OCTR provides fiscal support services to principal investigators and administrative staff conducting clinical trials or research at UConn Health. Newly approved clinical trials will be assigned a fund number on the university’s Banner accounting system. This account will be set up and administered in our office in order to track study related financial activity.

• Banner Fund Set-up
• Initial Budget and Budget Supplements
• IPAS+
• Sponsor Payments
• Study Related Expenses

Banner Fund Set-Up

OCTR staff will assign a clinical trial INFOED number and assign a Banner fund number to the study. The six digit fund code is unique to the study and will be used to designate all transactions associated with the study in the university’s Banner accounting system. In addition to the six digit fund code, a complete set of coding will include the organization code, account code and program code. FOAPAL refers to:

Once the Banner fund is set-up, we will notify you by email.

Initial Budget and Supplements

Once the Banner fund account has been established, OCTR staff will load the initial budget into Banner. The initial budget will be set at a portion of the expected income and expense anticipated over the course of the study. A memo will be sent to the Study Administrator and the Principal Investigator (PI) detailing the accounts and amount of funds included in the initial budget.

Supplements to the budget will be completed as the study progresses, subjects are added and payments are received. A memo will be sent notifying administrative staff and the PI of each new budget supplement.

Institutional Prior Approval System (IPAS) or No Cost Extension

Frequently studies are extended beyond the contractual end date of the original agreement between the sponsor and the PI. Once an addendum to the clinical trial agreement (CTA) has been completed, the study administrator should initiate an IPAS+ Form.

OCTR will then extend the study on Banner.

Sponsor Payments

Payments by check are received in research finance and by wire in general accounting. If you receive the check directly, please deliver the check to research finance as soon as possible (MC 5335).

Once deposited, OCTR will be notified of the payment and a copy of the check will be scanned and sent by email to the study administrator.

Study Expenses

Study Expenses Payable by Invoice

Study administrative staff may need to invoice the sponsor periodically for reimbursement of items requiring an invoice to the sponsor (refer to Budget Workbook and CTA). An invoice template is provided for this purpose. Pay careful attention to the payment section of the executed CTA for information on when an invoice is required. Start-up costs generally fall into this category.

Expenses

Once the setup of the fund is complete, study related charges can be initiated for payment by the administrative staff and will be reflected in the fund’s financial results. Reflection of proper time and effort (T&E) by the PI, study coordinator and administrative staff will not be charged to the fund automatically.

Allocation of study related T&E must be initiated by the study staff. Please refer to Research Finance › Policies & Procedures › Time and Effort Reporting.

When reviewing proposed studies, the Institutional Review Board (IRB) works very closely with several other offices and committees. The interaction between the IRB and these various departments or committees is described below. The descriptions are limited to this interaction and are not representative of the entire function of the department or committee. The IRB application checklist directs the investigator as to when to contact these various departments or committees.

Financial Conflict of Interest in Research Committee (FCOIC): On an annual basis, all investigators are required to disclose significant financial interests to the FCOIC. The FCOIC will determine if a conflict of interest exists. If so, the FCOIC institutes a conflict of interest management plan. The FCOIC provides the IRB with copies of such plans. Investigators must also disclose any conflicts of interest within each IRB application. This ensures 1) that any conflict of interest is being addressed in accordance with the management plan and 2) that any new conflicts that develop during the course of the year are addressed. Investigators are encouraged to become familiar with the individual financial conflict of interest in research policy. Investigators may contact Gus Fernandez-Wolff in the Office of the Vice President for Research for additional information.

Environmental Health and Safety (EHS): Investigators proposing a research study that will use ionizing radiation, non-ionizing radiation, biological material, or hazardous chemicals must obtain a Risk Assessment Report from EHS. Investigators may contact Steve Jacobs for additional information.

