NIH All About Grants Podcast: Animal Welfare Assurances

>> From the National Institutes of Health in Bethesda, Maryland. This is all about grants.

Kosub >> Hello and welcome to another virtual edition of NIH�s All About Grants podcast. I�m your host David Kosub with the NIH Office of Extramural Research. And today we're going to be talking all about how to work with the Office of Laboratory Animal Welfare within NIH on obtaining an Animal Welfare Assurance. And I'm glad to say we have with us Dr. Jane Na. She directs the Division of Assurances within the Office of Laboratory Animal Welfare. And I welcome you to the show. Jane.

Na >> Thanks. I'm glad to be here.

Kosub >> All right. So, let's just start with the very high-level description of what an Assurance is and why they're important.

Na >> Yes, certainly. So, an Animal Welfare Assurance is a binding agreement or like a contract between the institution and the federal government. I mean, it's a requirement for any institution that's involved in vertebrate animal research, teaching or testing funded by NIH. And there's actually other funding entities that the Office of Laboratory Animal Welfare provides oversight for. And even though I understand that this podcast is the NIH All About Grants Podcast, I'll mention them since individuals listening may also be involved in projects with animals that are funded by these other sources. So, in addition to NIH funded animal activities, institutions that must have an animal welfare Assurance include anything funded with components of the Public Health Service, the PHS. So PHS funding components include the NIH, CDC, which is the Centers for Disease Control and Prevention, the FDA, Food and Drug Administration and the Biomedical Advanced Research and Development Authority, BARDA are some of the more common ones that we deal with. Additionally, OLAW has memoranda of understanding and provide oversight for vertebrate animal activities funded by NASA and the National Science Foundation, NSF, and the Department of Veterans Affairs. So, institutions that conduct research involving animals with NSF, NASA, and VA funding also require the Animal Welfare Assurance. So back to what an Assurance is. The Assurance document is a statement of compliance and commits the institution to follow the PHS Policy on Humane Care and Use of Laboratory Animals and applicable federal animal welfare requirements, and it's really the principal method for compliance oversight. And again, it's a requirement of PHS Policy. And PHS Policy implements the Health Research Extension Act of 1985 and really the overall goal of the policy is in its name. It's for the humane care and use of animals when their involvement is necessary in research, testing and training. And so, when organizations have an approved Assurance with OLAW, they agree to minimize animal discomfort, pain, and distress to the extent possible in order to meet the scientific aims, to acquire fundamental knowledge about living systems, and to improve human and animal health. The awardee or recipient organization of the funding and all animal performance sites � that is, places that are outside of where the awardee organization is, which can include collaborating institutions, laboratories. All of these entities must have Animal Welfare Assurances negotiated and approved by OLAW prior to conducting animal activity. So that's it in a nutshell.

Kosub >> Well, let's crack open that nutshell just a little bit more and get more into that. You had said that they have to negotiate and work with OLAW on getting these Animal Welfare Assurances, like they talk more about that, like how should someone prepare for these conversations, and you know, what are the expectations?

Na >> Absolutely. Institutions can browse on our website for sample Assurance documents which are available. If you go to olaw.nih.gov, it's available under our resources section, under documents. And there are actually examples with instructions for the Domestic Assurance, the Foreign Assurance, and the Interinstitutional Assurance. The kind of main important item for institutions to be aware is that because OLAW provides oversight that's dependent on funding, if an organization does not already have an Assurance, the action that actually triggers the Assurance negotiation process is a request from the funding entity. So usually, OLAW is contacted by grants management specialist or contract specialist from the awarding institute or center that and they tell us that an Assurance is required. So, without confirmation from the funding component, OLAW actually not start the Assurance negotiation process until we do have that confirmation.

Kosub >> And so what kind of questions might OLAW be asking as part of this process? I mean, are there any differences? You mentioned Foreign Assurances and all the institutional Assurances. Are there any differences in that?

Na >> Yes, there are differences. So, as I had mentioned earlier, there are three different types of Assurances, the Domestic, Foreign, and Interinstitutional Assurances. And I'll just briefly go over what the differences of each Assurance is before kind of going into like what we might ask for each. So domestic and foreign institutions that are to obtain, obtain an Animal Welfare Assurance are institutions that have their own animal care and use programs that control their own facilities. And they also must conduct animal research, testing or training on site. Domestic institutions would have an animal care and use program with an Institutional Official or an IO for short. And they will also have an Institutional Animal Care and Use Committee, the IACUC, as well as a veterinarian with program authority and access to all animals. And that's different from foreign institutions where, due to the various laws, they may or may not have an animal committee per say, but they do have to have their own program of animal use and care. And then institutions that obtain an Interinstitutional Assurance are organizations that don't actually have their own animal care and use program, or they don't have facilities where they house animals; They may not have an IACUC, that committee, and they wouldn't conduct animals [activities] on site at their location. And instead, those institutions perform the animal activity at a secondary Assured institution, and those are referred to as performance sites where the animal activity will occur. So, the most extensive application kind of document for the Assurances is the Domestic Assurance, and that goes through all the different components of an animal caring use and program. There are lots of prompts in the sample document that's provided with instructions for institutions that are going through the process of drafting their Domestic Assurance. And it goes into veterinary care, IACUC, the committee processes and procedures, as well as occupational health and safety. And, the document that's provided in our website is very thorough, so it's always instructed for institutions to follow those instructions very carefully. The foreign institution does provide information of their local laws and regulations that they follow, and essentially, it's a commitment to the humane care and use of animals in their research. And it's a little bit of a shorter document, but similar to the Domestic aAsurance document, there are prompts providing the applicant the information necessary to complete the document. And the Interinstitutional Assurance is a similar, fairly short document that just obtains information and ensures that the organization that is signing the Interinstitutional Assurance is aware of their responsibilities for humane care and use of the animals and in coordination with the Assured institution, will fulfill the objectives of the proposed work.

