Guidance

Animal Care/Use

Name	Description
Adjuvants Use in Research	NIH ARAC guidelines for researchers using adjuvants. Document Link
Agricultural Guide	Guide for the Care and Use of Agricultural Animals in Research and Teaching Download File
Amphibian Eggs and Oocytes	NIH ARAC guidelines to assist investigators in research involving the harvest of eggs and oocytes in Xenopus laevis. Document Link
Cell Line PCR Submission	Procedure for Cell Line PCR submission Download File
Diet Control in Behavioral Animal Studies	NIH ARAC guidelines to assist investigators using diet control in behavioral animal studies.
Disinfectants - NIH Recommendations	Provides guidelines for recommended hard surface disinfectants.
Euthanasia of Animals - AVMA Guidelines	Provides additional guidance regarding the euthanasia of animals. Document Link
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. Document Link
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. Document Link
Guillotine Use and Maintenance	This SOP is intended to provide information for researchers at UMASS using rodent guillotines. Document Link
Non-Pharmaceutical Grade Compounds - Use	Provides guidelines for the use of non-pharmaceutical grade compounds.
Pain and Distress in Laboratory Animals - Responsibilities	NIH ARAC guidelines regarding pain and distress in laboratory animals and the responsibilities of researchers. Document Link
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.
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	NIH ARAC guidelines to assist investigators in research involving rodent surgery. Document Link
USDA/APHIS Animal Care Policies	USDA/APHIS Animal Care Policies
Use of Fishes in Research	Provides guidelines for the use of fish in research. Document Link
Zebrafish - Use in NIH Intramural Research	Guidelines for use of zebrafish in the NIH Intramural Research Program Document Link

Animal Subjects/IACUC

Name	Description
Adjuvants Use in Research	NIH ARAC guidelines for researchers using adjuvants. Document Link
Amphibian Eggs and Oocytes	NIH ARAC guidelines to assist investigators in research involving the harvest of eggs and oocytes in Xenopus laevis. Document Link
Authority/Attending Veterinarian	Guidelines for the Attending Veterinarian (AV) or his/her designee(s) under the authority and/or direction of the AV.
Diet Control in Behavioral Animal Studies	NIH ARAC guidelines to assist investigators using diet control in behavioral animal studies.
Disinfectants - NIH Recommendations	Provides guidelines for recommended hard surface disinfectants.
Euthanasia of Animals - AVMA Guidelines	Provides additional guidance regarding the euthanasia of animals. Document Link
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. Document Link
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. Document Link
Non-Pharmaceutical Grade Compounds - Use	Provides guidelines for the use of non-pharmaceutical grade compounds.
Pain and Distress in Laboratory Animals - Responsibilities	NIH ARAC guidelines regarding pain and distress in laboratory animals and the responsibilities of researchers. Document Link
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.
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	NIH ARAC guidelines to assist investigators in research involving rodent surgery. Document Link
USDA/APHIS Animal Care Policies	USDA/APHIS Animal Care Policies
Use of Fishes in Research	Provides guidelines for the use of fish in research. Document Link
Zebrafish - Use in NIH Intramural Research	Guidelines for use of zebrafish in the NIH Intramural Research Program Document Link

Award Related

Name	Description
AHA Guidance Document	Guidance from the American Heart Association.
Award Workflow Chart	A diagram that depicts the award workflow steps through OGCA. Download File
DOE Guidance Document	US Department of Energy Guidance Document
Effort Reporting - Related Documents	Documents of interest related to effort reporting
Effort Reporting Policies Guidance	Guidance on Effort Reporting Policies Download File
Effort Reporting Video Slides	Effort Reporting Slides Download File
Exemptions in Openness in Research	Procedure for dealing with restrictions to Open 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. Download File
Fringe Rate Agreement	State Approved Fringe Rate Agreement Download File
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. Download File
Important NIH Announcements January 2016	Description of recent important NIH Announcements regarding sponsored activities. Download File
Industry Funding Contract Signatory Authority Matrix	Guidance on who signs Agreements and Contracts involving industry. Download File
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
NASA Guidance Document	National Aeronautics and Space Administration Guidance Document
NIH Guidance Document	National Institutes of Health Guidance Document
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
NSF Data Management Plan	As of January 18, 2011, grant proposals submitted to the National Science Foundation will require a two-page supplemental plan for data management and the sharing of research products. The Office of Research and the University Libraries are partnering to help investigators comply with this new requirement.
NSF Guidance Document	National Science Foundation Guidance Document
OMB Uniform Guidance at UMass	This document describes specific differences between the Uniform Guidance and its predecessors, Circulars A21, A110, and A133 and the impact at UMass.
SmartGrant Routing Add/Delete Feature	This document describes the routing process and how to add or delete routing levels. Download File
SmartGrant Routing MOU Award Process	This document describes routing an Award MOU GPID Download File
SmartGrant Routing PIAA Award Process	This document describes routing an Award PIAA GPID Download File
SmartGrant Routing Re-Notify Feature	This document describes the general routing process and the Re-Notify Feature Download File
STScI Guidance Document	Space Telescope Science Institute Guidance Document
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. Download File
USDA Guidance Document	US Department of Agriculture Guidance Document
Web browser clear cache instructions	See this document for instructions on clearing your browser cache - sometimes necessary after new software is installed Download File