EPIC in Research:  When a clinical research study will utilize Epic (UConn Health’s electronic medical record system) for scheduling, billing, or ordering the Epic Command Center is responsible for building the profile of that study within the system.  The study build submission form must be completed and submitted to the Command Center for this to occur. Questions should be directed to servicedesk@uchc.edu.

Institutional Biosafety Committee (IBC): Investigators must obtain approval from the IBC prior to seeking local IRB approval for research studies that deal with recombinant DNA. Investigators may contact ibc@uchc.edu for additional information.

Office of Clinical and Translational Research (OCTR): Investigators proposing a research study that is sponsored by an external source, typically an industry sponsor, must have a fully executed contract in place. When the sponsor is providing for subject injury, the IRB must receive the final contract prior to granting final IRB approval. Both the OCTR and the IRB will verify that language regarding subject injury is consistent between the consent form and the contract. Studies that will generate charges, whether sponsored or investigator originated, must also have an approved budget in place, confirmation that it is in process, or confirmation from the budget office that a budget workbook is not necessary. Investigators may contact Ella Sun or Donald Deyo for more information.

Sponsored Program Services (SPS): Investigators proposing a study that is grant supported or funded by a private non-profit agency will need to route the proposal through SPS. The IRB must review all funded grant applications. In general, federal grant applications will require IRB review once the determination is made that funding will occur. At such time investigators must submit a complete IRB application, in addition to the grant application, to the IRB. Non-federal grant applications typically require that IRB review occur prior to a funding decision having been made. Investigators may contact Paul Hudabenko for additional information.

Stem Cell Research Oversight (SCRO) Committee: UConn’s Stem Cell Research Oversight Committee (SCRO) provides oversight of all ethical issues related to the derivation and research use of human stem cell lines at all schools, colleges, campuses, and research arms of UConn regardless of the source of funding, and reviews all proposals submitted by University investigators for funds from the State of Connecticut. The SCRO Committee will ensure that sensitive research is well-justified and that inappropriate research is not conducted. Review by the SCRO Committee will supplement but not replace the usual reviews for compliance with federal, state, and local regulations (e.g., reviews by IACUC, IRB, IBC, etc.). Investigators may contact Ellen Ciesielski for additional information.

The following information is provided to orient potential study volunteers to the clinical research process. If you have already participated in a study, or are currently in a study, we would like to hear from you about your experience. We are interested in your feedback (e.g. compliments, suggestions, complaints, concerns) for purposes of quality assurance / improvement. If you would like to provide feedback you may either complete the Participant Feedback Form (Word), or send an e-mail to our office. Forms or e-mails should be sent to irb@uchc.edu

If you have questions regarding your rights as a volunteer in a research study you may call a Regulatory Specialist at the Institutional Review Board Office at UConn Health at 860-679-4849 or 860-679-8729.

Frequently Asked Questions

What is clinical research and how does it benefit society?
Clinical research is designed to evaluate health risks and to test new approaches to the diagnosis, treatment and prevention of specific diseases or disorders. Clinical research may help to improve the quality of healthcare or may involve gathering information about health risks. The knowledge that may be gained from this type of work can be of great value to our society. To ensure the safety of volunteers who enroll in clinical studies, each project must be approved by an Institutional Review Board (IRB) before it can begin. During the review process, the IRB evaluates the potential risks and benefits associated with the study and decides whether or not to approve it.

Who participates in clinical research studies?
All types of people are eligible to participate in research studies. Volunteers include adults, children, healthy individuals, and individuals with illness. Each study has a specific set of criteria that determines who is eligible to participate. People who choose to participate in clinical research studies may do so in hopes of improving their own health or advancing scientific knowledge about the cause, treatment and prevention of disease. Some people may benefit directly from participating in a study, for example if a drug being used in the study proves to be effective. Some people may not benefit directly, but their participation may help to advance knowledge that could benefit others in the future.

