The mission of the Office of University Compliance is to assist the University and UConn Health in achieving their financial, operational and strategic goals while maintaining compliance with all associated laws and/or regulations.

The Office of University Compliance accomplishes this goal by identifying institutional risks; performing audits, reviews and investigations; augmenting institutional compliance through effective education and training programs; and fostering the values of knowledge, honesty, integrity, respect and professionalism as outlined in the University’s Code of Conduct.

To register your study on ClinicalTrials.gov:

1. 1. Request the creation of a user account for the ClinicalTrials.gov Protocol Registration and Results System (PRS) by emailing Ellen Ciesielski, UConn/UConn Health’s ClinicalTrials.gov Administrator.
      • A record can have only one “Owner” who may be the Principal Investigator (PI) or may be someone designated by the PI to create/update the record on his/her behalf. The PI will always log in to perform the final review and approval of the record and each subsequent update.
   2. Receive your username and a temporary password by automated email from the PRS System.
   3. Go to the Clinicaltrials.gov Registration log-in page to enter your username, password and Organization. In the Organization field, enter “UConn.”
   4. On the Main Menu page, under “Records” click on “New Record” from the drop down menu. The system will walk you through the creation of your record, section by section. On each page, select “Continue” to save data entered and proceed to the next page. On any page, select “Quit” to stop entering data. Data entered on previous pages will be retained so that you can return to complete the record at a later date.

As the Principal Investigator (PI), or PI designee, you are the Record Owner and are responsible for entering accurate information about your trial and updating the information in a timely manner (see table below for specific deadlines).

Complete the below fields as follows:

1. 1. • Organization’s Unique Protocol ID: Enter the IRB number.
      • Secondary IDs: Enter the grant number.
      • Record Verification Date: Enter the month and year in which you are completing the record. This field will need to be updated each time you update the record after it is registered.
      • Primary Completion Date: Enter the anticipated final data collection date, specifically regarding the Primary Outcome Measure.
      • Responsible Party: Select the Principal Investigator from the drop down menu.
      • Collaborators: Add any other organizations providing support, including funding, design, implementation, data analysis and reporting.

1. 1. • Board Name: University of Connecticut IRB
      • Board Affiliation: University of Connecticut
      • Board Contact phone and e-mail: Doug Bradway doug.bradway@uconn.edu 860.486.0986
      • Board Contact Address: UConn IRB, 438 Whitney Road Extension, Unit 1246, Storrs, CT 06269

To remain in compliance with the Final Rule, update the data fields on the scheduled detailed in the table:

The InfoEd portal is secured with your UConn NetID single sign-on. If you have forgotten your NetID or password, call the University Information Technology Services (UITS) Service Desk at 860.486.4357 or email at helpcenter@uconn.edu. You can also access the NetID website (https://netid.uconn.edu) to obtain your NetID and change/reset your password.  

How To: Change Your InfoEd (NetID) Password
How To: Reset You Forgotten InfoEd (NetID) Password

Basic InfoEd Access

The InfoEd eRA portal is secured with the UConn NetID single sign-on. All users are required to have a valid UConn NetID. UConn faculty and staff including UConn Health faculty and staff are automatically set up with an account. Graduate students and external users (e.g. UConn affiliates) should request access after obtaining an UConn NetID through University Information Technology Services (UITS).

1. If you have an UConn NetID, first try to see if you can login to the InfoEd eRA system at https://www.infoed.uconn.edu.  If you are trying to access the UConn Health instance of InfoEd please login at https://uchealth.infoed.uconn.edu.
2. If you cannot login, make sure you are using your correct NetID and password combination or your correct username and password. Consult the https://netid.uconn.edu website tools to verify your NetID and password credentials or contact the eRA Help Desk at 860.486.7944.
3. Faculty may also add undergraduate students to InfoEd using a new automated process

If you still cannot access the InfoEd eRA portal after verifying your correct credentials and attempting to login, contact the eRA Help Desk at 860.486.7944 to verify that you have an account on the particular system. If you do not have an account or you need additional permissions, you can request access by completing the eRA Access Request Form.

Account Access Request Form

This form is also used if you are requesting additional security permissions for InfoEd (e.g. a Department Administrator requesting view access to proposals/protocols/accounts in his/her department or school) or another system. It is also for revoking access. You may type directly on the form and print it. The form must be signed by the applicant/requester and the applicant’s/requester’s supervisor and scanned or emailed to era-support@uconn.edu.