Biosafety

Name	Description
Biosafety - IBC Administrative Policies and Procedures	UMass Amherst has an Institutional Biosafety Committee in compliance with NIH and BMBL guidelines.
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
rDNA or Synthetic DNA	Requirements for review of research projects involving the use of rDNA or synthetic DNA.
Select Agents	Explains process by which research institutions collect information regarding "select agents" and register their presence with the federal government.

Budget

Name	Description
Cost Sharing Approval Process	Memorandum outlining updated procedures for obtaining approval to cost share on grants and contracts. Download File
Cost Sharing FAQ	Download File
Cost Sharing Requests to VCRE or Provost	Outlines procedures for requesting cost share from the VCRE or Provost Download File
Cost Sharing Sources and Types	An outline of the cost share sources and the types of mandatory cost share in order of priority use
Fabricated Equipment Checklist	Use this tool to help determine if your project meets the criteria for Fabricated Equipment and to provide the documentation necessary for approval to include Fabricated Equipment in a proposal Download File
Indirect Cost Calculation as Percentage of Total Project Costs	Some sponsors request that indirect costs do not exceed a percentage of total project costs. See this formula for calculating indirect costs when indirect costs are a percentage of total proposal costs
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. Download File

Compensation/Effort

Name	Description
AY Salary Recovery and Summer Ad Comp	For a more thorough detail of the policy requirements, please refer to the Guidance Document. Download File
Effort Reporting - Related Documents	Documents of interest related to effort reporting
Summer Ad Comp	Further guidance on Summer Ad Comp

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.
Adjuvants Use in Research	NIH ARAC guidelines for researchers using adjuvants. Document Link
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.
Agricultural Guide	Guide for the Care and Use of Agricultural Animals in Research and Teaching Download File
Amphibian Eggs and Oocytes	NIH ARAC guidelines to assist investigators in research involving the harvest of eggs and oocytes in Xenopus laevis. Document Link
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. Download File
Conflict of Interest (COI) Policy	Overview of UMass Amherst COI policies. Download File
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 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 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) Download File
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. 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 Animals - AVMA Guidelines	Provides additional guidance regarding the euthanasia of animals. Document Link
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. Document Link
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: "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
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." Download File
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. Document Link
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
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. 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.
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. Document Link
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. Download File
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. 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.
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. Download File
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	NIH ARAC guidelines to assist investigators in research involving rodent surgery. Document Link
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 Export Control Seminar	Seminar slides from UMass Export Control seminar, 2009. Download File
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. Document Link
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 Document Link

Conflict of Interest

Name	Description
Conflict of Interest (COI) Policy	Overview of UMass Amherst COI policies. Download File
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 Download File
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.
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

Cost Sharing

Name	Description
Cost Sharing Approval Process	Memorandum outlining updated procedures for obtaining approval to cost share on grants and contracts. Download File
Cost Sharing FAQ	Download File
Cost Sharing Requests to VCRE or Provost	Outlines procedures for requesting cost share from the VCRE or Provost Download File
Cost Sharing Sources and Types	An outline of the cost share sources and the types of mandatory cost share in order of priority use

Data Access

Name	Description
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.

E-Protocol

Name	Description
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. Download File

Export Control

Name	Description
Chancellor's Memo on Export Control	Outlines campus policies and procedures in the area of export control.
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: "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
Fundamental Research Decision Tree	Helps to determine whether or not proposed research is considered "Fundamental." Download File
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.
Travel Tips from the National Counterintelligence Executive	Tips for traveling oversees with mobile phones, laptops, PDAs, and other electronic devices. Download File
UMass Export Control Seminar	Seminar slides from UMass Export Control seminar, 2009. Download File

Human Subjects/IRB

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.
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.
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.
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.
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. 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 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.
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. 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.
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.
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.
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.
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.
MTurk Guidance	Provides guidance and elements to be considered when utilizing Amazon's Mechanical Turk to conduct human subject research over the internet.
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.
Recruiting at UMass	Outlines requirements for researchers not affiliated with UMass Amherst who wish to recruit students, faculty, or staff as research participants.
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.
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.
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. Download File
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.
Types of Review	Explains the different types of review required for research involving human subjects.
Unanticipated Problems	Defines the types of unanticipated problems and outlines reporting requirements.

