Recommendations for the training and qualifications needed of nutrigenomics specialists interacting with healthy volunteers and patients in human nutrigenomics studies

Background and Justification

A rapidly increasing number of nutrigenomic studies involving more and more participants creates a need for experts that are able to explain the complexities of the nutrigenomic research to patients. Good understanding of the aims, methods, risks and benefits of the research is the prerequisite of compliance and long-term participation, that would be mutually satisfactory for healthy volunteers or patients (subjects in such studies) and also for scientists, and which might be expected to gain wide public acceptance. Another relevant area of fast development is a commercial activity of companies offering testing for several genetic risk factors, including some that might relate to nutrient metabolism. The expanding availability of such testing leads to a growing demand from patients for guidance in the selection of these tests and interpretation of their results.
Although the Ethical Guidelines for Nutrigenomic Research, developed recently within NuGO Work Package 6, emphasize that the nutrigenomic specialists interacting with patients be adequately skilled, no further recommendations were formulated regarding the educational requirements or expert competencies of such specialists.
This document is the first attempt to address this problem.


An interaction with a patient in the setting of nutrigenomic research has been defined as any contact with a study participant, including specifically description of the study aims and methods, obtaining informed consent, discussion of possible outcomes and associated risks, as well as disclosure of the results and their interpretation in the context of the patient’s own health and well-being, and possible implications for other family members and reproductive planning. Such contact may occur in a face-to-face setting, by telephone , by letter or through other media such as e-mail.

Process Description and Resources

The literature collected for the development of the Ethical Guidelines for Nutrigenomic Research was re-evaluated to identify information relevant to the training and skills of nutrigenomics specialists having contact with study volunteers. The computerized search of publications referenced in MEDLINE provided additional articles. Common Internet-based search engines were used to identify useful links, of which particular attention should be paid to the Internet sites of the European Society of Human Genetics ( and the EuroGentest Project (, both providing extensive listings of relevant resources. The EuroGentest is an ongoing five-year EU-funded FP6 Network of Excellence project aimed at the harmonization and improvement of genetic services across Europe. The Unit 6 of this project is focused on Patient and Professional Perspectives of Genetic Information/Education in Europe and is specifically relevant to the development of these guidelines.
This first draft of the guidelines for the training and qualifications needed of nutrigenomics specialists interacting with healthy volunteers and patients in human nutrigenomics studies has been proposed as a basis for further consensus discussions within the NuGO community and for peer-review by a panel of external experts.

Limitations of Evidence

The available evidence is limited to a widely heterogeneous collection of documents implemented rather locally, i.e. at a level of a single centre, university, or centre network, or, at best, nation-wide. International or pan-European guidelines are lacking other than general position statements, of which the 25 Recommendations of the European Commission (EC) are representative, and can be considered as a general code of conduct in the procedures involving genetic testing and counseling, and related issues.
It should be emphasized that the vast majority of data regarding educational programmes, training curricula, and competence requirements for interaction with patients in the context of genetic analysis refer to the clinical setting and diagnostic testing for a specific health-related problem (such as establishing a medical diagnosis, or predicting a disease risk). To a large extent, such recommendations have yet to be developed for research work with healthy volunteers which is likely to be a significant component of nutrigenomics research. Although the EC Recommendations distinguish between the implementation of genetic testing in healthcare systems and its use as a research tool, and the EuroGentest recognizes that genetic variation may contribute to common (multifactorial) disorders, testing of complex genetic interactions underlying polygenic conditions or traits is not usually defined as a separate and distinct issue. Accordingly, there are limited data that would help establish, which aspects of the competence required of an expert in clinical genetics are relevant or necessary for specialists communicating complex and probabilistic genetic information (to patients and healthy volunteers) which will be the case in nutrigenomics.
It is important to note that the EuroGentest recognizes different levels of educational needs and accepts that specialists other than clinical geneticists, such as nurses, midwives, or paramedical genetic counselors, may be involved in the process of genetic testing.


  1. Nutrigenomic specialists interacting with patients or healthy volunteers in human nutrigenomics studies are not required to be certified experts in clinical genetics and/or metabolic medicine, but they should have a sufficient understanding of general genetics, of human metabolism of dietary components, as well as design and legal aspects of human studies, including nutritional intervention trials to appreciate the implications for the volunteer of the proposed nutrigenomics study.
  2. Specifically, such specialists should receive training in complex interactions of genetic and environmental factors underlying nutrient processing, including potential impact on the health status of an individual, and predictive value of nutrigenomic tests.
  3. They should understand and be able to explain to volunteers differences between monogenic and polygenic (multifactorial) conditions, and to reassure volunteers if they are concerned about heredity and reproductive planning.
  4. Such nutrigenomics specialists should not provide formal genetic counseling and/or treatment in the clinical or community setting, but where they suspect a possible medical problem (e.g. a clustering of cases within a family), with the permission of the volunteer, they should refer the him/her to an appropriate health care professional.
  5. Such nutrigenomics specialists should not provide formal dietary or metabolic counseling and/or treatment in the clinical or community setting, but where they suspect a possible medical problem, with the permission of the volunteer, they should and refer him/ her to an appropriate health care professional.
  6. Such nutrigenomics specialists should acquire adequate communication skills to enable them to explain the issues in the specific study and to answer volunteers’ questions appropriately.
  7. Such nutrigenomics specialists should be aware of possible ethical, psychological, social, and vocational implications of nutrigenomic research.

Future Research, Education and Collaboration

This initial draft of the guidelines requires further consensus discussions and validation. Considering the rapid progress in nutrigenomics, independent procedures should be established that would ensure a continuous updating process. Once endorsed, these recommendations should help develop core competencies and training curricula for nutrigenomic specialists interacting with healthy volunteers and patients independent of any differences in genetic testing policies between individual EU Member States.
It is recommended that NuGO seeks collaboration with the European Society of Human Genetics, the EuroGentest Network of Excellence, and other relevant organizations to benefit from their experience and to make them aware of specific problems related to the genetic analysis of complex traits in the context of nutrigenomics research.

Please, send comments to:
Marek Bodzioch