What are Gene Transfer Studies?
As stated in the brochure from the Office of Biotechnology Activities (OBA), thousands of genes are found in every cell in your body. Each of these genes contains a set of instructions that are read by the cell, allowing your body to make the proteins it needs. However, in may individuals, a gene’s instructions aren’t written properly, which can result in disease. In a gene transfer study, new genes are inserted into a person in an attempt to treat the disease. This is a relatively new area and researchers are trying to learn more about it to make sure it is safe to use in people and to see if it works.

Am I Eligible?
Your eligibility may be determined by various factors, depending on the nature of the study. If you meet the screening conditions, you will be given an “Informed Consent Form” containing a detailed written description of the project, any risks involved, and your rights as a participant. If the screening process involves any type of intervention, such as obtaining a blood sample or documenting personal health information , the consent process will be conducted prior to the screening to ensure that you are informed of what will be required of you and of any potential risks to your well-being. By signing and returning the consent form you agree to participate. If you should have second thoughts about participating, or become uncomfortable during the study, you have the right to withdraw at any time without any penalty whatsoever.

Who will be conducting the study?
Each study has a Principal Investigator (PI) who is in charge of the project. The PI may be a physician, a dentist, a basic research scientist or other faculty member. Colleagues of the PI from either within or outside the institution may also be involved with conducting the study. In addition to the PI and colleagues, a Research Coordinator or a Nurse, who is specially trained in clinical research, could be involved with conducting a study. The Research Coordinator or Nurse usually serves as your main point of contact regarding scheduling issues and any questions or problems you may have relating to the study.

What should I consider before deciding whether or not to participate?
Participating in clinical research may have a significant impact on your life. It is important that you are well informed and feel confident about your decision. You may want to consult with your doctor, family members and the research staff of the project to discuss any concerns you may have. Before finalizing your decision, be sure you know the answers to the following questions:

1. What are the major goals of the study?
2. What will be required of me?
3. What are the risks, how likely are they to occur and what will be done to minimize them?
4. What role will I play in the study – healthy volunteer or patient volunteer?
5. Is the study likely to benefit me directly?
6. What are the potential benefits to others?
7. How long is my participation required?
8. What discomforts, inconveniences and costs are involved?
9. Do I want to participate in this study?

What are my rights as a participant?
As a research participant, you have the right to:

1. be treated with respect,
2. know the risks involved with the study,
3. know what alternatives are available,
4. withdraw from the study without penalty,
5. have a sufficient amount of time to make your decision regarding participation,
6. know the name, credentials and contact information of the Principal Investigator,
7. know the purpose of the study,
8. know who will have access to your information,
9. know what procedures may be performed and what drugs may be used, and
10. ask questions during the informed consent process or at any time during the study.

What are my responsibilities?
In addition to complying with the specific requirements of a study in which you may enroll, you will also be expected to adhere to a general set of responsibilities. These responsibilities include:

1. arriving for all scheduled appointments or calling ahead if you are unable to keep an appointment,
2. arranging your own transportation to and from the study site(s),
3. following the directions of the researchers,
4. making sure your contact information is up to date,
5. providing accurate information about your past/present medical history if it is relevant to the study,
6. asking the researchers to answer any questions you may have at any point,
7. informing the research staff of any adverse events you experience while enrolled in the study, and
8. informing the Institutional Review Board Office if you feel your rights as a subject have been violated. The phone numbers for the IRB are 860-679-4849 or 860-679-8729.

Education Session:

• ” Things to Consider Before You Become a Participant in a Research Study” Presentation Flyer

Helpful Links:

• About Research Participation from the Office of Human Research Protections
• The Center for Information and Study on Clinical Research Participants
• Research Advocacy Network
• Participant Newsletter

Click Here to Go to iRIS if you are already familiar with using the system. 

GET HELP: iRIS is the electronic system used by research personnel and the Institutional Review Board (IRB) for the submission and review of research projects that will involve human participants.  Individuals who need to use iRIS are strongly encouraged to attend an iRIS training session before using the system for the first time.  Please review the training schedule and contact the HSPP at irb@uchc.edu  to register for a session.  Please register at least five business days prior to the training day.

