Research Protocol Form " Approval Requirements"

‫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 research protocol 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, then section (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) A copy of 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 11
‫حكومةتي هةريَمي كوردستان‪-‬عيراق‬
‫‪Kurdistan Regional Government-Iraq‬‬
‫‪Council of Ministers‬‬
‫& ‪Ministry of Higher Education‬‬
‫زانستي‬
‫‪Scientific Research‬‬
‫ِ‬ ‫بؤ‬ ‫كوردستان‬ ‫ئةنجومةني‬
‫‪Kurdistan Board of Medical Specialties‬‬
‫‪Research Protocol Ethics Committee‬‬
‫)‪SECTION (I‬‬
‫بؤ ‪ /‬ليذنةى نةريتى تويَذينةوةى ثزيشكى‬

‫‪ /‬ليذنةى زانستى تويَذينةوةى ثزيشكى‬
‫كولَى تويَذينةوة‪D‬‬
‫تو َ‬
‫ثرو َ‬
‫بابةت‪ /‬ثةسةندكردنى َ‬
‫سالَو ِ‬
‫وريَز‪/‬‬
‫هاوثيَض ف__ةرمانى ك__ارطيَ ِرى_ ئةنجوم__ةنى كوردس__تان ب_ َو ثس__ث َو ِرية ثزيش__كيةكان ك__ة تايبةت_ة ب__ة دةستنيش__ان‬
‫)‪ .‬داوا‬ ‫) ل_ة ب__ةروارى_ (‬ ‫كردنى سةرثةرشتيارى تويَذينةوةم ذم__ارة (‬
‫كولَى_ تويَذينةوةكةم بة ناونيشانى‪:‬‬‫ثروتو َ‬
‫َ‬ ‫لة بةريَزتان دةكةم رةزامةندى بفةرموون بؤ ثةسةندكردنى_‬
‫(‬
‫)‬
‫لةطة َل ِريَزم‬
‫واذوو‪:‬‬
‫‪/‬‬ ‫‪/ 20‬‬ ‫بةروار‪:‬‬ ‫ناوي سيانى ِراهيَنراو‪:‬‬
‫‪Page 2 of 11‬‬
‫زانستي‬
SECTION (II)
Scientific Research
Kurdistan
RESEARCHBoard of Medical
PROTOCOLSpecialties SCENTIFIC FORM‫ثزيشكيةكان‬
1. Research Title:
2. Principle Investigator:
a. )‫ناوى سيانى (بة كوردى‬:
b. Full name (in English):
c. )‫ثسثو ِرى (بة كوردى‬:

َ )‫ ناوى ئةنجومةن (بة كوردى‬:
d. Specialty (in English): Name of council of clinical specialty:
e. Training center:
f. Full Address: Phone no.: Email:
g. Qualification (‫بروانامة‬
ِ ):
☐Ministry of Health ☐ Ministry of Higher Education & Scientific Research
h. Affiliation (
☐ Ministry of Peshmarga ☐ others, please identify ----------------------------

‫)ميالك‬:
3. Co-investigators (if applicable) (mention name, qualification, and affiliation of each):
Page 3 of 11
4.Kurdistan
ResearchRegional
Supervisor: ‫عيراق‬-‫حكومةتي هةريَمي كوردستان‬
Government-Iraq
a.)‫كوردى‬
Council of ‫(بة‬ ‫ ناوى سيانى‬:
Ministers
‫زانستي‬
Scientific Research
b.Kurdistan
Full nameBoard
(in English):
of Medical Specialties
c. )‫ثسث َو ِرى (بة كوردى‬:
d. Specialty (in English):
e. Training center:
f. Full Address: Phone no.: Email:
g. Qualification (‫بروانامة‬
ِ ):
☐Ministry of Health ☐ Ministry of Higher Education & Scientific Research
h. Affiliation (
☐ Ministry of Peshmarga ☐ others, please identify ----------------------------

‫)ميالك‬:
5. Research Co- Supervisor (if applicable):
a. )‫ ناوى سيانى (بة كوردى‬: b. Full name (in English):
c. )‫ثسث َو ِرى (بة كوردى‬: d. Specialty (in English):
6. Introduction:
a. Aim (s) of the study (The aim of the study, i.e. the overall purpose of the study,
should be clearly and concisely defined. The aims are broad statements of desired
outcomes, or the general intentions of the research, emphasize what is to be
accomplished (not how it is to be accomplished) and address the long-term project
outcomes, i.e. they should reflect expectations of the research topic):
Page 4 of 11
‫زانستي‬
Scientific Research
b. Research
Specific objectives of theCommittee
Protocol Ethics study (Are the steps you are going‫ثزيشكيةكان‬
to take
to answer your research questions or a specific list of tasks needed to
accomplish the goals of the project) :
7. Patients / Subjects/ Materials and methods of study:

a. Study design:
b. Study duration:
c. Study setting (place of the study, city, governorate):
d. Sampling method and sample size:
e. Inclusion criteria:
Page 5 of 11
‫زانستي‬
Scientific Research
f. Exclusion criteria:
8. 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):
9. 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 by Research protocol scientific committee. Hence;
Page 6 of 11
notKurdistan
fulfills theRegional
requirement of submission to ‫عيراق‬-‫كوردستان‬
Research ‫حكومةتي هةريَمي‬
Protocol Ethics
Government-Iraq
Committee.).
1. Member ‫زانستي‬
Scientific Research (should be the supervisor of the Research
Protocol): ‫ثسثؤرية‬
Full name :
Signature:
Date (day/month/year):
2. Member:
Full name :
Signature:
3. Head of Research Protocol Scientific Committee:
Full name :
Signature:
SECTION (III)
RESEARCH PROTOCOL ETHICS FORM
A. Participants informed consent:

