Compliance

Animal Care Service Ordering Policy

  • Animal orders must be submitted to AnimalOrders@research.umass.edu by 5:00 p.m. on Tuesday for deliveries the following week.
  • Orders received after Tuesday will be processed for delivery the following week.
  • Late or rush orders may not be accepted or may incur additional fees for processing.
  • Orders will be validated* on Thursdays (*protocol approval verified, the number of animals ordered cross-checked against the number of animals approved and already used for the protocol, and cage type and housing space availability verified for room/building requested in the order).
  • Approved orders will be placed no later than Friday.
  • Barbara Miller, 413-545-0668, bsmiller@research.umass.edu, is the ACS (Animal Care Services) office contact for questions or clarifications regarding animal ordering or delivery.
  • After order has been placed, an electronic order confirmation specifying the delivery date and site(s) will be emailed to the ordering PI,all animal care staff who work in the area(s) scheduled to receive,animal transport personnel and ACS managers.
  • Researchers will be notified by the ACS staff via e-mail once animals have arrived and are housed.
  • If any issues are found at time of arrival, ACS will contact PI to coordinate correction to order.

Animal Deliveries

The responsibility of Animal Care Services

  • All animal deliveries should arrive on campus by 2:00 p.m. to the location(s) specified in the confirmations.
  • Animals should be unpacked and their health status and sex evaluated within four hours of delivery.
  • Evaluation of every animal delivery must be completed prior to staff departure for the day.
  • Once ACS staff confirms the animal delivery has been received, order is correct, and animals are healthy, a confirmation of receipt must be communicated via e-mail to the following: the ordering PI, all animal care staff who work in the area(s) scheduled to receive, Animal Ordering Coordinator who ordered animals and ACS managers.
  • These emails will officially document receipt and initial evaluation, and will become part of the permanent record system.

Delayed or Canceled Deliveries

  • If/when a scheduled animal delivery has been delayed and has not been received by 2:00 p.m., the ACS staff in the facility expecting the delivery MUST call ACS Animal Ordering Coordinator, ACS Managers or Barbara no later than 2:15 p.m.

Note: Leaving a voice message or sending an email is not sufficient - ACS staff must speak to a live person.   

  • The Animal Ordering Coordinator will contact the vendor(s) for a delivery update and communicate information back to the PI,affected ACS staff and ACS Managers.
  • Receipt of deliveries delayed or scheduled to arrive after 2:00 p.m. will be coordinated with affected ACS staff by the Animal Ordering Coordinator and ACS Managers.
  • If/when shipment has to be cancelled, the Animal Ordering Coordinator will inform ACS Managers.
  • ACS Managers will coordinate with the PI and affected ACS staff receipt of the animals.
    • NOTE: Affected ACS staff will not be required to remain late and/or work beyond their normal work shift hours in order to receive delayed/rescheduled animal deliveries.  Individual staff members may volunteer to do so for overtime pay or comp time. If no staff is available, ACS Managers will receive the animals and house them.

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Release Info: 

3/26/15

NIH Surgery Guidelines for disinfectants. See Recommended Hard Surface Disinfectants 

Source: NIH Intramural Research Program Guidelines for Survival Rodent SurgeryTraining in Survival Rodent Surgery. CD-ROM. Bethesda, MD: NIH. 

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Classification of Animal Pain and Distress Levels

For the purpose of this categorization, assume that any procedure known to cause pain or distress to humans will have a similar effect on other vertebrate animals. The Animal Welfare Act requires placing animal usage into categories according to potential pain and distress and the reporting of such usage annually to the U. S. Department of Agriculture.

Classifications

Classification B: Animals being bred, conditioned, or held for use in teaching, testing, experiments, research, or surgery, but not yet used for such purposes. Examples:

  • Breeding colonies of any animal species that are held in legal sized caging and handled in accordance with the Guide for the Care and Use of Laboratory Animals and other applicable regulations. Breeding colony includes parents and offspring.
  • Newly acquired animals that are held in proper caging and handled in accordance with applicable regulations.
  • Animals held under proper captive conditions or wild animals that are being observed.

Classification C: Animals upon which teaching, research, experiments, or tests will be conducted involving no pain, distress, or use of pain-relieving drugs. Examples:

  • Procedures performed by trained personnel such as the administration of electrolytes/fluids, administration of oral medication, blood collection from a common peripheral vein per standard veterinary practice (dog cephalic, cat jugular) or catheterization of same, standard radiography, parenteral injections of non-irritating substances.
  • Euthanasia performed in accordance with the recommendations of the most recent AVMA Panel on Euthanasia, utilizing procedures that produce rapid unconsciousness and subsequent humane death.
  • Manual restraint that is no longer than would be required for a simple exam; short period of chair restraint for an adapted nonhuman primate.

