Policy for Funding Research Studies
Introduction: American Humane Association ("AHA") understands that excellent research is required to advance the protection, welfare, health and benefit of children and animals and their role in society.
When either children or animals participate in any research study that is funded by AHA, scientists (which for purposes of this policy shall be deemed to include all scientists involved in each such study) must always comply with the following guidelines:
- Research must be directed to advancement of the protection, welfare, health and/or benefit of children and/or animals and/or their role in society.
- The participation of children and animals shall be consistent with applicable laws and regulations and with applicable standards established by federal, state and local governing bodies whose function is the oversight of children or animals in research (e.g., Institutional Review Board ("IRB") for children (as described in 45 C.F.R. part 46), Institutional Animal Care and Use Committee ("IACUC") for animals (as described in 9 C.F.R. section 2.31)). When a standard IRB or IACUC, as applicable, is unavailable (e.g., foreign country, hospital, veterinary practice, wildlife preserve, etc.), AHA will require the review of the proposed child/animal participation by an equivalent institutional review committee/agency. In addition, AHA will also review each research study involving children and/or animals through its internal IRB and/or IACUC process. Scientists shall have appropriate qualifications and experience for conducting any research study to be funded by AHA and shall provide a full curriculum vitae indicating those qualifications and that experience. Scientists must be in good standing with the bodies governing their field of research and, if required by AHA, must pass a background check.
- Scientists must complete all trainings required by law and AHA prior to submitting any application for review. Applicable Office for Human Research Protections ("OHRP") training will be required for all applications involving children. Applicable Collaborative Institutional Training Initiative ("CITI") training will be required for all applications. Modules specific to child protection and animal protection will be included in the CITI training; scientists will complete the modules that apply to their field of research. In addition to, or in lieu of, the foregoing, alternate applicable training that is approved by AHA may be required (provided that all training required by law is conducted).
- AHA will not fund any health study that requires the induction of disease or injury, and will not fund any health study that requires euthanasia as the study end point. AHA will not fund any health study that induces or allows pain or distress, unless the pain/distress is minor and short-term (e.g., needle stick from venipuncture).
- AHA may require IRB or IACUC approval from the submitting institution for all clinical trials and other studies even though such approval may not be a requirement of the institution. If a study utilizes archived samples, AHA reserves the right to request a copy of any applicable application and approval (IRB, IACUC, wildlife permit, etc.) covering the original collection of those samples.
- Appropriate informed consent (e.g., parental consent, owner consent, etc.) and assent by children capable thereof, in each case as determined by IRB or IACUC, must be obtained for all research studies.
- Animal study investigators must ensure appropriate behavioral/environmental enrichment suitable to the species, as well as to provide appropriate nutrition.
- AHA reserves the right to perform announced or unannounced site visits and/or independent audits for any funded research study.
- Funding requests shall include statistical evidence that a proposed research study is appropriate and adequate to achieve the proposed results and to ensure that any risk is justified by anticipated benefits in each case as determined by IRB or IACUC, and AHA. It is also imperative that scientists requesting funding have reviewed relevant literature (including foreign literature) to prevent unnecessary replication of research. Collaboration is highly encouraged so that science can be efficiently and rapidly advanced.
- AHA reserves the right and may be required to terminate a study if progress is deemed unsatisfactory or if there are concerns about child and/or animal well-being or risk to AHA. Scientists shall promptly report to AHA any unanticipated problems (e.g., involving risks or injuries) during the course of the research study.
- Institutions receiving funding must be in a position to assume administrative and financial responsibility for AHA funding.
- Research study records must be kept in accordance with applicable laws and regulations.
- Any potential conflict of interest that any scientist may have relating to the research study (including but not limited to having a proprietary interest that may be affected by the outcome of the research project) must be disclosed to AHA in advance and approved by AHA before allowing a research study to begin (or to continue if such conflict first arises during the course of the research study).
- In the event that any study involving children requires participation of adults in research, all of the above guidelines applicable to children shall also apply to such adults, with appropriate modifications as necessitated by the differences between children and adults.
- AHA will not fund any research study unless and until a written agreement with AHA is executed.
- Any research study proposal that does not comply with any of the above guidelines shall not be approved or funded by AHA. Any ongoing research study approved and funded by AHA that ceases to comply with any of the above guidelines may be terminated by AHA.
- AHA strongly encourages publication of results from all funded work, so that health and welfare advancements might be shared. Funded scientific teams should duly credit support by AHA in publications, presentations, posters and other forms of communication unless specified that the source of funding is to remain confidential. AHA shall receive a final report of all funded studies.
- AHA may develop, and update as needed, procedural guidelines for research proposal submission.
This policy was adopted by the Board of the American Humane Association on May 19, 2011.
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