|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.|
|Adjuvants Use in Research||
NIH ARAC guidelines for researchers using adjuvants.
|Adverse Event Reporting||Provides an overview of IRB policies and procedures for reporting adverse events to ensure that the risks/benefits relationship to subjects participating in research studies remains acceptable.|
|Adverse Event Reporting in e-Protocol||Describes in detail how to report an adverse event through e-Protocol.|
|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.|
Guide for the Care and Use of Agricultural Animals in Research and Teaching
|Amphibian Eggs and Oocytes||
NIH ARAC guidelines to assist investigators in research involving the harvest of eggs and oocytes in Xenopus laevis.
|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.|
|Chancellor's Memo on Export Control||Outlines campus policies and procedures in the area of export control.|
|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.
|Conflict of Interest (COI) Policy||
Overview of UMass Amherst COI policies.
|Conflict of Interest Law for State Employees||Summary of the conflict of interest law, General Laws chapter 268A, and how it applies to state employees.|
|Conflict of Interest 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 an e-Protocol submission that incorporates deception and/or requires a debriefing process.|
|Determining Whether IRB Review is Required for an Activity||Provides information (including flowchart) 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.|
|Diet Control in Behavioral Animal Studies||NIH ARAC guidelines to assist investigators using diet control in behavioral animal studies.|
|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)
|e-Protocol User Guide||
Provides guidance on e-Protocol submission so that users can easily navigate through the e-Protocol system. All requests for approval of human subject research (including revisions and renewals) must be submitted electronically through the e-Protocol system.
|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 Animals - AVMA Guidelines||
Provides additional guidance regarding the euthanasia of animals.
|Euthanasia of Neonates||NIH ARAC guidelines for researchers working with rodent fetuses or neonates.|
|Euthanasia of Rodents by CO2||
NIH ARAC guidelines for researchers using carbon dioxide for the euthanasia of rodents.
|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: "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.
|Final Reports||Final reports 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.|
|Focus Group Research||Provides guidance to consider when convening focus groups as a way to gather data from multiple participants.|
|Fundamental Research Decision Tree||
Helps to determine whether or not proposed research is considered "Fundamental."
|Genotyping Mice and Rats||NIH ARAC guidelines to assist investigators in research involving genotyping of mice and rats.|
|Guide for the Care and Use of Laboratory Animals||
Guide authored by the Institute of Laboratory Animal Research, Commission on Life Sciences, National Research Council.
|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.
|Informed Consent Guidance||Describes the requirements for informed consent -- the process by which researchers provide information to participants regarding the details of a research study prior to their enrollment.|
|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.|
|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.
|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.|
|Non-Pharmaceutical Grade Compounds - Use||Provides guidelines for the use of non-pharmaceutical grade compounds.|
|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.|
|Outline of Guidance Principles for Faculty on Conflicts of Interest||Provides an overview of the various types of potential conflicts of interest that researchers need to be aware of.|
|Pain and Distress in Laboratory Animals - Responsibilities||
NIH ARAC guidelines regarding pain and distress in laboratory animals and the responsibilities of researchers.
|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.|
|Removal of Principal Investigators||The MSP contract details how and when Principal Investigators can be removed.|
|Renewal/Continuing Review||Describes the monitoring mechanism requirement to ensure that safeguards remain in place to protect the rights and welfare of study participants. Researchers are responsible for providing continuing review information to the IRB on an annual basis at a minimum.|
|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.
|Responsible Conduct in Research - Instructions for CITI Training||
Step-by-step instructions for enrolling in the CITI training for Responsible Conduct in Research, required by all Graduate Students and Post Docs funded through an NSF award.
|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.|
|Student Handbook: A Guide to Conducting Human Subject Research||
Handbook guides student investigators by summarizing important components of the federal regulations, introducing the commonly cited ethical principles that serve as the foundation for the ethical conduct of human subject research, and providing guidance on UMass Amherst human subject research policies and Institutional Review Board (IRB) processes.
|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.
|Survival Rodent Surgery||
NIH ARAC guidelines to assist investigators in research involving rodent surgery.
|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 Export Control Seminar||
Seminar slides from UMass Export Control seminar, 2009.
|Unanticipated Problems||Defines the types of unanticipated problems and outlines reporting requirements.|
|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/APHIS Animal Care Policies||USDA/APHIS Animal Care Policies|
|Zebrafish - Use in NIH Intramural Research||
Guidelines for use of zebrafish in the NIH Intramural Research Program