Classification D: Animals upon which experiments, teaching, research, surgery, or tests will be conducted involving accompanying pain or distress to the animals and for which appropriate anesthetic, analgesic, or tranquilizing drugs will be used. Examples:

  • Surgical procedures conducted by trained personnel in accordance with standard veterinary practice such as biopsies, gonadectomy, exposure of blood vessels, chronic catheter implantation, laparotomy or laparoscopy.
  • Blood collection by more invasive routes such as intracardiac or periorbital collection from species without a true orbital sinus such as rats and guinea pigs.
  • Administration of drugs, chemicals, toxins, or organisms that would be expected to produce pain or distress but which will be alleviated by analgesics.

Classification E: Animals upon which teaching, experiments, research, surgery, or tests will be conducted involving accompanying pain or distress to the animals and for which the use of appropriate anesthetic, analgesic, or tranquilizing drugs will adversely affect the procedures, results, or interpretation of the teaching, research, experiments, surgery, or tests. Examples:

  • Procedures producing pain or distress unrrelieved by analgesics such as toxicity studies, microbial virulence testing, radiation sickness, and research on stress, shock, or pain.
  • Surgical and postsurgical sequella from invasion of body cavities, orthopedic procedures, dentistry or other hard or soft tissue damage that produces unrelieved pain or distress.
  • Negative conditioning via electric shocks that would cause pain in humans.
  • Chairing of nonhuman primates not conditioned to the procedure for the time period used.

Note regarding classification E: An explanation of the procedures producing pain or distress in these animals and the justification for not using appropriate anesthetic, analgesic or tranquilizing drugs must be provided in Kuali. This information is required to be reported to the USDA, will be available from USDA under the Freedom of Information Act, and may be publicly available through the Internet via USDA's website.

Consideration of Alternatives

If any procedures fall into USDA's Classification D or E, causing more than momentary or slight pain or distress to the animals, describe your consideration of alternatives and your determination that alternatives are not available. Delineate the methods and sources used in the search. Database references must include databases searched, the date of the search, period covered, and the keywords used. Alternatives include methods that

  • refine existing tests by minimizing animal distress
  • reduce the number of animals necessary for an experiment, or
  • replace whole-animal use with in vitro or other tests

When ascites production is used to produce antibodies, justification needs to be given as to why in vitro systems cannot be used. Note that you must certify in Section Q.5. that no valid alternative was identified to any described procedures which may cause more than momentary pain or distress, whether relieved or not.

Death as an Endpoint

In order to comply with guidelines governing the use of animals in experimentation, the use of death as an endpoint to experimental manipulation, rather than performing euthanasia to humanely terminate an animal, is strongly discouraged. Investigators must perform euthanasia on all moribund experimental animals unless there is scientific justification that euthanasia would invalidate experimental data collection. Moribund is defined as "in a dying state". Animals are considered to be moribund if the following criteria are met:

  1. They manifest one or more of the following clinical signs:
  2. Inability to ambulate that prevents the animal's easy access to food and/or water.
  3. Inability to maintain itself in an upright position.
  4. Prolonged (greater than 48 hours) inappetance and/or clinical dehydration.
  5. Agonal breathing and cyanosis; chronic diarrhea or constipation.
  6. Hematologic or biochemical parameters that indicate organ failure incompatible with life.
  7. Unconsciousness with no response to external stimuli such as toe-pinch withdrawal test.

The above symptoms are not a temporary consequence of an experimental treatment (e.g., a surgical manipulation or drug treatment) that has been described and justified in an approved protocol.

If an experimental animal appears to be moribund, the Animal Care Office should be notified promptly so that the attending veterinarian can examine the animal, discuss the animal's condition with the researcher, and determine if euthanasia is warranted.

If killing a moribund animal would invalidate the study, the scientific justification for using death as an endpoint must be provided in writing as part of the animal care protocol and must be approved by the IACUC prior to initiating this procedure. Investigators who receive approval from the IACUC to use death as an experimental endpoint must also agree to the following:

  1. To use the minimum number of animals necessary to achieve statistical significance and to use alternative endpoints other than death whenever possible.
  2. Animals must be monitored twice daily (in the early morning and late afternoon including weekends and holidays) and any animals evidencing clinically abnormal behavior must be removed from group housing situations and housed individually with easy access to food and water.
  3. Written records of all monitoring sessions, indicating the time of the observations, the person observing the animals, and any observations such as the number of animals evidencing clinically abnormal behavior and the number of animals found dead, must be maintained and made available to the Animal Care Office or IACUC on request.

