Research Safety/Security

Document File: 

Topics: 

Data Ownership, Retention, and Access at UMass Amherst

Sen. Doc. No. 06-047

SPECIAL REPORT

of the

RESEARCH COUNCIL

concerning

THE POLICY

ON

DATA OWNERSHIP, RETENTION, AND ACCESS

AT THE

UNIVERSITY OF MASSACHUSETTS AMHERST

Presented at the

654th Regular Meeting of the Faculty Senate

May 18, 2006

Jenny Adams

Krishna Melnattur

Iqbal Agha

John Mullin

D. Anthony Butterfield

David Ostendorf

Charles Clifton

William Patterson

Kourosh Danai

Stanley Scarpati

Andrea Foulkes

Jay Schafer

Dorothy Gilbert

Lynnette Leidy Sievert

Paul Kostecki

Carol Sprague

Mason Lowance

Jean Swinney

Michael Malone

Martha Taunton

Ernest May

Paul Utgoff, Chair

Juan Zamora

 

Sen. Doc. No. 06-047

 

Data Ownership, Retention, and Access at the University of Massachusetts Amherst

Approved by Research Council on May 5, 2006. Forwarded to Faculty Senate on May 5, 2006.

 

The University of Massachusetts Amherst supports a wide variety of research and scholarly activity. A fundamental component of many research investigations is the creation and use of data. It is in the interest of the research enterprise at large to make such data available to others, to the extent possible. This is important for furthering new research efforts and for enabling others to examine previous research in detail. It is in the University's interest to facilitate these processes, and to assist and protect those who conduct research and scholarly activities on behalf of the University.

 

External Policies and Guidelines

Various federal agencies have formulated policies regarding data ownership, retention, and access. For example, see Part C.53 of the Office of Management and Budget's (OMB) grants management circular A-110, the Council on Government Relations (COGR) document `Access to and Retention of Research Data: Rights and Responsibilities,' Chapter 6 of Steneck's  `Introduction to the Responsible Conduct of Research,'and the various requirements regarding research data stated by the National Science Foundation (NSF), the National Institute for Health (NIH), and other government funding agencies. Some publishers impose requirements on the access to data as a condition for publication.

The Amherst Campus policy (this document) applies to all campus research and researchers, regardless of funding source, if any. For sponsored research, any relevant policies of the sponsor shall apply in addition to those provided here. Any apparent conflicts of policies are to be resolved in writing and approved by the Vice Chancellor for Research and Engagement prior to accepting an award, contract, or other binding agreement.

 

Data Definition

Data shall be construed as all recorded information, regardless of medium, and all actual samples or examples, that were created or gathered and that could serve to influence or support a research finding or conclusion. Data does not include such items as research papers cited by the researcher, preliminary notes or paper drafts, reviews, or related communications, or items that are already the property of others. This definition is intended to characterize current research norms, not to modify them.

 

Data Ownership

The Amherst campus of the University of Massachusetts is the owner

or joint owner of all data that is created or collected by its employees or contractors, except when the creation or collection of such data is governed by a written agreement or contract to the contrary, approved in writing by the Vice Chancellor for Research and Engagement. Terms of the campus policy on intellectual property may apply as well.

When another research institution or entity has joint ownership rights to data, agreed in writing prior to creation of the data, the data shall be owned jointly as agreed. Each such institution shall have unfettered access rights to the original data. Such an institution not holding or serving as custodian for the original data may copy the data and own the copy.

When a creator of data ceases to be an employee or contractor of the University, the creator must leave the data in the physical possession of the owner(s), but will continue to have access rights to the data. The creator may take a copy of the data, at creator's expense.

 

Data Custody

The researcher(s) who created the data typically serve as the custodian of the University's data. Such researchers act on behalf of the University, without limiting the University's ownership rights. Data may not be removed from the University premises, except on a temporary basis when work occurs elsewhere, without written approval of the Vice Chancellor for Research and Engagement. The custodian of the data shall take all reasonable steps to protect the data from damage or loss, including

damage or loss due to catastrophic events. The owner of the data shall provide storage space and financial support as necessary to maintain the data. The University may elect to serve as custodian of the data, but may not limit the creator's access to those data.

Data Quality

Data shall be maintained in a manner that prevents alteration or that makes any and all alterations evident. For example, written data should be recorded in a bound notebook with numbered pages. If a datum is revised, the reason for revising it must be documented and dated. Electronic data should be kept on a read-only medium, or in a read-only mode. The creator of data should be able to document and defend any modification of the data.

 

Data Retention

Data shall be retained for at least three years after its creation. If the data were created as part of a sponsored research project, then the data shall be retained for at least three years after the final report to the sponsor has been submitted, or the ending date of the project, whichever is later. The data shall be retained for a longer period as dictated by any applicable policy or written agreement. If more than one minimum period of retention is deemed to apply, the data will be retained for the longest of these

periods. If the data led to the granting of a patent, then the data shall be retained for the life of the patent and its extensions. The data shall be retained while any litigation or legal action or investigation of allegations regarding it is pending. The data shall otherwise be retained for as long as anyone expresses, in writing, an interest in its retention. In no case will the data be discarded or destroyed when it is known to be in use.

 

Data Access

Researchers shall endeavor to make their data publicly available as soon as possible, and to the extent possible. Access may be delayed while the correctness of the data is being verified, until an initial publication based on the data appears, for the minimum period needed to file a patent application, or for any other reasonable need. Data should be released early if benefit to the public is likely.

