‫عيراق‬-‫حكومةتي هةريَمي كوردستان‬

Kurdistan Regional Government-Iraq

‫سةرؤكايةتي ئةنجومةني وةزيران‬
Council of Ministers
‫وةزارةتي خويَندني باآل و تويَذينةوةي‬
Ministry of Higher Education &
‫زانستي‬
Scientific Research
‫ثسثؤرية‬
ِ ‫بؤ‬ ‫كوردستان‬ ‫ئةنجومةني‬
Kurdistan Board of Medical Specialties
‫ثزيشكيةكان‬
Research Protocol Ethics Committee
‫ليذنةى نةريتى تويَذينةوةي ثزيشكى‬

Research Protocol Form "Approval Requirements"

Dear KBMS Trainee:

This document is prepared to facilitate the process of approval on your research protocol. Kindly
read below instructions carefully in order to guide you to the basic requirements necessary for
approval by researchprotocol ethics committee:
1. This document composed of three sections and 11 pages, section (I) request letter, section (II)
research protocol scientific form, section (III) research protocol ethics form.
2. Section (I) has to be prepared by the trainee, section (II) should be signed by all three
members of the research protocol scientific committee; the establishment of aforementioned
committee is the responsibility of the head of training center ( the research protocol
scientific committee should composed of head of the training center, supervisor of the
research, and the third member has to be nominated by the head of the training center) , lack
of any signature means not eligible for the next step, thensection (III),research protocol ethics
committee will review all the documents to decide the eligibility of the documents for the
process of approval. The trainee should comply with aforementioned steps to avoid any delay
on the process of approval on research protocol.
3. This document should be attached with below mentioned papers; otherwise the document
will not be revised by the research protocol ethics committee.
a) Acopyof consent form prepared by the trainee;if applicable.
b) KBMS official letter on appointing of the supervisor for the trainee and the title of his/her
research title.The name of the supervisor and trainee in both request letter by the trainee
(section I) and KBMS official letter should match.
4. Upon fulfillment of all above requested documents and conduction of the meeting by
research protocol ethics committee; feedback on your request will be shared with you soon
via SMS and KBMS website.

Page 1 of 12
 ‫حكومةتي هةريَمي كوردستان‪-‬عيراق‬
‫‪Kurdistan Regional Government-Iraq‬‬
‫سةرؤكايةتي ئةنجومةني وةزيران‬
‫‪Council of Ministers‬‬
‫وةزارةتي خويَندني باآل و تويَذينةوةي‬
‫& ‪Ministry of Higher Education‬‬
‫زانستي‬
‫‪Scientific Research‬‬
‫ثسثؤرية‬
‫ِ‬ ‫بؤ‬ ‫كوردستان‬ ‫ئةنجومةني‬
‫‪Kurdistan Board of Medical Specialties‬‬
‫ثزيشكيةكان‬
‫‪Research Protocol Ethics Committee‬‬
‫ليذنةى نةريتى تويَذينةوةي ثزيشكى‬

‫)‪SECTION (I‬‬

‫بؤ ‪ /‬ليذنةى نةريتى تويَذينةوةى ثزيشكى‬

‫‪/‬ليذنةىزانستى تويَذينةوةى‪ D‬ثزيشكى‬
‫كولَى تويَذينةوة‬
‫تو َ‬
‫ثرو َ‬
‫بابةت‪ /‬ثةسةندكردنى َ‬

‫سالَو ِ‬
‫وريَز_‪/‬‬
‫بو ثسث َو ِرية ثزيشكيةكانكة تايبةتة بة دةستنيشان كردنى‬
‫هاوثيَض فةرمانى_ كارطيَ ِرى ئةنجومةنى كوردستان َ‬
‫سةرثةرشتيارى_ تويَذينةوةم_ ذمارة (‪ )2081‬لة بةروارى_ (‪ .)2019 12\\4‬داوا لة بةريَزتان دةكةم‬
‫كولَى تويَذينةوةكةمبة ناونيشان‬
‫ثروتو َ‬
‫َ‬ ‫رةزامةندى بفةرموون بؤ ثةسةندكردنى_‬
‫‪Factors affecting the outcome of ureteroscopy in the management of ureteral stones in children:‬‬
‫‪.A single center experience‬‬