Investigators should note that any approved use of death as an experimental endpoint will be noted on all protocol forms and regulatory papers as being in the highest USDA pain level category "E" unless analgesics or anesthetics are provided to alleviate pain or distress in the experimental animals.

Euthanasia Endpoint Criteria

Category I

  • ruffled hair coat
  • hunched posture
  • lethargy
  • ocular discharge/eyes closed
  • diarrhea

Category II

  • obvious weight loss or dehydration
  • inability to eat or drink
  • failure or delay to right when placed on back
  • dyspnea
  • bleeding from gastrointestinal or respiratory tract
  • neurological signs, such as circling, head tilt, partial paresis, seizures

Any animal exhibiting any two of Category I clinical signs or any one of Category II clinical signs will be humanely euthanized using the method of euthanasia listed on the original animal subjects approval form.

Hazardous Agents and Animals

Use of any hazardous materials (biohazards, toxic chemicals or drugs and radiation hazards) in animals is limited to activities which can be safely carried out in the available facilities and personnel are trained appropriately.  Investigators using hazardous agents in animals must be guided by the Material Safety Data Sheet (MSDS), federal and state regulations, and University policies.  Hazardous Materials and Right to Know training is required by Massachusetts law before working with hazardous materials.  Contact EHS for a training schedule. Before the project involving hazardous materials is approved by the IACUC the project must also be reviewed and approved by the appropriate oversight committee and/or Environmental Health and Safety personnel.

Biohazardous Agents

Use of any biohazardous agents in animals, including recombinant DNA, is limited to activities which can be safely carried out in the available facilities.  The Biosafety Officer and the Institutional Biosafety Committee(IBC) review and approve projects using biohazardous agents including Select Agents

Radioactive Agents

The Radiation Use Committee oversees use of radioactive materials and radiation sources. RUC review and review by the Radiation Safety Officer (RSO) in EHS proceeds concurrently with IACUC review. The RSO ensures that all investigators using radioactive materials in animals have appropriate training and that the use, storage and disposal of radioactive materials will be in compliance with federal and state regulations before the research begins.

Use of Animal Blood and Tissues

If animals are euthanized for a research project for the purpose of obtaining blood or tissue an IACUC protocol is required. IACUC approval is not required if tissue collection takes place postmortem as a by-product of a commercial enterprise like a slaughterhouse. IACUC approval is not required for the harvest of tissues from dead animals from other research projects as long as the collection of tissues does not alter the approved procedures in any way and the animals were used exclusively for the other research project. 

PIs should be aware that if the “use of vertebrate animals” box is not checked on the face page of a PHS grant application form references to use of animals in the grant proposal may trigger questions about IACUC approval. To avoid delays in peer review of the proposal the PI is advised to explain in the grant application the source of the tissues.

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The AVMA Guidelines for the Euthanasia of Animals: 2013 Edition provides additional guidance for researchers.

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Where available, the IACUC requires animal users to follow NIH ARAC Guidelines that apply to the project.

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Office of Primary Responsibility:                                              Subject:

Vice Chancellor for Research and Engagement                          Institutional Chemical Safety Committee

_____________________________________________________________________________________

1.0 Purpose

To ensure that protocols in research and teaching conform with the proper guidelines and regulations associated with the handling of toxic/hazardous chemicals and carcinogens and provide assurance that activities at the University of Massachusetts Amherst do not present unacceptable risks to the health or safety of faculty, staff, students, visitors and the local community.

 

2.0 Policy

The Institutional Chemical Safety Committee [ICSC] is the principal campus committee charged with advising on matters that relate to the safe use of chemicals on campus with a focus on research laboratories.  Policies and procedures related to personnel safety, equipment, and operations, are to be addressed along with educational programs designated to promote safety awareness and safe practices. Committee recommendations are forwarded in writing to the Vice Chancellor for Research and Engagement for necessary action.

 

3.0 Procedure

3.1          The ICSC advises Environmental Health & Safety (EHS) and approves chemical use protocols, guidelines describing standard procedures and practices for the use of hazardous chemicals. 

