Introduction

The president and vice president of NRC for research and international affairs will oversee the research practices and will assure that these practices will conform to the principles of research ethics. Part of this assurance includes the establishment of an appropriated constituted Medical Research Ethics Committee (MREC) which shall have the responsibility to review and monitor research involving human or animal subjects.

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.

While the primary goal of research is to enhance the well-being of society, an important objective of research involving human subjects is protection of the rights and welfare of subjects who participate in such research. Accordingly, research should be guided by the ethical principles embraced by the National Laws and by-Laws as well as Declaration of Helsinki, Belmont Report and The International Guiding Principles for Biomedical Research Involving Animals issued by the Council for International Organizations of Medical Sciences (CIOMS).

These principles in human subject research include autonomy (respect for persons), beneficence

(Protecting subject welfare), non-maleficence (Minimizing potential harms of research) and justice (Avoidance of exploitation). Justice also requires that the benefits and burdens of research be distributed fairly among all groups and classes in a society, as well as between the different countries who are participating in the research.

In animal subject research the principles are the 3Rs,

1. Replacement: methods which avoid or replace the use of animals in research
2. Reduction: use of methods that enable researchers to obtain comparable levels of information from fewer animals, or to obtain more information from the same number of animals.

3. Refinement: use of methods that alleviate or minimize potential pain, suffering or distress, and enhance animal welfare for the animals used.

Vision

MREC is to be the best Medical Research Ethics Committee model in the Middle East Region and one of the best Internationally in evaluating research and offering professional services to preserve human dignity, rights, safety and welfare and health of participant subjects.

Mission

• Ensures that research involving human participants or animal subjects abides by all ethical responsibility for safeguarding their rights and welfare

• Monitoring the conduct of the research to guarantee safety and standing to the approved protocol
• Empowers the MREC members partnering with sponsors, investigators, volunteer subjects, institution, community to promote the highest level of human and animal subject protection through scientifically and ethically sound research.

• Continuously evolving our processes to match the international standards while complying with regulatory, legal, and ethical requirements.

• Advocating, with peers, regulators and the public in the interest of improving the research atmosphere

• Dedicated to educate MRECs and investigators while creating, applying and sharing research education that has significance for our organization and society.

Values

Our MREC believes in working through a Teamwork manner, Confidentiality, Problem Solving, Fairness, Integrity, Justice, non-Prejudice, Secrecy, Equality, Transparency, Responsiveness to the protection of human subjects and animal rights and Independency.

Goals

We strive to achieve our mission and vision through the following organizational goals:

• Protection of human subjects involved in research clinical trials and animal subjects involved in pre-clinical trials.

• Providing ongoing lifelong refresher training of the MREC members to keep their standards competent and expert.

• Raise awareness of the community about research and the human rights in participating in the clinical trials and animal welfare in pre-clinical trials.

• Orientation of young investigators about the standards of writing, conducting and ethical review of the protocols

• Serving as a facilitator and resource to researchers
• Valuing different types of research, including experiential and clinical trials.
• Promote collaborations with international research agencies

Objectives:

1. Protection of the rights, and welfare of all research subjects

The MREC will advise investigators while designing research projects in a manner to minimize potential harm to human subjects, and protect the animal welfare. We will also, review all planned research involving human or animal subjects prior to initiation of the research. Approval of research that meets established criteria for protection of human subjects. We will monitor approved research to ascertain that human subjects are indeed protected.

All human or animal subjects research carried out must be reviewed and approved or determined exempt by the MREC prior to the involvement of human or animal subjects in research. Accordingly, the MREC has the responsibilities and authority of:

• Reviewing and approving, requiring modifications in (to secure approval), or disapprove initial and continuing reviews of all research activities;

• The authority to suspend or terminate approval of research that is not being conducted in accordance with the MREC’s requirements or that has been associated with unexpected serious harm to subjects.

• The MREC will report to the Vice president of the NRC any unanticipated problems involving risks to subjects and others or serious or continuing noncompliance by investigators.

2. Offer a balanced range of workshops courses and seminars to investigators and newly MREC candidates.

3. Conduct continuous medical educational training program to MREC members to keep them updated by the new controversial ethical research issues which will definitely add to them experience and performance.

4. Establish channels to communicate with community to increase the awareness of human subjects about their rights when participating in clinical research trials.

5. Enhance and promote the relationship between our MREC and other Peer MREC, investigators and research sponsors at the national and international level to standardize and update the concept and principles of tackling the controversial research ethical issues.

6. Establishing a data and safety monitoring board (DSMB) —as an independent group of experts who monitor patient safety and treatment efficacy data while a clinical trial is ongoing.