News

News

We submitted comment for the proposed amendment to ethical research guidelines during the period of public comment.

The period for public comment on the proposed amendment to ethical research guidelines began 2016.9.22 and lasted until 2016.10.21.

Ethical guidelines for medical research involving humans (medical guidelines)

http://search.e-gov.go.jp/servlet/Public?CLASSNAME=PCMMSTDETAIL&id=495160181&Mode=0

Ethical guidelines for human genome and genetic analysis research (human genome guidelines)

http://search.e-gov.go.jp/servlet/Public?CLASSNAME=PCMMSTDETAIL&id=595116073&Mode=0

Guidelines for clinical research including genetic treatment

http://search.e-gov.go.jp/servlet/Public?CLASSNAME=PCMMSTDETAIL&id=495160180&Mode=0

The GS Unit has submitted comment for both medical guidelines and for human genome guidelines proposals, the contents of which can be viewed here:[LINK]

The primary goal of this amendment to the guidelines is to adapt them to the recently amended Japan’s Protection of Personal Information Act, which pertains to civil law, private incorporated administrative law, and administrative organ law. Some kinds of personal genome information and personal clinical information have been included in the newly-introduced categories of individual identification code information and information requiring special care. We are still waiting on the finalized guidelines from the Committee for Protection of Personal Information for more detailed definitions of the kinds of information that will be included in these categories. Once the finalized guidelines have been published we will announce the details here on our website. For the committee guidelines, please see the link below. Public comment is still ongoing.

The public comment page for the proposed guidelines concerning Protection of Personal Information Act (general rules, providing information to third parties in foreign countries, confirmation and record keeping when providing information to third parties, and anonymization):

http://search.e-gov.go.jp/servlet/Public?CLASSNAME=PCMMSTDETAIL&id=240000025&Mode=0