View slides from Nathan Herschler's presentation at the ILAR/Harvard Animal Law Roundtable on January 26th, 2018. His presentation addresses significant and potential legal conflicts related to animals in laboratories in the coming years.

1. NEAVS
New England Anti-Vivisection Society
Resolving Upcoming Conflicts in
the Laboratory Animal Law System

2. Overview
I. Introduction to NEAVS
II. Resolving Pending Conflicts
III. Ethical and Legal Implications of Advancing Technology
IV. From Conflict to Collaboration

3. I. NEAVS
Who we are
And…
What that means.

4. We can be friends, right?
“You can’t stay in your corner of the
forest waiting for others to come to you.
You have to go to them sometimes.”
— Winnie The Pooh

5. II. Resolving pending conflicts
1. The push for de-regulation
2. USDA blackout
3. Third-party investigations

6. FASEB Reforming
Animal Research
Regulations:
Workshop
Recommendations

7. Points of contention with the FASEB et al. report
Reduction of burdensome bureaucracy is fine, but this cannot come at the
expense of animal welfare, lack of transparency, or weakened oversight.
■ Moving to the lowest common denominator of regulation
■ Moving from bi-annual to annual IACUC inspection
■ Removing the requirement for annual USDA inspection
■ Limiting IACUC oversight for “low risk, noninvasive, or minimally
invasive” research
■ Limiting reporting to include only incidents that jeopardize the health
or wellbeing of animals

8. USDA transparency and APHIS third-party investigations

9. III. Possible legal implications of novel technology
A. Regulation of human-animal chimera
B. CRISPR, Ethics, and Law
i. Animals in Labs
ii. Farmed Animals
iii. Wildlife
iv. Pain

10. Human-animal chimera,
the slippery slope, and law

11. “Human glial chimeric mice exhibit
enhanced performance in four
different learning tasks….
Moreover, the analysis of auditory
fear conditioning indicates that
alloengrafment by mouse GPCs
did not affect the learning of the
recipient mice, supporting the
notion that the improved learning
in the humanized chimeras
resulted from the presence of
human glia, rather than from cell
engraftment per se.”
Han et al., Forebrain Engraftment by Human Glial Progenitor
Cells Enhances Synaptic Plasticity and Learning in Adult
Mice, Cell Stem Cell, Vol 12, Iss. 3, 342-353 (Mar. 7 2013).

12. Within one year, the human glial progenitor cells in newborn mouse pup brains
almost entirely displaced the mouse glial cells in the brain, resulting in mice with
a totally humanized glial progenitor population.
However, the team decided not to try putting human cells into monkeys.
“We briefly considered it but decided not to because of all the potential ethical
issues,” Goldman says.
Enard agrees that it could be difficult to decide which animals to put human
brain cells into. “If you make animals more human-like, where do you stop?” he
says. (emphasis added)

13. “Where do you stop?”

14. ALDF petition to regulate chimeras under
Public Health Services Act (PHSA)
The HHS Policy for Protection of Human Research Subjects
(“the Common Rule”) requires:
■ IRB initial approval of research proposals and continued monitoring.
45 C.F.R. § 46.109
■ Approval only if, among other requirements: informed consent is given,
confidentiality is protected, risks to research subjects are minimized, and
selection of subjects is equitable.
45 C.F.R. §§ 46.109(b); 46.116; 46.102(f)(2); 46.111(a)(1)-(2); 46.111(a)(3)
■ There are limited exceptions to informed consent requirement where
there is no more than minimal risk to the subjects and research could
not be carried out without the waiver.
See 45 C.F.R. §§ 46.116(c), (d)

15. Petition to regulate chimeras under
Public Health Services Act (PHSA)
2009 NIH Guidelines for Human Stem Cell Research:
■ Deny federal funding to research involving the transplant of
human embryonic or induced pluripotent stem cells in nonhuman
primate blastocysts.
■ Deny federal support for research involving the breeding of
human-animal chimeras where human embryonic or induced
pluripotent stem cells may contribute to the germ line.

16. Key criteria of the petition’s proposal
■ Humanized chimera should have the same protection as
other human research subjects;
■ If during review IRB finds there is a substantial risk that the
subject will become or has obtained humanized chimera
status, it shall require researchers to reduce risks, it shall
require researchers to reduce risks to a non-substantial
level or to protect the individual as a research subject
under existing rules;
■ IRB shall monitor human-animal chimera testing even if it
initially determines there is no substantial risk of the chimera
becoming humanized.

17. What regulation might look like
At 42 C.F.R. Pt. 45 Sub. E-F.
Research Not Eligible for NIH Funding:
E. Research in any way involving animals where human stem cells or other
human genetic material has contributed or might contribute to
substantively enhanced cognitive capacity, where “substantively
enhanced” is defined as mental ability substantively increased from
animal baselines and attributable to human genetic material.
F. Research involving the introduction of human stem cells or other human
genetic material that does not provide for regular oversight from an IRB
to ensure that human genetic material are not contributing to
substantively enhanced cognitive capacity in an animal.

18. CRISPR
“Next year we will have it; will we allow it?”

19. Ethical considerations
■ We can use CRISPR to
make animals sick;
■ We can use cloning to
make more sick animals.

20. Ethical considerations—farmed animals
Risks include (but are not limited to):
■ Off-target edits
■ Reduced genetic diversity
■ Potential for environmental damage if gene-edited material is spread to
closely related populations.

21. Ethical considerations—wildlife
■ De-extinction
■ Competition with native species

22. Eliminating an animal’s ability to feel pain

23. IV. From conflict to collaboration
1. Reducing regulatory
burden
2. Co-development of
alternatives
(Reuters/Pool photo)
(National Center for Advancing Translational Sciences photo)

24. Nathan Herschler, Esq.
Executive Director
nherschler@neavs.org | 617.523.6020 | neavs.org
Contact