**2.1. Historical background**

The past 20 years have seen a considerable shift in the location of clinical drug trials sponsored by transnational pharmaceutical companies (TNCs) being conducted in low- and middle-income settings [1]. One of the primary obligations of the Declaration of Helsinki (DH) is to promote human well-being over the interest of science and society. According to DH, any medical study should provide every participant with the best proven diagnostic and therapeutic method [2]. The primary ethical commitment would be obtaining rapid, nonargued answers that may make researchers cross the line that forbids treating human subjects as a means to an end, leaving nothing to protect patients from underestimating their dignity, rights, and safety for the sake of research goals [3].

One of the great challenges in medical research is to conduct clinical trials in developing countries that benefit the citizens of these countries. After the textbook example of the unethical 40-year nontherapeutic study of 400 African American sharecroppers in "the Tuskegee Study of Untreated Syphilis" (TSUS), ethical concern stood on its head and led to the overhauling of federal guidelines for health research [4]. These reforms, however, do not extend to health studies conducted outside the United States [5].

Ethical review committees are present in developing countries in the form of research institutes or other scientific panels [6]. However, the reality is that these panels need to be independent and able to review clinical trials without prejudice. Also, the characteristics of many developing countries, which include population afflicted with life-threatening endemic diseases, poverty, and a low level of investment in health care systems, affect both the ease of performing trials and the selection of trials that can benefit the populations of the countries. Conflict of interest of physicians/researchers from developing countries is a detrimental factor in research bias. There are also some structural problems including the fact that operations of pharmaceutical research companies are not adequately controlled or authorities seem unwilling to address unethical drug testing [7].

There appears to be a general retreat from the clear principles enunciated in the Nuremberg Code and the DH as applied to research in the third world. Angell in 1997 wondered, "Why is that?!!" He attributed it to the differences in local standard of care or variation in diseases and their treatments in those regions, so that information gained in the industrialized world has no relevance making it a must to start from scratch [3].

#### **2.2. International situation in developing countries**

Many researches are driven by economic or academic interests that may or may not reflect the needs of the host country. One critic of such trials is the need to test new drugs for malaria, sleeping sickness, and Chagas disease that people in poor countries suffer from rather than on

There is also the delicate matter of double standards, which highlights the need to develop an ethical model for research and training partnerships between developed and developing countries employing an approach with long-term advantage for the latter or both partners at

The past 20 years have seen a considerable shift in the location of clinical drug trials sponsored by transnational pharmaceutical companies (TNCs) being conducted in low- and middle-income settings [1]. One of the primary obligations of the Declaration of Helsinki (DH) is to promote human well-being over the interest of science and society. According to DH, any medical study should provide every participant with the best proven diagnostic and therapeutic method [2]. The primary ethical commitment would be obtaining rapid, nonargued answers that may make researchers cross the line that forbids treating human subjects as a means to an end, leaving nothing to protect patients from underestimating their dignity,

One of the great challenges in medical research is to conduct clinical trials in developing countries that benefit the citizens of these countries. After the textbook example of the unethical 40-year nontherapeutic study of 400 African American sharecroppers in "the Tuskegee Study of Untreated Syphilis" (TSUS), ethical concern stood on its head and led to the overhauling of federal guidelines for health research [4]. These reforms, however, do not extend to health

Ethical review committees are present in developing countries in the form of research institutes or other scientific panels [6]. However, the reality is that these panels need to be independent and able to review clinical trials without prejudice. Also, the characteristics of many developing countries, which include population afflicted with life-threatening endemic diseases, poverty, and a low level of investment in health care systems, affect both the ease of performing trials and the selection of trials that can benefit the populations of the countries. Conflict of interest of physicians/researchers from developing countries is a detrimental factor in research bias. There are also some structural problems including the fact that operations of pharmaceutical research companies are not adequately controlled or authorities seem unwilling to

There appears to be a general retreat from the clear principles enunciated in the Nuremberg Code and the DH as applied to research in the third world. Angell in 1997 wondered, "Why

diseases of interest primarily to the developed nations.

rights, and safety for the sake of research goals [3].

studies conducted outside the United States [5].

address unethical drug testing [7].

**2. Realities of medical research in developing countries**

least in an equal manner.

