No research on the campus involves the testing of cosmetics.
Neither dogs nor cats are used at this campus. The majority of animals involved in research studies or teaching at UMass-Amherst are fish and healthy, purpose-bred laboratory rodents. Rodents are generally purchased from pre-approved vendors. Those interested in finding out more about the regulations surrounding the use of dogs and cats in research, and how their use is monitored by the USDA, can find more information on the USDA website or can email the USDA at firstname.lastname@example.org.
The process for reporting a concern, and the institution’s procedure for investigating reports of concerns, is as follows:
- A list of campus individuals who can be contacted in the event of a concern about animal welfare is provided to all new animal users at the basic IACUC New User Training and new users are informed of protections afforded by Massachusetts "Whistle Blower" statutes. The instructor informs the new user that they can report a concern to anyone on the list and the report will be acted upon promptly.
- Reporting Animal Welfare Concerns
- The person receiving the complaint records a description of the problem and contact information from the person reporting the issue. If the person reporting the issue wishes to remain anonymous this is respected.
- The person receiving the complaint discusses it with the IACUC Chair (or Associate Chair in the Chair’s absence) on the same day and the Chair appoints an IACUC investigator to investigate the complaint.
- The investigator checks on the situation and reports his/her findings to the IACUC Chair within 24 hours.
- If the investigator finds no basis for the complaint the IACUC Chair communicates this finding to the person lodging the complaint if the person has provided contact information.
- If the investigator finds there is a basis for the complaint the IACUC Chair contacts the responsible person with a plan to correct the deficiency promptly.
- If the situation poses an immediate threat to the health or safety of the animals and the responsible person is not cooperative, the Chair convenes a special IACUC meeting with quorum to discuss the issue and decide on actions to be taken to remedy the problem. In the event the IACUC finds serious animal welfare issues that must be addressed immediately the IACUC may vote to suspend the activity involving animals pending resolution of the problem.
OLAW, USDA, and Federal and/or private funding agencies are notified, as required by federal law or agreements with funding agencies, of significant deficiencies and/or suspension, with a timetable for correction.
The animals are checked for health and well-being and fed and watered every day by Animal Care staff throughout the year, including weekends and holidays. The director observes all the animals at least once per week. Cleaning is performed on a schedule to provide the animals with the best possible environment and to comply with species-specific requirements of the federal animal welfare laws.
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. The committee may schedule additional meetings as needed. Sub-committees if the IACUC meet every six months to conduct semi-annual inspections of the animal facilities and animal use areas, and review the animal care and use program.
The use of laboratory animals is one of the most regulated uses of animals in the United States, and other countries as well. 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. Some states and U.S. cities also have animal welfare laws that govern the use of laboratory animals.
The AWA has been in effect since 1966, with several amendments to provide additional coverage for animal care and use. The AWA is enforced by the United States Department of Agriculture (USDA). The AWA covers many of the common laboratory species. All institutions using AWA-covered animals must register with the USDA, and can be inspected at any time, without prior notification. The University renewed its registration with the USDA in 2008.
The PHS Policy has been law since 1985, and is enforced by the Office of Laboratory Animal Welfare (OLAW) of the National Institutes of Health (NIH). The PHS Policy covers use of cold- and warm- blooded vertebrates used in NIH-funded research and the terms of the UMass Assurance with OLAW at NIH expands this oversight to all use of vertebrate animals in research and teaching at the University. The PHS Policy requires compliance with the guidelines and standards in the Guide for the Care and Use of Laboratory Animals (the Guide). The PHS Policy covers training and research funded by NIH but most institutions apply its requirements and standards for all animal use at the institution. The institution must apply for, and if approved, maintain an Animal Welfare Assurance with OLAW. Documentation is mostly by correspondence on a regular basis, but site visits by OLAW are conducted periodically. The University renewed its NIH Animal Welfare Assurance in 2010.
Both laws 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.
Guidance on Clarification on the Roles of NIH Scientific Review Groups (SRG) and Institutional Animal Care and Use Committees (IACUC) in Review of Vertebrate Animal Research has been published in the NIH Guide for Grants and Contracts on September 1, 2010, NOT-OD-10-128 which includes the following:
- “An institution that elects to proceed according to “just-in-time” procedures for IACUC approval bears the responsibility for supporting the decisions of the IACUC”.
- “Under no circumstances may an IACUC be pressured to approve a protocol or be overruled on its decision to withhold approval”.
