Investigators and study personnel should be familiar with the following policies that relate to human subject protections. (Policies are in PDF.)

• Authority of the Human Subjects Protection Office, Policy 2004-02
• Clinical Research / Trials Budget Review, Policy 2006-07
• Clinical Research Trials Facility Discount for Hospital-Based Outpatient Programs, Policy 2010-01
• Clinical Research Trials Patient Billing Compliance, Policy 2006-08
• Clinical Trials Under Contract – Administrative Requirements, Policy 2007-06
• Confidentiality, Policy 2002-43
• Conflicts of Interest in Research Policy, 2006-01
• Data Ownership Policy, 2003-42
• Electronic Communication of Confidential Data, Policy 2011-004
• Information Security:  Anti-Virus and Software Update, Policy 2005-10
• Information Security:  Data Authentication, Physical Safeguards, Policy 2011-01
• Information Security:  Risk Assessment, Policy 2005-08
• Information Technology Security:  Systems Access Control, Policy 2011-03
• IRB Approval of Human Research Conducted by Subcontractors, Policy 2004-04
• Manufacturing of Drugs, Devices or Biologics for Human Research, Policy 2005-12
• Mobile Computing Device (MCD) Security, Policy 2008-03
• Review and Approval of Research Involving Human Subjects, Policy 2002-42
• Review of Alleged Misconduct of Research
• Rules of Conduct, Policy 2002-03
• Written Agreements for Sponsored/Funded Research Involving Human Subjects, Policy 2004-05

Short Form Consent Templates from University of Michigan:

• English
• Arabic
• Croatian
• French
• Hmong
• Khmer
• Lao
• Oromo
• Russian
• Somali
• Spanish
• Vietnamese

Short Form Consent Templates from University of Southern California:

• English
• Armenian
• Chinese
• Farsi
• Korean
• Tagalog
• Thai

iRIS Training Sessions:

Departments/Centers are encouraged to select one or two individuals who will be the point persons for navigating the iRIS system. The Educational and Development Specialist (EDS) will provide training for using the system to these individuals; and they in turn can train others in their department/center.

Individuals are invited and encouraged to request iRIS training. To schedule a session e-mail the HSPP at irb@uchc.edu. Classes are held in the L- Building – 5th Floor – Room  L5035.

 

 

 

 

 

 

Budget Workbook

Electronic tool used by OCTR in conjunction with study team to identify, segregate and monitor charges

Clinical Research

1. Patient-oriented research. Research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. This area of research includes:

• Mechanisms of human disease
• Therapeutic interventions
• Clinical trials
• Development of new technologies

1. Epidemiologic and behavioral studies.
2. Outcomes research and health services research.

Clinical Trial

A clinical trial is a systematic, organized, prospective intervention study in human subjects that is conducted according to a formal study plan (protocol) and that has measurable efficacy and/or safety-related outcomes that are amenable to statistical analysis. It employs one or more intervention technique(s) including prophylactic, screening, diagnostic, or therapeutic agents, devices, or procedures. It must have the approval of the IRB or the IRB’s review with a determination of exemption. Clinical trials are distinguished from other types of clinical research (e.g., behavioral research) that may need IRB approval but do not meet the other criteria of clinical trials.

Clinical Trials Initiation Form

Upon IRB approval, this form is generated by OCTR  to notify all departments involved of the services to be charged to the trial. This form includes critical billing information such as: BANNER account number,  party responsible for EPIC Research Billing Review, name of recipient of Transfer Vouchers, list of services to be charged, and category of sponsor.

Preliminary Budget Information Packet

OCTR document that initiates the Budget Workbook process. Packet is emailed to PI/Study Coordinator in response to query regarding doing a Budget Workbook; it is completed by the study team and returned to OCTR via email prior to study team meeting with OCTR staff

Protocol Induced Costs (PIC)

Items and services that are specifically excluded from the definition of Routine Clinical Services in a qualifying clinical trial such as:

• The investigational item or service itself
• Items and services provided solely to satisfy data collection and analysis needs and that are not used in the direct clinical management of the patient
• Items and services customarily provided by the research free of charge for any enrollee in the trial
• Items and services provided solely to determine trial eligibility

Qualifying Clinical Trial

As per the Medicare National Coverage Determination (“Routine Costs in Clinical Trials, also known as the CMS Clinical Trial Policy or “CMS CTP”): Any clinical trial receiving Medicare coverage of routine costs must meet both the basic three requirements and seven desirable characteristics to qualify for coverage.

https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/downloads/R74NCD.pdf

“Deemed” studies automatically meet the criteria for the seven desirable characteristics.

