Frequently Asked Questions

Animal Subjects

No research on the campus involves the testing of cosmetics.

Dogs and cats are used at UMass Amherst and the UMass Mount Ida campus for instruction in the Veterinary Technology program. This Bachelor of Science degree program provides students with the opportunity to spend two years at the Amherst campus in laboratories and on the farm, followed by two years at the Mount Ida Campus. No cats and dogs are housed at UMass Amherst. Vet Tech lab courses at Amherst provide students with hands-on experience, using privately owned animals on a volunteer basis in a student clinic. More information about the regulations surrounding the use of dogs and cats and monitoring by the USDA is available on the USDA website.

Like at all research institutions that utilize animals, UMass Amherst faculty requesting use of live animals in studies and classes must demonstrate that the whole organism must be used in order to study the interaction of different physiological processes in living systems.

Fields of study in which use of live animals is crucial include conservation research in field settings, neuroscience, behavior, immunology, and nutrition, among others. In all cases, justification for the use of the animals must be provided in writing as part of an animal use protocol. Each protocol must be reviewed and approved by the Institutional Animal Care and Use Committee (IACUC) before the animal use begins.

Alternatives to the use of whole living animals are being developed constantly, and significant progress has been made in this area over the past 20 years. Animal cell culture lines and computer programs have been substituted in some areas of research, which has contributed to the decrease in the use of live animals.

However, whole animals continue to be necessary in many areas of research where the complicated, multi-system interactions and effects must be assessed. No computer on earth can mimic an entire living system and all the diseases and conditions that can impact that system.

The UMass Institutional Animal Care and Use Committee (IACUC) reviews all classroom and research projects, whether sponsored or unsponsored, to ensure the humane care and use of animals. This includes classroom exercises and demonstrations as well as all research projects, including student projects.

The university’s IACUC membership includes veterinarians, a non-affiliated member, non-scientists, compliance staff, and scientists/faculty members from various departments who conduct research and teach. The committee meets every month to review animal use protocols and to discuss other aspects of the animal care and use program at the university. Campus experts in environmental health and safety also participate in protocol reviews to ensure human health and safety.  More information on the IACUC can be found here.

The Attending Veterinarian/Director of Animal Care Services works with a team of professionals, including clinical veterinary staff, husbandry technicians, and compliance experts, to oversee animal care on campus. Together with the IACUC, these skilled employees ensure proper care, health, and welfare of all animals used in research and teaching on campus.

The university investigates, assesses, self-reports, and corrects any reported or identified incidents of non-compliance. Concerns about animal welfare can be reported to the Office of Research Compliance, 413-545-5204 or rescomp@research.umass.edu.

Questions about animal care can be directed to the Director for Animal Care at (413) 545-5268.

The use of laboratory animals is one of the most regulated uses of animals in the United States, as well as other countries. In the U.S., the federal Animal Welfare Act (AWA) and the Public Health Service Policy on Humane Care and Use of Laboratory Animals (PHS Policy) regulate the use of laboratory animals. The PHS policy requires compliance with the guidelines and standards in the Guide for the Care and Use of Laboratory Animals.  Massachusetts also has its own regulations on treatment of animals.

All institutions using AWA-covered animals must register with the USDA. The USDA inspects institutions’ animal facilities at least annually and may inspect at any time without prior notice. The results of these inspections are posted publicly on the USDA website. The university renewed its registration with the USDA in 2020 and renewed its NIH Animal Welfare Assurance in 2018. 

Both registrations include specifics about the housing, daily husbandry, veterinary care, emergency coverage, training of all personnel involved with the animals, and maintenance of physical facilities. Both require the active participation of the attending laboratory animal veterinarian and an Institutional Animal Care and Use Committee.

Animal Use policy at UMass Amherst applies standards required by these federal regulations equally to all vertebrate animal used for research and teaching.

