Compliance

Where available, the IACUC requires animal users to follow NIH ARAC Guidelines that apply to the project. For Diet Control in Behavioral Animal Studies - see Guidelines 

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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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Guidelines developed by NIH ARAC to assist investigators in research involving euthanasia of rodents using carbon dioxide.

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Where available, the IACUC requires that animal users follow NIH ARAC Guidelines that apply to the project. See Guidelines for the Use of Rodent Fetuses or Neonates

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Where available, the IACUC requires animal users to follow NIH Guidelines that apply to the project. See Guidelines for the Genotyping of Mice and Rats

 

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

These guidelines have been developed to assist investigators and National Institutes of Health Animal Care and Use Committees in their choice and application of survival rodent bleeding techniques.

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"Whistleblowing" legislation notice to Employees

University of Massachusetts Amherst

Whistleblowing Policy

Massachusetts General Laws c. 149, § 185 protects employees from retaliation for engaging in what is commonly known as "whistleblowing" activities. The scope of the law is very broad. It protects state employees who report or threaten to report illegalities, regulatory violations, health and safety violations, and environmental hazards committed by the employer or by another employer with whom the employer has a business relationship. The law also protects employees who refuse to participate in such activities and provides protections for employees who testify or report crimes. As a general matter, employees are protected against retaliatory action so long as the employee has brought the matter to the attention of a supervisor by written notice and has afforded the employer a reasonable opportunity to correct the activity, policy, or practice. Written notice may not be required to be filed when an emergency exists, when the employee reasonably believes the University has knowledge, or when the employee fears physical harm asa result of disclosure.

The following notice will be posted on the appropriate website and brought to the attention of all employees.

NOTICE TO EMPLOYEES:

Protection Against Retaliation

Massachusetts General Laws, Chapter 149, Section 185 offers protections against retaliation to an employee of the Commonwealth who:

  • Discloses, or threatens to disclose to a supervisor or to a public body an activity, policy or practice of the employer, or of another employer with whom the employee's employer has a business relationship, that the employee reasonably believes is in violation of a law, or a rule or regulation promulgated pursuant to law, or which the employee reasonably believes poses a risk to public health, safety or the environment;
  • Provides information to, or testifies before, any public body conducting an investigation, hearing or inquiry into any violation of law, or a rule or regulation promulgated pursuant to law, or activity, policy or practice which the employee reasonably believes poses a risk to public health, safety or the environment by the employer, or by another employer with whom the employee's employer has a business relationship; or
  • Objects to, or refuses to participate in any activity, policy or practice which the employee reasonably believes is in violation of a law, or a rule or regulation promulgated pursuant to law, or which the employee reasonably believes poses a risk to public health, safety or the environment.

Although some specific statutory exceptions exist, these protections against retaliatory action… "shall not apply to an employee who makes disclosures… unless the employee has brought the activity… to the attention of a supervisor of the employee by written notice and has afforded the employer a reasonable opportunity to correct the activity, policy, or practice".

How to File a Complaint of Retaliation

Employees with complaints should file their notices to the Deputy Chancellor, Chancellor’s Office, Whitmore Administration Building, University of Massachusetts Amherst.

All complaints of retaliation shall be made in writing and include a clear, detailed, and factual description of the retaliation action, employee(s) involved, and specific date(s) or timeline(s) of the retaliatory action. When relevant, the notices should include a discussion of oral reporting of the issue to managers or supervisors and/or internal communication regarding the issue.

All complaints of retaliation shall be made within two (2) years of the incident that the complainant believes to be retaliation. A complaint is considered filed based on the date it is postmarked, hand- delivered, faxed, or emailed to the Deputy Chancellor.

Processing a Complaint of Retaliation

Initial response to a Complaint

The Deputy Chancellor shall confirm receipt of the complaint in writing to the complainant.

The Deputy Chancellor shall review the details of the complaint to determine if an investigation should occur. An investigation shall occur if the complaint:

a.    Is filed within twelve (12) months of the retaliatory incident.

b.    At least one negative personnel action occurred after the date of the retaliatory incident and in connection with the person(s) named in the complaint.

If a complaint does not meet the conditions under which an investigation shall occur, the Deputy Chancellor shall notify the complainant in writing within fifteen (15) calendar days of the decision not to pursue an investigation.

Initiating an Investigation

The Deputy Chancellor shall notify the employee(s) accused of retaliation in writing that an investigation shall commence. The accused employee(s) shall receive a copy of the complaint.

The Deputy Chancellor shall interview the accused employee(s) and provide an opportunity for the accused employee(s) to respond to the complaint in writing. Responses shall be made in writing to the Deputy Chancellor within 30 calendar days of the accused employee(s)’s receipt of the notification of an investigation or the date of the interview, as indicated by the Deputy Chancellor.

