Compliance

Conflict of Interest Human Subjects - UMass Medical School

These procedures are promulgated pursuant to the University of Massachusetts Conflicts Committee Guidelines for the Oversight of Individual and Institutional Financial Interests in Human Subjects Research dated December 22, 2009, as amended on May 1, 2012 (Guidelines) and were approved by the President effective as of May 1, 2012.

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UMass Guidelines for the Oversight of Individual and Institutional Financial Interests in Human Subjects Research

(Doc. T96 -039)

I. Introduction.

The missions of the of University of Massachusetts (UMass) and its five campuses include the important goal to advance the health and well-being of the people in the Commonwealth of Massachusetts, the nation, and the world through advances in education, research and knowledge. It has become increasing apparent that in order to fulfill its mission, UMass must engage in a variety of complex relationships with commercial entities, such as, pharmaceutical and biotechnology companies, with whom we share the critical responsibility of promoting the development of novel therapies for individuals for whom current health outcomes are inadequate.

In the course of these relationships, there are occasions in which the potential for real or apparent conflicts of interest arise that might call into question the integrity of advancements that are developed by UMass. It is the responsibility of individual investigators, other faculty, administrative leaders, and the institution itself to delineate clearly how and why it may be justified to act in a manner that may involve conflicts of interest or the appearance of conflicts of interest. Justification of conflicts of interest may only be maintained insofar as those interests are fully disclosed and do not materially damage the interests of research subjects, patients, UMass employees, UMass, or the Commonwealth of Massachusetts. The purpose of this document is to provide a framework for pursuing such interactions in keeping with overall University of Massachusetts policy and accepted best practices.

II. Association of American Medical Colleges (AAMC) and Association of American Universities (AAU) -“Protecting Subjects, Preserving Trust, Promoting Progress” (Parts 1 and 2), 2001 and 2002 and “Protecting Patients, Preserving Integrity, Advancing Health: Accelerating the Implementation of COI Policies in Human Subjects Research,” 2008.

The AAMC comprises the 137 accredited US medical schools with participation by their associated teaching hospitals through the Council of Teaching Hospitals. The AAU comprises 61 leading United States and Canadian universities that are distinguished by the breadth and quality of their programs of graduate education and research. As such, these organizations represent a widely accepted source of community standards of best practice with regard to the conduct of research within universities and academic medical centers. In 2001 and 2002, the AAMC and the AAU issued two sets of Policies and Guidelines regarding the oversight of conflicts of interest, the first dealing with individual financial interests and the second dealing with institutional interests. Each of these reports was authored by a panel of experts and leaders in academic medicine and was thoroughly researched and referenced. In February 2008 the AAMC and the AAU issued a new report that refined the two earlier reports and urged United States universities and medical schools to establish clear and consistent conflicts of interest policies. These three reports (AAMC Reports) form the impetus and basis for these Guidelines.

The UMass Policy on Conflicts of Interest Relating to Intellectual Property and Commercial Ventures (Conflicts Policy) is aligned with both of the AAMC - AAU reports, and our institutional mission and vision regarding this guidance document are based upon the following principles:

