Compliance

Procedure for Dealing with Restrictions to Open Research

 

Review relevant document (e.g., Request for Proposal or Request for Application, draft research agreement, draft Material Transfer Agreement).

Upon receipt of these documents, research administrators in the Office of Grant and Contract Administration (OGCA) or the University of Massachusetts Innovation Institute (UMII) review the document for clauses that:

A. Constrain the University from disclosing:

a. the existence of the contract or grant;

b. the identity of the sponsor or the grantor and, if a subcontract is involved, the identity of the prime contractor; and

c. the purpose and the scope of the proposed research in sufficient detail:

i. to permit informal discussion concerning the wisdom of such research within the University; and

ii. to inform colleagues in immediate and related disciplines of the nature and importance of the potential contribution to the disciplines involved

B. Limit the ability to disseminate fully and promptly the results of the research or specifically permit retroactive classification (other than standard clauses found in federal contract templates that are not germane to the research).

C. Restrict who can participate in the research project.

 

Determine whether research is "proprietary" or "restricted."

If research administrators find restrictive clauses, they will work with the Office of Research Compliance (ORC) export control staff to determine whether the clauses fit into the "proprietary" or "restricted" categories:

Proprietary research: Industrially-sponsored research that uses the sponsor's proprietary information or results in intellectual property for which the sponsor has an option to an exclusive license. These sponsors often request restrictions on who can discuss the research and under what circumstances. They also may prohibit publication of confidential company information or ask the researcher to delay publication of research results so that they can review the material for proprietary information or take steps to secure intellectual property rights to possible inventions.

The University accepts "proprietary" research agreements that do not restrict who can work on the project and do not request unreasonable (>12 months) publication delays. Agreements containing other restrictions fall under the definition of "restricted" research.

Restricted research: Research that is restricted in who can work on the project or how and when the researchers can discuss the results of the project. This type of research includes projects that are labeled as "sensitive but unclassified" by the sponsor.

Principal investigators seeking to conduct restricted research must request an exemption from the Openness in Research policy through the Office of Research Compliance (ORC) and approved by the Vice Chancellor for Research and Engagement (VCRE).  Under expanded authority delegated by the University of Massachusetts President's Office (UMPO) to the Amherst campus, the VCRE is empowered to accept certain restricted research under the auspices of the UMII and with the technical assistance of ORC.  NOTE: The University will not accept government classified research (i.e., "secret" or "top secret").

 

If the research falls within the definition of restricted research, the research administrator refers the matter to the Office of Research Compliance (ORC) for analysis, technology control plans and to assist the principal investigator with the process of seeking an exemption to openness.

 

Negotiate to remove or amend restrictive clauses.

OGCA or UMII research administrators, with guidance and assistance from ORC as appropriate, will attempt to negotiate an agreement that is satisfactory to the potential sponsor and principal investigator, and in compliance with the University's policies and the principles of academic freedom.

 

Refuse the contract or request an exemption

If the sponsor does not agree to remove the restrictions, the principal investigator may opt to decline the award or to seek an exemption to Trustee policy requiring free and open dissemination of research results.

 

Initiate exemption Request.

The principal investigator must initiate the Exemption Request (Request for Exemption Form). This form facilitates the flow of information among the groups that will discuss and recommend approval or denial of the exemption request.

ORC will assist the principal investigator(s) in seeking the exemption.  To request an exemption, complete the steps below.  Note that sponsored research awards that deviate from standard policies, such as publication and dissemination norms, will be processed through UMII.

 

Complete the Request.

Within three business days for receiving the request, the directors of OGCA and ORC will complete their sections of the request documenting the circumstances and efforts made to negotiate more favorable terms and conditions as appropriate to the nature of the research.

 

Forward exemption request to the Open Research Committee.

ORC submits the exemption request to the office of the Vice Chancellor for Research and Engagement and assists the VCRE in convening an ad hoc advisory committee to evaluate it.  Typical composition of the ad hoc committee includes the department head/chair, the relevant dean and another "arm's length"dean, a Research Council member and Research and Engagement senior staff.