Routine Clinical Services (RC)

Routine costs of a clinical trial include all items and services that otherwise would be generally available to Medicare beneficiaries regardless of whether they are assigned to the experimental or control arm of a qualifying clinical trial. “Generally available” means that the item or service falls within an existing Medicare benefit category that is not excluded from coverage by another provision in the law and that is not the subject of an NCD stating that the item or service is not covered. If an item is covered outside of a clinical trial it is covered within the clinical trial.

Study

In this context, synomous with clinical trial/clinical research

Animals have been central to the advancement of knowledge that has led to a vast array of benefits to both human and animal health. The University of Connecticut regards the use of animals in research, teaching, and testing to be an integral component of continued progress in science, education, and agriculture. The University expects all of its animal facilities and programs to maintain high ethical standards for animal care and use, and to be operated in accordance with applicable federal, state, and local laws, regulations, policies, and guidelines.

The animal care and use program refers to all the components that exist in support of the University’s activities involving live animals. These components include facilities, employees, researchers, policies and procedures, equipment and animals. The Animal Care and Use Program is accredited by AAALAC International.

The Center for Comparative Medicine is responsible for providing veterinary care, veterinary husbandry services and expert consultation on the selection, care and use of animals in research and educational programs.

The Institutional Animal Care and Use Committee (IACUC) qualified through the experience and expertise of its members to oversee the University’s animal program, facilities, and procedures in accordance with the applicable laws, guidelines, and regulations.

Contract Negotiation Synopsis

Introduction

The negotiation and execution of contracts is a substantial component of the genesis of a clinical trial. Clinical trials at UConn Health cannot commence until a contract has been fully negotiated, approved, and executed and the clinical trial has received final IRB approval.

Historically, the negotiation of clinical trial agreements contributed to the delay in the opening of pharmaceutical/industry clinical trials. OCTR has alleviated many of these issues by redefining the contract procedure to include the following:

1. Parallel budget determination
2. Standardization of contract templates
3. Organization of contract negotiation procedures
4. Coordination with the Institutional Review Board (IRB)
5. Full execution of contracts after IRB contingent approval

Types of Contracts

The OCTR negotiates industry-sponsored or investigator initiated industry-supported contracts, university-to-university agreements, co-operative group contracts and foundation-supported contracts, which include the following:

• Clinical Trial Agreements (CTA)
• Confidentiality Disclosure Agreements (CDA)
• Contract Amendments
• Letters of Indemnification (LOI)

OCTR does not negotiate:

• Federally funded investigator initiated agreements* **
• Clinical trials or clinical research in which the Prime Award is in response to a public solicitation (e.g., Request for Information (RFI), Request for Application (RFA), Funding Opportunity Announcement (FOA))

* In this instance, the proposals will be negotiated by the staff in the Sponsored Programs Services (SPS). If you are pursuing a federally-funded agreement or a study in which the prime award is in response to a public solicitation, please contact SPS at 860-679-4040 or go to their website.

** Appendix I: The following represent the main types of federally funded grant awards and projects that will continue to be negotiated by the Sponsored Programs Services (SPS) at UConn Health. See listing of all NIH grant mechanisms.

