NOT-OD-16-095: NIH Research Involving Chimpanzees

NIH Research Involving Chimpanzees

Notice Number: NOT-OD-16-095

Key Dates
Release Date: May 26, 2016

Related Announcements
NOT-OD-15-097
NOT-OD-14-075
NOT-OD-14-024
NOT-OD-13-078
NOT-OD-13-026
NOT-OD-12-116
NOT-OD-18-191

Issued by
National Institutes of Health (NIH)

Purpose

The National Institutes of Health (NIH) is informing the research community about permissible types of agency-supported research involving chimpanzees (Pan troglodytes) and changes to agency processes for projects that propose to use chimpanzees in NIH-supported research.

Background

On February 9, 2016, the NIH published a Federal Register notice (see 81 FR 6873) that provided information on: 1) the agency’s reassessment of the need to maintain a colony of 50 chimpanzees for future research, 2) decision to no longer maintain a chimpanzee colony for research, and 3) conforming updates and procedures related to this action. Consistent with the NIH’s reassessment and decision to no longer maintain a chimpanzee colony for research, the NIH is limiting its future support for research using chimpanzees to that which would be permissible in the federal sanctuary system under the Chimpanzee Health Improvement, Maintenance and Protection (CHIMP) Act and the implementing regulations at 42 CFR part 9. The Federal Register notice announced that such research must either be noninvasive behavioral studies or medical studies based on information collected during the course of normal veterinary care that is provided for the benefit of the chimpanzee, provided that any such study involves minimal physical and mental harm, pain, distress, and disturbance to the chimpanzee and the social group in which the chimpanzee lives.

In addition, the Federal Register notice announced that NIH may issue future guidance about permissible non-invasive research involving chimpanzees. Specifically, the NIH’s decision to limit its future support for research involving chimpanzee requires conforming changes pertinent to previously issued NIH GUIDE notices, such as NOT-OD-14-024 and NOT-OD-15-097.

Actions

Beginning on May 25, 2016, NIH will not fund any research involving chimpanzees proposed in new or other competing projects (renewal and revisions) unless the research is consistent with the definition of noninvasive research, as described in the Standards of Care for Chimpanzees Held in the Federally Supported Chimpanzee Sanctuary System at 42 CFR part 9. Some examples of noninvasive studies are:

Visual observation.
Behavioral studies designed to improve the establishment and maintenance of social groups. These activities may cause stress as a result of novel interactions between chimpanzees and caregivers, but they are not considered invasive as long as they are intended to maximize the well-being of the chimpanzees.
Medical examinations as deemed necessary to oversee the health of the chimpanzees, in the least invasive manner possible. Collection of samples routinely obtained during a physical examination for processing during this time is also considered noninvasive since a separate event is not required.
Administration and evaluation of environmental enrichment used to promote the psychological well-being of the chimpanzees.
Actions taken to provide essential medical treatment to an individual chimpanzee exhibiting symptoms of illness. This applies only to serious illness that cannot be treated while the chimpanzee remains within the colony.
Observational studies and collection of biomaterial in the wild without interfering with the chimpanzee.
Collections of biological materials (e.g., saliva, oral or other cavity specimens, urine, feces, or hair) obtained voluntarily from a chimpanzee that has been trained through positive reinforcement to cooperate in the collection. This excludes venipuncture or other more invasive methods.

The NIH also considers the services of the Chimpanzee Research Use Panel to be complete and is disbanding this working group of the Council of Councils. Grant applications, contract proposals, intramural research protocols, and 3rd party projects that propose to conduct research that is inconsistent with noninvasive research as described above will not receive support from the NIH for such research.

Implementation

Grant applicants who propose the use of chimpanzees or chimpanzee biomaterials in new or competing research will undergo the following process:

Upon receipt of the grant application by NIH, an automated query in the electronic Research Administration (eRA) system (the system used by NIH to support the full grant life cycle) identifies applications that contain words or phrases that may indicate the use of chimpanzees in the project. These applications will receive a chimpanzee flag in the NIH system. Before the application receives funding, this flag must be addressed by satisfying the NIH criteria for use of chimpanzees in research, or by the applicant certifying that no chimpanzees or chimpanzee biomaterials are involved. Note that the flag is used by NIH program officers and other staff for administrative purposes and is not available to peer review panels or Council members.
When the NIH Institute or Center (IC) Director is considering funding an application after the two-level peer review process has been completed, an email notification will be sent from the Chimpanzee Research Use (CRU) Reporting System to the principal investigator and the institutional signing official describing two possible paths for resolving the chimpanzee flag .
The first path is for a grant application that received the chimpanzee flag designation, but the project does not involve the use of chimpanzees or chimpanzee biomaterials (i.e., the flag is incorrect or a false positive). The information provided by the applicant may be reviewed by the NIH Office of Laboratory Animal Welfare (OLAW) to verify that the project does not involve the use of chimpanzees or chimpanzee biomaterials. No substantial delay in the award process is anticipated for this path.
The second path is for research involving chimpanzees or chimpanzee biomaterials. In this case, the grant applicant enters the CRU Reporting System and indicates that the research is consistent with noninvasive research, as described in the Standards of Care for Chimpanzees Held in the Federally Supported Chimpanzee Sanctuary System and provides a justification. The information provided by the applicant will be reviewed by the NIH Office of Laboratory Animal Welfare (OLAW) in consultation with the NIH Office of Research Infrastructure Programs the entity that oversees the federal chimpanzee sanctuary system.

If NIH believes the research is inconsistent with the definition of noninvasive research, as described in the Standards of Care for Chimpanzees Held in the Federally Supported Chimpanzee Sanctuary System, the principal investigator, the institutional signing official, and the NIH Program Officer will be notified through the CRU Reporting System that the chimpanzee flag will remain; and the portion(s) of the application that are inconsistent with noninvasive research cannot receive NIH funding. Applicants may wish to contact their NIH Program Officer to discuss revising or resubmitting an application.

The process as it relates to contract proposals, intramural protocols, and 3rd party projects is similar to grant applications but does not, for example, involve electronic flagging upon receipt. Please contact the Division of Program Coordination, Planning, and Strategic Initiatives for specific details related to these mechanisms.

Invasive Chimpanzee Research will not be Funded

The NIH will not fund, and therefore discourages, grant applications, contract proposals, intramural protocols, and 3rd party projects that propose to conduct invasive research using chimpanzees. Invasive research, as described by the Standards of Care for Chimpanzees Held in the Federally Supported Chimpanzee Sanctuary System at 42 CFR part 9, utilizes those procedures that cause more than momentary pain, distress, fear, discomfort, injury, or other negative modalities to a chimpanzee. Any procedure that enters or exposes a body cavity is considered to be invasive. Some examples of invasive research are:

Experimental exposure to a substance that may be detrimental to a chimpanzee's health (e.g., infectious disease, radiation). This does not include accidental exposures to infectious diseases transmitted from cage mates or from radiation or other exposures at the time of regularly scheduled or necessary veterinary examinations and treatments.
Any invasion of a body cavity. For the sake of clarity, the NIH considers research involving the collection of biopsies as invasive research unless the specimen is taken for the health of the chimpanzee. This includes liver, percutaneous, and other biopsies.
Surgery and surgical implantation of devices that are not a part of a veterinary medical treatment or colony management purposes.
Behavioral studies that cause distress or discomfort, such as induction of a fear response.
Testing of any drug.
Purposeful manipulation of social groups or the removal from their social group or addition of individuals in order to conduct behavioral research (for example, on aggression). Creation and refinement of social groups will be necessary when the animals arrive at the Sanctuary and this should take place only when necessary in regards to colony management and should not be driven by independently initiated research studies.
Restraint unless it is in conjunction with the annual exam or clinical care.
Darting or anesthesia induction other than at annual exam, for veterinary clinical indications, or in the case of an emergency in which the chimpanzee's well-being is at stake. For the sake of clarity, imaging studies such as radiography and external ultrasounds are considered to be invasive research unless they are for the benefit of the chimpanzees. However, digital or other resultant images obtained from procedures conducted for the benefit of the chimpanzees may be used for secondary purposes of research.
Procedures such as lavage, catheterization, or venipuncture, unless for veterinary clinical indications.

The NIH's decision to allow the support of noninvasive research involving the use of chimpanzees, as described in this notice, does not affect requirements for investigators and/or their institutions to obtain permits from the U.S. Fish and Wildlife Service, if applicable, nor does it affect the responsibility to meet all applicable veterinary, colony, and husbandry obligations.

Inquiries

Please direct all inquiries to:

Division of Program Coordination, Planning, and Strategic Initiatives
Email: dpcpsi@od.nih.gov.