UMass complies with the Public Health Service (PHS) policy, including self-regulation and self-reporting. Issues of non-compliance may be found during the required semi-annual inspections, during routine post-approval monitoring, or through individual reporting of concerns. Examples of non-compliance may be found on the NIH website.

Self-reporting is done as soon as possible through verbal and/or written communication to the Office of Laboratory Welfare. More details on the process of reporting and timelines can be found here.

During their initial training, all new animal users are informed about how to report concerns, as well as the protections afforded by Massachusetts’ “Whistle Blower” statutes. Reporters may choose to remain anonymous. Concerns about animal welfare can be reported to the Office of Research Compliance, 413-545-5204 or rescomp@research.umass.edu.

All reported concerns are promptly acted upon and brought to the attention of the UMass Institutional Animal Care and Use Committee (IACUC). An IACUC member is appointed to investigate and promptly report findings to the IACUC. If a problem is discovered, a plan is developed to resolve the issue as soon as possible and prevent it in the future. The result of the investigation is reported back to the person who lodged the complaint. 

As required by federal law or agreement with funding agencies, OLAW, USDA, and federal and/or private funding agencies are notified of significant problems along with a timetable for correction.

Animal Care staff check animals for health and well-being, and provide water and food, every day of the year, including weekends and holidays. The Director of Animal Care/Attending Veterinarian observes all the animals at least once per week. Cleaning is performed on a regular schedule to provide the animals with the best possible environment and to comply with species-specific requirements of the federal animal welfare laws.

The laboratory animals live in facilities at several sites, in quarters approved by the Institutional Animal Care and Use Committee (IACUC), which are monitored and inspected regularly for compliance with federal animal welfare laws. Facilities are located as close as possible to the classrooms and laboratories where the animals are used to minimize transportation stress. Heating, ventilation, air conditioning, humidity, lighting, and access are carefully controlled to maintain the health of the colonies.

Biological Safety

A requestor is any person who receives or seeks to receive, through any means, a select agent subject to this part from any other person.

The training programs are listed on the Environmental Health and Safety website. Review the requirements here.

The USA PATRIOT Act is a law signed by President Bush on October 26, 2001 that places restrictions on persons who possess select agents and provides criminal penalties for possession of such agents that cannot be justified for specified peaceful purposes. More information on the Patriot Act can be found on the Federal Government's Select Agents website.

A Select Agent is a microorganism (virus, bacterium, fungus, rickettsia) or toxin listed in Appendix A to Part 72-Select Agents. The term also includes:

  1. genetically modified microorganisms or genetic elements from organisms on Appendix A shown to produce or encode for a factor associated with a disease and
  2. genetically modified microorganisms or genetic materials that contain nucleic acid sequence coding for any of the toxins on appendix a or their toxic subunits

Everyone who handles agents on the list of Select Agents. Principal investigators (PIs) must register the possession of select agents with the Biological Safety officer in EHS. Failure to comply could result in criminal penalties. In addition, the Patriot Act of 2001 prohibits restricted persons from possessing, shipping, transporting or receiving select agents. In addition, the Patriot Act prohibits the possession of a "biological agent, toxin or delivery" (a list broader than select agents) of a type or quantity that is not reasonably justified by a prophylactic, protective, bona fide research, or other peaceful purpose.

No one who works with, ships, transports or receives anything on the list of Select Agents, is exempt from the provisions of the Patriot Act.

You need to submit the rDNA Registration Form to Allison Miller by email or mail to Office of Research Compliance,100 Venture Way, Suite 216, Hadley, MA  01035.

An entity or facility is defined as any individual or government agency, university, corporation, company, partnership, society, association, firm, or other legal entity located at a single geographic site that may transfer or receive through any means a select agent to this part.