Research Grants:

• R01 – NIH Research Project Grant Program
• R03 – NIH Small Grant Program
• R13/U13 – NIH Support for Conferences and Scientific Meetings
• R15 – AREA: NIH Academic Research Enhancement Award
• R21 – NIH Exploratory/Development Grant Award
• R34 – NIH Clinical Trial Planning Grant
• R41/R42 – STTR: Small Business Technology Transfer
• R43/R44 – SBIR: Small Business Innovative Research
• R56 – NIH High Priority, Short-Term Project Award
• U01 – Research Project Cooperative Agreement
• K99/R00 – NIH Pathway to Independence (PI) Award

Career Development Awards (K series)

Research Training and Fellowships (T & F series)

Program Project/Center Grants

• P01 – Research Program Project Grant
• P02 – Exploratory Grant
• P30 – Center Core Grants
• P50 – Specialized Center Grants

Resource Grants

• R24 – Resource-Related Research Projects
• R25 – Education Projects
• X01 – Resource Access Program

Trans-NIH Program

• BISTI: Biomedical Information Science and Technology Initiative
• Blueprint: NIH Blueprint for Neuroscience Research
• Diversity Supplements
• Administrative Supplements
• ES I: New and Early Stage Investigators Policies
• GWAS: Genome-Wide Association Studies
• NIH Common Fund: NIH Roadmap for Medical Research
• OppNet: NIH Basic Behavioral and Social Science Research Opportunity Network
• PECASE: Presidential Early Career Award for Scientists and Engineers
• Stem Cells

Contract Negotiation Process

Industry Sponsored Clinical Trial Agreements

If an industry sponsor is interested in conducting a clinical trial at UConn Health, the sponsor will initially send a non-disclosure agreement or a confidentiality disclosure agreement (CDA) to the researcher. Once received, the researcher should forward the CDA to the contract specialist in the OCTR. The CDA will then be reviewed, negotiated, approved, and executed. Thereafter, the researcher will review the data and the study components in order to determine whether to participate in the study.

After review of the sponsor’s data and proposed study, the researcher and the sponsor will make a mutual decision whether or not to engage in the study. If the researcher decides to engage in the study, the sponsor will send a clinical trial agreement (CTA) to the researcher or the researcher’s study coordinator. The clinical trial agreement is then forwarded to the contract specialist in the OCTR for review and negotiation. Once the CTA is negotiated, the contract specialist will obtain signatures from an authorized representative of UConn Health, the researcher, and the sponsor.

Another type of CTA is the “University to University” agreement. University to University agreements are subcontracts with a university that has a governing contract with a company sponsor. The negotiation procedure for University to University agreements is similar to the negotiation procedure for industry-sponsored clinical trial agreements.

Investigator-Initiated Clinical Trial Agreements

An investigator-initiated clinical trial is one that is authored by the investigator and financially supported by industry, a foundation, or another university. The funding agency may send its own company contract to OCTR for negotiation, or OCTR may send the funding agency a clinical trial agreement generated by UConn Health. Thereafter, the negotiation procedure is generally tantamount to the process described above for industry-sponsored studies.

Cooperative Group Studies

UConn Health has master agreements with cooperative groups which are designed to promote and support clinical trials. OCTR negotiates all agreements pertaining to the cooperative group studies or its corresponding master contract.

Budget and Institutional Review Board (IRB)

All clinical trials that incur JDH and/or UMG and/or Dental charges will need a completed Budget Workbook before IRB submission. During contract negotiations, OCTR staff reviews the protocol, informed consent, and contract to ascertain that patient costs and patient injury language are in agreement within all documents. At the time of review, the IRB will also assess concordance among the protocol, patient consent, and contract relative to patient costs and patient injury language. If the protocol is contingently approved by the IRB, the contract can be signed by the Director of Sponsored Program Services and sent back to the company while contingencies are being met.

A clinical trial agreement cannot be signed until the study has received contingent approval from the IRB. Thus, an executed contract is not required for IRB submission. However, if a clinical trial agreement contains subject injury language, said language may be required for submission. The subject injury language can be requested from the OCTR.

No clinical trials can open or begin accrual without final IRB approval.