The Deputy Chancellor may request that the complainant and/or accused employee(s) submit supplementary information for the investigation, including the names of witnesses.

Within six (6) months of the date that the Deputy Chancellor notified the complainant that an investigation shall commence, the Deputy Chancellor shall prepare a written report of the investigation findings, including the original complaint of retaliation, a list of individuals interviewed, and any other documentation collected during the investigation.

The Deputy Chancellor shall render a decision on the complaint within six (6) months of the close of the investigation. The complainant and accused employee(s) shall receive notification of the decision in writing. The complainant has no right to appeal a final decision.

The decision and written report shall remain on file in the Deputy Chancellor’s Office for a period of five (5) years.

Reporting Improper Activity

Filing a Report of Improper Activity

Employees with complaints should file their written notice of improper activities with their immediate supervisor or other appropriate administrator within their unit. When there is the potential for a conflict of interest, notices may be filed with the Deputy Chancellor, Chancellor's Office, Whitmore Administration Building, University of Massachusetts Amherst. When the issue involves the Chancellor or his office, notices should be made to the UMass President, Office of the President, 333 South St, Shrewsbury, MA 01545.

Responsibilities of Supervisors and Administrators

Supervisors and administrators who receive notice of significant improper activities -- as defined as those which constitute a violation of the law or regulation, or which the employee reasonably believes poses a risk to public health, safety or the environment,--shall immediately report such allegations in writing to the Deputy Chancellor, with a copy to their unit’s Vice Chancellor. Significant improper activities include, but are not limited to:

  • Allegations that reflect a problem with an internal policy that is likely to exist at other units within the University.
  • Allegations that are likely to receive media or public attention. Allegations that involve the misuse of University resources.
  • Allegations that have the potential to create significant liability for the University. Allegations that are criminal in nature.
  • Allegations that have the potential to pose a threat to the health and safety of members of the University and/or the public. 
  • Allegations that are judged by the supervisor or administrator to be sensitive for another reason.

Description of Notices

All notices shall be made in writing and include a clear, detailed, and factual description of the issue and employee(s) involved. When relevant, the notices should include a discussion of oral reporting of the issue to managers or supervisors and/or internal communication regarding the issue. Notices may be submitted anonymously. Notices submitted anonymously must provide sufficient evidence to justify an investigation.

Investigation Process

Upon receipt of a notice, the Deputy Chancellor shall promptly review the documentation provided and investigate the allegations in conjunction with relevant University or State agencies or units based on their areas of expertise.

Upon completion of the investigation(s), the Deputy Chancellor shall classify allegations as “improper” or “not improper” activities. When an allegation is classified as “not improper,” the investigation shall be formally closed and findings shall be communicated in writing to the employee(s) who initiated the notice. When an allegation is classified as “improper” activity, the Deputy Chancellor shall notify appropriate University or State agencies or units and initiate appropriate legal or disciplinary procedures as required by University policy and/or state or federal law.

Paperwork documenting the notice and investigation shall be kept on file in the Office of the Deputy Chancellor for three (3) years.

Supporting documents:

 Massachusetts General Laws, Chapter 149, Section 185 

Revised 07/14/15

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Office of Primary Responsibility:                                                           Subject:

Vice Chancellor for Research and Engagement                       Institutional Biosafety Committee

 

1.0 Purpose

The University of Massachusetts Amherst (the University) has an Institutional Biosafety Committee (IBC) in compliance with the NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines, 2002) and in accordance with Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th Edition, 2007.   The following sections describes the University’s policy and procedures for the IBC

 

2.0 Policy

The IBC follows NIH Guidelines for practices for reviewing projects that require constructing and handling:  (i) rDNA molecules, and (ii) organisms and viruses containing rDNA molecules.  The IBC also reviews activities involving use of Select Agents and Toxins and other biohazardous agents that must be handled at BSL3 and 4.  The IBC will assist the Biosafety Officer (BSO) in the Department of Environmental Health & Safety (EH&S) in formulating policies and procedures related to the use of biohazards.  The IBC is also charged with reviewing the biological and medical waste management program annually according to The Department of Public Health’s regulation on the minimum requirements for the management of medical and biological waste CMR 480.000  The IBC may advise the institution and the Principal Investigator (PI) concerning management of research that is classified as “dual use”.

3.0 Procedure

3.1          IBC members are appointed by the Vice Chancellor for Research and Engagement for 3-year terms.  At the end of a member’s term he/she may be reappointed for a further term.