• Account Request Form – A fillable PDF file

Potential conflicts may occur when a University employee hires a student in any non-University supported activity. Therefore, University employees who choose to employ students in any non-University activity must disclose the intent to do so in writing, prior to employing the student.

This disclosure should be made in writing to the Department Head/Dean or the appropriate University official.

Please review the complete policy on Use of Students in Outside Employment.

Websites

• • Council On Governmental Relations (COGR)
  • Higher Education Compliance Alliance
  • AUECO – Association of University Export Control Officers
  • Higher Education and National Security – FBI
  • Export Law Blog
  • White House Directive on Fundamental Research – National Security Decision Directive 189

PowerPoint Presentations and Audio Presentations

• • 2013: The Impact of Export Controls on Higher Education Scientific Institutions Conference
  • COGR Deemed Export Controls Presentation
  • BIS Essentials of Export Controls

Export Administration Regulations (EAR)

• U.S. Department of Commerce
• Commerce Department Export Controls
• Commerce Control List Index

International Traffic in Arms Regulations (ITAR)

• U.S. Department of State
• ITAR Regulations and Reference

Office of Foreign Assets Control (OFAC)

• U.S. Department of Treasury ~ Office of Foreign Assets Control
• List of Specially Designated Nationals and Blocked Persons

The University of Connecticut has implemented mandatory export control training for UConn researchers involved in any research that is export controlled.

As a result, any UConn investigator listed as project personnel for a grant, contract, or cooperative agreement where export control regulations apply must complete export control training certification prior to starting any work on that project.  Such certification is valid for one (1) year from the date the training is completed.  Certification must be completed annually if the investigator is still personnel on a project where export control regulations apply.

The training is available online and offered through the CITI Program.  The Export Control Course offers eleven modules.  They are:

Introduction to Export Compliance (ID: 16800)
Export Compliance for Researchers: Part I (ID: 16801)
Export Compliance for Researchers: Part II (ID: 16802)
Export Compliance for Research Administrators (ID: 16803)
Export Compliance and Biosafety (ID: 16805)
Export Compliance for Operational Departments (ID: 16806)
Export Compliance for International Shipping (ID: 16807)
Export Compliance and Purchasing (ID: 16808)
Export Compliance and International and Foreign Waters (ID: 16809)
Export Compliance and Collaborations (ID: 16810)
Export Compliance and United States Sanctions Programs (ID: 16812)

You will need to complete three modules to meet the training requirement. 

Under Required, complete Introduction to Export Compliance (ID: 16800).
And under Supplemental, complete:
Export Compliance for Researchers: Part I (ID: 16801).
Export Compliance for Researchers: Part II (ID: 16802)

You may be required to complete other modules based on the nature of the regulations that apply to your research project.  Research Integrity and Compliance Services will let you know if additional modules are required.

Once the required training certification has been completed, you will have met your export control training requirements for the year.  Please make a note of the date of the certification as you will be required to complete the training again prior to the annual expiration date.

Policy

UConn’s Export Control Policy can be found here.

Guidelines

These guidelines and sample documents are designed to determine if the EAR or the ITAR affect a particular research project, and to take appropriate action to ensure compliance with the Federal Export Control regulations.

• Decision Tree: Overview of Process
• Export Control Compliance Package (Blank)
• Investigator Compliance Letter (Sample)
• Final Compliance Report (Sample)

Marking Documents

In order to ensure that items are appropriately identified as EAR or ITAR controlled, the following processes will be implemented for all hardcopy or electronic documents that contain EAR or ITAR controlled Technical Data:

The following statement shall be included on the cover page, sleeve, or cover of any design file, software disc, or document (hardcopy or electronic) containing EAR or ITAR controlled Technical Data:

This document contains technical data whose export is restricted by the Arms Export Control Act (Title 22, U.S.C., Sec 2751, et q.) or the Export Administration Act of 1979, as amended, Title 50, U.S.C., App. 2401 et seq. Violations of these export laws are subject to severe criminal penalties.

Include the appropriate following statement in the footer on each page of design files or documents (hardcopy or electronic) which contains EAR or ITAR controlled Technical Data:

This page contains EAR Restricted Data.

This page contains ITAR Restricted Data.