40 International Development

**2.1. Historical background**

Indeed, the scale of the problem is unknown, because it cannot be estimated how many unethical clinical trials escape public attention and therefore remain unnoticed. Starting in 1996, TSUS-like scenario occurred in Pfizer's controversial Trovan clinical trials that took place in Kano over 200 persons, mostly children [8]. The new quinolone was tested without parents' informed consents; patients were unaware of the experiment and without an ethical review committee's approval of the trial in advance. Out of 190 children that were enrolled in the trial, five receiving the drug died while others suffered brain damage and paralysis. A panel of Nigerian medical experts reported that the trials had been illegal and exploitative and violated Nigerian law, the DH, and the UN Convention on the Rights of the Child. However, Pfizer denied that the drug trial was unethical [9].

One of the major examples of the Tuskegee-like trials in the third world is the regimens to prevent the vertical transmission of human immunodeficiency virus (HIV) [10]. According to CDC, 18 randomized, controlled trials of interventions to prevent perinatal HIV transmission were identified until 1997, 16 were conducted in developing countries in Côte d'Ivoire, Uganda, Tanzania, South Africa, Malawi, Thailand, Ethiopia, Burkina Faso, Zimbabwe, Kenya, and the Dominican Republic [11].

These trials involved a total of more than 17,000 women. In 15 of these trials, some or all of the patients were not provided with clearly effective zidovudine antiretroviral drug as they employ placebo-treated control groups. Failures to get patients' consent about changes in the experiment, administering wrong doses, serious problems in record keeping, delayed and underreporting of fatal and life-threatening problems, nondiscloser of thousands of side effects and adverse reactions, not following procedures for divulging Serious Adverse Events (SAEs), and destroying an early copy of the research reports are part of the violation of guidelines [10, 12].

Another same example was the dramatic Cariporide clinical trial applied in the Naval Hospital in Buenos Aires, Argentina to protect against heart damage after cardiac insult. Patients' consents were either faked or the patients did not know its contents. Thirteen patients died and at least three of them were considered murders. Data in medical records were changed and key documentation disappeared [13]. Although before 2005, the Schedule Y of the Indian Drug and Cosmetic Act prohibited clinical trials in India of drugs developed outside the country before Phase II trials were completed abroad, a review revealed that some illegal studies were conducted in 1999–2000. Phase III trials involving cilansetron, a new molecule of Solvay Pharmaceuticals for treatment for diarrhea from irritable bowel syndrome (IBS) [14], Pfizer's zoniporide trial that control perioperative cardiac events [15], nordihydroguaiaretic acid (NDGA) as treatment for oral cancer, and Otsuka's cilostazol trials for treatment of intermittent claudication were tested before the required animal experiments had been completed and serious adverse events were not reported [15, 16].

Between 2002 and 2006, the number of trials to compare antiretroviral standard continuous and intermittent therapies was conducted in Africa. The Development of Anti-Retroviral Therapy (DART) trial had recruited 3300 volunteers in Uganda and Zimbabwe [17]. Unfortunately, unethical trials continue to be conducted. One recent trial in India, reported in *The Lancet* in 2014, evaluated human-bovine (116E) vaccine for preventing a very common, potentially life-threatening viral infection "rotavirus" [18]. Two rotavirus vaccines have been available for the past decades that were proved to be highly effective in preventing rotavirus-induced gastroenteritis and the need for hospitalization. One of the unfair examples, despite the availability of these vaccines, more than 2000 children in the Indian trial received placebo injections of salt water rather than one of the available effective vaccines in a clinical trial funded by multiple private and government sources and enrolled approximately 6800 infants between 2011 and 2012 [18].

The central ethical question should be: why has not the successful intervention that is currently used as a matter of course in Western countries become the standard of care worldwide? Clinical trials have become a big business with many studies done in developing countries, as it is necessary to do quick work with minimal obstacles. Poverty and ignorance play a role in commercial industry like this. This does not suit the standards of the sponsoring countries and puts us not very far from Tuskegee even after more than 80 years [19]. This is a big concern for all of human race. Like Lurie and Wolfe [10], we need to redouble our commitment to the highest ethical standards, no matter where the research is conducted, and sponsoring agencies need to enforce those standards, not undercut them.

#### **2.3. The case of Egypt: strength versus weakness**

The contract research organization (CRO) Quintiles even recently advertised Russia, Turkey, and the Middle East and the Northern Africa MENA region as the "new darlings" in the world of biopharmaceutical sales [20]. According to the *ClinicalTrial.gov*, a service of the U.S. National Institute of Health (NIH), 1234 clinical trials were conducted in Egypt with the number of clinical trials nearly tripling between 2008 and 2011 making Egypt second only to South Africa on the African continent in terms of the number of TNC-sponsored studies [21, 22]. Based on the registry of clinical trials (CTs) in Egypt, treatment was the most common study purpose followed by prevention. Combined safety/efficacy was the most common endpoint followed by efficacy alone. For interventional studies, the most common intervention was drug use followed by procedure. The most common study phase was phase 3 followed phase 4 and phase 2. However, the output of the big number of health professionals and faculty members is definitely more than the registered studies, which, may be related to absence of Egyptian national trial registry and the national mandates for trial registration [23].

