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NeuroTech Guidebook vol.2 

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NeuroTech Guidebook vol.1
　 　*Revision History

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NeuroTech Evidencebook

CONTENTS

<a id="project_en"></a>Towards the Establishment of Trusted Neurotechnology

<a id="workshop"></a>Public Workshop

“Toward the Realization of Trusted NeuroTech/BMI”

October 3, 2022
NeuroTech Guidebook Development Committee

Moonshot Goal 1 R&D project, “Liberation from Biological Limitations via Physical, Cognitive and Perceptual Augmentation” (Project Manager: Ryota Kanai, Representative Organization: Advanced Telecommunications Research Institute International, hereinafter referred to as Moonshot Kanai Project) released the “NeuroTech Guidebook ver1.0” (in Japanese) in October 2022.

Shortly after the release of the Guidebook, the workshop for “Trusted NeuroTech / BMI” will be held to discuss issues and solutions necessary for NeuroTech to become a trusted technology from the viewpoint of “What kind of efforts are necessary for new technologies to be trusted by society?”

In this workshop, experts will introduce the state of evidence and industry-academia collaboration, and those involved in business will introduce their actual efforts to build evidence for new technologies and to gain the trust of society. In the panel discussion at the end of the workshop, challenges, and solutions to realize trusted NeuroTech will be discussed.

Outline of the workshop

Date and Time: October 28, 2022 (Friday) 15:00-19:00

Venue:  Business Center Tokyo Station Yaesu Dori, Room 604
　　　　https://abc-kaigishitsu.com/tokyo_yaesudori/yaesudori.html
　　　　Also, provided via zoom webinar

*Advance registration is required. Please register through the form at the bottom of this page.

Program

Click here to register
(in Japanese)

*Please note that all the lectures, including the panel discussion, will be conducted in Japanese.

For inquiries, please contact

NeuroTech Guidebook Development Committee Secretariat
E-mail：info_guideline@brains.link

<span style="color: #000000;"><a id="public_comment"></a>“Draft NeuroTech Guidebook” Call for Public Comment</span>

August 1, 2022
NeuroTech Guidebook Development Committee

Moonshot Goal 1 R&D project, “Liberation from Biological Limitations via Physical, Cognitive and Perceptual Augmentation” (Project Manager: Ryota Kanai, Representative Organization: Advanced Telecommunications Research Institute International, hereinafter referred to as Moonshot Kanai Project) plans to publish a “NeuroTech Guidebook” in September 2022 as part of the project. We have prepared a draft of the Guidebook and would like to invite public comments from experts and the general public from Monday, August 1, 2022, to Saturday, August 20, 2022.

1. Background and Purpose

Health care utilizing the finding of brain science and technology, known as “NeuroTech,” is an emerging market that is expected to grow to US$520 million by 2025. In particular, the market for direct-to-consumer (DTC) products is expanding rapidly, especially in the U.S. and Europe, and their product brochures are full of attractive claims such as “improved concentration,” “improved sleep,” and “improved exercise performance.” However, many questions remain as to whether there is any scientific basis for these effects, and whether there is any risk involved in the general consumer using NeuroTech products on their own.

To answer these questions, Moonshot Kanai Project is working on a “Guidebook” that will provide the accurate knowledge and thoughts that are currently available and how to deal with NeuroTech. The draft of the Guidebook is now ready for public comment and we would like to receive a wide range of opinions from the public.

In parallel with the Guidebook, we are also developing an “Evidence Book” that summarizes the effectiveness and safety of NeuroTech based on the results of systematic reviews. The “Evidence Book” will be released as soon as it is ready.

2. Materials subject to public comment

3. (The call for public comments has been closed.)

After reading the Guidebook, please submit your thoughts, suggestions for improvement, and other comments in the “Comments” section of the public comment submission form. Your comments may be published on our website.

4. Public comments-open period

From Monday, August 1, 2022, to Saturday, August 20, 2022
Comments will be accepted until 23:59 Japan time on August 20, 2022.

5. Notes

The above is a draft Guidebook. Please do not refer to, it because the contents have not been approved. 

6. For inquiries, please contact

NeuroTech Guidebook Development Committee Secretariat
E-mail: info_guideline@brains.link

<strong><a id="coi_policy"></a>Policy on Conflict of Interest (COI) in Moonshot Goal 1 R&D Project “Liberation from Biological Limitations via Physical, Cognitive and Perceptual Augmentation”

</strong>

NeuroTech Guidebook Development Committee

1. What is COI?

A conflict of interest (COI) is a situation where the social responsibility of a professional involved in education and research conflicts with the interests that arise from industry-academia collaborative activities.

COI is broadly classified into financial COI, which is related to financial relationships with specific companies/organizations, acquisition of research funds, etc., and COI other than financial COI such as academic COI (research activities, expertise, etc.) (hereinafter referred to as “academic COI”). In addition, as well as personal COI, the financial and academic COI of universities and other educational institutions, academic societies, and other academic organizations to which members involved in the development of the NeuroTech Guidebook/Evidence Book belong may also affect the creation of the Guidebook/Evidence Book.
(Reference: Minds Clinical Practice Guideline Development Manual 2020)

2. Basic concept of COI and management policy

Under Moonshot Goal 1 R&D project, “Liberation from Biological Limitations via Physical, Cognitive and Perceptual Augmentation” (Project Manager: Ryota Kanai, Representative Organization: Advanced Telecommunications Research Institute International, Inc.), we believe that it is important to understand COI and to define the measures to be taken in cases where COI is present.