Transfer is the conveyance or movement from a point of origination to a point of destination either:

  • from one or territory to another
  • or entirely within one contiguous state or territory

Intrafacility transfers within a registered facility located at a single geographic site are not covered by the provisions of the CDC select agent standard, section 72.6(d), (e) and (f) provide that:

  • the intended use of the agent remains consistent with that specified in the most current transfer
  • for each intrafacility transfer, the facility maintains records that include the name and location of the recipient; the amount of agent transferred, and the date transferred. Such records must be maintained for a period of five years after the date of transfer or for 5 years after the agents are consumed or properly disposed, whichever is longer.

Transferor is any person who transfers or seeks to transfer through any means a select agent to this part to any other person.

 

In the context of the NIH Guidelines, recombinant DNA (rDNA) molecules are defined as either:

  • molecules that are constructed outside living cells by joining natural or synthetic DNA segments to DNA molecules that replicate in a living cell or
  • molecules that form from the replication of those described above

The NIH Guidelines is a document in constant evolution that was first drafted in 1976 by scientists concerned about developing standards for the safe practice of research involving rDNA as well as with organisms containing rDNA. An institution must follow the NIH Guidelines if it is conducting or sponsoring any recombinant DNA research that is funded by NIH.

Experiments are typically exempt when they involve rDNA that is:

  • Not in organisms and viruses
  • Entirely DNA segments from a single non chromosomal or viral DNA source
  • Entirely from a prokaryotic host including its indigenous plasmids or viruses when propagated only in that host or when transferred into another host by well established physiological means
  • Entirely from a eukaryotic host including its chloroplasts, mitochondria, or plasmids when propagated only in that host or a closely related strain of the same species
  • Entirely segments from a different species that exchange DNA by known physiological processes, though one or more may be synthetic equivalent (see Appendix A of the NIH Guidelines)
  • Not a significant risk to health or the environments as determined by the NIH Director (see Appendix C of the NIH Guidelines)

Research listed above may not be exempt if it also involves:

  • The deliberate transfer of a drug resistance trait to microorganisms not known to acquire the trait naturally if such transfer could compromise the use of the drug to control disease agents in humans, veterinary medicine or agriculture
  • Deliberate formation of rDNA containing genes for the biosynthesis of toxin molecules lethal for vertebrates at an LD50 of less than 100 nanograms/kilogram of body weight, or
  • The deliberate transfer of rDNA or DNA or RNA derived from rDNA into human research subjects.

 

Institutional Biosafety Committee approval of an rDNA registration is for a maximum of five years or to the end of the grant period. You will need to reapply at the end of the funding period or when you make substantial changes to your research using rDNA that were not described in the original proposal.

Send the completed rDNA form to Allison Miller, Office of Research Compliance. It may be emailed or mailed to 100 Venture Way, Suite 216, Hadley, MA  01035.

Initial screening and review is by the Biological Safety officer (BSO). The BSO assigns a review status to the registration as either

  1. no further review needed
  2. requires review by the Institutional Biosafety Committee (IBC) or higher (a federal agency)

The BSO will inform the investigator when the pre-screening/initial review of the rDNA registration is completed and will inform them if the review needs to go to another level.

The IBC currently includes six UMass faculty with a broad spectrum of expertise on biosafety issues, the Director of Animal Care, the Biological Safety Officer, the Research Compliance Officer, and two community members.

For more details on general compliance issues contact Alison Bardwell. For specific questions regarding biological safety issues contact Judith LaDuc.

No. You are not required to submit any other forms.

The IBC meets at least four times per academic year. Please contact Allison Miller for their current schedule.

No. Your rDNA registration is valid for the life of your grant or a maximum of five years. If you make significant changes to your research or wish to continue your project beyond its expiration date you should send a memo to the Biological Safety Officer/EHS, stating that you wish to extend your project.

You can submit your rDNA registration at any time since it will be pre-screened, and usually reviewed, by the Biological Safety Officer (BSO). The BSO may determine that a registration requires review by the full IBC at its next meeting.

Only one copy of the registration form is required.

You will receive a letter from the compliance office letting you know that your rDNA registration has been reviewed and registered.

Send a memo to the Biosafety Officer/EHS in Draper Hall, stating the changes. The officer will let you know if you need to take any further action. 

