uconn

NSF Fastlane Password Registration

NIH eCommons Account Request

General Cost Principles

The proposal budget is the financial plan of action that reflects the costs required to perform the proposed work statement.  The following information has been prepared to help you develop your budget plan.  See our Budgeting and Costing Guide for current information on fringe benefits, graduate stipends, Facilities and Administration (F&A) rates (Indirect Costs) and other budgetary matters.

It is important to demonstrate that the budget proposed is reasonable.  A budget justification should be submitted in order to allow each budget item to be explained relative to the proposed research.  The specifics of the sponsoring agency’s budgetary guidelines should be followed carefully.  Budgets should be prepared for the entire proposed project. Both direct and F & A costs should be identified in the budget. The following categories are generally included in the preparation of a proposal budget.

Budget Categories and Justification

Salaries and Wages

List all personnel, including the names, roles, how many months, or the percent of effort that will be devoted to the project. Salaries and wages should be budgeted with an inflation rate specified on the Budgeting and Costing Guide. Information on salaries and rates can be found on the Budgeting and Costing Guide.  Salary classifications and compensation can be found at the Human Resources website. or at the Payroll website.  The NIH Guidelines for Salary Limitation on grants should be adhered to when calculating faculty salaries.

Faculty

Faculty on nine-month appointments may receive salary during the summer months. A maximum of three-ninths of the academic year salary may be requested. Sponsor guidelines will often dictate the number of months that can be allotted for summer salary.

Graduate Assistants

The Graduate School regulations state that full-time graduate assistants will devote no more than 20 hours per week to their assistantship duties during the academic year. Federal immigration regulations prohibit International students on F-1 or J-1 visas from working more than this amount when classes are in session. When classes are not in session, both international and domestic students may devote their full-time efforts to employment. Under special circumstances, a domestic graduate student may devote more than 20 hours per week to employment on campus during the academic year. In those cases, assurance must be given by his or her advisory committee, that such effort will not compromise satisfactory progress toward the degree.

Graduate Assistantship appointments ordinarily are made for a nine-month period during the academic year. They may also be made for a maximum of three summer months, depending upon the availability of funding.

The budget justification for graduate students should include the number of graduate students; their level of experience, whether it is an academic year or calendar year appointment, and how many hours will be spent on the project per week (20 hours a week for a quarter-time Graduate Assistant). Refer to the Graduate School website. for detailed information on graduate education, tuition costs and levels of experiences.  Detailed costing information can be found on the SPS Budgeting and Costing Guide.

Student Labor

Costs should reflect the hours, the hourly rate and length of time being spent on the proposal. Please refer to the Student Employment website. for levels of experience and compensation.

Other Professionals

Personnel included in this category are typically research assistants and associates, technicians, and computer programmers. The percentage of effort or hours should be stated for this category of personnel.

Post Doctoral Fellows

Post Doctoral Fellow stipends should follow the NIH NRSA stipend levels which can be found on the NIH website. The percentage of effort or hours should be stated for this category of personnel.

Administrative/Clerical Staff

OMB Uniform Guidance states that the salaries of administrative/clerical staff should normally be treated as F & A costs; however a request for administrative and clerical salaries may be included in a federal proposal budget when the following conditions are met:

1. Administrative or clerical services are integral* to a project or activity;

2. Individuals involved can be specifically identified with the project or activity.

Such costs must be explicitly included in the budget.

If these requirements are met, PIs/departments should include a justification statement that explains how the services are integral for the project to facilitate the required agency approval.

*Integral means the services are essential, vital, or fundamental to the project goals or activity, rather than necessary for the overall operation of the institution.

Programmatic Salary Costs

Costs related to protocol development and maintenance, managing substances/chemicals, managing and securing project-specific data, and coordination of research subjects are allowable direct costs when they are “contributing and directly related to work under an agreement.” Thus, these programmatic costs may be direct charged using the same underlying requirements as other types of direct costs, and are not subject to the extra approval requirements required of administrative and clerical costs. They are still subject to all regular costing requirements (e.g., allocability, reasonableness, allowable by terms of the award, incurred within award period).

Fringe Benefits

The fringe benefit rates should reflect the current rate schedule for the employment category being proposed.  Please refer to the Budgeting and Costing Guide.

Equipment

Equipment is defined as tangible, non-expendable, personal property having an anticipated life of one year or more with a unit acquisition cost of $5,000 or greater. Equipment includes, but is not limited to, furnishings, scientific apparatus, machinery, library volumes, artwork, motor vehicles, boats and livestock. You will need to identify the individual pieces of equipment requested, the importance to the project, and why existing equipment does not suffice.  Price quotes or the basis for projected prices may be required for larger pieces of equipment. Equipment costs are excluded from the Facilities and Administrative base. For more information see equipment definitions on the Accounting website.

Travel

Travel costs are classified as those expenses for transportation, lodging, subsistence and related items incurred by employees who are traveling on official University business. Domestic and foreign travel should be separately identified. Unless otherwise stated by the sponsor, domestic travel is considered to be travel among any of the 50 United States, its possessions and territories, and Canada. Foreign travel is classified as travel outside these areas. Travel justification should include who is traveling, where, the purpose of the trip, the number of trips, the costs for the air fare, per diem, lodging, car rental and other costs associated with the travel. For more information see the Travel website.

Materials and Supplies

Supplies and materials are any consumable item having an acquisition unit cost of less than $1,000.  These costs should be project-specific, reasonable and based on actual or historical use. It is not necessary to break down each individual item, but a general description and amount by general classification should be provided (e.g. glassware, test tubes, or chemicals).

Publication Costs

Publication costs consist of the documenting, preparing, publishing, disseminating, page and reprint charges, and sharing of project findings and supporting material. Budgets should be based on actual experience with an inflation factor built in for future years.

Subcontracts

If a portion of the work is to be completed by another institution, we will need an Information and Compliance Form for Subrecipients signed by an authorized representative of the sub-contractor’s institution, stating their willingness to participate with the University on the proposed project. The sub-contractor will need to provide our office with a statement of work, budget, budget justification and F&A Rate Agreement.  Facilities and Administrative costs are charged on the first $25,000 of each sub-contract.

Consultants

Consultants are independent contractors, not employees, who provide a service that cannot be performed satisfactorily by existing University personnel during the performance of the project.  The consultant costs should include the period of service or the number of days on the project, the professional fee, travel expenses and other related expenses.  Consultants should provide a letter of intent to  Sponsored Program Services.

Animal Care Costs

Animal costs should reflect the type of animal, the number of animals and the unit cost per animal. Per Diem costs should list the number of days of Per Diem.  Per Diem rates can be found on the Animal Care Services website. The current F & A rate should be applied to Animal Care Costs.

Other Expenses

Indicate any other project-related expenses, such as postage, long-distance telephone charges, equipment maintenance, boat charges, computer services, participant stipends and human subject costs.  Justification would include the number of units and cost per unit.

Indirect Costs

Indirect costs are those costs that are incurred for common or joint objectives and therefore cannot be identified readily and specifically with a particular sponsored project.

It is the policy of the University to collect full indirect costs at the federally negotiated rates from all funding sources whenever possible.  Occasionally, a sponsoring agency will specify an indirect cost policy inconsistent with the University’s negotiated rate.  Only the Office of the Vice President for Research has the authority to accept a reimbursement rate other than our negotiated rate. These payments from the various programs are reimbursement to the University for certain actual costs incurred by support functions to conducting sponsored research programs at the University.  In addition, a portion of this money from research grants goes to the Research Council to be used for research incentive funds, grant programs for faculty and graduate students, and to meet cost sharing requirements for large equipment purchases. The University negotiates its rate with the DHHS, which is based on Modified Total Direct Costs (MTDC).  UConn’s negotiated rate agreement can be found under Frequently Requested Information, along with the name and address of our Cognizant Agency.

In accordance with our current Indirect Cost Rate Agreement:

For all activities performed in facilities not owned by the institution and to which rent is directly allocated to the project(s), the off campus rate will apply. Grants or contracts will not be subject to more than one indirect cost rate.  If more than 50% of a project is performed off campus, the off campus rate will apply to the entire project.

The off campus indirect cost rate can be budgeted as follows:

  • If rent is directly charged to the project.
  • If more than 50% of all program activities are performed off campus.   (with written confirmation from the PI).
  • If the sponsor specifically requires the off-campus rate per the solicitation.

