PERMASALAHAN INFORMED CONSENT PENELITIAN KESEHATAII

PERMASALAHAN INFORMED CONSENT
PENELITIAN KESEHATAII
Made Agus Nurjana' dan Helda'

ABSTRACT
I

Inforrned consent is consent given by research subjects after he obtained the information
completely. One ofthe most important problems is the lack ofunderstanding of the subject of
the content of the informed consent form caused by the use of inappropriate standards and
language that is not easily understood. Thu,s the existence ofthis paper is expected to minimize
errors due to informed consent of research through literature search sourced eitherfrom the
study materials, books, j ournals, magazines and the Internet.
Formulation of an appropriate informed consent refers to the Nuremberg standard code
(1947), Declaration of Helsinki (1964, revised 2002, 2004, and 2008) and research ethics in
each country. Ytlith the appropriate standardform and simple language, the subject will be
easier to understand and is upected to provide a rational agreement andwithout coercion.
Keywords : Infonned Consent FoFm, Understanding, Health Res earch

PEI\DAIIT]LUAN

Penelitian dan pengembangan
kesehatan adalah kegiatan iLniah yang
dilakukan menurut metode yang sistimatik

untuk menemukan informasi ilmiah

danlatat teknologi yang baru,
membuktikan kebenaran atau

ketidakbenaran hipotesis sehingga dapat
dirumuskan teori atau suatu proses gejala
alam dan/atau sosial di bidang kesehatan,

dan dilanjutkan dengan menguji

peneraparulya untuk tujuan praktis di
bidangkesehatan'.
Manusia sebagai subjek penelitian
sangatlah penting untuk diperhatikan hakhaknya, meskipun intervensi yang
dilal