Health Center Research Advisory Council
UConn Health
263 Farmington Avenue
Farmington, CT 06030-6403
For questions or comments about the HCRAC please contact one of the following individuals.
| Name | Title | Phone | |
|---|---|---|---|
| Christopher Heinen | Council Chair | (860) 679-8859 | cheinen@uchc.edu |
| Stephanie Holden | HCRAC Coordinator | (860) 679-2513 | sholden@uchc.edu |
This program has been established to support travel costs for postdoctoral fellows who present research results in-person at scientific meetings and symposia. The program will support costs of that travel up to a limit of $700 per fiscal year. Note, HCRAC travel funds cannot be combined with any other UConn travel support.
Awards are made on a first-come, first-served basis, until the funds for this program have been exhausted.
If there are any questions about this travel grant program, please contact Stephanie Holden at 860.679.2513 or sholden@uchc.edu.
The UConn Health InfoEd is an enterprise-level, web-based application designed to manage all activities related to the management and execution of the research project life cycle – from cradle to grave. The system comprises a suite of modules, each designed to manage a specific aspect of the research project cycle. These include: proposal development and submission to the funding entity during the pre-award phase (Proposal Development – PD) ; proposal tracking and management in the post-award phase (Proposal Tracking – PT); human research protocol application management (Human Subjects Management – HSM); lab animal protocol application management (Lab Animals Management – LAM); environmental safety management (Environmental Safety Management – ESM); intellectual property management (Technology Transfer – TT); and clinical trial management, case report form (CRF) design, and scientific data collection and management (Clinical Trials Management – CTM). Modules currently installed at UConn Health include:
ResearchMatch.org is a national online recruitment tool for health research, funded by the National Institutes of Health and maintained at Vanderbilt University. ResearchMatch connects health researchers with individuals interested in volunteering, through its secure online matching tool. UConn Health is part of the ResearchMatch Network. There is no cost to UConn Health researchers to use ResearchMatch. There are currently over 120,000 registered volunteers across the country. ResearchMatch is also now available in Spanish and simplified Chinese.
To see if ResearchMatch might be a useful recruitment tool for your health-outcomes research study, use this link to register: https://www.researchmatch.org/researchers/. You do not need to be a Principal Investigator to register. The registration process takes less than 10 minutes. Once registered, you will be granted “feasibility access” to search volunteer aggregate data, including geographic and health demographics. Please note that you may not use ResearchMatch to recruit for a registry.
For questions about how to use ResearchMatch for your health research, please contact UConn/UConn Health ResearchMatch Liaison, Ellen Ciesielski, eciesielski@uchc.edu.
1. Request an account by emailing Ellen Ciesielski, UConn/UConn Health’s ClinicalTrials.gov PRS Administrator. You will be sent an automated email from the PRS system with your username and password.
2. On the PRS log-in page, in the Organization field, enter “UConnHealth” (no spaces) if your account was created under UConn Health or “UConn” if your account was created under UConn.
3. Click on the blue “Create New Record” button on the far right of the page. The system will walk you through the creation of the record. Data entered on previous pages will be retained so that you can return to complete the record at a later date.
The person who creates the record is the “Record Owner.” The Record Owner may be the Principal Investigator (PI) or someone designated by the PI to create/update the record on his/her behalf. The PI must perform the final review and approval of the record and each subsequent update in the PRS. The PI is responsible for ensuring that accurate information about the trial is entered and that updates to the record are completed in a timely manner (see table below for specific deadlines).
For studies reviewed by UConn Health:
For studies reviewed by UConn Storrs and Regional Campuses:
| Data Field | Deadline for Updating (i.e., not later than the specified date) |
|---|---|
| Study Start Date | 30 calendar days after the first subject is enrolled (if the first human subject was not enrolled at the time of registration). |
| Intervention Name(s) | 30 calendar days after a nonproprietary name is established. |
| Availability of Expanded Access | 30 calendar days after expanded access becomes available (if available after registration); and 30 calendar days after an NCT number is assigned to a newly created expanded access record. |
| Expanded Access Status | 30 calendar days after a change in the availability of expanded access. |
| Expanded Access Type | 30 calendar days after a change in the type(s) of available expanded access. |
| Overall Recruitment Status | 30 calendar days after a change in overall recruitment status. If Overall Recruitment Status is changed to “suspended,” “terminated,” or “withdrawn,” the Why Study Stopped data element must be submitted at the time the update is made. |
| Individual Site Status | 30 calendar days after a change in status of any individual site. |
| Human Subjects Protection Review Board Status | 30 calendar days after a change in status. |
| Primary Completion Date | 30 calendar days after the clinical trial reaches its actual primary completion date. |
| Enrollment | At the time the primary completion date is changed to “actual,” the actual number of participants enrolled must be submitted. |
| Study Completion Date | 30 calendar days after the clinical trial reaches its actual study completion date. |
| Responsible Party, by Official Title | 30 calendar days after a change in the responsible party or the official title of the responsible party. |
| Responsible Party Contact Information | 30 calendar days after a change in the responsible party or the contact information for the responsible party. |
| Device Product Not Approved or Cleared by U.S. FDA | 15 calendar days after a change in approval or clearance status has occurred. |
| Device Product Not Approved or Cleared by U.S. FDA | 15 calendar days after a change in approval or clearance status has occurred. |
| Record Verification Date | Any time the responsible party reviews the complete set of submitted clinical trial information for accuracy and not less than every 12 months, even if no other updated information is submitted at that time. |
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.