It depends on the level of review needed. It can take any time between 2 days to 1 month. When you submit your registration you can ask for an estimate of how long the review process will take.

Approval of an rDNA registration extends to the end of the granting period for a maximum of 5 years. You will need to reapply at the end of the funding period or when you make substantial changes to your research using rDNA that were not described in the original proposal.

Graduate students can fill out an rDNA registration form but their PI/advisor must sign the form. Postdocs can submit a registration under their own name.

Grants and Contracts

You may already have one or you may need to ask for assistance. Logons are the user's NetID and password. Please see Access to Research Electronic Data Systems for more information.

The DUNS number for the University of Massachusetts Amherst is 153926712. For more institutional information, see the Fact Sheet.

The Unique Entity Identifier (UEI) for UMass Amherst is VGJHK59NMPK9. The UEI is a 12-character unique number assigned to all entities (public and private companies, individuals, institutions, or organizations) who must register to do business with the federal government in SAM.gov. The UEI replaced the DUNS number as the official identifier used by the federal government on April 4, 2022. See the Fact Sheet for more institutional information.

Why does the university require faculty and others to disclose outside activities and outside financial interests?

University faculty and other personnel are Commonwealth employees and thereby subject to the Massachusetts ethics regulations. Faculty and others engaged in teaching and academic research have a negotiated “carve out” from these regulations, subject to certain requirements for the university to review, approve, and manage potential conflicts of interest stemming from outside activities. This allowance is in place to foster technology transfer and economic development activities that benefit the Commonwealth. Because university employees are compensated using taxpayer dollars, we must strive to embody and model the highest ethical standards for our students and Massachusetts taxpayers. The Amherst campus leadership reminds faculty and others that these types of entrepreneurial activities, when disclosed and approved properly, are points of pride and celebration as they represent the university’s commitment and obligation as a public land grant university to economic development and community service.

Outside financial interests (unrelated to an outside activity) must also be disclosed, not only to comply with Massachusetts ethics regulations, but also Federal regulations which may be applicable based upon one’s funding sources for research and sponsored projects.

What specific activities need to be disclosed?

Generally, ongoing engagements with outside entities where that engagement is related to an individual’s institutional duties, such as editorship service (if not awarded through UMass); short- or long-term consulting; paid or unpaid service on board of trustees, science advisory boards, etc. These activities and the associated financial interests (e.g., consulting income, equity) should be disclosed, reviewed, and approved by the university. In addition, outside financial interests unrelated to outside activities such as equity, royalties, and stock options must be disclosed. Monetary thresholds for disclosure depend upon one’s external funding. For PHS funded researchers, remuneration or equity in a public entity totaling more than $5,000 in the previous 12 months must be disclosed, as well as any equity at all in a private entity. For NSF and other Federally-funded researchers, the threshold is $10,000 or 5% equity (public or private). If faculty have no Federal funding, the threshold is $10,000 or 1% equity for non-clinical research and $1,000 and any equity for clinical research. Faculty who work with human subjects and who are conflicted have a higher bar for approval to engage in the research because university policy presumes denial in most cases to ensure the health and welfare of human subjects in the research.

What if I start a business?

The university, as a land grant institution, has a primary commitment to the transfer of knowledge and, by extension, the economic well-being of the Commonwealth. Entrepreneurial activity is a component of this commitment and a key goal for research at public universities throughout the United States. As full-time employees of the Commonwealth, faculty and other personnel owe a primary “fiduciary obligation” to the university as our employer and to the taxpayers of Massachusetts who fund the university. If an outside business conflicts with (because it overlaps with) areas of expertise or university responsibility, an individual may be at risk of an ethics violation by participating in that activity without disclosure and approval through the university process. Research and Engagement professionals in the Office of Research Compliance and the Technology Transfer Office are available to support faculty start-up efforts with business envisioning, entrepreneurial guidance, and conflicts management.

Where do I get help?