 

3.2          The ICSC members and its chairperson are appointed by Vice Chancellor for Research and Engagement for a term of 3 years.  The committee meets as required but no less than once each 3 months on a date established by the chairperson.  A quorum shall be a majority of the membership. The chairperson votes in case of ties. Minutes and other recordings are forwarded to the Vice Chancellor for Research and Engagement and to the other members of the committee.

 

3.3          Committee membership for the present includes at least the chairperson, the director of EH&S or his or her designee, the Vice Chancellor for Research and Engagement or his or her designee, the Director of Research Compliance, the Assoc. Vice Chancellor Facilities and Campus Planning or his or her designee, a representative from the colleges of Humanities and Fine Arts, Public Health and Health Sciences, Social and Behavioral Sciences, and Engineering, and up to five representatives from the College of Natural Sciences and up to three members at large. 

 

3.4          Meetings of the committee will be called by the chairperson at any time to consider a request by the investigator, or person of similar responsible position, for permission to possess and use extremely toxic and hazardous chemicals, and as may be required by statutory or mandated regulations to consider changes in policies and operations of the committee or for any other matter within the scope of the committee. Minutes of all activities of the committee will be maintained and approved at meetings of the ICSC.

 

3.5          The ICSC reviews and approves programs and procedures that establish requirements for anyone requesting to use hazardous chemicals.

 

3.6          The ICSC approves standard procedures and guidelines relating to chemical hazards. The committee may also recommend necessary consultation and educational (training) activities to assist the departments in the performance of safe techniques and procedures to assure an awareness of ICC review requirements.

3.7         The ICSC reviews and approves systematic procedures to assure that all activities that involve any chemical usage on the Amherst campus and/or its associated facilities used in lab-based teaching and research activities are identified and properly reviewed.

3.8        The ICSC reviews monitoring reports related to its area of concern to determine if additional or amended institutional policies, guidelines or procedures are needed.

 

 

Rev. 3/31/2016

Approved by ICSC: September 8, 2016

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Roles and Responsibilities of Principal Investigators/Co-Investigators

Sen. Doc. No. 09-032

SPECIAL REPORT of the RESEARCH COUNCIL concerning

PRINCIPAL AND CO-PRINCIPAL INVESTIGATORS: ELIGIBILITY, ROLES, RIGHTS, RESPONSIBILITIES,  AND OBLIGATIONS

 Presented at the 683rd Regular Faculty Senate Meeting March 26, 2009

COUNCIL MEMBERSHIP:  Jenny Adams, Leslie Button, Lori Clarke, Paul Cormier, Kourosh Danai, David Evans - Chair, Andrea Foulkes , Cynthia Jacelon, Jane Kent-Braun, Paul Kostecki, Mason Lowance, Michael Malone, Michael Maroney,   Ernest May, Jane Miller, John Mullin, David Ostendorf, William Patterson, Stephen Rich, Jay Schafer, Linda Shea, Lynnette Leidy Seivert, Carol Sprague, Martha Taunton, Emily West, Hilary Woodcock

Principal and Co-Principal Investigators: 

Eligibility, Roles, Rights, Responsibilities, and Obligations

 Definition(s)

Principal Investigator (PI) – A Principal Investigator is the primary individual responsible for the preparation, conduct, and administration of a research grant, cooperative agreement, training or public service project, contract, or other sponsored project in compliance with applicable laws and regulations and institutional policy governing the conduct of sponsored research.

Co-Principal Investigator or Co-Investigator (Co-PI/Co-I) –Co-PIs/Co-Is are key personnel who have responsibilities similar to that of a PI on research projects.  While the PI has ultimate responsibility for the conduct of a research project, the Co-PI/Co-I is also obligated to ensure the project is conducted in compliance with applicable laws and regulations and institutional policy governing the conduct of sponsored research.

Faculty Participant – University of Massachusetts Amherst Faculty may be involved in projects key personnel without the same responsibilities of a PI or Co-PI/Co-I.  These faculty are not responsible for the conduct of the project, are not a signatory to an MOU, and normally do not share in the return of indirect cost, unless specified in the MOU.  Faculty participants may participate in the research, may collect salary, and may have a role in publications.  A Faculty Participant may also be referred to as a   Faculty Investigator or Senior Personnel.  The term “faculty Participant” is used below to refer to this category.

Eligibility

Being granted PI and Co-PI status is a privilege granted to eligible University personnel who meet the criteria identified below.  All persons granted PI and Co-PI authority must accept all of the responsibilities associated with the application for and administration of awarded sponsored projects.