If you have questions, please contact your SPS Grants/Contracts Specialist.

Cost Sharing/Matching

Definition

Cost sharing or matching on grants and contracts reflects the university’s contribution to the total costs of a sponsored research project. Cost sharing, therefore, represents the portion of the project costs not paid for by the sponsor.

General Information

Cost sharing should be limited to those situations where it is mandated by the sponsor. In certain circumstances, the University may determine that a contribution is necessary to ensure the success of a competitive award or competition. All cost sharing dollars require written approval from the source of the commitment.

The PI or department should refrain from making commitments voluntarily, as any promised cost share becomes part of the project cost, even if only mentioned in the narrative and not in the budget. Once awarded, the commitment will have to be tracked in the University’s accounting system and is subject to audit. Failure to comply with the cost-sharing commitment may result in a loss of funding.

Required Approval

For internal commitments, the “Cost Share Commitments” section on the Internal Proposal Review form should be completed and signed by the appropriate Unit/Department Head or Dean.

For external commitments, a letter of commitment signed by the agency’s authorized official is required.

Criteria for Cost Sharing Commitments

The Uniform Guidance  states that contributions, including cash and third party in-kind, are acceptable as cost-sharing contributions.

The cost sharing/match must meet the following criteria to be accepted:

  • The match must be verifiable from the recipient’s records. You will be asked to specify an account in the University’s accounting system (KFS);
  • Not included as a contribution for any other project;
  • Necessary and reasonable to accomplish the project’s objectives;
  • Allowable under the Cost Principles;
  • Not paid by the Federal Government under another award, except where authorized by Federal statute to be used as cost sharing or matching;
  • Are provided for in the approved budget.
Types of Cost Sharing

Typical examples of cost sharing include the percentage of personnel effort to be expended on the project; associated employee benefits; Graduate Research Assistant Tuition and un-recovered indirect costs. Costs incurred prior to the award are not allowable matches. Program income earned under an award may not count as cost sharing unless authorized by the sponsor.

Cash contributions are sources of funds from either internal or external sources.  University cost sharing is considered cash, as it can be accounted for from the University’s records. In-Kind contributions are non-cash contributions typically provided from outside sources such as donations of equipment, sub-contractors  of time or facilities, or volunteer services.

General Cost Principles

Sponsoring agency’s budget requirements vary considerably depending on the sponsor and type of proposal. Cost principles specified in the Office of Management and Budget (OMB) Uniform Grant Guidance are used to describe the cost principles for all sponsored agreements at the University of Connecticut. The tests for appropriateness under these principles are:

  • Reasonableness – A cost may be considered reasonable if the nature of the expenditure and the amount involved reflects the action that a prudent person would take under the circumstances.
  • Allocability – A cost is allocable if it is beneficial to the project.
  • Allowability – Costs must be allowed in accordance with the Uniform Grant Guidance and the terms of the sponsored agreement.
  • Consistency – Costs incurred for the same purpose in like circumstances must be treated consistently as either direct or facilities and administrative (F&A) costs, and the method used to estimate, record, and report costs must be consistent as well.  See the table below for a description of how costs should be treated.

Nonrecoverable (Unallowable) Costs

Expenditures that cannot, by federal regulation (Uniform Grant Guidance) be reimbursed, either in whole or in part, from the federal government are considered non-recoverable (unallowable) costs. When preparing a budget, the following costs are considered non-recoverable and should not be included in your proposal budget. Please consult with Sponsored Program Services if you have questions regarding these items.

  • Alcoholic beverages
  • Alumni activities
  • Bad debts
  • Commencement and convocation costs
  • Donations and contributions
  • Development/fundraising costs
  • Entertainment costs
  • Employee morale
  • Excessive employment recruitment costs
  • Fines and penalties
  • Goods or services for personal use
  • Housing and personal living expenses
  • Investment management costs
  • Lobbying costs
  • Memberships
  • Moving costs
  • Student activity costs
  • Travel costs in excess of commercial coach airfare

Direct and F & A (Indirect) Costs Items

Direct costs are those costs that can be specifically identified with a particular sponsored activity.  Direct costs are those costs that can be assigned to an activity relatively easily and with a high degree of accuracy.

F&A costs are costs that are incurred for common or joint objectives and therefore cannot be identified readily and specifically with a particular sponsored project, an instructional activity or any other institutional activity.

Costs must be treated consistently.  Consistent treatment means that similar costs must be treated uniformly in the same manner as either a direct cost or as F & A costs.  Certain types of costs, such as the salaries of administrative and clerical staff, office supplies and postage are normally treated as F & A costs, therefore, the same types of costs cannot be charged directly to federally sponsored agreements.

Direct Costs F & A Costs
Salaries & Wages/Fringe Benefits: Faculty, other professionals, technicians, post doc associates, research associates, graduate students. Salaries & Wages/Fringe Benefits: Typically clerical and administrative assistants, fiscal manager, secretaries, directors.
Office Supplies: Office supplies are normally included in the indirect costs base. Office Supplies: Pens, pencil, paper, staple, transparencies, toner cartridges, diskettes, printer paper, word processing and spreadsheet programs.
Lab and Computer Supplies: Medical, scientific pharmaceutical supplies. Software and/or diskettes for research data collection and/or scientific and technical purposes. General Computer Supplies: Diskettes, printer paper, word processing and spreadsheet programs.
Equipment: Equipment and computing devises used for scientific, technical, and research purposes. Equipment: General office equipment such as copiers, printers, computers, fax machines.
Facilities: Project specific space rental for off-campus facilities from a third party. Facilities: Utilities, building use, grounds maintenance, renovations, and alterations.
Postage, printing and photocopying: Normally indirect unless the specific project scope of work, such as surveys or questionnaires, clearly indicates a need for a volume of costs beyond routine. Postage, printing and photocopying: US non-priority or inter-office mail delivery, printing of administrative forms, or photocopying of routine low volume material.
Telephone:  Long distance calls, phone surveys or calls to project participants. Telephone: Local calls, cell phones, installation and maintenance.
Maintenance & Repairs: Requires justification that the expenditures are directly related to the specific award. Maintenance & Repairs:  Maintenance and repairs to general purpose equipment, buildings and grounds.
Advertising: Recruitment of research subjects or for personnel approved for a specific project. Advertising:  Public relations.
Publications:  Project specific research. Publications: General.
Freight/express deliveries: Justification required that cost was needed to transport project material in a timely manner. Freight/express deliveries: Routine or internal courier.
Consulting:  Project specific research. Consulting:  General.
Miscellaneous Costs: Subcontract Costs; Service Center Charges;  Training costs, Miscellaneous Costs:  Dues, memberships and subscriptions; Computer network charges; Utilities.

See also the Implementation Guide (Uniform Grant Guidance)  for Principal Investigators and Department Administrators.

The OVPR SPS reviews the appropriateness of costs to determine if they qualify as direct costs. Exceptions (allowing costs listed in the F & A Column as direct costs) to the above list are rare and are reviewed on a case by case basis by the OVPR SPS. Exceptions may occur when:

  • The program is a large complex project such as a center project that involves assembling and managing teams of investigators from a large number of institutions or units.
  • The project involves extensive data collection, analysis and entry, surveying, tabulation, cataloging, searching literature, or reporting.
  • The project requires coordinating travel and meeting arrangements for a large number of program participants, patients or subjects; or for conferences or seminars.
  • A project where the principal focus is the preparation and production of manuals, large reports, books or monographs (excluding routine progress and technical reports.)
  • The project is off campus and does not have access to normal department administrative services.

Oversight Committee Approval

The Research Compliance Services (RCS) can assist you in obtaining appropriate review and approval of research areas that will need the consideration of an oversight committee. Many times a sponsor will require a signature from a compliance office at the time of submission while other sponsors only require compliance review and approval upon award. If your research will use any of the areas listed below, please contact the ORC at 486.8513.

Animal Subjects

The University of Connecticut has established, and must maintain, policies and procedures to ensure the humane care and use of live vertebrate animals involved in research and teaching activities. The University’s animal program, facilities, and procedures are overseen by an Institutional Animal Care and Use Committee (IACUC). All plans for research, teaching or training activities involving the use of animal subjects must be submitted for review and approval to the IACUC. See the IACUC home page  for forms, policies and contact information.

