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Ethics Application Form

1) The document is an ethics committee application form for research conducted at Alexandria University's High Institute of Public Health. 2) The applicant is seeking approval to conduct a study on the pattern of use of prophylactic enoxaparin in gynecologic operations at El-Shatby Maternity University Hospital. 3) The study involves collecting data from medical records but does not involve giving any investigational drugs or collecting biological samples, so only verbal consent is required from participants.

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Mohamed Salem
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59 views5 pages

Ethics Application Form

1) The document is an ethics committee application form for research conducted at Alexandria University's High Institute of Public Health. 2) The applicant is seeking approval to conduct a study on the pattern of use of prophylactic enoxaparin in gynecologic operations at El-Shatby Maternity University Hospital. 3) The study involves collecting data from medical records but does not involve giving any investigational drugs or collecting biological samples, so only verbal consent is required from participants.

Uploaded by

Mohamed Salem
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOC, PDF, TXT or read online on Scribd
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Alexandria University

High Institute of Public Health


:Reference Number

ETHICS COMMITTEE APPLICATION FORM

1- Applicant name:

Other
Principal investigator
researchers *
Name
Position/Professional status
Qualifications
Affiliation
Telephone/fax
Email address
Primary contact name:

2- Purpose of research proposal:

Degree:  Master thesis □ Doctor thesis

Non degree □ Research Paper □ Research Project □ Others (specify)………………………….

3- Full title of study:

English

Pattern of Use of Prophylactic Enoxaparin in Gynecologic Operations in El-Shatby


Maternity University Hospital

‫العنوان باللغة العربية‬


‫نمط استخدام اإلينوكسابارين الوقائي في عمليات أمراض النساء بمستشفى الشاطبى الجامعى للنساء والتوليد‬
4- Nature or type of research:
□ Biomedical  Population □ Health policy □ Environmental
□ Other

5- Subject of research:
 Human □ Animal species □ Food samples
□ Biological samples □ Environmental samples

1
Alexandria University

High Institute of Public Health


:Reference Number

□ Other (medical records)

6- Funding / Support of the research: How will the research be funded?

The research will be funded by the researcher.

7- What are the benefits from the research to the community and participants?

8- What are the potential risks, adverse effects, or hazard from the above research?
There are no potential risks, adverse effects, or hazards from the above research.

9- Is there any investigational medicinal or any other product involved? Yes □ No 


If yes:
9.1- Does it have a license in the country in which the study will take place?
........................................................................................................................................
........................................................................................................................................
9.2-Will it be used outside the terms of its license (including use at a higher dose)?
........................................................................................................................................
........................................................................................................................................

Informed consent
10- State the consent process: how it will be done, steps to provide information
(written sheet, videos, interactive material).
Verbal consent will be obtained from the study participants after explanation of the
purpose and benefits of the research.
11- Informed consent form: Yes □ No 
If no, please state why:
Verbal consent is sufficient because the study does not involve giving any
investigational medicine or taking any biological samples.

Confidentiality, data and sample security:


12- What measures have been put in place to ensure confidentiality of personal data:
collection, storage, access to and disposal of data and security of biological
samples?
Alexandria University

High Institute of Public Health


:Reference Number

Questionnaires will be coded by serial numbers and not by names and personal
details of participants will not be announced.

Payments and incentives:


13- Will individual participants receive any payment or incentive for taking part in
the research?
No.

Management of the research


14-Is permission / approval of relevant authority required?
Yes 
No

If yes, state name(s)

15-How do you intend to report the results? To whom will results be made
available? How will the findings be reported to the research participants?
The results will be reported during presentation of the thesis and data will be
available for scientific publications in peer reviewed journals. A copy of thesis at the
High Institute of Public Health Library, Bibliotheca Alexandria Library, Alexandria
Central Library, and Ain Shams University Library. Findings will also be reported to
the responsible authorities and to the research participants.
Alexandria University

High Institute of Public Health


:Reference Number

Declarations:

We agree that:

If approved, this study will be conducted in accordance with the protocol, other
details described in this application and international ethical guidelines for
research.

The study will not start until ethical approval has been obtained.

Applicant

Signature:

Date: .…………………………………….

Supervisor (if a thesis) / Principal investigator (if not a thesis)

Signature:

Date: ……………………………………..

Please retain for yourself and provide electronic and paper copies of this
application and protocol, if you are a student, for your supervisor.

You have to scan this page and submit it electronically and a hard copy to be sent
directly to the Ethics Committee Secretary with your application.
Alexandria University

High Institute of Public Health


:Reference Number

ETHICS COMMITTEE DECISION FORM

Submission date:.................................................................................................................
Application presented to Ethics Committee member on:...................................................
Research title:

Result:

1. Approval

2. Approval after the following modifications


........................................................................................................................................
........................................................................................................................................
........................................................................................................................................
........................................................................................................................................
........................................................................................................................................
........................................................................................................................................

3. Rejection for the following reasons


........................................................................................................................................
........................................................................................................................................
........................................................................................................................................
........................................................................................................................................

Name of committee member: …………………….

Date: ………………….

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