1. Preliminary Report of Audit Findings
   Based on the Research Financial Compliance Audit, a preliminary report is sent to the principal investigator and s/he is given 30 days to review for accuracy
2. Violations
   Major billing financial violations, or substantive systematic deficiencies are reported immediately to the Associate Dean of Clinical Research Planning and Administration

Final Report of Audit Findings

1. A final audit summary is provided to the principal investigator, with copies to:
   • Associate Dean of Clinical Research Planning and Administration
   • Vice President for Research Finance
   • Vice President of Research Compliance
   • Director of Sponsored Program Services
   • Compliance Integrity/Privacy Officer
   • It includes:
     1. Comments on audit procedure and the findings
     2. Description of deficiencies or violations
     3. Recommendations for corrective action plan, including correcting billing errors
2. The researcher is given 21 days to respond with a corrective action plan
3. When the corrective action plan is accepted and implemented and no outstanding items remain
   • A letter of acknowledgement is sent to the PI and the audit is officially closed
   • The financial compliance summary form is completed and attached to the file

Notification

• Written notification of pending audit is sent from the OCTR Administrative Fiscal Assistant. It is the responsibility of the research compliance monitor to schedule the visit after notice has been received.

Timing

• Random audits will be scheduled two to four weeks in advance; however unscheduled “mini” audits may be performed within five days.
• For cause audits may be performed without prior notice.

Random Audit for Financial Compliance

Scheduled Audit

This type of review is considered a full audit. Focus of review includes:

• Budget determination
• Delineation of PIC and RC
• Adherence to the Medicare National Coverage Decision (NCD)
• Adherence to the UConn Health research financial policies and state laws and regulations
• Appropriate approval from Medicaid and other third party payers for payment of RC associated with a clinical trial.
• Review may also include:
  1. review of contract
  2. review of PIC paid by sponsor
  3. review of RC paid by third party payer or participant
  4. review of all patient charges/billing
  5. review of any charges/billing for adverse events
  6. review of charges billed to the study Banner account #
  7. changes in budget
  8. changes in contract

Unscheduled Audit

This type of audit is done to assess one or two elements of the full audit, such as

• Budget delineation, or
• Patient charges.

For Cause Audit for Financial Compliance

This type of audit is performed when concerns regarding research financial compliance are brought to the attention of the Office of Clinical and Translational Research (OCTR), the Human Subjects Protection Office (HSPO), Institutional Review Board (IRB) or Research Compliance.

First Subject Reconciliation

A first subject reconciliation is completed early in the trial to establish that study related transactions are happening according to plan or that problems are found early and corrective action may be taken. Areas of focus are listed below.

• Research related charges for UMG and JDH are correct, complete and reflect the proper CPT/Procedure code in accordance with the Budget Workbook.
• All start-up fees were received from the sponsor and allocated to the study Banner fund. Regular study payments are correctly recorded (if yet received).
• Study personnel have allocated proper Time & Effort via payroll distribution or through cost sharing.
• Study related charges are paid to UMG or JDH at the proper rate and discount.

Investigators and study personnel are responsible for being knowledgeable of the following policies and procedures of the Human Subjects Protection Program (HSPP).

