Research agreements between the University and outside entities come in many form and serve a wide array of purposes. They cover applied research, evaluation, training, demonstrations, material transfers, confidentiality terms and data use, intellectual property, and more.

Through these agreements, we partner with a wide array of entities, both governmental (local, state and federal) and private (corporate and non-profit).

Our Contracts Team assists you in creating, negotiating and executing these agreements by facilitating discussion and negotiating terms.

Contact us at spscontracts@uconn.edu. Bring us in early. We are here to help!

The mission of Environmental Health & Safety is to provide comprehensive environmental health and safety services for the University community by developing and administering effective policies and procedures that prevent personal injuries and maintain regulatory compliance in the areas of biological, chemical, occupational, and radiation safety, thereby supporting the University’s mission of teaching, research, and public service.

In order for the University to conduct human subjects research supported by the Department of Navy (DON) through contracts, grants, cooperative agreements, or through other arrangements such as collaborations with DON personnel, the UConn IRB obtained a DOD-Navy Addendum to the FWA held by UConn.  The DON Human Research Protection Program requires training for Extramural Performers.  To meet the requirements for continuing education, all personnel who conduct, review, approve, support, manage or oversee DON-supported human research must complete three to six hours of continuing research ethics and human subject protections training every three years.

UConn researchers (PIs, Postdoctoral Fellows, Research Assistants, Graduate/Undergraduate students) are considered Extramural Performers as are IRB Members, IRB Staff and the University’s Institutional Official.  All Extramural Performers, regardless of their role in research, will complete the CITI training course “DON-Supported Extramural Performers.”

There are several options available to meet the continuing training requirement, including a new Refresher Course on the Collaborative Institutional Training Initiative (CITI) website.  Personnel who completed initial training through CITI may now access and complete the Refresher Training course in order to fulfill continuing education requirements for Extramural Performers.

Investigators who plan to apply to the Department of Navy for funding are strongly encouraged to plan accordingly and to contact Research Compliance Services before the research proposal is submitted to discuss these and other requirements.

1. 1. Login to CITI. If you’ve forgotten your username or password, contact Doug Bradway at 6-0986 or by email at doug.bradway@uconn.edu.
   2. Under the Main Menu second bullet, select the link for “Affiliate with another institution.”
   3. Go to the “Participating Institutions” pull down menu and select “Department of The Navy” and click “Submit.”
   4. Complete the required member information fields. In the “Your Command” field select “DON Extramural Performers” and click “Submit.”

You will now be asked to answer a series of questions. Please select the following:

1. What kind of research are you conducting? Select the first option ” I am conducting, planning to conduct, or am otherwise involved in research with human subjects, tissues from humans and/or patient records” and click “Next.”
2. Social/Behavioral Science Question. Select “The Biomedical Sciences” since the UConn IRB reviews both Biomedical and Social and Behavioral Science research. Click “Next.”
3. Are you taking initial or refresher? Select “Initial” and click “Next.”
4. What is your role? Select “DON-Supported Extramural Performers – Biomedical” and click “Next.”
5. Are you required to complete the CITI Good Clinical Practice Course? Select “No, not at this time” and click “Next.”
6. Are you required to complete the RCR training? Select “No, not at this time” and click “Next.”
7. Do you want to review IRB Reference Resource materials? Select “NO – Perhaps some other time” and click “Next.”
8. Now, you should be back to the Main Menu and the Department of the Navy “DON-supported Extramural Performers, Initial Training” course should be listed as “Incomplete.” Click the “Re-enter” link.
9. The required modules should be listed. You may receive credit for prior modules completed at UConn. If so, the module name and completion date will be listed in green. Click “The Integrity Assurance Statement” link, read the statement and select the appropriate assurance statement. Click “Submit.”
10. Now, you should be back to the required modules list. The first module you’ll need to complete should be underlined. Click this link and complete the module. Continue to complete all the modules until the course is completed. Note that some modules do not have an exam.

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

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.

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.

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.