1. Will informed written consent be obtained? ☐Yes ☐No
2. If yes, please:
Page 7 of 11
a. Outline
Kurdistan the Government-Iraq
Regional consent process in full. ‫عيراق‬-‫كوردستان‬
(How will‫مي‬consent
َ‫حكومةتي هةري‬
be
obtained,
Council when, by whom and
of Ministers from whom etc?)
‫زانستي‬
Scientific Research
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.
4. Will participants be informed of their right to refuse to participate and their right to
withdraw from this research study? ☐ Yes ☐ No
5. If no, please justify.
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.
Page 8 of 11
C. Access
Council to health care records:
of Ministers
‫وةزارةتي خويَندني باآل و تويذينةوةي‬
1. Doesof the
Ministry study
Higher involve& access to
Education healthcareَ records (hard copy
‫زانستي‬
Scientific Research
/ electronic)? ☐Yes ‫ثسثؤرية‬
☐No
ِ ‫ئةنجومةني كوردستان بؤ‬
Kurdistan
2. If yes, Board of Medical
please Specialties
elaborate (how you will access the health care
Research Protocol
records?). Ethics Committee
3. Who will access these healthcare records?
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)
Page 9 of 11
PROJECT ‫عيراق‬-‫حكومةتي هةريَمي كوردستان‬
KurdistanTITLE
Regional Government-Iraq
PROJECT SUMMARY ‫وةزارةتي خويَندني باآل و تويَذينةوةي‬
‫زانستي‬
ByScientific
signing Research
below, you are agreeing that: (1) you have read and
‫ثسثؤرية‬ ‫بؤ‬ ‫كوردستان‬ ‫ئةنجومةني‬
understood Board
Kurdistan of Medical Specialties
the participant information sheet, (2)ِ questions about your
Research Protocol
participation in this Ethics Committee
study have been answered satisfactorily, (3) you
are aware of the potential risks (if any), and (4) you are taking part in this
research study voluntarily.
_________________________________
Participant’s Name
_________________________________ _________________________________
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:‫ ثالثا‬,‫حول أشتراككم_ في البحث أجيبت بشكل مرضي‬
. ‫ أشتراكك في هذا البحث يكون طوعيا‬:‫رابعا‬, ‫مشاركتكم_ في هذا البحث‬
: _‫أسم المشارك‬
: ‫تأريخ و توقيع المشارك‬
: ‫أسم و توقيع الباحث‬
APPROVAL OF RESEARCH PROTOCOL ETHICS COMMITTEE

(Note: this section will be signed by the Research ethics committee members after fulfillment of
all requirements).
Page 10 of 11
Signature:
Ministry of Higher Education & :Signature
‫زانستي‬
Scientific Research
Head of the committee Member
‫معروف تحسين حسن‬.‫د‬.‫ى‬.‫ث‬
Research Protocol Ethics Committee ‫عبد هللا فقي يزدين‬.‫د‬.‫ى‬.‫ث‬ ‫ثزيشكيةكان‬
Date (day/month/year) ‫ليذنةى نةريتى تويَذينةوةي ثزيشكى‬
‫أحمد‬
Date (day/month/year)
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 11 of 11

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‫عيراق‬-‫حكومةتي هةريَمي كوردستان‬

Kurdistan Regional Government-Iraq

Research Protocol Form "Approval Requirements"

Dear KBMS Trainee:

‫بؤ ‪ /‬ليذنةى نةريتى تويَذينةوةى ثزيشكى‬

‫‪/‬‬ ‫‪/ 20‬‬ ‫بةروار‪:‬‬ ‫ناوي سيانى ِراهيَنراو‪:‬‬

c. )‫ثسثو ِرى (بة كوردى‬:

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

f. Full Address: Phone no.: Email:

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

3. Co-investigators (if applicable) (mention name, qualification, and affiliation of each):

d. Specialty (in English):

f. Full Address: Phone no.: Email:

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

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

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

c. Study setting (place of the study, city, governorate):

d. Sampling method and sample size:

9. Date of Research Protocol Presentation (Day/month/year):

APPROVAL OF RESEARCH PROTOCOL SCIENTIFIC COMMITTEE

3. Head of Research Protocol Scientific Committee:

A. Participants informed consent:

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

3. Who will access these healthcare records?

EXAMPLE OF INFORMED CONSENT FORM

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

‫نموذج من موافقة البحث باللغة العربية‬

APPROVAL OF RESEARCH PROTOCOL ETHICS COMMITTEE

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