The Office of Research Compliance can assist faculty and other university personnel with actual or apparent conflicts of interest, or in properly documenting, as needed, any outside activities related to one’s institutional duties. Please let us help! (413) 545-5283 or rescomp@research.umass.edu.

HIPAA

HIPAA stands for the Health Insurance Portability & Accountability Act of 1996. HIPAA is also known as the Kennedy-Kassebaum Act.

It calls for:

  1. Standardization of electronic patient health, administrative and financial data;
  2. Unique identifiers for individuals, employers, health plans and health acre providers;
  3. Security standards protecting the confidentiality and integrity of health information.

No. HIPAA does not override IRB requirements. After April 14, 2003 you will need to comply with both the Common Rule and the Privacy Rule. Here is a summary of their requirements.

  • The Common Rule requires either an informed consent or a waiver of informed consent for any human subjects research. Records review research is usually approved via an expedited review and a waiver of informed consent. The common rule allows a waiver only if specific criteria are met.
  • The Privacy Rule requires a written authorization or waiver of authorization for access to existing protected health information. It is assumed that most records review will be allowed with a waiver of the authorization. The Privacy Rule allows a waiver of authorization if specific criteria are met.

The rule protects access to individually identifiable health information that is:

  • Created or received by a "covered entity" including a health care provider, health plan, or health care clearing house
  • That relates to the past, present or future physical or mental health or condition of the individual, or
  • That relates to the provision of health care in the past, present or future.

The Privacy Rule gives all individuals, and hence research subjects, a number of new rights. Items 3, 4 and 6 are of particular relevance to research. Under HIPAA everybody can:

  1. Request access to their health care information
  2. Request that their health care information be amended
  3. Receive, upon request, an accounting of all disclosures of their medical information, if they haven't specifically authorized the disclosures (or another exception does not apply)
  4. Revoke authorization for the use/disclosure of identifiable health information, to the extent the researchers have not already relied on it.
  5. Request alternative means or places of being contacted (e.g. home vs. work)
  6. Request restrictions on uses or disclosures (but a covered entity or researcher is not required to agree).

If you are not doing research that requires access to protected health information (PHI), HIPAA and the Privacy rule will not impact your research. UMass Amherst researchers who need access to their subject's PHI for research purposes should understand the structure of UMass Amherst as an organization under HIPAA. Under HIPAA, UMass Amherst is a hybrid entity.  Researchers outside a covered entity (like most UMass Amherst PIs) must request the covered entity, via a signed authorization from the subject, to "disclose" the subject's PHI to them. This includes requests for review of medical records except where a waiver has been obtained. Once a covered entity discloses PHI to a researcher outside the covered entity, HIPAA and the Privacy rule no longer cover those records. However, a researcher outside the covered entity should expect to follow the spirit of the Privacy rule, as well as the Common Rule, and protect a subject's PHI by providing assurance to the subject in the informed consent document that the PHI will only be used for the purposes described in the informed consent document. The PHI should not be disclosed to any third parties not mentioned in the consent document without prior approval by the subject.

A covered entity is a healthcare provider, health plan, payer, clearing house or any other entity that processes health data electronically. Because of the kind of health information it processes, and the way it is processed, a covered entity must comply with HIPAA and the Privacy Rule. UMass Amherst as an institution is not a covered entity but is considered a hybrid entity.  This means that it performs both covered and noncovered functions as part of its business operation, for example the activities of University Health Services (UHS) would be considered covered. Most investigators at UMass Amherst will need authorization from their subjects to allow a covered entity like UHS or Baystate Health to disclose protected health information (PHI) to them. A covered entity must limit the amount of PHI disclosed to recipients to the "minimum necessary."

