|Activities Involving Human Subjects Research||Outlines the Institutional Review Board's responsibility for protecting the individuals who are subjects in UMass research activities and clarifies and defines the types of activity, both research and non-research, that involves human subjects.|
|Adverse Events Reporting||Guidance for researchers for when reporting adverse events in research to the IRB, and in some cases, Federal agencies and sponsors is required by Federal regulations.|
|Advertising and Subject Recruitment||Describes the recruitment of research subjects as part of the informed consent process and the required recruitment plan that must be approved by the IRB.|
|AHA Guidance Document||Guidance from the American Heart Association.|
|Assent Guidance for Minors||Provides general guidelines for creating an assent form for research studies where children are involved.|
|Audio Recordings of Research Participants||Provides IRB guidance on the timeframes for the destruction of audio, video, or digital recordings which contain research participants' images, voices or other personally identifiable information.|
|Authority/Attending Veterinarian||Guidelines for the Attending Veterinarian (AV) or his/her designee(s) under the authority and/or direction of the AV.|
|AY Salary Recovery and Summer Ad Comp||
For a more thorough detail of the policy requirements, please refer to the Guidance Document.
|Baystate Collaborative Research/IRB Review||Provides guidance for UMass Amherst researchers working with Baystate collaborators who may be eligible to seek IRB review at Baystate only thereby avoiding the requirement for both UMass and Baystate IRB review.|
|Biological Specimens & Private Information||An advanced topic video focused on activities involving biological specimens and other private information, which is best suited for viewing by individuals already possessing a basic understanding of the HHS regulations for the protection of human subjects.|
|Biosafety - IBC Administrative Policies and Procedures||UMass Amherst has an Institutional Biosafety Committee in compliance with NIH and BMBL guidelines.|
|Cell Line PCR Submission||
Procedure for Cell Line PCR submission
|Certificates of Confidentiality Tip Sheet||Describes the use of Certificates of Confidentiality issued by the National Institute of Health (NIH) to help researchers protect identifiable research information from forced disclosures such as court orders and subpoenas.|
|Classroom Research Projects and the IRB||
Outlines what studies constitute "classroom projects" which do not meet the regulatory definition of research and therefore do not require IRB review or approval.
|Close Requests||Close requests must be submitted upon completion of the IRB study. For the purposes of submitting the IRB final report, the study will be considered complete if only data analysis using de-identified data remains. Also outlines the requirements for submission of final reports upon study completion.|
|Conflict of Interest (COI) -Outline of Guidance Principles for Faculty on COI||Provides an overview of the various types of potential conflicts of interest that researchers need to be aware of.|
|Conflict of Interest (COI) Policies (UMass Amherst) - Overview||
Town Hall meeting on UMass Amherst COI Policies.
|Conflict of Interest (COI) Relating to Intellectual Property and Commercial Ventures||
Workshop on UMass Amherst Policy on COI Relating to Intellectual Property and Commercial Ventures presented by Tom Chmura and Liz Rodriguez on March 16, 2009
|Data Monitoring||Describes the regulatory requirement that the IRB determine that research plans submitted provide adequate provisions for monitoring data collected to ensure the safety of subjects.|
|Data Use Agreements||Describes IRB requirements for the University and researchers to enter into Data Use Agreements (a contractual document used for the transfer of non-public or restricted use data) with an external entity.|
|Debriefing Process Guidance||Provides guidelines for preparing a Kuali Protocol submission that incorporates deception and/or requires a debriefing process.|
|Determining Whether IRB Review is Required for an Activity||Provides information to help determine whether a project requires review by the IRB. However, the final determination whether a project requires IRB review will be made by HRPO.|
|Disclosure of Research Results||Faculty seeking external support for research activities need to inform potential sponsors that any grant, contract, or cooperative agreement accepted by UMass must conform to the University disclosure policy.|
|Disinfectants - NIH Recommendations||Provides guidelines for recommended hard surface disinfectants.|
|DOE Guidance Document||US Department of Energy Guidance Document|
|Dual Use - Bridging Science and Security for Biological Research||
Explains dual use review and oversight at research institutions (from September 2012 Report of the American Association for the Advancement of Science, Association of American Universities, Association of Public and Land-grant Universities, and the Federal Bureau of Investigation)
|Education Research Settings||Provides information to determine if a study is exempt from IRB review, issues to consider if submitting, and guidelines for conducting research in educational settings.|
|Effort Reporting - Related Documents||Documents of interest related to effort reporting|
|Effort Reporting Policies Guidance||
Guidance on Effort Reporting Policies
|Ethnographic Research||Provides guidance on ethnography-specific research and its intersection with the IRB and federal regulations.|
|Exemptions in Openness in Research||Procedure for dealing with restrictions to Open Research|
|Export Control and Universities: Information and Case Studies||
Brochure that describes relevant information about export controls and how they affect the academic research enterprise (produced by the Council on Government Relations).