Export control laws are federal regulations that govern how certain information, technologies, and commodities can be transmitted overseas or to a foreign national on U.S. soil. The scope of the regulations is broad: they cover exports in virtually all fields of science, engineering, and technology and apply to research activities regardless of the source of funding. Failure to comply with these laws can have serious consequences, both for the institution and for the individual researcher. Potential penalties include fines and possibly imprisonment. It is thus critical for UConn researchers to understand their obligations under these regulations and to work with Research Integrity and Compliance Services to ensure that the University is in compliance.

The International Traffic in Arms Regulations (ITAR) regulate defense articles, services, and related technical data that are identified on the Munitions Control List. They are administered by the Department of State. The Export Administration Regulations regulate the export of dual use items, i.e. items with both military and commercial applications, identified on the Commerce Control List. They are administered by the Department of Commerce. The Office of Foreign Assets Control Regulations (OFAC Regulations) regulate economic trade with foreign countries and administer the statutory economic trade sanctions imposed against several foreign countries. They are administered by the U.S. Department of the Treasury, through the Office of Foreign Assets Control.

Material on this website is intended to assist faculty and staff in understanding the regulations. Furthermore it outlines UConn guidelines and procedures that are designed to ensure compliance.

If you have any questions about Export Control, please email exportcontrol@uconn.edu.

Over the past ten years, government agencies and the International Committee of Medical Journal Editors (ICMJE) have issued laws and directives on the subject of trial registration. All parties have consistently agreed that the purpose of trial registration is to promote the public good by ensuring that the existence and design of clinical trials are publicly available. The registration effort began with the development of a publicly available website, ClinicalTrials.gov, a service of the National Institutes of Health (NIH), developed by the National Library of Congress.

In 1997, the Food and Drug Administration (FDA)/NIH began requiring registration for only a limited number of trials. Then in September 2007, the FDA Amendments Act (Title VIII. Sec. 801) significantly expanded the scope of clinical trials that must be registered and set civil monetary penalties for failing to register “applicable trials.” In 2004, the ICMJE defined trials that must be registered in order to be considered for publication in journals that adhere to ICMJE standards. In 2007, the ICMJE expanded the definition of trials that must be registered. Scores of journals (not limited to medical journals) have adopted the registration policy. In 2016, the final rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11), which clarifies and expands the requirements in FDAAA 801, was released, and the NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information was published.

The bottom line:
The FDA, NIH and the ICMJE each have their own requirements for registration, and while some of the requirements overlap, there are some differences. In order to comply with the law and preserve the ability to publish in many journals, all sets of requirements must be met. UConn is committed to compliance with the regulations of the FDA, NIH and ICMJE in supporting Principal Investigators (PIs) with meeting the requirements concerning the public availability of clinical trial data in ClinicalTrials.gov, as outlined in our University ClincalTrials.gov policy.

How is “clinical trial” defined and what are the registration deadlines?

According to NIH:

A clinical trial is a research study¹  in which one or more human subjects² are prospectively assigned³ to one or more interventions⁴ (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.⁵  All clinical trials must be registered within 21 days of enrollment of the first participant.

¹See Common Rule definition of research at 45 CFR 46.102(d).

²See Common Rule definition of human subject at 45 CFR 46.102(f).

³The term “prospectively assigned” refers to a pre-defined process (e.g., randomization) specified in an approved protocol that stipulates the assignment of research subjects (individually or in clusters) to one or more arms (e.g., intervention, placebo, or other control) of a clinical trial.

⁴An intervention is defined as a manipulation of the subject or subject’s environment for the purpose of modifying one or more health-related biomedical or behavioral processes and/or endpoints.  Examples include:  drugs/small molecules/compounds; biologics; devices; procedures (e.g., surgical techniques); delivery systems (e.g., telemedicine, face-to-face interviews); strategies to change health-related behavior (e.g., diet, cognitive therapy, exercise, development of new habits); treatment strategies; prevention strategies; and, diagnostic strategies.

⁵Health-related biomedical or behavioral outcome is defined as the pre-specified goal(s) or condition(s) that reflect the effect of one or more interventions on human subjects’ biomedical or behavioral status or quality of life.  Examples include:  positive or negative changes to physiological or biological parameters (e.g., improvement of lung capacity, gene expression); positive or negative changes to psychological or neurodevelopmental parameters (e.g., mood management intervention for smokers; reading comprehension and /or information retention); positive or negative changes to disease processes; positive or negative changes to health-related behaviors; and, positive or negative changes to quality of life.

