The Role of the Institutional Animal Care and Use Committee
What is an IACUC?
An Institutional Animal Care and Use Committee (IACUC) is the group responsible for overseeing the ethical use of animals in research within an institution. Under the Animal Welfare Act and Regulations (AWAR), every institution (e.g., a university or private research facility) that uses animals for research must have an IACUC. An institution’s IACUC serves as the internal watchdog, ensuring that animal research conducted by the institution maintains the highest animal welfare standards and that any proposed animal study is scientifically valid.
Role of an IACUC
The primary responsibility of the IACUC is to review and approve animal research to ensure that all projects involving the use of animals comply with the AWAR, and any additional regulations, guidelines, and policies governing animal use. IACUCs are also responsible for monitoring their respective animal facilities and animal care practices, reviewing incidents, and recommending appropriate corrective actions. Other responsibilities of IACUCs include providing education and training to researchers, staff, and students involved in animal research. Finally, IACUCs are responsible for investigating any reports of animal welfare concerns or non-compliance.
External and Internal IACUCs
To comply with the AWAR, research institutions can outsource their IACUC to a for-profit, external contractor, or they can choose to form an internal IACUC composed primarily of employees of the institution.
While there can be advantages to utilizing an external IACUC, like being outside the organization’s direct compensation structure, there can also be significant disadvantages: external IACUCs may lack adequate expertise in the organization’s area of research, leading to risks of duplicative or ill-designed studies; similarly, the committee members may not be experts in animal welfare or the particular species selected for the study. External IACUCs are not free from compensation-based conflicts of interest either, as the contract IACUC may be incentivized to vote in the direction that favors the client organization (i.e., rubber-stamping protocols) to garner repeat business.
On the other hand, internal IACUCs allow for assembling committee members with a deep expertise in the specific area of research being conducted and, therefore, allow for a more thorough review of the justifications for animal use and extent to which the proposed research is appropriately refined.
Neuralink’s IACUC
At Neuralink, we opted to form our own internal IACUC rather than relying on an external one. Just as internal IACUCs at academic institutions are comprised primarily of university employees (e.g., professors overseeing research labs), Neuralink’s IACUC is comprised primarily of our employees. Because Neuralink employs individuals from a diverse array of disciplines, including veterinarians, animal welfare scientists, neuroscientists, surgeons, and engineers, our internal IACUC represents both a broader range of perspectives and more depth than we would be able to achieve relying on an external contractor to serve as our IACUC.
Neuralink's Full IACUC Roster
Potential Conflicts of Interest
As with all research institutions, our internal IACUC has to deal with potential conflicts of interest. The AWAR states that “no member may participate in the IACUC Review or approval of an activity in which that member has a conflicting interest (e.g. is personally involved in the activity), except to provide information requested by the IACUC, nor may a member who has a conflicting interest contribute to the constitution of quorum,” (9 CFR 2.31(d)(2)).
In compliance with the regulations, Neuralink enacted the following conflict of interest policy at the inception of its IACUC:
Due to a conflict of interest, any IACUC member who is involved with the research project being reviewed by the committee may not participate in the discussions or deliberations (other than to provide information as requested), nor vote on it. If any of the following are applicable, the member is required to recuse themselves:
- When a member is named on the protocol in any capacity.
- Where an immediate family member of the member or consultant is involved in the design, conduct, and reporting of the research.
- Any other situation where a member believes that another interest conflicts with his or her ability to deliberate objectively on a protocol.
At Neuralink, every single employee contributes to the company’s success and, accordingly, all full-time employees receive equity in the company. As a result, members of Neuralink’s IACUC hold equity in the company. This is typical of any company’s IACUC. Members of Neuralink’s IACUC who are employees of the company do not receive additional compensation for their role on the IACUC, and non-affiliated members, as is standard practice, are compensated only for the cost of lunch and transportation to each meeting.