  • The welfare of research subjects is of foremost concern in Clinical Research studies. The Conflicts Committee affirms that all Pecuniary Interests in Research (as defined in the attachment to these Guidelines) with respect to Clinical Research are potentially problematic, and, therefore, require close scrutiny and rigorous review. Thus, UMass hereby establishes the presumption that an individual who holds any Pecuniary Interests in Research with respect to Clinical Research proposed to be conducted at UMass may not conduct that research. This presumption applies regardless of the source of funding. A key feature of these Guidelines, however, is that this presumption is potentially rebuttable when the investigator or institution can make a compelling argument for exemption. “Clinical Research” is defined in the Conflicts Policy as research involving human subjects.
  • The same presumption is in force when the institution holds Pecuniary Interests in Research (as defined in the 2001 AAMC report) with respect to Clinical Research. UMass may have a conflict of interest in Clinical Research whenever the financial interests of the institution (such as an equity or royalty interest), or of an institutional official acting within his or her authority on behalf of the institution, might affect– or reasonably appear to affect – institutional processes for the design, conduct, reporting, review, or oversight of the Clinical Research. Similarly, due consideration, informed by the AAMC Reports, shall be made of any substantial gifts, major institutional purchases or non-routine supply contracts with a company that sponsors Clinical Research at UMass.  Each VCR shall be responsible for developing procedures, using available databases, to identify potential institutional financial interests in accordance with the principles established in these Guidelines and the AAMC Reports. 
  • A Covered Individual with Pecuniary Interests in Research with respect to Clinical Research may rebut the presumption against allowing conduct of the Clinical Research and be permitted to conduct the Clinical Research only after a showing of compelling circumstances and approval by the Conflicts Committee, including its plan for managing or reducing the conflict. Similarly, compelling circumstances may exist to justify the conduct of Clinical Research within UMass despite an institutional conflict of interest.
  • Whether the circumstances are deemed compelling will depend in each case upon the nature of the science, the nature of the financial interest, how closely the financial interest is related to the Clinical Research, and the degree to which the financial interest may affect or be affected by the research. Special consideration may be given to protocols that are directed at orphan diseases (as defined by the U.S. Food and Drug Administration) and to protocols for compassionate use of potential therapeutics. When the interest is very direct and the potential effects substantial, the risk is greatest, and the bar must be high. However, when the individual UMass investigator holding the financial interest is uniquely qualified by virtue of expertise and experience, and the work could not otherwise be conducted safely or effectively without that individual, he or she would be permitted the opportunity to rebut the presumption against conducting the research by demonstrating these facts along with an effective management plan.
  • Transparency of reporting of real or perceived financial conflicts of interest, whether they are individual or institutional shall be disclosed (a) within the written informed consent documents, (b) within all publications (print or electronic), and (c) within all presentations of the Clinical Research outside the  University.
  • A plan for effective, disinterested monitoring of the Clinical Research should be included in any request to rebut the presumption. Examples of appropriate features of monitoring include the utilization of an external data monitor (with periodic on -site inspection of source documents and reconciliation of documents with the case report forms) and the use of external data and safety monitoring committees or boards (composed of peer reviewers who periodically examine data and reports redacted by the independent study monitor). In the case of an institutional conflict of interest, it may be deemed appropriate to use an external IRB for initial protocol review.
  • These Guidelines apply to all Clinical Research in which any Covered Individual participates or for which they assume any role or responsibility, whether or not the study is to be conducted at the University or at another venue such as another institution, a hospital or a private concern (and all such Covered Individuals are subject to the authority of the respective campus Institutional Review Board (IRB)).
  • Often a Covered Individual who has a Pecuniary Interest in Clinical Research has made prior disclosures of related financial interests for non-Clinical Research pursuant to the Policy on Faculty Consulting and Outside Activities (DOC. T96-047), the Conflicts Policy and/or the applicable Federal financial conflict of interest regulations. However, those prior disclosures or approvals do not replace or circumvent the disclosure and approval required under these Guidelines with respect to Clinical Research.
  • For Clinical Research supported by the PHS (including the NIH), if the Department of Health and Human Services determines that a PHS -funded project of clinical research, who se purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment, was designed, conducted, or reportedly an investigator with a financial conflict of interest that was not properly disclosed or managed as required under the PHS Financial Conflict of Interest Regulations, the University, through the respective office of the VCR, must require the investigator(s) to disclose the financial conflict of interest in each public presentation (such as articles, manuscripts and oral presentations, including classroom materials) of the results of the research and to request an addendum to previously published presentations.

III. Conflicts Reporting Process.

Covered Individuals shall report to the Vice Chancellor for Research (VCR) when he/she perceives that any individual or institutional conflict of interest in Clinical Research exists, may exist, or may be perceived to exist. This is in addition to reporting all financial interests to the campus Institutional Review Board (IRB).

  • Upon the VCR’s receipt of the disclosure of the Covered Individual, the VCR shall determine whether any individual Pecuniary Interests in Research exists, may exist, or may be perceived to exist. In addition, the VCR shall also consider whether there are institutional conflicts of interests that exist, may exist,r may be perceived to exist and whether any of those interests constitute Pecuniary Interests in Research.
  • With respect to specific Clinical Research to be conducted at UMass or being conducted at UMass, it is incumbent on administrative officials with direct responsibility for the Clinical Research to immediately make known to the VCR if they hold Pecuniary Interests in Research in a commercial research sponsor or an entity that owns or controls an investigational product. The VCR shall assist these officials in making a determination whether there is a conflict of interest for consideration in the case.
  • It is the responsibility of the VCR to ensure that all of these applicable individual and institutional conflicts of interests are presented for review of the Clinical Research by the campus and the Conflicts Committee.
  • If any campus review procedures apply in accordance with IV. below, the VCR shall ensure that those procedures are undertaken promptly and shall notify the Conflicts Committee of his/her receipt of the disclosure and the initiation of the campus procedures.
  • The VCR shall refer the Clinical Research case to the Conflicts Committee for review and consideration in accordance with the standard of review established in these Guidelines, after completion of the campus procedures, if any. The VCR shall present to the Conflicts Committee, in writing, the background of the case, including an explanation of the individual and institutional conflicts for consideration, the deliberations of any campus committee(s), the risk-benefit analysis conducted including what compelling circumstances and special considerations were identified and considered, and the recommendation of the campus.
  • Even in the presence of compelling circumstances, any approval will include a sufficient plan to disclose the conflict to volunteer subjects and to provide external monitoring of the protocol.
  • If the Conflicts Committee does not approve the Clinical Research, the VCR shall inform the IRB in writing and the Clinical Research may not be approved.
  • Only upon final approval by the Conflicts Committee may the enrollment of the first volunteer research subject commence.

