Guidance

Compliance

Name	Description
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.
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.
Agricultural Guide	Guide for the Care and Use of Agricultural Animals in Research and Teaching Download File
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.
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.
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.
Changes to the Continuing Review Procedures	Describes changes to the Continuing Review procedures due to the revised Common Rule.
Changes to the Exempt Categories	Outlines changes to the Exempt Categories due to the Common Rule.
Changes to the Informed Consent	Describes changes to the Informed Consent due to the Common Rule.
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. Download File
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) Law for State Employees	Summary of the conflict of interest law, General Laws chapter 268A, and how it applies to state employees. Document Link
Conflict of Interest (COI) Policies (UMass Amherst) - Overview	Town Hall meeting on UMass Amherst COI Policies. Download File
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 Download File
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.
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) Download File
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.
Ethnographic Research	Provides guidance on ethnography-specific research and its intersection with the IRB and federal regulations.
Euthanasia of Rodents by CO2	Guidelines for researchers using carbon dioxide for the euthanasia of rodents. Download File
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). Download File
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. Download File
Export Control Policy	Outlines campus policies and procedures in the area of export control. Document Link
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. Download File
Extra Credit for Participating in Research	Provides guidance on offering extra credit for participating in research.
Focus Group Research	Provides guidance to consider when convening focus groups as a way to gather data from multiple participants.
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. Download File
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. Download File
MTurk Guidance	Provides guidance and elements to be considered when utilizing Amazon's Mechanical Turk to conduct human subject research over the internet.
Needle and Syringe Use	Links to Massachusetts regulation guiding purchase.
NIH Revision to Definition of a Clinical Trial	Describes the revisions to NIH policy governing Clinical Trials. The attached document also provides step by step guidance for researchers and staff to understand the significant changes which will affect NIH sponsored activities and human subjects research. Download File
NIH Revision to the Policy on Certificates of Confidentiality	Describes the revision to the NIH policy governing Certificates of Confidentiality. 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.
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.
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.
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. Download File
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.
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.
Survey Guidelines	Provides guidance on items to consider when conducting surveys or questionnaires as a way to gather data from many participants.
Survival Bleeding of Mice and Rats	NIH ARAC guidelines to assist investigators in their choice and application of survival rodent bleeding techniques. Document Link
Survival Rodent Surgery	Guidelines to assist investigators in research involving rodent surgery. Download File
Travel Tips from the National Counterintelligence Executive	Tips for traveling oversees with mobile phones, laptops, PDAs, and other electronic devices. Download File
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. Download File
UMass Export Control Seminar	Seminar slides from UMass Export Control seminar, 2009. Download File
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. Document Link