Under the guidance and leadership of the IACUC Chair, Neuralink’s IACUC fosters a culture of transparency and robust consideration of dissenting opinions. The committee rigorously reviews each protocol submission and only approves protocols when they satisfactorily safeguard animal welfare and support high-quality scientific data. Indeed, this can be seen in how our IACUC has voted over the past three years on protocols and amendments that were presented and reviewed at our monthly meetings.
Neuralink's IACUC Voting on Initial Protocol Submissions Presented at Full Committee 2020 - 2023
Approved
After consultation with the Attending Veterinarian, the IACUC does not require further modifications to the protocol.
Modification Required to Secure Approval
After consultation with the Attending Veterinarian, the IACUC does not require further modifications to the protocol.
Tabled / Not Approved
The protocol submitted lacks substantive information necessary for the IACUC to make a vote and/or did not receive approval.
Who are the Members of Neuralink’s IACUC?
The AWAR requires that every IACUC must include certain key positions. In addition, animal care programs that are AAALAC International accredited, as Neuralink’s program is, voluntarily abide by the additional recommendations for IACUC membership listed in the Guide for the Care and Use of Laboratory Animals (“The Guide”). At Neuralink, we have assembled a diverse committee of members to fill each required role:
Director of IACUC Office: leads and conducts all IACUC activities
Our Director is a Certified Professional in IACUC Administration (CPIA) and has 12+ years of experience educating committee members, organizing meetings and documentation, and leading IACUC functions.
IACUC Chair: facilitates committee meetings, ensuring all members are able to voice concerns and encouraging all members to fully engage in the process.
Our IACUC Chair is an Animal Welfare Scientist with 20+ years of experience in refining the care of animals in the medical research setting. She was intentionally selected for her candor in being our harshest critic, determination in holding us to higher standards than typically practiced in the industry, and perseverance in driving the transparency of our program.
Doctor of Veterinary Medicine: oversees medical health of animals and educates committee on best practices in animal care.
Our Attending Veterinarian is American College of Laboratory Animal Medicine (ACLAM) certified, as well as a progressive leader in the field of laboratory animal medicine and welfare with 12+ years of experience caring for animals in medical research.
Non-Affiliated: defined by federal regulation as an individual who “shall not be affiliated in any way with such facility other than as a member of the Committee; shall not be a member of the immediate family of a person who is affiliated with such facility; and is intended to provide representation for general community interests in the proper care and treatment of animals.” The person filling this position is intended to represent society's "less specialized" concerns regarding the welfare of the animal subjects.
Our public non-affiliated members consist of a special education teacher, a web developer, and a school executive director; each providing representation of general community interests.
Practicing Scientist: provides scientific knowledge to help ensure proposed studies have appropriate study design and justification.
We rotate scientists through this role to give our scientists a chance to learn and share their perspective. They provide crucial expertise on appropriate study design and assurance the test will answer the question as intended.
Non-Scientist: a member from a nonscientific background, provides a non-scientific perspective on the study but with knowledge of the workings of the company.
We rotate non-scientists through this role to give a variety of our employees a chance to share their perspective.
Appendix A: How Neuralink’s IACUC Ensures the Highest Level of Animal Welfare Standards
Protocol Review:
The IACUC must review and approve all research conducted on animals prior to the initiation of the study. As part of the review of the animal use protocol the committee focuses on some of these key aspects:
Justification of Animal Use
AWAR (9 CFR 2.31(e)(2)): A proposal must include a rationale for involving animals, and for the appropriateness of the species and numbers of animals to be used.
Neuralink requires animal studies to be confirmatory, not exploratory. Accordingly:
- Bench-top testing must be performed ahead of any request for the use of animals;
- A detailed hypothesis is generated based on this prior work; and
- The intent of the study is to confirm or disconfirm the expected outcome.
Our Preclinical team, consisting of study managers and directors, is responsible for managing our study pipeline to meet these internal standards.
Animal Numbers
AWAR (9 CFR 2.31(e)(2)): A proposal must include a rationale for involving animals, and for the appropriateness of the species and numbers of animals to be used.