3.2          IBC membership conforms to NIH Guideline IV-B-2-a-(3). 

3.3          The IBC meets no less than four times a year for review of projects using rDNA that require review at NIH review level IIIE and higher, or for any other matter within the scope of the committee.  A meeting is conducted in person or via conference call.  A quorum is a majority of the membership. When possible, and consistent with the protection of privacy and proprietary interests, IBC meetings are open to the public. 

3.4          The Research Compliance Coordinator serves as Executive Secretary to the IBC including preparation of IBC minutes and filing reports with OBA.  Annual Reports to OBA are filed on or before the anniversary of the previous Annual Report.  Reports of significant problems or violations are reported to OBA within 30 days of the incident

3.5          An IBC member may not be involved in the review of any project in which he/she or a close relative or  spouse has a personal or financial interest.

3.6          The IBC may approve a registration for a period of up to 5 years. 

3.7          The PI is notified in writing that a registration has been approved by the IBC.  The approval letter includes the registration number, expiration date, and any other pertinent information and special approval conditions.  Approval letters for reviews conducted at NIH review level IIIE may be signed by the Executive Secretary.  All other approval letters are signed by the IBC Chair.

3.8          The IBC has been granted authority to investigate potential violations or compliance problems related to its area of oversight

3.9          Requests from members of the public for documents relating to IBC activities are handled in accordance with provisions of the Massachusetts Open Records Law (M.G.L. c. 66, § 10) and University policy for handling requests for documents related to research.  The University policy documents a process for review and redaction of research records before they are sent to a requestor.  The institution’s response to a request for records is handled in consultation with Legal Counsel.  The Vice Chancellor for Research and Engagement responds to the request.

 

Approved by Vice Chancellor for Research and Engagement Michael Malone

 

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OUTLINE OF GUIDANCE PRINCIPLES FOR FACULTY

ON CONFLICTS OF INTEREST

By

Tom Chmura, Vice President for Economic Development,

Chair, University Conflicts of Interest Committee

And

Liz Rodriguez, Associate Counsel

Counsel for the University Conflicts of Interest Committee

 

BACKGROUND

  • Prior to 1996-97 when the University adopted its own conflict of interest policies and procedures, all faculty were subject to the state ethics law called 268A and the oversight of the state ethics commission for all possible conflicts of interest matters (including those related to technology commercialization).
  • Under previous arrangements, faculty were subject to the cumbersome and prohibitive constraints of 268A when developing University relationships (e.g., start-up companies, licensing of technology, sponsored industrial R&D) with companies in which they had a financial interest.

FORMATION OF UNIVERSITY POLICIES AND PROCEDURES

  • In 1996-97, the University (as permitted by the five-campus merger legislation) developed its own policies and procedures for governing financial conflicts of interests in matters specifically related to intellectual property and technology transfer.
  • The policies and procedures (including the creating of a system-wide conflicts of interest committee) were developed by a system-wide task force with the assistance of outside counsel and with the extensive review of the practices of leading universities.
  • The new University policies and procedures were approved by the Board of Trustees and successfully negotiated with collective bargaining units at each of the campuses (except for Worcester, where they were reviewed and adopted by the Scientific Council).
  • With the adoption of these new policies and procedures, the University became the primary entity in the Commonwealth to have control over conflicts of interest regarding intellectual property and commercial ventures at the University.
  • The University's Conflicts Committee reviews conflict situations on a case-by-case basis and has broad discretion to approve, deny, or approve with conditions proposed relationships.

PERSPECTIVES AND INTERESTS OF THE UNIVERSITY

  • University policy states that it is assumed that all faculty members conduct themselves according to the highest standards of ethical conduct.
  • Moreover, University policy and priorities are supportive of patenting and licensing of inventions that are based on University research, participating in industry partnerships designed to commercialize technology, and making other contributions to the economic development of the Commonwealth.
  • Such activities can enable the translation of research results into practical applications for society, the receipt of licensing income for the University and faculty, the provision of additional sources of research funding for the University, economic development benefits for the Commonwealth, and important learning experiences for students.
  • However, the involvement of faculty with private companies in which they have financial interests carries with it the potential for inappropriately diverting the University and its faculty from their primary University missions of education, research and service. Such conflicts are not necessarily prohibited, but they do need to be disclosed, reviewed, and formally considered by the University. Where permitted, they need to be managed appropriately so as to preserve the values and interests of the University and the Commonwealth, including primarily the integrity of the University research.
  • In its review of any proposed faculty arrangement with private companies that have a potential for conflict of interest, the University is concerned that the faculty maintain their primary commitment and allegiance to the University, the University's educational/research/service mission, and the University's financial interests. The Conflicts Committee has responsibility for ruling on different kinds of conflicts, and, where it allows a conflict, for developing strategies for managing the conflict to preserve the values and interests of the University.

