uconn health

Export Control

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.

ClinicalTrials.gov

Over the past two decades, government agencies and the International Committee of Medical Journal Editors (ICMJE) have issued laws and directives on the subject of clinical 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 Medicine.

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 Health is committed to supporting Principal Investigators (PIs) with meeting the requirements concerning the public availability of clinical trial data in ClinicalTrials.gov, as outlined in our University ClinicalTrials.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,” regardless of funder, 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 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.

According to the FDA/NIH:

Penalties may include civil monetary penalties up to $14,724 fine for failing to submit or for submitting fraudulent information to ClinicalTrials.gov. After notification of noncompliance, the fine may go up to $14,724 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?

To comply with University policy regarding ClinicalTrials.gov, please direct any questions to the local Protocol Registration and Results System (PRS) Administrator for UConn/UConn Health, Ellen Ciesielski, Research Integrity & Compliance. The local PRS Administrator serves as a point of contact for resolving requests by ClinicalTrials.gov and regularly monitors to promote compliance with the requirements.

Responsible Conduct of Research

The mandate of the RCR Office within Research Integrity & Compliance is to promote the responsible conduct of research at UConn and UConn Health. The program’s mission is to educate and participate in an ongoing dialogue to create an environment of robust, ethical performance of all research activities, including conflict of interest, mentor/mentee relationships, safety in research and research environments, collaborative research, peer review, data acquisition and analysis, secure data use and confidentiality, and responsible authorship and and publication. In support of this commitment and to fulfill funder requirements, UConn offers Responsible Conduct of Research (RCR) training and education with the goal of engaging researchers in the exploration of best ethical practices. Projects funded by the National Science Foundation (NSF), National Institutes of Health (NIH), and National Institute of Food and Agriculture (NIFA) have specific requirements regarding training in RCR.    

Faculty Consulting

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.

Stem Cell Research Oversight (SCRO) Committee

The role of the UConn/UConn Health Stem Cell Research Oversight (SCRO) Committee is to ensure that human embryonic stem cell (hESC) and human induced pluripotent stem cell (hiPSC) research is well-justified and that inappropriate and/or unethical research is not conducted. Its mandate is to provide oversight of ethical issues related to the derivation and research use of human pluripotent stem cell lines at all schools, colleges, campuses, and research arms of the UConn/UConn Health per University policy, regardless of the source of funding. From a legal perspective, the review and approval of human embryonic stem cell research by a SCRO committee or its equivalent is required by the State of Connecticut. At a deeper level, SCRO committees exist to protect both the public interest and the progress of biomedical stem cell research. The ethical mandate of the SCRO Committee is to ensure that appropriate respect is given to the value of human life. 

SCRO approval is required prior to any of the following:

  1. All research involving human embryonic stem cells (hESCs) (SCRO approval is required by the State of Connecticut and University policy.)
  2. In vitro human induced pluripotent stem cell (hiPSC) research involving the generation of gametes, embryos, or other totipotent cells (SCRO approval is required by University policy.)
  3. In vivo research involving introduction of human induced pluripotent stem cells (hiPSC) directly into prenatal animals or into the central nervous system of post-natal animals or elsewhere in the animal where cells could potentially enter the central nervous system (SCRO approval is required by University policy.)
  4. Stem cell research project funded by the State of Connecticut through the Connecticut Bioscience Innovation Fund, including those that do not use human embryonic stem cells (SCRO approval is required by the State of Connecticut.docx.)
  5. All research involving the development of brain or neural organoids or embryo organoids using hESCs or hiPSCs
  6. All research involving Very Small Embryonic-Like (VSEL) stem cells

 

 

Limited Submission Policies

Limited Submission Process Overview

Increasingly, funding programs sponsored by federal agencies and private foundations place restrictions on the number of applicants from a single institution who are allowed to submit proposals/applications. These limited submission grants or awards require selection/nomination by the applicant’s host institution before proposals/applications can be submitted. At UConn/UConn Health, the selection process for limited submission awards is facilitated by the Office of the Vice President for Research (OVPR), and it is governed by the following guidelines. In order to ensure a fair and competitive selection process, the OVPR requires all investigators interested in limited submission funding to follow this process.

  1. Program advertisement: When the OVPR becomes aware of an upcoming limited submission funding opportunity, a request for proposals (RFP) will be released to notify the University community. The RFP will be posted on the OVPR website, sent out via the Storrs Daily Digest and UConn Health Lifeline email digest, and distributed to key grant administrators via listserv. If you become aware of a limited submission opportunity, please check the OVPR website to find out program-specific details and important internal deadline dates. If the opportunity is not yet listed on the website, please send an email to research@uconn.edu describing the program, including a link to the program announcement if possible. The OVPR will announce the program to the wider community, if appropriate, or will give you other instructions regarding how to proceed.
  2. General application guidelines: For most limited submissions, a two stage internal competition is held.
    • Stage 1 is the Notification of Intent to Submit (NOI). NOIs are used to determine the level of interest within the UConn/UConn Health community for a given opportunity. If there are more potential applicants than allowed under the program guidelines, the internal competition will proceed to Stage 2. A Notification of Intent to Submit is required for all limited submission RFPs, unless specified in the OVPR announcement. The NOI form is brief, and the information provided is not used in the selection process other than to gauge interest and to help select internal reviewers.  NOIs are submitted through the UConn Quest Portal as of January 2019
    • Stage 2 is the internal review of pre-proposals. If Stage 1 reveals that an internal competition is necessary, all NOI participants will be required to submit a pre-proposal (using the Quest Portal).  We provide general guidelines for pre-proposals (see pre-proposal guideline section below), though the specific requirements can vary from program to program. Please contact the OVPR at research@uconn.edu or 860.486.6378 if you have questions about what is required for a given opportunity. Pre-proposals are reviewed and rated by an ad-hoc faculty committee organized by the OVPR consisting of faculty members experienced in grant submission and familiar with the area of research addressed for a given opportunity. When necessary, external reviewers will be utilized as well. Final selections are made by the Vice President for Research based on the results of the faculty review.
    • All participants will receive notification of the results (and reviewer feedback, when available) at the conclusion of the review. Selected investigators will be given the go-ahead to complete full-length proposals according to sponsor guidelines. Final proposals must be submitted to Sponsored Program Services (SPS) at Storrs or UConn Health for final internal review at least 5 business days before the sponsor’s deadline. SPS will conduct a final review and provide instructions for submitting the proposal to the sponsor.