 

IV. Campus Review Procedures

Due to the unique complexities and health and safety concerns raised by Clinical Research and the myriad of campus constituencies and administrative bodies that participate in these decisions, including the campus IRB, the campuses may, but are not obliged, to develop additional procedures, beyond those set forth herein, for assisting the VCR in the consideration of these Clinical Research cases. Such campus -specific procedures would be supplemental to those set forth herein and are not in lieu of the Conflicts Committee deliberations and determination. However, each campus may develop its procedures and submit them to the Conflicts Committee or to the President (or his/her designee) for adoption if the procedures are consistent with these Guidelines (including the principles established in the AAMC Reports) and the Conflicts Policy and are found to not unduly delay the consideration of these cases by the Conflicts Committee.

 

V. Relationship of UMass Policy to Faculty Physicians employed by UMass Memorial Health Center (UMMHC). 

Physicians and other providers employed by UMMHC who hold faculty or other positions (e.g., student, resident, fellow, or other health care provider) at the University of Massachusetts Medical School are Covered Individuals who are subject to the Conflicts Policy for all participation in Clinical Research within the UMMHC or elsewhere, including clinical or research sites operated by the University of Massachusetts Medical School or its divisions (including Commonwealth Medicine and the Massachusetts Biologic Laboratories). This element of the policy is in keeping with the statement in the 2002 AAMC - AAU policy document.

 

Pecuniary Interest in Research (Defined)

Pecuniary Interest in Research include the following interests of the Covered Individual (and spouse/domestic partner and dependent children) that is reasonably related to the Covered Individual’s Institutional Responsibilities:

With regards to Publicly-Traded Entities, any payment or value, including salary, consultant payments, honoraria, paid authorship, equity interest (stock, stock option or other ownership interest) during the prior twelve months. 

With regards to Privately Held Entities, any payment or value, including salary, consultant payments, honoraria, paid authorship, equity interest (stock, stock option or other ownership interest) during the prior twelve months. 

With regards to Intellectual Property, intellectual property rights and interests (patents, copyrights) upon receipt of income related to such rights and interests.

With regards to Travel Reimbursements, any reimbursed or sponsored travel related to the Covered Individual’s Institutional Responsibilities during the prior twelve months (with the exception of travel that is reimbursed or sponsored by a Federal, state, or local government agency, an institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education.

The term “Pecuniary Interest in Research” does not include: salary, royalties, or other remuneration paid by the University to the Covered Individual if the Covered Individual is currently employed or otherwise appointed, including intellectual property rights assigned to the Institution and agreements to share royalties related to such rights; income from investment vehicles, such as mutual funds and retirement accounts; income from seminars, lectures, or teaching engagements sponsored by a Federal, state, or local government agency, an institution of higher education, an academic teaching hospital, a medical center, or a research institute affiliated with an institution of higher education; or income from service on advisory committees or review panels for a Federal, state, or local government agency, an institution of highereducation, an academic teaching hospital, a medical center, or a research institute affiliated with an institution of higher education.

 

These Guidelines are issued pursuant to the Board of Trustees’ Policy on Conflicts of Interest Relating to Intellectual Property and Commercial Ventures (DOC. T96-39) (Conflicts Policy) and here approved by the

President on December 22, 2009 and amended effective as of May 1, 2012. All terms which are capitalized but not defined within these Guidelines have the meaning ascribed to those terms in the corresponding campus Conflicts

Policy.

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Revised May 1, 2012

There may be times when it is more appropriate for consent to be presented and obtained orally rather than in written form, particularly if participants have limited proficiency with the English language.  In such instances, an investigator may use a short form written consent document, stating that the elements of informed consent have been presented orally to the subject or the subject's legally authorized representative.

The oral and short form written consent process is designed to provide a mechanism for individuals with limited English language proficiency to participate in human subject research where their lack of proficiency would otherwise be a barrier to their participation.

Participants who have limited English proficiency may be enrolled in research provided that researchers have the resources to communicate effectively during the recruitment process, while obtaining consent, and for the duration of the study.  Oral consent in combination with short form written consent may be used to obtain a subject’s consent.

The use of oral and short form written consent is not intended for use when research is focused on an entire or large population that lacks proficiency with the English language; in these cases, the normal consent process should be used with consent documents translated into the subject population’s native language.

Investigator Responsibilities

Investigators must obtain IRB approval for use of the short form written consent process.  For new studies, this request should be made when completing the application in Kuali.

The investigator must provide the following to the IRB for review:

  • A written summary of the information that will be presented orally to participants or their legally authorized representatives.
  • The short form document that will be signed by the participant and the person obtaining consent.
  • Identification of the individual obtaining consent.
  • Confirmation that there will be a witness to the oral presentation of consent (this cannot be the same individual who is obtaining consent).  When the person obtaining consent is assisted by a translator, the translator may serve as the witness.
  • Confirmation that the witness is fluent in the same language as the potential participant.

The short form written consent document and written summary of oral presentation must be translated into the participants’ native language.

When this method is used, there must be a witness to the oral presentation. Only the short form itself is to be signed by the participant or legally authorized representative.  The witness must sign both the short form and a copy of the summary, and the person actually obtaining consent must sign a copy of the summary.  The investigator must provide the participant with both a copy of the summary and a copy of the signed short form.

