The 2024 Declaration of Helsinki: Taking Forward Bioethics and Human Rights

August 5 and 26, 2024

Co-organized by:
The Brazilian Society of Bioethics (SBB); International Federation of Associations of Pharmaceutical Physicians and PharmaceuticalMedicine (IFAPP); Clinical Evaluation Inc.; The 129th Pharmaceutical Study Group

Patient and Public Opinions
to the Revisionof the Declaration of Helsinki:
Our Proposals to the WMA
presentation by Yoshiko Saito, breast cancer survivor
Fellow Member of the Japan Association for Bioethics
Slides prepared in collaboration with Prof. Chieko Kurihara,
based on discussions among patients and the public1

Contents
1 Background2 Our Opinion on the WMA’s Draft Documentfor Revising the *Declaration of Helsinki
3 Future perspectives*DoH2

Contents
1 Background2 Our Opinion on the WMA’s Draft Documentfor Revising the Declaration of Helsinki
3 Future perspectives
3Declaration of Helsinki
2020 Establishment of Ji4pe* Working Group*Japanese Institute for Public Engagement

Addressed from physicians
Patients and the generalpublic will read theinformed consent sectionin the form asking toparticipate in medicalresearch.

To physicians
The text is difficult tounderstand,e.g., double-negativephrases…

★Designed by
Noriko Kishi,
CMT Association JAPAN(one of the group members)

OUR WMA Declaration of Helsinki
Addressed frompatients/public

To patients/public

Our WMA Declaration of Helsinki

Let’s re-write the DoH
in our own“plain language”!

1. Reproduction of the DoH under
the permission of WMA and JMA
2. Re-writing/explanation of theDoH in patient/public language
3. Our opinion on the DoH frompatient/public perspectives

OUR WMA Declaration of Helsinki
Addressed frompatients/public

To patients/public

Our WMA Declaration of Helsinki
1. Reproduction of the DoH under
the permission of WMA and JMA
2. Re-writing/explanation of theDoH in patient/public language
3. Our opinion on the DoH frompatient/public perspectives
6

OUR WMA Declaration of Helsinki
Addressed frompatients/public

To patients/public

Our WMA Declaration of Helsinki
1. Reproduction of the DoH under
the permission of WMA and JMA
2. Re-writing/explanation of theDoH in patient/public language
3. Our opinion on the DoH frompatient/public perspectives
7Explanation / Opinions on the DoHby Patients & Public addressed to Patients & Public
Submitting our opinions
in response to WMA’s call for
public consultation
for the revision of the DoH
Establishment ofNEW Bioethics Working Groupof the Ji4pe
Publication of“Our WMA Declaration ofHelsinki” in Japanese8International Norms
The necessity of a shared understanding among members
Let’s deepen our understanding of the foundations of research ethics principles.1/2

WHO Constitution

1946

VSJapanese Constitution §25

Health as a Human Right
UN Universal Declarationof Human Rights
1948

VSJapanese Constitution §13
and other sections

International Norms
The necessity of a shared understanding among members
Let’s deepen our understanding of the foundations of research ethics principles. 2/2

cf. South African Constitution: Right of research participant

UN International Covenantsof Human Rights 1966

VS

Clinical Trials 2017

Equal rights of all the research participants. Not Limited to Medical ResearchInternational standardsof Personal Data Protection Laws
(OECD, EU-GDPR)

VSJapanese Act
of Personal Information Protection

Privacy protection in research ethics principles

Other important principles by the WMA
How about the care?
Research Ethics

Medical Ethics(ModernizedHippocratic Oath)

Declaration of Helsinki Professional Code of Physicians1964, last amended 2013
International Code ofTo be amended 2024
Medical Ethics
1949, last amended 2022

Declaration of Geneva
1948, last amended 2017

Patient Rights in Research and in Medical Care
Patient Rights
Declaration of Lisbon
1981, last revised 2015

Declaration of Patient Safety
2002, revised 2012

Health Databases and Biobanks
Declaration of Taipei
2002, revised 2016

Contents
1 Background2 Our Opinion on the WMA’s Draft Documentfor Revising the Declaration of Helsinki
3 Future perspectives
12

2 Our Opinions on the WMA’s Draft Documentfor Revising the Declaration of Helsinki1) Three Key Points
in the WMA Draft Document
2) Main Opinions We Submitted to the WMA
During the Two Public Consultation13

2 Our Opinions on the WMA’s Draft Documentfor Revising the Declaration of Helsinki
1) Three Key Points
in the WMA Draft Document
2) Main Opinions We Submitted to the WMA
During the Two Public Consultation
14

Three Key Points in the WMA Draft Document❶Simplifying
the language❷Participants
Not Subjects❸Ensuring
Participants protection15

2 Our Opinions on the WMA’s Draft Documentfor Revising the Declaration of Helsinki
1) Three Key Points
in the WMA Draft Document
2) Main Opinions We Submitted to the WMA
During the Two Public Consultation
16

Public Consultations
Prof.Chieko Kurihara

supporting our group discussion

Acknowledgment
Comment preparers

17

Main Points of Our Public Comments Submitted to the WMA 1/2#1 Social Value towards
achieving the SDGs
#2 Finding advocates toprotect the rights andinterests of participants
who can’t consent.
#3 Promoting Shared
Decision Making#4 the fairness of research ethics
committees#5 Patients struggle tounderstand placebo use when
an intervention is already proven.
#6 We believe that post-trial
access should be guaranteed
and included in the informed
consent form.

18

Main Points of Our Public Comments Submitted to the WMA 2/2#7 Comparison with WHO
Broad Informed Consent& Dynamic Consent
the Right to Know
& the Right Now to Know
Open Access & Open Science
https://www.who.int/publications/i/item/9789240041745

19

Contents
1 Background2 Our Opinion on the WMA’s Draft Documentfor Revising the Declaration of Helsinki
3 Future perspectives
20

Future perspectives
Bioethics working group

comprised of patient and public
as one of the working groups of Ji4Pe
1 Develop a patients and public research ethics
statement
2 Publish the 2nd edition of OUR WMA
Declaration of Helsinki

3 Conduct a survey on Patients and publicparticipation regarding a medical care basedon the report from CIOMS

21

http://cont.o.oo7.jp

VISIT the Website!
Clinical evaluation
臨床評価
http://cont.o.oo7.jp

Graphic Recordings by Kanna Yoshikawa

Thank you for your attention!
Acknowledgment: Members of the Bioethics Working Group of Ji4pe

Yoshiko Saito

Yoshikazu Funabashi Keiko Inoue
previous leader

Hiroto Kai

Noriko Kishi

Akemi KugeSpecialThanks toPresidentof Ji4peProf. Chieko
Kurihara
our mentor

Toshie Murakami

Katsura Suzuki Eiko Uchida

Dr. Kyoko Imamura
President, Ji4pe23