Kosub >> And so building on that, you've mentioned the components. You mentioned some samples that are on OLAW�s websites for the different types of Assurances. And then I'm just looking at what kind of lessons learned, have you, can you share? You know, someone is putting together their application. Obviously, you want them to look at the samples and all that good stuff, you know, just things that you've noticed that are helpful in other potential pitfalls that might be out there to avoid.

Na >> Yes. So as part of the process, after OLAW receives the request from the funding entity, the grants or contract specialist, that the institution requires an Animal Welfare Assurance. In addition to starting the paperwork for that process, our office will review what is called in the grant application, the Vertebrate Animals Section and the contract proposals will have a similar section that describes the Vertebrate Animals Section. And on our website, we have an extensive guidance web page for those types of applications and what information is required for that. I'm just going to refer to the Vertebrate Animals Section (VAS) for short from here on out. But essentially the VAS needs to be a complete document and it needs to really include the location, each specific institution where live vertebrate animals will be undergoing procedures. This is a commonly missed item where reference is made to one institution and another institution, but they don't describe animal work that's going on at the second institution. So just because the animal activities are being performed by somebody else or at a location other than the applicant or recipient organization, that doesn't mean that the animal work can be not described. So essentially, even if the awardee organization isn't performing the work, the animal work needs to be described.

Kosub >> Mm hmm.

Na >> And so if animals wouldn't otherwise undergo procedures that are, you know, specific for a project, the animal activities should be described in that Vertebrate Animals Section and OLAW reviews the description of the animal work. And then we may request additional information or clarifications until it's determined to be acceptable. And to us that means that the VAS is complete and that the information addresses the humane care and use of animals involved in that project. And that is certainly a component that we won't move forward with the Assurance approval until the VAS is thoroughly addressed, if there are any issues.

Kosub >> Well, actually, just to build on that. Can you tell us more about like when how you know, how OLAW is going to be addressing, you know, like not approving or withholding an Assurance, especially if the information in the VAS is not appropriate.

Na >> Right. Certainly so, in the PHS Policy, OLAW has the ability or responsibility to potentially disapprove an Assurance, and although we don't frequently withhold approval, it does occur. And these decisions are really handled on a case-by-case basis and are determined during the evaluation of the adequacy of the institution's proposed program for the care and use of animals, and in assessing compliance with PHS Policy and essentially in association with the VAS review that acceptable standards for the animal use will be met. In many cases, another organization is identified that either already has an approved Assurance or our office will negotiate and approve an Assurance once the Assurance document meets the standards of the PHS Policy.

Kosub >> All right. Well, thank you for that one. Before we kind of close our additional question about what kind of information may be releasable from an Animal Welfare Assurance, you know, upon a request.

Na >> Right. So, a cautious approach for institutions to take would be to plan for the entire Assurance document to be publicly released Because the only way to guarantee that something is not released is to not provide it in the first place. So, the process with the public release of documents is that any individual or entity like an organization can file a Federal Freedom of Information Act request to obtain records from the Office of Laboratory Animal Welfare, since we're an office of a government agency in the executive branch. There are certain exemptions for things that wouldn't be released, such as like classified information or trade secrets, like confidential commercial information, and the one thing that we often won't release is anything that's currently undergoing deliberations, so anything pre-decisional, and that would include draft Assurances that haven't completed the negotiation process and haven't been approved yet by OLAW. And part of the process in the preparation of documents for release does include redaction, which is when portions of the text are like blacked out or obscured. And the Office of Laboratory Animal Welfare, ourselves, don't perform the redactions. It's the NIH FOIA office that does that. And, you know, with any process, there's the potential for accidents and unintentional release of information is possible. So, names and contact information for individuals where their information is not required is best left out of the Assurance document. So, there are certain people that must be named in the Assurance and that include the IO, the institutional official, as well as the institutional veterinarian, and any individuals serving in the capacity of the IACUC Chair. And there's actually a recent OLAW webinar from December 2020 that really provides good additional information about FOIA and public release of all our records and from our website. It can be found in the education section under webinars. So, I do recommend, and I highly recommend people check it out.

Kosub >> Cool. And before we close out officially, any final thoughts you'd like to leave our listeners regarding these Assurances?

Na >> Yes, absolutely. So, institutions that would be receiving Assurances or have Assurances: the main purpose is to provide humane care for these animals that are used in research, teaching or training. And the Office of Laboratory Animal Welfare is very open to questions and want to assist institutions be compliant and provide that good animal welfare. Thank you for having me.

Kosub >> Cool. Well, thank you very much, Jane. This has been a great opportunity to learn more about the process that the Office of Laboratory Animal Welfare uses for obtaining an Animal Welfare Assurance. And as Jane mentioned throughout, please check out the OLAW�s website. There's a wealth of information there, including that webinar and sample documents and a whole bunch of other good information that'll help you better understand this process. And with that, this has been David Kosub with the NIH�s All About Grants. Thank you.