Each PI and Co-PI certifies with every proposal submission that all information provided is true and complete and that the proposal conforms to the University policies and procedures applicable to sponsored activities.  In order to be certified as a PI or Co-PI, a researcher must confirm that he/she will comply with all regulatory compliance directives; that all information submitted within the proposal is true, complete, and accurate to the best of his/her knowledge; that any false, fictitious, or fraudulent statements or claims may subject the investigator(s) to criminal, civil, or administrative penalties; and that the investigators(s) agree to accept responsibility for the conduct of the project and to provide all required reports as applicable if a project is awarded as a result of the proposal.

Upon accepting the award, each PI , Co-PI and, if appropriate, each Faculty Participant must also confirm  that he/she will be responsible for project management of the award and agree to carry out the project with the highest professional standards and within the time period awarded.  The PI assumes responsibility to read, understand, and comply with all of the terms and conditions contained in the award.  Finally, the PI must confirm that he/she understands his/her responsibility to abide by University and sponsor policies, procedures and directives for the proper administration of sponsored projects.

Who can be a PI?

Persons holding the following positions may be designated as PIs in applications for externally sponsored funding:

  1. All tenured and tenure-track Assistant, Associate, and Full Professors and Librarians.
  2. All persons holding appointments as Research Assistant Professor, Research Associate Professor and Research Professor, Extension Specialists, and Clinical Professors.
  3. All persons holding Adjunct, Visiting, Emeritus or other faculty positions at the University of Massachusetts, Amherst not included under 1 or 2, and who have the approval of the appropriate governance bodies of a Department and, also, the approval of the Dean of the relevant School or College.  Such approval is indicated by the signature of the named governance bodies on the Internal Processing Form.  PI’sin one of these categories should also include a Co-Principal Investigator from appointment types included in 1 and 2 above.  In the event a Co-Principal Investigator is not named, the appropriate governance bodies of the Department and, also, the Dean of the relevant School or College shall accept full fiscal and administrative liability and responsibility for the actions of the Principal Investigator included in this category.
  4. All Post-Doctoral Fellows who have the approval of the appropriate governance bodies of a Department and, also, the approval of the Dean of the relevant School or College.  Such approval is indicated by the signature of named governance bodies on the Internal Processing Form. The Post-Doctoral Fellow’s mentor must be listed as a co-principal investigator.
  5. All Professional Staff who are not also students, provided they have the approval of the appropriate governance bodies of a Department and the approval of the Dean of the relevant School or College or the Vice Chancellor, if an administrative unit.  Such approval is indicated by the signature of the named governance body or bodies on the Internal Processing Form.

Note:  Neither undergraduate nor graduate students may be designated as PIs.  When a Sponsor’s program guidelines require the student to be listed as PI on the Proposal application, the student’s mentor/advisor shall be the PI of record on Internal Processing Form and responsible for the conduct and oversight of the project.

Who can be a Co-PI?

Persons eligible for designation as PI are also eligible to be designated as Co-PIs.  No undergraduate or graduate students may be designated as Co-PIs.  Persons who are located at other universities and who do not hold appointments in eligible categories at the University of Massachusetts Amherst may not be designated as Co-PIs.  Relations with collaborators at other universities, research institutes or corporations should be handled through subcontracts to the institutions involved.

PI Responsibilities:

PROPOSAL PREPARATION AND SUBMISSION

General

The Principal Investigator confirms that the entire proposal meets requirements outlined in the Program Announcement, Request for Application (RFA), Request for Proposal (RFP), or other application instructions. Examples of such requirements include, but are not limited to, award minimums/maximums, page limitations, font/margins, electronic file type/size, deadlines, and mailing addresses. The Principal Investigator may delegate this responsibility to Departmental Administrative Staff. If the Principal Investigator’s unit lacks Departmental Administrative Staff for proposal preparation or other sponsored programs administration requirements, he/she assumes these responsibilities or seeks support from the respective Department/Unit Head or Dean.

Technical Proposal

The Principal Investigator:

  • Prepares the technical proposal and may collaborate with others in its preparation.
  • Identifies the need for subrecipient agreements.
  • Determines whether on- or off-campus space in addition to that already assigned to the Principal Investigator is needed.  (The Principal Investigator identifies the need, and requests it from his/her supervisor, or other appropriate University manager.)
  • Takes responsibility for keeping his/her CV or biosketch updated.
  • Ensures that procedures used are consistent with sound research design and do not unnecessarily expose subjects to risk/harm.
  • Assures that the design is appropriate to the proposed question.
  • Determines that the project will contribute original scholarship.