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.”
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.
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:
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.
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.
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.
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.
1. PURPOSE
1.1 This policy establishes the responsibilities and roles of IACUC members, as well as the processes to add and remove an IACUC member to the roster.
2. IACUC MEMBERSHIP
2.1 IACUC members shall be selected in accordance with Public Health Service Policy on Humane Care and Use of Laboratory Animals Policy IV.A.3, IV.B., and IV.A.C , Animal Welfare Act Regulations 2.31, and the “IACUC Constitution and Function” detailed in The Guide for the Care and Use of Laboratory Animals. PHS policy is regulated by the Office of Laboratory Animal Welfare (OLAW) and the Animal Welfare Act is regulated by the United States Department of Agriculture Animal and Plant Health Inspection Service (USDA-APHIS). IACUC members will be selected based on qualifications, education, and/or experience and a positive attitude toward IACUC membership.
2.2 Membership is contingent upon commitment to items listed in section 2.4 of this policy and subject to review by the IACUC executive staff (Institutional Official [IO], IACUC Chair, IACUC Vice Chair, and the Director). Scientific members shall be appointed to a 3-year term subject to the above-mentioned annual performance review. Appointments can be renewed. IACUC members shall inform the IACUC Administrator by email that they accept their appointment when they receive the appointment letter from the IO.
2.3 Program Responsibilities of the IACUC as defined by the above regulations
2.3.1 Ensure compliance with all regulatory agencies and AAALACi
2.3.2 Semi-annual review of the program and inspection of all facilities and prepare reports of results to the Institutional Official
2.3.3 Review of all activities involving live animals
2.3.4 Review, and investigate if necessary, all concerns involving live animal care and use.
2.3.5 Making recommendations to the Institutional Official regarding any aspect of the animal care and use program
2.3.6 Suspending activities as required
2.3.7 Oversight of training programs related to animal care and use
2.3.8 Oversight of occupational health and safety protocols related to animal care and use
2.3.9 Oversight of policies pertaining to animal care and use
2.3.10 Meeting as necessary to ensure required activities occur
2.3.11 Advise on facility security as related to animal care and use
2.3.12 Advise on emergency and disaster planning as related to animal care and use
2.3.13 Conduct post-approval monitoring activities
2.4 Individual IACUC member responsibilities
2.4.1 Review all materials provided for IACUC meetings
2.4.2 Familiarize yourself with all protocols on he agenda for a full committee review (FCR)
2.4.3 Declare any potential conflict of interest related to their work on the IACUC; if there is a conflict of interest during review, recuse yourself from the vote
2.4.4 Be aware of federal regulations in the Animal Welfare Act, Title 7, Chapter 54, section 2157 – it is unlawful for any member of an IACUC to release confidential information to a third party or to use, or attempt to use, confidential information to their own advantage.
2.4.5 Complete all training and continuing education sessions as assigned by the IACUC Administrator
2.4.6 Attend a majority of the scheduled committee meetings
2.4.7 Demonstrate a professional and courteous manner towards other members, staff, and faculty.
2.4.8 Familiarize yourself with applicable policies, regulations, and guidelines given to you in your “IACUC Member Handbook”.
2.4.9 Act as a liaison for your colleagues
2.4.10 Complete all assigned protocol reviews by the due date assigned by the IACUC administrative staff. If you cannot, contact the IACUC Administrator so another reviewer can be assigned.
2.5 Individual IACUC member rights
2.5.1 Request FCR for any animal activity for any reason within the timeframe given to you.
2.5.2 Voice a minority opinion for the record related to any topic covered in the semi-annual report to the IO.
2.5.3 Participate in any scheduled facility inspection or program review activity.
2.5.4 Raise policy issues to the Committee for discussion
2.6 Expectations of Committee members at meetings
2.6.1 Share your unique input to get all the issues “on the table”. Members are expected to be active participants in IACUC discussions; for instance, if you have information that has not been discussed, share it.
2.6.2 Think critically but fairly and use the criteria for approval (Appendix I) to decide whether to approve the research. If you have a concern, problem, or recommended change, be able to base it on the criteria for approval.
