L/O/G/O HELP Series IV, 5th Batch 20 - 22 February 2019

Main Theme: HELP Approach to Bioethical Problems in

Health/Medical Research

Informed Consent in Research

Vulnerable & Incapable Person
DR. CB. Kusmaryanto, SCJ
Contents

1 Introduction

2 International Ethical Principles

3 Inormed consent

4 Special protection
 LOGO
Introduction
 Informed consent seharusnya diterjemahkan dengan istilah
Persetujuan Setelah Penjelasan (PSP) dan bukan “Persetujuan
Tindakan Kedokteran” (Permenkes no. 290 tahun 2009 tentang
Persetujuan Tindakan Kedokteran.)
 Informed Consent ialah persetujuan dan sekaligus pemberian
wewenang (otorisasi) yang diberikan secara bebas dan otonom
oleh pasien atau subjek penelitian kepada pelayan kesehatan atau
kepada peneliti untuk dapat dilaksanakan intervensi medis atau
untuk ikut serta dalam sebuah riset setelah mendapatkan
keterangan yg baik, benar dan lengkap.
 LOGO
Introduction
 Informed consent itu merupakan suatu proses:
diberi informasi  mengerti informasi  menyetujui 
memberikan wewenang/otorisasi.
 Unsur-unsur informasinya ada tiga yakni:
Baik menyangkut cara penyampaiannya.
Benar menyangkut isi informasinya.
Lengkap menyangkut kandungan keseluruhan isi informasi
(bdk. Permenkes no. 290 tahun 2008, pasal 7.3)
 Proses Informed Consent
Elemen-elemen penting untuk informed consent
I. Unsur permulaan (prekondisi)
1. Kompetensi untuk mengerti dan memutuskan
2. Kesediaan di dalam membuat keputusan
II. Unsur informasi
3. Pemberian informasi
4. Rekomendasi sebuah perencanaan
5. Pemahaman atas informasi dan rencana (no. 3 - 4)
III. Unsur persetujuan
6. Keputusan atas rencana itu
7. Otorisasi (pemberian wewenang) untuk melakukan rencana
 Vulnerable

 Vulnerability (kerentanan) adalah keadaan yang terpapar

secara tinggi kepada resiko tertentu, yang
dikombinasikan dengan berkurangnya kemampuan
untuk melindungi atau mempertahankan diri melawan
resiko tersebut dan juga melawan konsekuensi
negatifnya.
 International Ethical Principles
Vulnerable and ancapable persons

LOGO
 WMA-Helsinki 2013 no. 19

 Some groups and individuals are particularly vulnerable and

may have an increased likelihood of being wronged or of
incurring additional harm.
 All vulnerable groups and individuals should receive
specifically considered protection.
 WMA-Helsinki 2013 no. 20

 Medical research with a vulnerable group is only justified if

the research is responsive to the health needs or priorities
of this group and the research cannot be carried out in a
non-vulnerable group. In addition, this group should stand
to benefit from the knowledge, practices or interventions
that result from the research.
 CIOMS 2016 Guideline No. 15

„ When vulnerable individuals and groups are considered for

recruitment in research, researchers and research ethics committees
must ensure that specific protections are in place to safeguard the
rights and welfare of these individuals and groups in the conduct of
the research.
 CIOMS 2016 Guideline No. 16
„ Adults who are not capable of giving informed consent must be
included in health-related research unless a good scientific reason
justifies their exclusion. As adults who are not capable of giving
informed consent have distinctive physiologies and health needs,
they merit special consideration by researchers and research ethics
committees. At the same time, they may not be able to protect their
own interests due to their lack of capacity to provide informed
consent. Specific protections to safeguard the rights and welfare of
these persons in research are therefore necessary.
 CIOMS 2016 Guideline No. 16
 Before undertaking research with adults who are not capable of giving
informed consent, the researcher and the research ethics committee must
ensure that:
 a legally authorized representative of the person who is incapable of
giving informed consent has given permission and this permission
takes account of the participant’s previously formed preferences and
values (if any); and
 the assent of the subject has been obtained to the extent of that
person’s capacity, after having been provided with adequate
information about the research at the level of the subject’s capacity for
understanding this information.
 CIOMS 2016 Guideline No. 16
„ If participants become capable of giving informed consent during
the research, their consent to continued participation must be
obtained.
„ In general, a potential participant’s refusal to enrol in the research
must be respected, unless, in exceptional circumstances, research
participation is considered the best available medical option for an
individual who is incapable of giving informed consent.
„ If participants have made advance directives for participation in
research while fully capable of giving informed consent, the
directives should be respected.
 CIOMS 2016 Guideline No. 16
„ For research interventions or procedures that have the potential to benefit
adults who are incapable of giving informed consent, the risks must be
minimized and outweighed by the prospect of potential individual benefit.
For research interventions or procedures that have no potential individual
benefits for participants, two conditions apply:
‟ the interventions and procedures should be studied first in persons who
can give consent when these interventions and procedures target
conditions that affect persons who are not capable of giving informed
consent as well as those who are capable, unless the necessary data
cannot be obtained without participation of persons who are incapable
of giving ic;
 CIOMS 2016 Guideline No. 16

‟ the risks must be minimized and no more than minimal.

„ When the social value of the studies with such research interventions
and procedures is compelling, and these studies cannot be conducted
in persons who can give informed consent, a research ethics
committee may permit a minor increase above minimal risk.
 LOGO
Special Protection CIOMS 2016

 Special protections for these groups can include:

 allowing no more than minimal risks for procedures that offer
no potential individual benefits for participants;
 supplementing the participant’s agreement by the permission of
family members, legal guardians, or other appropriate
representatives;
 or requiring that the research be carried out only when it is
targeted at conditions that affect these groups.
 LOGO
Special Protection CIOMS 2016

 Safeguards can be designed to promote voluntary decision-

making, limit the potential for confidentiality breaches, and
otherwise work to protect the interests of those at increased
risk of harm.
 Research ethics committees need to be sensitive to not
overly excluding people, and allow them to participate by
requiring that special protections be put in place.
 LOGO
Special Protection
 Dalam mendapatkan IC, bukan pertama-tama kalau sudah
ditandatangani dan oleh karena dengan demikian maka syah.
Peneliti perlu melihat, apakah membahayakan hak-hak dan walfare
(kesejahteraan) bagi subjek penelitian yang vulnerable itu.
 Ketika penelitian sedang berlangsung, dan peneliti melihat resiko
yang membahayakan hak-hak dan kesejahteraannya, maka
parrtisipasi subjek penelitian harus dihentikan walaupun subjek
masih igin melanjutkan
 Final step
„ Consent is an ongoing process
„ Reassess vulnerability and take steps to protect subjects
„ Reassess capacity
 Final Steps
„ Ethical research is guided by the principles of justice,
respect for persons, and beneficence. Vulnerable subjects
should be included but also deserve special protections.
Think carefully about the populations you plan to include in
your research and take steps to ensure their rights and
welfare are protected.
L/O/G/O

Thank You!