Proposal Budget

The Principal Investigator:

  • Prepares or directly supervises the preparation of the budget and its justification.
  • Selects the appropriate facilities and administrative or indirect cost rate from the negotiated rates, under guidance from OGCA and/or the Dean’s Office.
  • If appropriate, makes a Facilities & Administrative cost (i.e. Indirect Cost) waiver request to the Department Head and Dean and then forwards this request to the Vice Chancellor for Research and Engagement for final approval;
  • Requests matching funds from University officials or identifies in-kind contributions from appropriate sources, when necessary.
  • Proposes cost sharing through contributed effort or other approved mechanisms and seeks approval from appropriate University officials.
  • Identifies all available financial resources in direct support of this or other research endeavors (other support) either at proposal submission or “Just In Time” in accordance with sponsor requirements.
  • Identifies anticipated program income.

Regulatory Requirements

The Principal Investigator:

  • Prepares the appropriate forms (either at proposal submission time or “Just In Time” in accordance with sponsor requirements) for the University Human Subjects IRB, or the Animal Care IACUC, the Radiation Safety Office and/or the Office of Environmental Health and Safety (EH&S), if the proposal involves:
    • human subjects;
    • live animals as subjects;
    • recombinant DNA, infectious agents, narcotics or biological toxins;
    • human blood or body fluids;
    • radioactive materials and/or ionizing or non-ionizing radiation-producing equipment;
    • hazardous materials; or
    • Protected Health Information (PHI).
  • Completes a Participation Agreement (PAG) prior to conducting sponsored research.
  • Discloses all potentially significant conflict of interest situations, and prepares a Conflict Disclosure Form and submits it to his/her supervisor, Department Head and Dean.
  • Affirms that he/she is not excluded or debarred from receiving Federal funds, and is not delinquent in student loans.
  • Ensures that other personnel involved in the project sign the University Internal Processing Form (IPF) as required.

Internal Processing Form (IPF)

The Principal Investigator:

  • Prepares or directly supervises the preparation of the Internal Processing Form. (The Principal Investigator must be the person who checks the boxes on the in section V of the IPF; this responsibility may not be delegated.)
  • Discloses the involvement of other departments or schools/colleges and ensures the appropriate signatures are included in the Internal Processing Form (IPF) approval.
  • Signs the Internal Processing Form. This responsibility cannot be delegated and the signature certifies that each item on the form is filled-out completely and accurately.

PRE-AWARD REQUIREMENTS

Pre-Establishment/ Pre-Award of Expenditure Account

The Principal Investigator requests pre-established accounts, if necessary. The Department/Unit Head will authorize and approve the pre-established account. (Department Administrative Staff should be cognizant of the need for (and use of) pre-established accounts, which minimizes cost transfers and/or reallocations.)

Small Business Subcontracting Plan

When applicable and required by the Sponsor’s requirements, the PI works with the Procurement Office and Departmental Administrative Staff to develop a Small Business contracting plan.

Negotiations with Sponsor

Formal negotiations with the sponsor are conducted only by OGCA staff.  All submissions of revised budgets and revised work scopes, as well as other information requested by the sponsor, must be coordinated with and submitted by OGCA to the sponsor.

The Principal Investigator role in negotiations:

  • Negotiates informally and forwards the approved revised project work scope to OGCA for submission to the sponsor.
  • In collaboration with Department Administrative Staff and the Office of Grant & Contract Administration (OGCA), the Principal Investigator modifies the project budget in line with the sponsor’s instructions for modification. (Department Administrative Staff should be involved in any budget modification, as this can impact other budgeting and effort issues on other projects or departmental accounts.)
  • The Principal Investigator communicates with the Co-PIs and other Faculty Participants concerning any changes in scope of work or budget that would substantially impact their participation in the project.  When Co-PIs or other Faculty Participants have their participation impacted substantially, the PI should provide to them verbatim copies of the relevant sections from peer reviews when those are available.
  • Completes a revised IPF and forwards the complete package through the signature process.
  • Notifies the appropriate regulatory office if changes to project scope will affect approved protocols.
  • Obtains approvals if cost sharing becomes necessary.

Acceptance of Award

When the Principal Investigator receives from OGCA the Principal Investigator Award Agreement (PIAA), he/she reviews the Notice of Award (NOA) that stipulates the approved budget and the terms and conditions of the award, and further delegates to Departmental Administrative Staff the review of the NOA for their part in helping the PI administer the project.  The PI then must sign and return the PIAA to OGCA indicating his/her acceptance of the terms and agreement to carry out the project in compliance with the terms in the NOA, University policy, and other applicable regulations and guidelines.  OGCA shall furnish a copy of the PIAA to the Co-PI’s and other Faculty Participants if they are named in the MOU.

