National Research Centre
Medical Research Ethics Committee

National Research Centre — Egypt

Medical Research

Ethics Committee

Submit, track, and receive decisions on your research protocols through Egypt’s leading ethics oversight body — transparent, fast, and fully digital.

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Live Overview

Total Submissions

1,240+

All Time

Pending Review

38

Active

Approved Last Year

214

2025

Accredited Ethics Committee · National Research Centre, Cairo, Egypt · Download our Standard Operating Procedures →

Our Services

What We Review

Comprehensive ethical oversight for all medical research involving human participants at the National Research Centre.

01

Full Board Review

Complete ethical review for studies involving greater than minimal risk to human participants, conducted by the full MREC committee.

02

Expedited Review

Streamlined review for minimal-risk research protocols requiring a faster turnaround time with designated reviewers.

03

Exemption Review

Determination of whether research proposals qualify for exemption from full ethical review, per SOP 05-C/V5.

04

Protocol Amendments

Review and approval of modifications to already approved protocols ensuring sustained ethical compliance.

05

Continuing Review

Annual or periodic review of ongoing studies to ensure compliance with ethical standards throughout the research period.

06

Waiver of Consent

Formal review process for research requesting a waiver or alteration of standard informed consent requirements.

Submission Process

How It Works

Five clear steps from creating your account to receiving your official ethics certificate.

Step 1
Create an Account

Register on the MREC portal as a researcher to gain full access to the submission system and document library.

Step 1
Step 2
Complete Account Details

Fill in your full researcher profile including name in Arabic and English, affiliation, institute, department, and scientific degree.

Step 2
Step 3
Add a New Research

Fill in your full researcher profile including name in Arabic and English, affiliation, institute, department, and scientific degree.

Step 3
Step 4
Review Pathway Assignment

Fill in your full researcher profile including name in Arabic and English, affiliation, institute, department, and scientific degree.

Step 4
Step 5
Receive Your Formal Decision

Fill in your full researcher profile including name in Arabic and English, affiliation, institute, department, and scientific degree.

Step 5

Exemption

Apply for Exemption of Ethical Review for studies that do not require full MREC approval per SOP 05-C/V5.

Guidelines

Consent Form

Apply for Exemption of Ethical Review for studies that do not require full MREC approval per SOP 05-C/V5.

Download Form

Waiver of Consent

Apply for Waiver of Informed Consent for research that qualifies under specific ethical criteria.

Guidelines

Appeal

Apply for Appeal against a committee decision. Submit your appeal form with full supporting documentation.

Apply Now

About MREC

Upholding Ethical Standards in Medical Research

The MREC was established as an independent committee by the NRC Presidential Decree Number 258/2003. It is committed to ensure the welfare of human and animal subjects involved in research. Also, to ascertain that researches are warranting all aspects of the health and behavior of people and these researches are only possible through the participation of humans or animals.

About the Committee
Laws & Regulations

Independent & Accredited

Fully accredited committee operating independently from research institutions to ensure unbiased review.

Fast Turnaround

Decisions communicated within 5 working days for expedited reviews and standard protocols.

Transparent SOPs

All Standard Operating Procedures are publicly available for download and reference by researchers.

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Meeting between the President of...
The President of the National Research Centre, Professor Dr. Hussein Darwish, met with the Head of the Cairo Medical Syndicate,...
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Professor Dr. Fajr Abdel-Gawad, Acting President of the National Research Centre (NRC), extended her sincere gratitude and congratulations to the...
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Exemption from Ethics Review

Standard Operating Procedure (SOP)

Purpose

The purpose of this Standard Operating Procedure (SOP) is to describe which clinical research projects can be exempted from ethics review and do not require the approval of the Medical Research Ethics Committee (MREC). The Exemption Form AX 01/SOP 05-C/V5 is designed to standardize the process of exemption.

Scope

This SOP applies to the all protocols submitted for exemption from review by the MREC. The specific points in the Exemption Form should guide the Chairperson of MREC to determine whether the protocol qualifies for exemption from review. The decision should be taken by the Chairperson in consultation with the Vice Chairperson and should be informed to the Members in the forthcoming MREC meeting.

Responsibility

It is the responsibility of the MREC Chairperson or whom he/ she will delegate to consider the decision in the Exemption Form with reasons. The MREC Secretariat is responsible for recording and filing the decision including the reasons for that decision. The Chairperson/ Vice Chairperson must sign and date letter conveying the decision AX 01/SOP 05-C/V5.

