Compliance

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. Toxic/Infectious agents used in conjunction with animals and plants.
  2. Oncogenic viruses used in conjunction with animals.
  3. 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.
  4. Recombinant DNA
  5. Human blood and blood products, human body fluids, human tissue, and/or human cells.
  6. Biological toxins.
  7. Agents regulated by CDC or USDA (e.g. on the list of Select Agents)
  8. Whenever a contractual agreement or grant proposal requires Institutional Biosafety Committee approval for the safe handling of a biological or chemical product.
  9. Any research that requires a permit from USDA Animal and Plant Health Inspection Service (APHIS).
  10. 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, 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, recombinant DNA, Select Agents, a copy of the proposal is forwarded 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 PI should submit an IBC protocol through the Kuali system. 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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Determination of Human Subject Research Form

Human Subjects Determination Process in Kuali

Researchers seeking Determinations should create an IRB Determination submission within the Kuali Protocols module.  Upon creation of the IRB submission, Kuali will prompt researchers to indicate whether they are seeking a Human Subjects Research Determination. If so, researchers will be prompted to complete a Determination Form within the Kuali system.

Determination Submission Instructions

The process is the same as submitting an IRB Protocol (review the Kuali IRB User Guide if you are unfamiliar with the Kuali system):

  • Log in to the Kuali Protocols module and click the “+New Protocol” button located on the upper right-hand side of the screen.
  • Select “IRB” from the drop-down menu that will appear.
  • Complete the General Information fields (Principal Investigator, Department, and Protocol Title)
  • Click “Next” on the right-hand side of the screen.
  • Complete the questions regarding project type (Biomedical or Social Behavioral) and Community Engagement. 
  • The final question on this page will be “Are you seeking to determine whether or not your project requires IRB review?” Answering “YES” to this question and clicking "Next" on the right-hand side of the screen will open the Determination form.
  • This will trigger an abbreviated form that only requests essential information for our office to decide whether your project needs IRB review or whether it falls outside the federal regulations.

If you have any questions about this process you can reach us by phone at (413) 545.3428 or via email at humansubjects@ora.umass.edu

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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 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 a Determination in Kuali.

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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Animal Care Service Ordering Procedure

  • NEW! As of 9/1/2023, all live animal orders including aquatics, farm animals, etc. must be submitted through the online Animal Order Request Form. This is necessary in order to track animal usage on approved protocols.
    • Requests using any of the old pdf order forms will not be accepted.
  • In the case of aquatics and farm animals, you will still be able to procure your own animals, as long as you go through the process of completing and submitting an order request form.
  • For animals other than aquatics or farm animals, orders must be placed by by 5:00 p.m. on Tuesday for deliveries the following week.
    • Orders received after Tuesday will be processed for delivery the following week.
    • Late or rush orders may not be accepted or may incur additional fees for processing.
    • Orders will be validated* on Thursdays (*protocol approval verified, the number of animals ordered cross-checked against the number of animals approved and already used for the protocol, and cage type and housing space availability verified for room/building requested in the order).
    • Approved orders will be placed no later than Friday.
    • Contact animalorders@research.umass.edu with questions or to request clarifications regarding animal ordering or delivery.
    • After order has been placed, an electronic order confirmation specifying the delivery date and site(s) will be emailed to the ordering PI,all animal care staff who work in the area(s) scheduled to receive,animal transport personnel and ACS managers.
    • Researchers will be notified by the ACS staff via e-mail once animals have arrived and are housed.
    • If any issues are found at time of arrival, ACS will contact PI to coordinate correction to order.

Animal Deliveries

The responsibility of Animal Care Services

  • All animal deliveries should arrive on campus by 3:00 p.m. to the location(s) specified in the confirmations.
  • Animals should be unpacked and their health status and sex evaluated within two hours of delivery.
  • Evaluation of every animal delivery must be completed prior to staff departure for the day.
  • Once ACS staff confirms the animal delivery has been received, order is correct, and animals are healthy, a confirmation of receipt must be communicated via e-mail to the following: the ordering PI, all animal care staff who work in the area(s) scheduled to receive, Animal Ordering Coordinator who ordered animals and ACS managers.
  • These emails will officially document receipt and initial evaluation, and will become part of the permanent record system.

Delayed or Canceled Deliveries

  • If/when a scheduled animal delivery has been delayed and has not been received by 3:00 p.m., the ACS staff in the facility expecting the delivery MUST call ACS Animal Ordering Coordinator, ACS Managers no later than 3:15 p.m.

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

  • The Animal Ordering Coordinator will contact the vendor(s) for a delivery update and communicate information back to the PI,affected ACS staff and ACS Managers.
  • Receipt of deliveries delayed or scheduled to arrive after 3:00 p.m. will be coordinated with affected ACS staff by the Animal Ordering Coordinator and ACS Managers.
  • If/when shipment has to be canceled, the Animal Ordering Coordinator will inform ACS Managers.
  • ACS Managers will coordinate with the PI and affected ACS staff receipt of the animals.
    • NOTE: Affected ACS staff will not be required to remain late and/or work beyond their normal work shift hours in order to receive delayed/rescheduled animal deliveries.  Individual staff members may volunteer to do so for overtime pay or comp time. If no staff is available, ACS Managers will receive the animals and house them.

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Release Info: 

3/26/15

NIH Surgery Guidelines for disinfectants. See Recommended Hard Surface Disinfectants 

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

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Classification of Animal Pain and Distress Levels

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

Classifications

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

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

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

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

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

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

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

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

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

Consideration of Alternatives

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

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

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

Death as an Endpoint

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

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

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

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

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

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

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

Euthanasia Endpoint Criteria

Category I

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

Category II

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

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

Hazardous Agents and Animals

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

Biohazardous Agents

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

Radioactive Agents

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

Use of Animal Blood and Tissues

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

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

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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 the Vice Chancellor for Research and Engagement (VCRE). The committee meets as required but no less than once each 3 months on a date established by the chairperson. A quorum will be 5 members (which must include the chairperson, EHS, and 3 other members). Minutes are shared with the VCRE.

3.3  Committee membership for the present includes chairperson, the director of EHS or designee, the VCRE or designee, Facilities and Campus Planning or designee, Department of chemistry, IALS.

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 ICSC 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. 5/23/2022

Approved by ICSC: September 8, 2016

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