Memorandum of Understanding (MOU):

A Memorandum of Understanding (MOU) is required for every funded grant or contract proposal that includes one or more Co-PIs.  The MOU must be signed by each PI and Co-PI, as well as their associated department head and dean thereby signifying each individual’s agreement to the responsibilities and terms as stated in the MOU.  The MOU may accompany the IPF.  However OGCA will not authorize the establishment of any accounts for a funded grant or contract until the MOU has been filed. OGCA will provide a standard MOU for PI’s and Co-PIs.  If the PI and Co-PIs want to file their own MOU, these MOUs must make clear the mutual understandings among the signatories concerning the following issues:

1. Who may authorize expenditures from grant or contract funds.

2. Responsibilities for carrying out major tasks specified in the proposal and granting instruments, including the preparation of reports required by grants or contracts (with the exception of invoices and financial reports to be prepared by Accounting).

3.  Percent of Credit to be attributed to each PI, as reflected by a pro-rated share of the awarded dollars in annual sponsored activity and expenditure reports. (This should not be confused with the percentage of effort committed to the project by the investigators.)

4. Division of RTF returned to investigators, department heads and deans.

5. Rules of succession in the event of the resignation or incapacity of a signatory.

6. Authorship and IP rights. These rights should be consistent with existing policies and procedures.

7.  The Dept ID numbers for all investigators, their department heads and deans.

The terms of any MOU cannot contravene or replace existing statutory or University regulations.

POST-AWARD CONDUCT AND MANAGEMENT OF THE PROJECT

General

Principal Investigators should reference the Office of Research web site: (http://www.umass.edu/research) or contact appropriate university offices to obtain information about rules and requirements governing sponsored funding. Principal Investigators are responsible for knowing what actions require sponsor approval and for obtaining that approval with involvement/assistance from OGCA.

Individual faculty - as principal investigators, research directors, and mentors - encourage their students and other research personnel to participate in educational programs on the responsible conduct of research or research ethics.

Conduct of the Research

The Principal Investigator:

  • Is responsible for all actions required to manage and complete the scientific and programmatic aspects of the sponsored project.
  • Initiates programmatic changes to the project and seeks approval from the sponsor via request to OGCA when required.
  • Initiates the hiring or assignment process and approves the selection or appointment of individuals to the project, and is responsible for communicating staff changes to Departmental Administrative Staff.
  • Ensures the integrity and safeguarding of notebooks and scientific data.
  • Ensures the completion, accuracy and timeliness of programmatic (technical) reports.
  • Initiates requests for and monitors subrecipient agreements prepared by OGCA.
  • Ensures the quality, timeliness, and programmatic (technical) performance of subrecipients.
  • Initiates a materials transfer agreement with the office of Commercial Ventures and Intellectual Property (CVIP) when using or providing materials to or from another source.

Budget Management

While the Principal Investigator retains primary responsibility for financial accountability, the Principal Investigator or the Department/Unit Head can delegate an authorized representative to act on his or her behalf for departmental account/project management.  Accounts should be managed by persons trained in these responsibilities. The University Controllers Office is responsible for account management at the University level and responsible for all payments, invoices, financial reporting, etc. to the sponsoring agency.

The Principal Investigator:

  • Initiates purchases.
  • At the time expenditures are initiated, determines that expenditures are allowable, allocable, and reasonable; approves them; and provides scientific justification for the transaction, if necessary. In both budgeting and charging of expenses, the Principal Investigator adheres to Cost Accounting Standards, such as consistency in allocating costs.
  • Initiates the process of documenting cost sharing and/or matching and for ensuring that cost sharing obligations are met from allowable and verifiable sources, including those by third party collaborators, if included in approved budget.
  • Initiates requests for rebudgeting as the sponsor requires.
  • Initiates cost transfer requests. When salary transfer requests are made, ensures these are based on actual effort expended and not merely as budgeted (per OMB Circular A-21).
  • Identifies and proposes a resolution of any account deficit.
  • Reviews subrecipient invoices for appropriateness and, to monitor progress of the work, approves payment of subrecipient invoices.
  • Uses PeopleSoft for financial monitoring, identifies and resolves errors in the account in a timely manner; certifies or documents a monthly review of ledgers. If appropriate and required at budget period end, the Principal Investigator requests that remaining balances are carried forward.