 

VCRE decision to grant or deny the exemption request.

Consistent with UMPO's delegation of authority, the VCRE makes the final decision, based upon the recommendations and input from the ad hoc advisory committee.  An affirmative decision by the VCRE will be predicated upon appropriate compliance protocols being initiated to mitigate any risks, including technology control plans or U.S. government licensing, if required.  Restricted agreements are processed under the auspices of UMII in accordance with the campus delegations received from the UMPO.

Reporting

The Office of Research Compliance tracks requests for exemptions and provides reporting to campus stakeholders and governance groups, including the Faculty Senate Research Council and other interested offices, as necessary.

 

 

* this procedure has been adapted from materials developed by the University of Minnesota for similar purposes

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Human Body Fluids Precautions Policy

 

Sen. Doc. No. 90-028

University of Massachusetts
Amherst, Massachusetts

POLICY: HUMAN BODY FLUIDS PRECAUTIONS

Statement of Policy

The Amherst campus of the University of Massachusetts shall establish, adopt, and enforce a comprehensive set of standards, guidelines, and procedures that will minimize the risk to students, faculty, and staff of occupational exposure to human body fluids and other materials that may contain agents of human infection. In areas and activities similar to non-campus settings (e.g. laboratories, health care facilities, etc.), the policy shall apply regulations, standards and practices that have been developed by relevant governmental or professional agencies (e.g., U.S. Public Health Service, Centers for Disease Control, Occupational Safety and Health Administration, Massachusetts Department. of Public Health, National Collegiate Athletic Association, etc.) insofar as they are not in conflict with laws governing the University of Massachusetts or the ethical standards of the academic community. In other areas or activities in which risks are identified or suspected and for which legal or professional standards have not been developed and/or published, the Amherst campus shall adopt standards, guidelines, and practices that are appropriate for the level of risk identified. Included will be educational activities to explain risks and to allay unwarranted fears arising from misconceptions of risk.

Inherent in this policy is the responsibility of the Amherst campus to identify risks, to differentiate them according to severity, and to maintain adherence to reasonable or established standards, guidelines, and practices. Administrative oversight for the risk identification and reduction program is the responsibility of Environmental Health and Safety, in collaboration with all segments of the University community. Actual implementation of the policy and adherence to the policy is the responsibility of the department or unit involved.

Background

Human blood, body fluids, and other body tissues are widely recognized as vehicles for the transmission of human disease. Although many of these diseases are readily identified and can be prevented and/or treated successfully by well-accepted measures (e.g. syphilis and tuberculosis), others are not.

At least three infectious agents transmitted through human blood products and/or body fluids (BBF) continue to present a serious health problem: hepatitis B virus (HBV), hepatitis C virus (HCV) and human immuno-deficiency virus (HIV). Because of difficulties in identifying, preventing, and treating the diseases they cause, special precautions for minimizing the risk of exposure to them are warranted. The means of transmission are common to all.

HBV, the more common of the three infectious agents, causes a serious form of hepatitis, which can lead to a permanent loss of liver function or even death. When suspected, it can be detected readily in blood or body fluids. Persons exposed can be protected temporarily by the use of hepatitis B immune globulin. An available vaccine provides long-term protection for those whose work or travel entails a high risk of exposure. Its cost is high but readily justifiable in view of the serious consequences of clinical disease.

HCV, once called non-A non-B hepatitis also causes a serious form of hepatitis which can lead to a permanent loss of liver function and death. There is no vaccine to protect against this type of hepatitis but this disease can be partially treated in some cases with interferon.

HIV may cause Acquired Immuno-Deficiency Syndrome (AIDS). In addition, once introduced, it may exist in humans for many years before causing symptoms; during this long latent period, it can be transmitted through blood products and other body fluids. Unprotected sexual contact is widely recognized as the most common mode of transmission but transmission is well recognized via transfusion, shared use of intravenous needles, and pregnancy. Documented cases have been traced to work related inadvertent contact, such as needle sticks with infected blood.