Controlled Substances

Controlled substances are regulated by the CT Department of Consumer Protection Drug Control Division (DCD).  The Department of Environmental Health and Safety (EH&S) maintains a database of personnel who are licensed by the DCD to use controlled substances on any of the University’s campuses.  Individuals with valid needs to utilize controlled substances for University-sanctioned research protocols and related project work must complete a DCD registration form.  In addition, researchers must also register with the federal Drug Enforcement Administration (DEA).  Contact Stefan Wawzyniecki, Chemical Health and Safety Manager, for further information on procedures for obtaining a license prior to the use of any controlled substance in research-related activities on University property.

Human Subjects

All plans for research, teaching and training activities involving the use of human subjects must be submitted for prior review by the Committee on the Use of Human Subjects in Research to ensure that no research done under the jurisdiction of the University exposes persons who participate as subjects or respondents to unreasonable risks to their health, general well-being or privacy. See the IRB home page for forms, policies and contact information.

Laboratory Safety

The Laboratory Safety Committee oversees the laboratory safety program administered by the Department of Environmental Health and Safety (EH&S).  The Committee develops and reviews policies that help: 1) ensure a safe working environment within laboratories, and 2) maintain compliance with US Environmental Protection Agency (US EPA), CT Department of Environmental Protection (CT DEP), and CT Occupational Safety and Health Administration (CT OSHA) regulations.  The Committee is comprised of faculty, laboratory, administration, and EH&S representatives, and meets quarterly to review laboratory safety and hazardous chemical waste issues at the University, including the Regional Campuses.  Initial laboratory safety training is required for all new professors, staff, and graduate students who will be working in laboratories; thereafter, refresher training is required every other year.

For information or assistance with issues pertaining to laboratory safety or hazardous waste storage and disposal procedures, please contact the University’s Chemical Health and Safety Manager, Stefan Wawzyniecki, or the Laboratory Safety Committee Chairperson, Dr. Ben Bahr.  Training schedules and other pertinent information are available on the EH&S webpage.

Laser Safety

The Laser Safety Committee oversees the laser safety program administered by the Department of Environmental Health and Safety (EH&S).  The Committee develops and reviews policies that help: 1) ensure a safe working environment within laboratories, and 2) maintain compliance with CT Occupational Safety and Health Administration (CT OSHA) regulations.  The Committee is comprised of faculty, administration, and EH&S representatives, and meets quarterly to review laser safety issues at the University, including the Regional Campuses.  Anyone using lasers must successfully complete the University’s online laser safety training program; please contact Dawn Kemp for enrollment information.  A laboratory-specific Standard Operating Procedure (SOP) must be developed by the Primary Laser Researcher (PLR) for each laser in use.  Specialized systems may require further training and protective equipment provided by the PLR.

For information or assistance with issues pertaining to laser safety or the development of a laser SOP, please contact the University’s Laser Safety Officer, Dr. Martin Graham, or the Laser Safety Committee Chairperson, Dr. Doug Hamilton.  Additional information is available on the Laser Safety home page.

Radiation Safety

The Radiation Safety Committee oversees the radiation safety program administered by the Department of Environmental Health and Safety (EH&S).  The Committee reviews radioactive material research protocols and develops policies that help: 1) ensure a safe working environment within laboratories, and 2) maintain compliance with US Nuclear Regulatory Commission (US NRC) regulations.  The Committee is comprised of faculty, laboratory, administration, and EH&S representatives, and meets quarterly to review radiation safety and low-level radioactive waste disposal issues at the University, including the Regional Campuses.  Initial radiation safety training is required for all new professors, staff, and graduate students who will be working with radioactive materials or x-ray producing equipment; thereafter, refresher training is required on an annual basis.  Research protocols must be reviewed and approved by the Committee before radioactive material can be ordered through EH&S.  Initial training is required for non-users who work in a laboratory where radioactive materials are used; thereafter, refresher training is provided on an as-needed basis.

For information or assistance with issues pertaining to radiation safety or radioactive waste storage and disposal procedures, please contact the University’s Radiation Safety Manager, Dr. Martin Graham, or the Radiation Safety Committee Chairperson, Dr. Carol Teschke.  Training schedules and other pertinent information, including the Radiation Safety Manual for UConn, are available on the Radiation Safety Home page.

Recombinant DNA (rDNA) and Biological Agents

The Institutional Biosafety Committee (IBC) reviews all research and teaching activities that involve recombinant DNA (rDNA), biological agents and toxins.  The purpose of the IBC review is to ensure that University activities comply with government regulations and provide appropriate safeguards for human health and the environment.  For each research or teaching project, an internal document known as a ‘Memorandum of Understanding and Agreement’ (MUA) should be submitted by the faculty member.  The IBC home page provides links to the MUA form, applicable government documents (e.g. guidelines from NIH and CDC), and other information.  For more information and further assistance with biosafety issues contact David Cavallaro, Biological Safety Officer with Environmental Health & Safety, at 860.486.3613 or Carol Auer, faculty Chairperson of the IBC, at 860.486.1878.

IRB Policies and Procedures Introduction

Overview of the Human Research Protection Program

The UConn Storrs Institutional Review Board (IRB) is responsible for the review of all human participants research at the UConn Storrs campus, the four regional campuses, the School of Social Work, and the School of Law (hereafter named UConn Storrs). The primary purpose of the Human Research Protection Program (HRPP) is to enforce the regulations which govern the protection of research participants enrolled in UConn Storrs studies through oversight by the IRB and IRB staff.

Reporting Structure

The IRB staff currently consists of the Director of Research Compliance (DRC), Regulatory Compliance Coordinator (RCC), IRB Administrator, and IRB Education and Compliance Monitor (IRB Monitor). The IRB Monitor, Regulatory Compliance Coordinator and the IRB Administrator report to the DRC. The DRC reports directly to the Vice President for Research (hereafter named VPR), the assurance signatory official (IO) for the institution.

Ethical Principles Governing Research

The HRPP supports the advancement of research by creating a collaborative relationship with the research community to ensure that research with human participants is conducted in accordance with the ethical principles of Respect for Persons, Beneficence, and Justice, as put forth in the Belmont Report. The principle of respect for persons is applied through the informed consent process. The principle of beneficence is applied through the risk/benefit analysis which includes a review of the design of the study and the procedures in place to minimize risks. The principle of justice is applied through recruitment strategies and selection of research participants.

These ethical principles are the basis of the regulations which govern the protection of human participants in research, and apply regardless of the regulatory category (i.e., exempt, expedited, or full board) under which a study is approved. Furthermore, UConn assures that equal protections will apply to all research involving human participants, regardless of funding source.

Authority from the Institution

As the IO, the VPR is charged with the responsibility of protecting human participants in research. The VPR empowers the IRB to suspend or terminate any study previously approved by the IRB or to require additional reviews. Suspension or termination may be due to serious and/or unexpected increased risks to participants, or continuing or serious noncompliance of the investigator(s) or other factors that the IRB deems warrant suspension or termination. The VPR cannot influence the decision of the IRB or approve a study that has not been approved by the IRB. The VPR also empowers the IRB to create and implement policy that will serve to protect human participants.

Policy Implementation

The authority to create, change and implement policy is shared by the IRB and Research Integrity & Compliance Services (RICS). New policies or changes to policies may be presented to the IRB to solicit input from the committee members. The VPR and DRC may also be asked to review and comment on new or changed policies and to advise the IRB/RICS regarding policy decisions. At the discretion of the VPR or DRC, input may also be sought from those parties that would be affected by the policy.

Policy Review

Every three years, the VPR and DRC will review all RICS/IRB policies that are posted on its website, regardless of the date on which the policy was implemented. Such review will include an assessment of the accuracy and relevancy of the policies, a determination as to whether the policies are in-line with institutional policies and whether there is a need for new policies to be developed. Within this document and posted on the IRB website, if an individual policy has been revised, it will show a revision date.

Support from the Institution

The institution provides support to the RICS/IRB and the IRB members in terms of staffing, office space and an operating budget, including educational opportunities. The VPR reviews the RICS/IRB budget annually with the DRC to ensure adequate resources continue to be available.

