Opinions and Recommendations regarding Ethical Issues in Medical Research and Research Presentations

Dear Members,

In recent years, the development of new medical research fields has required those engaged in research, medical care, and medical education to respond ethically as necessary for their respective positions. The Japanese Society for Clinical Nutrition and Metabolism has decided to draw the attention of its members to the following ethical issues concerning the future submission of papers to this Society and the presentation of medical research at academic meetings, and to deepen their understanding of bioethical issues. In all medical research, due consideration should be given to the rights of patients, as well as the ethics of the research itself.

Members of this Society are requested to give due consideration to ethical issues related to the protection of patient privacy and informed consent, especially when conducting medical research involving human subjects.

With respect to ethical issues in medical research presentations, one of the following conditions must be met.

A. Research involving human subjects:

1. Human genome/genetic research in compliance with the provisions outlined in Japanese “Ethical Guidelines for Human Genome/Gene Analysis Research”.
(Ministry of Education, Culture, Sports, Science and Technology, Ministry of Health, Labour and Welfare, and Ministry of Economy, Trade and Industry)
(Amended in full on December 28, 2004, amended in part on June 29, 2005, and amended in part on December 1, 2008)

2. Research other than that listed above that requires the approval of the Ethics Review Committee of the respective institution, and that has received such approval

3. Research that does not require the approval of an Ethics Review Committee, but adheres to the spirit of the Declaration of Helsinki (substantially revised in 2008) (with the exception of Articles 15, 25, and 29)

B. Research involving animal subjects:
Research approved by the Review Committee on Animal Experiments

C. Research involving non-human and/or non-animal subjects:
Bioethics in the broadest sense must be considered.

D. Research Ethics and Misconduct
Overall understanding of research ethics, and exercising due care to avoid misconduct

Comments:
In this section, medical research is divided into two categories: research involving human subjects (including research on human material that could be used to identify an individual and data that could be used to identify an individual) and research involving non-human subjects. In addition, research involving human subjects is divided into two further categories: “human genome and genetic research” and “other research”.

A. Research involving human subjects:

1. Human genome/genetic research is governed by the “Ethical Guidelines for Human Genome/Gene Analysis Research” (Ministry of Education, Culture, Sports, Science and Technology, Ministry of Health, Labor and Welfare, and Ministry of Economy, Trade and Industry) (amended in full on December 28, 2004, amended in part on June 29, 2005, and amended in part on December 1, 2008) (http://www.lifescience.mext.go.jp/files/pdf/40_126.pdf). These guidelines must be carefully read, understood, and complied with. In this case, approval by the Ethics Review Committee at the relevant institution is required. As a transitional issue at this time, for research completed before these guidelines were issued, please follow “Detailed Regulation 1 (Detailed Regulation Regarding Research Before Enforcement of These Guidelines): Although these guidelines do not apply to human genome/gene analysis research that was initiated before these guidelines came into effect and is currently being conducted, it is recommended that such research be conducted appropriately in accordance with these guidelines to the extent possible”.

2. In principle, approval by the Ethics Review Committee of the relevant institution is required for “other research” in accordance with the “Ethical Guidelines for Clinical Research” (Ministry of Health, Labour and Welfare) (amended in full on December 28, 2004, amended in part on July 31, 2008) (presented as 2.) In addition, epidemiological research is governed by the “Ethical Guidelines for Epidemiological Research” (Ministry of Education, Culture, Sports, Science and Technology, Ministry of Health, Labour and Welfare) (amended in full on August 16, 2007, amended in part on December 1, 2008). These guidelines must be carefully read, understood, and complied with. In some cases, such as “demographic research” and “case studies (including case reports)” of cases conducted for the purpose of treatment with informed consent, review by an Ethics Review Committee might not be required*. However, even in such instances, the spirit of the World Medical Association Declaration of Helsinki (substantially revised in October 2008; see the Japan Medical Association website) must be given due consideration (with the exception of Articles 15, 25, and 29, which require the submission of the experimental protocol to an Ethics Review Committee) (presented as 3.). For case reports, please comply with the “Guidelines for Protecting Patient Privacy regarding Case Reports” (Council of Surgical Associations).

*: We believe that case studies (research presentations based on the summary of cases) and case reports are generally reports on the results of practical medical care, and are not included in the “medical research involving human subjects” covered by the Declaration of Helsinki.

B. Research involving animal subjects:

1. In the case of medical research involving animal subjects, approval by the Review Committee at the relevant institution is required, and the “Guidelines for Proper Conduct of Animal Experiments” (Science Council of Japan, June 1, 2006) must be observed.

C. Research involving non-human and/or non-animal subjects:

1. Although some areas of medical engineering and some areas of research on organisms other than animals do not require consideration of ethical issues, due consideration must be given to bioethics in a broad sense (including issues regarding chemical weapons production, global environmental issues, etc.).

D. Research Ethics and Misconduct

The basis of the code of conduct for scientists is an understanding of comprehensive research ethics, including an evaluation of safety and the impact of research activities on people, society, and nature. Regarding research activities and the publication of results, we will pay due attention to avoiding not only fabrication (creation of data that does not exist), falsification (alteration or falsification of data), and plagiarism (use of another person’s ideas, data, or research results without proper citation), but also inappropriate authorship, duplicate publication, inadequate or improper citation, improper management of safety in the research process, incorrect processing and management of experimental materials, and errors in information management.

February 25, 2010
The Japanese Society for Clinical Nutrition and Metabolism