Contact: For questions about limited submission opportunities or internal reviews, please contact Dr. Matt Mroz, Internal Funding Coordinator, at research@uconn.edu or 860.486.6378.

Limited Submission Resubmission Policy

The Office of the Vice President for Research (OVPR) is aware that for many funding mechanisms, one attempt at submission is not enough.  In order to be successful, PIs must have the opportunity to learn from and respond thoughtfully to reviewer feedback.  Because of this, we recognize the need for the limited submission selection process to strike a balance between allowing previously selected PIs to resubmit and allowing PIs with new projects an opportunity to submit.

Therefore, the OVPR is establishing the following policies to guide review teams and to set expectations for PIs who submit for limited submission opportunities.  While we expect that most competitions will follow these guidelines, please note that the VPR reserves the right to select the applicants that best meet the needs of the University.

Limited Submission Resubmission Guidelines:

  1. For mechanisms that allow more than one UConn applicant, each PI that submits to the sponsor will be allowed to resubmit the same project at least one additional time within two years of the original submission without being required to re-compete for a submission slot.
    1. If reviews are provided by the sponsor, resubmission is contingent upon receiving promising feedback.
    2. Applications that are rejected because of missing elements or eligibility questions cannot be resubmitted automatically.
    3. PIs must communicate their desire to resubmit to the OVPR Internal Funding Coordinator in a timely manner.
  2. For mechanisms that allow only one UConn applicant, resubmitting applicants must re-compete for a submission slot unless a previously submitting PI receives very strong feedback and contacts the OVPR regarding resubmission before a new internal competition is opened.
  3. Limited Submission Awards (those mechanisms that are judged on the PIs record of accomplishment rather than the quality of proposed research), resubmitting applicants must re-compete for a submission slot.
  4. Limited Submission applicants that are not chosen through an open competition (i.e. applicants who are nominated by deans, department heads, or other senior administrators) are not guaranteed resubmission.
  5. If a Limited Submission program cycle includes resubmitting applicants, the OVPR may allow other strong applicants from that cycle’s internal competition who are not selected the option to submit to the next cycle without competing again.
  6. Note: Internal competition notification emails will include language regarding whether resubmission is allowed or not in particular circumstances

Limited Submission Pre-proposal Guidelines

If an internal competition is necessary to select applicants for a limited submission opportunity, pre-proposals will be submitted via the UConn Quest Portal.  Unless other instructions are given in the UConn limited submission announcement, pre-proposals should include:

1. Cover page, to include:

  • Complete contact information for the applicant
  • Sponsor
  • Name of program
  • Title of project

2. Maximum two-page summary describing the project and demonstrating how it will:

  • Fulfill the program/solicitation criteria
  • Contribute to meeting the research and/or educational goals of the institution.

3. Maximum two-page budget (if applicable) and budget justification, or summary of costs, including cost sharing commitment required in the solicitation. If a cost sharing commitment is required by the Sponsor, a letter of support is required from the Dean/Department Head as to how this commitment will potentially be achieved.

4. Maximum two-page list of investigators, summarizing credentials and role in the project.  Brief CVs are also acceptable.

5. Optional maximum two-page attachment containing any additional relevant information.  For example, if a proposal is a resubmission, a summary of available comments/reviews can be attached

Please adhere to these guidelines, unless otherwise directed by the OVPR.  Pre-proposals will be reviewed by an internal screening committee with respect to program eligibility and criteria. Reviewers may, or may not, return comments.  Principal Investigators will be notified of approval to submit.

Final proposals are due to the Sponsored Program Services, Storrs or the Office of Research and Sponsored Programs, UConn Health, a minimum of 5 working days prior to the sponsor’s deadline for final review prior to submission.

Research IT eRA Help Desk

Research IT Services in the Office of the Vice President for Research supports a wide array of services and is a key player in shaping the future of research at the University of Connecticut including UConn Health.

We have embarked on a bold initiative to modernize and boost our portfolio of software solutions in an effort to reduce the administrative burdens on our researchers and make it easier for them to access and monitor their research activity and information.

A full suite of enterprise applications will provide a template for grant proposal development, automate routing and allow for electronic submission to certain sponsors. In addition, it will provide functionality for awards management; human and animal subjects protocol development and review; financial conflict of interest disclosures; effort reporting and commitment management; and core facility management (research store).

eRA Help Desk

We have coined our initiative to modernize our Enterprise Research IT systems and automate research administration functions the Electronic Research Administration, or eRA. We have created the eRA Help Desk to assist you with your questions and technical problems. The Help Desk contact info is listed below.

 

eRA Help DeskeRA Help Desk

Telephone: 860.486.7944
Email: eRA-support@uconn.edu
Staffed 8:00 AM – 4:30 PM Weekdays

 

Self-Service Portal: https://it.research.uconn.edu/SelfService/ (secured with NetID)
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