lab animalProtocol review

https://doi.org/10.1038/s41684-023-01306-x

Emotional support for everyone
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While emotional support animals
can provide comfort for those withmental or emotional disabilities,
several factors must be consideredwhen determining the necessary
oversight of these animals ininstitutional academic or researchbuildings. We invited experts
from Wayne State University(Erin Katz), University of California
San Francisco (Carine Serageldine)and the University of Oregon(Stephanie Womack, Audrey Harrisand Kathy Snell) along with ActingDirector, OLAW (Axel Wolff) torespond to a perplexing situation at
Great Eastern University.

W

hen Mr. Cooper, Great Eastern
University (GEU)’s Post-Approval
Monitor, discovered emotional
support animals (ESAs) that
GEU’s faculty member Dr. T. Guaio has been
keeping in his office for the past several months,
Cooper immediately notified the Attending
Veterinarian (AV) to obtain clinical care forthe animals. Evidently, Guaio simply purchased
five rats from a pet store (i.e., animals not bred
for research), set up a large cage in his officeand started housing the rats. Although Guaiohandles the rats daily, provides clean food andwater, and does his best to keep the cage clean,
the maintenance of these animals is far below
the expected standards of care of GEU’s animalcare and use program, and is even below thestandards one would expect for pet animals.
All of this was quite upsetting to Mr. Cooper
and to GEU’s veterinary staff and IACUC.
Consequently, Guaio was asked to attend an
IACUC meeting to discuss the matter.
In advance of the meeting, Guaio wrote aletter to the IACUC indicating that these ratswere ESAs, and therefore were covered by theAmericans with Disabilities Act (ADA). In short,the IACUC had no purview over these animals
or their care.
During the IACUC meeting, Cooper informed
Guaio and the IACUC that although there arelaws addressing service animals (i.e., the ADA
and Section 504 of the Rehabilitation Act (SeeRelated links)), there are no laws governing
Lab Animal | Volume 53 | January 2024 | 1–3ESAs. The ADA1 defines a service animal as“any dog that is individually trained to do workor perform tasks for the benefit of an individualwith a disability, including a physical, sensory,psychiatric, intellectual, or other mental disability,” and further states that “While Emotional
Support Animals or Comfort Animals are often
used as part of a medical treatment plan as therapy animals, they are not considered service
animals under the ADA.” Therefore, ESAs are
not subject to the same laws as service animals.
Cooper also provided the IACUC with a few
examples of the problems with the care of theseanimals; the cages for the rats had never beensanitized, the animals received no thermoregulatory support, the lighting was inconsistent, theroom was often kept quite dark and the animals
had no enrichment or areas to play. The IACUC
deliberated on the matter (e.g., discussed thecare of the animals; whether they were exempt
from IACUC review and approval; the fact thatthe animals were visible to all students who met
with Guaio in his office), and determined (bymajority vote of a quorum) that Guaio must submit an IACUC protocol application immediately
and that the AV would, on a fee-for-service basis,take over the husbandry and veterinary care ofthese rats until IACUC approval and standard
operating procedures on the husbandry and careof the animals were in place.
What do you think:• Do (should) ESAs fall under the IACUC’spurview?
• How else could GEU have handled thissituation?

Response from EK and CS

ESAs fall under the purview of the institution,
not the IACUC which is charged with oversightof the animal care program for animals used inresearch, teaching and testing2. The requirement
for an animal use protocol, and institutionally provided husbandry and veterinary care
exemplify a gross overreach of power. Instead,
GEU should establish policies and guidelines forESAs, similarly to service animals (see Relatedlinks). Such policies should be collectively
drafted by many GEU departments, including
occupational health and safety, legal, senioradministration, as well as disability services
and/or diversity and inclusion, and potentiallyothers. The IACUC and institutional biosafetycommittees may play a role if such animals enter