Indirect Cost

Name	Description
Fabricated Equipment Guidance (FAQs)	Guidance on Fabricated Equipment Download File
Indirect Cost Calculation as Percentage of Total Project Costs	Some sponsors request that indirect costs do not exceed a percentage of total project costs. See this formula for calculating indirect costs when indirect costs are a percentage of total proposal costs
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. Download File

Intellectual Property & Data

Name	Description
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.
Industry Funding Contract Signatory Authority Matrix	Guidance on who signs Agreements and Contracts involving industry. Download File
NSF Data Management Plan	As of January 18, 2011, grant proposals submitted to the National Science Foundation will require a two-page supplemental plan for data management and the sharing of research products. The Office of Research and the University Libraries are partnering to help investigators comply with this new requirement.
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

Proposal Related

Name	Description
AY Salary Recovery and Summer Ad Comp	For a more thorough detail of the policy requirements, please refer to the Guidance Document. Download File
Cost Sharing Approval Process	Memorandum outlining updated procedures for obtaining approval to cost share on grants and contracts. Download File
Cost Sharing FAQ	Download File
Cost Sharing Requests to VCRE or Provost	Outlines procedures for requesting cost share from the VCRE or Provost Download File
Cost Sharing Sources and Types	An outline of the cost share sources and the types of mandatory cost share in order of priority use
Fabricated Equipment Checklist	Use this tool to help determine if your project meets the criteria for Fabricated Equipment and to provide the documentation necessary for approval to include Fabricated Equipment in a proposal Download File
Fabricated Equipment Guidance (FAQs)	Guidance on Fabricated Equipment Download File
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. Download File
Five-Day Proposal Submission Procedure Overview	A brief overview of the Five-Day Proposal Submission Procedure established by the Vice Chancellor for Research and Engagement VCRE.
Fringe Rate Agreement	State Approved Fringe Rate Agreement Download File
Important NIH Announcements January 2016	Description of recent important NIH Announcements regarding sponsored activities. Download File
Indirect Cost Calculation as Percentage of Total Project Costs	Some sponsors request that indirect costs do not exceed a percentage of total project costs. See this formula for calculating indirect costs when indirect costs are a percentage of total proposal costs
JIT Other Support Example	Provides an example of how to fill out the form. Download File
NIH - Managing Effort	PDF of a Powerpoint presentation on "Budgeting and Managing Effort on NIH Grants" from the Pre-Award Administration Workshop Series presented by OGCA Download File
NIH Just-In-Time Process at UMass (JIT)	The JIT feature becomes available after the completion of the peer review process for applications that fall within a priority score range deemed potentially fundable. NIH will explicitly request JIT documentation from the PI via email and/or phone – only then load JIT documentation to the Commons. Here is a presentation about the JIT Process at UMass. Download File
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.
NIH Subcontracts with UMass as Lead	NIH specific guidance on process and requirements when UMass is the Lead Institution and plans to issue subcontracts.
NSF CAREER Program	The following is a summary as to how the CAREER program varies from standard NSF applications as detailed in NSF’s Grant Proposal Guide, NSF 17-1, effective January 30, 2017
NSF Proposal Checklist and Outline	Find out what NSF requires for components and formatting in your proposal - the GPG distilled. Download File
NSF Research Experience for Undergraduates (REU)	The Research Experiences for Undergraduates (REU) program supports active research participation by undergraduate students in any of the areas of research funded by the National Science Foundation. REU projects involve students in meaningful ways in ongoing research programs or in research projects specifically designed for the REU program. This guidance is a summary of the variance between standard NSF applications and the REU.
NSF Subawardee Documentation Requirements	Outlines the documentation that OGCA must receive from prospective subawardee(s) on NSF proposals before the proposal can be submitted to the agency. Download File
OMB Uniform Guidance at UMass	This document describes specific differences between the Uniform Guidance and its predecessors, Circulars A21, A110, and A133 and the impact at UMass.
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. Download File
Proposal Workflow Chart	A diagram that depicts the proposal workflow steps through OGCA. Download File
SBIR Procedures	Describes procedures for the SBIR Program. Download File
SmartGrant Browser Settings	Please see this vendor supplied document for required browser settings for proper functioning of the SmartGrant interface. Download File
SmartGrant Routing Add/Delete Feature	This document describes the routing process and how to add or delete routing levels. Download File
SmartGrant Routing Re-Notify Feature	This document describes the general routing process and the Re-Notify Feature Download File
STTR Procedure	The STTR Program is a highly competitive program that reserves a specific percentage of federal R&D funding for awards to small business and nonprofit academic institution partners.
Summer Ad Comp	Further guidance on Summer Ad Comp
Web browser clear cache instructions	See this document for instructions on clearing your browser cache - sometimes necessary after new software is installed Download File