In February 2016, 21 international pharmaceutical and biotechnology companies were sponsoring active drug trials in Egypt. The two Swiss giants Novartis and Roche carried out the lion's share of trials. These trials took place at 131 sites spread over 9 cities in Egypt. Unsurprisingly, the majority was in Cairo (75), followed by Alexandria (31)—together accounting for about 81% of all sites. Over half of all international active drug studies in Egypt are cancer trials, followed far behind by infectious diseases (10%) and metabolic disorders (10%) [21].

An attractive research infrastructure, a fast-growing and largely treatment-naïve population, a mosaic panel of research areas, and incomparably low cost of living make Egypt among the most popular places in the MENA region for off-shoring medicine testing "pharmerging countries" [24]. Egypt has 41 universities and 94 health-related faculties and medical schools. There are 24 faculties of medicine with up to 34 departments in each faculty. There are more than 42,000 faculty members and 344,000 postgraduate students, 140,000 physicians, 18,200 dentists, 37,500 pharmacists, 176,000 nurses, and 35,000 physical therapists. Clinical research including clinical trials is an essential mandate for getting masters and doctorate degrees. Moreover, clinical research for publication is a mandate for promotion for faculty members according to the rules of the supreme council of Egyptian universities [23].

Between 2002 and 2006, the number of trials to compare antiretroviral standard continuous and intermittent therapies was conducted in Africa. The Development of Anti-Retroviral Therapy (DART) trial had recruited 3300 volunteers in Uganda and Zimbabwe [17]. Unfortunately, unethical trials continue to be conducted. One recent trial in India, reported in *The Lancet* in 2014, evaluated human-bovine (116E) vaccine for preventing a very common, potentially life-threatening viral infection "rotavirus" [18]. Two rotavirus vaccines have been available for the past decades that were proved to be highly effective in preventing rotavirus-induced gastroenteritis and the need for hospitalization. One of the unfair examples, despite the availability of these vaccines, more than 2000 children in the Indian trial received placebo injections of salt water rather than one of the available effective vaccines in a clinical trial funded by multiple private and government sources and enrolled approximately 6800 infants between 2011 and 2012 [18]. The central ethical question should be: why has not the successful intervention that is currently used as a matter of course in Western countries become the standard of care worldwide? Clinical trials have become a big business with many studies done in developing countries, as it is necessary to do quick work with minimal obstacles. Poverty and ignorance play a role in commercial industry like this. This does not suit the standards of the sponsoring countries and puts us not very far from Tuskegee even after more than 80 years [19]. This is a big concern for all of human race. Like Lurie and Wolfe [10], we need to redouble our commitment to the highest ethical standards, no matter where the research is conducted, and sponsoring

The contract research organization (CRO) Quintiles even recently advertised Russia, Turkey, and the Middle East and the Northern Africa MENA region as the "new darlings" in the world of biopharmaceutical sales [20]. According to the *ClinicalTrial.gov*, a service of the U.S. National Institute of Health (NIH), 1234 clinical trials were conducted in Egypt with the number of clinical trials nearly tripling between 2008 and 2011 making Egypt second only to South Africa on the African continent in terms of the number of TNC-sponsored studies [21, 22]. Based on the registry of clinical trials (CTs) in Egypt, treatment was the most common study purpose followed by prevention. Combined safety/efficacy was the most common endpoint followed by efficacy alone. For interventional studies, the most common intervention was drug use followed by procedure. The most common study phase was phase 3 followed phase 4 and phase 2. However, the output of the big number of health professionals and faculty members is definitely more than the registered studies, which, may be related to absence of Egyptian national trial registry and the national mandates for

In February 2016, 21 international pharmaceutical and biotechnology companies were sponsoring active drug trials in Egypt. The two Swiss giants Novartis and Roche carried out the lion's share of trials. These trials took place at 131 sites spread over 9 cities in Egypt. Unsurprisingly, the majority was in Cairo (75), followed by Alexandria (31)—together accounting for about 81% of all sites. Over half of all international active drug studies in Egypt are cancer trials, fol-

lowed far behind by infectious diseases (10%) and metabolic disorders (10%) [21].

agencies need to enforce those standards, not undercut them.