Individuals affiliated with UConn Health can log in with their UConn Health username and password.  Individuals external to UConn Health should go to iRIS and click the Request Account option, being sure to describe why the account is needed.

Per vendor requirements, training guides may not be posted to the web.  User manuals can be found in the Help section of iRIS.

iRIS Frequently Asked Questions:

How do I create an account in iRIS?

UConn Health employees: If you have an active UConn Health username and password you do not need to request an account.  Your network username and password (what you use to access your UConn Health email) can be used to log in to iRIS and activate an account.

Individuals external to UConn Health should go to iRIS and click the Request Account option, being sure to describe why the account is needed and noting the name of the UConn Health person with whom they will be working.

How do I access iRIS from outside of UConn Health?

The web location for iRIS  is https://imedris.uchc.edu/

Do I need to submit the Principal Investigator’s C.V or biosketch when completing an application in iRIS?

Attachment of the C.V. or biosketch is necessary if the qualifications of the PI are not described within the application.

Who needs to sign the initial submission of an application in iRIS?

The Principal Investigator (PI) and all key study personnel listed on the application are required to electronically sign the initial application.  Contact persons and study authors are not required to sign the form if they have no other role on the study.

If the initial application has been returned for corrections from the screening phase, only the person responding to the corrections needs to sign the submission correction form associated to the application.  If the initial application has been returned for responses from the official IRB review process, only the PI would need sign the submission response form.  If other members of the study team are defaulted to being selected for inclusion in the signature routing process, you can uncheck the box to deselect their names when responding to changes required by the IRB.

Who needs to sign other types of submissions in iRIS?

Continuations, Modifications, Problem Reports Forms and Closure Forms:  Only the PI’s electronic signature is required for the submission types of continuation, modification, problem report or study closure.  If necessary, manually uncheck the names of the personnel who are not required to provide a signature.  When new personnel are being added to the study, they will be asked to sign the form by the IRB as a contingency for approval.

Submission Correction Forms: A submission correction form is generated from the IRB screening process which occurs prior to official review by an IRB member.  Only one person needs to sign this form; and it will most often be the person responding to the IRB Contingencies (e.g. a study coordinator).

Submission Response Forms:  A submission response form is generated after the IRB has conducted an official review.  The PI is the only person required to sign a completed review response form.

Who do I need to list as a study contact in the iRIS application?

The study contacts automatically receive all system generated correspondence (e.g. reminders to request continuations, notifications of lapses in approval, IRB approval letters).  The Principal Investigator and Study Coordinator(s) should always be listed in this section; as well as any persons who may be designated to complete IRB submission forms for the study. For studies applying to use resources of the Clinical Research Center (CRC), investigators should add Elizabeth Laska (CRC Nurse Manager) as a study contact.   Study contacts must be listed by individual names.

What should I do if I have problems attaching and /or opening documents in iRIS? 

 If you are unable to open documents and/or upload documents  you should make sure that your computer has a compatible browser (Internet Explorer 9.0 browser is preferred) and that the popup blocker setting is off.

How do I know if the IRB has received a submission I completed in iRIS?

To confirm that your submission has been routed by the system to the IRB you can go to your Study Assistant tab, and click on “My Studies.”  Then open the study you have completed and submitted. Once you are in the Submission tab, click on the Submission History and then on the Track Location. If the submission has arrived to the IRB queue, you will see the following statement: “UConn Health received the submission.”

If I am adding a modification form in iRIS and the modification includes adding a new person to the study team, does this person need to sign the modification form?

The modification form should be submitted to the IRB with the PI’s signature.   The IRB will then accept the personnel change and return the submission with a contingency that the person being added apply their signature.