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What is MTurk?

MTurk is a website run by Amazon that works as a readily available marketplace to match “workers” with available work from various “requesters.”  Amazon describes MTurk as, “a marketplace for work that requires human intelligence.  The Mechanical Turk service gives businesses access to a diverse, on-demand, scalable workforce and gives workers a selection of thousands of tasks to complete whenever it’s convenient.”

How are academic researchers using MTurk?

MTurk allows researchers to have access to a large population of willing participants for research studies.  Researchers can generate a HIT (Human Intelligence Task) that gives MTurk users a Title and description of the online task.  It also states the amount of compensation users will receive and the amount of time it takes to complete.  Because MTurk is being used primarily as a recruitment site, researchers have been routing users to links for their online survey’s that are housed at different online survey software sites (i.e. – Qualtrics, Survey Monkey, Google Forms, Survey Gizmo, etc.).  MTurk houses a more diverse, heterogeneous, population that is more attractive to researchers than the typical college campus population.  It also allows for pseudo-anonymity between researchers and participants by having a third party (Amazon) overseeing payments (compensation) to participants.

Amazon Mechanical Turk is a site primarily for matching people with work and submitting payments to workers.  It is not designed with an eye towards human subjects research.  It lacks the sophistication and security measures of dedicated survey software tools and collection of data by Amazon is subject to Amazon’s Privacy Policy and Terms of Service.

What do academic researchers need to consider when submitting an MTurk study to the IRB?

Recruitment: The title of the study and the description of the HIT are acting as a form of recruitment.  Researchers should be sure to include the title and HIT description as part of the Kuali application. In the description, researchers should be sure to include the following information:

  • Researchers should be clear about compensation and bonuses.  Also, it would be useful for participants to know how long it will take for the researchers to approve their HIT (i.e. – how long it takes for turkers to receive payment).
  • Clearly and accurately state the time required to complete the task.
  • Participants should be told if there is a screener in order to qualify.  It would be important for researchers to make clear if participants are being paid for the time it takes to complete the screener or not.  One option would be to list qualifications for participation in the description.  Another option would be to make a hit for the Screener (which would pay a nominal amount) and then if a turker is eligible for the main study, they get a bonus amount or are invited to a follow-up HIT which includes the main study.
  • If any extraneous software is required to complete the task, this should be stated in the description (e.g. this task requires javascript or inquisit).
  • Researchers should be clear about the type of task participants are being asked to do.  For instance, if the task involves writing, or watching videos, this should be stated in the description.  Also be aware that certain types of tasks, such as writing tasks, elicit higher compensation.
  • The researchers name and/or school affiliation should be listed either as the Requester or in the description of the HIT.
  • If applicable: The link to the online survey should be included.

Consent: The first page of the online survey should be the consent document. The online consent will have all of the elements of a regular consent, but it will not require a signature.  Participants will either click an “I Agree” or an “I do not Agree” box.  The “I Agree” box will take them into the survey.  The “I do not agree” box will thank them for their time and take them away from the survey.  For a sample of an online consent form, please see our one page, online survey consent template.

Debrief: If the researchers are using deception or incomplete disclosure (i.e. – are not stating exactly what the study is about so as not to bias participants responses), then it is important to include a debriefing form at the end of the survey.  This debriefing form could be embedded into the last page of the survey and would require participants to answer a final question allowing researchers to use their data (or not use their data) now that they know the true purpose of the study.  For more information on debriefing forms, please see our debriefing process. Please note: For particularly sensitive topics, the IRB may want to ensure that participants receive a debriefing form, even if they do not complete the full study (i.e. – they click out before the end of the survey).  This might mean contacting participants (through MTurk) and providing them a debriefing form.  If this is something that will happen for your study, it would be important to include a statement in the HIT description and in the informed consent that the researchers will be providing participants with additional information after the study and that they may contact participants through MTurk.  This might mean collecting participants MTurk worker IDs.  Researchers should be sure to state that the collection of MTurk worker IDs will only be for debriefing purposes and after debriefing, MTurk worker IDs will be deleted and will at no time ever be linked to their survey data.

Confidentiality: While it may have been the goal that MTurk workers were anonymous to academic researchers, the reality is that anonymity cannot be guaranteed in any online environment were data is being collected.  Recent research shows that MTurk worker IDs can easily be linked to individuals Amazon profiles including individuals wish lists and previous product reviews.  This means that researchers must be careful in deciding what information to collect from participants.  The default should be that participants MTurk worker IDs not be collected.  If it is necessary to collect worker IDs, then the researchers should ensure that worker IDs are kept confidential and secure, are not linked back to survey data, and are deleted after use.