**2.3. The case of Egypt: strength versus weakness**

trial registration [23].

42 International Development

According to the Professional Ethics Regulations issued by the Ministry of Health (MOH) No. 238/2003, part four: "conducting medical research and experiments on human beings, any experiments for drugs and techniques on human beings prior to being endorsed by the competent quarters and acquiring a detailed study of the risks/benefits relationship are prohibited." The volunteers must comply in a clear way of the targets of the research, the research approaches, the benefits expected, the probable risks, and the extent of their effect on them with official written consent and/or approval of the official guardian or curator in the presence of a prosecution witness. The volunteers have the right to cease or withdraw from the research without sustaining any negative consequences. The researcher is required to submit a detailed and clear research targets report with justifications for conducting it on human beings to the approving authority for approval [25]. The same meaning was maintained in Law 71/2009 and a new draft law of 2014 [26, 27]. However, this draft caused much public concern because it contained an article allowing trials on children, pregnant women, drug addicts, detainees, and psychiatric patients. According to critics, it would have paved the way to experimentation of medicines on vulnerable people. Thus, this law has never seen the light of day [27].

The researcher is expected to discontinue any experiments on human beings if the accompanying risks exceed the benefits expected of the research and ensuring all preventive, diagnostic, and therapeutic methods for each patient for conducting the study. The draft of the national law on clinical trials driven from the constitution of Egypt that was leaked to the media in 2014 tried to lift those safeguards [27].

Besides these regulations, more than 56 RECs and Institutional Review Board (IRB) registered were designed in many health-related faculties, foundations, and institutes in Alexandria, Assuit, Aswan, BeniSuif, Benha, Fayoum, Giza, Ismailia, Mansoura, Minia, Sohag, Tanta, and Zagazig. Egyptian Network of Research Ethics Committees (ENREC) was created in 2008 to raise the harmonization between Research Ethics Committees, facilitate more uniform ethical review, and simplify REC procedures and standards [6].

Since there is no robust legislative constraints and clear guidance to charge entities or stakeholders involved in overseeing or executing clinical trials, concerns are increasingly being raised, whether ethical pitfalls of clinical research are adequately addressed, and whether the safety and the rights of subjects are constantly prioritized and maintained, leaving room for different interpretations and making it more difficult to identify violations and impose sanctions [28, 29]. Unlike other emerging countries, Egypt does not make it obligatory to have clinical trials conducted on their population before marketing approval is granted [30]. Moreover, there are concerns that RECs in Egypt may not be able to provide high standards of human subjects' protection due to its inadequate functioning ethics review system and reluctance of the national regulations and bureaucracy that occurs when they interact with the MOH [22, 31].

An extensive review carried out by multiorganizations, published in June 2016 and based on United Nation International Aid Program (UNIAID), Egyptian experts and clinical trial participants' interviewee and various media reports, many critics were assumed. Although they admit that the current requirements of Egypt's regulatory authorities that no clinical trial sponsored by a TNC can be conducted in Egypt unless the product being tested has been granted market approval in the originating country with several Egyptian experts interviewed during this research confirmed this prerequisite, they pointed to the absence of regulatory obligation to conduct clinical trials in the country before being able to request a license for the drug. This "conditional approval" may happen based on medical grounds such as genetic or disease specificities prevailing in Egypt [22].

Of the 57 international drug trials that were active in Egypt in February 2016, Declaration of Helsinki concluded that the vast majority are late-stage clinical trials related to products already licensed in high-income countries. However, 16% are Phase I and Phase II trials, raising ethical issues as to the relevance and benefit of these trials for the Egyptian population since tests on these medical products were completed elsewhere for marketing approval in a high-income country. These include cancer trials testing medicines that were not yet registered in high-income countries, off-label use, had no specific protection mechanism for vulnerable participants, and no posttrial treatment access mechanisms. International experts raised doubts about the scientific validity of the designs of several of these cancer trials [32].


for its opacity. The "Sovaldi deal" generated diverging opinions among Egyptian experts as to whether the state-subsidized free treatment program is, in fact, a disguised clinical trial of national scale [36]. Given the absence of patent protection, several Egyptian companies were able to produce generic versions of DAAs for the market [32].