Assessment of Resources

On an annual basis, corresponding with the budget cycles, the VPR will assess the operations of the RICS/IRB to determine if additional resources are required in terms of supplies, education, staff, and/or equipment. Expenditures from the previous year, response time from the IRB to investigators, number of protocols reviewed per meeting, the number of audits conducted and types of findings, will be among the items included in the assessment. Information may also be solicited from IRB members and staff. The VPR will also take into consideration whether there were any activities, supplies or equipment that were previously forgone due to lack of resources.

Assessment of RICS/IRB Performance

On an annual basis the VPR will review a number of criteria in order to assess the overall performance of RICS/IRB and when necessary to take action to improve the performance. Criteria to be used in the evaluation include the following:

  • The number of new full board studies reviewed by the IRB annually in order to assess whether additional boards are needed due to the volume of work or whether additional expertise is needed in a certain area.
  • The findings of the audits conducted by the IRB Monitor to determine if there are common areas of noncompliance that could be improved upon with education, clarification of policy or development of new policies.
  • The performance evaluations of IRB members which consider contribution to discussion, attendance, thoroughness of review, volume of work reviewed, and participation in educational activities.
  • The performance evaluations of staff members which consider contribution to achieving the goals of the office, level of service provided to faculty, students and staff, and professional development activities.
  • The nature, number and outcome of participant complaints to determine if proper action was taken or if improvements can be made.
  • The educational opportunities with IRB members and staff attended throughout the year and whether opportunities were foregone due to lack of funding.
  • The principal investigators’ (PI) responses to the IRB Research Assessment Tool (RAT) Survey.

Applicable Regulations

It is the policy of UConn Storrs that all research involving human participants conducted by the faculty, students and staff of UConn, or research conducted using UConn facilities, is conducted in accordance with federal regulations, regardless of the funding source. Those regulations include, but are not limited to, the following:

  • Code of Federal Regulations, Title 45 Public Welfare, Department of Health and Human Services, National Institutes of Health Office for Protection from Research Risks, Part 46, Protection of Human Participants;
  • Code of Federal Regulations, 21 CFR 50, 56, 312, 812, as established by the Food and Drug Administration.

Per 45 CFR 46.103, because UConn Storrs is engaged in human subjects research (not otherwise exempt) that may be conducted or supported by an agency of the U.S. Department of Health and Human Services (HHS), UConn Storrs has an Office of Human Research Protections (OHRP)-approved Federalwide Assurance (FWA) whereby the University agrees to conduct all human subjects research in compliance with the HHS regulations. The UConn Storrs FWA number is 00007125. UConn Storrs also has an FWA with the Department of Defense (DOD)/Navy. The DoD-Navy FWA Addendum number is DoD N-A3167.

 

IRB Policy & Procedures Manual

The IRB Policies and Procedures (PDF) document sets forth the standard operating policies and procedures for Research Integrity & Compliance Services’ (RICS) Human Research Protection Program (HRPP) at the University of Connecticut, Storrs campus, the four regional campuses, the School of Social Work, and the School of Law. RICS and the IRB are the institutional entities that implement the HRPP.

This document also describes the relationships of the HRPP and IRB with other internal and external agencies. All members of the IRB, IRB staff, and research personnel are expected to be familiar with these policies.

IRB Meeting Schedule and Submission Dates

The meeting schedule and submission deadlines are posted on the web. Adjustments to the meeting schedule may be made due to holidays or other issues. Adjustments will either be noted in the published meeting schedule (when known in advance) or announced via e-mail. The submission deadline for full board reviews is 10 working days prior to the meeting date.

Material requiring full-board review must be submitted by the published submission deadlines to provide sufficient time for screening and review prior to the meeting date. The IRB staff will send the agenda and material to IRB members via hand delivery or express mail within 2 – 3 working days after the submission deadline to allow members to have at least 7 working days for review of the material prior to the meeting date.

Under unusual circumstances, the Chair may call an emergency meeting of the board. However, such a meeting will not be called due to the negligence of the investigator to submit material on time. An emergency meeting may be called, for example, when a quorum for the originally scheduled meeting was not met and review is required to prevent lapse of a study, or if an investigator is faced with a situation beyond his/her control. If not already distributed, material must be distributed to members as soon as possible to allow for sufficient review. The investigator may be asked to attend the meeting to address questions, or provide additional information or clarification.

Under unusual circumstances, the IRB staff, in consultation with the Chair, may also add an item to the agenda after the submission deadline. Such circumstances generally involve situations in which an investigator is faced with a situation beyond his/her control and an amendment must be made to the protocol. The material must be distributed (via hand delivery, e-mail or express mail) to members as soon as possible to allow for sufficient review.

ClinicalTrials.gov Registration

To register your study on ClinicalTrials.gov:

    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:

      • 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.
      • 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:

        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.

        Sponsored Program Administration (SPA) Archive

        • November 18, 2024 – Presentation slides
          •  Agenda
            • Pre-Award Services
              • Federal Sponsor Updates
                • NIH: JIT, Updated Grants Site, Calendar of Events
                • NSF: Multifactor Authentication
              • Proposal Tips & Tricks
                • Subcontract Proposal Due Dates
                • OVPR Foreign Collaborations page update
              • Negotiated Indirect Cost Rate Agreement (NICRA) Update
            • Post-Award Services
              • Food Related Expenses on Sponsored Awards
            • SPA Training
              • SRA Modules & Training Initiative
              • NIH Upcoming Events
              • NSF Fall 2024 Virtual Grants Conference
              • Training Resources

         

        • October 16, 2024 – Presentation slides
          •  Agenda
            • Pre-Award Services
              • Federal Sponsor Updates
                • NIH:  FORMS-I & Progress Reports
                • NASA:  Common Forms and new material
                • Uniform Guidance Revision
              • Proposal Tips & Tricks
              • Federal Contracting Team Reminders
            • Post-Award Services
              • Payroll Cost Transfers
            • SPA Training
              • NIH Upcoming Events
              • New NCURA videos available on the website

           

          • September 18, 2024 – Presentation slides
            • Agenda
              • Pre-Award Services
                • Federal Sponsor Updates
                  • USDA NIFA AFRI (Part I)
                  • NASA
                  • NIH
                • Proposal Tips & Tricks
                  • Intake Reminder: Full Guidelines
                  • USDA NIFA AFRI (Part II)
                • Rate Agreement Update
              • Federal Contracting Team
                • PI-Sponsor Relationships
                • Reminder: Amendment “Requests”
              • Award Set Up – Updates
            • Post-Award Services
              • Upcoming changes to Uniform Guidance
              • P-Card Transactional Reviews

           

           

          • May 15, 2024 – Presentation slides
            • Agenda
              • Export Control Overview – Mike Shelton
              • Business Integrations and Solutions – overview
              • Pre-Award Services
                • Federal Sponsor Updates
                  • NRSA Stipends
                  • NSF Common Forms effective May 20
                • Proposal Tips and Tricks
                  • Submitted Application copies
                  • Participant Support vs. Human Subject Incentives
              • Federal Contracting Team – Contracting Process
              • Post-Award Services
                • Fiscal Year-End Reminders
              • Malign Foreign Talent Recruitment Program
              • SPA Training – Upcoming SPA Meeting

           

          • April 17, 2024 – Presentation slides
            • Agenda
              • IACUC Overview – Karen Moré
              • Pre-Award Services
                • Staffing Updates
                • Federal Sponsor Updates
                  • Malign Foreign Talent Programs – UPDATE
                  • NSF – PAPPG Updates May 2024 (continued)
                • Federal Contracting Team – Unfunded Agreements 101 (Part 2)
              • Post-Award Services
                • Award Coming to an End – Best Practices
              • SPA Training
                • NCURA Region 1 Spring Meeting
                • Upcoming SPA
            • March 20, 2024 – Presentation slides
              • Agenda
                • Open Mike
                • IRB Overview – Joan Levine
                • Research Security – Mike Rock
                • Pre-Award Services
                  • Federal Sponsor Updates
                    • NSF – PAPPG Updates May 2024
                      • Malign Foreign Talent Programs
                      • Proposals Impacting Tribal Resources or Interests
                    • NIH – NRSA Fellowship Certification Form
                  • Federal Contracting Team – Unfunded Agreements 101 (Part I)
                • Post-Award Services
                  • Cost Allocation – Reminders and Best Practices

