General Directorate of Health Affairs

In Tabuk Region
Institutional Review Board
‫لجنة أخالقيات البحوث‬

Application Form for IRB Approval

Title of the proposed research project:

To report the pregnant women were admitted to ICU and study the maternal and neonatal outcomes and the
management protocol related to COVID-19

Objectives of the research:

To assess the maternal and neonatal outcomes related to COVID-19 infection.

1) To describe the socio-demographic characteristics of pregnant women admitted to ICU

2) To identify the risk factor related to the ICU admission of pregnant women with COVID-19 infection
3) To describe maternal and neonatal outcomes related to COVID-19 infection
4) To identify the management protocol of pregnant women with COVID-19 infection
5) To describe the symptoms and medical situation COVID-19 infection of pregnant women

Duration of the research: ..........3 months ....................................................

Research site: ..............KFSH-T.................................................................
Following documents have been attached with this application (please tick):

Documents Yes No
a. Full research proposal (in accordance with Article 10.14 by the ✓
National Committee of Bioethics, Kingdom of Saudi Arabia)
b. “Informed Consent” form ✓
c. Data collection instrument (e.g. questionnaire, checklist, etc.) ✓
d. An updated, signed and dated CV of the principal ✓
investigator and all co-investigators
e. Proof of passing a valid research ethics course for all ✓
investigators

Signature: Date of submission:.......1-2-2022.......

Name of the Principal Investigator: .... Dr.Abeer Salem
Alatawi
Institution/Affiliation:......MCH-T......
Email: Abeer.Atawi@hotmail.com
Contact Phone: 966549992090

Page 1 of 2
 General Directorate of Health Affairs
In Tabuk Region
Institutional Review Board
‫لجنة أخالقيات البحوث‬

Article (10.14)

The research proposal shall comprise the following:

1. An abstract of the research within one page (Size: A4);
2. Research objectives;
3. Statistical methodology, including sample size calculations, taking into account the
possibility of obtaining statistically significant results by using the minimum number of
research subjects;
4. The rationale for introducing any procedure, tool or device that has not been used before;
5. The rationale for using any substances that could be dangerous or harmful to the human
subject or his surroundings and methods of disposal of said substances after the research
is completed;
6. Plan for dealing with risky cases;
7. Plan for disposal of the extra biological samples;
8. A clear description of the duties and responsibilities of the research team;
9. Time schedule of research and criteria of research suspension or termination;
10. Case registration forms, daily cards, and questionnaires set for research subjects, in case
of clinical research;
11. Research sample shall be determined according to the following considerations:
a. Characteristics of the sample from which the subjects will be selected;
b. Criteria for inclusion and exclusion of the human subject;
c. Methods through which initial contact and selection are carried out;
d. Means of providing complete information to potential participants in the research or
their representatives.
12. In clinical research, the principal investigator shall present a description of the individuals
who will be given access to personal data of research subjects, including medical records
and biological samples;
13. A list of expected results and ways to benefit therefrom;
14. A list of references.

[Adopted from: "Implementing Regulations of the Law of Ethics of Research on Living Creatures",
2nd Edition, 2016. National Committee of BioEthics (NCBE), Kingdom of Saudi Arabia.]

Page 2 of 2