‫لةطة َل ِريَزم_‬

‫واذوو‪:‬‬

‫بةروار‪/ 3/ 2021 24:‬‬ ‫ناوي سيانى ِراهيَنراو‪ :‬ديراو سعيد عتمان‬

‫‪Page 2 of 12‬‬
 ‫عيراق‬-‫حكومةتي هةريَمي كوردستان‬
Kurdistan Regional Government-Iraq
‫سةرؤكايةتي ئةنجومةني وةزيران‬
Council of Ministers
‫وةزارةتي خويَندني باآل و تويَذينةوةي‬
Ministry of Higher Education &
‫زانستي‬
Scientific Research
‫ثسثؤرية‬
ِ ‫بؤ‬ ‫كوردستان‬ ‫ئةنجومةني‬
Kurdistan Board of Medical Specialties
‫ثزيشكيةكان‬
Research Protocol Ethics Committee
‫ليذنةى نةريتى تويَذينةوةي ثزيشكى‬
SECTION (II)
RESEARCH PROTOCOL SCENTIFIC FORM

Research Title:Factors affecting the outcome of ureteroscopy in the management of

.ureteral stones in children: A single center experience

1.Principle Investigator:
a.‫ ديراو سعيد عتمان‬:)‫كوردى‬ ‫ناوى سيانى (بة‬
b. Full name (in English): Deraw Saeid Othman

c. )‫ثسث َو ِرى (بة كوردى‬: ‫ ئه نجومه نى بوردى‬: )‫ناوى ئةنجومةن (بة كوردى‬
‫كوردستانى‬
‫نه شته ركه رى كورجيله و ميزو ميزه رو‬

d. Specialty (in English): Name of council of clinical specialty:

Urology Kurdistan board for medical speciality

e. Training center: Kurdistan board for medical speciality_Sulaymaniah

f. Full Address: Phone no.:+9647703521611 Email:dr.deraw79@yahoo.com

g. Qualification (‫بروانامة‬
ِ ):M.B.CH.B - HD (Urology)

h. Affiliation(‫)ميالك‬: ☐Ministry of Health ☐ Ministry of Higher Education & Scientific Research

☐ Ministry of Peshmarga ☐ others, please identify ----------------------------

Page 3 of 12
 ‫عيراق‬-‫حكومةتي هةريَمي كوردستان‬
Kurdistan Regional Government-Iraq
‫سةرؤكايةتي ئةنجومةني وةزيران‬
Council of Ministers
‫وةزارةتي خويَندني باآل و تويَذينةوةي‬
Ministry of Higher Education &
‫زانستي‬
Scientific Research
‫ثسثؤرية‬
ِ ‫بؤ‬ ‫كوردستان‬ ‫ئةنجومةني‬
Kurdistan Board of Medical Specialties
2.Research
Co-investigators (if applicable) (mention name, qualification,‫ثزيشكيةكان‬
Protocol Ethics Committee
‫ليذنةى نةريتى تويَذينةوةي ثزيشكى‬
and affiliation of each):

3.Research Supervisor:
a.‫ئاسو عمر رشيد‬.‫ د‬:)‫كوردى‬ ‫ناوى سيانى (بة‬
b. Full name (in English):Aso Omer Rashid

c.‫نه شته ركه رى كورجيله و ميزو ميزه رو‬ :)‫ثسثو ِرى (بة كوردى‬
َ

d. Specialty (in English): Urology

e. Training center: Kurdistan board for medical speciality_Sulaymaniah

f. Full Address: Phone no.:+9647701990616 Email:

g. Qualification (‫بروانامة‬
ِ ): Board degree in Urology
h. Affiliation(‫)ميالك‬: ☐Ministry of Health ☐ Ministry of Higher Education & Scientific Research

☐ Ministry of Peshmarga ☐ others, please identify ----------------------------

4.Research Co- Supervisor (if applicable):

a.)‫كوردى‬ ‫ناوى سيانى (بة‬: b. Full name (in English):

c.)‫كوردى‬ ‫ثسث َو ِرى (بة‬: d. Specialty (in English):

