Complying With Limits on Using Human-Animal Chimeras in Biomedical Research

One Quality

chimerasExperiments involving human-animal chimeras can help scientists answer critical medical questions, but the NIH has proposed strict new guidelines on this researchImage Credit: Flickr user Tareq Salahuddin

Human-animal chimeras may sound like science fiction, but they have the potential to revolutionize medical research. By conducting experiments that involve adding human stem cells to animal embryos, scientists can gain critical insight into human development, grow human organs for transplant, and generate animal models of disease that can be used to develop and test new treatment and prevention strategies.1  

In September 2015, the NIH issued a moratorium on funding for studies involving human-animal chimeras due to ethical concerns about unexpected consequences. But in August 2016, it released a proposal to reinstate funding for the research—subject to certain stipulations. Some types of experiments would be required to undergo ethical review prior to approval, and existing regulations on stem cell research would be tightened.2  The lifting of the moratorium was greeted with excitement by many in the scientific community, since this research has the potential to lead to major medical breakthroughs, but as life sciences firms take advantage of this latest opening in the biomedical research field, they must remain diligent about following NIH guidelines. With a quality strategy in place, labs can ensure that they are in compliance as they conduct cutting-edge disease research using human-animal chimeras.

Readying a Research Proposal for Ethical Review

One of the key aspects of the new NIH guidelines on using human-animal chimeras in biomedical research is that two types of studies will be subject to ethical review by an NIH steering committee of scientists, ethicists and animal welfare experts. First, studies will be need to be reviewed by the committee if they involve adding human stem cells to nonvertebrate animal embryos at any point in development through the gastrulation stage. Second, research proposals will undergo extra scrutiny if they introduce human stem cells into the brains of post-gastrulation mammals other than rodents.3  Whether researchers are interested in improving disease models or testing biologic therapeutics for psychiatric disorders, both of these types of studies can facilitate the advancement of innovative medical research.

In order for one of these types of studies to be approved by the NIH steering committee, scientists at life sciences firms must present clear, well-documented justification for the research. That often means distilling the information from hundreds of documents into a few succinct paragraphs and graphics. With a company-wide quality strategy in place, researchers can be sure that all of the documents they might need to include in an NIH research proposal are properly managed and readily accessible.

In addition to supporting document management, a quality strategy is designed to ensure that, in the preparation of documents like research proposals, the right input materials are used for the right purposes. When scientists choose the highest quality, most persuasive data to include in their proposals and leave out data from less relevant documents, the submitted study will have the highest possible chance of approval from the NIH steering committee.

Remaining In Compliance With New Restrictions on Stem Cell Research

The other major element of the new NIH proposal regulating human-animal chimeras in biomedical research is the tightening of existing restrictions on stem cell research. While current guidelines only prohibit the addition of human cells to primate embryos in the blastocyst stage, the new proposal would ban these studies in all of the earlier stages of embryo development as well. The new limits would also prevent the breeding of all chimeric animals that might have human egg or sperm cells, instead of just animals with pluripotent human stem cells, as is currently the case.

When these new guidelines go into effect, researchers at life sciences companies need to be able to guarantee that all of their experiments adhere to the new regulations. A quality strategy ensures that all materials and samples in a lab are properly managed from the moment they arrive in the lab to their disposal. By cultivating a culture of compliance, the strategy significantly reduces the likelihood that a noncompliant experiment will mistakenly be conducted at any point in the research process.

The Importance of Procedural Consistency in the Lab

According to the NIH, the primary reason that there must be strict regulations on the use of human-animal chimeras in biomedical research is the potential for experiments to have unexpected results that could lead to ethically questionable and even dangerous consequences. Given the sensitive nature of this research, it is critical for labs at life sciences firms to ensure methodological consistency in order to guarantee safety and compliance at every stage of research. By automating research processes wherever possible, a quality strategy can help protect against manual errors or experimental inconsistencies that could have unintended consequences. That way, researchers at life sciences companies can safely use human-animal chimeras to answer fundamental biomedical questions.

The BIOVIA One Quality Solution provides a broad range of strategies that can be used to streamline research and development processes at life sciences firms. As labs adapt to the new NIH guidelines regarding the use of human-animal chimeras in biomedical research, a quality strategy can increase the likelihood that their proposals will be approved and reduce the risk of noncompliance. Contact us today to learn more about how One Quality can revolutionize R&D in your lab.

  1. “NIH to Lift Ban On Research Funds for Part-Human, Part-Animal Embryos,” August 4, 2016,
  2. “Human-Animal Chimera Studies Will Soon Be Allowed In the U.S.,” August 5, 2016,
  3. “NIH to lift moratorium on animal-human chimera research,” August 4, 2016,