Research Ethics

Name	Description
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. Download File
Conflict of Interest (COI) Policy	Overview of UMass Amherst COI policies. Download File
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 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.
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
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
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.
Removal of Principal Investigators	The MSP contract details how and when Principal Investigators can be removed.
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.
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
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. Download File

Research Safety/Security

Name	Description
Biosafety - IBC Administrative Policies and Procedures	UMass Amherst has an Institutional Biosafety Committee in compliance with NIH and BMBL guidelines.
Chancellor's Memo on Export Control	Outlines campus policies and procedures in the area of export control.
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.
Needle and Syringe Use	Links to Massachusetts regulation guiding purchase.
rDNA or Synthetic DNA	Requirements for review of research projects involving the use of rDNA or synthetic DNA.

SmartGrant

Name	Description
SmartGrant Browser Settings	Please see this vendor supplied document for required browser settings for proper functioning of the SmartGrant interface. Download File
SmartGrant Routing Add/Delete Feature	This document describes the routing process and how to add or delete routing levels. Download File
SmartGrant Routing MOU Award Process	This document describes routing an Award MOU GPID Download File
SmartGrant Routing PIAA Award Process	This document describes routing an Award PIAA GPID Download File
SmartGrant Routing Re-Notify Feature	This document describes the general routing process and the Re-Notify Feature Download File
Web browser clear cache instructions	See this document for instructions on clearing your browser cache - sometimes necessary after new software is installed Download File

Sponsor

Name	Description
AHA Guidance Document	Guidance from the American Heart Association.
DOE Guidance Document	US Department of Energy Guidance Document
Important NIH Announcements January 2016	Description of recent important NIH Announcements regarding sponsored activities. Download File
Industry Funding Contract Signatory Authority Matrix	Guidance on who signs Agreements and Contracts involving industry. Download File
JIT Other Support Example	Provides an example of how to fill out the form. Download File
NASA Guidance Document	National Aeronautics and Space Administration Guidance Document
NIH - Managing Effort	PDF of a Powerpoint presentation on "Budgeting and Managing Effort on NIH Grants" from the Pre-Award Administration Workshop Series presented by OGCA Download File
NIH Guidance Document	National Institutes of Health Guidance Document
NIH Just-In-Time Process at UMass (JIT)	The JIT feature becomes available after the completion of the peer review process for applications that fall within a priority score range deemed potentially fundable. NIH will explicitly request JIT documentation from the PI via email and/or phone – only then load JIT documentation to the Commons. Here is a presentation about the JIT Process at UMass. Download File
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 Subcontracts with UMass as Lead	NIH specific guidance on process and requirements when UMass is the Lead Institution and plans to issue subcontracts.
NSF CAREER Program	The following is a summary as to how the CAREER program varies from standard NSF applications as detailed in NSF’s Grant Proposal Guide, NSF 17-1, effective January 30, 2017
NSF Guidance Document	National Science Foundation Guidance Document
NSF Proposal Checklist and Outline	Find out what NSF requires for components and formatting in your proposal - the GPG distilled. Download File
NSF Research Experience for Undergraduates (REU)	The Research Experiences for Undergraduates (REU) program supports active research participation by undergraduate students in any of the areas of research funded by the National Science Foundation. REU projects involve students in meaningful ways in ongoing research programs or in research projects specifically designed for the REU program. This guidance is a summary of the variance between standard NSF applications and the REU.
NSF Subawardee Documentation Requirements	Outlines the documentation that OGCA must receive from prospective subawardee(s) on NSF proposals before the proposal can be submitted to the agency. Download File
STScI Guidance Document	Space Telescope Science Institute Guidance Document
USDA Guidance Document	US Department of Agriculture Guidance Document

Subawards

Name	Description
NIH Subcontracts with UMass as Lead	NIH specific guidance on process and requirements when UMass is the Lead Institution and plans to issue subcontracts.
NSF Subawardee Documentation Requirements	Outlines the documentation that OGCA must receive from prospective subawardee(s) on NSF proposals before the proposal can be submitted to the agency. Download File