             

             

            • January 17, 2024 – Presentation slides
              • Agenda
                • New FCOI Form – Kristen Tremblay, FCOI Research Committee
                • Pre-award
                  • Federal Sponsor Updates
                    • U.S. Department of Energy Pre-Award Information Sheets
                    • NIH Foreign Subawards policy
                  • Proposal Tips & Tricks
                  • Federal Contracts Team Updates
                  • Award Set-Up Updates
                  • Post-award
                    • GEMS Transition – RPPR Reporting Update
                    • Final Reporting Enforcement
                  • SPA Training announcements
                    • New e-learning modules
                    • Resources
                    • Next SPA meeting

             

            • November 15, 2023 – Presentation Slides
              • Agenda
                • InfoEd v13 Portal View Sunset
                • Pre-Award Services
                  • Organizational Updates
                  • Federal Sponsor Updates
                  • Proposal Tips & Tricks
                • Pre-Award Services – Fed Team Updates
                  • Requesting Award Action or Review
                • Post-Award Services
                  • Cost Transfer Best Practices
                • SPA Training
                  • NCURA – Region 1 Spring Meeting
                  • SPA Training Resources
                  • December SPA meeting
            • October 18, 2023 – Presentation Slides
              • Agenda
                • AP/Travel Updates – Dan Warren and Nancy Patrylak
                  • Update on Concur Working group
                  • Outstanding University Travel Card transactions as well as Concur Expense reports
                • Effort Reporting Updates
                • Pre-Award Services
                  • Federal Updates and Deadlines
                  • DMPTool Resource
                  • Proposal Tips and Tricks
                • Pre-Award Services – Fed Team
                  • Read and Comply for “TikTok Ban”
                • Post-Award Services
                  • InfoEd – Post-Award Overview
                  • GEMS Transition – Reporting
                  • NSF Project Reporting Enforcement Pilot
                • SPA Training resources
            • September 20, 2023 – Presentation Slides
              • Agenda
                • IBC presentation – Danielle Delage and David Cavallo
                • Procurement updates – David Denuzzio and BJ Pivonka
                • Pre-Award Services
                  • Reminders re: Full Applications
                  • Federal Updates/Deadlines
                    • NSF RCR requirement
                    • NSF FastLane (9/29/23) and ScIENcv (10/23/23) deadlines; CPS document certification
                    • Upcoming NASA COI change (12/1/23); upcoming CT Space Grant deadline (10/13/23)
                    • NIH DMS Costs (no longer in a single line item) (10/5/23)
                  • Proposal Tips & Tricks/Upcoming Guidance
                      • Transfer application IDC rates
                      • Cost Share Priority Grid
                  • SPS Agreements
                    • Two Teams: Fed and Non-Fed
                    • Single Inbox for agreements
                • Post-Award Services
                  • Rebudgeting Best Practices
                  • Consulting/Professional Services Invoice Checklist guidance
                • SPA Training – upcoming classes
              • May 17, 2023 – Presentation Slides
                • Agenda
                  • Contracts Update
                  • Staffing Updates – SPS
                  • Pre-Award Services
                    • Federal System Updates
                    • Creation of System Logins
                    • Reps and Certs
                    • Proposals Tips and Tricks: 
                      • Upcoming Resources
                  • Post-Award Services
                    • New Awards Best Practices
                    • Year End Reminders
                  • SPA Training
                    • Upcoming SPA Training classes –  class attendance request
                    • Next SPA meeting
              • April 19, 2023 – Presentation Slides
                • Agenda
                  • Pre-Award Services
                    • Review of Late Submissions
                    • Redaction of NASA ROSES Budgets
                    • NSF: Safe and Inclusive Research Update​
                    • NSF:  Results from Prior NSF Suppport
                    • Proposals Tips and Tricks: 
                      • FCOI Reminders
                  • Post-Award Services
                    • Closeouts Best Practices
                  • SPA Training
                    • Upcoming SPA Training classes
              • March 15, 2023 – Presentation Slides
                • Agenda
                  • Pre-Award Services
                    • Cost Share Budget Fringe Benefit Rates​
                    • U.S. Department of Energy Interim Conflict of Interest Policy​
                    • Proposals Tips and Tricks: 
                      • IDCs on Cost-Shared Expenses 
                      • Participant Support vs. Human Subjects
                  • Post-Award Services
                  • SPA Training
                    • Upcoming SPA Training classes
              • February 22, 2023 – Presentation Slides
                • Agenda
                  • Tax & Compliance Office
                    • BEC Designations in Concur
                  • Pre-Award Services
                    • NIH Reminders: NRSA Stipends Updated 
                    • Pre-Award Delegated Signature Authority 
                    • NSF Safe & Inclusive Work Environment Requirements 
                    • Top 5 IPR Pitfalls 
                    • Final Submission Documents Reminder 
                    • Proposals Tips and Tricks: 
                    • Using the OSA rate  
                    • F&A Costs for State Entity Sponsors 
                  • Post-Award Services
                    • Best practices for submitting No-Cost Extensions
                    • NCE Matrix
                  • SPA Training
                    • Updated SPS Policies
                    • CRA study group
                    • Upcoming SPA Training classes
              • January 25, 2023 – Presentation Slides
                • Agenda
                  • Pre-Award Services
                    • January 2023 Federal Agency Updates
                    • New SPS Federal Disclosure Resources
                    • Full Proposal Document(s) at Intake
                    • Proposal Tips and Tricks!
                  • Contract Services Group
                    • Non-Disclosure Agreements
                  • SPA Training Update
              • November 16, 2022 – Presentation Slides
                • Agenda
                  • Procurement Process Challenges & Improvement Plan – Joe Thompson
                  • InfoEd updates
                  • Pre-Award Announcements and Reminders
                  • Best Practices: Proposal Materials
                  • Proposal Tips and Tricks
                    • Determining PI Eligibility
                    • Budgeting – Equipment vs. Supplies
                  • Concur from the Post Award Lens
                  • Overview of Agreements reviewed/negotiated by Contracts Group
                  • SPA Training Announcements and Update
              • October 19, 2022 – Presentation Slides
                • Agenda
                  • Accounts Payable – Concur Best Practices
                  • NASA Certification Reminder
                  • NIH Data Sharing and Management Plan
                  • Proposal Tips and Tricks!
                  • Greenphire Update
                  • Annual Data
                  • SEBAC increases final update/review of payroll transactions & anticipated impact on effort reporting
                  • Contract Submission reminders
                  • SPA Training – upcoming classes
              • September 21, 2022 – Presentation Slides
                • Agenda
                  • Introduction of new Pre-Award staff
                  • Salary increases and proposal budget escalation
                  • Grants.gov downtime 9/23-29
                  • Transition from FastLane to Research.gov
                  • NASA Questionnaire
                  • NIH Data Management and Sharing Policy – upcoming changes
                  • Budgeting of fellowships vs. salaries
                  • Post-Award staff changes
                  • Post-Award operations updates
                  • Contract Services Group – contacts and updates
                  • SPA Training – Upcoming classes
              • May 18, 2022 – Presentation Slides
                • Agenda
                  • SPA Announcement
                  • Pre-Award Announcements and Reminders
                  • Demystifying Other Support and Current & Pending:  Tools, Tips, and Tricks
                  • SPS Projects in the Works
              • April 20, 2022 – Presentation Slides
                • Agenda
                  • Year-end reminders
                  • Transition from Fastlane to Research.gov
                  • Transition to UEI usage – all subaward commitment forms and grants.gov packages
                  • NIH FAQ
                  • DocuSign drop-in sessions – learn about the visibility session
                  • Proposal Policy Implementation Update
                  • USDA IDC Rate calculation – Pre-Award and Post-Award perspective
              • February 16, 2022 – Presentation Slides
                • Agenda
                  • Pre-Award Updates
                  • DHHS/NIH Update – Salary Cap
                  • Addition of UEI to Subrecipient Commitment Form
                  • Update on NIH ‘Other Support’ process
                  • Clarification on 5-day proposal process
                  • Overview of 50K program
                  • Subaward Invoice Review
                  • FileLocker
                  • Mid Year Review
                  • Leadership Updates
              • October 20, 2021 – Presentation Slides
                • Agenda
                  • Research Development Services
                  • Greenphire Updates
                  • Fall 2021 NIH Virtual Seminar on Program Funding and Grants Administration Registration
                  • Change to NIDCD Admin Reduction Guidance for Modular R01 Awards
                  • New Hires to SPS
                  • Pre-Award Updates
                  • Proposal Dashboard Addition
                  • IPR Language Update
                  • Black Friday Update
              • September 15, 2021 – Presentation Slides
                • Agenda
                  • Fall 2021 NIH Virtual Seminar on Program Funding and Grants Administration Registration
                  • Unique Entity Identifier for Federal Sponsors
                  • NIH Updated Policy for Family Leave and Unpaid Leave for Extramural Loan Repayment Program
                  • NSF Website Enhancements
                  • Extending the Special Exception to the NIH/AHRQ/NIOSH Post Submission Material Policy During COVID-19
                  • NSF Pre-Award and Post Award Disclosures Related to the Bio-Sketch
                  • Scope of Work Change
              • June 16, 2021 – Presentation Slides
                • Agenda
                  • Staff Introductions
                  • Fringe Benefits
                  • NSF Publications Repository Changes
                  • New NIH Inbox for Biographical Sketch and Other Support Questions
                  • Revised NIH Grants Policy Statement
                  • eRA Commons Expanding Requirements for IDs
                  • What’s an Application Packet and When is it Needed
                  • Proposal Submission 9:00 am Due Date
              • May 19, 2021 – Presentation Slides
                • Agenda
                  • Effort Reports are available (no slide, just a reminder)
                  • Introduction – Rashonda Harris, Director of Post Award
                  • Year End Reminders
                  • Proposal Submission Policy Timeline and Reminders
                  • Fringe Benefit Rates
                  • NIH Biographical Sketch and Other Support
                  • Training Reminders
              • April 21, 2021 – Presentation Slides
                • Agenda
                  • Joni Gould Retirement
                  • C onsultants & Contractors on Sponsored Awards – Kathleen Kearney
                  • Salary Cap
                  • American Heart Association Carryover and No Cost Extension Updates and Reminders
                  • Publications and Printing Costs on Sponsored Awards
                  • IPR Routing Tips
                  • eRA Commons Phasing Out Internet Explorer
                  • Redesigned RePORT Tool
                  • eRA Commons Login Tip
                  • NIH Biographical Sketch and Other Support
              • March 17, 2021 – Presentation Slides
                • Agenda
                  • Proposal Development Services Overview
                  • IPR Form Overview
                  • NIH Update
                  • SPS Metrics YTD Comparison-Proposals/Awards
                  • Proposal Deadline Implementation
              • February 17, 2021 – Presentation Slides
                • Agenda
                  • New Initiatives with Trish Casey
                  • Cost Transfers
                  • NRSA
                  • Salary Cap
                  • Summer 2021 Effort
                  • Pcard Transactions
                  • SPS Personnel Update
                  • Preaward Update/Presidential Group
              • December 16, 2020 – Presentation Slides
                • Agenda
                  • Foreign Influence-Wesley Byerly
                  • Current and Pending – Other Support
                  • General Ledger Transfers
                  • HRSA/PMS
                  • January Federal Costing Principles Training
                  • SPA Meeting Calendar Request
                  • ERA Commons Update
              • November 18, 2020 – Presentation Slides
                • Agenda
                  • Procard Presentation
                  • Greenphire
                  • UConn Sponsored Program Metrics
                  • Effort Reporting Covid-19 Related Certification Statement
                  • OVPR Proposal Submission Faculty Survey Results
                  • Proposal Submission Update
              • October 21, 2020 – Presentation Slides
                • Agenda
                  • F&A on Projects of $50K or Less
                  • Use of Hypertext in NIH Grant Applications
                  • Cost Sharing Reminders and Clarifications
                  • NIH Virtual Seminar
                  • Expenditures on Sponsored Awards – Guidance
                  • Pay on Federal Grants in June 2020 – PI Verification
                  • Proposal Process – Under Development
                  • Jeopardy!
              • September 16, 2020 – Presentation Slides
                • Agenda
                  • Effort Reporting
                  • NIH & HRSA Transition to Payment Management System
                  • No-Cost Extension Request Form Updates
                  • Subaward Invoice Review
                  • KFS Upgrade – Non-Payroll Cost Transfers
                  • Book Club and CRA Study Group Updates

