each of these issues:
- Lack of Understanding: Employees may not recognize when they are dealing with an ethics or risk issue, or they may lack understanding of the rules and standards that apply. Sometimes, it can be simply not realizing their responsibilities in a sticky situation.
Remedy: Watch the news, check out blogs and talk to your team about the types of risks and ethical challenges that may occur in your organization. Pick one or two issues that are particularly relevant to your staff and the work they do. Work through the “what if” situation using our code and policies as guidance. This helps them walk through the process of ethical decision making in advance of a problem while demonstrating your willingness to help with a tough issue.
- Pressure: Time and performance pressure are part of today’s business world. However, pressure applied by management or peers to achieve an impossible deadline, or to do something that violates values or rules, can push good people to cross the line. Inappropriate incentives can do the same thing.
Remedy: Keep an eye on the pressure meter in your workgroup and any extraordinary incentives to “get the numbers” or “have zero safety incidents.” Verbalize to your staff, often, that there is no justification for misconduct.
- Not Enough Accountability: Inconsistent discipline for misconduct sends the message that our organization is not serious about doing the right thing. Discounting future consequences in favor of immediate gain is a risk when there does not seem to be accountability for making ethical decisions.
Remedy: Make sure to take corrective action consistently when needed. And when you educate your team on the issues they may encounter, be sure to emphasize the consequences of bad behavior—both short and long term.
- Self Interest: It is, unfortunately, human nature to believe that we are smarter, more deserving and better than we really are. In the workplace, this can lead to a “slippery slope” situation where someone rationalizes doing just one small bad thing, which makes the next bad decision easier, and so on. By his own admission, this type of thinking landed Andrew Fastow of Enron fame in jail for many years.
Remedy: Talk with your staff about the human frailties we all share, and do it often. Awareness of a temptation can be built through periodic repetition of the potential risk.
It’s easy to overlook the good decisions being made in your work group. Make a point of looking for these and mentioning them in staff meetings. Such decisions make good instructional moments—and the person who did the right thing will appreciate the kudos.
The Office for Human Research Protections’ Division of Education and Development has launched its new Luminaries Lecture Series, featuring talks by esteemed individuals with thought-provoking insights on human subjects research protections. The series is intended to be of broad interest to investigators and IRB professionals, as well as anyone involved in human subjects research. Some of the featured lectures include: (1) Dr. Celia Fisher on “Ethics and Social Justice in Health Research Involving Vulnerable Adolescents” and (2) Dr. Richard Gorman considering the question “How Do You Know What You Think You Know?”
The United States and Canada have agreed that the Joint Certification Program (JCP) certification process (DD 2345) can be used to facilitate visits to U.S. or Canadian military installations that involve access to unclassified technical data (e.g., Directly Arranged Visits). Activities intended to be covered through the Directly Arranged Visit process include:
- Attendance at restricted meetings, conferences, symposia, or program briefings where technical data governed by Department of Defense (DOD) Directive 5230.25 or Canadian Technical Data Control Regulations will be presented.
- Procurement activities such as pre-solicitation conferences.
- Discussions related to unclassified solicitations.
- Collection of procurement unclassified documents (RFQ's, RFP's, bid sets, etc.) .
- Performance of an unclassified contract.
- Scientific research, in a professional capacity, in support of unclassified U.S. or Canadian defense initiatives.
It is the JCP’s procedure to have each university represented by a single JCP Certification. Therefore, FSU’s certification is maintained by FSU’s Office of Research Compliance Programs. Please contact the Director, Diana Key, to obtain a copy of FSU’s JCP Certification (DD2345) for your visit. Faculty and departments are not to apply to the JCP for individual certifications.
Researchers often collaborate on research or share research tools with other scientists or institutions without receiving or providing funding. For many unfunded collaborations, a formal agreement is beneficial or necessary. Often these agreements are incorporated (by attachment or reference) within funded agreements. It is important to note that an unfunded agreement may involve the provision or exchange of something of value, and the relevant department will need to determine whether what FSU provides under the agreement is commensurate in value with what it is receiving. Further, unfunded agreements sometimes contain restrictive language that may conflict with basic academic rights, intellectual property rights, and/or other terms that must be negotiated. All unfunded agreements are legal contracts between two parties; therefore, faculty members, chairs, and deans do not have the authority to sign these agreements on behalf of the University. Please visit https://www.research.fsu.edu/research-compliance/unfunded-agreements/ to see a matrix of agreements and which person/office handles them.
Health and Human Services’ Office of Research Integrity has published a new infographic titled, “5 Ways Supervisors Can Promote Research Integrity.” While these five tips may seem obvious, printing and posting this infographic in research labs would be a good visual reminder when working with research trainees. Number 5 on the list is “Know Your Research Integrity Officer.” FSU’s Research Integrity Officer is the Director of the Office of Research Compliance Programs, Diana Key. The infographic may be found at https://ori.hhs.gov/blog/new-infographic-5-ways-supervisors-can-promote-research-integrity.