TYPES OF CONFLICTS AND APPROACHES TO DEALING WITH THEM

  • Since its creation in 1995, the University's Conflicts Committee has considered more than 150 cases involving faculty from across the system (all campuses except Boston), and it has developed experience with a variety of conflicts and means of handling them.

CONFLICTS OF FINANCIAL INTEREST

  • As employees of the University, faculty are expected to place the financial wellbeing of the University above that of any commercial entity. According to the policy, faculty have a conflict of interest when they have a financial stake in the well-being of a company engaged in commercialization activities with the University.
  • In simple cases (e.g., faculty owns a small amount of stock or has a consulting. arrangement with a company sponsoring research at the University), the Conflicts Committee may require public disclosure of the conflict at the University, notification of the conflict in publications and presentations (e.g., research papers), use of University standard rider on intellectual property with any consulting agreement with the company, and oversight of the research by a special review committee (with regular written reports from the faculty member to the review committee).
  • Financial conflicts have been deemed much more serious by the Conflicts Committee when the faculty member assumes personal responsibility for the financial well-being of a commercial entity by taking on a role as a member of the board or as chief executive or officer of the company. In virtually all cases, the Committee has required faculty to relinquish board and executive/officer positions to resolve such conflicts, and urged adoption of a scientific consultant/advisor role instead. Only with the most early stage companies has the Conflicts Committee permitted board or management positions, and then only with strict time limitations.

CONFLICT OF COMMITMENT

  • Each campus is responsible for its own conflict of commitment policy, but such issues are often entangled with conflict of financial interest cases. All campus policies require that faculty give their primary commitment and allegiance to the University, not to a commercial entity in which they have a financial take. The amount of time a faculty needs to spend on certain commercial ventures could result in a serious conflict of commitment.
  • Frequently, the Conflicts Committee has urged a campus to establish special review mechanisms (e.g., department heads, deans) that would oversee both the conflicts of financial interest and commitment. In extreme cases, the Committee has urged a faculty to consider an unpaid leave of absence (e.g., during the startup period of a new company) as an appropriate means of managing this conflict.

RESEARCH INTEGRITY

  • Faculty are required to maintain the highest level of scientific integrity in the conduct of their research and to adhere to generally accepted academic standards regarding dissemination of research findings. A faculty member's financial interests in a commercial entity should never be allowed or appear to allow influence over the integrity of University research.
  • In cases where this issue has arisen, the Conflicts Committee has typically required full public disclosure of the faculty's financial interest in any research (including in presentations and publications), appointed an independent oversight committee for the research program, and required independent review of research results before publication.
  • In more serious cases where the level of financial interest is especially high, the Committee has also required the appointment of independent principal investigators or co-principal investigators on research grants from commercial entities in which a faculty has a financial interest.
  • The Committee may also seek assurance that any federal agency sponsoring research in a faculty's laboratory is aware of and comfortable with the commercialization arrangements.

HUMAN SUBJECTS  RESEARCH

  • In no area of research do concerns about research integrity loom greater than in the field of human subjects research. Thereby, practically any financial interest relating to human subjects research requires full review by the Conflicts Committee.
  • The University's guidelines in this area adhere to the standards established by the AAMC and the AAU. There is a presumption against allowing a personal financial interest to exist in the context of a human subjects study. Further, there is a presumption against conducting human subjects research on technology developed at the University.
  • These individual and institutional conflicts are ordinarily disallowed. Upon a showing of compelling circumstances and after a thorough assessment of therisks, it is possible to overcome the presumption against proceeding with the study. In those rare cases, there must be proper disclosure of the financial interest to the subjects and meaningful external monitoring of the study.

EDUCATIONAL MISSION

  • Faculty have a responsibility to provide their students and advisees witheducationally appropriate experiences. The educational process must not be compromised by the commercial goals of a commercial entity in which a faculty member has an interest.
  • In cases where this issue has arisen, the Conflicts Committee has generally insisted that no students who are students or advisees of a faculty member involved with a commercial entity have any link to that commercial entity or work on research supported by funding from the commercial entity.
  • On the other hand, students who are not the responsibility of a faculty with the commercial entity may find useful educational and/or employment opportunities with such companies.

ASSISTANCE FOR FACULTY

  • In sum, the Conflicts Committee seeks to help faculty in developing and approving arrangements that effectively commercialize University technology and put it into public use, while adequately protecting the University's institutional interests and appropriately managing the personal conflict of interest issues in each case.
  • Faculty with questions about the Conflicts Policy and workings of the Committee should contact their Vice Chancellor for Research or equivalent chief research officer.

10/22/2010

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