|Export Control Compliance Guidelines - UMass Amherst||
Export controls apply to virtually all fields of science and engineering and restrict both physical shipments and electronic transmission of information. These laws apply to all activities – not just sponsored research projects.
|Export Control Policy||
Outlines campus policies and procedures in the area of export control.
|Export Control: "Don't Let This Happen to You!"||
Provides an introduction to U.S. Export Law (published by the Department of Commerce, Bureau of Industry and Security.
|Extra Credit for Participating in Research||Provides guidance on offering extra credit for participating in research.|
|Fact Sheet||Institution related data and information necessary for preparing and budgeting in one place - Legal name, Authorized Approvers, Indirect cost rates, fringe rates, etc.|
|Focus Group Research||Provides guidance to consider when convening focus groups as a way to gather data from multiple participants.|
|Grant/Contract vs. Gift||
Outlines and defines the characteristics of a sponsored project which is considered to be any externally funded research or scholarly activity that has a defined scope of work or set of objectives which provides a basis for sponsor expectations. Also lists characteristics to clarify how external funds from non-governmental entities are classified and processed.
|Guillotine Use and Maintenance||
This SOP is intended to provide information for researchers at UMass using rodent guillotines.
|HIPAA (Health Insurance Portability and Accountability Act) Privacy Rule||Explains how HIPAA regulations affect the use of protected health information (person-identifiable information produced as a result of health-care services) in research.|
|Implementing the NIH COI Final Rule||
Provides institutions subject to the new Conflict of Interest rule with insight into how peer institutions considered these issues after the announcement of the new rule, and provides a range of possible approaches.
|Industry Funding Contract Signatory Authority Matrix||
Guidance on who signs Agreements and Contracts involving industry.
|Institutional Chemical Safety Committee Policy and Procedures||Administrative policies and procedures of committee charged with advising on matters that relate to the safe use of chemicals in the laboratory environment.|
|International Affective Picture System (IAPs)||Provides guidance for researchers submitting protocols with images known as International Affective Picture System (IAPS), designed to elicit an emotional response from research participants.|
|Mandatory Reporting||Defines the term "mandatory reporting" and identifies which individuals engaged in human subject research are required by law to report the abuse of children when uncovered as par too that research.|
|Misconduct in Research & Scholarly Activities - UMass Procedures||
Misconduct in research and scholarly activities is injurious to the University's teaching, research, and public service missions and cannot be tolerated. This document provides procedures for investigations of allegations of misconduct in research and scholarly activities. It is written to comply with federal regulations requiring such procedures and also to maintain and enhance the integrity of research.
|MTurk Guidance||Provides guidance and elements to be considered when utilizing Amazon's Mechanical Turk to conduct human subject research over the internet.|
|NASA Guidance Document||National Aeronautics and Space Administration Guidance Document|
|Needle and Syringe Use||Links to Massachusetts regulation guiding purchase.|
|NEW - Environmental Chamber Housing Standards||
Standards to ensure the highest level of animal welfare and compliance for research animals in various environmental and research chambers.
|NEW - Mouse Breeding Guidance for ACS Vivaria||
The aim of this guidance is to meet the intent of the Guide for the Care and Use of Laboratory Animals using performance based standards of animal care and use while keeping in mind the special needs of investigators maintaining transgenic mouse breeding colonies.
|NEW- Hamster Breeding Guidance||
In order to remain in compliance with federal animal welfare regulations, UMass Animal Care follows the guidelines in the Guide for the Care and Use of Laboratory Animals and the USDA Animal Welfare Regulations. The current edition (8th ed.) of the Guide contains specific floor space recommendations for hamsters.
|NIH Guidance Document||National Institutes of Health Guidance Document|
|NIH Single IRB Policy for Multi-site Research||Describes changes affecting NIH policies governing Single IRBs for Multi-Site research. The guidance provides step by step guidance for researchers and staff to understand the significant changes which will affect NIH sponsored activities and human subjects research.|
|NSF Guidance Document||National Science Foundation Guidance Document|
|Oral and Short Form Written Consent||Outlines the process for the use of oral and short form written consent 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.|
|Oral History||Describes what is meant by the term "oral history" based on guidance put forth by the Office of Human Research Protection.|
|Pain and Stress Classification Levels||Describes the classification of animal pain and distress levels and provides guidance for action and response based on this classification system.|
|Photography of Research Animals||
IACUC Guidelines on Photography of Research Animals
|Project Types for F&A Purposes||
Definitions of project types to help determine what type of project you are requesting funding to support and what F&A rate should be applied.