Ethics in health research is a collective consciousness and concerns of researchers, institutes, funders, medical journals' editors, regulatory agencies, and others. Ethical approval by one of these entities does not relieve others from responsibility. Egyptian authorities should develop a single, robust legislative framework with a functional independent control system that takes the DH and the Council for International Organizations of Medical Research (CIOMS) Guidelines as their reference point for ethical standards. Egyptian authorities should also create an online, regularly updated public registry of clinical trials conducted in Egypt. Ensuring access to information must be guaranteed, as it is a fundamental prerequisite to enable civil society to play its role in signaling, observing, auditing, and unveiling unethical clinical trials practices.

#### **2.4. Tanta Faculty of Medicine model experience**

University hospitals have their own in-house IRBs, which provide training to medical doctors and researchers participating in clinical trials. The only mechanism available to protect participants is the REC in the MOH, in the research centers, and in university hospitals [37].

To develop an educational and medical research policy in Tanta Faculty of Medicine, we plan the following standards to be on the track of international standards.

## *2.4.1. Research Ethics Committee*

Research Ethics Committee (REC) plays a central role of ethical oversight of research involving humans or animals in our organization. REC reviews research proposals involving human or animal participants to ensure that they are ethically acceptable and in accordance with relevant standards and guidelines. Our REC includes institutional review board members and was organized and approved at the Faculty and University levels in June 2010.

In undertaking this role, REC is guided by relevant standards, which include those in the *International Statement on Ethical Conduct in Human Research* issued by CIOMS and WHO [38, 39]. Consequently, this Statement identifies the demands, principles, and values by which research should be designed and applied and to which HREC should refer when reviewing research proposals.

It also sets up requirements and responsibilities for:


different interpretations and making it more difficult to identify violations and impose sanctions [28, 29]. Unlike other emerging countries, Egypt does not make it obligatory to have clinical trials conducted on their population before marketing approval is granted [30]. Moreover, there are concerns that RECs in Egypt may not be able to provide high standards of human subjects' protection due to its inadequate functioning ethics review system and reluctance of the national regulations and bureaucracy that occurs when they interact with the MOH [22, 31]. An extensive review carried out by multiorganizations, published in June 2016 and based on United Nation International Aid Program (UNIAID), Egyptian experts and clinical trial participants' interviewee and various media reports, many critics were assumed. Although they admit that the current requirements of Egypt's regulatory authorities that no clinical trial sponsored by a TNC can be conducted in Egypt unless the product being tested has been granted market approval in the originating country with several Egyptian experts interviewed during this research confirmed this prerequisite, they pointed to the absence of regulatory obligation to conduct clinical trials in the country before being able to request a license for the drug. This "conditional approval" may happen based on medical grounds such as

Of the 57 international drug trials that were active in Egypt in February 2016, Declaration of Helsinki concluded that the vast majority are late-stage clinical trials related to products already licensed in high-income countries. However, 16% are Phase I and Phase II trials, raising ethical issues as to the relevance and benefit of these trials for the Egyptian population since tests on these medical products were completed elsewhere for marketing approval in a high-income country. These include cancer trials testing medicines that were not yet registered in high-income countries, off-label use, had no specific protection mechanism for vulnerable participants, and no posttrial treatment access mechanisms. International experts raised doubts about the scientific validity of the designs of several of

• Kotb in 2012 recounts an incident that was under official investigation. The trials used drug ursofalk (ursodeoxycholic acid) that was conducted on children at one of Cairo University's hospitals, providing evidence that only 9% of the children improved while most of the cohort receiving treatment developed hepatic failure, lethal pneumonia, otitis media,

• According to the Declaration of Helsinki Study, cancer trials described in Egypt were considered to be the clearest illustration of the vulnerability of trial participants and the profound inequality of their situation compared to cancer patients in wealthier nations. Due to the high prices of cancer treatments, experimental drugs may be the only medication that Egyptian cancer patient will receive. As such, they run an unknown risk of experiencing

• Egypt has the highest prevalence of viral hepatitis C in the world and was the first low- or middle-income country in 2014 to negotiate preferential pricing for the new direct acting antiviral (DAA) treatment sofosbuvir (Sovaldi) with manufacturer Gileadc [35]. However, the deal (US\$ 300 per month of treatment instead of US\$ 84,000 in the U.S.) was criticized

genetic or disease specificities prevailing in Egypt [22].

and ascites with high incidence of death was uncovered [33].

serious side effects while already suffering a serious disease [34].

these cancer trials [32].

44 International Development

(1) Considering and reaching decisions regarding these proposals and in monitoring the conduct of approved research plus to monitor and reporting any scientific misconduct.