HIV appears to be very fragile, hence, unable to survive for substantial periods outside the body of humans. Efforts to develop a useful vaccine have not been successful; researchers generally hold out scant hope for success in the near future. Although there is no cure for HIV disease, it is important to recognize the disease at an early stage so that treatment for the disease can be initiated. A particularly disturbing feature of the HIV infection is the long latent period between introduction of the virus into a person's body and clinical symptoms, which may average five to seven years. There appears to be no bar to transmission during the latent period. This characteristic poses an especially serious threat to human health since there is neither an effective cure nor an agent for prevention, such as a vaccine. Disease control must rest solely, therefore, with behavioral strategies at both the individual and collective levels. Individual protective behaviors can result from programs to provide information and alter attitudes; the adoption of collective measures is an institutional and social responsibility.

Definitions

Infectious body fluids shall include blood, semen, vaginal secretions, cerebrospinal fluid, synovial fluid, pleural fluid, pericardial fluid, peritoneal fluid, amniotic fluid, saliva in dental procedures, any body fluid that is visibly contaminated with blood, and all body fluids in situations where it is difficult or impossible to differentiate between body fluids.

Other potentially infectious materials shall include infectious body fluids, any unfixed human tissue or organ, HIV, HCV, or HBV containing cell or tissue cultures, organ cultures, culture medium, or blood, organs, or other tissues from experimental animals infected with HIV,HCV, or HBV.

Occupational Exposure means reasonably anticipated skin, eye, mucous membrane, or parenteral contact with blood or other potentially infectious materials during the performance of an employee's duties or assignments of a student in a class.

"HIV infection" shall include all stages in the progression of infection, including HIV seropositivity and AIDS.

Levels of Exposure:

The campus policy is intended to apply to occupational exposure to human blood, or other materials which may be potentially infected with human immuno-deficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV) or any other bloodborne pathogen (other potentially infectious material).

Each on- or off-campus activity in which students, faculty, or staff may participate in shall be classified as Category I (exposure) or Category II (non-exposure). This is consistent with occupational exposure as established by the U.S. Department of Labor, Occupational Safety and Health Administration standards(OSHA Occupational Exposure to Bloodborne Pathogens, 29 CFR 1910, December 6, 1991).

  • Category I (Exposure): Procedures and activities that involve (known or predictable) contact with human blood, body fluids, or tissues - including spills or splashes. Risks are identifiable, since they are inherent in regular job-related tasks. Examples: laboratories, dental offices, and other health care settings.
  • Category II (Non-exposure): Procedures and activities that do not involve regular or occasional contact with human blood, body fluids, or tissue and in which there is an extremely low risk of transmission of HBV,HCV or HIV. Examples: sharing wind instruments (saliva does not transmit HIV), hand shaking, use of public or shared toilets or phones. (Note: This is not to suggest or imply that other infectious diseases, such as upper respiratory infections are not transmitted via direct or indirect contact. These diseases are either self-limited or treatable by available therapeutic agents. Customary hygienic precautions, based primarily on individually adopted procedures, are adequate measures of protection.)

Control Measures

  • Category I: Appropriate protective measures shall be identified, adopted and required for every person whose work or activity is classified as Category I. These shall be outlined in a written Exposure Control Plan which will specify which job classifications and specific tasks are defined as potential occupational exposures. The Amherst campus shall be responsible for providing appropriate protective supplies and equipment (e.g. gloves for routine use by anyone drawing human blood samples.) The Amherst campus shall provide immunization to protect against HBV infection and appropriate medical treatment following contact with human blood and other potentially infectious materials for all students and employees whose work involves this level of risk.
  • Category II: Educational programs shall be introduced to explain lack of risk to persons active in these settings. In addition, appropriate medical treatment following contacts with human blood and other potentially infectious materials shall be provided if an accidental exposure occurs.