Program Income

The Principal Investigator:

  • When applicable, is required to understand the definition of program income.
  • Identifies all program income and notifies the Controller’s Office when program is anticipated/received.
  • Initiates the processes and proposes the allocation of program income.
  • Monitors receipt of program income.
  • Reviews program income reported to the sponsor by the University Controller’s Office.

Effort Reporting

To ensure compliance with the effort reporting (Plan Confirmation) policy, Principal Investigators sign and certify effort for themselves and employees on the grants in accordance with the University’s Time and Effort Reporting Guidelines, designed in compliance with OMB Circular A-21.

Project Transfer

All awards are made to the University and not to the individual investigator.  In the event a PI leaves the University, he/she must notify Co-PIs, Faculty Participants, the department head and dean of such departure in advance and seek appropriate next step instructions from the department head, dean, and OGCA.

Should the PI wish to take the grant/contract with him/her to the new institution, the PI must request and document written approval from his/her department head and dean to have the project officially relinquished.  Should the department head and dean approve of the transfer, the PI must provide OGCA with a memo confirming agreement to the transfer and other materials necessary to obtain appropriate sponsor permission.

Should the PI choose to leave the award with the University, the PI must notify OGCA of their departure as soon as possible and assist with the proper sponsor notification.  Such notification will either be a replacement investigator, or termination of the award.

Inventions and Intellectual Property

The Principal Investigator:

  • Adheres to the principles and policies outlined in the University’s Intellectual Property Policy and the Conflict of Interest Policy.
  • Ensures that all employees working on the project also comply with the policy.
  • Initiates the disclosure process and completes the Invention Disclosure Form in order to notify the Office of CVIP.
  • Assists in preparing patent applications.
  • Assists in the processing of copyright registration or other intellectual property protection.

Implementing a Small Business Plan (if required)

The Principal Investigator:

  • Directs purchases that are consistent with the project budget and the approved Small Business Plan (if required).
  • The PI or his/her delegate interacts with Procurement staff regarding progress toward achievement of Small Business Plan goals and reviews periodic reports about goals.
  • Provides an explanation when Small Business Plan goals are not achieved.

Project Closure

The Principal Investigator:

  • Prepares the final programmatic (technical) narrative report, which may include contributions by subrecipients or collaborators.
  • Submits any close out documentation needed in order for the Controller’s Office to submit financial status reports on a timely basis.
  • Provides information on other close out reports, such as for patents (to OGCA) and on equipment (to Property and Inventory Control).
  • Retains the scientific data in accordance with the University’s Policy on Access and Retention of Data.

Regulatory Compliance

The Principal Investigator:

  • Prepares a Conflict Disclosure Form in order to notify her or his Department Head and Dean if a potential conflict of interest exists and makes additional disclosures in a timely manner if a conflict of interest arises.
  • Is responsible for adhering to all educational and training requirements as the University requires.
  • Adheres to protocols and policies for research subjects, and notifies the IRB or IACUC if changes are made to protocols.
  • Meets continuing IRB/IACUC protocol review requirements and assists with inspections.
  • Adheres to chemical, biological, physical and radiation safety requirements, and notifies the appropriate office if accidents occur.
  • Adheres to the policies and procedures for using investigational new drugs and/or devices for clinical research.
  • Participates in the annual cost sharing certification (if applicable), as well as the periodic space and equipment survey.
  • Takes responsibility for adherence to record retention policy for all financial and scientific documentation.
  • Takes responsibility for cooperating in the audit process, whether internal or external audit staff is involved.
  • Takes responsibility for accounting of PHI disclosures, as required by HIPAA.
  • Takes responsibility for understanding and compliance with all institutional and sponsor policies, practices, and procedures.

 

MOVED:        That the Faculty Senate approved the Principal and Co-Principal Investigators:

33-09               Eligibility, Roles, Rights, Responsibilities, and Obligations, as presented in Sen. Doc. No. 09-032.

 

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Animals can experience pain and distress.  It is the ethical and legal obligation of all personnel involved with the use of animals in research to reduce or eliminate pain and distress in research animals whenever such actions do not interfere with the research objectives.

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Where available, the IACUC requires animal users to follow NIH ARAC Guidelines that apply to the project. See Guidelines for Egg and Oocyte Harvesting in Xenopus laevis.

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Where available, the IACUC requires animal users to follow NIH ARAC Guidelines that apply to the project. See Guidelines for the Use of Adjuvants in Research

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