Registration Deadline: The NIH Policy on Dissemination of NIH-funded Clinical Trial Information applies to applications for funding submitted to NIH on or after 1/18/17. Registration is required no later than 21 days after the first patient is enrolled. The consent form for the trial is required to include the following language: “A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law.  This Website will not include information that can identify you.  At most, the Website will include a summary of the results.  You can search this Website at any time.”

According to the ICMJE:

A clinical trial is any research project that prospectively assigns people or a group of people to an intervention, with or without concurrent comparison or control groups, to study the cause-and-effect relationship between a health-related intervention and a health outcome. Health-related interventions are those used to modify a biomedical or health-related outcome; examples include drugs, surgical procedures, devices, behavioral treatments, educational programs, dietary interventions, quality improvement interventions, and process-of-care changes. Health outcomes are any biomedical or health-related measures obtained in patients or participants, including pharmacokinetic measures and adverse events. Those who are uncertain whether their trial meets the expanded ICMJE definition should err on the side of registration if they wish to seek publication in an ICMJE journal.

Registration Deadline: Registration at or before the time of first patient enrollment is as a condition of consideration for publication in an ICMJE journal.

According to the FDA:

The U.S. Department of Health and Human Services in September 2016 issued a final rule that specifies requirements for registering certain clinical trials and submitting summary results information to ClinicalTrials.gov. The new rule expands the legal requirements for submitting registration and results information for clinical trials involving U.S. Food and Drug Administration-regulated drug, biological, and device products. The FDA Amendments Act (Title VIII. Sec. 801) requires registration for all “applicable clinical trials,” including Federal, industry-sponsored, and investigator-initiated that are:

1. Trials of drugs and biologics: Controlled, clinical investigations, other than Phase I investigations, of a product subject to FDA regulation, and
2. Trials of devices: Prospective clinical studies of health outcomes comparing an intervention with a device against a control in human subjects (other than small clinical trials to determine the feasibility of a device, or clinical trials to test prototype devices where the primary outcome measure relates to feasibility and not to health outcomes); and pediatric postmarket surveillance studies, as required under the Federal Food, Drug and Cosmetic Act.

Registration Deadline: The FDA Amendments Act of 2007 requires that all trials, regardless of sponsor, must be registered in full no later than 21 days after the first patient was enrolled.

Who is responsible for registering a trial?

The Principal Investigator (PI) is ultimately responsible for determining that registration requirements are met. Although some industry sponsors will do the actual registration work, it is still the PI’s responsibility to ensure that the registration has been accomplished and is accurate.

What are the penalties for failing to register?

According to the ICMJE:

Unregistered trials will not be considered for publication in journals that adhere to ICMJE standards. Questions about policies of a specific journal should be addressed to that journal directly. A list of journals whose editors or publishers have signed on to the ICMJE Uniform Requirements for Manuscripts Submitted to Biomedical Journals may be found at http://www.icmje.org/journals.html.

According to the FDA/NIH:

Penalties may include civil monetary penalties up to $14,262 fine for failing to submit or for submitting fraudulent information to ClinicalTrials.gov. After notification of noncompliance, the fine may go up to $14,262 per day until resolved. For federally funded grants, penalties may include the withholding or recovery of grant funds.

Who can help with questions about meeting the requirements?

Please contact the local Protocol Registration and Results System (PRS) Administrator for UConn/UConn Health, Ellen Ciesielski, Office of the Vice President for Research, Research Integrity & Compliance at 860.679.6004 for any questions related to ClinicalTrials.gov. The PRS Administrator serves as a point of contact for resolving requests by ClinicalTrials.gov and regularly monitors to promote compliance with the requirements.

Consulting is a time honored and frequent activity of faculty throughout U.S. research universities.  The ability to consult is important in promoting recruitment and retention of faculty of the highest quality. Often, such consulting activities provide a range of benefits including fostering economic development, enhancing the reputation of the University, promoting faculty development and enhancing the faculty’s ability to bring to the classroom current and relevant “real world” experiences, among others.

Consulting is an activity performed by a faculty member for compensation as a result of his/her expertise or prominence in his/her field while not acting in his/her official capacity as a State employee (i.e. in his/her own time.) The University’s Laws and Bylaws prohibit faculty from consulting on “time due to the University.”

Visit the UConn Faculty Consulting Website for faculty consulting requests and other resources.