2.6.3 Listen and learn from the group but think and vote independently. Vote according to your own conscience in an informed manner.
2.6.4 Respect minority opinions when offered.
2.6.5 Remember that all discussions and Committee decisions are considered confidential.
2.6.6 Understand that Committee decisions are made by majority rule and not consensus.
2.7 IACUC Chair
2.7.1 Responsibilities
2.7.1.1 Assigns/Approves reviewers for protocols meeting the criteria for a Designed Member Review
2.7.1.2 Signs OLAW Inter-Institutional Assurances
2.7.1.3 Runs the IACUC meetings
2.7.1.4 Has the authority to make exemptions to IACUC Policies
2.7.1.5 Assigns members to subcommittees when required
2.7.1.6 Any other as defined by laws, regulations, guidelines, or policies
2.7.2 The IACUC Chair should normally be an IACUC member who is a respected individual with knowledge of research ethics, regulations, and guidance that govern animal research.
2.7.3 The IACUC Chair will be appointed to a 3-year term.
2.8 IACUC Vice Chair
2.8.1 Responsibilities
2.8.1.1 Discharge the IACUC Chair’s responsibilities when the Chair is unable to do so
2.8.1.2 Discharge the responsibilities assigned by the IACUC Chair
2.8.1.3 Assist in the operation of the IACUC
2.8.2 Appointment of the Vice Chair is made by the IACUC Chair and the IACUC Administrator wit the approval of the IO.
2.8.3 The IACUC Vice Chair should commit to a 3-year appointment unless renewed or appointed to become IACUC Chair, thereupon the responsibilities and appointment term will be exclusive as defined above.
3. Process for Appointment of IACUC Members
3.1 Process of nomination of new members
3.1.1 The IACUC Chair, Vice Chair, Director, and/or Administrator identify and nominate an individual for a vacancy on the IACUC.
3.1.2 The IACUC Administrator obtains the resumé or curriculum vitae of the nominee and forwards to the IACUC Chair and IO for review
3.1.3 If all parties agree that the background of the potential member is a good fit with the current membership of the IACUC, an interview (telephone, web, or in-person) will be conducted with the IACUC Chair, Vice Chair, Director, Administrator, and the IO.
3.1.4 After the interview, a decision by all parties will be made regarding the appointment.
3.1.5 Once the nominee has been appointed, the IACUC Administrator prepares and appointment letter which is signed by the IO and send to the individual.
3.1.6 Once the nominee has accepted the appointment, a meeting will be held between the new member and the IACUC Administrator who assigns any training and provides the individual with an “IACUC Member Handbook”. Training, documents given, etc. are all recorded on a new member orientation form held by the IACUC office. The individual is added to the IACUC roster.
3.1.7 The new IACUC member is assigned a mentor – typically, a seasoned IACUC member who will help guide the new member with regard to protocol reviews and provide any other help the new member may need.
3.2 Process for reappointment of members
3.2.1 Members are appointed to a three-year term, subject to annual continuation. After the annual evaluation of the member (see section 2.2 above), if all parties agree the member should continue for the next year, a continuation appointment letter will be prepared by the IACUC Administrator and sent to the IACUC member.
4. Process for Removal of IACUC Members
4.1 The IO or their designee is responsible for deciding whether to remove an IACUC member.
4.2 If the IACUC member will no longer serve as an IACUC member, the IACUC administrator will prepare a thank you letter which will be signed by the IO and sent to the member.
4.3 The membership roster will be updated as required.
Effective Dates: December 5, 2024 through December 31, 2027
Appendix I:
Criteria for Reviewing Animal Care and Use Protocols
Compiled from regulations set forth from:
* Animal Welfare Act (Title 7, Chapter 54, United States Code)
* Animal Welfare Regulations (9 CFR, Chapter 1, subchapter A, parts 1-4)
* PHS Policy on the Humane Care and Use of Laboratory Animals
* US Government Principles
I: Selection and Justification of Species
II: Living Conditions of the Animals
III: Justification for the Use of Animals
IV: Application of the Principles of Replacement, Reduction, and Refinement
-PI must provide a written narrative describing the methods and sources used to determine that alternatives to painful/distressful procedures were not available:
Database search* (must be >1) if utilizing USDA-regulated species must include:
Databases searched
Date of search
Years covered by search
Search strategy used
*Other sources consulted (e.g., experts in field, standard reference books, etc.)
V: Ethical Cost-Benefit Relationship
VI: Treatment of Pain and Discomfort
VII: Post-Procedure Monitoring
VIII: Restraint
IX: Euthanasia
X: Qualification of Research Personnel
XI: Occupational Health and Safety
Please use the form below to send us your feedback, questions or to report a problem with the UConn Health OVPR website.