For this reason, the COI status of the parties involved will be reported, and COI will be managed appropriately through measures such as the establishment of a review group structure that maintains neutrality and openness in the development of the NeuroTech Guidebook/Evidence Book. This will ensure that the contents of the NeuroTech Guidebook/Evidence Book are appropriate and lead to the gain of trust in the use of NeuroTech by society.

3. Management of COI

The Committee will manage COI as follows.

• Not only financial COI but also academic COI will be reported.
• COI management policy is decided by the members of the NeuroTech Guidebook Development Committee prior to the preparation of the NeuroTech Guidebook/Evidence Book.
• Disclose the COI management policy on the NeuroTech Guidebook/Evidence Book.
• The COI management policy will be disclosed upon the publication of the NeuroTech Guidebook/Evidence Book.
  (Reference: Minds Clinical Practice Guideline Development Manual 2020)

4. Persons and activities subject to COI reporting

The following persons subject to COI reporting are obliged to disclose whether or not they have any COI during the three years preceding their appointment. Each year, they are required to submit a self-report on COI if there is any COI that meets the criteria specified below about the existence of COI during the previous year. In addition, if it is found that there is a correction in the content of a previous self-report, the obligation is to promptly file an amended report after notifying the secretariat.

１）Persons subject to reporting

• Member of NeuroTech Guidebook Development Committee
• Member of the NeuroTech Evidence Evaluation Committee
• Member of the systematic review team
• Members of the Secretariat and External Evaluation Committee
• Family members of the above (spouse and first-degree relatives)

２）Reporting criteria

[Financial COI]

1. Amount of remuneration as a director or advisor of a company, corporate organizations, and for-profit organizations related to the research: 1,000,000 yen or more per year from one company, organization, or association.
2. Profit from stock: Profit from stock (sum of dividends and gains on sale) of 1,000,000 yen or more per year from a single company, or those owning 5% or more of all such shares.
3. Patent royalties: The amount of royalty from patent royalties is 1,000,000 yen or more per year from a company, organization, or association.
4. Per diem (honoraria, lecture fees, etc.): A total of 500,000 yen or more per year from a single company/organization.
5. Manuscript fees: A total of 500,000 yen or more per year from one company/organization.
6. Research funds, grants, etc.: Research funds/grants for medical/healthcare research (contracted research, joint research, clinical trials, etc.) from a single company or for-profit corporate organization or group. The amount allocated is 1,000,000 yen or more per year.
7. Scholarship (incentive) donation, etc.: Donations of 1,000,000 yen or more per year from a single company, organization, or group to an individual member or a course, division, or laboratory to which the member belongs.
8. Endowed courses offered by companies, etc.: Report only if the member belongs to the company.
9. Others (e.g., travel expenses, gifts, etc.): 50,000 yen or more per year from a single company, organization, or association.

[Academic COI]

1. Citation of his/her academic paper in a systematic review of the review question (RQ) for which he/she is in charge.
2. Family relationship with another member of the committee.
3. Close master-disciple relationship or direct employment relationship with another member of the committee.
4. Endowed courses related to Neurotech provided by an organization, which is a corporation or a for-profit corporation at the same department, major, etc. of a university, national research institute, or other research organization or company to which the member belongs.
5. Not applicable to the above, but there is a possible conflict of interest.
6. The above does not apply, nor is there a conflict of interest.

*The “same department, major, etc.” in the above refers to a group of one level above the smallest research unit, such as a laboratory or research team.

Partially revised on October 10, 2022

For inquiries, please contact

NeuroTech Guidebook Development Committee Secretariat
E-mail: info_guideline@brains.link

<a id="prospectus"></a>[Prospectus] Notice of Establishment and Start of Activities of the NeuroTech Guidebook Development Committee

Ryota Kanai

Project Manager, Moonshot Goal 1 R&D Project
“Liberation from Biological Limitations via Physical, Cognitive and Perceptual Augmentation”

Edition 1, July 30, 2021

“NeuroTech” is an emerging market that will grow to US$520 million by 2025. Whether it is for comfortable sleep, efficient learning, easing mood swings, or stress management, NeuroTech is expected to become more accessible and used by the general public in the future.

On the other hand, NeuroTech is still a developing market, so there are many questions to be answered, such as “for whom and how well does it work? (Efficacy)” and “Are there any side effects? (Safety)”

Therefore, to summarize what is currently known by science in an easy-to-understand manner and to provide a Guidebook for use based on this evidence, the Moonshot Project “Liberation from Biological Limitations via Physical, Cognitive and Perceptual Augmentation” has established NeuroTech Guidebook Development Committee and started its activities.

These efforts will not only encourage consumers to use NeuroTech appropriately but also encourage NeuroTech manufacturers and scientists to develop and build evidence appropriately.

For NeuroTech to be supported by society and recognized as a trusted technology, we will develop the NeuroTech Guidebook and disseminate it the society.