|rDNA or Synthetic DNA||Requirements for review of research projects involving the use of rDNA or synthetic DNA.|
|Recruiting at UMass||Outlines requirements for researchers not affiliated with UMass Amherst who wish to recruit students, faculty, or staff as research participants.|
|Red Flag Indicators in Export Transactions||A list of indicators that the buyer of your products may not be authorized to receive them due to EAR or ITAR regulations.|
|Research in Higher Education Settings||Provides information to determine if a study is exempt from IRB review, issues to consider if submitting, and guidelines for conducting research in higher education settings.|
|Research in K-12 Settings||Provides information to determine if a study is exempt from IRB review, issues to consider if submitting, and guidelines for conducting research in K-12 settings.|
|Research Involving Minors||Outlines regulations and policies associated with doing research that involves minors.|
|Research Responsibility||Outlines human subjects researchers responsibilities when engaging in research.|
|Responsible Conduct in Research - NSF- related Primer for Undergraduates||
This is an introduction to Responsible and Ethical Conduct of Research (RCR) for undergraduates who are engaged in research activities that are supported by NSF.
|Revisions to a Protocol||Outlines the policy on revisions and changes to a previously IRB approved project. As a reminder, all changes and revisions to a previously IRB-approved protocol must be received and approved by the IRB before they are initiated (except where necessary to eliminate apparent immediate hazard to the subject).|
|Screening Activities Used to Determine Eligibility for Participation in Research||Describes items to consider for having potential participants engage in some type of screening activity to determine their eligibility for participation in a study.|
|Select Agents||Explains process by which research institutions collect information regarding "select agents" and register their presence with the federal government.|
|Sensitive Topics||Provides guidance on what must be done if your study deals with sensitive topics, such as alcohol/drug use, suicide or child abuse, or uses the Beck Depression Inventory (BDI). Participants should be forewarned in the informed consent form that they will be asked questions on sensitive topics.|
|Social Media Research Guidance||Provides guidance to researchers on the use of social media and its intersection with human subjects research. The guidance recommends best practices in this ever-changing field of study.|
|Sponsored Project Proposal Submission Requirements and Procedures||This page clarifies and updates campus procedures for proposal preparation and submission in support of sponsored projects to conform to Board of Trustee Policy DOC. T94-034. This includes the five-day deadline and new procedures developed in consultation with the deans to reduce duplication of administrative steps between department or college/school offices and the central Office of Pre-Award Services (OPAS).|
|STScI Guidance Document||Space Telescope Science Institute Guidance Document|
|Student Researchers and Advisors||Provides guidelines for students conducting research involving human subjects. Student researchers are subject to the same policies and procedures as faculty members.|
|Study Personnel||Defines who the University of Massachusetts Amherst considers study personnel.|
|Subject Recruitment Databases||Describes items to consider when researchers want to maintain subject information for the purpose of future recruitment. Researchers must submit such a request to the IRB. Databases must be maintained by one responsible qualified UMass researcher and in most cases subjects will fill out a consent form agreeing to the inclusion of their information into such a system.|
|Suicidal Ideation Response Guidance||This guidance gives the general action plans that will be required for all studies that involve questions about suicidality but is particularly meant to support researchers who are not experts in the specific field of depression and suicidality.|
|Summer Ad Comp||Further guidance on Summer Ad Comp|
|Survey Guidelines||Provides guidance on items to consider when conducting surveys or questionnaires as a way to gather data from many participants.|
|Tabletop Isoflurane Anesthesia Machines||
Operating Instructions for Tabletop Isoflurane Anesthesia Machines
|Transfer of PI to another Institution||
It is the practice of UMass Amherst to allow investigators to take their grants with them – with explicit department head and dean approval – when they transfer to another institution. There are issues inherent in this type of transfer. This guide offers resolution of these issues.
|Travel Tips from the National Counterintelligence Executive||
Tips for traveling oversees with mobile phones, laptops, PDAs, and other electronic devices.
|Types of Review||Explains the different types of review required for research involving human subjects.|
|UMass Amherst Export Control Compliance Program Guidelines||
These guidelines outline procedures for members of the UMA community to follow to ensure compliance with all export control laws and regulations.
|UMass Procedure to meet NSF Safe and Inclusive Working Environments||This document details new National Science Foundation (NSF) requirements related to “off-site” and “off-campus” research. The Office of Pre-Award Services (OPAS) is now required to certify that a plan is in place to address safe and inclusive working environments at the time a proposal is submitted. This will be accomplished by agreeing to a series of attestations which will be uploaded to the Kuali Research proposal record.|
|Uniform Consulting Agreement Provisions - UMass Amherst||
All faculty members at the University of Massachusetts are subject to the University Policy on Faculty Consulting and Outside Activities. The Consulting Policy recommends that faculty members at the University attach these Uniform Consulting Agreement Provisions to any agreement or arrangement under which a faculty member will provide consulting services to, or will engage in other non-academic activities in his or her area of expertise on behalf of, any for-profit organization.
|USDA Guidance Document||US Department of Agriculture Guidance Document|