5.Introduction:
Page 4 of 12
a.Aim (s) of the study(The aim of the ‫عيراق‬-‫كوردستان‬
study,  i.e. the overall‫هةريَمي‬purpose
‫حكومةتي‬
Kurdistan Regional Government-Iraq
‫سةرؤكايةتي ئةنجومةني وةزيران‬
ofCouncil
the study, should be clearly and
of Ministers concisely defined. The aims
‫وةزارةتي خويَندني باآل و تويَذينةوةي‬
are broad statements
Ministry of desired&outcomes,
of Higher Education or the general intentions of the
‫زانستي‬
Scientific Research
research, emphasize what is to be accomplished
‫ثسثؤرية‬
ِ ‫(بؤ‬not how‫ئةنجومةني‬
‫كوردستان‬ it is to
beKurdistan Board of Medical
accomplished)and Specialties
address the long- term project
‫ثزيشكيةكان‬
Research Protocol
outcomes, i.e. they Ethics Committee
should reflect expectations of the research
‫ذينةوةي ثزيشكى‬ َ‫نةريتى توي‬ ‫ليذنةى‬
topic):

To identify the factors involved in outcomes in term of stone free rate and post-operative
.complications of ureteroscopy ( in the treatment of ureteric stones in children

b.Specific objectives of the study (Are the steps you are going to take to answer your research
questions or a specific list of tasks needed to accomplish the goals of the project) :
c.

Efficacy of ureteroscopy in ureter in children and predictors factors involved in outcomes of

the procedure .

6.Patients / Subjects/ Materials and methods of study:

a. Study design: Cohort study, SPSS-21

b. Study duration: 2 years

c. Study setting (place of the study, city, governorate): Sulaimanyah Teaching hospital,
Shar Teaching Hospital.

Page 5 of 12
 ‫عيراق‬-‫حكومةتي هةريَمي كوردستان‬
Kurdistan Regional Government-Iraq
‫سةرؤكايةتي ئةنجومةني وةزيران‬
Council of Ministers
‫وةزارةتي خويَندني باآل و تويَذينةوةي‬
Ministry of Higher Education &
‫زانستي‬
Scientific Research
‫ثسثؤرية‬
ِ ‫بؤ‬ ‫كوردستان‬ ‫ئةنجومةني‬
Kurdistan Board of Medical Specialties
‫ثزيشكيةكان‬
Research Protocolmethod
d. Sampling Ethics Committee
and sample size: 50 cases
‫ثزيشكى‬ ‫ليذنةى نةريتى تويَذينةوةي‬

e. Inclusion criteria:
1.children under age of 12 years. Of both gender
2.Failure of conservative management including (persistant pain, urosepsis and
fever, progressive hydronephrosis on serial ultrasound or sever hydronephrosis on
presentation).
3- Stone size : 6-15mm
4- Ureteric stone ( Lower, Middle and Upper)
5- Previous ESWL, Operations.

f. Exclusion criteria:
1.stone associated with urinary tract anomaly or a non-functioning kidney.
2. stone> 15mm in size or patient with severe orthopedic deformities.

7.Statistical analysis(Brief description of statistical methods used and the statistical

significance of the findings (when appropriate) giving references to the statistical methods
and defining statistical terms and abbreviations. Computer software and version used
should be specified):
Statistical analysis will be performed using:
The Chi-square or Fisher's exact test.
IBM SPSS-21 Statistics program is used for the analysis of the data.

Page 6 of 12
 ‫عيراق‬-‫حكومةتي هةريَمي كوردستان‬
AKurdistan Regional Government-Iraq
P-value of is considered statistically significant
‫وةزيران‬ ‫سةرؤكايةتي ئةنجومةني‬
Council of Ministers
‫وةزارةتي خويَندني باآل و تويَذينةوةي‬
Ministry of Higher Education &
‫زانستي‬
Scientific Research
‫ثسثؤرية‬
ِ ‫بؤ‬ ‫كوردستان‬ ‫ئةنجومةني‬
Kurdistan Board of Medical Specialties
‫ثزيشكيةكان‬
Research Protocol Ethics Committee
‫ليذنةى نةريتى تويَذينةوةي ثزيشكى‬
8.Date of Research Protocol Presentation (Day/month/year):