                              Types of Research

                              While FDA-regulated and other biomedical studies are conducted on campus, the research conducted at UConn Storrs is primarily social/behavioral in nature.  Although federal regulations for the protection of human participants cover both biomedical and social/behavioral research, they are not specific regarding the various types of social/behavioral research.  Therefore, the IRB developed the guidance to assist in the development and review of Qualitative/Ethnographic, Focus Groups, Oral History and other types of social/behavioral research.  The guidance is available on the IRB website.

                              Review of Studies Conducted in Foreign Countries

                              Research conducted by UConn investigators in foreign countries remains under UConn purview and guidelines.  While adjustments may be made to some requirements to respect cultural differences, our standards for ethical conduct are not relaxed.

                              The IRB may require that research projects be approved by the local equivalent of an IRB before the IRB will grant final approval.  Where there is no equivalent board or group, investigators must rely on local experts or community leaders to provide approval.  The PI must provide the IRB with documentation of this “local approval” and documentation of the authority and expertise of the individual or group who granted approval.  There must also be detailed plans in place for local monitoring of studies that pose more than minimal risk to participants.  Researchers must describe what, if any, knowledge or experience they possess regarding the language and culture of the country in question.  If the IRB is not satisfied with the review of local experts and/or the plans for continued monitoring there is the possibility that the study will not be approved.

                              The IRB may seek guidance first from OHRP’s International Compilation of Human Subject Research Protections or it may contact OHRP to determine whether procedures described by a foreign institution afford protections that are at least equivalent to U.S. regulations 45 CFR 46.101(h) and may be substituted for the U.S. regulations.  Under this provision, OHRP investigates the foreign country’s guidelines for human participants research, and if the foreign guidelines are found to be equivalent to U.S. regulations, the investigator is permitted to substitute those foreign procedures.

                              Research Requiring Review More Frequent Than Annually

                              The IRB will require that continuing review occur more often than annually in the following circumstances:

                              • The research involves the use of procedures that have not been studied in humans.
                              • The research is expected to result in a high frequency of morbidity or mortality.
                              • The investigator has a history of serious or continuing noncompliance that the IRB believes necessitates closer monitoring.
                              • Any other situation in which the IRB believes that more frequent continuing review is warranted.

                               

                              Verification from Sources Other Than Investigators:

                              The IRB will require independent verification from sources other than the investigator that no material changes (i.e. changes that are both relevant and consequential) have occurred since previous IRB review in the following situations:

                              • When there is inconsistency in the information presented by the investigator to the IRB and those inconsistencies cannot be easily resolved.
                              • When the IRB questions the ability or the willingness of the investigator to provide accurate information.
                              • When concerns have been raised, via continuing review or from other sources, that material changes have been implemented without IRB approval.
                              • Other circumstances for which the IRB deems independent verification is needed.

                               

                              In most cases the Research Compliance Monitor will conduct the verification.  The monitor has access to all research data and may observe the research and consent process.  The IRB may require that an ad-hoc consultant with particular expertise review the research activity.  Such consultants will not have a professional or financial interest in the research.  The IRB Chair may determine who will act as the consultant and will also confirm that no conflicts exist.  The individual performing the verification will provide the IRB staff with a written statement of the verification.  The IRB staff will make this information available to the IRB members and also place a copy in the IRB study file.

                              Scientific Review

                              The Common Rule and corresponding FDA regulations require the IRB to determine that the study is designed so that risks to participants are minimized and justified by potential benefits (refer to 45 CFR 46.111(a)).  Therefore, the IRB will carefully consider the study design and overall scientific quality of each study, particularly those studies that are investigator-initiated and/or unfunded.  In evaluating the scientific design, the primary reviewer (exempt and expedited studies) or the primary reviewer and convened IRB (full board studies), will consider the following:

                              • clarity of the research question
                              • appropriateness and efficiency of design
                              • rigor and feasibility of methods
                              • qualifications and expertise of the research team
                              • scholarship and pertinence of background material and rationale
                              • adequacy of sample size and relevance of controls and
                              • the validity of the statistical analysis plan.