research areas. Management and implementation of such policies should involve the humanresources department.
While the IACUC is correct that ESAs are notservice animals protected under federal law1
(and see Related links), there may be applicablestate or local laws (see Related links). Thus, it
is imperative that legal counsel assists in drafting an institutional policy. California law, forexample, provides protections and accommodations for employees with ESA under the Fair
Employment and Housing Act3. Thus, while
Dr. Guaio made wrong inferences based on
the ADA, he may still be afforded protections
in his respective state and may have a case of
discrimination against GEU. Although GEU
may be required by law to provide reasonableaccommodations for Dr. Guaio, the institution
can impose stipulations such as documentation on necessity from a medical professionaland ensure that the animal does not endanger
the health or safety of others. This should be
discussed prior to bringing the ESA to work,
which Dr. Guaio failed to do. Additionally, there
are no requirements to allow multiple ESAs orpermanent housing of an ESA on campus.
Regardless of Dr. Guaio’s protection under
the law from discrimination, this does not grant
immunity from animal cruelty prevention laws.
Again, using California as an example, failureof an owner or keeper of any animal to provide
care and attention is a misdemeanor4. While it isunlikely that substandard care rises to the legal
definition of failure to provide care, it is concerning that care described is below the standard
expected for a pet rat. However, this may havebeen easily remedied with education and training on rat husbandry and species-specific needs,
rather than forcing Dr. Guaio to relinquish all
rat care to GEU’s laboratory animal department.
The AV and/or the IACUC could have provided
such training.
In conclusion, mistakes were made by bothparties resulting in this unfortunate and avoidable situation. GEU should have establishedan ESA policy pursuant to local and state laws.
Dr. Guaio should have consulted the policy,provided any required documentation, andreceived prior approval before bringing the rats
to campus. The IACUC, upon discovery of therats, should have involved upper management
and legal on how to best handle the situation(as no ESA policy existed), rather than treat it1

lab animalProtocol review

Box 1 | A Word from OLAWIn this scenario, an IACUC deliberates thedegree of oversight required for emotional
support animals at the institution. Per thePublic Health Service Policy on Humane
Care and Use of Laboratory Animals(PHS Policy), the IACUC is responsible
for oversight of activities involving live
vertebrate animals used or intended
for use in research, research training,
experimentation, or biological testing, orfor related purposes in PHS-funded orsupported activities6,7. The PHS Policy
applies to research conducted or supported
by several PHS agencies including
the National Institutes of Health (NIH),
Biomedical Advanced Researchand Development Authority (BARDA),
Centers for Disease Control andPrevention (CDC), and Food and Drug
Administration (FDA). Through memorandaof understanding, this requirement
also applies to activities conducted or
supported by the National Aeronautics
and Space Administration (NASA),
National Science Foundation (NSF), andDepartment of Veterans Affairs (VA)8(and see Related links). If additional
activities and animals are covered underthe Assurance, the institution is expectedto follow its Assurance as described9,10.
Further, care must be taken to prevent
activities not subject to the PHS Policy

from adversely affecting animals that aresubject to the PHS policy11.
The IACUC may choose to extend
oversight to animals not described in theAssurance, and in doing so may choose torequire a protocol or use other methods ofoversight at its discretion, such as standard
operating procedures and institutional
policies10. To ensure that animals subject
to the PHS Policy are not impacted,
consultation with the veterinarian regarding
potential biosecurity and health concerns
is recommended. To ensure the integrityof the health program for personnel who
work in laboratory animal facilities or havecontact with animals, and so that risks tostudents and visitors to Dr. Guaio’s offce areassessed and minimized, consultation withoccupational health and safety personnel
is recommended12. As mentioned bycommenters, it is also important to involve
institutional leadership and legal counsel toidentify applicable federal, state, and local
laws, as well as relevant institutional policies
and potential liabilities.
Keep in mind that this scenario does
not describe emotional support animals
as part of a study subject to the PHS
Policy. However, such studies are sometimes
conducted and animal subjects mustthen be covered in accordance with thePHS Policy.

as unauthorized animal use, due to the absenceof an approved protocol.