- “The PHS Policy requires that modifications required by the IACUC be submitted to the NIH with the verification of IACUC approval, and it is the responsibility of institutions to communicate any IACUC-imposed changes to NIH staff”.
- “It is incumbent upon investigators to be totally forthcoming and timely in conveying to the IACUC any modifications related to project scope and animal usage that may result from the NIH review and award processes”.
- “Should an institution find that one of its investigators disregards his/her responsibilities, the institution may, for example, determine that all animal protocols from that investigator be subject to IACUC approval prior to allowing that investigator to submit an application”.
Essential information includes the following:
- an overview of the animal use and an explanation of the reasons for and benefits from the use of animals in the proposed research
- assurance that the proposed work does not duplicate previous research and that no alternative to the use of live animals is available
- a list of species, strains or types of animals to be used; the source of the animals; the numbers needed
- justifications for the species and numbers
- description of specialized housing or care for the animals needed for the studies
- detailed technical description of how the animals will be used, including any medications or materials administered to them
- anesthetics and analgesics that will be use
- explanations if analgesics cannot be used (for a procedure during or after which the animals would normally be given analgesics) because of interference with the data collected during the study
- a clear description of the endpoints of the studies
- descriptions of the euthanasia procedures in accordance with standards published by the American Veterinary Medical Association
- identification of personnel involved in the work and descriptions of their training and qualifications to use the animals
The University's IACUC membership includes three veterinarians (a local practitioner with research and laboratory animal care experience, a large animal veterinarian and the Campus Attending Veterinarian), one non-affiliated member from the local community, non-scientists, the Director of Animal Care, the Director of Laboratory Safety in Environmental Health and Safety, the Research Compliance Coordinator and scientists/faculty members who conduct research and teach.
Although the AWA and PHS Policy differ slightly in IACUC membership requirements, the core membership must include a veterinarian with experience and/or training in the care and use of laboratory animals with responsibility for the animals at the institution (the attending veterinarian), one community member, a practicing scientist experienced in research involving animals, and a non-scientist. There must be a minimum of five members on the committee. Members are appointed by the Chief Executive Officer of the institution or their designee. At UMass Amherst, the Chancellor has delegated the appointing authority for IACUC members to the Vice Chancellor for Research and Engagement who also serves as the Institutional Official for oversight of animal use.
The laboratory animals live in quarters approved by the Institutional Animal Care and Use Committee, and the facilities are checked regularly for compliance with federal animal welfare laws.
There are facilities at six sites. Facilities are located close to the classrooms and laboratories where the animals are used to minimize transportation stress. The heating, ventilation, air conditioning, humidity, lighting and access by unauthorized personnel are carefully controlled to maintain the health of the colonies.
The Director of Animal Care and Campus Veterinarian have primary responsibility for the care of UMass animals, and the members of the federally mandated Institutional Animal Care and Use Committee also contribute substantially to the oversight of the care and use of the laboratory animals. Those with questions about laboratory animals at UMass Amherst can contact the Animal Care Services at (413) 545-0668 or the Director for Animal Care (same number) for questions concerning animal use in research and teaching.
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 and their use has contributed to the decrease in the use of live animals.
However, whole animals continue to be required in many areas of research where the complicated, multiple- system interactions and effects mentioned above must be assessed.
For the studies and classes where live animals are used, the faculty requesting these uses explain that the whole organism must be used in order to study the interaction of different physiological processes in living systems.
Examples of fields of study where use of live animals is crucial include, but are not limited to, conservation research in field settings, neuroscience, behavior, immunology, and nutrition. 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 approved by the Institutional Animal Care and Use Committee (IACUC) before the animal use begins.
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:
- genetically modified microorganisms or genetic elements from organisms on Appendix A shown to produce or encode for a factor associated with a disease and
- 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 Barbara Miller, Office of Research Compliance, 70 Butterfield Terrace.
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 Barbara Miller, Office of Research Compliance, 70 Butterfield Terrace.
Initial screening and review is by the Biological Safety officer (BSO). The BSO assigns a review status to the registration as either
- no further review needed
- 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.
No. You are not required to submit any other forms.
The IBC meets at least four times per academic year. Please contact Barbara 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.
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 email@example.com.
HIPAA stands for the Health Insurance Portability & Accountability Act of 1996. HIPAA is also known as the Kennedy-Kassebaum Act.