APPROVAL OF RESEARCH PROTOCOL SCIENTIFIC COMMITTEE

(Note: this section should be filled by the Research protocol scientific committee members.The
establishment of aforementioned committee is the responsibility of the head of training center
( the research protocol scientific committee should include head of the training center,
supervisor of the research, and the third member has to be nominated by the head of the
training center). If the following information and signatures missed from the form; then the
research protocol considered not approved byResearch protocol scientific committee. Hence;
not fulfills the requirement of submission to Research Protocol EthicsCommittee.).
1. Member (should be the supervisor of theResearch Protocol):

Full name : Aso Omer Rashid

Signature:
Date (day/month/year):

2. Member:

Full name :
Signature:
Date (day/month/year):

3. Head of Research Protocol Scientific Committee:

Full name : Signature:

Page 7 of 12
 Date (day/month/year): ‫عيراق‬-‫حكومةتي هةريَمي كوردستان‬
Kurdistan Regional Government-Iraq
‫سةرؤكايةتي ئةنجومةني وةزيران‬
Council of Ministers
‫وةزارةتي خويَندني باآل و تويَذينةوةي‬
Ministry of Higher Education &
‫زانستي‬
Scientific Research
‫ثسثؤرية‬
ِ ‫بؤ‬ ‫كوردستان‬ ‫ئةنجومةني‬
Kurdistan Board of Medical Specialties
‫ثزيشكيةكان‬
Research Protocol Ethics Committee
‫ليذنةى نةريتى تويَذينةوةي ثزيشكى‬

SECTION (III)
RESEARCH PROTOCOL ETHICS FORM

A. Participants informed consent:

1. Will informed written consent be obtained? ☐Yes ☐No
2. If yes, please:
a. Outline the consent process in full. (How will consent be obtained, when, by whom
and from whom etc?)
Consent taken by giving a patients parent a hard copy of informed concent that includes:
outcome of surgery, advantage and disadvantage of surgical option, and explaining the
confidentiality issue, consent taken before management of the patient, consent taken by
investigater (doctor him or, herself) , consent taken directly from patients parents.

b. Attach a copy of the consent form; it should be in a language that the participants
understand.
3. If no, please justify. You must provide a full and detailed explanation as to why informed
consent will not be obtained.

Page 8 of 12
 ‫عيراق‬-‫حكومةتي هةريَمي كوردستان‬
Kurdistan Regional Government-Iraq
‫سةرؤكايةتي ئةنجومةني وةزيران‬
Council of Ministers
4. Willofparticipants
Ministry be informed
Higher Education & of their‫ذينةوةي‬َ‫باآل و توي‬
right to ‫ندني‬refuse
َ‫وةزارةتي خوي‬
to
participate ‫زانستي‬
Scientific Researchand their right to withdraw from this research
study?Board
☐Yes ☐No Specialties ‫ثسثؤرية‬
ِ ‫ئةنجومةني كوردستان بؤ‬
Kurdistan of Medical
‫ثزيشكيةكان‬
Research Protocol Ethics Committee
5. If no, please justify. ‫ليذنةى نةريتى تويَذينةوةي ثزيشكى‬
Because patient under age of 12 years, so his or her parents participate in
research

B. Adult participants capacity (aged 18 y or over):

1. Will all adult research participants have the capacity to give informed consent?
☐Yes ☐No
2. If no, please elaborate.

Patient under age of 12 years

C.
D.
E.
F.
G.
H.
I. Access to health care records:
1. Does the study involve access to healthcare records (hard copy / electronic)?
☐Yes ☐No
2. If yes, please elaborate (how you will access the health care records?).

