| ●Editorial | Mitsuishi T | 4-6 |
| ●CIOMS Guidelines for Biomedical Research | ||
| International Ethical Guidelines for Biomedical Research Involving Human
Subjects Council for International Organizations of Medical Sciences(CIOMS) | (trans. by Mitsuishi T, Kurihara C,Uchiyama Y, Saio T) | 7-74 |
| Explanatory review: Comparing the 1993 CIOMS guidelines for biomedical research involving human subjects with the 2002 guidelines | Mitsuishi T, Kurihara C | 75-82 |
| ●Articles | ||
| The French research participants protection regulations in 2006(2) ―From authorization to completion of research― | Nudeshima J | 83-92 |
| The relationship between human dignity and human rights ―Can we balance human dignity with the conflicting value of human rights, such as academic and research freedom, right to the pursuit of happiness, and/or right to self-determination?― | Mitsuishi T | 93-101 |
| Ethics in research involving children : introduction ―Historical review over ethical dilemma and regulatory development in the world― | Kurihara C | 103-22 |
| ●Material | ||
| Obstacles to Critical Path Research in Japan | Murayama T | 123-5 |
| Innovation･Stagnation Critical Path Opportunities Report U. S. Department of Health and Human Services, Food and Drug Administration | (trans. by Nishikawa A, Murayama T) | 127-54 |
| Innovation･Stagnation Critical Path Opportunities List U. S. Department of Health and Human Services, Food and Drug Administration | (trans. by Murayama T, Yokode M) | 155-78 |
| The JSQA Guideline for GCP Auditing | JSQA, GCP Division, Special Project | 179-201 |
| ●Forum | ||
| Honestly speaking, do you really need Phase-Ⅰ study in drug development? | Itoh K | 203-5 |
| Will the microdose study really succeed in Japan? | Kawakami K | 206-7 |
| ●Instructions for authors [English] | 209-14 | |
| ●Editor's note | Kurihara M | 215 |