as research, research training, experimentation, or biological testing or for related purposes)5. Biosecurity/cross-contamination risks
to research animals from the random sourced
rats as well as health risks to individuals exposedto the animals or entering the location housing
the animals are other important considerations.
Including these issues in the discussion would
likely have led to a different selection of animalcare providers than the AV, if the IACUC isdeemed to have such authority. Representationfrom the institutional safety unit on the IACUC
is prudent to include as standing to ensure
human safety concerns are taken into consideration in every IACUC review.
While ESAs are a valuable source of symptom mitigation for those with mental or emotional disabilities, there are a variety of factorsthat must be considered prior to approval andallowance of ESAs in institutional academicor research buildings. These factors should beconsidered in detail by the IACUC along withResponse from SW, AH and KS

While there are no Federal laws that are applicable to this scenario, when animals are living ininstitutional academic or research buildings, theIACUC should review existing institutional policy, including any policies about ESAs and animals on institutionally owned property. IACUCs
must be empowered to make recommendations
to the Institution to ensure the policy is upheld.
This may include working with upper administrators, occupational or environmental safety,
risk management and/or legal counsel.
Additional issues than those raised in theoriginal article also need to be part of the IACUC
discussion; including the IACUC’s authority
to require actions, as these animals are not a
USDA-covered species, and students entering
the office do not fall within the PHS definition of IACUC-covered animal activities (suchLab Animal | Volume 53 | January 2024 | 1–3

other regulatory bodies across the University toreach consensus that aligns with current policies
and procedures. Careful consideration should begiven to biosecurity risks that may impact thehealth status of research animals and the subsequent effects on research across the University.

Compliance considerations

The Protocol Review coordinators offer the following compliance considerations:
Do (should) ESAs fall under the IACUC’s purview and how should GEU’s IACUC handle
this situation? No, ESAs do not fall under thepurview of the IACUC: they are not used forresearch, teaching or testing. Consequently, thestandards set forth in the regulations (e.g., theGuide) do not apply. Furthermore:• Under Title II and Title III of the ADA, dogs
are the only species eligible to be service animals (although miniature horses may be eligible under certain circumstances).
• Service dogs do work for people with diagnosed disabilities.
• ESAs must be prescribed by physicians orlicensed mental health professionals and arefor individuals with disabling mental illness,affording these individuals certain rights
under the U.S. Fair Housing Act.
• Tere are no limitations on what species canbe claimed as an ESA.
• Unlike service dogs, ESAs can be refusedentry to public spaces and privately ownedentities.
• While “Employers are required to provide
reasonable accommodation,” the ADA also
states that “Both service and emotional support animals may be excluded from the workplace if they pose either an undue hardship ora direct threat in the workplace1.”
Other considerations. Further considerations
on this scenario include:• Guaio’s rats (that he owns personally) are notcovered under the ADA and would not qualify
as ESAs if they were not prescribed by a physical/mental health provider.
• If the rats pose a direct threat in the workplace,then GEU can exclude them, for example:∘ Guaio also uses rats in research; what risk dothese ESAs pose to the health and safety of
the research colony (e.g., does it violate theAV’s biosecurity program)?
∘ Guaio is a student advisor to non-animal
users; what risks (e.g., allergies) do theseESAs pose to students and other visitors?
• If GEU permits ESAs to be housed on campus, then who is ultimately responsible forensuring the well-being of these animals and2

lab animalhow should this be documented, if at all?
For example:∘ Husbandry and clinical care (weekends,holidays, vacations).
∘ In case of emergencies (e.g., fire, power outage, natural disaster).
∘ Should GEU communicate the fact thatthese pets do not fall under the purview
of the IACUC and are not governed by thesame regulations as research animals anddelineate limitations on the location anduse of these ESAs (e.g., they should not
be brought into the lab, and should not beused for teaching or demonstration withoutIACUC approval)?