No data may be published or made available in a form that would breach aconfidentiality. For example, the medical and financial records of an individual are private. The identity of human subjects is also typically held in confidence. The confidential aspects of confidential data are to be protected by both the custodian and the owner of the data. This may include physically securing the data. When a means of hiding the identity of a protected individual or entity is possible, say by the encoding or removal of names, such steps will taken so that the data may be made public to the greatest extent possible. If the data cannot be made satisfactorily anonymous, it shall not be made public, and the Vice Chancellor forResearch and Engagement will be informed of the existence of the data and the reasons that it cannot be made public. The creator of the data must make every reasonable effort to release the data in a useful form. If the veracity of confidential research data is challenged, the creator must cooperate with the Vice Chancellor for Research and Engagement to devise a means to satisfy the challenge. As owner, the University will defend any challenge, with the cooperation of the researcher. All applicable laws and legal protections regarding confidentiality will be obeyed.

Data that is deemed sensitive may require restricted access or other limitations. The owner and custodian of such data will comply with applicable laws.

Applicable non-disclosure agreements must be honored. However, the Vice Chancellor for Research and Engagement must approve any non-disclosure agreement ahead of time and be a co-signer. Such agreements shall generally be of limited duration, to give a sponsor sufficient time to file a patent application or for other protection.

When a collaboration comes to an end, and data was created during the collaboration, each member of the collaboration shall retain access to that data.

 

MOVED: That the Faculty Senate approve the Policy on Data Ownership Retention, and Access at the University of Massachusetts Amherst, as presented in Sen. Doc. No. 06-047.

52-06

 

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Document File: 

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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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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The Institutional Biosafety Committee protocol form can be found here.

The University has a Biological Safety Officer in Environmental Health and Safety and a federally mandated Institutional Biosafety Committe (IBC) , which includes faculty, the Biosafety Officer, the Compliance Coordinator, the Director of Animal Care, and community representatives. All research projects involving the use of rDNA  or synthetic DNA must be registered with the Office of Research Compliance which provides reports to the IBC. The Biological Safety Officer pre-reviews registrations and determines the level of IBC review required.  The review process is briefly summarized here:

Conducting IBC reviews of use of rDNA and synthetic DNA at UMass Amherst.

UMass Amherst is required by the NIH to ensure appropriate review of research involving the use of rDNA or synthetic DNA by the Institutional Biosafety Committee (IBC) in compliance with the NIH Guidelines for Research Involving Recombinant or Synthetic DNA Molecules.  OPAM post-award staff may hold back release of funding for research involving use of rDNA or synthetic DNA until they get confirmation from the Office of Research Compliance that a registration covering this research has been submitted for IBC review or is already on file.

Registrations must be submitted by UMass employees who satisfy the Faculty Senate Policy that defines a PI at UMass (Sen. doc. No. 09-032).

Each registration is pre-reviewed by the Biosafety Officer in EH&S to verify that the NIH review level indicated by the PI is correct and to ensure the registration is complete.  The IBC review process follows NIH Guidelines.

For review level IIIE, the IBC is notified of the registration as soon as the pre-review is completed and the research may start prior to the PI receiving notice of formal IBC approval. 

For higher NIH review levels (IIID to IIA), the work cannot start until the PI receives an approval letter signed by the IBC Chair.   

Approval is for 5 years after which  time a new registration must be submitted if the use of rDNA or synthetic DNA is to continue.

Synthetic DNA in PCR products that are not clones is exempt from registration with the IBC.  However, use of commercially available nucleic acid molecules is not a determinant of exemption.

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According to Massachusetts regulation enacted September 18, 2006 anyone in Massachusetts over the age of 18 can purchase hypodermic needles and syringes without a prescription. The supplier may request proof that the buyer is over 18 when needles and syringes are purchased without a prescription.

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To the Campus Community:

The Office of Research Compliance (ORC) maintains and implements UMass Amherst's policies and procedures regarding U.S. export controls. This memo reintroduces those policies and procedures, identifies recent changes thereto, and provides basic background information about export controls.

Export controls are U.S. laws and regulations that restrict the release of critical technologies, information, and services to foreign nationals, within and outside of the United States, and foreign countries for reasons of foreign policy and national security. These laws and regulations, which include international sanctions programs, also restrict activities within certain countries and with designated institutions, entities, and individuals, even if no controlled items are involved.

The term “export” is defined broadly within U.S. export controls and includes, but is not limited to, releasing identified items and information to foreign nationals within the U.S. UMass Amherst’s Export Controls Compliance Program Guidelines, training materials, resources, and guidance on the laws and regulations are available on the ORC website.

It is the responsibility of all campus community members to be familiar with and adhere to the requirements of export control regulations. Individuals and institutions that violate federal regulations governing export-controlled activities may be subject to civil and criminal penalties that can include significant fines, jail terms, denial of export or research privileges, and debarment from government contracting.

Because of the broad scope of export-controlled items, which include, but are not limited to, equipment, software code, chemical and biological materials, and technical data, these laws and regulations apply to virtually all fields of science and engineering and restrict both physical shipments and electronic transmission of information. Further, country-specific sanctions programs apply regardless of research subject matter. Export control laws apply to all activities – not just sponsored research projects.

University of Massachusetts policy requires compliance with all U.S. export control laws and regulations, which apply to both researchers individually and their institutions. Therefore, all faculty, staff, graduate students, and undergraduates involved in export-controlled research are required to have training before beginning those projects. Further, it is strongly suggested that all community members involved in sponsored or international research take advantage of two export control training modules available through the CITI program:

  • Export Compliance for Researchers: Part I, and
  • Export Compliance and United States Sanctions Programs.

For more information see https://www.umass.edu/research/compliance/research-safety-and-security/export-control-training-program. Should you have questions, or to schedule training on the application of export controls to your research area, please contact the Office of Research Compliance at (413) 545-5283 or via email at rescomp@research.umass.edu.

Copyright 2018. University of Massachusetts Amherst

 

 

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