Implementation

Administrative oversight for the risk identification and reduction program rests with the Environmental Health and Safety (EH&S). The primary goal of the program is to provide a systematic approach aimed at the primary recognition, evaluation and control of (Category I, II.) exposures to human blood, body fluids, and other potentially infectious materials. Successful implementation of this policy requires close collaboration between all segments of the University community. EH&S is responsible for providing central coordination of the program, but adherence with established Safe Operating Practices (SOP's) is a shared campus-wide responsibility. The EH&S Biological Safety Program will be responsible for providing the following services:

  1. Identification and categorization of activities (I or II) that may fall within the scope of this policy and developing exposure control plans. University Health Services, Occupational Health Program and individual departments shall assist in this effort;
  2. Development of SOP's in consultation with the individual departments and appropriate committees, such as the Graduate School Biological Safety Committee and the University Health Services Infection Control Committee;
  3. Monitoring of work places and activities on a periodic basis to assure that the departments are cognizant of the SOP's and proper precautions are being followed;
  4. Investigation of known or suspected exposures to determine the circumstances and to prevent recurrence;
  5. Development of appropriate educational programs in cooperation with the Occupational Health Program and the Employee Assistance Program;
  6. Ongoing review of the overall program to insure that the intent of the policy is being achieved. Periodic reports shall be made to the appropriate Faculty Senate committees including the Biological Safety Committee of the Graduate School, the University Health Council of the Faculty Senate, the University Committee on AIDS or other appropriate body.

Actual implementation of the policy and adherence to the policy is the responsibility of each department or unit where human blood, body fluids, or other infectious materials may pose a risk to the safety of students, faculty, or staff. It is the responsibility of the principal investigator, researcher, or administrative unit head to be aware of appropriate federal, state, or university regulations involving the safe handling of human body fluids, to implement policies and procedures that adequately protect the environment and those working in the environment, and to request assistance whenever potential or actual violations of prudent practices occur. Inadequate attention to human body fluid precautions may lead to appropriate sanctions or disciplinary actions within approved health and safety practices of the University.

University Health Services will be responsible for providing the HBV immunizations and the medical treatment of employees and students following occupational contacts with human blood and other potentially infectious materials.

MOTION 16-90: APPROVED on December 7, 1989: That the Faculty Senate recommend to the administration the adoption of the Policy on Human Body Fluids Precautions developed and approved by the University Health Council as set forth in Sen. Doc. No. 90-028.

University Health Services
Environmental Health and Safety

 

GUIDELINES FOR MANAGEMENT OF
OCCUPATIONAL EXPOSURE TO HUMAN BLOOD OR BODY FLUIDS

Transmission of hepatitis B virus (HBV), human immunodeficiency virus (AIDS virus, HIV), and other pathogenic microorganisms to health care and research workers through human blood, body fluids, and other body tissues has been documented. Although all efforts should be made to prevent exposure, employees who are performing known or predictable procedures and activities with human body fluids (see campus policy Human Body Fluids Precautions), may be exposed to infectious agents. As part of the occupational health program, University Health Services (UHS) will provide medical care if an accident occurs and an employee becomes exposed to human blood or body fluids during his/her job.

If an employee has a parenteral (E.g. needlestick, cut, bite) or mucous membrane (splash to the eye or mouth) exposure to human blood or other body fluids, or has a skin exposure involving large amounts of human blood or prolonged contact with blood especially when the exposed skin is chapped, abraded, or afflicted with dermatitis (eczema):

1. This incident should be reported to the supervisor.

2. The employee should report to UHS, Urgent Care immediately to have the exposure evaluated. If necessary, post exposure treatment should be initiated within 2 hours of exposure.

3. The supervisor should report accidents to the Division of Environmental Health and Safety.

4. If you have any questions, please call the Biological and Chemical Safety Officer at Environmental Health and Safety (545-2682) or the Occupational Health Physician at UHS (577-5000).

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