Additional things to consider with regard to confidentiality of participants identity and data are the Amazon MTurk (AMT) Terms of Service (TOS) and online survey software (qualtrics, survey monkey, google forms, survey gizmo, zoho survey, etc.) TOS especially as it relates to the collection of participants online behavior and history (through the use of cookies or other tracking systems) and the selling of participants data to third parties.  It would also be important for researchers to be aware of any policies or procedures in place by AMT and/or online survey software companies when a breach of data occurs.  It might be helpful to think about the researchers own protocol for when a breach of data security occurs.  Working with IT to solidify this process may be necessary.  This information could then be relayed to participants through the consent.

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Policy on Biohazardous Materials in Research and Instruction

University of Massachusetts Amherst

Policy on Use of Biohazardous Materials in Research and Instruction 

Purpose

The University of Massachusetts Amherst (the University) is committed to ensuring the safe handling, storage, and disposal of potentially biohazardous materials, as defined below, used in University research or instructional projects.  This policy is designed to ensure that employees, students and visitors follow safe practices when working with or near potentially biologically hazardous materials or recombinant DNA.  The University will pursue biological safety through ensuring prudent practices to protect people and the environment from biological hazards and will conform to state and federal biosafety directives and guidelines.  Implementation of this policy by the University is intended to provide a safe working atmosphere and a well-controlled research environment. The University’s concern is for all biosafety issues but in particular it is concerned with activities involving

  • Infectious agents
  • Recombinant DNA research
  • Agents on the list of Select Agents
  • Potentially biologically hazardous materials

This policy statement describes the role of the University and the Office of Research Compliance (ORC), the Environmental Health and Safety Director (who is the Responsible Official with oversight over biosafety issues) and the Institutional Biological Safety Officer (BSO) in EHS, the Institutional Biosafety Committee (IBC), and the IBC’s structure and function.  The Biological Safety Officer and IBC are charged with reviewing and approving projects that need to comply with federal regulations on the use of recombinant DNA and Select Agents.  The review process is described below.

Definition

Biosafety promotes safe laboratory practices, procedures and proper use of containment equipment and facilities among University staff and visitors.

Biohazardous Material -

The following categories represent the areas of primary concern with respect to biosafety.  Projects involving material(s) included in any of these categories should be submitted to the BSO for initial review and may require IBC approval.

  1. Chemical Carcinogens used in conjunction with animals.
  2. Toxic/Infectious agents used in conjunction with animals and plants.
  3. Oncogenic viruses used in conjunction with animals.
  4. Infectious agents requiring handling conditions above Biosafety Level-1.(Biosafety Level determinations are based on the recommendations outlined by the CDC-NIH publication Biosafety in Microbiological and Biomedical Laboratories.
  5. Recombinant DNA
  6. Human blood and blood products, human body fluids, human tissue, and/or human cells.
  7. Biological toxins.
  8. Agents regulated by CDC or USDA (e.g. on the list of Select Agents)
  9. Whenever a contractual agreement or grant proposal requires Institutional Biosafety Committee approval for the safe handling of a biological or chemical product.
  10. Any research that requires a permit from USDA Animal and Plant Health Inspection Service (APHIS).
  11. Wild Poliovirus or materials that may contain wild poliovirus [contact Environmental Health and Safety (413) 545-2682 for additional information on this subject].

Policy

This policy applies to all research and instructional activities, sponsored and unsponsored, conducted under the auspices of the University. This policy is applicable to all University locations.  University projects involving the use of biohazardous materials at other institutions should receive Institutional Biosafety Committee (IBC) approval from the cooperating institution.  Copies of approvals from cooperating institutions should be forwarded to the Office of Pre-Award Services (OPAS) and the Office of Research Compliance (ORC) on request.

All University research and instructional activities involving biohazardous materials must be reviewed and approved by the Biological Safety Officer and, as required, the Institutional Biosafety Committee (IBC).  Projects submitted for sponsorship by external agencies will be submitted for review prior to acceptance of funding. The IBC review process is coordinated by the Research Compliance Coordinator in the Office of Research Compliance (ORC) in 109 Research Administration Building (545-5274).

Responsibility

Administrative heads of departments and other units have responsibility for the biosafety of people, and the environment within their jurisdiction.  Appropriate planning, provision of appropriate space and equipment, and training of personnel are essential in potentially biohazardous activities.

Principal investigators (PIs), instructors, supervisors and other personnel in charge of potentially hazardous activities are key to the biosafety effort.  PIs must set an example by their own actions to ensure compliance with the regulations and the University’s biosafety policy, directives and guidelines regarding the work they supervise.  They must report biologically hazardous incidents to the Biological Safety Officer (BSO) promptly and assist in any resulting decontamination, investigation and/or reporting that may be required.  They are responsible for posting biohazard warning signs at the entrance to the laboratory.  They are responsible for notifying the Office of Research Compliance of any proposed activity using biohazards by indicating so on the Kuali Questionnaire that accompanies a grant proposal submitted to the Office of Pre-Award Services (OPAS). They are responsible for making the initial determination of the required level of physical and biological containment in accordance with National Institute of Health (NIH) and Center for Disease Control (CDC) Guidelines. Once the project starts they are responsible for reporting any significant problems to the appropriate authorities (BSO, and/or Greenhouse or Animal Care Director as appropriate).  It is the responsibility of the PI to ensure that copies of approval letters are properly directed to any funding agency or sponsor. It is also the PI’s responsibility to renew approved projects with the ORC and provide a current listing of personnel involved in approved projects to the ORC.