Flow chart

No. Activity Responsibility
1Receive the submitted documents.MREC Secretariat
2Review of protocol and Exemption FormMember
3Recording the decision on Exemption Form in consultation with the ChairpersonAdministrative Secretary
4Communicate the decision to the Investigator & MREC members in forthcoming meetingAdministrative Secretary

Detailed instructions

5.1 Receive the submitted documents

The Secretariat will receive the Exemption from review Application Form AX 01/SOP 05-C/V5, Protocol and other documents submitted by the investigators.

5.2 Determining the protocols eligible for exemption from review

The proposal submitted for initial review or where investigator have requested for the exemption from review stating the reason in the ‘Review Exemption Application Form’ to the MREC will be evaluated for the exemption from review.

Proposals which involve less than minimal risk fall under this category.

Minimal risk would be defined as one which may be anticipated as harm or discomfort not greater than that encountered in routine daily life activities of the general population or during the performance of routine physical or psychological examinations or tests. However, in some cases like surgery, chemotherapy or radiation therapy, great risk would be inherent in the treatment itself, but this may be within the range of minimal risk for the research participant undergoing these interventions since it would be undertaken as part of current everyday life.

The MREC Member will determine whether a protocol qualifies for exemption from review based on the following criteria. Final decision will be made by the Chairperson. The research proposals which do not involve live human participants or data derived from them are exempt from ethics review. For example:

  • Audits of educational practices
  • Experimental Research on non-human non-animal cells
  • Research on microbes cultured in the laboratory
  • Research on immortalized cell lines
  • Analysis of data freely available in public domain

5.3 Recording the decision on Exemption Form in consultation with the Chairperson

If the protocol and related documents satisfy the criteria as listed in 5.2, the assigned Member in consultation with the Chairperson will review the brief summary of the project and the Exemption Form. The Member will record the decision.

5.4 Communicate the decision to the Investigator & MREC members

The reviewing member will communicate the decision to the Principal Investigator within 5 working days after the decision regarding the exemption is taken. The reviewing member will inform the MREC members about the decision at the next full board meeting and minute it in the meeting notes.

Any changes to the protocol must be brought to the notice of the MREC prior to implementation by the investigator. Any correspondence with the MREC office regarding this action should mention the allocated study number indicated at the top of this letter.

Glossary

Exemption from review: A research study is said to be exempt from review when it does not require the Medical Ethics Committee approval for its conduct.

References

[1] WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects. Link

Annexure

Annexure 1: AX 01/SOP 05-C/V5 Application for Review Exemption Form

Annexure 2: AX 02/SOP 05-C/V5 Approval of Exempt Review Document

N.B.: No research can be counted as low risk if it involves:

  • Invasive physical procedures or potential for physical harm
  • Procedures causing mental/emotional stress or distress
  • Personal or sensitive issues / Vulnerable groups
  • Investigation of illegal behavior(s) / Invasion of privacy
  • Collection of information disadvantageous to the participant
  • Use of information collected under confidentiality agreement
  • Participants unable to give informed consent
  • Conflict of interest or power relationships
  • Deception / Audio or visual recording without consent
  • Withholding benefits from “control” groups
  • Inducements / Risks to the researcher

Guidelines for Waiver of Informed Consent

Under the Policy for the Protection of Human Participants, MREC may approve an informed consent process that:

  • Waives the requirement to obtain informed consent, or
  • Alters some or all of the elements of informed consent, or
  • Waives the requirement to document informed consent (i.e., to obtain a signature)

Waiver or Alteration of Informed Consent

For research that is no more than minimal risk the MREC may approve a request to waive of some or all of the required elements of informed consent under specific circumstances. Waivers of informed consent are primarily requested for researches involving the secondary analysis of existing data or in researches involving deception. However, in all circumstances the intent of this waiver criterion is to require debriefing for participants in deception research.

To waive in total or to alter informed consent elements, the MREC must determine that:

  1. The research involves no more than minimal risk to subjects;
  2. The research could not be carried out practicably without the waiver or alteration;
  3. The waiver or alteration will not adversely affect the rights and welfare of the subjects; and,
  4. Whenever appropriate, the participants or legally authorized representatives will be provided with additional pertinent information after participation.
Note: If the research involves identifiable private information or identifiable biospecimens, this research could not be carried out practicably without using the information/specimen in an identifiable form. It is not appropriate to request a waiver of documentation of informed consent for human subject projects that collect biospecimens.

Waiver of Documentation of Informed Consent

For some researches, the MREC will approve a request to waive the documentation of informed consent. This means that the study team must provide the participant with the required consent information, but the study team is not required to obtain the participant’s signature on the informed consent document. Each participant (or legally authorized representative) will be asked whether the participant wants documentation linking the participant with the research, and the his/ her wishes will govern.