Page 9 of 12
 ‫عيراق‬-‫حكومةتي هةريَمي كوردستان‬
Kurdistan Regional Government-Iraq
‫سةرؤكايةتي ئةنجومةني وةزيران‬
Council of Ministers
‫وةزارةتي خويَندني باآل و تويَذينةوةي‬
Ministry of Higher Education &
‫زانستي‬
Scientific Research
‫ثسثؤرية‬
ِ ‫بؤ‬ ‫كوردستان‬ ‫ئةنجومةني‬
Kurdistan Board of Medical Specialties
‫ثزيشكيةكان‬
Research Protocol Ethics Committee
‫ليذنةى نةريتى تويَذينةوةي ثزيشكى‬

3. Who will access these healthcare records?

No one

4. Will consent be taken from patients by research team members to access their
healthcare records? ☐Yes ☐No

EXAMPLE OF INFORMED CONSENT FORM

(Should be written in a language that participants understand i.e.: Kurdish, Arabic or

English)
PROJECT TITLE
PROJECT SUMMARY
By signing below, you are agreeing that: (1) you have read and understood the participant
information sheet, (2) questions about your participation in this study have been answered

Page 10 of 12
satisfactorily, (3) youGovernment-Iraq
are aware of the ‫عيراق‬-‫كوردستان‬
potential risks (if ‫مي‬َ‫ هةري‬and
any), ‫حكومةتي‬
(4)
Kurdistan Regional
‫سةرؤكايةتي ئةنجومةني وةزيران‬
youCouncil
are taking part in this research study
of Ministers voluntarily.
‫وةزارةتي خويَندني باآل و تويَذينةوةي‬
Ministry of Higher Education &
_________________________________ ‫زانستي‬
Scientific Research
Participant’s Name ‫ثسثؤرية‬
ِ ‫بؤ‬ ‫كوردستان‬ ‫ئةنجومةني‬
Kurdistan Board of Medical Specialties
_________________________________ ‫ثزيشكيةكان‬
Research Protocol Ethics Committee
_________________________________ ‫ليذنةى نةريتى تويَذينةوةي ثزيشكى‬
Participant’s signature Date
_______________________________
_________________________________ Name of person obtaining consent
Signature of person obtaining consent

‫نموذج من موافقة البحث باللغة العربية‬

:‫عنوان البحث‬
:‫ملخص البحث‬
‫ جميع األسئلة‬:‫ثانيا‬, ‫قرأت وفهمت نموذج من موافقة المشاركة في البحث‬:‫أوال‬: ‫بتوقيعكم_ أدناه توافقون على‬
‫مدركون بوجود اي خطورة (اذا وجدت )عند مشاركتكم‬:‫ثالثا‬,‫حول أشتراككم في البحث أجيبت بشكل مرضي‬
.‫أشتراكك في هذا البحث يكون طوعيا‬:‫رابعا‬, ‫في هذا البحث‬
: ‫أسم المشارك‬
: ‫تأريخ و توقيع المشارك‬
: ‫أسمو توقيع_ الباحث‬

APPROVAL OF RESEARCH PROTOCOL ETHICS COMMITTEE

(Note: this section will be signed by the Research ethics committeemembers after fulfillment of
all requirements).

Signature: :Signature
Head of the committee Member

Page 11 of 12
 ‫عيراق‬-‫حكومةتي هةريَمي كوردستان‬
‫معروف تحسين حسن‬.‫د‬.‫ى‬.‫ث‬
Kurdistan Regional Government-Iraq
Council of Ministers
‫وةزيرانيزدين‬
‫هللا فقي‬ ‫عبد‬.‫د‬.‫ى‬.‫ث‬
‫ئةنجومةني‬ ‫سةرؤكايةتي‬
Date(day/month/year) ‫أحمد تويَذينةوةي‬
‫وةزارةتي خويَندني باآل و‬
Ministry of Higher Education &
‫زانستي‬
Scientific Research Date(day/month/year)
‫ئةنجومةني كوردستان بؤ ثسثؤرية‬
ِ
Kurdistan Board of Medical Specialties
‫ثزيشكيةكان‬
Research Protocol Ethics Committee
‫ليذنةى نةريتى تويَذينةوةي ثزيشكى‬

Signature: :Signature
Member Member
‫شيَرزاد على اسماعيل‬.‫ د‬.‫ ي‬.‫ث‬ ‫ئارى نوزاد عبداهلل‬
Date(day/month/year) Date(day/month/year)

Signature: :Signature
Rapporteur Secretary
‫مؤيد عبدهللا وهاب‬.‫د‬.‫ى‬.‫م‬ ‫محمد عبداهلل عزيز‬
Date(day/month/year) Date(day/month/year)

Page 12 of 12