All personnel involved in potentially biologically hazardous activity share biosafety responsibility and must follow specified procedures, take appropriate training, act responsibly, and report incidents and hazardous circumstances. They should inform their supervisor of any personal condition such as illness, medications, pregnancy, or reduced immunity which could make their work more hazardous to themselves and others.

The Biological Safety Officer (BSO) is appointed by the University and is a member of the EHS staff.  The BSO who is charged with oversight of research and other activities involving the use of biohazardous materials.  The EHS Director is the Responsible Official for biosafety issues and the BSO is his/her Alternate as required by the Homeland Security Act.  The Director of EHS and the BSO set containment levels in accordance with the National Institute of Health Guidelines and the Center for Disease Control Prevention.  The BSO reports any violations of the NIH Guidelines to the Responsible Official and the Institutional Biosafety Committee.  The BSO and other EHS personnel maintain an inventory of all potentially biologically hazardous materials, including Select Agents.  EHS records include a biohazard’s nature, location, and the Principal Investigator(s) involved.  The BSO is responsible for:

  • advising and training the Institutional Biosafety Committee members, faculty and staff concerning biologically hazardous materials and their control
  • reviewing (or pre-reviewing for the IBC) registrations of rDNA and Select Agents
  • inspecting facilities
  • reviewing and inspecting biologically hazardous activities in coordination with other EHS personnel and activities, the Animal Care Director, Greenhouse Managers, and the Compliance Coordinator in the Office of Research Affairs
  • providing technical advice to investigators on laboratory containment facilities, safety equipment, security and research safety procedures
  • developing emergency plans for containment and handling spills and personnel contamination
  • investigating accidents involving biologically hazardous materials. 

The Research Compliance Coordinator (CC) is a professional staff member in the Office of Research Compliance (ORC).  The CC works closely with the BSO and EHS Director to ensure that research with biologically hazardous materials and organisms at the University is conducted in accordance with all applicable local, state and federal regulations.  The CC and staff in the Office of Research Compliance have responsibility for:

  • managing the rDNA and Select Agent registrations database
  • managing the registration review process and interfacing with the BSO and the IBC for registration review
  • taking IBC meeting minutes
  • recording registrations submitted and actions taken
  • providing administrative support to the IBC and BSO
  • notifying the principal investigator of the outcome of a registration review
  • filing the IBC Annual Report for the University of Massachusetts Amherst with the NIH/Office of Biotechnology Activities
  • reporting oversight activity to the IBC when, according to State and Federal Regulations, the activity does not require the committee’s direct oversight
  • interfacing between the BSO and the IBC and other University oversight committees like the Institutional Animal Care and Use Committee (IACUC) and the Institutional Review Board (IRB).  The CC attends meetings of all three committees.

The University is responsible for

  • establishing an IBC and appointing the IBC Chair
  • ensuring that the IBC members, the BSO, the CC, PIs and laboratory staff have appropriate expertise and training
  • ensuring that an Annual Report is filed with the NIH Office of Biotechnology Activities and that the report includes (1) a roster of IBC members indicating their expertise; and (2) biosketches of the members.  [The Institution has an Approval on file with the NIH/Office of Biotechnology Activities.  The Approval must be renewed annually.  The expiration date for the current Approval is July 29, 2013.] 
  • establishing procedures for the IBC
  • Handling requests for copies of  IBC documents.

The Institutional Biosafety Committee

The Institutional Biosafety Committee (IBC) is a University-wide review body appointed by the Vice Chancellor for Research and Engagement to review and approve potentially biohazardous research. When it is unclear as to whether a material constitutes a potential biohazard, questions should be directed to the BSO in the Office of Environmental Health and Safety (EHS) (545-2682). 

Note: In the past the University had two standing committees to oversee rDNA, and pathogens,oncogenes, carcinogens and toxins. These activities are now combined, as reflected by the IBC’s charge which encompasses:

  • Review of policies, programs and directives regarding biological hazards in academic, research, clinical and animal care activities. 
  • Review and approval of research that involves potentially biohazardous materials (plant and animal pathogens, oncogenes, carcinogens, toxins and recombinant DNA), as required by University, State and Federal directives.  Review includes: (i) an independent assessment of the containment levels required by the NIH guidelines for the proposed research, (ii) assessment of the facilities, procedures, practices and training and expertise of the personnel involved in rDNA research, and (iii) ensuring compliance with all reporting and adverse event reporting required by the NIH guidelines.  The committee may approve, disapprove, or request revisions which would lead to approval.
  • Advising the Administration regarding problems of a biologically hazardous nature and recommending actions.  Recommendations include: denial of proposed activities where adequate facilities, equipment or personnel are not available; sanctions against individuals who are non-cooperative in biosafety matters; suspension of any biohazardous activity judged to pose a significant risk to health of safety.
  • Review of emergency plans covering spills and personnel contamination resulting from rDNA research and research using biohazards.