Should the name of each person obtaining consent be listed in Section 3.2 –B of an initial application in iRIS?

Unless already identified as PI or a co-investigator,  yes, every person who will be obtaining consent must be listed in this section.

What documents should I submit with a continuation and/or a modification form?

The documents that are required for submission at continuation can be found on the submission checklist available on the HSPP website.  The documents required for a modification are submission specific so a checklist is not available.   In general you need to submit the revised version of any previously approved form, any new form not previously approved for use with the study (e.g. new recruitment material), or new information that pertains to the study (e.g. outcomes of meetings of the data safety monitoring board).

What  types of documents can I submit in iRIS?

You can attach a variety of document types, however iRIS can only stamp/approve documents that are submitted in Microsoft Words or PDF formats.  Furthermore, different documents types sometimes cause problems on the IRB review side, such as corrupting system generated pdf files.  Study personnel are strongly encouraged to convert other document types (e.g., excel, jpg, gif, ppt) to a PDF file prior to attaching them to a submission.

Can I work in iRIS using Mozilla Firefox  or Chrome?

Internet Explorer 9.0+ is the recommended browser.  Internet explorer is the browser used by the IRB and the browser upon which all training materials are based.  Per the vendor the system should also be compatible with Safari 6.0, Chrome 30.0+ or Firefox 24.0+.   The iRIS home page provides a link that will show compatible browsers.

UConn Health holds a Federalwide Assurance which is an agreement between this institution and the government, in particular the Office for Human Research Protections within the Department of Health and Human Services, that assures that whenever UConn Health engages in non-exempt human subjects research conducted or supported by any federal department or agency that has adopted the Common Rule, UConn Health will comply with the terms of the assurance. While the assurance is applicable to federally funded research, UConn Health applies equivalent protection standards to all human subject research, regardless of the funding source.  Mr. Michael Centola, Associate Vice President for Research Integrity, is the assurance signatory official who holds ultimate responsibility to ensure compliance with the terms of our FWA. The operational aspect of that responsibility has been delegated to the Director of the Human Subjects Protection Program, Monika Lau, who is designated as the Administrator of our FWA. Our FWA number is 00006064 and its expiration date is April 23, 2029.

The vision of the Human Subjects Protection Program at UConn Health is to provide complete protection to all volunteer subjects enrolled in research studies and to have that protection be an integral part of a fluid process that responds to the needs of the subject, the researcher, and the institution.

• HSPP Full Description (Word)

The primary mission of the Human Subjects Protections Program is to ensure that the rights and welfare of those who participate in research studies are protected. This mission is carried out by first ensuring that all research involving human subjects is reviewed and approved by the Institutional Review Board prior to initiation and subsequently by continuing review and monitoring of approved studies. These functions ensure that studies are being conducted in accordance with the ethical principles of autonomy, beneficence and justice as set forth in the Belmont Report, and in compliance with internal policies, and Federal regulation.

The Director of the Human Subjects Protection Program (HSPP) has oversight responsibility of the Institutional Review Boards and Regulatory Specialists, the Research Compliance Monitor, the Education and Development Specialist, and the HSPP Scientific Review Committee. The Director of the HSPP cannot influence or change any decision made by the IRB. As outlined in the organizational chart (PDF), the HSPP reports to the Associate Vice President for Research Integrity and Regulatory Affairs, who in turn reports to the Vice President for Research, Innovation and Entrepreneurship.

Investigators and study personnel are encouraged to call the office for assistance in preparing an application for the IRB or with any other questions, comments, suggestions and/or concerns.

The HSPP is inclusive of the following individuals.