It calls for:
- Standardization of electronic patient health, administrative and financial data;
- Unique identifiers for individuals, employers, health plans and health acre providers;
- 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:
- Request access to their health care information
- Request that their health care information be amended
- 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)
- Revoke authorization for the use/disclosure of identifiable health information, to the extent the researchers have not already relied on it.
- Request alternative means or places of being contacted (e.g. home vs. work)
- 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:
- the covered entity may release only the minimum necessary information, so the intended recipient must indicate what is needed; and
- 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:
- a waiver of authorization has been approved
- the research is on decedents
- the activity is preparatory to research
- 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.
The UMass Amherst IRB currently consists of a community member, some non-scientific members, two physicians and eight faculty members from a range of academic departments.
The IRB meets monthly. Protocols requiring review by the full IRB should be submitted 10 days in advance of the full board meeting. Meeting times and places are posted on the Compliance web site.
Studies undertaken by students must be sponsored by a faculty advisor. Postdoctoral scholars may submit independently if they have written approval from the Department and Dean. Otherwise they should submit listing the faculty mentor as Co-Investigator.
Not usually. Course-related research projects usually are limited in scope, do not lead to generalizable knowledge and are not undertaken with that goal in mind. These projects are considered classroom exercises and are not subject to review by the IRB.
An informed consent document is a document that records a subject's voluntary participation in a research study and which provides the subject with a description of the study, the risks and benefits of the study to the subject and society, and contact information.
Usually subjects are asked to provide written consent to participate in the study by signing the informed consent document, but there are times when written consent is not needed (e.g., if the data collected are to be anonymous). In those cases, a subject can be “consented” through consent discussion and be provided with an information sheet which provides a description of the study and contact information. If verbal consent is to be obtained the researcher should provide a script for the IRB to review.
All modification/changes in a project previously approved by the IRB must be received and approved by the IRB before they are initiated except where necessary to eliminate apparent immediate hazard to the subject.
Requests for approval of modifications/changes may be submitted at any time by an investigator. Additional guidelines may be found at Revisions to a Protocol.
Investigators and laboratory or department heads are responsible for reporting promptly to the IRB any serious or continuing noncompliance with university policies or federal regulations.
In addition, every approval of a research project is granted with the stipulation that any unanticipated problems and risks, changes in the research plan, and any injury to subjects be reported to the Committee. Please follow the instructions included in Adverse Events Reporting.
If your protocol was reviewed and found to be exempt you will only need to update your protocol once every 3 years or if you wish to change the scope of work.
For all other protocols IRB approval is for a maximum period of 1 year. At the end of this period you need to return an annual update form to the IRB requesting a renewal. If you have made significant changes to your research you will need to submit a new protocol.
At any time, if you make changes to your procedures and/or your informed consent document you must inform the Review Board. Sensitive research may need review by the IRB at more frequent intervals. The interval will be determined at the time the protocol is first reviewed.
Normally yes. Every effort is made to remind you when your annual update is due by sending you a Continuing/Final Report Form when your protocol is approaching the end of its approval period. However, it is ultimately your responsibility to keep track of the deadlines and keep your approvals current.
For e-Protocol continuations, please see instructions at Renewal/Continuation of an Approved Protocol for e-Protocol Submissions.
The Human Research Protection Office (HRPO) has converted to the online human subject approval system called e-Protocol.
In order to access e-Protocol, you will need to contact the HRPO and provide the following information: Name, Department, Title (e.g., graduate student, postdoc, associate professor), e-mail and NETID. Please note: the CITI human subjects on-line training must be complete before a login can be provided for e-Protocol.
Once your submission is complete it goes to the IRB chair who reviews your protocol and decides the appropriate level of review from three options:
- Protocol is exempt from further IRB oversight
- Protocol will receive expedited review
- Protocol requires review by the full IRB
Depending on the level of review required he/she will assign reviewer(s) from among the IRB members.
HIPAA is shorthand for the Health Insurance Portability and Accountability Act which contains privacy regulations affecting researchers collecting data from a covered entity, such as Baystate Medical Center. (UMass is a hybrid entity). These regulations provide significant new privacy protections for the health information of patients and research subjects including the following:
- Gives patients more control over their health information.
- Sets boundaries on the use and release of health records.
- Establishes appropriate safeguards that health care providers and others must achieve to protect the privacy of health information.