Neuralink’s IACUC considers the following in the review of animal numbers:
- Statistical justification of animal groups based on anticipated differences between groups;
- Group sizes as determined by the FDA and international consensus standards (e.g., ISO-10993-11:2017 - 4.5 .1 Size of groups - Table 1); and
- Pilot studies when the statistical effect size (the magnitude of difference between variables in the study) is not known in advance.
Provision of Anesthetics and Analgesics
AWAR (9 CFR 2.31(d)(1)(iv)): Procedures that may cause more than momentary or slight pain or distress to the animals will: (A) Be performed with appropriate sedatives, analgesics or anesthetics, unless withholding such agents is justified for scientific reasons, in writing, by the principal investigator and will continue for only the necessary period of time; (B) Involve, in their planning, consultation with the attending veterinarian or his or her designee; (C) Not include the use of paralytics without anesthesia;
All animals at Neuralink are provided with anesthesia and analgesia for any procedures that may cause more than momentary pain or distress to the animals. To assess this need, the Neuralink IACUC assumes that any procedure that would be expected to cause more than momentary pain or distress in a human being, would also cause a similar level of pain or distress in our animals.
The veterinary team at Neralink is committed to providing a high level of multimodal analgesia to provide comfort post-operatively, and designs anesthetic protocols to be inline with those used in the human clinics for patients undergoing equivalent surgeries.
Minimization of Harm or Suffering
AWAR (9 CFR 2.31(e)(4)): A description of procedures designed to assure that discomfort and pain to animals will be limited to that which is unavoidable for the conduct of scientifically valuable research
Neuralink believes that our animals should have as much agency as we can provide them (see our Husbandry Refinement blog post). To ensure this, the IACUC reviews all proposed procedures to ensure that the data is being collected in a way that allows for the animal to volunteer to participate whenever possible. To ensure this, animal advocates with expertise in animal training are hired to perform the hands-on care of the animals.
Additionally, IACUC review includes justification for why a less invasive alternative would not be used if one is currently available.
Facility Inspection and Program Review:
AWAR (9 CFR 2.31(c)(2)): Inspect, at least once every six months, all of the research facility's animal facilities, including animal study areas, and review the animal use program.
Our previous blog on Neuralink’s Commitment to Animal Welfare highlights our spirit of routinely challenging ourselves to exceed industry standards.
Animal Welfare Monitoring:
AWAR (9 CFR 2.31(d)(1)(vi)): The animals' living conditions will be appropriate for their species in accordance with part 3 of this subchapter, and contribute to their health and comfort.
The IACUC monitors animal welfare to ensure that animals are maintained in a humane and ethical manner. The committee reviews animal incidents and veterinary records to ensure that animals are receiving adequate care.
Neuralink’s IACUC has found their environmental enrichment coordinators, animal behaviorists, animal welfare scientists, and veterinary staff extremely valuable when assessing all facets making up the total well-being of the animals.
Neuralink engages in a robust Post Approval Monitoring program. This ensures the IACUC periodically observes procedures once approved to ensure they remain in compliance with the approved protocol. This process also allows for procedural refinements to be identified and implemented, enhancing the wellbeing of our animals.
Finally, Neuralink has methods in place for any person at the company to either directly or anonymously inform the IACUC of any animal welfare concerns. All concerns are promptly investigated by the IACUC.
Training and Education:
AWAR (9 CFR 2.31(d)(1)(viii)): Personnel conducting procedures on the species being maintained or studied will be appropriately qualified and trained in those procedures.
The Guide: All personnel involved with the care and use of animals must be adequately educated, trained, and/or qualified in basic principles of laboratory animal science to help ensure high-quality science and animal well-being.
Neuralink provides a mix of online courses, in-person orientations, and species-specific training for all individuals working directly with our animals.
Training opportunities are also offered to our IACUC members through initial New Member Orientation coupled with ongoing support in attending meetings and workshops. Members are exposed to IACUCs at other institutions, learn how they are managed, and help identify areas of improvement in our own program.