#### *2.4.2. Research plan*

In general, the educational mission of the Faculties of Medicine is fortified by a highly successful research enterprise that includes widely varied scientific fields such as basic molecular and cellular biology and population health as well as hospital and community applied clinical researches.

Our institution's goal was to develop a plan to support research excellence in strategic areas, train the next generation of health researchers, and facilitate the translation of new knowledge into beneficial health outcomes for the patients, the population, and policy makers. Our Faculty has developed and established a strategic research plan in 2010. This plan was reviewed and modified according to Tanta University research plan and updated the paths proposed by the Ministry of Higher Education, then reapproved in June 2015. These plans are the outcome of an institutional planning committee after extensive consultation with all faculty departments.

#### **2.5. The settled research priorities and guidelines of the ongoing plan are**

Nine health-related areas of high priority were chosen guided by the international standards and based on the approved research plan of our university, mission, and vision of our faculty, needs assessment of the community at local, national and regional levels, interests and specialties of our staff members, available research resources including that supplied by scientific and health organizations with mutual interest, and the updates in science and medicine [40].

These research priorities are:


(6) Geriatric diseases.

(2) Developing awareness and teaching the ethics of scientific research for the faculty post-

(3) Cooperation with the ethics committees of scientific research counterparts in Egypt, the

In general, the educational mission of the Faculties of Medicine is fortified by a highly successful research enterprise that includes widely varied scientific fields such as basic molecular and cellular biology and population health as well as hospital and community applied clinical

Our institution's goal was to develop a plan to support research excellence in strategic areas, train the next generation of health researchers, and facilitate the translation of new knowledge into beneficial health outcomes for the patients, the population, and policy makers. Our Faculty has developed and established a strategic research plan in 2010. This plan was reviewed and modified according to Tanta University research plan and updated the paths proposed by the Ministry of Higher Education, then reapproved in June 2015. These plans are the outcome of an institutional planning committee after extensive consultation with all

Nine health-related areas of high priority were chosen guided by the international standards and based on the approved research plan of our university, mission, and vision of our faculty, needs assessment of the community at local, national and regional levels, interests and specialties of our staff members, available research resources including that supplied by scientific and health organizations with mutual interest, and the updates in science and medi-

(1) Cancer research: to foster basic as well as clinical research in the field of early diagnosis,

(2) Emerging national health problems: The epidemiology, health effects, prevention, and eradication of emerging national health problems, e.g., hepatitis, H1N1, parasitic, and

(5) Immunogenetic diseases: our vision is to implement research in biotechnology.

**2.5. The settled research priorities and guidelines of the ongoing plan are**

graduate and undergraduate students.

Arab, and foreign countries.

*2.4.2. Research plan*

46 International Development

faculty departments.

These research priorities are:

recent treatment modalities, and prevention.

(3) Organ transplantation and artificial prostheses.

(4) Obesity researches: causes, treatment, and prevention.

endemic diseases in our country.

cine [40].

researches.


Our REC has reviewed 2823 research protocols and project proposals in the last 6 years up to July 31, 2016. Note that 1705 proposals (60.4%) were accepted while 1118 (39.6%) needed modifications with rejection rate of 18% after corrections. The activity of REC has significant impact on our research. In 2011, Tanta Faculty of Medicine had about 140 international publication cited on PubMed, this number reached 616 at the beginning of 2016 with almost threefold increase in 5 years. Additionally, in an attempt to strengthen medical research, we established our official medical journal (Tanta Med J) as an online peer-reviewed journal published by Wolters Kluwer—Medknow. Since January 30, 2014, more than 200 articles were published in it apart from those cited in PubMed.

The REC committee has members from academic and clinical medical departments. They are selected based on their experience in different medical fields and their reputation for a term of 3 years. To insure its independence, our Faculty Dean and Vice deans were excluded from the committee board. The committee members also included representatives of the community: professor in Islamic religion, representative of the Orthodox Church, governor (or his representative), certified trainer in research ethics, certified trainer in human rights, and a judge as representative of the legal authority. Clear regulations were approved to support the committee's role. The number of the committee members range from 5 to 15 according to its regulations (in the current term there are 13 members), they meet on a monthly basis to discuss research proposals and to follow-up on approved projects. The committee pays members a very small incentive for each meeting and there are no fees charged for protocol review. IRBs face numerous obstacles to achieving their goals, as there is no law in Egypt that regulates the selection of members of IRBs. Other problems include budget constraints, inability to monitor approved protocols continuously, and a lack of national guidelines and accreditation mechanisms for IRBs. These points are our future concern to improve the performance of REC.
