No Med Reg :

Nama Lengkap :
Tgl Lahir :
PERSETUJUAN BERPARTISIPASI DALAM
Jenis Kelamin :
PENELITIAN KLINIS
(Mohon diisi atau tempelkan stiker jika ada)
Ruangan :

Saya yang bertanda tangan dibawah ini :

I Who Undersigned thi consent below :
Nama : Umur : tahun Jenis Kelamin : laki-laki (Male)
Name : Age : years Sex : Perempuan (Female)
Alamat : Bukti diri : KTP/SIM/Passport No :
Address : Proof of Identity : KTP/SIM/Passport No :
Telah mendapatkan penjelasan dari peneliti yang akan dilakukan terhadap :
I’ve received information about the study that will be conducted on :
Diri saya / Anak / Istri / Suami / Ayah / Ibu ……………………………… Saya Nama :
Of myself/Child/Wife/Husband/Father/Mother ……………………………….my Name :
Umur : tahun Jenis Kelamin : laki-laki (Male) No RM :
Age : years Sex : Perempuan (Female) Medical record No :
Tentang (on) :
1. Tujuan penelitian (study objectives)
………………………………………………………………………………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………………………………………………………………………………
2. Manfaat penelitian (study benefits)
……………………………………………………………………………………………………………………………………………………………………………………………..
……………………………………………………………………………………………………………………………………………………………………………………………..
……………………………………………………………………………………………………………………………………………………………………………………………..
3. Prosedur penelitian (study procedure)
…………………………………………………………………………………………………………………………………………………………………………………………….
…………………………………………………………………………………………………………………………………………………………………………………………….
…………………………………………………………………………………………………………………………………………………………………………………………….
4. Perkiraan jumlah subjek yang akan diikutsertakan dalam penelitian (estimated number of subjects to be include in the study)
…………………………………………………………………………………………………………………………………………………………………………………………….
…………………………………………………………………………………………………………………………………………………………………………………………….
…………………………………………………………………………………………………………………………………………………………………………………………….
5. Prosedur alternative (alternative procedure)
…………………………………………………………………………………………………………………………………………………………………………………………….
…………………………………………………………………………………………………………………………………………………………………………………………….
…………………………………………………………………………………………………………………………………………………………………………………………….
6. Kesukarelaan berpatisipasi (voluntary, no corection on recruitment)
…………………………………………………………………………………………………………………………………………………………………………………………….
…………………………………………………………………………………………………………………………………………………………………………………………….
…………………………………………………………………………………………………………………………………………………………………………………………….
7. Resiko penelitian dan ketidaknyamanan (potentian risk and discomport)
……………………………………………………………………………………………………………………………………………………………………………………………..
 ……………………………………………………………………………………………………………………………………………………………………………………………..
……………………………………………………………………………………………………………………………………………………………………………………………..

RSMH Palembang

8. Perlindungan terhadap efek samping penelitian (prevision for medical/psychososial support and treatmen for study related
injuries)
………………………………………………………………………………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………………………………………………………………………………
9. Menjaga privasi dan kerahasiaan (privacy and confidentiality)
……………………………………………………………………………………………………………………………………………………………………………………………..
……………………………………………………………………………………………………………………………………………………………………………………………..
……………………………………………………………………………………………………………………………………………………………………………………………..
10. Hak subyek untuk mengundurkan diri dari penelitian (righ of withdraw from the study)
…………………………………………………………………………………………………………………………………………………………………………………………….
…………………………………………………………………………………………………………………………………………………………………………………………….
…………………………………………………………………………………………………………………………………………………………………………………………….
11. Insentif bagi subyek (bila ada) (incentive for subject (if any)
…………………………………………………………………………………………………………………………………………………………………………………………….
…………………………………………………………………………………………………………………………………………………………………………………………….
…………………………………………………………………………………………………………………………………………………………………………………………….
12. Bila menolak/membatalkan untuk berpatisipasi, akses terhadap pelayanan akan dijamin tidak berpengaruh atau terganggu
(refucel or concellation of participation will not influence the right for optimal medical care)
…………………………………………………………………………………………………………………………………………………………………………………………….
…………………………………………………………………………………………………………………………………………………………………………………………….
…………………………………………………………………………………………………………………………………………………………………………………………….
13. Nama alamat dan kontak penelitian yang bisa dihubungi bila terjadi kecelakaan atau subyek ingin bertanya (contact person
(s) for participant)
…………………………………………………………………………………………………………………………………………………………………………………………….
…………………………………………………………………………………………………………………………………………………………………………………………….
…………………………………………………………………………………………………………………………………………………………………………………………….

Palembang,
Yang membuat pernyataan Peneliti/Dokter Saksi
Consignee (Investigator/dokter)

(………………………………………) (…………………………………..) (……………………………………..)

 Tanda tangan dan nama lengkap Tanda tangan dan nama lengkap Tanda tangan dan nama lengkap
Signature and full name Signature and full name Signature and full name

Saya sudah mendapatkan kesempatan untuk bertanya dan saya sudah mengerti dan puas dengan penjelasan yang diberikan
sehubungan pertanyaan-pertanyaan saya. Dengan ini saya menyatakan dengan sesungguhnya bahwa saya menyetujui diri
saya/anak/istri/suami/ayah/ibu …………………………………….. saya untuk ikut berpartisipasi dalam penelitian.
I’ve had the opportunity to ask and are satisfied with the explanation given in connection with my question. I have already
understood and I hereby declare that a AGREE for my self/child/wife/husband/father/mother my ………………………………………..to
participate in the study

Demikianlah persetujuan ini sya buat dengan penuh kesadaran dan tanpa paksaan
This agreement is made in full awareness and whitouth any coercion

Palembang,
Yang membuat pernyataan Peneliti/Dokter Saksi
Consignee (Investigator/dokter)

(………………………………………) (…………………………………..) (……………………………………..)

Tanda tangan dan nama lengkap Tanda tangan dan nama lengkap Tanda tangan dan nama lengkap
Signature and full name Signature and full name Signature and full name