IBC members are appointed for three-year terms to provide oversight over University operations and activities of a potentially biologically hazardous nature.  Membership of the IBC is consistent with NIH guidelines (sections IV-B-2-a and IV-B-2-b) on the review of projects involving the use of recombinant DNA and its make-up has been reviewed and approved by the NIH/Office of Biotechnology Activities.  The BSO is a member of the committee and the other members work closely with the BSO to recommend actions necessary to maintain and/or improve biosafety on the campus.  The IBC meets at least four times a year.  A quorum consists of a simple majority.  Minority views are recorded in the minutes.

Procedures

PIs conducting research with biohazardous materials must register with the BSO. 

Grant-funded research:  PIs proposing research that uses biohazardous materials must indicate the category on the Kuali Questionnaire.  When one or more of the following items are checked

  • biohazardous substances
  • carcinogenic substances
  • recombinant DNA
  • Select Agents

a copy of the proposal is forwarded from the Office of Grants and Contracts to the Office of Research Compliance.  When the research involves biohazardous or carcinogenic substances a copy of the proposal is forwarded to the BSO for review.  The BSO contacts  the PI and requests that he/she submit the appropriate form (EH&S Research Registration Form) to ensure that the procedures are in compliance with all relevant regulations. The BSO will forward registrations for biohazardous work at BSL2 & 3 to the IBC for review. 

Non-funded research and teaching activities:  Requirements for registration and review by the BSO/IBC are the same as for funded research.

When the research involves work with rDNA and/or Select Agents the ORC assistant reminds the PI to submit the appropriate form (rDNA registration or Select Agent registration) for review by the IBC.  The completed rDNA or Select Agent registration is returned to the Office of Research Compliance. where the information is entered into a database then forwarded to the BSO.   For work registered at Levels III-F and III-E the PI may begin the project prior to receipt of formal approval.   For work registered at Level III-D formal written approval must be received before the project can be started.  

For Select Agents registration the BSO follows up with the PI to ensure that all aspects of Homeland Security and the Patriot Act and other regulations are complied with including:

  • whether or not the Select Agents are exempt from registration with the CDC
  • justification of the type of Biological Agent, Toxin or Delivery system to be used
  • assurance that  “Restricted Persons” and/or unauthorized persons will not have access to the Select Agents
  • how the Select Agents will be secured and be controlled when not in storage
  • the locations where the Select Agents will be stored and used
  • disinfection and disposal methods

If the project is to be conducted in a University laboratory, the BSO contacts the PI and schedules an inspection of the site(s) where the research will be conducted.  If the research also needs review and approval by the IACUC or IRB, approval by these committees is withheld pending approval of the project by the BSO/IBC and an assurance from the BSO that procedures are in place to ensure the safety of any personnel that will come in contact with the biohazardous materials, including laboratory staff and students, and animal care or greenhouse technicians.

Note: The BSO will advise the PI regarding the need for a written Safety Protocol.  A written Safety Protocol is required for projects where the biohazardous material comes in contact with animals and animal care staff.

Approvals are for a maximum of five years. 

Records for the IBC and a database of BSO-approved protocols are maintained in the ORC. Laboratory inspection records, training records, and the inventory are maintained by EHS.

Disposal of Biohazardous Waste

All biohazardous waste must be disposed of in accordance with local, state and federal regulations  Biohazardous waste must be collected in a bag with the biohazard symbol marked on the bag.  Bags must be kept in a sturdy, covered, leak-proof container.  Biohazard waste must be decontaminated by autoclaving, disinfection, or incineration. Waste that cannot be decontaminated by laboratory personnel will be removed from the area by EHS personnel for disposal, shipment, or destruction in accordance with applicable regulations. Sharps waste must be collected in “sharps”containers and removed by EH&S personnel in accordance with applicable regulations. Refer to the EH&S Biohazardous Waste Packaging Guidelines.

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Process for Reviewing External Recruitment Requests

Researchers not affiliated with UMass Amherst who wish to recruit students, faculty, or staff as research participants are required to submit a recruitment request to the UMass Amherst Human Research Protection Office (HRPO) before beginning their research project. All requests will be screened by the UMass Amherst IRB; we also require research projects to have obtained prior approval through the non-UMass Amherst researcher’s home Institutional Review Board.

Submission Requirements

If you are an external researcher, and are interested in recruiting UMass Amherst students, faculty, or staff as research subjects, please send an email to humansubjects@ora.umass.edu that includes the following information:

  • An overview of your project, including a rationale and specific procedures for recruiting UMass Amherst students, faculty, or staff as participants
  • A copy of the completed research protocol application, including any data security plans, that was approved by your home institution’s IRB, along with the IRB’s approval letter
  • All relevant study materials (e.g. recruitment materials for UMass Amherst participants, interview questions, surveys)

Staff from the HRPO will contact you and may request more information if necessary. Approval to recruit on our campus is finalized once you receive an official letter from the HRPO that confirms approval to begin recruiting at UMass Amherst.