Response from OLAWProtocol review

University, Detroit, MI, USA. 4Animal Careand Use Program, University of California
San Francisco, San Francisco, CA, USA.
5
University of Oregon, Eugene, OR, USA.
6
Acting Director, Offce of Laboratory Animal
Welfare, OER, OD, NIH, HHS, Bethesda,
MD, USA.
e-mail: laurendanridge@princeton.edu

Published online: 3 January 2024
References
1.

2.

Comments from OLAW can be found in Box 1.
This protocol review was coordinated by Lauren
Danridge and Bill Greer.
Lauren Danridge1 , Bill Greer2,Erin M. Katz3, Carine E. Serageldine4,Stephanie Womack5, Audrey Harris5,
Kathy Snell5 & Axel Wolff6
1
Associate Director - IACUC/IBC/PAM,Princeton University, Princeton, NJ, USA.
2Animal Care & Use Offce, University ofMichigan, Ann Arbor, MI, USA. 3Division ofLaboratory Animal Resources, Wayne StateLab Animal | Volume 53 | January 2024 | 1–3

3.
4.

5.

6.

7.

Brennan, Jacquie; Nguyen, Vinh (Ed.). “Service Animals
and Emotional Support Animals.” The Americans
with Disabilities Act (ADA) National Network,https://adata.org/guide/service-animals-and-emotional-support-animals
Institute for Laboratory Animal Research. Guidefor the Care and Use of Laboratory Animals, 8thedition (National Academies Press, Washington,DC, 2011).
California Fair Employment and Housing Act (FEHA).
Government Code §12900-12996.
National Agricultural Law Center Research, CA Penal§597.1(a)(1) https://nationalaglawcenter.org/wp-content/uploads/assets/animalcruelty/california.pdf
Public Health Service. PHS Policy on Humane Care andUse of Laboratory Animals (U.S. Department of Health andHuman Services, National Institutes of Health, Bethesda,
MD, 2015).
OLAW, NIH. Public Health Service Policy on Humane
Care and Use of Laboratory Animals. (US Department ofHealth and Human Services, Bethesda, Maryland, USA,2015).
IV.A.3.a.
OLAW, NIH. Public Health Service Policy on Humane
Care and Use of Laboratory Animals. (US Departmentof Health and Human Services, Bethesda, Maryland,USA, 2015). III.

8.

OLAW, NIH. Public Health Service Policy on Humane
Care and Use of Laboratory Animals. (US Departmentof Health and Human Services, Bethesda, Maryland,USA, 2015). II.
9. OLAW, NIH. Public Health Service Policy on Humane
Care and Use of Laboratory Animals. (US Department ofHealth and Human Services, Bethesda, Maryland, USA,2015). IV.A.1.
10. Brown, P. Lab Anim (NY) 48, 69 (2019).
11. Public Health Service Policy on Humane Care and Use ofLaboratory Animals – Frequently Asked Questions.
Applicability of the PHS Policy, Question No. A.1.
(US Department of Health and Human Services,Washington, DC).
12. OLAW, NIH. Public Health Service Policy on Humane
Care and Use of Laboratory Animals. (US Departmentof Health and Human Services, Bethesda, Maryland,
USA, 2015). IV.A.1.f.

Competing interests
The authors declare no competing interests.

Disclaimer
The views expressed in “A word from OLAW and USDA”
represent the positions of OLAW/NIH and USDA, respectively,
but the remainder of the contributions in this article do not
represent offcial support or an endorsement by NIH, USDA,or any government agency.

Related links
U.S. DHHS, Fact Sheet: https://www.hhs.gov/sites/
default/fles/ocr/civilrights/resources/factsheets/504.pdf.
OLAW, Webinar 2021, I ACUC responsibilities regarding
service animals: https://olaw.nih.gov/education/
educational-resources/webinar-2021-06-10.htm.
ADA.gov, FAQs: https://www.ada.gov/resources/
service-animals-faqs/.
Memoranda of Understanding: https://olaw.nih.gov/
resources#meund3