- Holds violators accountable, with civil and criminal penalties that can be imposed if they violate patients' privacy rights.
- Strikes a balance when public responsibility requires disclosure of some forms of data - for example, to protect public health. For patients - it means being able to make informed choices when seeking care and reimbursement for care based on how personal health information may be used.
- Enables patients to find out how their information may be used and what disclosures of their information have been made.
- Generally limits release of information to the minimum reasonably needed for the purpose of the disclosure.
- Gives patients the right to examine and obtain a copy of their own health records and request corrections.
If you have any further questions, please contact HRPO at 545-3428.
UMass researchers working with collaborators at Baystate may now be eligible to seek IRB review at Baystate only, thereby avoiding the requirement for both UMass and Baystate IRB review. Please see IRB Guidance for more information.
Investigators should contact the Human Research Protection Office (HRPO) whenever collaborative research is planned. Separate IRB applications may be necessary, or an IRB collaboration agreement may be reached with the other institution depending on the nature of the study.
An assurance is a contract that the university enters into with the federal government to allow federally-sponsored human research to take place at that institution. The Federal Wide Assurance (FWA) number for UMass is FWA00003909.
Under certain conditions the IRB can waive the requirement that the subject sign an informed consent document. These conditions include the following :
- Where the informed consent document is the only record linking the subject and the research, and the principal risk would be potential harm resulting from breach of confidentiality, subjects may be asked whether or not they want documentation linking them to the research and their wishes should be respected.
- Where the research presents no more than minimal risk to the subjects and involves no procedures for which written consent is normally required outside the research context.
- For projects of minimal risk involving the use of questionnaires, the elements of informed consent may be included in an introductory letter attached to the instrument which should also include a statement to the effect that return of the questionnaire will constitute consent to participate.
Anonymous data are recorded so that the information can never be linked to the subject who supplied it.
Confidential data are recorded so that the information is not immediately identified with the subject who supplied it, but such a link is possible. Confidential data are usually coded–that is, the subject is assigned a unique identifier that will be used to identify the data. The code identifies the data and the subject's identity is kept separate from the code and data. Coded data are not anonymous.
Yes, the training is required of all investigators, including faculty, staff and students, who are interacting and/or intervening with human subjects or handle the personally identifiable data of a human subject.
No. There is no provision allowing you to be granted a pre-approval status to start your project. Your protocol must be submitted, reviewed and approved in writing before you can start your project so plan ahead.
Yes, researchers can be subjects in their own studies. However, UMASS Amherst policy considers investigator self-experimentation as research with human participants, and generally requires the same review and approval as research that recruits other people as subjects.
Though investigator self-experimentation may not raise the conventional ethical concerns outlined in the Belmont Report, all human research projects should undergo ethical review to assure the safety of people involved and the integrity of the research at the university. While researchers may be aware of the risks of self-experimentation, they may also be more willing to accept risks that are ill-advised. Application for review with the IRB office allows a neutral third party to raise concerns and/or propose measures to promote the welfare of researchers.
The IRB is looking for content in your protocol that will allow it to determine the following:
- That the participation of all the subjects is voluntary.
- That the rights and welfare of all the subjects will be adequately protected.
- That the consent process will be conducted in accordance with federal regulations and UMass human subjects policies.
- That the potential harms (risks) to the subjects are outweighed by the study's potential benefits to science and society.
This determination can only be made if the protocol contains a robust description of the study procedures. Note that the IRB can review only the information submitted in the protocol. Therefore an inadequately prepared protocol will be returned to the investigator for revision/clarification.
You can contact the Human Protections Administrator's office at 545-3428. They will help you decide whether your project 1) fits the definition of research, and 2) fits the definition of ‘human subjects' research. If it fits both definitions it will need oversight by the IRB.
Yes. Research can be approved as “exempt” if it is no more than “minimal risk” and fits one of the 6 federally designated exempt review categories. Studies that may qualify for “Exempt” must still be submitted to the IRB for review.
Yes, if human subjects are involved. Student researchers must have a faculty sponsor for each research project. Please refer to the Information for Students and their Advisors.
Yes. Federal regulations define human subjects research to broadly cover interactions as well as interventions with human subjects for research purposes. Surveys, interviews, and questionnaires are all covered by the federal regulations. IRB approval must be obtained before starting the research project. Most of this research, however, qualifies as "exempt".
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.
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.)