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Determining whether a project requires review by the IRB is sometimes difficult and for this reason it is always best to consult with the Human Research Protection Office (HRPO) for guidance.  The following flowchart is designed to assist in making this determination.

The HRPO makes the determination whether or not a project meets the definition of human subject research.  Federal regulations require that proposed research involving human subjects be reviewed and approved by the Institutional Review Board prior to project initiation. If you are unsure if your project meets the definition of research or if you require documentation that your project does not require IRB review, complete and submit the Determination of Human Subject Research form.

The determination of whether or not a project or activity is defined as human subject research rests on the answers to the following three questions:

  1.  Is it research? Federal regulation defines research as a systematic investigation, including research development, testing, and evaluation, that is designed to develop or contribute to generalizable knowledge.  Research is usually described in a protocol, a formal document that describes the research question or hypothesis and how it is to be tested (methodology) to establish facts and reach conclusions.
  2.  Is the intent to produce generalizable knowledge? The intent to develop or contribute to generalizable knowledge makes an activity research.  Generalizable knowledge is knowledge that is expressed in theories, principles, or statements of relationships that can be generally applied to our experiences.  Activities designed to contribute to generalizable knowledge are those designed to draw general conclusions, inform policy, or generalize findings beyond a single individual or an internal program.  The information is collected to share with others in a discipline and is created to make a broad statement (conclusion) about a group of people, procedures, programs, etc.

    *If the activity is not a systematic investigation designed to contribute to generalizable knowledge, the activity does not meet the regulatory definition of research.

    Generalizable knowledge includes one or more of the following concepts: (1) The information contributes to a theoretical framework or an established body of knowledge; (2) The primary beneficiaries of the study are other researchers, scholars, and practitioners in the field of study; (3) Publication, presentation or other distribution of the results is intended to inform the field of study; and, (4) The results are intended to be replicated in other settings

  3.  Does it involve human subjects? Although a seemingly straight-forward question, whether or not an activity involves human subjects can be somewhat confusing, especially when using coded private information or specimens.  Human subjects are defined as “living individuals about whom an investigator conducting research obtains:
  • Data through intervention or interaction with the individual, or
  • Identifiable private information

Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject. Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.

For purposes of this document, coded means that:

  • Identifying information (such as name or social security number) that would enable the investigator to readily ascertain the identity of the individual to whom the private information or specimens pertain has been replaced with a number, letter, symbol, or combination thereof (i.e., the code); and
  • A key to decipher the code exists, enabling linkage of the identifying information to the private information or specimens.

Determinations of what does or does not involve human subject research must be made by the IRB or individuals designated by the IRB Chair who have sufficient training and expertise in making such determinations.

In analyzing a particular activity under this question, it is important to focus on what is being obtained by the investigators. If the investigators are not obtaining either data through intervention or interaction with living individuals, or identifiable private information, then the research activity does not involve human subjects.

What about Research Involving Coded Private Information or Biological Specimens?

Whether or not an activity is classified as “not involving human subjects” or qualifies for exemption under 45 CFR 46.101(b)(4) is determined by the following:

  • the source of the data (primary or secondary data)
  • ability or inability of the investigator to link data or specimens to specific individuals either directly or indirectly through coding systems

Research involving only coded private information or specimens is not considered human subject research if both of the following conditions are met:

  1. The private information or specimens were not collected specifically for the currently proposed research project through an interaction or intervention with living individuals (i.e. it is pre-existing data); and
  2. The investigator(s) cannot readily ascertain the identity of the individual(s) to whom the coded private information or specimens pertain because, for example:
    1. The investigators and the holder of the key enter into an agreement prohibiting the release of the key to the investigators under any circumstances, until the individuals are deceased (note that the HHS regulations do not require the IRB to review and approve this agreement);
    2. There are IRB-approved written policies and operating procedures for a repository or data management center that prohibit the release of the key to the investigators under any circumstances, until the individuals are deceased; or
    3. There are other legal requirements prohibiting the release of the key to the investigators, until the individuals are deceased.

The exemption under 45 CFR 46.101(b)(4) applies to research involving private information and specimens when:

  1.  Data is already existing at the time the research is proposed and is available publicy, or
  2. The information is recorded by the investigator(s) in such a manner that subjects cannot be identified, directly or through identifiers linked to subjects.

This exemption would not apply if the investigators, having obtained identifiable private information or specimens from existing records or specimens, record the data or information in a coded manner, since the code would enable subjects to be identified through identifiers linked to the subjects.

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Investigators using laboratory animals in research are expected to use pharmaceutical grade compounds whenever possible. The guidelines presented here are a synthesis of the requirements and expectations for the use of non-pharmaceutical grade compounds when they are necessary. This document references the regulations, policies, and guidelines of the major animal research oversight organizations. 

See Guidelines for the Use of Non-Pharmaceutical Grade Compounds

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