• Ms. Monika Lau, Director, 959-258-0889, mlau@uchc.edu
• Ms. Julia Blair, Administrative Manager, 860-679-7555, jblair@uchc.edu
• Ms. Patricia Gneiting, Regulatory Specialist Panel 2, 860-679-4849, gneiting@uchc.edu
• Mr. Stephen MacKinnon, Regulatory Specialist, Panel 1, 860-679-8729, mackinnon@uchc.edu
• Mrs. Rebecca Burke, Research Compliance Monitor, 860-679-3054, burke@uchc.edu  
• Dr. Julian Ford, IRB Chair Panel 1 & 2, 860-679-8778, jford@uchc.edu
• Dr. Upendra Hegde, IRB Co-Chair Panel 2, 860-679-4249, uhegde@uchc.edu
• Dr. Ruchir Trivedi, IRB Vice Chair Panel 1, 860-679-2799, rtrivedi@uchc.edu
• Dr. Julie Wagner, Chair, Scientific Review Committee, 860-679-4508, juwagner@uchc.edu

Here is a list of acronyms used on our website and by the Office of Clinical & Translational Research.

BANNER         Financial Reporting System

CDA                Confidential Disclosure Agreement

CMP                Continuous Monitoring Process

CPOE              Computerized Physician Order Entry

CPT                 Clinical Procedural Terminology. codes for billing purposes

CRC                 Clinical Research Center

DCRC              Dental Clinical Research Center

F & A              Facilities & Administrative costs (formerly called “indirect costs”)

FOAPAL         Fund-Organization-Account-Program-Activity-Location. The abbreviation for the chart of accounts structure used by the Finance in the BANNER system

HSPO               Human Subjects Protection Office

IP                     Intellectual Property

IPAS                Institutional Prior Approval System

IRB                  Institutional Review Board

JDH                 John Dempsey Hospital

MAR                Medication Administration Record

NCD                National Coverage Decision 2000 (Medicare)

NCI                  National Cancer Institute

NIH                 National Institutes of Health; “NIH”

OCTR              Office of Clinical and Translational Research

PFS                  Patient Financial Services

PI                     Principal Investigator

PIC                  Protocol Induced Costs

POE                 Physician Order Entry

RA                   Research Assistant

RAF                 Research Administration and Finance

RC                   Routine Clinical Services. new Medicare terminology for Routine Care

RCM                Research Compliance Monitor

RFA                 Research Fiscal Administration

RFC                 Research Financial Compliance

SC                    Study Coordinator

SOM                School of Medicine

SODM             School of Dental Medicine

SPS                  Sponsored Program Services

T & E               Time and Effort

TV                   Transfer Voucher

UMG               UConn Medical Group

The purpose of the Research Financial Compliance Monitoring Program is to provide for continuous monitoring of financial compliance within all clinical research and clinical trials involving human subjects conducted within UConn Health, and to institute an audit plan that identifies and collects information necessary to support the UConn Health research compliance monitoring and audit activities.

Objective

The objective of the Research Financial Compliance Monitoring Program is to provide UConn Health investigators with:

• An internal mechanism for quality assurance, quality improvement and education pursuant to research financial/billing compliance and clinical research or clinical trials with human subjects.
• Practical support in the process of designing clinical trials budgets, assigning Protocol Induced Costs (PIC) and Routine Clinical Services (RC), identifying and complying with institutional policies as well as state and federal regulations and laws.

Selection of Studies

Most studies chosen for a compliance/billing audit will be clinical trials identified through a random process. There will be a focus on:

• Studies that combine both RC and PIC
• Investigator-initiated studies

Purpose

The Guide for the Care and Use of Laboratory Animals and the federal Animal Welfare Act require monitoring of animals subsequent to procedures, including surgical procedures, to which animals are subjected.

Appropriate monitoring criteria must be chosen based on consideration of the procedure(s) being performed, the expected and possible adverse effects animals may experience, the expected time course and progression of adverse effects, and the earliest predictive indicators of adverse effects.

It is essential that properly qualified personnel monitor the animals at appropriate intervals to ensure adequate observation and care of the animals. Optimally, studies should be terminated when animals begin to exhibit adverse clinical signs, if this endpoint is compatible with meeting research objectives, since such endpoints minimize pain or distress.