In all cases, even if MREC approves a waiver of documentation of consent, MREC will review a written description of the information provided to participants and should be offered a copy of the consent information for their records even when a signed document is not required for the study.

A waiver of documentation is permissible when:

  • The signature on the informed consent document would be the only record linking the participant to the research and the principal risk of harm to the participant would be a breach of confidentiality. For example, for research on sensitive topics, such as domestic violence or illegal activities; OR
  • The research presents no more than minimal risk of harm to participants and involves no procedures for which written consent is normally required outside the research context. OR
  • Alternative mechanism for documenting that informed consent was obtained.

Examples:

  • Surveys/interviews conducted via telephone or online and involves minimal risk.
  • Retrospective chart reviews
  • Studies of existing pathology specimens
  • Ethnographic research
  • Passive (opt-out) consent.

Public Demonstration Researches

MREC may waive or alter the requirements for informed consent in research involving public benefit and service programs if MREC finds and documents that:

  • The research or demonstration project is to be conducted by or subject to the approval of state or local government officials; and
  • The research is designed to study, evaluate or otherwise examine: (i) public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs; and
  • The research could not practicably be carried out without the waiver or alteration.

Screening, Recruiting, and Determining Eligibility Researches

MREC may approve a research proposal in which a researcher will obtain information or biospecimens for the purpose of screening, recruiting, or determining the eligibility of prospective participants without the informed consent of the prospective participant or the participant’s legally authorized representative, if either of the following conditions are met:

  • The researcher will obtain information through oral communication with the prospective participant or legally authorized representative, or
  • The researcher will obtain identifiable private information or identifiable biospecimens by accessing records or stored identifiable biospecimens.

Waiver of Requirement for Parental Permission

For research involving children as participants, MREC may waive the requirement to obtain parental permission if it finds and documents that:

  • An appropriate mechanism for protecting the children who will participate as participants in the research is substituted.
  • The research involves no more than minimal risk to the participants;
  • The waiver or alteration does not adversely affect the rights and welfare of the participants;
  • The research cannot practicably be carried out without the waiver or alteration e.g., domestic violence or children abuse;
  • When appropriate, the participants will be provided with additional pertinent information after participation.

Emergency Research

MREC may approve a waiver of consent or documentation in emergency research protocols in which participants are unable to give informed consent at the time of enrollment due to their medical condition. However, these studies require additional steps:

  • “Community Consultation” prior to MREC submission of the full study protocol
  • “Public Disclosure” (such as advertisements)
  • Assessment of investigation plans, risks, and benefits before study initiation
  • Disclosure of study results and demographics after study completion.
APPENDIX A

Exception from informed consent requirements for emergency research

MREC may approve the waiving of informed consent in emergency research if it finds and documents each of the following requirements:

  1. The human subjects are in a life-threatening situation and available treatments are unproven or unsatisfactory.
  2. Obtaining informed consent is not feasible because the subjects cannot consent due to their condition and intervention must be administered immediately.
  3. Participation holds prospect of direct benefit to the subjects.
  4. The investigation could not practicably be carried out without the waiver.
  5. Defined therapeutic window and commitment to contact LARs.
  6. Review and approval of informed consent procedures and documents.
  7. Additional protections including community consultation and public disclosure.
  8. Procedures to inform participants or LARs of inclusion at the earliest opportunity.
  9. Procedure to inform participants they may discontinue at any time without penalty.
  10. Documentation retention for at least 3 years after completion.
APPENDIX B: DEFINITIONS
Clinical investigation
Synonymous with research, clinical research, biomedical research, or clinical trial involving drugs or devices.
Clinical Investigator
Individual who actually conducts a clinical investigation and directs the test article.
Community
A group linked by common interests, region, or shared experiences.
Community consultation
Opportunity for discussions and soliciting opinions from the community where the study will take place.
Data Monitoring Committee (DMC)
Group with expertise that reviews accumulating data to advise on safety and scientific merit.
Emergency Research
Planned clinical investigation involving participants in life-threatening situations.
Legally authorized representative (LAR)
Individual or body authorized under applicable law to give informed consent on behalf of a subject.
Therapeutic window
Time period during which administration of the test article might produce a clinical effect.

Section 1: About the Waiver of Informed Consent

Use this form if none of the required elements of consent are given. MREC may approve provided:

  • The research involves no more than minimal risk
  • Rights and welfare of subjects are not adversely affected
  • It is not practicable to conduct without the waiver
  • Additional pertinent information is provided when appropriate

Section 2: Who Needs to Complete this Form

If you choose “waiver of informed consent / waiver of informed consent documentation or waiver of some items of informed consent" in the CONSENT FORM DOCUMENT, you will need to complete this form as part of your application.