                               

                              When necessary the IRB may ask consultants with additional expertise to review the research study.

                              Categories of Study Status

                              Submissions to the IRB will fall into one of the status categories noted below:

                              • Approved     This decision is used when a study is given final approval either through the exempt, expedited, or full board review process.  Final approval of a full board study means that all modifications initially required have been addressed.  If the study is approved through the expedited or exempt review process, the specific category by which expedited or exempt review is permissible is noted.  A study can begin only after final approval is granted.  This category is also used to reflect approval of requests for continuations and amendments.
                              • Modifications Required in Order to Secure Approval –    This decision is used when the full board has reviewed a study at a convened meeting and requires minor modifications before final approval will be given.  This category may also be used for expedited review, requests for continuation (re-approval), and amendments.  Upon satisfactory response to the request for modifications, the Chair or his/her designee is authorized to grant final approval without re-review by the full board. The IRB may also request that the PI make modifications to an application for initial or continuing expedited or exempt review.  This is communicated to investigators through letters from the IRB.  Final approval of an expedited or exempt study means that the requested modifications initially identified have been satisfactorily addressed.
                              • Deferred  –   This decision is used when the full board has reviewed a study at a convened meeting and has significant concerns with the protocol, consent document or other relevant material, or requires substantive clarifications on issues that relate to the required criteria for approval.  For example, if the protocol contains insufficient information to assess the nature and purpose of the study, or if the IRB requires clarification as to why a procedure is being followed in the study, the study will be deferred until the convened IRB can determine that risks to participants are minimized.  The PI is encouraged to make a point-by-point response in writing, and must resubmit the application for full board review.  This category may also be used for requests for continuation and amendments.
                              • Disapproved  –  This decision is used when the full board reviews a study and determines that one or more of the elements required for approval (refer to Criteria for Approval section) has not been met, and in the Board’s opinion, cannot be satisfied through revisions to the application (for example, if the Board determines that balance of risks to benefits is unacceptable).  This category may be used for requests for continuation and amendments.  The decision is made by the convened IRB.  Protocols may not be disapproved by the expedited or exempt review mechanism.
                              • Tabled    This category is used only when a study is not reviewed at the meeting for which it was originally scheduled, for example, due to loss of quorum.  This category may also be used for requests for continuation and amendments.
                              • Closed      This decision is used to reflect that a study is closed/completed.  An investigator may request closure of a study when the research project will no longer be pursued, or when data analysis is finished, and the essential work of the study is completed.
                              • Terminated  –  This decision is used to reflect that a study has been closed by the IRB.  A study may be terminated due to failure to request continuing review beyond a 30-day grace period after the study expiration date.  The IRB may terminate a study for noncompliance or due to the occurrence of serious or unexpected risks to participants.  Termination of previously approved research is defined as a permanent withdrawal of study approval that requires all study related activity to cease.  The investigator will be notified of studies terminated by the IRB.  Terminations are not reportable events.
                              • Suspended  –  This decision is used to reflect the imposition of a temporary hold on any or all research activity associated with a study, or a permanent stop to some portion of a previously approved research activity.

                              IBC & Biosafety Forms

                              IBC Registration – Biological Summary

                              The UConn IBC for Storrs and Regional Campuses use an electronic database called HuskySMS (powered by SciShield), to review and approve registrations and amendments. New labs must be bio-enabled by the IBC Coordinator. Please contact the IBC office via email, ibc@uconn.edu, to begin the registration process.

                              To access HuskySMS, use the following url: uconn.scishield.com. Personnel can log in using their UConn NetID and password.

                              If you have any questions about HuskySMS and or need assistance with the biological summary, please feel free to contact ibc@uconn.edu with  “HuskySMS Support” in the subject line.

                              IBC Incident Reporting Form

                              To report any research or instructional related incidents involving biological materials (e.g. needle sticks, percutaneous or mucous membrane exposures, spills outside of primary containment, etc.).

                              Training Verification Form

                              This form can be used to show that LSBM training has been completed on an annual basis. The rest of the training columns are optional, since all training is tracked in the HuskySMS Training Module.

                              If you choose not to include dates of training using this form, be sure to print personnel training records from HuskySMS and include a copy in the training tab of the LSBM. These records can be found in the “Training” tab of the lab’s dashboard, and selecting “Training Records”.

                              IACUC Forms

                              Animal Care and Use Protocol Form (IACUC-1)

                              Petition to Exempt Activities Using Invertebrates, Biological Materials, or Animal Observation in Teaching or Research (IACUC-2)

                              Owner Consent Form (Appendix B)

                              Personnel Assigned to Work on Animal Research Protocols (Appendix C)

                              Use of Hazardous Agents (Appendix D)

                              Consideration of Alternatives (Appendix E)

                              Surgery (Appendix G)

                              Occupational Health & Safety Animal Handler Form
                              Must be completed along with the IACUC-1 form and submitted to the appropriate department.

                              Animal Care Services Forms

                               


                              References and Checklists

                              Checklist of Required Documentation

                              Checklist of Required Content

                              Pain Classification

                              Principal Investigator Responsibilities

                              IRB Submissions, Forms & Templates

                              InfoEd IRB Module Updates Go-Live on December 16th!

                              See the InfoEd Updates page for more information.

                               

                              NEW studies with external funding and studies with more than 2 external collaborators/study personnel are now submitted to BRANY IRB.

                               

                              Please visit the BRANY IRB tab under IRB Reliance for more information.

                              IRB Submission Software 

                              Human Subject applications, protocols and associated supplemental materials are submitted to the IRB using the Human Subjects/IRB Module of the UConn InfoEd eRA Portal at https://www.infoed.uconn.edu. See the How To Guides for more information on using InfoEd, including step-by-step instructions for creating initial and other types of IRB submissions (amendments, requests for continuation/closure, and reportable information or events including protocol deviations or adverse events). For technical assistance using InfoEd, email era-support@uconn.edu or call 860.486.7944. The eRA Help Desk is staffed Monday-Friday, 8:00 a.m. to 4:30 p.m.

                              Adding Undergraduate Students to InfoEd

                              Undergraduate students are not auto-populated into InfoEd. Each undergraduate student must be manually added to the system. Click here to add undergraduate students to InfoEd prior to adding these students as key personnel on the Appendix A Personnel form. Adding the students before completing the Appendix A form will result in less time and effort completing the form.

                              Uploading CITI training completion reports to InfoEd

                              Please follow these instructions for uploading CITI completion reports as part of your IRB protocol submission. Completion reports are required only when (1) adding UConn personnel who completed training elsewhere or (2) adding non-UConn personnel.

                              Submission Forms

                              For assistance with preparing your IRB submissions forms, contact the IRB Office at irb@uconn.edu to schedule an individual help session.

                              Human Subjects Research (HSR) Determination

                              Investigators who are unsure if their proposed activity constitutes “human subjects research” according to federal regulations, may submit a Human Subjects Research (HSR) Determination Form through InfoEd. The IRB Chair and/or their designee will determine if the proposed activity meets the regulatory definitions of “human subjects” and “research” and advise as to next steps regarding need to secure formal exemption or approval from the IRB.

                              This form is also used for 45 CFR 46.118 certifications (aka Approval in Principle, Development Only, Delayed Onset).  A grant or contract may require certification of IRB approval as a condition of submitting for or releasing funds but before definitive plans for the involvement of human subjects have not been developed.  A sponsor may require this certification if the specific activities of the research have not yet been determined because there is significant activity needed prior to involving human subjects (i.e., development of measures, animal studies).  Refer to 4.1.15.2 in the NIH Grants Policy Statement or the NSF Proposal & Award Policies and Procedures Guide (PAPPG), Chapter II: proposal Preparation Instructions, Section E(5) for information.  Note that 45 CFR 46.118 certifications are not limited to proposals submitted to Federal Agencies.

                              Human Subjects Research (HSR) Determination Form

                              For help submitting the HSR determination form using InfoEd see this help guide.

                              Submission Components

                              For initial submission to the IRB, please submit the following components listed below. The IRB may request additional forms or information that are specific to the research and will assist the IRB review of the submission. Please note that students may not serve as PI, a faculty PI must be named and oversee student-initiated research.