The IACUC is requiring different monitoring procedures that are predicated upon the type of species being used.

Action

USDA-Regulated Species (all animals other than mice (Genus mus), rats (Genus rattus), fish, frogs, axolotls, and birds)

All monitoring of regulated species must be documented in the animal record that is kept with the animals. At a minimum, the monitoring must consist of:

• Date of monitoring
• Time of monitoring
• Initials of personnel who performed the monitoring
• The condition of the animals

Non USDA-Regulated Species (mice, rats, birds, and cold-blooded vertebrates)

All monitoring of non-regulated species must have written documentation. As most of these animals do not have individual animal records, the requirement for monitoring is more general. Monitoring can be written on the animals’ cage card(s), in a laboratory notebook, in a computer spreadsheet (e.g., Excel), or any other written documentation system that the PI chooses to use. At a minimum, the monitoring must consist of:

• Date of monitoring
• Time of monitoring
• Initials of personnel who performed the monitoring
• The condition of the animals

All animals must be monitored in accordance with the monitoring for each procedure being performed described in the animal care and use protocol. Each protocol will state the parameters being evaluated, the frequency of monitoring, and the length of monitoring for every procedure described in the animal care and use protocol. It is the responsibility of the Principal Investigator to ensure that the post-procedure and post-surgical monitoring is being performed as described in the animal care and use protocol.

References

1. The Guide for the Care and Use of Laboratory Animals, National Academy Press, 2011.
2. 9 CFR Chapter 1 – Animal Welfare Regulations, 2013.
3. PHS Policy on the Humane Care and Use of Laboratory Animals, OLAW, 2015.
4. Animal Care Resource Guide, USDA, 2000.

Effective Dates:  June 6, 2024 thru June 30, 2027

Purpose

There are times when the IACUC approves protocols that include the use of common therapeutic drugs or materials, but subsequently, these drugs or materials become either temporarily or permanently unavailable. This could be due to various reasons including, but not limited to: a company discontinues production of the drug/material, a company changing the product in some what that makes its use unacceptable, a back-order on a drug, or an inordinate price increase of a product which essentially makes the product unavailable for use.

In order to help researchers maintain compliance with federal regulations when faced with this type of difficulty, and its implications for the affected animal care and use protocols, the UConn Health IACUC has instituted a policy on unexpected unavailability of commonly used therapeutic drugs and materials.

Action

1. When a researcher discovers that a drug or material is not available, he/she must consult with the Attending Veterinarian (AV) who will determine acceptable alternatives. These alternatives will be based on scientific requirements of the affected research protocol(s), the clinical requirements of the animals, and the professional judgment of the AV.

2. The AV will be responsible for informing the research community of the alternative(s) available for any drug or material used at the institution that is temporarily or permanently unavailable through the CCM pharmacy. It is the responsibility of the PI to consult with the AV to determine which alternative is best for his/her protocol(s).

3. If the drug/material is permanently unavailable, the IACUC gives authority to the AV to authorize changes to the affected protocols without a modification being immediately submitted to the IACUC. The AV will notify the IACUC Administrator of these instances. A modification will be required at whichever of the following instances first occurs during the course of the affected protocol:

• Submission of the annual review of the protocol;
• Submission of the 3 year renewal of the protocol; or
• Submission of another required modification to the protocol.

4. If the drug/material is temporarily unavailable, the IACUC gives authority to the AV to authorize changes to the protocols without a modification being submitted to the IACUC, but the PI must work with the AV to assure a return to the original drug or material when that drug or material again becomes available. The AV will notify the IACUC Administrator of these instances.

5. This policy dos not allow for the change in an experimental drug without a modification being submitted to, and approved by, the IACUC.

This Policy has been approved by a majority vote of the IACUC members.

Effective Dates: June 6, 2024 thru June 30, 2027