• 2009-001.0 – Reporting Unanticipated Problems to the Institutional Review Board (6/29/2018)
• 2009-002.0 – Reporting Non-Compliance to the Institutional Review Board (6/9/2023)
• 2009-003.0 – Imposing and Lifting Suspensions of IRB Approval or Imposing Terminations of IRB approval – (6/5/2023)
• 2009-004.0 – Required Reporting to Institutional Officials and External Agencies (12/30/2021)
• 2009-005.0 – Monitoring of IRB Approved Studies (6/5/2023)
• 2011-006.0 – Additional Protections – General (2/5/2018)
• 2011-006.1 – Additional Protections – Pregnant Women, Fetuses or Neonates (6/9/2023)
• 2011-006.2 – Additional Protections – Prisoners (3/16/2023)
• 2011-006.3 – Additional Protections – Children (6/15/2017)
• 2011-006.4 – Additional Protections – Other Vulnerable Groups (6/5/2023)
• 2011-006.5 – Additional Protections – Fetal Tissue Transplants (6/5/2023)
• 2011-007.0 – Definitions Applied to Policies (11/20/2023)
• 2011-008.0– Informed Consent – Forms (3/16/2023)
• 2011-008.1 – Informed Consent – Process (6/9/2023)
• 2011-008.2 – Informed Consent – Waivers and Alterations (1/22/2024)
• 2011-008.3 – Informed Consent – Assent (5/1/2017)
• 2011-008.4 – Informed Consent – Short Form (11/20/2023)
• 2011-008.5 – Informed Consent – Providing and Obtaining Informed Consent (6/5/2023)
• 2011-009.0– Institutional Review Board – Membership (6/5/2023)
• 2011-009.1 – Institutional Review Board – Submission of Materials (5/1/2017)
• 2011-009.2 – Institutional Review Board – Exemptions (6/9/2023)
• 2011-009.3 – Institutional Review Board – Expedited Reviews (11/20/2023)
• 2011-009.4 – Institutional Review Board – Convened Meeting Operations (11/20/2023)
• 2011-009.5 – Institutional Review Board – Review by Convened Board (11/20/2023)
• 2011-009.6 – Institutional Review Board – Consultants (5/1/2017)
• 2011-009.7 – Institutional Review Board – Assignment of Status Codes (6/9/2023)
• 2011-009.8 – Institutional Review Board – Appeals Process (6/9/2023)
• 2011-009.9 – Institutional Review Board – Verification of No Material Changes  (5/1/2017)
• 2011-009.10 – Institutional Review Board – More Frequent Review (7/20/2023)
• 2011-009.11 – Institutional Review Board – Studies Conducted in Foreign Locations (11/20/2023)
• 2011-009.12 – Institutional Review Board – Criteria for Approval (6/9/2023)
• 2011-009.13 – Institutional Review Board – Lapse in IRB Approval (6/9/2023)
• 2011-009.14 – Institutional Review Board – Human Subject Research Determinations (6/5/2023)
• 2011-009.15.a – Institutional Review Board – Reliance on UConn Health as IRB of Record (11/20/2023)
• 2011-009.15.b – Institutional Review Board – Reliance on External IRB (11/20/2023)
• 2011-009.16 – Institutional Review Board – Undue Influence  (8/17/2017)
• 2011-010.0 – VACANT
• 2011-011.0 – Research Personnel (6/9/2023)
• 2011-012.0 – Conflict of Interest – Research Personnel (6/5/2023)
• 2011-012.1 – Conflict of Interest – IRB Members (6/5/2023)
• 2011-013.0 – Translation Policy (8/17/2017)
• 2011-014.0– Health Insurance Portability and Accountability Act (HIPAA) in Research (10/29/2019)
• 2011-015.0 – Recruitment and Payment (6/9/2023)
• 2011-016.0 – Scientific Review (6/9/2023)
• 2011-017.0 – UConn Health as Statistical, Operational or Coordinating Center (8/17/2017)
• 2011-018.0 – Complaints, Concerns, Suggestions (8/17/2017)
• 2011-019.0 – Research Registries and Repositories (3/25/2022)
• 2011-020.0 – Humanitarian Use Device (6/5/2023)
• 2011-021.0 – Investigational Device Studies (9/26/2017)
• 2011-021.1 – Investigational Device – Single Emergency Use (9/26/2017)
• 2011-022.0 – Study Drug – General (6/5/2023)
• 2011-022.1 – Investigational Drug Studies (9/26/2017)
• 2011-022.2 – Investigational Drug/Biologic – Expanded Access for Treatment Use, Including Single Emergency Use (6/5/2023)
• 2011-023.0 – Educational Requirements (6/5/2023)
• 2011-024.0 – File Requirements & Record Retention Requirements (9/26/2017)
• 2015-024.1 – Record Retention Format (12/29/2015)
  
• 2011-025.0 – HSPP Evaluation / Institutional Support (11/20/2023)
• 2011-026.0– Planned Emergency Research (6/15/2017)
• 2013-027.0 – Additional Requirements – Department of Defense (11/20/2023)
• 2014-028.0 – Additional Requirements – National Institute of Justice (11/20/2023)
• 2014-031.0– Additional Requirements – Department of Energy (11/20/2023)
• 2014-032.0 – Additional Requirements – Environmental Protection Agency (11/20/2023)
• 2014-033.0– Additional Requirements – Federal Bureau of Prisons (11/20/2023)
• 2014-034.0 – Additional Requirements – Department of Education (Federal) (6/9/2023)
• 2023-035.0 –  HSPP Emergency Preparedness Plan (6/12/2023)
• Combined Policy Manual (pdf) (1/22/2024)