Republic of Iraq

Ministry of Health & Environment

Approval form of a Research Protocol/ Ministry of Health & Environment ( Form number 02/2021)

)02/2021 ‫استمارة املوافقة على مشروع بحث في وزارة الصحة والبيئة (استمارة رقم‬
 This form should be filled in electronically (Manually filled in form will not be accepted) by the researcher and submitted manually to
the research unit at the relevant Health Directorate to be displayed at its Research committee. No research is allowed to be conducted
at the institutions of Ministry of Health without having in advance the committee’s approval.
 This form can be downloaded from the official website of Ministry of Health & Environment/ Iraq.

1. PERSONAL INFORMATION

1.1 Principal Investigator

Name Specialty Place of work Phone number E mail
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Click or tap here to enter text.
enter text. enter text. enter text. to enter text.

1.2 Other investigators

Name Specialty Place of work Phone number E mail
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2. RESEARCH INFORMATION

2.1 Is the research title from the Ministry of Health’s list of priorities: 2.1: The list is issued every year
and found on MoH website.
☐ Yes ☐ No
2.2 The purpose of doing the research: Choose an item.

If the answer is others, please, specify : Click or tap here to enter text.

3. RESEARCH TOPIC

3.1 The Research Title: 3.1: Write down the title of your
research.
Click or tap here to enter text.

3.2 The Research Question:

3.2: Write down the smart
Click or tap here to enter text. research question.

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3.3 Research Background (with references in Vancouver style): 3.3: Write concisely the scientific
bases of your research question.
Click or tap here to enter text. Use updated and new references.

3.4 Justification of Choosing this topic (Rationale): 3.4: Show the rationale of
choosing this research question
Click or tap here to enter text. and what are the expected gab
that this research is going to fill.
3.5 The Objective/s of the Research:

Click or tap here to enter text. 3.4: Write down primary and
secondary objectives

4. Research Setting

4.1 When will the sample be collected?

Start 8 January 2021 End 15 April 2021

4.2 Where will the study be implemented?

Name of Institution Name of authorized person Signature Date and stamp

1 Click or tap here to enter text.
2 Click or tap here to enter text.
3 Click or tap here to enter text.
4 Click or tap here to enter text.
5 Click or tap here to enter text.

4.3 The resources needed from the institution selected to implement the research?

The resource needed tick Amount and types

Laboratory sample (Blood, urine, ….) ☐ Click or tap here to enter text.
Devices, instrument, tools …… ☐ Click or tap here to enter text.
Patients’ or firm’s records ☐ Click or tap here to enter text.
Persons (patients, employers) ☐ Click or tap here to enter text.
Others specified ☐ Click or tap here to enter text.

4.4 Who will fund the research? Choose an item.

If the answer is others, please, specify :

Click or tap here to enter text.

5. RESEARCH METHODOLOGY
5.1: write the design of the study
5.1 Study Design: choose one from below that is going to answer your
research question

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 Choose an item.

If the answer is others, please, specify : Click or tap here to enter text. 5.2: It is the operational definition
used to enroll participants in the
5.2 Case Definition: study

Click or tap here to enter text.

5.3: the participants that fulfil
5.3 Exclusion Criteria: case definition, but excluded from
the study due to a specific cause
Click or tap here to enter text.
5.4: the method used to select the
5.4 Sampling Methods: participants of the sample from
the targeted sample.
Click or tap here to enter text.

5.5 Randomization and Blinding Methods (If relevant): 5.5: Write details about how to
allocate participants in study arms
Click or tap here to enter text. or blinding them if the study
design is relevant
5.6 Selection of Participants in control group (If Relevant):
5.6: Criteria of enrolling
Click or tap here to enter text. participants in the control group

5.7 Definition of Outcomes and how to measure it: 5.7: Variables used to answer the
research question. Write them in
Click or tap here to enter text. details; how do you measure
them, when and by whom.
5.8 The Procedure (steps) of the Study:
5.8: Steps of performing the
Click or tap here to enter text. study.

5.9 Statistical Analysis and sample size: 5.9: define types of variables.
What are the statistical tools used
Click or tap here to enter text. to measure p value? How are you
going to show your results? … etc

6. ETHICAL CONSIDERATION 6: Write down the type of consent

and provide a copy of it. Show
Click or tap here to enter text. how you abide by the terms of
Code of ethics in research.

7. ATTACHED DOCUMENTS (Tick the appropriate box)

☐ Participants’ Consent Form ☐ Questionnaire & Data Retrieving form ☐ University letter (Student)
☐ Professional ID ☐ Others: Click or tap here to enter text.

8. SIGNING A PLEDGE
We, the undersigned researcher/ researchers, pledge to:

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 1. Implement the research project as described in this version, and that we do not perform any changes or
modifications, after it was approved by the research committee, only with the written agreement of the
Research Committee in the Health Directorate that approved the mentioned project. 
2. That the preliminary approval was obtained from (Click or tap here to enter text.) to undertake research in
the aforementioned hospital and to take advantage from the facilities it provides to the researcher based
on what is mentioned in this project, and we herein certify the validity of the signature and stamp set out
paragraph (2-4).
3. That we will abide by all orders, instructions and regulatory directives issued by the management of the
health institution in which the research will be implemented. 
4. That we will maintain all the property of the health institution, including premises, devices, machines, tools,
material and documents, and not to misuse it physically or morally, not to impede or disrupt the daily work
of the institution as well while we are inside it to accomplish the research.
5. To obtain only what we are entitled to by the approval decision in order to conduct research based on the
preliminary approval of the health institution in which the research will be conducted.
6. That we have read the Code of Ethics in Research approved by the Ministry of Health and that we will
adhere to its entire provisions in all stages of implementing the research and that it is seen as
complementary to the decision of the Research Committee.
7. That we will brief the health institution on the research results for the purpose of taking advantage of them.

Principal researcher's name, signature, date: Click or tap here to enter text.

Researcher's name, signature, date: Click or tap here to enter text.

Researcher's name, signature, date: Click or tap here to enter text.

Researcher's name, signature, date: Click or tap here to enter text.

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