The Privacy Rule (HIPAA) classifies organizations that generate, use, or need access to protected health information (PHI) into several different organizational formats. These include:

  • Hybrid entity
  • Affiliated covered entity
  • Organized health care arrangement (covered entity)

A "hybrid entity" is an organization that includes one or more "covered entities" (i.e. entities covered by HIPAA) plus has other parts of the organization that are not healthcare providers, health plans, payers, clearing houses, and do not process health data electronically and thus are not covered by HIPAA. UMass Amherst as a whole is a hybrid entity.

The Privacy rule defines three categories of protected health information (PHI): identifiable information (to which the rule applies), de-identified information (to which the rule does not apply), and a limited data set (a middle option, to which limited parts of the rule apply). Each is explained below.

Identifiable information. The Privacy Rule defines "identifiable" information as information with any personal identifiers, as well as information about an individual, or his or her relatives, household members, or employer that alone or in combination could identify the individual. For more detail, see the list of 18 identifiers that must be removed to de-identify the information.

De-identified information. PHI that has been de-identified may be used without authorization and is not covered by the Privacy rule. Click here for a Fact sheet on De-Identification.

Limited data set. This is a data set that is not fully de-identified according to the Privacy rule regulations. While it excludes 15 of the 18 personal identifiers listed for de-identification, it allows the retention of :

Dates (e.g., date of birth, admission and discharge date)
Some geographic information (city, state and zip code but not street address) and other unique codes and characteristics that are not expressly excluded. Most Privacy Rule requirements do not apply to a limited data set used internally or disclosed (for example, disclosures do not have to be tracked). There are restrictions on the use of limited data sets including:

  • The limited data set option is available only for research, health care operations, and public health purposes.
  • AND, the following two requirements apply:
    1.  the covered entity may release only the minimum necessary information, so the intended recipient must indicate what is needed; and
    2.  the recipient must agree to a "data use agreement" which generally describes the permitted uses and disclosures of the information received and prohibits re-identifying or using this information to contact the individuals. A data use agreement is an agreement between the covered entity (perhaps via the Privacy Officer) and the recipient of the data. Note, a data use agreement is required for recipients that are both internal and external to the covered entity.

The Privacy Rule considers coded information to be de-identified if 18 specific identifiers are coded and the individual cannot reasonably be identified. The Privacy Rule does consider the code itself to be identifiable and hence, protected health information. Note, the Common Rule, in contrast to the Privacy rule, considers coded information to be identifiable. So while access to the coded information alone is not covered by the Privacy rule it is covered by the common rule and requires IRB review.

The Privacy Notice is a document that describes how the covered entity will use, disclose, and protect a person's health information. Everyone entering the covered entity should receive a copy of this notice, and a good faith effort must be made to have each recipient sign a form attesting to receipt of the notice. An Authorization is a document signed by a person to allow disclosure of their protected health information (PHI) to somebody outside the covered entity that stores the PHI. If you need access to your subjects' PHI you will need a signed Authorization from each subject that explains clearly to the subject what PHI you need to access, how you will use it, and who will see this information.  Authorization agreements must be secured from the covered entity providing access to the information.

  • Specific and meaningful description of what information will be used or disclosed.
  • Identification of who may use or disclose the PHI.
  • Identification of to whom the PHI will be disclosed.
  • Why the use or disclosure is being made - each purpose must be included.
  • Statement regarding how long the use or disclosure will continue. For research purposes no expiration date is required but this must be stated in the authorization.
  • Notice that the authorization may be revoked by the subject.
  • Notice that the information may be disclosed to others who are not subject to the Privacy Rule.
  • Notice that the covered entity may or may not condition treatment or payment on the individual's signature of the authorization.
  • Individual's signature and date.

Research subjects have had a longstanding right to revoke their consent to participate in research. In addition, the Privacy Rule permits a subject to revoke permission for researchers to use or disclose his or her identifiable information for research. The researchers must honor this request, except to the extent they have already relied on the permission. For example, if a researcher has already included a person's protected health information (PHI) in an analysis, the analysis can be maintained but the researcher should consult with the IRB regarding the individual's request. In addition, HHS guidance specifies that researchers may "continue using and disclosing protected health information that was obtained prior to the time the individual revoked his or her authorization, as necessary to maintain the integrity of the research study". Researchers may also use or disclose PHI already gathered for purposes such as accounting for the subject's withdrawal, reporting adverse events, or complying with investigations.