                              Exempt & Limited Submissions:

                              1. IRB-5 electronic application form. This form is located in InfoEd;
                              2. IRB-5 Word document Study Protocol;
                              3. Appendix A Personnel form for studies with key personnel in addition to the PI (or student and faculty advisor). This form is located in InfoEd;
                              4. Data Security Assessment Form;
                              5. Consent Forms, Assent Forms, Parental Permission forms (as applicable), Consent Scripts and Information Sheets;
                              6. Recruitment materials, including advertisements intended to be seen or heard by potential study participants;
                              7. Letter(s) of permission from any non-UConn-Storrs sites; or, when applicable, documentation of IRB approval or exemption from the external site;
                              8. Any other participant-facing materials (e.g., questionnaires, surveys, diaries, instructions, screening, etc.);
                              9. Internal UConn grant application, when applicable;

                              Quick Tips for Exempt Submissions

                              Expedited & Full Board Submissions:

                              1. IRB-1 electronic application form. This form is located in InfoEd;
                              2. Study Protocol (see templates below);
                              3. Appendix A Personnel form (unless study involves only PI or student and faculty advisor). This form is located in InfoEd;
                              4. Data Security Assessment Form;
                              5. Consent Forms, Assent Forms, Parental Permission forms (as applicable), Consent Scripts and Information Sheets;
                              6. Recruitment materials, including advertisements intended to be seen or heard by potential study participants;
                              7. Letter(s) of permission from any non-UConn-Storrs sites; or, when applicable, documentation of IRB approval or exemption from the external site;
                              8. Any other participant-facing materials (e.g., questionnaires, surveys, diaries, instructions, screening, etc.);
                              9. Details (e.g., investigator brochure, labeling, instructions for use, diagrams, etc.) concerning any test articles being evaluated

                              Study Protocol Forms

                              Standard Protocol Template

                              IRB-5 Study Protocol for Exempt and Limited IRB Review

                              Ethnographic Protocol Template

                              Repository Protocol Template

                              Data Security Assessment Form

                              Supplemental Forms

                              dbGaP Access Assurance Form

                              Faculty Review Sheet, to aid in the review of student projects

                              Templates

                              Consent Templates

                              Informed Consent Resource for Secondary Research with Data and Biospecimens: https://osp.od.nih.gov/wp-content/uploads/Informed-Consent-Resource-for-Secondary-Research-with-Data-and-Biospecimens.pdf

                              Consent Checklist for Investigators

                              For Non-exempt (Expedited, Full Board Review) Studies:

                              Adult Consent Form Template

                              Simplified Consent Form Template This template may be used in conjunction with the template for the adult consent form for people with communication disorders. Emily Myers, Ph.D. developed this form for research participants with communication disorders, such as aphasia, and generously provided permission for its use by others. This form or another method may be proposed when enrolling individuals with communication disorders where the process will help facilitate comprehension and enable participants to make informed decisions about research participation.

                              Parent Permission Form Template (for participants under 18 years old)

                              Assent Form for Minor Participants (under 18 years old)  Federal regulations do not dictate how minor assent is documented. This template is designed to be used with younger children with the content of the Adult Consent or Parent Permission Form used as a guide. The assent process should convey the information noted in the assent template using age-appropriate language. Use of this template is not required; Investigators should develop assent processes and forms that are appropriate for the population that they will enroll.  For example, when enrolling teens, it may be more appropriate to have an assent form that is similar to the Adult Consent or Parent Permission Form.

                              HIPAA Authorization Form Template

                              For Exempt/Limited Studies:

                              Exempt Study Adult Prospective Agreement/Consent Form Template

                              Exempt Study Parent Prospective Agreement/Permission Form Template (for participants under 18 years old)

                              Exempt Study Assent Form for Minor Participants (under 18 years old)  Federal regulations do not dictate how minor assent is documented. This template is designed to be used with younger children with the content of the Adult Consent or Parent Permission Form used as a guide. The assent process should convey the information noted in the assent template using age-appropriate language. Use of this template is not required; Investigators should develop assent processes and forms that are appropriate for the population that they will enroll.  For example, when enrolling teens, it may be more appropriate to have an assent form that is similar to the Adult Consent or Parent Permission Form.

                               

                               

                              Recruitment Flyer Template

                              Important! When preparing an announcement for the Daily Digest, Lifeline or similar, please be reminded that online platforms often have character limits that could impact study postings; tag lines and headings should provide information about the study and should not emphasize that subjects are paid for participation. The IRB study number is required on any announcement.

                              Sample Recruitment Flyer Template (with tabs)

                               

                              InfoEd

                              Human Subject applications, protocols and associated supplemental materials are submitted to the UConn Storrs and Regional Campus IRB using the Human Subjects / IRB Module of the UConn InfoEd eRA Portal at https://www.infoed.uconn.edu.

                              See the Human Subjects / IRB How To Guides for more information about the using the InfoEd (Storrs) eRA portal including step-by-step instructions for creating initial IRB protocols and other types of protocol submissions (modifications, requests for continuation/closure, and protocol deviations or adverse events).

                              For technical assistance using the InfoEd eRA Human Subjects module, email era-support@uconn.edu or call 860.486.7944. The eRA Help Desk is staffed Monday-Friday, 8:00 AM – 4:30 PM.

                              Proposal (Pre-Award) Forms

                              SPS must receive proposals and supporting documents at least 5 working days prior to the program deadline to ensure review and sign-off.

                              Internal Proposal Review Form
                              Required to be completed for all new proposals, requests for supplements, continuations, and renewals to be reviewed and approved by SPS. Save form to your PC before filling out the form.  Note: for preproposals and letters of intent, signatures are not required.

                              Instructions:

                              Distribution of Credit.

                              Program Type Definitions & Examples.

                              Key and/or Responsible Personnel Supplemental Form
                              Required to be completed for all proposals with more than eight Multiple PIs, Co-Principal Investigators, or other Key and/or Responsible Personnel. Save form to your PC before filling out the form.

                              Cost Share Form
                              Required to be completed for all proposals committing cost sharing. All cost sharing requires the written approval (documented by signature or other written form) from the appropriate individual providing the cost sharing.  This form is not required for salary over the cap.  Save form to your PC before filling out the form.

                              SPS Proposal Cover Page
                              Required to be completed by the PI and signed by SPS signatory if sponsor does not provide a document to be signed by SPS signatory including applications where UConn submits as a subawardee.

                              Attachment for Human Stem Cell Research
                              For all research that involves the use of human stem cells or human embryos, and for all research projects submitted to the State of Connecticut Regenerative Medicine Research Fund (RMRF).

                              Information and Compliance Form for Subrecipients
                              Required to be completed by the Subawardee and signed by Subawardee signatory.

                              External Investigator Financial Disclosure Form
                              Required to be completed by all responsible personnel from other institutions who do not have a compliant Financial Conflict of Interest policy.

                              NASA Certification
                              Required to be completed when seeking funding from NASA.

                              NIH Multiple PI Certification Form
                              Required to be completed and signed by PIs from other institutions involved in multiple PI applications.

                              NIH NRSA Fellowship Certification Form
                              Required to be completed by Individual Fellow and submitted with all NIH PHS 416-1 grant applications, PHS 416-9 progress reports, and prior approval requests. Save the form to your PC before filling out the form.

                              NSF Safe and Inclusive Working Environment Resource Document (includes Plan Template)
                              Plans must be provided to Pre-Award Services for all National Science Foundation proposals involving off-campus or off-site research.

                              Request for Approval to Serve as Principal Investigator Form
                              Required to be completed by employee requesting approval to serve as PI or Co-PI who are normally considered ineligible and submitted to SPS for approval.

                              Electronic Research Administration Forms

                              InfoEd User Account Information Request Form
                              Use this form if you have forgotten your InfoEd Username/Password or are unsure if you have a user account.

                              Research.gov Account Registration Form
                              Investigators who wish to obtain NSF funding are required to register with the Research.gov.  Complete this Research.gov form if you need to establish a user account.  Once completed, SPS will receive an email notification from Research.gov and approve the registration.  Step-by-step instructions can be found in the Account Registration Guide.

                              NIH eCommons Account Request
                              Investigators who wish to obtain NIH funding are required to register with the NIH e- Commons system. Complete this form if you need to establish a user account.

                              dbGaP
                              Use this form to request access to data sets from the appropriate dbGaP Data Access Committee.