Authorization of disclosure for research purposes is not generally required if:

  1. a waiver of authorization has been approved
  2. the research is on decedents
  3. the activity is preparatory to research
  4. the research involves a limited data set or de-identified health care information.

The Privacy Rule permits only the minimum necessary amount of information to be accessed under a waiver for research. You will have to identify and justify the specific identifiable health information you will need to the IRB and the waiver will only apply to this information.

Yes, for studies that require access the subjects' protected health information. The Common Rule already requires the informed consent process to address how confidentiality will be protected. The Privacy Rule imposes a more specific requirement. In addition to informed consent, investigators must obtain written authorization for the use and disclosure of subjects' identifiable health information. This authorization must include several details. Although the Privacy Rule allows an authorization to be incorporated into the informed consent form the UMass Amherst IRB will require a separate authorization form. In addition, the informed consent document should contain wording that states that the investigator plans to access the subject's existing protected health information (PHI), and that the subject's authorization to access this information will be obtained. Although the Privacy rule does not cover PHI once it has left a covered entity, the informed consent should also include information about how the researcher will use and disclose information generated in the course of the research.

Human Subjects

Research on human subjects allows researchers to acquire knowledge that is vital to the development of interventions and treatments that may ultimately benefit humans. Some research results in direct benefits to individual participants. More frequently, human subjects research results in societal benefits through the knowledge gained.

There are many different types of research studies conducted at UMass Amherst. Some focus on investigating attitudes or beliefs and others focus on developing interventions or treatments that will ultimately benefit society. Methods of data collection include surveys, interviews, focus groups, behavioral observations, and analysis of data that was previously collected for non-research purposes. Some research studies consist of behavioral tasks that involve problem-solving, performing exercise, or responding to visual or auditory stimuli. Researchers at UMass also conduct biomedical research that may include analysis of biospecimens or use of imaging techniques such as MRI.

The Institutional Review Board (IRB) is a federally required committee that reviews human subjects research to ensure that it is both ethical and conducted in compliance with federal regulations, state regulations, and institutional policies and procedures. The IRB must approve human subjects research prior to its initiation and oversees the progress of approved research via annual renewals and check-ins.

Before a researcher can begin work with human subjects, the researcher must submit a protocol outlining the intended procedures. Protocols submitted to the IRB receive a robust review focusing on the rights and welfare of those individuals who voluntarily agree to take part as research participants. The protocol must include necessary materials for the IRB to conduct the review including:

  • a detailed description of the project procedures, copies of items participants will be asked to complete (e.g., surveys, questionnaires, description of actions they will be asked to take, etc.);
  • a description of how participants will be recruited;
  • a description of how participants will provide consent to participate; and,
  • a description of how the subjects' privacy and confidentiality will be safeguarded, etc.

The IRB or representatives examine these materials to determine if the research participants are adequately protected. The IRB's consideration is based primarily on weighing the risks and benefits of the research. Risks may be physical, psychological, social, or economic. Benefits include both those to the individual research participant and to society as a whole. As part of that review, the IRB has the authority to approve, disapprove, monitor, and require modifications in all research activities that fall within its jurisdiction as specified by both the federal regulations and institutional policy.

For more information on the review process, view Getting Started – IRB Process Overview.

The Institutional Review Board (IRB) oversees recruitment of research participants to ensure that participation is voluntary and recruitment methods are appropriate for the proposed study, with minimal risk of individuals being coerced or unduly influenced to participate. A variety of methods are used for recruiting, including posting physical flyers, advertising studies in newspapers and/or on social media, radio announcements, email invitations sent to groups or organizations, and verbal announcements at meetings or in classes.

The benefits of participation in research vary depending on the study. Some research studies offer direct benefits such as providing participants with a health assessment or access to interventions or treatments, or small monetary compensation. Other research studies provide no direct benefit to participants. Nevertheless, participants may find it rewarding to contribute to research that will generate useful knowledge and potentially lead to benefits for others in the future.

Anyone with concerns about the treatment of human subjects in research at UMass Amherst should reach out to the Human Research Protection Office (HRPO) via phone (413-545-3428) or email (humansubjects@ora.umass.edu). All concerns are taken seriously. Once reports are received, they will be reviewed and an investigation into the matter will be initiated immediately. HRPO will attempt to remain in contact with the individual submitting the report and inform them of the outcome of the investigation.

Human Subjects/Training

The Collaborative IRB Training Initiative (CITI) is an educational program for the protection of human subjects in research.  CITI was developed by experts in the IRB community and is focused on different aspects of bioethics and human subject research.  There is a core course in biomedical research and one in social/behavioral research.  Each module includes educational materials that can either be read on the screen or printed out.  A brief quiz follows each module.

A person listed as study personnel in the IRB application is required to take the training.  Any individual who is interacting and/or intervening with human subjects or handles the personally identifiable data of a human subject is considered study personnel. Study personnel who are involved in the informed consent process should also be included on the IRB study personnel list. 

The University pays an annual fee for all UMASS Amherst users, individual users are not assessed a fee for the CITI training.

The training site can be found at the CITI website.  For more information on UMass requirements, please see: CITI Training for Human Subjects Research.

Researchers should select the track that corresponds to the type of research typically conducted.  Generally, the Biomedical Research Module would be required for medical, physiological or pharmacological studies. This includes, but is not limited to, research with drugs, devices or other interventions. The Social and Behavioral Research Module related to studies on sociological, psychological, anthropological or educational phenomena including observational and survey research and work with population and/or epidemiological studies.

All human subjects researchers at UMass are required to complete a CITI Training refresher every 5 years. If researchers completed the basic course more than 5 years ago, a refresher course will be required in order to be considered in good standing.

The time required to complete each of the basic modules varies between 10 to 30 minutes.  The total time is estimated to be 2-3 hours.  The course does not have to be completed in one sitting and you can enter the course at any time.  Units are designed to be taken sequentially.

The refresher course is comprised of various short modules which take about 5-10 minutes to complete. The refresher course in its entirety takes approximately 45 minutes to complete.

You do not need to complete the course in just one session.  You are encouraged to use several "log-on" sessions, but you should take the quizzes immediately after completing each module.

If you log off the site and return at a later time, you will re-enter at the "Learner's Menu" page. Choose the Basic or Refresher Course and you will be taken to the Grade Book to begin at the next required module.  The course software will keep track of your progress.  When you finish the quiz for a module, the software will give you a link to your next module or the opportunity to view the Grade Book.

A passing score of 80% is required.  If you are not satisfied with your score, you can retake the quiz to improve.

You are not required to submit your certification to the IRB. HRPO has access to the CITI course completion report and will review your training certification upon your submission to the IRB.

All human subjects researchers at UMass are required to complete the CITI course.  Certificates of training from other institutions are not accepted. To receive credit for modules previously taken from other institutions, you would need to affiliate your training with UMass. Because each institution determines which modules are available in their courses not all modules will transfer. For instructions on how to affiliate your training, please go to:  CITI Training for Human Subjects Research.

All human subjects researchers at UMASS are required to complete a CITI Training refresher every 5 years.  The refresher takes approximately 45 minutes to complete. If CITI training is expired (over 5 years) IRB submissions such as new studies, revisions, renewals will not be processed until the CITI refresher has been completed.  (Note: Those who were grandfathered in with the NIH or VA training must now complete the CITI training.)

Human Research Protection Office (HRPO)
Venture Way Center
100 Venture Way, Suite 106
Hadley, MA 01035

Phone: (413) 545-3428
Email: humansubjects@ora.umass.edu